Determining the oxygenation level of one or more cells

Abstract

One embodiment of a cellular oxygenation monitoring system includes a probe and a base. The probe is connectable to the base and configured to direct electromagnetic energy having a wavelength in a range of about 400 nm to 900 nm into a body having at least one cell and configured to receive a portion of the electromagnetic energy redirected by the body over a period of time. The base includes a generator configured to generate electromagnetic energy over the period of time and a computing circuit configured to determine an oxygenation level of one or more of the at least one cell in response to the portion of the redirected electromagnetic energy.

Description

[Technical field]

[0001] Related Patents

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 176,014, filed April 16, 2021, the contents of which are incorporated herein by reference in their entirety.

[0002]

[0002] This patent application discloses improvements and other differences to the subject matter described in U.S. Patent No. 9,951,999, entitled "DETERMINATION OF TISSUE OXYGENATION IN VIVO," filed on May 2, 2013, and issued on March 14, 2017, and U.S. Patent No. 10,463,286, entitled "DETERMINATION OF TISSUE OXYGENATION IN VIVO," filed on February 10, 2017, and issued on November 5, 2019, which are incorporated herein by reference.

[0003] overview

[0003] According to one or more embodiments, systems for determining and monitoring oxygenation levels in one or more cells forming one or more tissues of the body, components of such systems, methods of using such systems, and methods of training machine learning algorithms executed by such systems are described. [Background technology]

[0004]

[0004] Lack of oxygen to one or more vital organs is a complication that emergency medical specialists (EMS) or critical care specialists (CCS) (e.g., emergency room (ER) physicians, trauma surgeons) attempt to prevent and, if present, reverse, for example, in patients who are seriously ill (e.g., have an infection, have had a heart attack) or seriously injured (have one or more fractures, are internally bleeding, are in shock).

[0005]

[0005] Fortunately, there are many effective treatments that EMS or CCS can provide to patients who are lacking oxygen to one or more vital organs.

[0006]

[0006] However, the key to EMS or CCS having a high success rate in treating such patients is for the EMS or CCS to know with reasonable certainty, within a reasonable amount of time, whether the patient's vital organs are receiving sufficient oxygen.

[0007]

[0007] Unfortunately, currently available medical equipment and techniques often cannot determine with a sufficient level of accuracy and in sufficient time whether a patient's vital organs are adequately oxygenated. That is, by the time currently available medical equipment and techniques determine that a patient's vital organs are not adequately oxygenated, the organs are often deprived of oxygen for an extended period of time, after which it is too late for EMS or CCS to save the patient's life or prevent the patient's organ dysfunction or failure.

[0008]

[0008] Thus, if EMS or CCS, which rely on currently available medical equipment and technology, delays treatment until it is reasonably certain that one or more of the patient's vital organs are not adequately oxygenated, it runs the risk of depriving one or more of oxygen for an extended period of time that would render treatment ineffective at re-oxygenating the organ or organs, at least in time to prevent the patient from suffering serious permanent injury or death.

[0009]

[0009] Conversely, if EMS or CCS, knowingly unaware of the shortages of currently available medical equipment and techniques, decides not to delay treatment until it is reasonably certain that one or more of the patient's vital organs are not adequately oxygenated, it runs the risk that the patient's vital organs will not be adequately oxygenated and that the treatment itself will therefore cause serious illness or injury to the patient in addition to the illness or injury that led the patient to be treated by EMS or CCS in the first place.

[0010]

[0010] As a result, EMS or CCS, which rely on currently available medical equipment and techniques to determine whether one or more of a patient's vital organs are not adequately oxygenated, are often faced with a life-or-death conundrum. If EMS or CCS wait to treat a patient until they are reasonably certain that one or more of the patient's vital organs are not adequately oxygenated, they run the risk that the patient will suffer permanent injury or even die because they did not begin treatment soon enough. However, if EMS or CCS treat a patient before they are reasonably certain that one or more of the patient's vital organs are not adequately oxygenated, they run the risk that the patient will suffer unnecessary and significant further harm.

[0011]

[0011] A pulse oximeter is an example of a currently available medical device (usually worn on the patient's finger) that measures the oxygenation level, often referred to as "oxygen saturation," of a patient's arterial blood. For example, a blood oxygen saturation level of 85% means that the patient's blood is carrying enough oxygen such that 85% of the hemoglobin in the arterial blood is bound to oxygen. The healthy range for blood oxygen saturation levels in human blood is typically 98% or higher.

[0012]

[0012] Although a low level of blood oxygen saturation is, in itself, a good indication that one or more of the subject's vital organs will soon have or already have insufficient levels of cellular oxygenation, the opposite is not true. That is, a normal level of blood oxygen saturation is, in itself, not a good indicator that one or more of the subject's vital organs are at a sufficient level of cellular oxygenation and are not starved of oxygen. One reason why a normal level of blood oxygen saturation may not, in itself, be a reliable indicator that all of the subject's vital organs are adequately oxygenated is because there may be times when the subject's respiratory system adequately oxygenates the subject's blood, but the subject's circulatory system does not supply a sufficient amount of oxygenated blood to one or more of the vital organs. For example, the arteries or capillaries that supply blood to the vital organs, or the veins or capillaries that drain blood from the vital organs, may be severed, blocked or otherwise restricted or otherwise damaged, thus starving the organ of oxygenated blood.

[0013]

[0013] Yet another problem with currently available medical devices and techniques for determining and indicating blood oxygen saturation levels is that the determined and indicated blood oxygen saturation levels can exhibit significant errors caused by bias of the device or technique toward patients having or exhibiting particular traits.

[0014]

[0014] For example, researchers have recently discovered that at least some pulse oximeters exhibit racial bias in their blood oxygen saturation level measurements, a bias that may disadvantage black patients. Researchers have discovered that at least some pulse oximeters produce blood oxygen saturation readings for black patients that are significantly higher (e.g., up to 8 percentage points higher) than the black patient's actual blood oxygen saturation level. MW Sjoding, RP Dickson, TJ Iwashyna, SE Gay, TS Valley, “Racial Bias in Pulse Oximetry Measurement,” N. Engl. J. Med. 2020, 383(25): 2477-2478, incorporated by reference. As an example, a pulse oximeter may indicate that a black patient has a blood oxygen saturation level of 90% when the black patient's actual blood oxygen saturation level is 82%. As a result, EMS or CCS may delay treatment of a black patient based on an erroneous pulse oximeter reading that indicates the black patient's blood oxygen saturation level is higher than it actually is, and this delay may result in the black patient suffering serious additional illness or injury, or even death of the black patient.

[0015]

[0015] Fortunately, however, it is well known that when a mammalian body is unable to adequately oxygenate all of its tissues, the body will prioritize supplying oxygen to organs over skeletal muscles.

[0016]

[0016] It therefore follows (and has been demonstrated) that the level of oxygenation in muscle cells (e.g., the level of "cellular oxygenation" or "oxygenation" in muscle cells can be defined as the level of "myoglobin oxygen saturation" in muscle cells) can itself be a reliable indicator of whether one or more vital organs will become or are already not adequately oxygenated. As mentioned above, a body that is unable to oxygenate all of its tissues will properly direct blood flow away from skeletal muscle to the vital organs, i.e., prioritize blood flow to the vital organs over skeletal muscle. Thus, a normal level of oxygenation in skeletal muscle cells can reliably indicate that the body is not directing blood flow away from skeletal muscle (at least for a significant length of time) and thus the vital organs are not adequately oxygenated. In contrast, in the absence of injury that restricts blood flow to a particular skeletal muscle but does not reduce blood flow to vital organs, below normal levels of oxygenation in the cells of that particular skeletal muscle can reliably indicate that the body has redirected blood flow away from the skeletal muscle or that there has otherwise been a systemic oxygen deficiency condition affecting the vital organs and skeletal muscle, and thus that at least one vital organ is not receiving an adequate blood supply or others are not being adequately oxygenated. Summary of the Invention [Problem to be solved by the invention]

[0017]

[0017] As a result, a need has arisen for a system configured to measure, determine, monitor, and indicate oxygenation levels in one or more tissues (e.g., skeletal muscle tissue) of a subject's body, and to do so with little or no subject bias or other error due to or otherwise related to, for example, the subject's race (e.g., skin color), age, biological sex, or body mass index (BMI). [Means for solving the problem]

[0018]

[0018] One embodiment of a system for determining, monitoring, and indicating an oxygenation level in one or more cells of skeletal muscle tissue with little or no subject bias includes a probe and a base. The probe is connectable to the base and configured to direct electromagnetic energy into a body having at least one cell, and configured to receive a portion of the electromagnetic energy redirected by the body during a period of time. The base includes a generator configured to generate electromagnetic energy during the period of time, and a computing circuit configured to determine an oxygenation level (e.g., a myoglobin oxygen saturation level) of one or more of the at least one cell in response to the portion of the redirected electromagnetic energy. For example, the system is configurable or may be configured to determine, monitor, and indicate (or otherwise indicate or provide) an oxygenation level of one or more cells of skeletal muscle tissue in the thenar of a human hand.

[0019]

[0019] One embodiment of a probe of such a system includes a head, at least one collection optical fiber, at least one first illumination optical fiber, and at least one second illumination optical fiber, and a connector. The head is fixable to a body having at least one cell, and each of the at least one collection optical fiber has a respective collection end disposed on the head. Each of the at least one first illumination optical fiber has a respective first illumination end disposed on the head at approximately a first distance from the collection end of at least one of the at least one collection optical fiber, and each of the at least one second illumination optical fiber has a respective second illumination end disposed on the head at approximately a second distance from the collection end. Also, the connector is configured to couple the opposing ends of the at least one collection optical fiber, the at least one first illumination optical fiber, and the at least one second illumination optical fiber to a base configured to determine an oxygenation level (e.g., a myoglobin oxygen saturation level) of the at least one cell.

[0020]

[0020] One embodiment of the base of such a system includes a generator and a computing circuit. The generator is configured to provide electromagnetic energy to a probe configurable to direct the electromagnetic energy into a body having at least one cell, and to collect a portion of the electromagnetic energy redirected by the body over a period of time during which the generator provides the electromagnetic energy. The computing circuit is also configured to determine an oxygenation level (e.g., a myoglobin oxygen saturation level) of one or more of the at least one cell in response to the portion of the redirected electromagnetic energy.

[0021]

[0021] One embodiment of a method for indicating an oxygenation level (e.g., a myoglobin oxygen saturation level) includes generating electromagnetic energy during an oxygenation determination time and determining an oxygenation level of one or more of at least one cell in response to a portion of the electromagnetic energy redirected by a body having the at least one cell during that time.

[0022]

[0022] Additionally, an embodiment for generating data for training a machine learning algorithm performed or otherwise used by such a system or used in conjunction with such a method includes oxygenating cells in the body part, inducing ischemia in the body part, restoring normal blood flow to the body part, directing electromagnetic energy to the body part for each of at least one period of time between the oxygenating, inducing and returning, and for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the body part, generating a respective value of a characteristic of the at least one wavelength range during each of at least one first period of time, and storing the at least one respective value. [Brief description of the drawings]

[0023] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1]2 is a plot of electromagnetic energy absorbance of oxymyoglobin, deoxymyoglobin, oxyhemoglobin, and deoxyhemoglobin versus wavelength, and an expanded view of the plot in the range of 700 nanometers (nm) to 800 nm, according to one embodiment. [Diagram 2]

[0024] FIG. 1 is a block diagram of a system configured to determine, monitor, and indicate oxygenation levels in one or more cells of one or more tissues of the body, according to one embodiment. [Figure 3A]

[0025] FIG. 3 is an isometric view of the system of FIG. 2, according to one embodiment. [Figure 3B]

[0026] FIG. 3 is an isometric view of the system of FIG. 2 according to another embodiment. [Figure 4A]

[0027] 3 is a partially transparent top view of the umbilical cord and head of the probe of FIG. 2 in accordance with one embodiment. [Figure 4B]

[0028] FIG. 3C is a perspective view of the mounting portion of the probe of FIGS. 2 and 3B attached to the ball of a subject's hand, according to another embodiment. [Figure 4C]

[0029] 4B is a perspective view of the probe head of FIGS. 2 and 3B secured to the mounting portion of FIG. 4B according to one embodiment. [Figure 4D]

[0030] FIG. 5 is a perspective view of a calibrator mounted on the probe head of FIGS. 2, 3B, and 4C in accordance with one embodiment. [Diagram 5]

[0031] 3 is a flow diagram of a method of using and operation of the system of FIG. 2, according to one embodiment. [Figure 6]

[0032] FIG. 4 is a partially transparent, partially cut-away plan view of an array of light emitting diodes (LEDs) and a probe connector receptacle of the base of FIGS. 2-3B and the probe connector of the probe of FIGS. 2-3B, according to one embodiment. [Figure 7]

[0033] FIG. 7 is a bottom view of the probe connector of FIGS. 3A, 3B, and 6 according to one embodiment. [Figure 8]

[0034] FIG. 8 is a rear end view of the probe connector of FIGS. 3A, 3B, 6 and 7 according to one embodiment. [Figure 9]

[0035] FIG. 9 is a top view of the probe connector of FIGS. 3A, 3B, 6, 7 and 8 according to one embodiment. [Figure 10]

[0036] FIG. 10 is a front end view of the probe connector of FIGS. 3A, 3B, 6, 7, 8 and 9 according to one embodiment. [Figure 11]

[0037] FIG. 7 is a side view of the electromagnetic energy shield of FIG. 6, according to one embodiment. [Figure 12]

[0038] FIG. 11 is an isometric view of a close-up of a portion of a section of the front end of the probe connector of FIGS. 6, 7, 8, 9, and 10, in accordance with one embodiment. [Figure 13]

[0039] FIG. 13 is a cutaway side view of the probe connector receptacle of FIG. 2 without a probe connector installed and a clamping mechanism for holding the probe connectors of FIGS. 3A, 3B, 6, 7, 8, 9, and 10 in the probe connector receptacle and releasing the probe connector, according to one embodiment. [Figure 14]

[0040] FIG. 14 is a cutaway side view of the probe connector receptacle and clamping mechanism of FIG. 13 with the probe connector installed and retained within the receptacle, according to one embodiment. [Figure 15]

[0041] FIG. 15 is a top view of a portion of the probe connector of FIGS. 3A, 3B, 7, 8, 9, 10, and 14, with kinematic contact areas labeled, according to one embodiment. [Figure 16]

[0042] 3 is a portion of a flow diagram of a method for collecting training data and using the training data to train a machine learning cellular oxygen saturation level determination algorithm that the base of FIG. 2 is configured to execute, according to one embodiment. [Figure 17]

[0042] FIG. 3 is a portion of a flow diagram of a method for collecting training data and using the training data to train a machine learning cellular oxygen saturation level determination algorithm that the base of FIG. 2 is configured to execute, according to one embodiment. [Figure 18]

[0042] FIG. 3 is a portion of a flow diagram of a method for collecting training data and using the training data to train a machine learning cellular oxygen saturation level determination algorithm that the base of FIG. 2 is configured to execute, according to one embodiment. [Figure 19]

[0043] FIG. 13 is a diagram of a mounting member not attached to a probe head, according to one embodiment. [Figure 20]

[0044] FIG. 20 is a diagram of the mounting member of FIG. 19 secured to the ball of a human hand, according to one embodiment. [Figure 21]

[0045] FIG. 21 is a diagram of the mounting member of FIGS. 19 and 20 attached to a probe head while being fixed to the ball of a human hand, according to one embodiment. [Figure 22]

[0046] 22 is a diagram of the mounting member of FIGS. 19-21 with a protective film placed over the mounting member, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Detailed Description

[0047] Unless otherwise indicated, in this specification, each value, amount, or attribute preceded by "substantially," "approximately," "about," forms or derivatives thereof, or similar terms, includes a range that includes the value, amount, or attribute by ±20% of that value, amount, or attribute, or a range that includes a maximum difference of ±20% from that value, amount, or attribute, or a difference of ±20% between the range endpoints. For example, a range of "about" b to c is a range of b-20% x (cb) to c+20% x (cb). Furthermore, the terms "a," "an," and "the" can refer to one or more of the object they modify.

[0025]

[0048] FIG. 1 shows a superimposition of plots 1000, 1002, 1004, and 1006 of electromagnetic energy absorbance for oxyhemoglobin, deoxyhemoglobin, oxymyoglobin, and deoxymyoglobin, respectively, over wavelengths ranging from approximately 500 nm to 800 nm, including a close-up 1008 of the plots ranging from approximately 700 nm to 800 nm, according to one embodiment.

[0026]

[0049] Hemoglobin is a metalloprotein in the red blood cells of all vertebrates. The function of hemoglobin is to transport oxygen in mammalian (e.g., human) blood, and the electromagnetic energy absorbance of hemoglobin while saturated with oxygen molecules (i.e., while carrying one or more oxygen atoms or while bound to an oxygen atom) is significantly different from the electromagnetic energy absorbance of hemoglobin while devoid of oxygen molecules (i.e., not carrying at least one oxygen atom or not bound to an oxygen atom). Oxygen-saturated hemoglobin is called "oxyhemoglobin" and hemoglobin without bound oxygen is called "deoxyhemoglobin".

[0027]

[0050] As described above, a pulse oximeter can measure or otherwise determine the overall oxygen saturation level of total hemoglobin in arterial blood by irradiating a blood vessel of a subject with electromagnetic energy (e.g., through the skin of a finger), measuring the magnitude of two wavelengths (e.g., 660 nm and 940 nm) of electromagnetic energy redirected by the blood vessel, effectively comparing the measured magnitude to the magnitudes of plots 1000 and 1002 at the measured wavelengths, and calculating in a conventional manner the oxygen saturation of the total hemoglobin in the blood equal to [oxyhemoglobin] / ([oxyhemoglobin]+[deoxyhemoglobin])%.

[0028]

[0051] Because a pulse oximeter is typically placed in an area of ​​the subject's body that has little or no muscle and therefore little or no myoglobin (e.g., the fingertip), even though the electromagnetic absorbance spectra of oxyhemoglobin and oxymyoglobin are similar, as are the electromagnetic absorbance spectra of deoxyhemoglobin and deoxymyoglobin, absorption of redirected electromagnetic energy by oxymyoglobin or deoxymyoglobin has little effect on the determination of blood oxygen saturation levels by the pulse oximeter.

[0029]

[0052] Myoglobin, distantly related to hemoglobin, is an iron- and oxygen-binding protein commonly found in vertebrate skeletal muscle cells in nearly all mammals, and like hemoglobin, myoglobin has a significantly different electromagnetic energy absorbance while saturated with oxygen molecules (i.e., carrying one or more oxygen atoms or bound to oxygen atoms) than while devoid of oxygen molecules (i.e., not carrying at least one oxygen atom or not bound to oxygen atoms). Oxygen-saturated myoglobin is referred to as "oxymyoglobin" and myoglobin without bound oxygen is referred to as "deoxymyoglobin."

[0030]

[0053] Although the physiological function of myoglobin has yet to be conclusively established, it is hypothesized that myoglobin transports at least some oxygen within skeletal muscle cells and stores oxygen within the muscle cells.

[0031]

[0054] As discussed above, it has also been found that low or near zero oxygen saturation levels in skeletal muscle cells, resulting from low or near zero levels of oxymyoglobin in the same tissue, may indicate that the subject's body is redirecting available oxygen from the skeletal muscles to the vital organs or that the subject is otherwise in or in a state of physical shock due to a life-threatening illness or injury, resulting in a state of systemic oxygen deficiency affecting the vital organs and skeletal muscles.

[0032]

[0055] Because the absorbance spectra of oxyhemoglobin and oxymyoglobin and deoxyhemoglobin and deoxymyoglobin are similar, measuring or otherwise determining the oxygen saturation level of myoglobin has been more challenging than measuring or otherwise determining the oxygen saturation level of blood in muscle and tissues that do not have myoglobin (e.g., fingers).

[0033]

[0056] Fortunately, as described below, one embodiment of a system is configured to measure or otherwise determine oxygen saturation levels in tissue, such as skeletal muscle tissue, by taking advantage of the relatively slight differences between the electromagnetic absorbance spectra of oxyhemoglobin and oxymyoglobin, and deoxyhemoglobin and deoxymyoglobin, respectively, in the range of approximately 400 nm to 900 nm.

[0034]

[0057] FIG. 2 is a block diagram of a system 2000 configured to determine, monitor, and indicate oxygenation levels in one or more cells of one or more tissues of a subject's (e.g., a human or other mammal) body (not shown in FIG. 2 ), according to one embodiment.

[0035]

[0058] The cellular oxygenation level determination and monitoring system 2000 includes a probe (also referred to as a probe unit, probe assembly, or probe apparatus) 2002 and a base (also referred to as a base unit, base assembly, base apparatus, or base device) 2004.

[0036]

[0059] The probe 2002 is configured to receive electromagnetic energy generated by the base 2004, irradiate tissue within the subject's body with the received electromagnetic energy, receive, e.g., collect, a portion of the electromagnetic energy redirected by one or more cells forming the tissue, and return a collected portion of the redirected electromagnetic energy to the base. For example, the probe 2002 can be attached to the ball of a human hand and configured to irradiate the ball of the hand, collect, and return a portion of the electromagnetic energy redirected by one or more skeletal muscle cells of the ball of the hand to the base 2004.

[0037]

[0060] The probe 2002 includes a probe connection cord 2006 , also referred to as an “umbilical cord,” a probe connector 2008 , and a probe head 2010 .

[0038]

[0061] The probe umbilical cord 2006 is flexible and includes at least one illumination optical fiber (not shown in FIG. 2) configured to deliver irradiating electromagnetic energy from the base 2004 to the head 2010, and at least one collection optical fiber (not shown in FIG. 2) configured to collect a portion of the irradiating electromagnetic energy redirected by one or more cells forming one or more tissues of the body and return it to the base. Each of the at least one illumination optical fiber and the at least one collection optical fiber may be coated with or otherwise housed in a material that is opaque to the electromagnetic energy generated by the base 2004 to reduce crosstalk between the optical fibers to a suitable level or to eliminate it entirely. The probe umbilical cord 2006 is further described below in connection with FIGS. 4A, 6, 8, and 12.

[0039]

[0062] The probe connector 2008 is configured to receive and hold ends of at least one illumination optical fiber (not shown in FIG. 2) and at least one collection optical fiber (not shown in FIG. 2) and couple to a probe receptacle (described below) of the base 2004 such that an end of each of the at least one illumination optical fiber is stably aligned with a respective portion of an electromagnetic energy generator (described below) and an end of each of the at least one collection optical fiber is stably aligned with a respective input structure of a spectrometer (described below). The probe connector 2008 also includes one or more structures (not shown in FIG. 2) that reduce to a suitable level or completely eliminate crosstalk between the at least one illumination optical fiber and the at least one collection optical fiber. The probe connector 2008 is further described below in connection with FIGS. 6-12.

[0040]

[0063] The probe head 2010 includes ends of at least one illumination optical fiber and at least one collection optical fiber opposite ends disposed within the probe connector 2008, and includes a structure (e.g., adhesive or strap) configured to affix or otherwise secure the probe head to a site or portion of the body such as the ball of the foot, and because the layer of fat and other tissue between the skin and muscle is relatively and consistently thin and hairless in people of all skin colors, sexes, races, ages and BMIs, measuring cellular oxygenation levels in tissue at or near the ball of the foot reduces measurement biases induced by traits such as skin color / race, biological sex, age and BMI, and therefore reduces the amount of measurement inaccuracy that may be caused by such measurement biases. The probe head 2010 may also include a calibrator, authenticator, or both a calibrator and authenticator. The calibrator (described further below in connection with FIG. 4A and FIG. 4D ) is configured to enable the system 2000 to create and store base readings (e.g., base spectrometer readings) and adjust the electromagnetic energy generator (described below) or cellular oxygenation saturation level determination algorithm to account for one or more changes in one or more parameters (e.g., intensity, color, color temperature, wavelength shift at one or more wavelengths) compared to a recent cellular oxygenation saturation level determination or baseline electromagnetic spectrum. Alternatively, as described in connection with FIG. 5 , the calibrator is configured to enable the system 2000 to create and store calibration values ​​that the system can later use to calibrate or normalize values ​​of the electromagnetic spectrum collected from the subject's tissue by the probe 2002. The authenticator is also configured to provide information to the base 2004 that enables the base to determine that the probe 2002 is authorized for use with the base 2004. For example, the authenticator may prevent the use of probes that are not fully compatible with the base 2004, may prevent the use of the same probe 2002 on more than one subject to ensure safety and effectiveness (e.g., beyond the probe's single-use design limits), and may block the use of unauthorized, non-genuine probes that have not been proven compatible with the base 2004.If the authenticator is an electronic device, it may communicate with the base 2004 wirelessly or via conductive lines extending from the probe head 2010 through the umbilical cord 2006 to the base 2004, and may receive power from the base via the same or different conductive lines, or may include its own power source, such as a battery. Alternatively, the authenticator may be a barcode, QR code, or other printed code that a user enters into the base 2004 via an interface (described below), such as a barcode scanner. The authenticator is shown as being located on the probe head 2010, but may also be located on or within the probe connector 2008. The probe head 2010 is further described below in connection with Figures 4A-4D.

[0041]

[0064] Continuing with reference to FIG. 2, the base 2004 includes a probe receptacle 2020, an electromagnetic energy generator 2022, a temperature control circuit 2024, a spectrometer 2026, an operational circuit 2028, a memory 2030, a display 2032, an interface circuit 2034, a network connector 2036, and a local connector 2038.

[0042]

[0065] The probe receptacle 2020 is configured to receive and stably hold the probe connector 2008 such that an end of each of the at least one illumination optical fiber is aligned with a respective electromagnetic energy source of the generator 2022 and an end of each of the at least one collection optical fiber is aligned with a respective input of the spectrometer 2026. The receptacle 2020 includes a sensor 2040 (e.g., a push button type microswitch) configured to generate a sense signal in response to detecting the presence of the probe connector 2008 in the receptacle, and a clamping mechanism (further described in connection with FIGS. 13 and 14 ) configured to engage and stably hold the probe connector in the receptacle in optical alignment with the electromagnetic energy generator 2022 and the input of the spectrometer 2026 in response to the sense signal. For example, the operational circuitry 2028 can be configured to receive the sense signal and actuate the clamping mechanism in response to the sense signal. The receptacle 2020 also includes or is otherwise associated with a release mechanism 2042 that is configured, when actuated, to cause the clamping mechanism to disengage the probe connector 2008, allowing the probe connector to be removed from the receptacle. For example, the release mechanism 2042 may be a push button type switch, either physical or virtual (e.g., generated by the control circuitry 2028 as part of a graphical user interface on the display 2032), that a person presses when they wish to separate the probe 2002 from the base 2004. The receptacle 2020 is described further below in connection with Figures 6, 11, 13 and 14.

[0043]

[0066] The electromagnetic energy generator 2022 is configured to generate a spectrum of wavelengths of electromagnetic energy in the range of about 400 nm to 900 nm, such as, for example, in the range of about 500 nm to 800 nm or about 550 nm to 800 nm, and direct respective portions of the generated energy to an end of at least one illumination optical fiber in the probe connector 2008. The generator 2022 includes an array 2044 of light emitting diodes (LEDs shown in FIG. 6) and a driver circuit 2046. The array 2044 is one-dimensional (the LEDs are arranged in a row) and includes, for example, seven LEDs, one LED for each of the seven illumination optical fibers in the probe umbilical cord 2006 and the probe connector 2008. Each LED is of the same type, for example an LED configured to emit white light over a range of about 500 nm to 800 nm (possibly including one or more visible or infrared wavelengths of light). For example, each LED may include a blue LED configured to emit blue light and a yellow phosphor configured to absorb a portion of the blue light and phosphoresce a yellow light in response to absorbing the blue light, with the white light emitted by the LED being a combination of the unabsorbed blue light and the yellow light, and the color temperature of the emitted white light being determined, at least in part, by the wavelength of the emitted blue light and the wavelength of the emitted yellow light. Furthermore, where commercially feasible, the manufacturer of the system 2000 may form the LEDs on a common semiconductor die or fabricate them in the same run or batch to form the LED array 2044, such that each of the LEDs emits electromagnetic energy over a spectrum similar to that produced by the other LEDs in the array, e.g., in one or more of a wavelength range, intensity at each wavelength, and polarization at each wavelength. Furthermore, the intensity and consistency of the electromagnetic energy emitted by the LEDs is not hazardous to the human eye, and therefore the base unit 2004 does not require government or industry ratings typically given to light-emitting (or other electromagnetic energy emitting) devices. In addition, the emitting portion of each LED may be circular or cylindrical with a diameter of about 1.0 millimeter (mm), or any other suitable size.

[0044]

[0067] The driver circuit 2046 is configured to activate and deactivate each of the LEDs in the array 2044 individually as a subgroup or as a group in response to one or more LED drive control signals from the control circuit 2028, and while activating each LED, the driver circuit is configured to provide a respective stable drive current to the LED. The LEDs are single-junction (e.g., PN junction) semiconductor devices that generate a relatively constant voltage across the junction while active, within a range of about 1.6 volts (V) to 4.4 V, or within a range of about 2.5 V to 3.25 V ("relatively constant" accounts for small changes that may occur in the junction voltage due to temperature and the magnitude of the forward current through the LED). As a result, the driver circuit 2046 is configured to activate each of the LEDs in the array 2044 by driving the LED with a respective stable (typically regulated) drive current having a magnitude that causes the LED to radiate (or "light up") electromagnetic energy at a corresponding intensity level. That is, to cause an LED to emit light at a particular intensity level, the driver circuit 2046 is configured to drive the LED with a current having a magnitude corresponding to the particular intensity level. For example, the driver may include, for each LED in the array 2044, a respective current source configured to drive the LED with a stable current having a magnitude corresponding to the particular intensity level at which the LED is configured to emit light while the LED is active, or "on." In operation, the driver circuit 2046 drives the LED with a stable "on" current to turn the LED "on" such that the LED emits light at an intensity associated with the magnitude of the "on" current, and drives the LED with a stable "off" current to turn the LED "off" such that the LED emits light at an intensity associated with the magnitude of the "off" current, which may be approximately equal to zero, or at least small enough to cause the LED to emit little or no light at all.

[0045]

[0068] The driver circuit 2046 is configured to drive each of the LEDs in the array 2044 with approximately the same drive current such that each LED emits approximately the same spectrum of electromagnetic radiation, and it has been found that in at least some cellular oxygen saturation level determination applications, multiple LEDs emitting approximately the same spectrum of electromagnetic radiation provide a more accurate cellular oxygen saturation level reading than multiple LEDs in which one or more of the LEDs emit a different spectrum than one or more of the other LEDs.

[0046]

[0069] Because LEDs may tend to emit electromagnetic energy at a lower intensity for a given amount of drive current as they age, the generator 2022 may include circuitry in the driver circuit 2046 configured to increase the drive current to the LEDs as they age, so as to maintain the intensity of the electromagnetic energy generated by each LED at an approximately constant level over time and at approximately the same level relative to the other LEDs.

[0047]

[0070] Furthermore, for a given drive current, the intensity or other characteristics (e.g., spectral width, intensity at one wavelength relative to the intensity at another wavelength, polarization) of the electromagnetic energy emitted by an LED may change with temperature.

[0048]

[0071] Thus, the temperature controller 2024 is configured to maintain each of the LEDs in the array 2044 at a substantially constant uniform temperature. The controller 2028 can instruct or otherwise control the temperature controller 2024 to maintain each of the LEDs at a particular temperature such that the intensity or one or more other characteristics of the electromagnetic energy emitted by the LEDs changes little or not with changes in the ambient temperature inside the base 2004. Stated differently, the control circuitry 2028 is configured to control the temperature controller 2024 such that the temperature controller minimizes the slope of the temperature gradient across the LEDs (ideally a slope of zero). The temperature controller may include one or more of a fan, a heat sink, a thermoelectric cooler, a pumped liquid cooler, a compressed fluid heat pump configured to heat or cool, and a resistive or other type of heater.

[0049]

[0072] The spectrometer 2026 may be a commercially available spectrometer and is configured to separate the tissue redirected electromagnetic energy collected by the one or more collection optical fibers of the probe 2002 into a plurality of wavelength ranges and generate at least one signal for each wavelength range having a property characteristic of or otherwise related to the wavelengths in that range. For example, the spectrometer 2026 may be configured to generate an analog or digital signal having a magnitude related to the intensity of the wavelengths in each wavelength range. The spectrometer includes a structure having a diffraction grating between two collection mirrors (not shown in FIG. 2) configured to generate spatially separated ranges of wavelengths (similar to how a conventional prism generates spatially separated colors of visible light) that are incident on respective portions of a CMOS (or other) electronic pixel array (not shown in FIG. 2), which may be similar to the pixel array included in a smartphone or digital camera. Each portion of the pixel array on which the electromagnetic energy in each wavelength range is incident converts the incident energy into a respective electronic signal having a property (e.g., magnitude, phase) related to the property (e.g., intensity) of the incident energy. The spectrometer 2026 also provides signals (at least one signal each for each wavelength range) to the control circuitry 2028 for processing. The spectrometer 2026 may also include more optics, such as an optical train, between the optical input of the spectrometer and the collected energy output of the receptacle 2020 or the probe connector 2008.

[0050]

[0073] The control circuitry 2028 is configured (e.g., by one or more of software, firmware, and data streams) to control the configuration and operation of one or more other components of the base 2004, and includes an operational circuitry 2048 and a controller 2050. Each of the operational circuitry 2048 and the controller 2050 may include one or more of a microprocessor, a microcontroller, and a field programmable gate array (FPGA), respectively, or the operational circuitry and the controller may be located on the same set of one or more of a microprocessor, a microcontroller, and an FPGA. The operational circuitry 2048 may also be configured to execute an algorithm, such as a machine learning algorithm, to determine a cellular oxygen saturation level of one or more cells in the tissue of the subject illuminated by the probe head 2010 in response to one or more signals from the spectrometer 2026.

[0051]

[0074] The control circuit 2028 may include internal memory (not shown in FIG. 2), such as cache memory, working memory, and other volatile and non-volatile memory, which is in addition to memory 2030 that is external to the control circuit.

[0052]

[0075] The memory 2030 is configured to store data and may include one or more of any suitable type of volatile and non-volatile memory. Types of data that the memory 2030 may be configured to store include operating system instructions and application program instructions executed by the control circuitry 2028, firmware, respective data streams for each of one or more FPGAs that may form part of the control circuitry 2028, machine learning algorithm training data, cellular oxygenation saturation levels determined by the control circuitry, and still image or video data formatted to be rendered on the display 2032. Examples of volatile memory include static random access memory (SRAM) and dynamic random access memory (DRAM), while examples of non-volatile memory include read only memory (ROM), electrically programmable read only memory (EPROM), electrically programmable and erasable read only memory (EEPROM), flash memory, ferroelectric random access memory (FeRAM), magnetic disks, and optical disks.

[0053]

[0076] The display 2032 is configured to display, for example, a cellular oxygen saturation level most recently determined or updated by the computing circuitry 2048, the status of the system 2000, error messages, such as the probe 2002 is not authorized for use with the base unit 2004, and a menu of options, such as system set-up. The display 2032 may include, for example, one or more of a liquid crystal display, an organic light emitting diode (OLED) display, a dot matrix display, or any other suitable display. Additionally, the display 2032 may be, for example, a touch screen display that allows the EMS or CCS to select a subset of one or more menu options from a set of displayed menu options of a graphical user interface.

[0054]

[0077] The interface 2034 is configured to allow an EMS or CCS or other user to input information into and output information from the system 2000. For example, for input of information, the interface 2034 may include one or more of a keyboard, a mouse, a microphone (e.g., for inputting voice information that is converted to data by speech-to-text software running on the computing circuitry 2048), a barcode or QR code scanner (e.g., to scan an authentication code on the probe 2002), or if the display is a touch screen, the interface may include the display 2032. For output of information, the interface may also include one or more of a speaker, a transmitter such as a Bluetooth adapter (e.g., to transmit information to a smartphone), one or more lights (e.g., LEDs separate from the LEDs in the array 2044), and a display such as the display 2032.

[0055]

[0078] The network connector 2036 is configured to enable the system 2000 to communicate with another device or system, for example, to communicate with a remote server (e.g., a cloud server) via the Internet. The network connector 2036 may include, for example, one or more of a WiFi adapter, an Ethernet adapter and connector, a Bluetooth adapter, or other wireless adapter or connector. Additionally, the remote server or other device may send algorithms, software, firmware, and other updates to the control circuitry 2028 via the network connector 2036, and the control circuitry 2028 may send the status of the system 2000, spectral data collected from a subject, and other data to the remote server or other device via the network connector.

[0056]

[0079] The local connector is also configured to enable the system 2000 to communicate with another local device or system, such as one or more other electronic medical instruments connected to the patient, such as a cardiac monitor, etc. For example, the local connector can be a wireless adapter or a universal serial bus (USB) connector.

[0057]

[0080] 2, alternative embodiments of the system 2000 are contemplated. For example, the umbilical cord 2006 can be permanently connected to the base 2004, and the probe connector 2008 can be configured to receive the probe head 2010. Additionally, the generator 2022 can include one or more electromagnetic energy sources in addition to or other than LEDs. Furthermore, one or more of the computational functions of the computational circuitry 2048, such as determining a cellular oxygenation level in response to a signal generated by the spectrometer 2026, can be performed by a computational circuitry (e.g., a cloud server) remote from the base 2004. Additionally, the control circuitry 2028 can generate a graphical user interface on the display 2032 that allows a user to input commands, such as starting a cellular oxygen saturation level determination cycle, after the probe 2002 is connected to the control circuitry and authorized by the control circuitry. Further, while the probe receptacle is described as remaining open while the probe connector 2008 is not attached, it may have a spring-loaded flap or shutter that closes or seals the receptacle while the probe connector is not attached (e.g., to prevent dirt or other materials from entering the receptacle). Further, while it is described as sliding or "plugging" into the receptacle 2020, the probe connector 2008 and receptacle may be threaded such that the probe connector is configured to be screwed into and unplugged from the receptacle. Additionally, while the base 2004 is described as a stand-alone device, it may be integrated with one or more other devices, such as a cardiac monitor or an automated external defibrillator (AED). Furthermore, the control circuit 2028 may determine whether a signal from the spectrometer 2026 indicates that the collection optical fiber 4010 is receiving any redirected electromagnetic energy after activating one or more sets of LEDs in the LED array 2044.If the control circuitry 2028 determines that the collection optical fiber 4010 is receiving little or no redirected electromagnetic energy (e.g., the magnitude of some or all of the signal from the spectrometer 2026 is below a threshold), it determines that the probe head 2010 is not properly secured to the subject, deactivates the LEDs so that no electromagnetic energy is emitted from the probe head, and sounds an alarm or other notification (through a sound generator such as a speaker that is part of the base 2004 but not shown in FIG. 2) or generates on the display screen 2032 informing the user to secure the probe head to the subject. In addition, the LEDs may be of different types instead of being of the same type, e.g., each of one or more of the LEDs may be configured to emit a respective spectrum that is different from the spectrum emitted by the other of the one or more LEDs. Furthermore, each LED is described as having a diameter of about 1.0 mm, but may have any respective suitable dimensions, such as having a larger or smaller diameter. Additionally, the spectrometer 2026 may include another wavelength separation structure, such as a prism, instead of a diffraction grating between the two collection mirrors. Additionally, base 2004 may include an electromagnetic energy generator configured to generate a group of one to several wavelengths at any one time, sweeping one to several wavelengths through a range of, for example, about 500 nm to 850 nm, and may include a photodetector, in place of electromagnetic energy generator 2022 and spectrometer 2026. Since control circuitry 2028 "knows" which one to several the generator is generating at any one time, a broadband photodetector may detect, for example, the intensity of the one to several wavelengths, and the control circuitry may generate a correspondence between each detected intensity (or other detected characteristic of the energy) and the one to several wavelengths that generated the detected intensity (or other characteristic), to mimic the operation of spectrometer 2026.Alternatively, instead of a generator configured to generate and sweep one or more wavelengths at any given time, the generator may include a broadband source and a monochromator having a wavelength passband swept through a similar wavelength range, so that, similar to the swept energy generator example, the photodetector detects the intensity (or other characteristic) of a known group of one or more wavelengths at any given time. In another embodiment, the electromagnetic energy generator 2022 or a portion thereof (e.g., the LED array 2044) may be located in the probe 2002 rather than in the base 2004. Additionally, the embodiments described in connection with FIGS. 1 and 3A-18 may be applicable to the cellular oxygen saturation level determination system 2000 of FIG. 2.

[0058]

[0081] FIG. 3A is a perspective view of the cellular oxygenation level determining and monitoring system 2000 of FIG. 2 and a human hand 3000, according to one embodiment.

[0059]

[0082] 2 and 3A, the system 2000 includes a housing 3002 and a probe 2002 .

[0060]

[0083] Disposed within the housing 3002 are the probe receptacle 2020, the electromagnetic energy generator 2022, the temperature controller 2024, the spectrometer 2026, the control circuitry 2028, the memory 2030, the interface 2034, the network connector 2036, and the local connector 2038, and mounted on the housing are the display 2032, the system power on / off control (e.g., push button switch) 3004, and the probe connector release (e.g., push button switch) 3006. The housing 3002 may be formed from any suitable material, such as injection molded plastic or metal, and may have any suitable shape and size. For example, the housing 3002 may be shaped and otherwise configured to mount on a pole as part of a "tree" of medical equipment (e.g., heart rate monitors and blood pressure monitors) often found in patient rooms or other environments.

[0061]

[0084] The umbilical cord 2006 is a fiber optic ribbon cable, and the probe 2002 includes an attachment member 3008 configured to be attached (e.g., by adhesive) to a body part (e.g., the ball of a human hand), and the probe head 2010 is configured to be attached to the attachment member 3008. Additionally, the probe 2002 may include a separate calibrator (FIG. 4D) that can be attached to the probe head 2010 after connecting the probe to the base 2004 but before attaching the probe head to the attachment member 3008, so that the controller 2028 can perform a probe calibration procedure.

[0062]

[0085] In addition to causing the display 2032 to render the determined cellular oxygenation level, the controller 2028 can be configured to cause the display to render, e.g., a plot of the cellular oxygenation level over time and a graphical user interface that enables a user to, e.g., configure the system 2000 and enter commands (e.g., release the probe connector 2008 if the release portion 3006 is omitted) via the interface 2034, which may include the display 2032 if the display is a touchscreen display.

[0063]

[0086] With further reference to FIG. 3A, alternative embodiments of the system 2000 are contemplated. For example, the system 2000 can be configured to "travel with the patient", i.e., the system 2000 can be transported by ambulance personnel, used with the patient, and then "handed over" with the patient at the hospital so that there is no period during which the patient's cellular oxygenation level is not monitored. In such a configuration, the system 2000 can include dual power sources and a compartment for a battery so that the system can be powered by a wall outlet while the patient is at the hospital and by a battery while the patient is being transported (e.g., by ambulance or helicopter) to the hospital, between hospitals, or between different areas of the hospital (e.g., operating room, intensive care unit (ICU)). Additionally, even a system 2000 that is not configured to "travel" with the patient can include a compartment for a backup battery that the system utilizes to maintain power to the system, for example, in the event of a power outage or the power cord of the base station 2004 is accidentally "unplugged". The system 2000 can also include circuitry to charge the battery. In addition, the embodiments described in relation to FIGS. 1 and 2 and 3B-18 may be applicable to the cellular oxygenation level determination system 2000 of FIG.

[0064]

[0087] FIG. 3B is a perspective view of the cellular oxygenation level determination and monitoring system 2000 of FIG. 2, according to another embodiment.

[0065]

[0088] 2 and 3B, the system 2000 includes a housing 3020, a probe 2002, and a computer, such as a laptop computer 3022.

[0066]

[0089] One or more of the components of the system 2000 are disposed within a housing 3020, and one or more of the components of the system are disposed within (or functions performed by) a laptop 3022. For example, the probe receptacle 2020, the electromagnetic energy generator 2022, the temperature controller 2024, the spectrometer 2026, and the local connector 2038 are disposed within the housing 3020, and the control circuitry 2028, the memory 2030, the interface 2034, the network connector 2036, the power on / off control 3004, and the probe connector release control 3006 (or functions of these components are performed by the laptop) are disposed within the laptop 3022, and a display 3024 is attached to the laptop, which may function as a system display 2032. For example, the laptop computer 3022 may be coupled to the system components within the housing 3020 via the local connector 2038, which may be a USB connector, as described above.

[0067]

[0090] The housing 3020 can be formed from any suitable material, such as injection molded plastic or metal, and can have any suitable shape and size. For example, the housing 3020 can be shaped or otherwise configured such that a laptop 3022 can be mounted or otherwise placed on the housing.

[0068]

[0091] The probe 2002 may include a separate calibrator (FIG. 4D) that can be attached to the probe head 2010 after connecting the probe to the receptacle 2020, but before attaching the probe head to a mounting member, such as mounting member 3008 of FIG. 3A, so that the controller 2028 can perform a probe calibration procedure (described in connection with FIG. 5). Additionally, the umbilical cord 2006 includes a bundle of one or more individual illumination optical fibers (FIG. 4A) and one or more individual collection optical fibers 4010 (FIG. 4A).

[0069]

[0092] In addition to causing the display 3024 to render the determined cellular oxygenation level, the controller 2028 can be configured to cause the display 3024 to render, e.g., a plot of the cellular oxygenation level over time and a graphical user interface (GUI) that enables a user to, e.g., configure the system 2000 and enter commands (e.g., release the probe connector 2008) via the interface 2034, which may include the display 3024 if the display is a touchscreen display.

[0070]

[0093] With further reference to Figure 3B, alternative embodiments of the system 2000 are contemplated. For example, if the system includes a separate calibrator as described below in connection with Figure 4D, the separate calibrator may be, for example, removably or otherwise attached to the housing 3020. Additionally, the embodiments described in connection with Figures 1-3A and 4A-18 may be applicable to the cellular oxygenation level determination and monitoring system 2000 of Figure 2.

[0071]

[0094] In another alternative embodiment, the functions of the system 2000 may be integrated into a single integrated unit rather than a base unit and a probe unit. For example, such an integrated unit may include the components of the probe 2002 (probe head 2010, umbilical cord 2006, and probe connector 2008), sensors and circuits configured to perform the functions of the electromagnetic energy generator 2022 and the control circuitry 2028 in a single housing configured to be attached to the ball of a human hand or another body part. More specifically, according to one embodiment, the integrated unit may include an electromagnetic unit configured to direct electromagnetic (e.g., light) energy to a body part, such as the ball of the hand, and to receive a portion of the electromagnetic energy redirected by the body. An optical sensor, such as a spectrometer 2026, in the integrated unit is configured to convert the redirected portion from an electromagnetic signal to an electrical signal. An operational circuit in the integrated unit, such as an operational circuit 2048, is configured to determine a level of oxygenation of muscle cells based on the electrical signal. Additionally, the integrated unit may include a housing that includes one or more components of system 2000, including components of base 2004 and components that mimic the functionality of probe 2002. The housing may be of suitable dimensions for direct attachment to the ball of the foot or other part of a subject's body (e.g., a clip-on housing similar to a clip-on pulse oximeter housing). When implemented as an integrated unit, some components of system 2000, such as probe 2002, umbilical cord 2006, and connector 2008, may not be necessary.

[0072]

[0095] FIG. 4A is a top view of the umbilical cord 2006 and probe head 2010 of FIGS. 2 and 3B, according to one embodiment.

[0073]

[0096] The probe head 2010 includes ends of three sets 4000, 4002 and 4004 of illumination optical fibers 4006, ends of one set 4008 of collection optical fibers 4010 (the described embodiment includes only one collection optical fiber), a bottom adhesive surface 4012 configured to adhere to the ball of the subject's foot, a removable flexible plastic backing or strip 4014 that covers and protects the bottom adhesive surface and includes a calibration surface 4016 facing the bottom adhesive surface, and an authentication circuit 4018.

[0074]

[0097] The ends of each set 4000, 4002 and 4004 of illumination optical fibers 4006 are positioned along their respective arcs such that the ends of the sets are approximately the same radial distance from the end of one or more collection optical fibers, here one collection optical fiber 4010. The ends of the optical fibers 4006 of set 4000 are approximately the same radial distance r from the end of the collection optical fiber 4010. 1 and the ends of the optical fibers of set 4002 are each a radial distance r from the end of the collection optical fiber. 2 and the ends of the optical fibers of set 4004 are each a radial distance r from the end of the collection optical fiber. 3 For example, r 1 ≒2mm, r 2 ≒7mm and r 3 ≒12mm.

[0075]

[0098] Illuminating the tissue of interest, such as the tissue forming the ball of the foot, from two or more distances can generate information that allows the computational circuitry 2048 to better determine the oxygen saturation level of one or more cells forming the tissue, as compared to illuminating from only one distance. It has been found that the greater the distance from the end of the illumination optical fiber 4006 to the collection end of the collection optical fiber 4010, the deeper the illuminating "particles" (e.g., photons) will penetrate into the tissue before the tissue redirects the photons to the collection end of the collection optical fiber. By including multiple distances between the illumination optical fiber 4006 and the collection optical fiber 4010 (three distances in the described embodiment), the probe head 2010 is configured to collect and provide spectral information from multiple layers of tissue to the base 2004 (FIG. 2). For example, at distance r 1 The energy emitted from and redirected to the collecting end of the collection optical fiber 4010 provides information about the top layer or layers (e.g., skin, fat) of the tissue of interest. 2 The energy emitted from and redirected to the collecting end of the collection optical fiber 4010 provides information about the middle layer of the tissue of interest (e.g., the top layer or layers of a skeletal muscle). 3 The energy emitted from and redirected to the collecting end of collection optical fiber 4010 also provides information about the sub-layers of the target's tissue (e.g., from the middle to the sub-layers of skeletal muscle). Collecting spectral information about multiple layers of the target's soft tissue effectively enables the computing circuitry 2048 (FIG. 2) to distinguish oxymyoglobin, deoxymyoglobin, oxyhemoglobin, and deoxyhemoglobin from each other and from other substances.

[0076]

[0099] Additionally, the greater the radial distance, the greater the number of illumination optical fibers 4006 in the set, and therefore, for a given illumination time, the level of electromagnetic energy (e.g., the number of "particles," such as photons) redirected by the tissue to the end of the collection optical fiber 4010 over a given collection time window or period will vary with each radial distance (e.g., r 1 , r 2 and r 3) for any given set of radial distances, r 1 ,r 2 ,...,r n Assuming that each illumination optical fiber emits approximately the same intensity of electromagnetic energy for approximately the same amount of time as each of the other illumination optical fibers, the number of illumination optical fibers 4006 required at each radial distance can be determined so that the level of electromagnetic energy redirected from each radial distance to the end of the collection optical fiber 4010 is approximately the same.

[0077]

[0100] The adhesive on the probe surface 4012 may be any suitable adhesive, such as an adhesive used to secure electrocardiogram (EKG) electrodes or AED electrodes to a subject's skin.

[0078]

[0101] The calibration surface 4016 may be any surface suitable for use in calibrating the cellular oxygenation level determiner and monitor system 2000 (FIG. 2), for example, each time a new probe 2002 is installed, typically for each new subject. The calibration surface 4016 is a highly white reflective surface having a suitable color temperature, which is selected according to one or more wavelengths in the spectrum of electromagnetic energy generated by the generator 2022.

[0079]

[0102] A medical professional, such as a nurse, attaches the probe connector 2008 (FIGS. 2 and 3B) to the probe receptacle 2020 before removing the flexible plastic strip 4014 (the strip or other portion of the probe 2002 may include printed instructions not to remove the strip until after the probe is attached and after the control circuitry 2028 generates an indication on the display 2032 that the strip may be removed).

[0080]

[0103] In response to detecting the presence of the probe connector 2008 (FIG. 2) in the receptacle 2020 and that the probe connector is held in place by the clamping mechanism (FIGS. 13A and 13B) and communication from the authenticator 4018 confirming that the probe 2002 is authorized for use with the system 2000, the control circuitry 2028 causes the generator 2022 to "blink" the LEDs in the array 2044 for a calibration period. During the calibration period, electromagnetic energy propagates along the illumination optical fibers 4006 and exits from the ends of these fibers. The calibration surface 4016 redirects a portion of the electromagnetic energy into the ends of the collection optical fibers 4010, and the spectrometer 2026 spatially separates the wavelengths of the redirected electromagnetic energy into ranges as described above, and for each wavelength range, generates a respective calibration value corresponding to the combined intensity of the wavelengths in the range. The control circuitry 2028 then stores the one or more calibration values.

[0081]

[0104] Once the calibration procedure is complete, the control circuit 2028 can generate a notification on the display 2032 or using a sound generator that a nurse or other medical professional can remove the plastic strip 4014 and apply the probe head 2010 to the subject.

[0082]

[0105] Alternatively, the calibration procedure can be performed very quickly, so that as long as the clinician "plugs" the probe 2002 into the receptacle 2020 before removing the plastic strip 4014, the calibration procedure will end before even the fastest person can remove the plastic strip, allowing the clinician to remove the strip at any time thereafter. Thereafter (until a subsequent calibration procedure is performed), for each measurement of wavelength range intensity, the calculation circuitry 2048 calculates, for each wavelength range, the log of the ratio of the calibrated value to the current measurement. 10The calculation circuit 2048 generates a normalized intensity value equal to: ##EQU1## It is the normalized intensity value for the wavelength range or ranges that the calculation circuit 2048 uses in determining the oxygen saturation level of cells in the irradiated tissue. Such calibration can take into account changes and differences between the bases 2004 that may occur over time, such as changes or differences in the brightness of each of the one or more LEDs in the array 2044 or the respective spectra produced by each of them, due to changes or differences in one or more of the driver circuit 2046, the optical couplings (e.g., in the probe head 2010 or the probe receptacle 2020), and the spectrometer 2026. The calibration procedure is further described below in conjunction with FIG. 5.

[0083]

[0106] The authentication circuitry 4018 is configured to provide information to the base 2004 (FIG. 2) that enables the control circuitry 2028 (FIG. 2) to determine whether the probe 2002 is authorized for use with the base 2004 (e.g., to promote safety by preventing unauthorized, non-genuine probes from being used and by ensuring that other authorized probes are fully compatible with the base and are not used beyond their single-use design limits). For example, the authentication circuitry 4018 may include a memory 4020, a battery 4022, and a wireless transmitter (e.g., a Bluetooth transmitter including a suitable antenna) 4024, or may include a conventional radio frequency identification (RFID) tag or near field communication (NFC) circuitry. The memory 4020 is a suitable non-volatile memory such as a read only memory (ROM), an electrically programmable read only memory (EPROM), an electrically programmable and erasable read only memory (EEPROM) that stores an authentication value, which may be coded, for example the memory may be programmed by the manufacturer of the probe 2002 (FIG. 2) to store the authentication value before the probe is packaged and shipped for sale. The memory 4020 may be constructed in a conventional manner to prevent a person (e.g. a hacker) from later reading the authentication value from the memory. The battery 4022 is suitably sized to fit into the probe head 2010 and is configured to power the memory 4020 and the transmitter 4024. To extend the life of the battery 4022 while the probe 2002 is "on the shelf" waiting to be used, an insulator such as a strip of plastic may be placed between the contact electrodes of the battery and a power node of the circuitry mounted on the probe head 2010 to prevent the circuitry from drawing current from the battery, and the probe may include instructions printed on it (or on the insulator) for the user to remove the insulator so that the power node can make electrical contact with the battery's electrodes to allow the circuitry to draw power from the battery. The transmitter 4024 is configured to transmit the authentication value to the base 2004 via the network connector 2036 (FIG. 2) or the local connector 2038 (FIG. 2).For example, if the wireless transmitter is a Bluetooth transmitter, the transmitter may pair with the base 2004 in a conventional manner. Additionally, the transmitter 4024 may be configured to encode the authentication value prior to transmission, such that the transmitted value cannot be intercepted and used to enable the use of a third party or counterfeit probe with the base 2004. The control circuit 2028 (FIG. 2) is configured to receive the authentication value and decode the received authentication value as necessary. If the control circuit 2028 determines that the authentication value indicates that the probe 2002 is authorized for use with the base 2004, it maintains the base in a functional mode of operation. Conversely, if the control circuit 2028 does not receive an authentication value or receives an invalid authentication value, it disables the base from being used until an authorized probe 2002 is connected to the base via the receptacle 2020. Thus, the authentication feature may prevent third party or counterfeit probes from being used with the base 2004. Alternatively, the battery may be omitted and the probe 2002 may include one or more wires that connect to a power terminal in the receptacle 2020 (FIG. 2) so that the transmitter and memory are powered from the base 2004. In another alternative in which the authentication circuitry 4018 is or includes an RFID tag or NFC circuitry, the battery 4022 may be omitted and the authentication circuitry may be powered by polling or other signals transmitted by the base 2004 (which includes an RFID or NFC reader circuitry).

[0084]

[0107] 4A, the illumination optical fiber 4006 and the collection optical fiber 4010 can be any suitable type of optical fiber. For example, each fiber 4006 and 4010 can have an opaque outer sheath to reduce or completely eliminate crosstalk between the fibers, especially between the illumination optical fiber and the collection optical fiber. Furthermore, each of the one or more fibers 4006 and 4010 can be a respective glass fiber, but also a plastic fiber, for example a multi-core plastic fiber. Plastic optical fibers are usually cheaper than glass optical fibers, and multi-core plastic optical fibers can have a smaller minimum bend radius than single-core glass or plastic fibers. The smaller the bend radius of the optical fibers 4006 and 4010, the lower the height of the probe head 2010 can be. In addition, the collection optical fiber 4010 may include multiple collection cores, one or more of a first set of collection cores each configured to provide collected electromagnetic energy to the spectrometer 2026 as described elsewhere in this application, and one or more of a second set of collection cores each configured to provide light reflected from the body part to a detection circuit (e.g., a photodetector) mounted on the base 2004 while the probe head 2010 is properly attached to the body part of the subject. The control circuit 2028 may be configured to "recognize" the presence of reflected light as an indication that the probe head is properly attached to the body part. As a result, to prevent the electromagnetic energy generator 2022 from activating the LEDs while the probe head 2010 is not properly attached to the subject, the control circuit 2028 may be configured to enable operation of the base 2004 in response to detecting at least a threshold intensity level of reflected light from the second set of one or more collection cores, and to disable operation of the base otherwise.

[0085]

[0108] 4A, alternative embodiments of the probe head 2010 are contemplated. For example, although the optical fibers 4006 and 4010 are described as being arranged in an umbilical cord 2006, they could be arranged side-by-side, such as in a ribbon cable. Furthermore, although the number of illumination optical fibers 4006 in each group 4000, 4002, and 4004 increases as the radius r increases, and although each illumination optical fiber is described as providing electromagnetic energy having approximately the same intensity at its end, the probe head 2010 could include the same or similar number of illumination optical fibers as the illumination optical fibers in each group, and the system 2000 (FIG. 2) could be configured to provide higher intensity electromagnetic energy to each fiber in the group as the radius r increases, such that the total intensity of electromagnetic energy from each radius r is approximately the same at the collection end of at least one collection optical fiber 4010. Alternatively, to achieve the same result, the probe head 2010 may still include the same or similar number of illumination optical fibers in each group, and the system 2000 (FIG. 2) may be configured to provide electromagnetic energy to each fiber in a group for a longer period of time as the radius r increases, such that the total level of electromagnetic energy (where "level" is effectively the integral of the intensity) from each radius r is approximately the same at the collection end of the at least one collection optical fiber 4010. Furthermore, instead of or in addition to the adhesive surface 4012, the probe head 2010 may include another structure, such as a strap, for securing the probe head to a body part, such as the ball of the hand. Additionally, instead of locating the electromagnetic energy generator 2022 in the base 2004, the generator, including the LED array 2044, driver circuit 2046, and temperature controller 2024, may be located partially or completely within the probe head 2010 or in one other portion of the probe 2002, and in such an embodiment, the need to pass the illumination optical fiber 4006 through the base 2004 may be eliminated. Additionally, the authenticator 4018 may be located in the probe connector 2008 (FIG. 2) rather than in the probe 2010.Further, although the LEDs in array 2044 (FIG. 2) are described as each emitting electromagnetic energy of approximately the same spectrum and intensity, the LEDs may be configured to emit different spectra, different intensities, or both different spectra and different intensities. For example, illumination optical fiber 4006 in group 4004 (at radial distance r. 3The LEDs configured to drive the illumination optical fibers in groups 4001 and 4002 (fiber ends) may have approximately the same spectrum, which is different from the spectrum of the LEDs configured to drive the illumination optical fibers in one or both of groups 4002 and 4000. Additionally, although probe head 2010 is described as being configured to be fixed to the ball of the hand, it may be configured to be fixed to any other suitable body site, for example, a body site that includes skeletal muscle and has a skin and fat layer over the muscle that is about 3 mm thick or less, including the soles of the feet, the backs of the hands, the neck (sternocleidomastoid muscle), the chest (pectoralis major muscle), and the limbs of infants and young children. Further, in an embodiment of the probe 2002 including multiple illumination optical fibers 4006 and multiple collection optical fibers 4010, instead of time multiplexing the activation of the sets 4000, 4002 and 4004 of illumination optical fibers 4006, the base 2004 may include a respective spectrometer 2026 for each of the collection optical fibers, or may include a series of dichroic filters that effectively extract a "slice" of the spectrum and then recombine these slices in the operational circuitry 2048, thereby allowing all sets of illumination optical fibers to be energized simultaneously, i.e., multiplexing and demultiplexing is performed in the wavelength domain instead of the time domain; for example, in an embodiment having three collection optical fibers 4010, the base 2004 may include three spectrometers 2026, i.e., one spectrometer for each collection optical fiber. Alternatively, the spectrometer 2026 may include a two-dimensional sensor (instead of a linear sensor), and the probe receptacle 2020 and probe connector 2008 may be configured to direct the collected electromagnetic energy from each collection optical fiber 4010 onto a respective region of the two-dimensional sensor. In yet another alternative, the spectrometer 2026 includes an input optical multiplexer, and the control circuitry 2028 is configured to control the multiplexer to direct the collected electromagnetic energy output from each of the multiple collection optical fibers 4010 onto the spectrometer sensor at a respective time, such that at any given time, the control circuitry "knows" which collection optical fiber is providing the output being acted upon by the spectrometer.As noted elsewhere herein, in embodiments of the system 2000 including multiple collection optical fibers 4010, the system may include only one illumination optical fiber 2006. Additionally, the authentication circuitry 4018 may employ a conventional rolling code to deter hacking of the authentication data from the memory 4020 and to deter a hacker from controlling the transmitter 4024 to transmit a counterfeit authentication code to the control circuitry 2028 (FIG. 2). The authentication memory 4020 may also store certain data associated with the probe 2002 during manufacture, such as measurements taken, test results generated, etc., and after the probe is connected to the base 2004, as part of a calibration procedure, the control circuitry 2028 may compare some or all of the data with equivalent data generated by the control circuitry to determine whether the probe is malfunctioning or damaged and otherwise properly calibrated. Additionally, the embodiments described in connection with FIGS. 1-3 and 4B-17 may be applicable to the probe head 2010 of FIG. 4A.

[0086]

[0109] Figure 4B is a perspective view of a mounting member 4100 for use with the probe head 2010 of the probe 2002 of Figures 2 and 3B according to another embodiment, and configured to be attached to the ball 4102 of a subject's hand 4104. The mounting member 4100 is also configured for use with the embodiment of the probe head 2010 of Figure 4A in which the adhesive surface 4012 is absent from the probe head.

[0087]

[0110] The mounting member 4100 includes a flexible adhesive mesh 4106 and a probe head receptacle 4108 attached to the adhesive mesh by adhesive, sutures, or other suitable attachment technique.

[0088]

[0111] The flexible adhesive mesh 4106 includes a suitable adhesive, which may be conventional, on its attachment side facing the hand 4104, and a protective film (not shown in FIG. 4B) that the user removes before applying the attachment portion 4100 to the ball of the foot 4102. The mesh can be made of plastic, cloth, or a combination of plastic and cloth.

[0089]

[0112] The mesh 4106 includes at least one opening below the probe head receptacle 4108 that allows electromagnetic energy generated by the electromagnetic energy generator 2022 (FIG. 2) to propagate unimpeded from the output end of the illuminating optical fiber 4006 (FIG. 4A) to the skin, muscle and other tissue forming the thenar 4102, and that allows a portion of the illuminating electromagnetic energy redirected by the tissue to propagate unimpeded to one or more collection optical fibers 4010 (FIG. 4A).

[0090]

[0113] The probe head receptacle 4108 may be made from any suitable material, such as plastic, and may be assembled or otherwise configured to receive the probe head 2010 (e.g., FIGS. 3B and 4A and 4C (in an embodiment in which the adhesive surface 4012 is omitted)). For example, the receptacle 4108 and probe head 2010 may be configured to "snap" the probe head into the receptacle 4108, or the exterior of the probe head and the interior of the receptacle may be threaded such that the probe head can be twisted or screwed into the receptacle less than or more than one turn. Furthermore, the receptacle 4108 and probe head 2010 may be assembled or otherwise configured such that the probe head can be attached to the receptacle before or after the mounting member 4100 is secured to the ball of the subject's foot 4102 (or other body part). In addition, the receptacle 4108 has one or more openings extending through its bottom 4110 that are configured to allow electromagnetic energy emanating from the illumination optical fiber 4006 (FIG. 4A) and electromagnetic energy redirected by the target tissue toward the one or more collection optical fibers 4010 (FIG. 4A) to pass through the bottom unimpeded.

[0091]

[0114] 4B, alternative embodiments of the mounting member 4100 are contemplated. For example, the probe head receptacle 4108, while described as being circular, may have any suitable shape and may have any suitable color, such as black, having low reflectance in the wavelength range of the electromagnetic energy generated by the electromagnetic energy generator 2022 of FIG. 2. Further, the adhesive mesh 4106 may have any suitable shape and color. In addition, while the probe head 2010 is described as fitting inside the receptacle 4108, the receptacle may fit inside the probe head. Furthermore, the embodiments described in connection with FIGS. 1-4A and 4C-18 may be applicable to the probe head receptacle 4108 of FIG. 4B.

[0092]

[0115] Figure 4C is a perspective view of the probe head 2010, for example of Figures 2, 3B and 4A, inserted or otherwise secured into the receptacle 4108 of the mounting member 4100 of Figure 4B, according to one embodiment. The probe head 2010 has a two-piece (e.g., clamshell) construction, with the two pieces (top and bottom from the perspective of Figure 4C) held together by machine screws 4200.

[0093]

[0116] The probe head 2010 may be packaged attached to the mounting member 4100 to protect a face of the probe head (the side that faces the subject's body and that is placed inside the receptacle 4108 while the probe head is in use) while the probe head is packaged and stored awaiting use, or a protective film similar to film 4014 of FIG. 4A may be attached (e.g., by adhesive) to the face of the probe head, as described in connection with FIG. 4A. In the former case, a user may affix the mounting member 4100 to the subject's body without removing the probe head 2010 from the receptacle 4108, or may remove the probe head from the receptacle, affix the mounting member to the subject's body, and reinsert or otherwise reattach the probe head to the receptacle. If for any reason it becomes necessary to disengage the probe head 2010 from the receptacle 4108, the adhesive and the receptacle 4108 remain secured to the subject's body and the probe head 2010 can be re-engaged to resume examination of the subject's body.

[0094]

[0117] With further reference to Figure 4C, alternative embodiments of the mounting member 4100 and probe head 2010 are contemplated. For example, the embodiments described in connection with Figures 1-4B and 4D-18 may be applicable to the mounting member 4100 and probe head 2010 of Figure 4C.

[0095]

[0118] 4D is a perspective view of the probe head 2010 of FIGS. 2, 3B, 4A, and 4C mounted on a calibration member, or calibrator 4300, according to one embodiment. The probe head 2010 can be configured to mount on the calibration member 4300 in a manner similar to how it is configured to mount on the mounting member 4100 of FIG. 4B, with the calibrator 4300 being white in color and having a calibration front surface 4302 (the surface that faces the probe head 2010 while the probe head is mounted on the calibrator) that is otherwise similar to the calibration front surface 4016 of the protective film 4014 (FIG. 4A). The calibrator 4300 can be used to calibrate the system 2000 if the protective film 4014 has been intentionally or inadvertently removed from the probe head 2010 or if the calibration front surface 4016 of the protective film has been damaged.

[0096]

[0119] With further reference to Figure 4D, alternative embodiments of the probe head 2010 and calibrator 4300 are contemplated. For example, the embodiments described in connection with Figures 1-4C and 5-18 may be applicable to the probe head 2010 and calibrator 4300 of Figure 4D.

[0097]

[0120] Figure 5 is a flow diagram 5000 of a method of using and operating the cellular oxygenation level determiner and monitor system 2000 of Figure 2, according to one embodiment. The method is described according to an embodiment in which the probe 2002 of Figure 4A is used, although it is understood that the method may be similar if another version of the probe is used.

[0098]

[0121] 2-5, in step 5002, a user, such as an EMS or CCS (e.g., nurse, doctor, technician), connects the probe 2002 to the base 2004 by inserting the probe connector 2008 into the probe receptacle 2020. In response to the user inserting the probe connector 2008 into the receptacle 2020 sufficiently to "activate" the sensor 2040, the control circuit 2028, in response to a sensed signal from the sensor, activates a probe-connector clamping mechanism (FIGS. 13 and 14) to engage the probe connector into the probe receptacle and hold the probe connector in stable optical alignment with the LED array 2044 (see FIG. 6).

[0099]

[0122] Next, in step 5004, the control circuitry 2028 determines whether the probe 2002 is authorized for use with the base 2004. For example, the control circuitry 2028 sends a request for an authentication value to the wireless transmitter 4024 (FIG. 4A) of the probe head 2010 via the network connector 2036 operating in wireless mode (the transmitter may include or be part of a microprocessor, microcontroller or other circuit that processes the request), and if necessary, the transmitter retrieves a stored authentication value from the memory 4020 (FIG. 4A), encodes the authentication value, and transmits the encoded authentication value to the control circuitry via the network connector. The control circuitry 2028 decodes the authentication value and determines whether the authentication is valid. For example, the control circuitry 2028 compares the authentication value to a list of one or more valid authentication values ​​stored in the memory 2030, and enables the base 2004 for use with the probe 2002 if the received authentication value matches one of the stored authentication values. Instead, the control circuit 2028 processes the received authentication value according to an authentication algorithm, compares the result to a list of one or more valid results stored in memory 2030, and enables the base 2004 for use with the probe 2002 if the result obtained matches one of the stored results. If the control circuit 2028 determines that the received authentication value is valid, it proceeds to step 5006. However, if the control circuit 2028 determines that the authentication value or algorithm result is invalid, it proceeds to step 5008, where the control circuit disables the base 2004 from operating while an unauthenticated probe 2002 is installed.

[0100]

[0123] In step 5006, the base 2004 performs a spectral calibration. With reference to Figures 2 and 4A, the control circuit 2028 first generates a message on the display 2032 informing a user of the cellular oxygenation level determiner and monitor system 2000 that a calibration is being performed and instructing the user not to remove the protective strip 4014 from the adhesive surface 4012 of the probe head 2010. The control circuit 2028 then causes the electromagnetic energy generator 2022 to "blink" the LEDs in the array 2044 for one or more calibration times. More specifically, the control circuit 2028 activates the LEDs in the array 2044 corresponding to the group 4000 of illumination optical fibers 4006 for a first calibration time in the range of about 0.1 ms to 1 ms, for example about 0.4 ms, and deactivates the remaining LEDs in the array. The electromagnetic energy from the active LEDs propagates along the illumination optical fibers 4006 in the group 4000 and exits from the output ends of each of these fibers. The calibration surface 4016, e.g., white, of the protective strip 4014 redirects a portion of the incident electromagnetic energy to enter the input end of the collection optical fiber 4010, and the spectrometer 2026 spatially separates the wavelengths of the redirected electromagnetic energy into a plurality of ranges, as described in connection with FIG. 2. For each range, the spectrometer 2026 generates a respective calibration value corresponding to the combined intensity of the wavelengths in that range. The control circuit 2028 then stores in the memory 2030 one or more calibration values ​​corresponding to the illumination optical fiber group 4000. The control circuit 2028 then activates the LEDs corresponding to the group 4002 of illumination optical fibers 4006 in the array 2044 for a second calibration time in the range of about 1 ms to 10 ms, e.g., about 4 ms, and deactivates the remaining LEDs in the array. The electromagnetic energy from the active LEDs propagates along the illumination optical fibers 4006 in the group 4002 and exits from the output end of each of these fibers.The calibration surface 4016 of the protective strip 4014 redirects a portion of the incident electromagnetic energy into the input end of the collection optical fiber 4010, and the spectrometer 2026 spatially separates the wavelengths of the redirected electromagnetic energy into a plurality of ranges and generates, for each range, a respective calibration value corresponding to the combined intensity of the wavelengths in that range. The control circuit 2028 then stores in the memory 2030 one or more calibration values ​​corresponding to the illumination optical fiber group 4002. The control circuit 2028 then activates the LEDs corresponding to the group 4004 of illumination optical fibers 4006 in the array 2044 for a third calibration time in the range of about 1 ms to 10 ms, e.g., about 8 ms, and deactivates the remaining LEDs in the array. The electromagnetic energy from the active LEDs propagates along the illumination optical fibers 4006 in the group 4004 and exits from the output end of each of these fibers. The calibration surface 4016 of the protective strip 4014 redirects a portion of the incident electromagnetic energy into the input end of the collection optical fiber 4010, and the spectrometer 2026 spatially separates the wavelengths of the redirected electromagnetic energy into a plurality of ranges. For each range, the spectrometer 2026 generates a respective calibration value corresponding to the combined intensity of the wavelengths in that range. The control circuit 2028 then stores in the memory 2030 one or more calibration values ​​corresponding to the illumination optical fiber group 4004. The control circuit 2028 performs a similar calibration for each remaining group (if any) of the illumination optical fiber 4006. The control circuit 2028 then generates a notification via an audio generator (not shown in FIG. 2 ) or on the display 2032 that the calibration procedure is complete and the user may remove the protective strip 4014 from the face of the probe head 2010. Alternatively, the control circuit 2028 may complete the calibration procedure in a very short time such that, if no person, after attaching the probe 2002, is quick enough to remove the protective strip 4014 before the calibration procedure is completed, the control circuit 2028 may omit generating a calibration-related message via the audio generator or on the display 2032.In an alternative embodiment in which a separate calibrator (e.g., calibrator 4300 of FIG. 4D) is used in place of the calibration surface 4016 of the protective strip 4014, step 5006 is modified to include removing the protective strip 4014 from the probe head 2010 and attaching the external calibrator to the probe head before the calibration procedure is performed.

[0101]

[0124] Then, in step 5010, the control circuit 2028 determines whether each of the calibration values ​​is within a suitable range of values. For example, the control circuit 2028 compares each calibration value to a suitable calibration value threshold or range stored in the memory 2030 for the spectral range to which the calibration value corresponds.

[0102]

[0125] If one or more of the calibration values ​​are out of range, there may be a problem with one or more components of the system 2000, such as malfunction or damage to one or more of the LEDs in the array 2044, the driver circuit 2046, the temperature controller 2024, the spectrometer 2026, or the probe 2002. Such a problem may require that the system 2000 be serviced or repaired before use, or that the clinician replace a damaged or otherwise malfunctioning probe 2002 with another probe. For example, a calibration value for a particular wavelength range may be out of specification if the calibration value is below a threshold corresponding to 0.5 lumens.

[0103]

[0126] As a result, if in step 5010 the control circuit 2028 determines that at least one of the calibration values ​​is outside of a respective preferred range of values, the method proceeds to step 5012, where the control circuit 2028 disables the base 2004 from measuring cellular oxygen saturation levels and generates an error message on the display 2032 indicating, for example, that the system 2000 needs servicing before it can be used. Alternatively, the control circuit 2028 does not disable the base 2004, but generates a message on the display 2032 indicating that the system 2000 needs servicing and may result in inaccurate readings of cellular oxygenation levels until serviced.

[0104]

[0127] However, if, in step 5010 , the control circuit 2028 determines that each of the calibration values ​​has an acceptable relationship to the respective threshold value or is within a respective preferred range of values, then the method proceeds to step 5014 .

[0105]

[0128] In step 5014, the user removes the protective strip 4014 from the probe head 2010, places the adhesive surface 4012 over the ball area of ​​the subject's hand, and presses the probe head onto the hand to affix the probe head to the hand. If the probe head 2010 includes a strap or other attachment structure in addition to or instead of the adhesive surface 4012, the user secures the probe head onto the ball of the subject's hand accordingly.

[0106]

[0129] Next, in step 5016, the control circuitry 2028 causes the probe head 2010 to irradiate the tissue of interest with electromagnetic energy in a wavelength range of about 500 nm to 850 nm for a cellular oxygen saturation level measurement time. The control circuitry 2028 first activates an LED in the array 2044 corresponding to one illumination optical fiber 4006 in the group 4000 for a first irradiation time in a range of about 0.1 ms to 1.0 ms, e.g., about 0.4 ms, and deactivates the remaining LEDs in the array. The electromagnetic energy from the active LEDs propagates along the illumination optical fiber 4006 in the group 4000 and exits from an output end of the fiber. The outgoing electromagnetic energy diffuses into the target tissue, cells forming the target tissue (e.g., skeletal muscle cells) absorb a portion of the diffused electromagnetic energy, the target tissue redirects another portion of the diffused electromagnetic energy into the input end of the collection optical fiber 4010, and the redirected portion of the electromagnetic energy (also referred to as the "collected portion") propagates through the collection optical fiber 4010 to the spectrometer 2026. The time it takes for the electromagnetic energy emitted from the output end of one illumination optical fiber 4006 in the group 4000 to diffuse into the target tissue, cells forming the tissue absorb a portion of the diffused electromagnetic energy, the tissue redirects another portion of the diffused electromagnetic energy into the input end of the collection optical fiber 4010, and the collected electromagnetic energy to propagate along the collection optical fiber 4010 to the spectrometer 2026 is significantly shorter than the first irradiation time, e.g., about one-tenth or less of the first irradiation time.

[0107]

[0130] The control circuitry 2028 then activates the LEDs in the array 2044 corresponding to the group 4002 of two illumination optical fibers 4006 for a second illumination time in the range of about 1.0 ms to 10.0 ms, for example about 4.0 ms, and deactivates the remaining LEDs in the array. The electromagnetic energy from the active LEDs propagates along the two illumination optical fibers 4006 in the group 4002 and exits at the output ends of these fibers. The exiting electromagnetic energy diffuses into the tissue of interest, cells forming the tissue of interest (e.g., skeletal muscle cells) absorb a portion of the diffused electromagnetic energy, and the tissue of interest redirects another portion of the diffused electromagnetic energy to enter the input end of the collection optical fiber 4010, where the redirected portion of the electromagnetic energy propagates through the collection optical fiber 4010 to the spectrometer 2026. The time it takes for the electromagnetic energy emitted from the output end of the illumination optical fiber 4006 in group 4002 to diffuse into the target tissue, for the cells constituting the tissue to absorb a portion of the diffused electromagnetic energy, for the tissue to redirect another portion of the diffused electromagnetic energy to enter the input end of the collection optical fiber 4010, and for the collected electromagnetic energy to propagate along the collection optical fiber 4010 to the spectrometer 2026 is significantly shorter than the second illumination time, for example, less than about one-tenth of the second illumination time.

[0108]

[0131] In step 5016, the control circuit 2028 then activates the LEDs corresponding to the group 4004 of four illumination optical fibers 4006 in the array 2044 for a third illumination time in the range of about 1.0 ms to 10.0 ms, for example about 8.0 ms, and deactivates the remaining LEDs in the array. Electromagnetic energy from the active LEDs propagates along the four illumination optical fibers 4006 in the group 4004 and exits at the output ends of these fibers. The exiting electromagnetic energy diffuses into the tissue of interest, cells forming the tissue of interest (e.g., skeletal muscle cells) absorb a portion of the diffused electromagnetic energy, and the tissue of interest redirects another portion of the diffused electromagnetic energy to enter the input end of the collection optical fiber 4010, where the redirected portion of the electromagnetic energy propagates through the collection optical fiber 4010 to the spectrometer 2026. The time it takes for the electromagnetic energy emitted from the output end of the illumination optical fiber 4006 in group 4004 to diffuse into the target tissue, for the cells constituting the tissue to absorb a portion of the diffused electromagnetic energy, for the tissue to redirect another portion of the diffused electromagnetic energy to the input end of the collection optical fiber 4010, and for the collected electromagnetic energy to propagate along the collection optical fiber 4010 to the spectrometer 2026 is significantly shorter than the third illumination time, for example, by about one-tenth or less.

[0109]

[0132] Then, in step 5018, which is simultaneous with step 5016, the spectrometer 2026 resolves the redirected electromagnetic energy collected by the group 4008 of one collection optical fiber 4010 and provided to the spectrometer input into a plurality of wavelength ranges. For example, in an embodiment in which the wavelengths of the spectrum of the redirected electromagnetic energy range from approximately 501 nm to 850 nm, the spectrometer 2026 sensor has a wavelength resolution of approximately 0.31 nm per pixel such that the spectrometer resolves the collected electromagnetic energy into approximately 1126 wavelength bins or ranges (one bin / range per pixel), each approximately 0.31 nm wide. However, for purposes of illustration, it is assumed that the spectrometer 2026 resolves the collected electromagnetic energy into the following 35 wavelength ranges: approximately 501 nm to 510 nm, approximately 511 nm to 520 nm, approximately 521 nm to 530 nm, ..., approximately 831 nm to 840 nm, and approximately 841 nm to 850 nm. However, it will be understood that spectrometer 2026 may be configured to resolve the collected electromagnetic energy into any suitable number of wavelength bins or ranges across any suitable wavelength span, and the following description still applies.

[0110]

[0133] For each wavelength range, the spectrometer 2026 also generates one or more values ​​respectively related to one or more characteristics of the wavelengths in that wavelength range. For example, the spectrometer 2026 generates a value related to the combined intensity (e.g., magnitude, amplitude, power) of the wavelengths in the wavelength range. In a further example, the spectrometer 2026 generates a respective analog electrical signal as a representative of each value and converts the analog signal to a corresponding digital signal. In a further example, the spectrometer 2026 generates multiple digital samples of each characteristic for each wavelength range, and the control circuit 2028 mathematically combines (e.g., averages) these samples to generate a respective value for each analyzed spectral characteristic. As a further example, if the spectrometer 2026 produces digital values ​​of 5.0, 6.0, 8.0, and 4.0 across four samples of intensity for the wavelength range 511 nm to 520 nm, the control circuit 2028 produces an intensity value for this wavelength range of (5.0+6.0+7.0+4.0) / 2=11.0 and stores it in memory 2030.

[0111]

[0134] For purposes of clarity, in the following description, spectrometer 2026 generates only intensity-only values ​​for each wavelength range, but it will be understood that the spectrometer can generate values ​​of other wavelength range characteristics (e.g., phase, polarity) instead of or in addition to intensity for each wavelength range.

[0112]

[0135] Further in step 5018, for each wavelength range of the collected electromagnetic energy during the first illumination time, the spectrometer 2026 generates a respective value related to the intensity, as described above, and the control circuitry 2028 calculates each value as a function of the wavelength range and radius r of the group 4000 of one illumination optical fiber 4006. 1 The information is stored in the memory 2030 so as to be associated with the

[0113]

[0136] During the second illumination time, for each wavelength range of the collected electromagnetic energy, the spectrometer 2026 generates a respective value related to the intensity, and the control circuit 2028 calculates each value as a function of the wavelength range and radius r of the group 4002 of two illumination optical fibers 4006. 2 The information is stored in the memory 2030 so as to be associated with the

[0114]

[0137] During the third illumination time, for each wavelength range of collected electromagnetic energy, the spectrometer 2026 generates a respective value related to the intensity, and the control circuit 2028 calculates each value as a function of the wavelength range and radius r of the group 4004 of four illumination optical fibers 4006. 3 The information is stored in the memory 2030 so as to be associated with the

[0115]

[0138] For each wavelength range of collected electromagnetic energy, if present, during each subsequent illumination time, the spectrometer 2026 also generates a respective value related to the intensity, and the control circuit 2028 calculates that value in relation to the wavelength range and radius r of each group of one or more illumination optical fibers 4006. n The information is stored in the memory 2030 so as to be associated with the

[0116]

[0139] As noted above, the number of illumination optical fibers 4006 in a group increases with increasing radius r such that the level of electromagnetic energy (e.g., number of photons) that the one or more (here one) collection optical fiber 4010 collects during each of the first, second, third and any subsequent illumination periods are approximately equal. Alternatively, the levels of energy collected during the illumination periods may not be approximately equal to one another, so long as each level of energy collected during each illumination period has at least a minimum threshold energy level, which may be defined in terms of the signal-to-noise ratio (S / N) of the energy received by the collection optical fiber or optical fibers 4010.

[0117]

[0140] Next, in step 5020, the operational circuitry 2048 of the control circuitry 2028 determines a cellular oxygenation level in the tissue of the subject where the probe 2002 was irradiated with electromagnetic energy in response to the values ​​stored in the memory 2030 during the first, second, third and any subsequent irradiation times. For example, the determined cellular oxygenation level may effectively be an average or other mathematical combination of the cellular oxygenation levels of each irradiated cell in the tissue. The control circuitry 2028 also "assumes" that the cellular oxygenation level determined for the irradiated tissue is approximately the same as the cellular oxygenation level of a similar tissue (e.g., skeletal muscle tissue) in another part of the subject's body, unless it "knows" otherwise. For example, while an automated blood pressure monitor (i.e., blood pressure meter) informs the control circuit 2028 that a blood pressure cuff is inflated on the arm on which the probe head 2010 is attached, the control circuit can be configured to ignore the cellular oxygenation level reading calculated by the calculation circuit 2048 because it may not accurately reflect cellular oxygenation in other parts of the subject's body due to the ischemia that the inflated cuff induces in the hand being examined with the probe. Instead, if the time the cuff has been inflated is less than a threshold, and therefore not long enough to cause an inaccurate cellular oxygenation reading, the control circuit 2028 can be configured to accept the reading as accurate at least until the cuff inflation time increases above the threshold. Additionally, as part of determining the cellular oxygenation level, the calculation circuitry 2048 can calculate oxymyoglobin % (cellular oxygen saturation level)=[oxymyoglobin] / ([oxymyoglobin]+[deoxymyoglobin]) and oxyhemoglobin % (blood-oxygen saturation level)=[oxyhemoglobin] / ([oxyhemoglobin]+[deoxyhemoglobin]).

[0118]

[0141] First, the calculation circuit 2048 normalizes each of the values ​​stored in the memory 2030 during the first, second, third and any subsequent exposure times. For each stored value being normalized, the calculation circuit 2048 first divides the stored value by the corresponding calibration value previously determined in step 5006 and stored in the memory 2030. For example, if "550" is the value obtained by dividing the radial distance r during the first exposure time, the calculation circuit 2048 first divides the stored value by the corresponding calibration value previously determined in step 5006 and stored in the memory 2030.1 where "500" is the decimal representation of the digital value stored for the wavelength range 501 nm to 510 nm, and "500" is the decimal representation of the digital value stored for the same wavelength range and the same radial distance r during the calibration procedure. 1 where 0 is the decimal representation of the corresponding digital calibration value stored for log 0, then the calculation circuit 2048 produces the quotient 500 / 550=10 / 11=0.91. Then the calculation circuit 2048 calculates 10 The radial distance r of the first exposure time is equal to (0.91)=-0.41 1 Instead, the arithmetic circuit 2048 generates a normalized version of the value "550" for the wavelength range 501 nm to 510 nm in |log 10 2002。(0.91)|=0.41。 Arithmetic circuit 2048 normalizes each of the other values ​​stored in memory 2030 in a similar manner during the first, second, third and any subsequent illumination times. Normalizing the values ​​can reduce or completely eliminate the magnitude of errors caused by variations in the spectrum produced by the electromagnetic energy generator 2022 due to, for example, aging of the LEDs in the array 2044, variations in the temperature of the generator or the supply voltage supplied to the generator between subjects, and differences in the illumination and collection of electromagnetic energy between probes 2002.

[0119]

[0142] The computation circuitry 2048 then processes the values ​​stored in the memory 2030 during the first, second, third and any subsequent illumination times by applying normalized versions of these values ​​as inputs to a mathematical algorithm executed or otherwise implemented by the computation circuitry. Examples of suitable mathematical algorithms include learning algorithms (e.g., machine learning and statistical learning algorithms) such as locally weighted regression (LWR) models (see, e.g., U.S. Pat. No. 10,463,286, column 9, lines 25-32), support vector machines, decision tree methods (e.g., Random Forest, XGBoost), neural networks (NNs) (e.g., forward propagation, convolutional (CNN), recurrent, generative adversarial) and recommender systems. For each input value, the respective information available to the designer of the algorithm (and input to the algorithm itself) includes the distance r between the corresponding illumination optical fiber 4006 and one or more collection optical fibers 4010, ... n , duration of the first, second, third and subsequent exposure times, and one or more wavelengths in the wavelength range to which the input values ​​are associated. Then, based on this available information, the algorithm designer constructs an algorithm (training the algorithm is described below in conjunction with Figures 15-17) that has the ability to be trained to obtain accurate values ​​of cellular oxygenation.

[0120]

[0143] Further, in step 5020, the operational circuitry 2048 accurately determines the oxygenation level of cells in the tissue (e.g., skeletal muscle tissue) irradiated by the generated electromagnetic energy per step 5016. As described above, the determined cellular oxygenation level may in fact be an average or other mathematical combination of the cellular oxygen saturation levels of each of the cells forming the tissue.

[0121]

[0144] Next, in step 5022, the control circuitry 2028 generates the determined cellular oxygenation level, e.g., "95.6%", on the display 2032. The control circuitry 2028 also generates other information on the display 2032, such as an indication as to whether the displayed cellular oxygenation level is within a normal range (e.g., 90%-100%), a caution range (e.g., 70%-89.9%), or an emergency range (e.g., less than 70%). The control circuitry 2028 also generates an audio, visual, or both audio and visual alarm, e.g., to alert a nurse, if the subject's cellular oxygen saturation level is outside of the normal range.

[0122]

[0145] Then, in step 5024, the control circuitry 2028 determines whether to stop determining and monitoring the subject's cellular oxygen saturation level. For example, a user may input a "stop" command to the control circuitry 2028 via the interface 2034. Alternatively, in response to actuating the probe connector release 2042, or in response to the sensor 2040 generating a signal indicating that the probe connector 2008 is not in the receptacle 2020, the control circuitry 2028 may cease determining and monitoring the cellular oxygen saturation level, at least until another probe 2002 is attached to and authorized by the control circuitry.

[0123]

[0146] If the control circuitry 2028 determines that the system 2000 should cease determining and monitoring the subject's cellular oxygen saturation level, then the method represented by flowchart 5000 ends.

[0124]

[0147] If not, the control circuit 2028 proceeds to step 5026 .

[0125]

[0148] In step 5026, the control circuit 2028 implements the delay, the delay having a duration that may range from a suitable minimum duration, which may be as low as 0.0 seconds, to a suitable maximum delay time, such as 60 seconds or more. The control circuit 2028 may include a counter or other clock circuit that measures the delay, or may execute instructions of a clock or another time measurement software application to implement the delay.

[0126]

[0149] After the delay period has expired, the control circuit 2028 returns to step 5016 and repeats steps 5016, 5018, 5020, 5022, 5024 and 5026 until, in step 5024, the control circuit 2028 determines that the system 2000 should cease determining and monitoring the subject's cellular oxygenation level.

[0127]

[0150] 2, 3, 4, and 5, system 2000 and the method depicted in flow chart 5000 may provide one or more advantages over previously proposed systems for determining cellular oxygenation levels. For example, collecting and analyzing wavelengths of electromagnetic energy across a broad spectrum (e.g., about 400 nm to 900 nm or 500 nm to 800 nm) may provide a more accurate reading of cellular oxygenation (e.g., myoglobin oxygen saturation) than collecting and analyzing only a few (e.g., 1 to 5) wavelengths. Additionally, collecting and analyzing wavelengths in two or more spectral regions in the wavelength range of about 400 nm to 900 nm or 500 nm to 800 nm of the electromagnetic spectrum may provide a more accurate reading of cellular oxygen saturation than collecting and analyzing wavelengths in only one of these spectral regions. Additionally, collecting tissue redirected electromagnetic energy diffused within the tissue over multiple radial (e.g., lateral) distances can provide a more accurate reading of cellular oxygen saturation than collecting tissue redirected electromagnetic energy diffused within the tissue over only one radial distance.

[0128]

[0151] 2, 3, 4A-4D and 5, alternative embodiments of the method of use and operation represented by flow diagram 5000 are contemplated. For example, instead of storing an authentication value in memory 4020, the probe head 2010 may include an authentication barcode that the user scans and enters into the base 2004, either directly or via a separate barcode scanner and interface 2034 (the base 2004 may incorporate a barcode scanner), or the user goes online and presents a serial number or other number located on or associated with the probe 2002 to obtain an authentication code that is entered into the base via interface 2034. The control circuitry 2028 may also enable the system to operate, instead of disabling the system 2000 in response to determining that the probe 2002 is unauthorized, but transmits information via the internet to the manufacturer of the system 2000 informing them that an unauthorized probe 2002 has been used, so that the manufacturer can take appropriate action. Further, the order in which the circuitry 2028 activates the groups of illumination optical fibers 4006 during the calibration and cellular oxygen saturation level determination and monitoring procedures may be other than closest (smallest radial distance r) to farthest (largest radial distance), and the calibration procedures may differ from those described. In addition, instead of including an increasing number of illumination fibers 4006 in each group of one or more illumination fibers as the radius r increases, the number of illumination fibers in each group may be the same or similar, and the control circuitry 2028 may control the electromagnetic energy generator 2022 to generate higher intensity electromagnetic energy with increasing radius, such that the level of electromagnetic energy collected by the one or more collection optical fibers 4010 for each group of one or more illumination optical fibers 4006 is approximately the same, or at least has a minimum threshold S / N, regardless of the radial distance between the ends of the illumination optical fibers and the ends of the one or more collection optical fibers.Furthermore, instead of sequentially activating the LEDs corresponding to each group of illumination optical fibers 4006, the control circuitry 2028 can simultaneously activate the LEDs corresponding to all groups of illumination optical fibers according to an orthogonal activation paradigm (e.g., modulating the frequency at which the LEDs are turned "on" and "off" or the intensity of the LEDs according to an orthogonal encoding scheme) that allows the control circuitry 2028 to determine the respective levels of electromagnetic energy collected from each radial distance r, which can allow for the use of lower intensities of electromagnetic energy emitted by the LEDs. Furthermore, although the wavelength ranges over which the spectrometer 2026 spatially separates the collected electromagnetic energy have been described as having uniform widths (e.g., about 0.31 nm, about 10 nm), the width of one wavelength range can be approximately equal to the width of some of the other wavelength ranges or equal to the width of none of the other wavelength ranges. In addition, the control circuitry 2028 can normalize the values ​​determined for each wavelength range in any suitable manner different from the manner described above. Furthermore, the computation circuitry 2048 can implement any suitable algorithm that determines the cellular oxygenation level as a function of the normalized wavelength range values. Further, the control circuitry 2028 may repeat steps 5016, 5018, 5020, and 5022 multiple times before changing the value of the cellular oxygen saturation level on the display 2032, for example, the control circuitry may generate a displayed value of the cellular oxygen saturation level as an average or other mathematical combination of the values ​​of the cellular oxygen saturation level determined over update windows each about 4 seconds long. In addition, because the spectral information collected by the one or more collection optical fibers 4010 and processed by the operational circuitry 2048 is also sufficient for the operational circuitry to determine the blood oxygen saturation level of the subject, the control circuitry 2028 may generate a value of the blood oxygen saturation level on the display 2032 in addition to generating a value of the cellular oxygen saturation level.In addition, because melanin can impede the diffusion of electromagnetic energy in tissue (especially through the skin), the control circuitry 2028 can be configured to control the electromagnetic energy generator 2022 such that the intensity of the generated electromagnetic energy increases as the subject's skin becomes darker and decreases as the subject's skin becomes darker. Further, although the probe head 2010 has been described as including about one collection optical fiber 4010 and multiple illumination optical fibers 4006 spaced at respective distances from the collection optical fiber, it may include about one illumination optical fiber and multiple collection optical fibers spaced at respective distances from the illumination optical fiber (the intensity of the illumination electromagnetic energy is related (e.g., proportional) to the distance between the illumination optical fiber and the active collection optical fiber or fibers). Additionally, while system 2000 is described as being used in emergency and critical care, it can also be used in other applications, such as veterinary medicine (animals), athletic training, to inform surgeons where to amputate limbs (e.g., where the "line" between oxygenated and deoxygenated tissue is) and to monitor organs (e.g., the heart) whose cells contain detectable amounts of myoglobin for transplantation. For example, a medical team can use system 2000 to determine and monitor the cellular oxygenation level of a subject undergoing cardiac surgery or other cardiac procedures, and notify a surgeon, anesthesiologist, or other member of the team if the subject has a low cellular oxygenation level ("low" may be defined as below a set cellular oxygenation level threshold) at any time during the procedure. A medical team can also use system 2000 to determine and monitor the cellular oxygenation level of a subject undergoing surgery or another procedure in which the subject often experiences significant blood loss, so that a surgeon, anesthesiologist, or other member of the team can use the subject's cellular oxygenation level as a factor in determining whether the subject requires a blood transfusion. Examples of such surgeries and other procedures include spinal surgery and liver transplant surgery.Additionally, the control circuitry 2028 may generate an audio or visual (e.g., on the display 2032) alert if one or more of the spectral values ​​being generated by the spectrometer 2026 are outside a preferred range or above or below a threshold, and the alert may prompt the user to ensure that the probe 2002 is properly connected to the base 2004 and the subject. Further, the embodiments described in connection with Figures 1-4D and 6-17 may be applicable to the method represented by the flow diagram 5000 of Figure 5.

[0129]

[0152] FIG. 6 is a plan view, with some parts transparent and other parts cut away, of the array of LEDs 2044 and spectrometer input assembly 6014 of the probe receptacle 2020 of FIGS. 2-3B and the probe connector 2008 of FIGS. 2-3B installed in the probe receptacle, in accordance with one embodiment.

[0130]

[0153] The array 2044 is a fixed linear array of seven LEDs 6000, 6002, 6004, 6006, 6008, 6010, and 6012 arranged in a row, with their centers spaced apart by a distance d that ranges from about 1.5 mm to 5.0 mm. LED 6, the first group 4000 of one or more illumination optical fibers 4006 (one in FIG. 6) is spaced apart by 100 nm and their electromagnetic energy emission sides face into the probe receptacle 2020. To provide electromagnetic energy to the first group 4000 of one or more illumination optical fibers 4006 (one in FIG. 6), the electromagnetic energy generator 2022 (FIG. 2) is configured to activate the LED 6012. To provide electromagnetic energy to the second group 4002 of one or more illumination optical fibers 4006 (two fibers in FIG. 6), the generator 2022 is configured to activate the LEDs 6008 and 6010. To provide electromagnetic energy to the third group 4004 of one or more illumination optical fibers 4006 (four in FIG. 6), the generator 2022 is also configured to activate the LEDs 6000, 6002, 6004 and 6006.

[0131]

[0154] An input 6014 to the spectrometer 2026 (FIG. 2) is adjacent to the LED array 2044 and is configured to receive the redirected electromagnetic energy collected by the collection optical fiber 4010 and provide the received electromagnetic energy to a portion of the spectrometer 2026 (e.g., an optical grating or prism) configured to spatially separate the received electromagnetic energy into multiple wavelength ranges. The input 6014 may be any suitable structure, such as an optical train or other optical assembly.

[0132]

[0155] The probe connector 2008 includes a housing 6016 that includes one or more (seven in FIG. 6 ) illumination fiber channels 6018 configured to hold and secure input ends 6020 of one or more illumination optical fibers 4006, and one or more (one in FIG. 6 ) collection fiber optic channels 6022 configured to hold and secure output ends 6024 of one or more collection optical fibers 4010. The housing 6016 may be made from any suitable material, such as plastic or rubber.

[0133]

[0156] The probe connector 2008 further includes a back surface 6026 configured to face the LED array 2044 while the probe connector is installed in the probe receptacle 2020, and the illumination optical fiber 4006 and the collection optical fiber 4010 are spaced apart from each other by approximately the same distance d sufficient to protect the end faces 6028 and 6030 of the respective optical fibers 4006 and 4010 from damage. recess For example, the distance d recess can range from about 0.0 mm to 5 mm.

[0134]

[0157] While the probe connector 2008 is installed in the probe receptacle 2020, the rear end 6026 of the probe connector and the LEDs of the array 2044 are spaced apart by a distance d gap This distance d gapis sufficient to protect the probe connector from damage caused by heat generated by the LEDs, to protect the LEDs from damage and from materials (such as dirt) that may be transported by the probe connector and block, scatter, or redirect the electromagnetic energy emitted by the LEDs away from their respective channels 6018, and to protect the spectrometer input 6014 from damage and materials (such as dirt) that may be transported by the probe connector and block, scatter, or redirect the collected electromagnetic energy emanating from the end 6024 of the collection optical fiber 4010 away from the spectrometer input. recess In an embodiment where the separation distance d is approximately equal to zero, gap is also sufficient to protect the fiber end faces 6028 and 6030 from damage and materials (e.g., dirt) that may block, diffuse, or redirect the electromagnetic energy directed to the illumination optical fiber 4006 or emanating from the collection optical fiber 4010. For example, the separation distance d gap can range from about 0.0 mm to 5 mm.

[0135]

[0158] The receptacle 2020 includes a blocking member 6032 configured to prevent "crosstalk" of electromagnetic energy between the illumination optical fiber 4006 and the collection optical fiber 4010, as such crosstalk may cause errors in one or more cellular oxygen saturation levels determined by the computational circuitry 2048 (FIG. 2). (As used herein, "preventing crosstalk" means attenuating crosstalk with an attenuation factor that is at least about 50%). The blocking member 6032 may have any suitable dimensions and may be made from any material, such as an opaque plastic or metal, suitable for blocking one or wavelengths of electromagnetic energy emitted by the LEDs 6000-6012 (see also FIG. 11, which is a side view of the blocking member 6032).

[0136]

[0159] Furthermore, the distance d recess and d gapOne or both may also be deep enough and shallow enough, respectively, to prevent LED "crosstalk," i.e., to prevent light from an LED (e.g., LED 6000) from entering the face 6028 or 6030 of an optical fiber aligned with another LED (e.g., LED 6002).

[0137]

[0160] In addition, the diameter of the optical fibers 4006 and 4010 may be approximately the same as the diameter of the emitting portions of the LEDs in the array 2044 (eg, approximately 1.0 mm).

[0138]

[0161] 6, alternative embodiments of the probe connector 2008 and receptacle 2020 are contemplated. For example, the blocking member 6032 may be omitted if the channels 6018 and 6022 are surrounded by an electromagnetic energy blocking material sufficient to prevent "crosstalk" between the illumination optical fiber 4006 and the collection optical fiber 4010. Furthermore, the channels 6018 and 6022 may not be openings in a physical structure, but may be regions of space occupied by the illumination optical fiber 4006 and the collection optical fiber 4010, and the coating around the optical fibers may be made of an electromagnetic energy blocking material sufficient to prevent crosstalk between the optical fibers. Additionally, the embodiments described in connection with FIGS. 1-5 and 7-17 may be applicable to the probe connector 2008, the probe receptacle 2020, or both the probe connector and the probe receptacle of FIG. 6.

[0139]

[0162] FIG. 7 is a bottom view of the probe connector 2008 of FIGS. 2, 3A, 3B and 6, according to one embodiment.

[0140]

[0163] FIG. 8 is a view of the rear end 6026 of the probe connector 2008 of FIGS.

[0141]

[0164] FIG. 9 is a top view of the probe connector 2008 of FIGS. 2, 3A, 3B, 6, 7 and 8 according to one embodiment.

[0142]

[0165] FIG. 10 is a view of the front end of the probe connector 2008 of FIGS. 2, 3A, 3B, 6, 7, 8 and 9 according to one embodiment.

[0143]

[0166] 7-10, in addition to the illumination optical fiber channel 6018 and the collection optical fiber channel 6022, the probe connector 2008 includes a rear insertion end 7000, a front gripping end 7002, a blocking member cutout 7004, a latch engagement region 7006 (e.g., a latch engagement recess or cutout), and a front end face or surface 10000.

[0144]

[0167] The insertion back end 7000 includes a back end face 6026 through which the optical fiber channels 6018 and 6022 open and is adapted to be inserted into and engaged with a probe receptacle 2020 (FIGS. 2, 3A, 3B, and 6). For example, the back end 7000 can be formed from a rigid material such as a hard plastic.

[0145]

[0168] The gripping front end 7002 is attached to or integral with the insertion rear end 7000 and is constructed to be gripped by a human hand to facilitate insertion and removal of the insertion rear end from the probe receptacle 2020 (FIGS. 2, 3A, 3B, and 6). For example, the gripping front end 7002 includes a concave portion 7003 configured to facilitate gripping by hand and is formed from a flexible material such as vinyl or vinyl coated foam. The fiber optic channels 6018 and 6022 open through the front end face 10000 of the front end 7002, and the illumination fiber optic 4006 and the collection fiber optic 4010 (FIG. 4A) extend from the front end face 10000 of the front end 7002.

[0146]

[0169] The blocking member cutout 7004 is configured to engage with the blocking member 6032 of Figures 6 and 11. The cutout 7004 has a front portion 7008 that extends entirely through the rear end 7000 and a rear portion 7010 that extends only through a portion of the rear end. The cutout 7004 has an "L" shape (portion 7008 is the bottom of the "L") that complements the "L" shape of the blocking member 6032 (see Figure 11) such that during insertion of the rear end 7000 into the probe receptacle 2020, the blocking member eventually engages the rear end 7012 of portion 7010, which engagement acts to prevent further insertion of the rear end 7000 into the probe receptacle.

[0147]

[0170] The latch engagement region 7006 is also configured to engage with a latch of a probe connector clamping mechanism, as described in connection with Figures 13 and 14. For example, while the probe connector 2008 is installed in the probe receptacle 2020, the latch presses against the latch engagement region 7006 to hold the insertion end 7000 stable and rigid (e.g., with little or no wobble) within the receptacle, such that the channels 6018 and 6022 are brought into and remain optically aligned with the respective LEDs of the array 2044 (Figure 6) and the spectrometer input 6014 (Figure 6), respectively.

[0148]

[0171] 7-10, alternative embodiments of the probe connector 2008 are contemplated. For example, one or more of the insertion trailing end 7000, the front end 7002, the blocking member cutout 7004, and the latch engagement region 7006 may each have their own suitable shape and their own suitable characteristics other than those described. Additionally, the embodiments described in connection with Figures 1-6 and 11-17 may also be applicable to the probe connector 2008 of Figures 7-10.

[0149]

[0172] Figure 11 is a side view of the electromagnetic energy blocking member 6032 of Figure 6, according to one embodiment. The blocking member 6032 has a rear portion 11000 with a greater height toward the inside of the base 2004 (Figure 2) and a front portion 11002 with a lesser height toward the outside of the base, such that the blocking member 6032 has an "L" shape. The rear portion 11000 of the blocking member 6032 is configured to engage with a front portion 7008 of the blocking member cutout 7004 of the probe connector 2008 (Figures 7-10), and the blocking member front portion 11002 is configured to engage with portion 7010 of the blocking member cutout while the probe connector is fully inserted into the probe receptacle 2020 (Figure 6). While the probe connector 2008 is fully inserted and securely held within the probe receptacle 2020, the blocking member 6032 is configured to block electromagnetic energy leaking from the illumination optical fiber 4006 (FIG. 4) from leaking into the collection optical fiber 4010 and to block electromagnetic energy leaking from the collection optical fiber from leaking into one or more of the illumination optical fibers, thus limiting or eliminating crosstalk between the illumination optical fiber or optical fibers and the collection optical fiber or optical fibers. The surface 11004 of the blocking member 6032 acts to prevent further insertion of the probe connector 2008 (FIGS. 7-10) into the probe receptacle 2020 when the surface 11004 engages the end face 7012 of the cutout 7004. As discussed above, the blocking member 6032 may be formed from any suitable material that blocks electromagnetic energy in approximately the same wavelength range (e.g., about 500 nm to about 800 nm) as the electromagnetic energy emitted by the electromagnetic energy generator 2022 (FIG. 2) with an attenuation coefficient of at least about 50%. Examples of suitable materials include plastics, metals, and ceramics.

[0150]

[0173] 11, alternative embodiments of the electromagnetic energy blocking member 6032 are contemplated. For example, the blocking member 6032 may have any suitable shape other than an "L" shape. Additionally, the embodiments described in connection with FIGS. 1-10 and 12-17 may be applicable to the blocking member 6032 of FIG.

[0151]

[0174] 12 is a partially exploded isometric view of approximately one half of the front portion 12000 of the front end 7002 of the probe connector 2008 of FIGS. 2, 3, and 6-10, in accordance with one embodiment. The front end 7002 has a "clamshell" configuration, with the illustrated portion 12000 of the front end being one half of the clamshell. During manufacture of the probe connector 2008, after the optical fibers 4006 and 4010 (FIG. 6) are placed in one half of the clamshell, the two halves of the clamshell are aligned and then secured together in any suitable manner, such as with an adhesive or by welding.

[0152]

[0175] The portion 12000 has an inner fiber slot 12002 1 ~12002 8 and outer fiber slot 12004 1 ~12004 8 12002, each pair of linearly aligned inner and outer fiber slots configured to receive and hold a respective optical fiber (optical fiber not shown in FIG. 12). 1 and 12004 1 12002 includes a pair of linearly aligned inner and outer fiber slots 12003 configured to hold collection optical fibers 4010 (FIG. 6). 2 and 12004 2 4002 includes a pair of linearly aligned inner and outer fiber slots 12002 configured to hold the illumination optical fibers 4006 in the group 4000 (FIG. 6). 3 ~12002 4 and 12004 3 ~12004 4 4002 (FIG. 6) are linearly aligned pairs of inner and outer fiber slots 12002 each configured to hold a respective illumination optical fiber in group 4002 (FIG. 6). 5 ~12002 8 and 12004 5 ~12004 8are each configured to hold a respective illumination optical fiber in group 4004 (FIG. 6).

[0153]

[0176] Each inner fiber slot 12002 includes a respective pair of grippers 12006 that are configured to hold a respective one of the optical fibers to prevent damage to the probe connector 2008 (FIGS. 2-3B and 6-10) even if a person (e.g., a moving object) pulls on the fiber during normal use of the probe 2002 (FIG. 2). That is, the grippers 12006 are configured to counter at least a majority of the pulling forces that may be applied to the optical fibers 4006 and 4010 during normal use of the probe 2002. The grippers 12006 may be made of any suitable material, such as plastic or rubber, and are configured to counteract pulling forces having Cartesian (xyz) components of approximately 46.0 Newtons (N) in the axial (along the fiber, e.g., z) dimension, 8.0 N in the lateral (e.g., x) dimension, and up to 8.0 N in the up-down (e.g., y) dimension.

[0154]

[0177] Further, each of the outer slots 12004 has a width d in the range of about 1.7 mm to 2.7 mm, for example 2.2 mm. os Each of the inner slots 12002 has a width d between the grippers 12006 in the range of about 1.45 mm to 2.45 mm, e.g., 1.95 mm. is has.

[0155]

[0178] 12, alternative embodiments of region 12000 of probe connector front 7002 are contemplated. For example, region 12000 may have a configuration other than a clamshell configuration. Further, inner and outer slots 12002 and 12004 and gripper 12006 may have dimensions other than those described. Additionally, the other half of the clamshell may be similar to the half described, but does not have inner and outer fiber slots 12002 and 12004. Furthermore, the embodiments described in connection with FIGS. 1-11 and 13-18 may be applicable to region 12000 of FIG.

[0156]

[0179] FIG. 13 is a cutaway side view of the probe connector receptacle 2020 and the probe connector clamping mechanism 13000 in an open state with the probe connector 2008 not installed in the receptacle, according to one embodiment.

[0157]

[0180] FIG. 14 is a cutaway side view of the probe connector receptacle 2020 and clamping mechanism 13000 in a closed state with the probe connector 2008 installed and the mechanism holding the probe connector in place, according to one embodiment.

[0158]

[0181] FIG. 15 is a top view of the probe connector 2008 (with some features omitted) and kinematic alignment contact areas configured to contact corresponding areas of the probe receptacle 2020 of FIG. 2, according to one embodiment.

[0159]

[0182] 13 and 14, in addition to the probe connector sensor (a microswitch in the disclosed embodiment) 2040, the probe connector clamping mechanism 13000 includes a connector engagement latch 13002, a latch pivot rod 13004, a linking arm 13006, link arm pivot areas 13008 and 13010, a lever 13012, a lever pivot rod 13014, a bias spring 13016 (one spring is shown in FIGS. 13 and 14 in an open position 13018 (lighter shade) and a closed position 13020 (darker shade)), a motor 13022 with a D shaft 13024, a mechanism opening / closing cam 13026, and six kinematic alignment support areas (only two of which, 13028 and 13030, are shown in FIGS. 13 and 14).

[0160]

[0183] Machine screws 13032 secure a structure 13036 that forms the probe receptacle 2020 and at least a portion of the clamping mechanism 13000 to a bottom panel 13034 of the system housing (3002 in FIG. 3A and 3020 in FIG. 3B).

[0161]

[0184] Referring to FIG. 15, the probe connector 2008 and receptacle 2020 (FIGS. 13-14) are configured such that while the clamping mechanism 13000 is in an engaged state, the probe connector is stably kinematically aligned with the LED array 2044 (FIG. 2) and spectrometer input 6014 (FIG. 6) by contacting the inner walls of the receptacle at six kinematic alignment contact areas 15000, 15002, 15004, 15006, 15008 and 15010. Contact area 15000 is located along the side of the insertion trailing end 7000 of the probe connector 2008, contact areas 15002 and 15004 are located along the rear face 6026 of the probe connector, and contact areas 15006, 15008 and 15010 (shown in dashed lines) are located along the side of the probe connector opposite (e.g., the bottom side) from the side on which the latch engagement area 7006 is located. With reference to Figures 13 and 14, the receptacle 2020 may include a respective raised kinematic contact support area, such as areas 13028 and 13030, for each of one or more of the contact areas 15000, 15002, 15004, 15006, 15008 and 15010. The location of the contact area can be determined conventionally and is related to the characteristics of the probe connector 2008 (eg, dimensions, center of gravity, flexibility, location of the fiber optic channels 6018 and 6022).

[0162]

[0185] The operation of the probe connector fastening mechanism 13000 according to one embodiment will be described with reference to FIGS.

[0163]

[0186] The mechanism 13000 initially has an open state, as shown in FIG.

[0164]

[0187] The user then inserts the probe connector 2008 into the receptacle 2020 until the probe connector activates the sensor 2040, for example, if the sensor is a microswitch, the user fully inserts the probe connector until the rear face 6026 (FIG. 8) of the probe connector presses the microswitch button, thereby activating the switch.

[0165]

[0188] In response to the sensor 2040 being activated, the control circuit 2028 (FIG. 2) then actuates the motor 13022, causing the motor to rotate the cam 13026 from its disengaged position of FIG. 13 to its engaged position of FIG.

[0166]

[0189] The rotation of the cam 13026 from its disengaged position to its engaged position may result in the tensioned spring 13016 contracting from its disengaged (e.g., higher tension) state 13018 to its engaged (e.g., lower tension) state 13020.

[0167]

[0190] The contracting spring 13016 pulls the bottom of the lever 13012 towards the spring. When the spring is fully contracted, it pulls the lever 13012 with a force in the range of about 70 Newtons (N) to 90 N, for example 80 N. Furthermore, the cam 13026 in its engaged position barely supports the force generated by the spring 13016, for example, while the spring and cam are in their engaged state, a gap exists between the lever 13012 and the cam 13026 (not shown), such that the cam does not support any of the spring force while the clamping mechanism 13000 holds the probe connector 2008 in the receptacle 2020.

[0168]

[0191] As the contracting spring 13016 pulls the bottom of the lever 13012 towards the spring, the lever rotates counterclockwise about the pivot rod 13014 such that the upper portion of the lever urges the coupling member 13006 away from the spring.

[0169]

[0192] The coupling member 13006 moving away from the spring 13016 towards the receptacle 2020 causes the engagement latch 13002 to rotate in a counterclockwise direction about the pivot rod 13004 thus engaging the latch 13002 with the latch engagement region 7006 . When the latch 13002 engages with the latch engagement area 7006, it holds the optical fiber channels 6018 and 6022 (e.g., FIG. 6) in kinematically stable alignment with the LEDs and spectrometer input 6014 (FIG. 6) of the array 2044 (FIG. 6), respectively, by pressing the six kinematic alignment contact areas 15000, 15002, 15004, 15006, 15008 and 15010 with respective forces against respective kinematic contact support areas of one or more inner walls of the receptacle 2020, for example, the latch 13002 presses each of the contact areas 15008 and 15010 against support areas 13028 and 13030, respectively, of the probe receptacle. Because the force pressing contact area 15000 against an inner receptacle wall is orthogonal to the force pressing contact areas 15002 and 15004 against another inner receptacle wall, and is orthogonal to the force pressing contact areas 15006, 15008 and 15010 against yet another inner receptacle wall, pivot arm 13004 is not orthogonal to the page of Figures 13 and 14, but is tilted in the horizontal dimension from an orthogonal plane by an angle in the range of about 2.5° to 15°, such as in the range of 10° to 15°. The horizontal angle of pivot arm 13004 allows engagement latch 13002 to exert a force in both the vertical as well as the horizontal dimension. Further, the latch engagement region 7006 has a surface 15012 inclined at an angle a relative to an orthogonal plane 15014 (which is approximately parallel to the orthogonal plane about which the pivot arm 13004 is inclined) to accommodate the inclined pivot arm 13004, for example, angle a can be approximately equal to the angle at which the pivot arm 13004 is inclined.

[0170]

[0193] To remove the probe connector 2008 from the receptacle 2020, the user actuates the probe connector release 2042 (FIG. 2), which may be a physical button on the interface 2034 (FIG. 2) or a virtual button displayed on the display 2032.

[0171]

[0194] In response to a signal generated by actuation of the release portion 2042 (FIG. 2), the control circuit 2028 (FIG. 2) actuates the motor 13022, causing the motor to rotate the cam 13026 from its engaged position (FIG. 14) to its disengaged position (FIG. 13).

[0172]

[0195] As a result of the cam 13026 rotating from its engaged position to its disengaged position, the cam 13026 urges the bottom of the lever 13012 in a direction towards the receptacle 2020 , which causes the spring to extend from its engaged state 13020 to its disengaged state 13018 .

[0173]

[0196] The expanding spring 13016 pulls the bottom of the lever 13012 against the cam 13026, causing the cam 13026 to support most or all of the force generated by the spring 13016 in its disengaged position.

[0174]

[0197] As the cam 13026 urges the bottom of the lever 13012 away from the spring and toward the receptacle 2020, the lever rotates clockwise about the pivot rod 13014 such that the upper portion of the lever pulls the coupling member 13006 toward the spring 13016.

[0175]

[0198] Movement of the coupling member 13006 towards the spring 13016 and away from the receptacle 2020 causes the engagement latch 13002 to rotate clockwise about the pivot rod 13004 thus disengaging the latch 13002 from the latch engagement region 7006 of the probe connector 2008 .

[0176]

[0199] Once the latch 13002 disengages from the latch engagement region 7006 , the user can freely remove the probe connector 2008 from the receptacle 2020 with little or no resistance from the disengaged fastening mechanism 13000 or the inner walls of the receptacle 2020 .

[0177]

[0200] 13-15, alternative embodiments of the clamping mechanism 13000, the kinematic alignment aspects of the probe connector 2008, and the operation of the clamping mechanism are contemplated. For example, the latch pivot arm 13004 can be tilted vertically out of the plane perpendicular to the page of FIGS. 13 and 14 instead of or in addition to being tilted horizontally. Furthermore, the clamping mechanism 13000 can be omitted and the receptacle 2020 and probe connector 2008 can be designed such that the fit of the probe connector within the receptacle is sufficiently "tight" such that when the probe connector is inserted into the receptacle, the fiber optic channels 6018 and 6022 are held within the receptacle in stable kinematic alignment with the LEDs of the array 2044 (FIG. 2) and the input to the spectrometer 6014 (FIG. 6). Additionally, although the pivot arm 13014 is depicted as being orthogonal to the page in Figures 13 and 14, it may be tilted horizontally, vertically, or both horizontally and vertically relative to a plane orthogonal to the page in Figures 13 and 14. Additionally, the embodiments described in connection with Figures 1-12 and 16-18 may be applicable to the clamping mechanism 13000, its operation, and the kinematic alignment aspects of the probe connector 2008 of Figures 13-15.

[0178]

[0201] 16-18 are respective portions 16002, 17000 and 18000 of a flowchart 16000 of a method for generating and collecting data for training a cellular oxygen saturation level learning algorithm model executable by the computational circuit 2048 (FIG. 2) to determine a human's cellular oxygen saturation level, according to one embodiment.

[0179]

[0202] The training data is collected from human model-training subjects who are statistically diverse in at least the following physical traits: skin color (hereinafter "skin color"), as measured by, for example, the Fitzpatrick scale, body mass index (BMI), age, and biological sex. Other physical traits for which the human model-training subjects may be statistically diverse include the size of the body part (e.g., hand) from which the training data was generated, fitness level, hydration level, and overall health status (e.g., having diabetes) during the period the training data was collected. For example, it is theorized that a suitable number of sets of training data can be collected from a total of about 150 diverse humans (e.g., individuals statistically diverse in at least skin color, BMI, age, and biological sex).

[0180]

[0203] 2 and 16-18, a method represented by a flowchart 16000 will be described according to one embodiment.

[0181]

[0204] Referring to FIG. 16, in step 16004, a user, such as a medical professional or trained data collector, places the probe 2002 (FIGS. 2-3B) on the base 2004 (FIGS. 2-3B) by "plugging" the probe connector 2008 (FIGS. 13 and 14) into the probe connector receptacle 2020 (FIGS. 13 and 14).

[0182]

[0205] Next, in step 16006, the control circuit 2028 performs a spectral calibration, as described in connection with step 5006 of Figure 5. Assuming that the control circuit 2028 does not detect a problem during the calibration routine (see step 5010 of Figure 5), the control circuit proceeds to step 16006.

[0183]

[0206] In step 16008, the user attaches the probe head 2010 to the body part from which training data is being collected (eg, the ball of the subject's hand), as described in connection with step 5014 of FIG. 5 .

[0184]

[0207] 17, in step 17002, a user causes cells, e.g., skeletal muscle cells, in at least the body site to which the probe head 2010 is attached to be oxygenated. For example, the user may oxygenate cells in the body, e.g., skeletal muscle cells, with oxygen normally found in air (O 2 The subject can be fitted with a mask or cannula connected to a source of oxygen with a concentration higher than the circulating oxygen concentration, e.g., a concentration in the range of about 30%-100%. Assuming the subject is healthy, when the subject breathes in the high concentration of oxygen, the subject's cells become nearly or completely saturated with oxygen. For example, the subject's cells will have an oxygen saturation level in the range of about 95%-100%.

[0185]

[0208] Next, in step 17004, the control circuitry 2028 controls the system 2000 to execute or otherwise perform the training data collection protocol of FIG.

[0186]

[0209] 4 and 18, in step 18002, the control circuit 2028 operates the electromagnetic energy generator 2022 so that the LEDs of the array 2044 sequentially radiate electromagnetic energy to the input ends of the illumination optical fibers 4006 in groups 4000, 4002 and 4004 (and optionally additional groups) for first, second and third (and optionally subsequent) training illumination times, respectively, in a manner similar to that described in connection with step 5016 of FIG. 5.

[0187]

[0210] During the first training illumination time, emitted electromagnetic energy emerges from the output end of one or more illumination optical fibers 4006 in group 4000 (only one such fiber is shown in FIG. 4 ) and illuminates cells (e.g., skeletal muscle cells) in the region of the subject's body to which probe head 2010 is fixed. Even during the first training illumination time, the illuminated cells redirect a portion of this electromagnetic energy to be collected by one or more collection optical fibers 4010 (only one collection optical fiber is shown in FIG. 4 ), which direct the collected electromagnetic energy to an input 6014 of spectrometer 2026 ( FIG. 6 ).

[0188]

[0211] Similarly, during a second training irradiation time, radiated electromagnetic energy is emitted from the output end of one or more illumination optical fibers 4006 in group 4002 (only two such fibers are shown in FIG. 4 ) to irradiate cells (e.g., skeletal muscle cells) in the region of the subject's body to which the probe head 2010 is fixed.

[0189]

[0212] Further, during the second training illumination period, the irradiated cells redirect a portion of this electromagnetic energy for collection by one or more collection optical fibers 4010 (only one collection optical fiber is shown in FIG. 4), which direct the collected electromagnetic energy to an input 6014 of the spectrometer 2026 (FIG. 6).

[0190]

[0213] During the third training irradiation time, the radiated electromagnetic energy is also emitted from the output end of one or more illumination optical fibers 4006 in group 4004 (only four such fibers are shown in FIG. 4 ) to irradiate cells (e.g., skeletal muscle cells) in the region of the subject's body to which the probe head 2010 is fixed.

[0191]

[0214] Additionally, during the third training illumination period, the illuminated cell redirects a portion of this electromagnetic energy for collection by one or more collection optical fibers 4010 (only one collection optical fiber is shown in FIG. 4), which direct the collected electromagnetic energy to an input 6014 of the spectrometer 2026 (FIG. 6).

[0192]

[0215] 5 and concurrent with step 18002, the spectrometer 2026 resolves the redirected electromagnetic energy collected by the group 4008 of one or more collection optical fibers 4010 (one collection optical fiber in the described embodiment) and provided to the spectrometer input into a plurality of wavelength ranges. For example, in an embodiment in which the wavelengths of the spectrum of the redirected electromagnetic energy range from about 501 nm to 850 nm, the spectrometer 2026 may resolve the collected electromagnetic energy into the following 35 wavelength ranges: about 501 nm to 510 nm, about 511 nm to 520 nm, about 521 nm to 530 nm, ..., about 831 nm to 840 nm, and about 841 nm to 850 nm.

[0193]

[0216] For each wavelength range, the spectrometer 2026 also generates one or more values ​​respectively related to one or more characteristics of the wavelengths in the wavelength range. For example, the spectrometer generates a value related to the combined intensity (e.g., magnitude, amplitude, power) of the wavelengths in the wavelength range. In a further example, the spectrometer 2026 generates a respective analog electrical signal as a representative of each value and converts the analog signal to a corresponding digital signal. In yet another example, the spectrometer 2026 generates multiple digital samples of each characteristic for each wavelength range and mathematically combines (e.g., averages) these samples to generate a respective value of each analyzed spectral characteristic for each wavelength range.

[0194]

[0217] For purposes of clarity, in the following description, spectrometer 2026 generates only a value for intensity for each wavelength range, but it will be understood that the spectrometer can generate values ​​for other wavelength range characteristics instead of or in addition to intensity for each wavelength range.

[0195]

[0218] Further, in step 18004, for each wavelength range of the collected electromagnetic energy during the first training illumination time, the spectrometer 2026 generates a respective value related to the intensity as described above, and the control circuit 2028 calculates each value in relation to the wavelength range and radius r of the group 4000 of one or more (here one) illumination optical fibers 4006. 1 The information is stored in the memory 2030 so as to be associated with the

[0196]

[0219] During the second training illumination period, for each wavelength range of collected electromagnetic energy, the spectrometer 2026 generates a respective value related to the intensity, and the control circuit 2028 calculates each value in relation to the wavelength range and radius r of the group 4002 of one or more (here two) illumination optical fibers 4006. 2 The information is stored in the memory 2030 so as to be associated with the

[0197]

[0220] During the third training illumination period, for each wavelength range of collected electromagnetic energy, the spectrometer 2026 generates a respective value related to the intensity, and the control circuit 2028 calculates each value in relation to the wavelength range and radius r of one or more (here four) groups 4004 of illumination optical fibers 4006. 3 The information is stored in the memory 2030 so as to be associated with the

[0198]

[0221] For each wavelength range of collected electromagnetic energy, if present, during each subsequent training illumination period, the spectrometer 2026 also generates a respective value related to the intensity, and the control circuit 2028 calculates that value in relation to the wavelength range and radius r of each group of one or more illumination optical fibers 4006. n The information is stored in the memory 2030 so as to be associated with the

[0199]

[0222] As described above, the number of illumination optical fibers 4006 in a group increases with increasing radius r so that the level of electromagnetic energy (e.g., number of photons) collected by one or more (here one) collection optical fibers 4010 during each of the first, second, third and any subsequent illumination periods is approximately equal to the level of electromagnetic energy collected during other illumination periods or has at least a minimum threshold S / N.

[0200]

[0223] Next, in step 18006, the computation circuitry 2048 digitizes and stores in memory 2030 values ​​corresponding to one or more characteristics (e.g., intensity) of each of the collected wavelength ranges, which together constitute a respective training spectrum. The computation circuitry 2048 then normalizes, in step 18004, each of the values ​​stored in memory 2030 during the first, second, third and any subsequent training exposure times to generate values ​​that constitute the training spectrum. For each stored value that is being normalized, the computation circuitry 2048 first divides the stored value by the corresponding calibration value previously determined in step 16006 and stored in memory 2030. For example, if "200" is used to normalize the radial distance r during the first training exposure time, then the computation circuitry 2048 first divides the radial distance r during the first training exposure time. 1 If "300" is the decimal representation of the digital intensity values ​​stored for the wavelength range 501 nm to 510 nm and "300" is the decimal representation of the corresponding digital intensity calibration values ​​stored for the same wavelength range and same radial distance during the calibration procedure, then arithmetic circuit 2048 generates the quotient 300 / 200=3 / 2=1.50. Then arithmetic circuit 2048 calculates log 10 The radial distance r over the first exposure time is equal to (1.50)=0.18 1 Instead, the arithmetic circuit 2048 generates a normalized version of the value "200" in the wavelength range 501 nm to 510 nm in |log 10(1.50)|=0.18. The computation circuitry 2048 normalizes each of the other values ​​stored in the memory 2030 during the first, second, third and any subsequent training illumination times in a similar manner. Normalizing the values ​​can reduce the magnitude of errors or completely eliminate errors caused by variations in the spectrum generated by the electromagnetic energy generator 2022 due to, for example, aging of the LEDs in the array 2044, variations in the temperature of the generator or the supply voltage provided to the generator between training subjects, and differences in the electromagnetic energy irradiated and collected between the probes 2002 during the training procedure. As described above, the set of stored normalized intensity values ​​for all of the wavelength ranges and radii over the set of illumination times constitutes a single set of training data representative of highly oxygenated cells, i.e., data that can be used to train a cellular oxygenation level determination model executed by the computation circuitry 2048 to accurately determine the cellular oxygenation level of highly oxygenated cells.

[0201]

[0224] 17, in step 17006, the control circuitry 2028 determines whether the time to oxygenate the body part being trained has expired; for example, the control circuitry may include a hardwired clock or may execute program instructions that cause the control circuitry to act as a clock to "count down" a set oxygenation time, which may range, for example, from about 1.0 to 20.0 minutes. If the oxygenation time has not expired, in step 17007, the control circuitry 2028 implements a delay ranging from about 0 to 60 seconds, and after the expiration of the delay, returns to step 17002 to generate another set of training data representative of cells whose oxygenation has either risen from normal to a high level or stabilized at a high level. However, if the oxygenation time has expired, the training method proceeds to step 17008.

[0202]

[0225] In step 17008, the training data collection technician induces ischemia in the subject's body part to which the probe head 2010 (FIGS. 2 and 4) is attached. For example, if the probe head 2010 is attached to the ball of the model training subject's hand, the technician places a blood pressure cuff on the subject's arm to which the hand is attached and inflates the cuff to occlude blood flow to the hand. The training method then proceeds to step 17010.

[0203]

[0226] Next, in step 17010, the control circuit 2028 again performs steps 18002, 18004, and 18006 of FIG. 18 to generate and store in memory 2030 a set of training data representing cells having oxygenation levels that drop from a high level (e.g., 95%-100%) to a low level (e.g., 0%-50%) and stabilize at the low level in a manner similar to that described in connection with step 17004.

[0204]

[0227] Then, in step 17012, the control circuitry 2028 determines whether the time for inducing ischemia in the body part being trained has expired; for example, the control circuitry 2028 may include a hardwired clock or may execute program instructions that cause the control circuitry to act as a clock to "count down" a set ischemia induction time, which may range, for example, from about 1.0 to 20.0 minutes. If the ischemia induction time has not expired, in step 17013, the control circuitry 2028 implements a delay ranging from about 0 to 60 seconds, and after expiration of the delay, returns to step 17008 to generate another set of training data representative of cells whose oxygenation has either decreased from a high level to a low level or stabilized at a low (oxygen deficient) level. However, if the ischemia induction time has expired, the training method proceeds to step 17014.

[0205]

[0228] In step 17014, the training data collection technician removes the cause of the ischemia induced in step 17008 to restore normal blood flow to the subject's body part to which the probe head 2010 (FIGS. 2 and 4) is attached. For example, if the probe head 2010 is attached to the ball of the training subject's hand and in step 17008 the technician placed a blood pressure cuff from a sphygmomanometer around the subject's arm to which the hand is attached, the technician deflates the cuff to restore blood flow to the hand while the training subject inhales normal air. The training method then proceeds to step 17016.

[0206]

[0229] Next, in step 17016, the control circuitry 2028 again performs steps 18002, 18004, and 18006 of FIG. 18 to generate and store in memory 2030 a set of training data representing cells whose oxygenation has increased from a low level (oxygen deprivation) to a normal level (e.g., 88%-95%) or is stable at a normal level, in a manner similar to that described in connection with step 17004.

[0207]

[0230] Then, in step 17018, the control circuitry 2028 determines whether the time to reoxygenate the body part being trained has expired; for example, the control circuitry 2028 may include a hardwired clock or may execute program instructions that cause the control circuitry to act as a clock to "count down" a set reoxygenation time, which may range, for example, from about 1.0 to 20.0 minutes. If the cellular reoxygenation time has not expired, in step 17020, the training method waits a delay ranging from about 0 to 60 seconds and returns to step 17014 to generate another set of training data representative of cells reoxygenating. However, if the reoxygenation time has expired, the training method proceeds to step 17022.

[0208]

[0231] In step 17022, the training technician or control circuitry 2028 determines whether training data should be generated using another test subject. If the technician or control circuitry 2028 determines that training data should be generated using another subject, the technician removes or otherwise releases the probe head 2010 from the subject, removes the probe connector 2008 from the receptacle 2020, discards the probe 2002, and the training method returns to step 16004 (FIG. 16). However, if the technician or control circuitry 2028 determines that no additional training data needs to be generated, the training method proceeds to step 17024.

[0209]

[0232] In step 17024, a person (not necessarily a training technician) trains the learning algorithm model executed by the computing circuitry 2048 using the generated and stored (at least initially in memory 2030) training data according to any suitable training protocol, which may be conventional. The training in step 17024 does not have to occur within any particular time after step 17022 and may be considered a method that is not part of the method represented by flowchart 16000. For example, the stored training data may be transported to a location remote from the training data collection site, such as a computer lab, for training the algorithm model.

[0210]

[0233] 16-18, the training data includes the spectrum occurring during all potential cellular oxygenation and cellular deoxygenation events that may be experienced by a patient or other subject having a wide set of physical traits. By appropriately setting the oxygenation, ischemia and cellular reoxygenation times per steps 17006, 17012 and 17018, the described training method generates and collects training data representative of cells whose oxygenation rises from a normal level to a high level, remains stable at a high level, falls from a high level to a low level and remains stable at a low level, rises from a low level to a normal level and remains stable at a normal level. Furthermore, by testing a suitable number of subjects with statistically diverse traits such as age, biological sex, skin color and BMI, the amount and variety of training data is suitable for training an algorithmic model executed by the computing circuitry 2048 such that the cellular oxygenation level determination and monitoring system 2000 (FIG. 2) can accurately determine and monitor cellular oxygenation levels for most or all patients experiencing most or all known medical events. For example, testing about 100-200 subjects, such as about 150 subjects, following the methods and subject diversity described in connection with Figures 16-18 can result in a large number of diverse training spectra, in the range of about 50,000-2,000,000, which is sufficient to train an algorithmic model to exhibit no bias, at least with respect to traits that are statistically diverse among the test subjects.

[0211]

[0234] 16-18, alternative embodiments of the training data generation and collection method are contemplated. For example, one or more of steps 17002, 17008, and 17014 may be omitted from the method. Furthermore, instead of collecting training data for one algorithmic model and training the algorithmic model, one may collect training data for multiple algorithmic models, one model for each of multiple physical traits, and train such algorithmic models. For example, there may be a respective model for each skin color as defined by Fitzpatrick skin type, each of multiple BMI ranges, each biological sex, or each of multiple age ranges. In such an embodiment, the control circuitry 2028 (FIG. 2) may be configured to generate a model selection menu on the display 2032 (FIG. 2) to allow a user to select the model that best suits a particular subject. Additionally, the embodiments described in connection with FIGS. 1-15 may be applicable to the training data generation and collection method of FIGS. 16-18.

[0212]

[0235] 19-22 are views of an alternative embodiment of a mounting member configured to securely mount a probe head to a portion of a human hand, such as the ball of the foot. FIG. 19 is a perspective view of a mounting member 19000 that is not attached to a probe head (such as probe head 2010 of FIG. 2) of a probe (such as probe 2002 of FIG. 2). FIG. 20 is a view of the mounting member 19000 secured to the ball of a human hand. FIG. 21 is a perspective view of a probe head 21010 attached to the mounting member 19000 while the mounting member 19000 is secured to the ball of a human hand. FIG. 22 is also a perspective view of the mounting member 19000 according to one embodiment, where a protective film 19006 is placed over the mounting member 19000.

[0213]

[0236] 19, the mounting member 19000 includes a receptacle 19004 having a bottom 19002, according to one embodiment. The receptacle 19004 is coupled to a plurality of adhesive surfaces 19005 (four of which are shown). Each adhesive surface 19005 is coupled to one side of the receptacle 19004 that is orthogonal to another adhesive surface 19005. Each adhesive surface 19005 is also initially covered with a protective film 19006. The protective film 19006 is configured to be removed from the adhesive surface 19005, for example, by peeling the protective film 19006 to expose the adhesive underneath. Each adhesive surface 19005 also engages a portion of a human hand. The receptacle 19004 is configured to engage a probe head of a probe, for example, the probe head 2010 of the probe 2002 of FIG. 2. Referring to FIG. 22, the mounting member 19000 also includes a protective film 19006 that is disposed on the bottom 19002 of the receptacle 19004 and is configured to be removed prior to mounting the probe head to the receptacle 19004.

[0214]

[0237] Referring to FIG. 20, the attachment member 19000 engages the ball of a human hand. After removing the protective film 19006 covering the adhesive surface 19005, the attachment member 19000 engages the ball of the hand by fixing the adhesive surface 19005 to different parts of the hand proximate to the ball of the hand. For example, one adhesive surface 19005A can be attached horizontally across the palm, and another adhesive surface 19005B can be attached vertically upwards towards the index finger. Furthermore, the adhesive surface 19005 is flexible enough to bend or shape to the contours of the surface of the hand. A third adhesive surface 19005C engages the hand by wrapping around the base of the thumb. Another adhesive surface 19005D can be attached to the base of the palm area and extend to the wrist. Engaging the adhesive surface 19005 with the hand in the manner described above typically ensures that the mounting member 19000 is securely secured to the hand, and therefore typically ensures that the sensing measurements are suitably accurate.

[0215]

[0238] 21, once secured to the ball of the foot, the probe head 21010 may be secured to the mounting member 19000. For example, the probe head 21010 may be secured by threading or "clicking" into the receptacle 19004. The probe head 21010 is coupled to an umbilical cord 21012 configured to couple electromagnetic energy to a base, as previously described. For example, the probe head 21010, umbilical cord 21012 and base may be the same as or similar to the probe head 2010, umbilical cord 2006 and base 2004, respectively, of FIG.

[0216]

[0239] 19-22, alternative embodiments of the mounting member 19000 are contemplated. For example, the embodiments described in connection with Figures 1-18 may be applicable to the mounting member 19000 of Figures 19-22.

[0217] Example embodiment

[0269] Example 1 includes a system including a housing; an electromagnetic unit disposed within the housing, the electromagnetic unit configured to generate electromagnetic energy over a period of time and direct the electromagnetic energy into a body having at least one muscle cell; an optical sensor disposed within the housing, the optical sensor configured to receive a portion of the electromagnetic energy redirected by the body and convert the received portion of the electromagnetic energy into a signal; and a computing circuit disposed within the housing, the computing circuit coupled to the electromagnetic unit and the optical sensor and configured to determine an oxygenation level of one or more of the at least one muscle cell in response to the signal.

[0218]

[0270] Example 2 includes the system of any of Examples 1-2, wherein the electromagnetic unit includes at least one light emitting diode.

[0219]

[0271] Example 3 includes the system of Example 1, wherein the electromagnetic unit includes at least one light emitting diode configured to generate at least one wavelength in a range of about 400 nm to 900 nm and having a first intensity, and at least one wavelength in a range of about 400 nm to 900 nm and having a second intensity less than the first intensity.

[0220]

[0272] Example 4 includes the system of any of Examples 1-4, wherein the electromagnetic unit includes at least one light emitting diode each configured to generate at least one wavelength in the range of 400-900 nm.

[0221]

[0273] Example 5 includes the system of example 1, wherein the electromagnetic unit includes a linear arrangement of a plurality of light emitting diodes.

[0222]

[0274] Example 6 includes the system of any of Examples 1-5, wherein the electromagnetic unit includes a light emitting diode and a driver circuit configured to selectively activate and power the light emitting diode.

[0223]

[0275] Example 7 includes the system of any of Examples 1-6, wherein the electromagnetic unit includes light emitting diodes and temperature control circuitry configured to maintain a respective temperature of each of the light emitting diodes within a temperature range.

[0224]

[0276] Example 8 includes the system of any of Examples 1-8, wherein the optical sensor includes a spectrometer configured to receive the redirected portion of the electromagnetic energy and generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of the characteristic of the at least one wavelength range.

[0225]

[0277] Example 9 includes the system of Example 1, further including a housing configured to be attached directly to the body, the electromagnetic unit, the optical sensor, and the computing circuitry being disposed within the housing.

[0226]

[0278] Example 10 includes the system of any of Examples 1-9, wherein the computing circuitry is configured to determine an oxygenation level of one or more of the at least one muscle cell in response to a respective value of the characteristic of each of the at least one wavelength range of the portion of the redirected electromagnetic energy.

[0227]

[0279] Example 11 includes the system of any of Examples 1-10, wherein the computational circuitry is configured to implement a machine learning algorithm and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented machine learning algorithm.

[0228]

[0280] Example 12 includes the system of any of Examples 1-11, wherein the computational circuitry is configured to: implement a local weighted regression model; and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented local weighted regression model.

[0229]

[0281] Example 13 includes a probe including a head fixable to a body having muscle cells, a collection optical fiber having a collection end disposed on the head, at least one first illumination optical fiber each having a respective first illumination end disposed on the head approximately a first distance from the collection end, and at least one second illumination optical fiber each having a respective second illumination end disposed on the head approximately a second distance from the collection end, and a connector configured to couple opposing ends of the collection optical fiber, the at least one first illumination optical fiber, and the at least one second illumination optical fiber to a device configured to determine at least one oxygenation level of the muscle cells.

[0230]

[0282] Example 14 includes the probe of example 13, wherein the head includes an adhesive configured to adhere the head to the body.

[0231]

[0283] Example 15 includes the probe of any of Examples 13-14, including at least one third illumination optical fiber each having a respective third illumination end disposed on the head at approximately a third distance from the collecting end, and a connector configured to couple the at least one third illumination optical fiber to a device configured to determine at least one oxygenation level of muscle cells.

[0232]

[0284] Example 16 includes the probe of any of Examples 14-15, wherein the head is configured to be removable and reattachable to the receptacle while the receptacle is attached to the body.

[0233]

[0285] Example 17 includes the probe of any of Examples 13-16, wherein the head is fixable to the ball of a human hand.

[0234]

[0286] Example 18 includes the probe of any of Examples 13-17, where a protective film is disposed between the light collecting end and the body.

[0235]

[0287] Example 19 includes the probe of any of Examples 13-18, wherein the number of the at least one first illumination optical fiber is an integer multiple of the number of the at least one second illumination optical fiber.

[0236]

[0288] Example 20 includes the probe of any of Examples 13-19, wherein a ratio of the number of the at least one first illumination optical fiber to the first distance is approximately equal to a number of the at least one second illumination optical fiber to the second distance.

[0237]

[0289] Example 21 includes the probe of any of Examples 13-20, further including a calibrator.

[0238]

[0290] Example 22 includes the probe of any of Examples 13-21, further including an authenticator.

[0239]

[0291] Example 23 includes the probe of any of Examples 13-22, wherein the connector includes a blocking slot separating at least a portion of the collection optical fiber from at least a portion of the at least one first illumination optical fiber and at least a portion of the at least one second illumination optical fiber.

[0240]

[0292] Example 24 includes the probe of any of Examples 13-23, further including an electromagnetic energy generator.

[0241]

[0293] Example 25 includes a system including a probe configurable to direct electromagnetic energy into a body having at least one muscle cell and to receive a portion of the electromagnetic energy redirected by the body over a period of time; and a base configured to couple to the probe, the base including a generator configured to generate electromagnetic energy over the period of time, an optical sensor configured to receive the portion of the redirected electromagnetic energy and convert the portion into a signal, and a computing circuit configured to determine an oxygenation level of one or more of the at least one muscle cell in response to the signal.

[0242]

[0294] Example 26 includes the system of example 25, wherein the generator includes at least one light emitting diode.

[0243]

[0295] Example 27 includes the system of any of Examples 25-26, wherein the generator includes at least one light emitting diode configured to generate at least one wavelength in a range of about 400 nm to 900 nm having a first intensity, and at least one infrared wavelength in a range of about 400 nm to 900 nm having a second intensity less than the first intensity.

[0244]

[0296] Example 28 includes the system of any of Examples 25-27, wherein the generators include at least one light emitting diode each configured to generate at least one wavelength in the range of 400-900 nm.

[0245]

[0297] Example 29 includes the system of any of Examples 25-28, wherein the generator includes light emitting diodes, the light emitting diodes each configured to generate electromagnetic energy over a respective spectrum including wavelengths in a range of about 400 nm to 900 nm and approximately equal to a respective respective spectrum generated by another one or more of the light emitting diodes.

[0246]

[0298] Example 30 includes the system of any of Examples 25-29, wherein the probe is configured to direct electromagnetic energy into the body at one or more distances from where the probe receives the portion of the redirected electromagnetic energy.

[0247]

[0299] Example 31 includes the system of any of Examples 25-30, where electromagnetic energy is directed into or out of the body via optical fiber at one or more distances from where the light is received.

[0248]

[0300] Example 32 includes the system of any of examples 25-31, wherein the generator includes an arrangement of seven light emitting diodes.

[0249]

[0301] Example 33 includes the system of any of Examples 25-32, wherein the generator includes a light emitting diode and a drive circuit configured to selectively activate and power the light emitting diode.

[0250]

[0302] Example 34 includes the system of any of Examples 25-33, wherein the generator includes light emitting diodes and temperature control circuitry configured to maintain a respective temperature of each of the light emitting diodes within a temperature range.

[0251]

[0303] Example 35 includes the system of any of Examples 25-34, wherein the generator includes a light emitting diode, the probe includes a connector that receives ends of the optical fibers, and the system further includes a receptacle configured to receive the connector and align each of the ends of the optical fibers with a respective one of the light emitting diodes.

[0252]

[0304] Example 36 includes the system of any of Examples 25-35, wherein the generator includes a light emitting diode and the probe includes a connector that accommodates ends of the optical fibers, and the system further includes a receptacle assembly including a receptacle configured to receive the connector, a latch, and a motor configured to align each of the ends of the optical fibers with a respective one of the light emitting diodes by engaging the latch with the connector.

[0253]

[0305] Example 37 includes the system of Example 36, wherein the motor is configured to disengage the latch from the connector, thereby releasing the connector for removal from the receptacle.

[0254]

[0306] Example 38 includes the system of any of Examples 25-37, wherein the generator includes a light emitting diode, the probe includes a connector that accommodates ends of optical fibers, and the base includes a receptacle configured to receive the connector, a latch, a first sensor configured to detect the connector in the receptacle, and a motor configured to align each of the ends of the optical fibers with a respective one of the light emitting diodes by engaging the latch with the connector in response to the light sensor detecting the connector in the receptacle.

[0255]

[0307] Example 39 includes the system of Example 38, wherein the motor is configured to release the connector for removal from the receptacle by disengaging the latch from the connector in response to the second sensor.

[0256]

[0308] Example 40 includes the system of example 39, wherein the second sensor includes an electronic switch.

[0257]

[0309] Example 41 includes the system of any of Examples 25-40, wherein the generator includes a light emitting diode, the probe includes a connector that receives an end of an optical fiber and a latch engagement region, and the base includes a receptacle having a contact region and configured to receive the connector, a latch, and a motor configured to align each of the ends of the optical fiber with a respective one of the light emitting diodes by engaging the latch with the latch engagement region to press the connector against the contact region.

[0258]

[0310] Example 42 includes the system of Example 41, wherein the motor is further configured to disengage the latch from the latch engagement region, thereby releasing the connector for removal from the receptacle.

[0259]

[0311] Example 43 includes the system of any of Examples 41-42, wherein the generator includes a light emitting diode, the probe includes a connector that accommodates an end of an optical fiber, and the system further includes a receptacle assembly including a receptacle configured to receive the connector, a latch, and a motor configured to align each of the ends of the optical fiber with a respective one of the light emitting diodes by engaging the latch with the connector, the motor further configured to release the connector for removal from the receptacle by disengaging the latch with the latch engagement region.

[0260]

[0314] Example 44 includes the system of any of Examples 25-43, wherein the optical sensor includes a spectrometer configured to receive the redirected portion of the electromagnetic energy from the probe and generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of the characteristic of the at least one wavelength range.

[0261]

[0313] Example 45 includes the system of any of Examples 25-44, wherein the optical sensor includes a spectrometer configured to receive a redirected portion of the electromagnetic energy from the probe and generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electrical signal related to the intensity of one or more wavelengths present in the at least one wavelength range.

[0262]

[0314] Example 46 includes the system of any of Examples 25-45, wherein the generator includes a light emitting diode, the probe includes a connector that receives an end of an optical fiber, and the base further includes a spectrometer having an input configured to receive a redirected portion of the electromagnetic energy from the probe and configured to generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range, and a receptacle configured to receive the connector, align each of some of the ends of the optical fiber with a respective one of the light emitting diodes, and align each of the ends of at least one other of the optical fibers with the spectrometer input.

[0263]

[0315] Example 47 includes the system of any of Examples 25-46, wherein the generator includes a light emitting diode, the probe includes a connector that receives an end of an optical fiber, and the base further includes a spectrometer having an input configured to receive a redirected portion of the electromagnetic energy from the probe and configured to generate, for each of the at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range, and a receptacle configured to receive the connector and configured to align each of the ends of the optical fibers of the optical fibers with a respective one of the light emitting diodes and each of the ends of the at least one other of the optical fibers with the spectrometer input, the receptacle having a structure configured to prevent coupling of light between the spectrometer input and an output of the electromagnetic energy generator while the optical fibers are respectively aligned with the light emitting diode and while the at least one other of the optical fibers is aligned with the spectrometer input.

[0264]

[0316] Example 48 includes the system of any of Examples 25-47, wherein the generator includes a light emitting diode, the probe includes a connector that receives ends of optical fibers and has a slot between the first set of optical fibers and the at least one second set of optical fibers, and the base includes a spectrometer having an input configured to receive a redirected portion of electromagnetic energy from the probe and configured to generate, for each of the at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range, and a receptacle configured to receive the connector and configured to align each of the ends of the first set of optical fibers with a respective one of the light emitting diodes and each of the ends of the at least one optical fiber of the second set with the spectrometer input, and including an electromagnetic radiation shielding material configured to be disposed in the slot.

[0265]

[0317] Example 49 includes the system of any of Examples 25-48, wherein the operational circuitry is configured to control the generator.

[0266]

[0318] Example 50 includes the system of any of Examples 25-49, wherein the probe includes an authenticator, and the computing circuitry is configured to determine, in response to the authenticator, whether the probe is authorized for use with the base.

[0267]

[0319] Example 51 includes the system of any of Examples 25-50, wherein the probe includes an authenticator, and the computing circuitry is configured to, in response to the authenticator, determine whether the probe is suitable for coupling to the generator, and in response to determining that the probe is not suitable, disable the base from functioning when the probe is installed in the base.

[0268]

[0320] Example 52 includes the system of any of Examples 25-51, wherein the computing circuitry is configured to determine an oxygenation level of one or more of the at least one muscle cell in response to a respective value of the characteristic of each of the at least one wavelength range of the portion of the redirected electromagnetic energy.

[0269]

[0321] Example 53 includes the system of any of Examples 25-52, wherein the computational circuitry is configured to implement a machine learning algorithm and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented machine learning algorithm.

[0270]

[0322] Example 54 includes the system of any of Examples 25-53, wherein the operational circuitry is configured to implement a mathematical algorithm and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented mathematical algorithm.

[0271]

[0323] Example 55 includes the system of any of Examples 25-54, wherein the computational circuitry is configured to implement a mathematical model and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented mathematical model.

[0272]

[0324] Example 56 includes the system of any of Examples 25-55, wherein the computational circuitry is configured to: implement a local weighted regression model; and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented local weighted regression model.

[0273]

[0325] Example 57 includes an apparatus including a generator configured to provide wavelength electromagnetic energy in a range of approximately 400 nm to 900 nm to a probe, the probe being configurable to direct the electromagnetic energy into a body having at least one muscle cell and to collect a portion of the electromagnetic energy redirected by the body over a time period during which the generator provides the electromagnetic energy; and computing circuitry configured to determine an oxygenation level of one or more of the at least one muscle cell in response to the portion of the redirected electromagnetic energy.

[0274]

[0326] Example 58 includes the apparatus of example 57, wherein the generator includes at least one light emitting diode.

[0275]

[0327] Example 59 includes the apparatus of any of examples 57-58, where the generator includes at least one light emitting diode configured to generate at least one wavelength having a first intensity and at least one wavelength having a second intensity less than the first intensity.

[0276]

[0328] Example 60 includes the apparatus of any of Examples 57-59, wherein the generator includes at least one light emitting diode configured to generate at least one visible wavelength and at least one infrared wavelength, respectively.

[0277]

[0329] Example 61 includes the apparatus of any of Examples 57-60, wherein the generator includes light emitting diodes, the light emitting diodes each configured to generate electromagnetic energy over a respective spectrum approximately equal to a respective spectrum generated by another one or more of the light emitting diodes.

[0278]

[0330] Example 62 includes the apparatus of any of examples 57-61, wherein the generator includes a row of seven light emitting diodes.

[0279]

[0331] Example 63 includes the apparatus of any of Examples 57-62, wherein the generator includes a light emitting diode and a drive circuit configured to selectively activate and power the light emitting diode.

[0280]

[0332] Example 64 includes the apparatus of any of Examples 57-63, wherein the generator includes light emitting diodes and temperature control circuitry configured to maintain a respective temperature of each of the light emitting diodes within a temperature range.

[0281]

[0333] Example 65 includes the device of any of Examples 57-64, wherein the generator includes light emitting diodes, and the device further includes a receptacle configured to receive a probe connector that accommodates ends of the optical fibers and align each of the ends of the optical fibers with a respective one of the light emitting diodes.

[0282]

[0334] Example 66 includes the apparatus of any of Examples 57-65, wherein the generator includes light emitting diodes, and the apparatus further includes a receptacle configured to receive a probe connector that houses the ends of the optical fibers, a latch, and a motor configured to align each of the ends of the optical fibers with a respective one of the light emitting diodes by engaging the latch with the probe connector.

[0283]

[0335] Example 67 includes the apparatus of example 66, wherein the motor is configured to release the probe connector for removal from the receptacle by disengaging the latch with the connector.

[0284]

[0336] Example 68 includes the apparatus of any of Examples 57-67, wherein the generator includes light emitting diodes, and the apparatus further includes a receptacle configured to receive a probe connector housing ends of optical fibers, a latch, a first sensor configured to detect the probe connector in the receptacle, and a motor configured to align each of the ends of the optical fibers with a respective one of the light emitting diodes by engaging the latch with the connector in response to the sensor detecting the connector in the receptacle.

[0285]

[0337] Example 69 includes the apparatus of example 68, wherein the motor is configured to, in response to the second sensor, cause the latch to disengage the probe connector, thereby releasing the probe connector for removal from the receptacle.

[0286]

[0338] Example 70 includes the device of example 69, wherein the second sensor includes an electronic switch.

[0287]

[0339] Example 71 includes the apparatus of any of Examples 57-70, wherein the generator includes a light emitting diode and the apparatus further includes a receptacle having a contact area configured to accommodate an end of the optical fiber and to receive a probe connector including a latch engagement area, a latch, and a motor configured to align each of the ends of the optical fiber with a respective one of the light emitting diodes by engaging the latch with the latch engagement area to press the probe connector against the contact area.

[0288]

[0340] Example 72 includes the apparatus of Example 71, wherein the motor is further configured to disengage the latch from the latch engagement region, thereby releasing the probe connector for removal from the receptacle.

[0289]

[0341] Example 73 includes the apparatus of any of Examples 57-72, further including a spectrometer configured to receive a redirected portion of the electromagnetic energy from the probe and generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range.

[0290]

[0342] Example 74 includes the apparatus of any of Examples 57-73, further including a spectrometer configured to receive from the probe a redirected portion of the electromagnetic energy and generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electrical signal related to a combined intensity of one or more wavelengths present in the at least one wavelength range.

[0291]

[0343] Example 75 includes the apparatus of any of Examples 57-74, wherein the generator includes a light emitting diode and the apparatus further includes a spectrometer having an input configured to receive a redirected portion of the electromagnetic energy from the probe and configured to generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; and a receptacle configured to receive a probe connector that accommodates ends of optical fibers, align each of some ends of the optical fibers with a respective one of the light emitting diodes, and align each of an end of at least one other one of the optical fibers with the spectrometer input.

[0292]

[0344] Example 76 includes the apparatus of any of Examples 57-75, wherein the generator includes a light emitting diode and the apparatus further includes a spectrometer having an input configured to receive a redirected portion of the electromagnetic energy from the probe and configured to generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; and a receptacle configured to receive a probe connector that accommodates ends of optical fibers, configured to align each of the ends of the optical fibers with a respective one of the light emitting diodes and each of the ends of the at least one other of the optical fibers with the spectrometer input, and including an electromagnetic radiation shielding material configured to be disposed between the optical fibers of the optical fibers while respectively aligned with the light emitting diode and the at least one other of the optical fibers while aligned with the spectrometer input.

[0293]

[0345] Example 77 includes the apparatus of any of Examples 57-76, wherein the generator includes a light emitting diode and the apparatus further includes a spectrometer having an input configured to receive the redirected portion of the electromagnetic energy from the probe and configured to generate, for each of the at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; and a receptacle configured to receive the probe connector, the receptacle including an electromagnetic radiation shielding material configured to receive the optical fibers and having a slot between the first set of optical fibers and the at least one second set of optical fibers, the receptacle configured to align each of the ends of the optical fibers of the first set with a respective one of the light emitting diodes and to align each of the ends of the at least one optical fiber of the second set with the spectrometer input and to be disposed within the slot.

[0294]

[0346] Example 78 includes the apparatus of any of examples 57-77, wherein the operational circuitry is configured to control the generator.

[0295]

[0347] Example 79 includes the device of any of Examples 57-78, wherein the computing circuitry is configured to determine an oxygenation level of one or more of the at least one cell in response to a respective value of the characteristic of each of the at least one wavelength range of the portion of the redirected electromagnetic energy.

[0296]

[0348] Example 80 includes the device of any of Examples 57-79, wherein the computational circuitry is configured to implement a machine learning algorithm and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented machine learning algorithm.

[0297]

[0349] Example 81 includes the device of any of Examples 57-80, wherein the operational circuitry is configured to implement a mathematical algorithm and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented mathematical algorithm.

[0298]

[0350] Example 82 includes the device of any of Examples 57-81, wherein the computational circuitry is configured to: implement a mathematical model; and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented mathematical model.

[0299]

[0351] Example 83 includes the device of any of Examples 57-82, wherein the computational circuitry is configured to: implement a local weighted regression model; and determine an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of a portion of the redirected electromagnetic energy as at least one input to the implemented local weighted regression model.

[0300]

[0352] Example 84 includes a method including generating electromagnetic energy including a wavelength in a range of about 400 nm to 900 nm during an oxygenation determination time, and determining an oxygenation level of one or more of the at least one muscle cell in response to a portion of the electromagnetic energy redirected by a body having the at least one muscle cell during the oxygenation determination time.

[0301]

[0353] Example 85 includes the method of Example 84, further including: generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal associated with at least one value of a characteristic of the at least one wavelength range; and determining an oxygenation level in response to the value of the at least one characteristic.

[0302]

[0354] Example 86 includes the method of any of Examples 84-85, further including: generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a combined intensity of one or more wavelengths in the at least one wavelength range; and determining an oxygenation level in response to at least one of the combined intensities.

[0303]

[0355] Example 87 includes the method of any of Examples 84-86, further including: generating electromagnetic energy during a calibration time; generating, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the probe, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the respective values.

[0304]

[0356] Example 88 includes the method of any of Examples 84-87, further including: generating electromagnetic energy during a calibration time; generating, for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the values.

[0305]

[0357] Example 89 includes the method of any of Examples 84-88, further including generating electromagnetic energy during a calibration time; generating, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the calibrator during the calibration time, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the values.

[0306]

[0358] Example 90 includes the method of any of Examples 84-89, further including generating electromagnetic energy during a calibration time; generating, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the calibrator of the probe, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the values.

[0307]

[0359] Example 91 includes the method of any of Examples 84-90, further including generating electromagnetic energy during a calibration time; for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, generating a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; storing at least one of the at least one value; and determining an oxygenation level of one or more of the at least one muscle cell in response to the stored at least one of the at least one value.

[0308]

[0360] Example 92 includes the method of any of Examples 84-91, further including: generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal associated with at least one value of the characteristic of the at least one wavelength range; generating the electromagnetic energy during a calibration time; generating, for each of the at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with at least one calibrated value of the characteristic of the at least one wavelength range; and determining an oxygenation level of one or more of the at least one muscle cell as a function of a respective ratio of each of the at least one of the at least one values ​​to each of the at least one calibrated values, for each one of the at least one wavelength range.

[0309]

[0361] Example 93 includes the method of any of Examples 84-92, further including: generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal associated with at least one value of the characteristic of the at least one wavelength range; generating the electromagnetic energy during a calibration time; generating, for each of the at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with at least one calibrated value of the characteristic of the at least one wavelength range; and determining an oxygenation level of one or more of the at least one muscle cell as a function of a logarithm of a respective ratio of each of the at least one of the at least one values ​​to each of the at least one calibrated values, for each one of the at least one wavelength range.

[0310]

[0362] Example 94 includes a method including oxygenating cells at a body part; inducing ischemia in the body part; restoring normal blood flow to the body part; directing electromagnetic energy toward the body part including a wavelength in a range of about 400 nm to 900 nm for each of at least one first time period between oxygenating, inducing, and returning; generating, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the body part, a respective value of a characteristic of the at least one wavelength range during each of the at least one first time period; and storing the at least one value.

[0311]

[0363] Example 95 includes the method of Example 94, wherein oxygenating the cells includes having a subject having the body part inhale a concentration of oxygen greater than the concentration of oxygen in air for at least one second period that is longer than the first period.

[0312]

[0364] Example 96 includes the method of any of Examples 94-95, wherein inducing ischemia includes reducing blood flow to the body site.

[0313]

[0365] Example 97 includes the method of any of Examples 94-96, wherein inducing ischemia includes inflating a cuff positioned around the body site.

[0314]

[0366] Example 98 includes the method of any of Examples 94-97, wherein inducing ischemia includes inflating a cuff placed around the body part, and restoring normal blood flow includes deflating the cuff.

[0315]

[0367] Example 99 includes the method of any of Examples 94-98, wherein the body part includes the ball of the human hand.

[0316]

[0368] Example 100 includes the method of any of Examples 94-99, where directing the electromagnetic energy includes generating electromagnetic energy with at least one light emitting diode and directing the electromagnetic energy from each of the at least one light emitting diode toward the body part using a respective optical fiber.

[0317]

[0369] Example 101 includes the method of any of Examples 94-100, where the generating includes collecting the redirected portion of the electromagnetic energy with at least one optical fiber and generating a respective value for each of the at least one wavelength range using a spectrometer during each of the at least one first time.

[0318]

[0370] Example 102 includes the method of any of Examples 94-101, further including training an algorithm using the stored at least one value of the characteristic.

[0319]

[0371] Example 103 includes the method of any of Examples 94-102, further including training a locally weighted regression model using the stored at least one value of the characteristic.

[0320]

[0372] Example 104 includes the method of any of Examples 94-103, further including training a neural network using the stored at least one value of the characteristic.

[0321]

[0373] Example 105 includes the method of any of Examples 94-104, further including training a convolutional neural network using the stored at least one value of the characteristic.

[0322]

[0374] Example 106 includes the method of any of Examples 94-105, further including training a machine learning algorithm using the stored at least one value of the characteristic.

[0323]

[0375] Example 107 includes the method of any of Examples 94-106, further including training a statistical learning algorithm using the stored at least one value of the characteristic.

[0324]

[0376] Example 108 includes the method of any of Examples 94-107, further including training a support vector machine algorithm using the stored at least one value of the characteristic.

[0325]

[0377] Example 109 includes the method of any of Examples 94-108, further including training a decision tree algorithm using the stored at least one value of the characteristic.

[0326]

[0378] Example 110 includes the method of any of Examples 94-109, further including training a random forest algorithm using the stored at least one value of the characteristic.

[0327]

[0379] Example 111 includes the method of any of Examples 94-110, further including training an XGBoost algorithm using the stored at least one value of the characteristic.

[0328]

[0380] Example 112 includes the method of any of Examples 94-111, further including training a feed-forward neural network using the stored at least one value of the characteristic.

[0329]

[0381] Example 113 includes the method of any of Examples 94-112, further including training a recurrent neural network using the stored at least one value of the characteristic.

[0330]

[0382] Example 114 includes the method of any of Examples 94-113, further including training a generative adversarial neural network using the stored at least one value of the characteristic.

[0331]

[0383] Example 115 includes the method of any of Examples 94-114, further including training a recommender system algorithm using the stored at least one value of the characteristic.

[0332]

[0384] Example 116 includes a program product including a non-transitory processor-readable medium having program instructions embodied thereon configured to be executed by at least one processor, the program instructions, when executed by the at least one processor, causing the at least one processor to generate electromagnetic energy including a wavelength in a range of approximately 400 nm to 900 nm during an oxygenation determination time; and determine an oxygenation level of one or more of the at least one muscle cell in response to a portion of the electromagnetic energy redirected by a body having the at least one muscle cell during the oxygenation determination time.

[0333]

[0385] Example 117 includes the program product of Example 116, wherein the program instructions cause the at least one processor to generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a combined intensity of one or more wavelengths in the at least one wavelength range, and determine an oxygenation level in response to at least one of the combined intensities.

[0334]

[0386] Example 118 includes the program product of any of Examples 116-117, wherein the program instructions cause at least one processor to generate, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the probe, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range, and determine an oxygenation level of one or more of the at least one muscle cell in response to at least one of the at least one value.

[0335]

[0387] Example 119 includes the program product of any of Examples 116-118, wherein the program instructions cause at least one processor to generate, for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range, and determine an oxygenation level of one or more of the at least one cell in response to at least one of the values.

[0336]

[0388] Example 120 includes the program product of any of Examples 116-119, wherein the program instructions cause at least one processor to generate, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the calibrator during a calibration time, a respective electronic signal associated with at least one value of a characteristic of the at least one wavelength range, and determine an oxygenation level of one or more of the at least one muscle cell in response to at least one of the at least one value.

[0337]

[0389] Example 121 includes the program product of any of Examples 116-120, wherein the program instructions cause at least one processor to generate, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the calibrator of the probe, a respective electronic signal associated with at least one value of a characteristic of the at least one wavelength range, and determine an oxygenation level of one or more of the at least one muscle cell in response to at least one of the at least one value.

[0338]

[0390] Example 122 includes the program product of any of Examples 116-121, wherein the program instructions cause at least one processor to generate, for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with at least one value of a characteristic of the at least one wavelength range, store at least one of the at least one value, and determine an oxygenation level of one or more of the at least one muscle cell in response to the stored at least one of the at least one value.

[0339]

[0391] Example 123 includes the program product of any of Examples 116-122, wherein the program instructions cause the at least one processor to generate, for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with a calibration value of a characteristic of the at least one wavelength range, and determine, for each one of the at least one wavelength range, an oxygenation level of one or more of the at least one muscle cell as a function of a respective ratio of each of the at least one of the at least one values ​​to each of the at least one of the at least one calibration values.

[0340]

[0392] Example 124 includes the program product of any of Examples 116-123, wherein the program instructions cause the at least one processor to generate, for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with at least one calibration value of a characteristic of the at least one wavelength range, and determine, for each one of the at least one wavelength range, an oxygenation level of one or more of the at least one muscle cell as a function of a logarithm of a respective ratio between each of the at least one of the at least one values ​​and each of the at least one calibration value.

[0341]

[0393] Example 125 includes an apparatus including a means for generating electromagnetic energy comprising a wavelength in a range of about 400 nm to 900 nm during an oxygenation determination time, and a means for determining an oxygenation level of one or more of the at least one muscle cell in response to a portion of the electromagnetic energy redirected by a body having the at least one muscle cell during the oxygenation determination time.

[0342]

[0394] Example 126 includes the apparatus of Example 125, further including means for generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal associated with at least one value of a characteristic of the at least one wavelength range, and means for determining an oxygenation level in response to the value of the at least one characteristic.

[0343]

[0395] Example 127 includes the device of any of Examples 125-126, further including: means for generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a combined intensity of one or more wavelengths in the at least one wavelength range; and means for determining an oxygenation level in response to at least one of the combined intensities.

[0344]

[0396] Example 128 includes the apparatus of any of Examples 125-127, further including: means for generating electromagnetic energy during a calibration time; means for generating, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the probe, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and means for determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the values.

[0345]

[0397] Example 129 includes the apparatus of any of Examples 125-128, further including: means for generating electromagnetic energy during a calibration time; means for generating, for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and means for determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the values.

[0346]

[0398] Example 130 includes the apparatus of any of Examples 125-129, further including: means for generating electromagnetic energy during a calibration time; means for generating, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the calibrator during the calibration time, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and means for determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the values.

[0347]

[0399] Example 131 includes the apparatus of any of Examples 125-130, further including: means for generating electromagnetic energy during a calibration time; means for generating, for each of at least one wavelength range of a portion of the electromagnetic energy redirected by the calibrator of the probe, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; and means for determining an oxygenation level of one or more of the at least one muscle cell in response to at least one of the values.

[0348]

[0400] Example 132 includes the apparatus of any of Examples 125-131, further including: means for generating electromagnetic energy during a calibration time; means for generating, for each of at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with a value of a characteristic of the at least one wavelength range; means for storing at least one of the at least one value; and means for determining an oxygenation level of one or more of the at least one muscle cell in response to the stored at least one of the at least one value.

[0349]

[0401] Example 133 includes the apparatus of any of Examples 125-132, further including: means for generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal associated with at least one value of the characteristic of the at least one wavelength range; means for generating the electromagnetic energy during a calibration time; means for generating, for each of the at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with at least one calibrated value of the characteristic of the at least one wavelength range; and means for determining an oxygenation level of one or more of the at least one muscle cell as a function of a respective ratio of each of the at least one of the at least one values ​​to each of the at least one calibrated values, for each one of the at least one wavelength range.

[0350]

[0402] Example 134 includes the apparatus of any of Examples 125-133, further including: means for generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal associated with at least one value of the characteristic of the at least one wavelength range; means for generating the electromagnetic energy during a calibration time; means for generating, for each of the at least one wavelength range of the portion of the electromagnetic energy redirected by the calibrator, a respective electronic signal associated with at least one calibrated value of the characteristic of the at least one wavelength range; and means for determining an oxygenation level of one or more of the at least one muscle cell as a function of a logarithm of a respective ratio of each of the at least one of the at least one values ​​to each of the at least one calibrated values, for each one of the at least one wavelength range.

[0351]

[0403] From the foregoing, it will be understood that, although specific embodiments have been described herein for purposes of illustration, various modifications may be made without departing from the spirit and scope of the present disclosure. Moreover, where an alternative to a particular embodiment is disclosed, this alternative may also be applied to other embodiments, even if not specifically described. Moreover, one or more components of a described device or system, or one or more steps of a described method, may be omitted from the description for clarity or for other reasons. In addition, one or more components of a described device or system that are included in the description may be omitted from the device or system, and one or more steps of a described method that are included in the description may be omitted from the method.

Claims

1. Housing and an electromagnetic unit disposed within the housing, the electromagnetic unit configured to generate electromagnetic energy and direct the electromagnetic energy into a body having at least one muscle cell at a plurality of illumination locations that are different distances from at least one collection location; an optical sensor disposed within the housing, the optical sensor configured to receive a portion of the electromagnetic energy redirected by the body at the at least one collection location and convert the received portion of the electromagnetic energy into a signal; a computing circuit disposed within the housing, the computing circuit coupled to the electromagnetic unit and the optical sensor and configured to determine an oxygenation level of one or more of the at least one muscle cell in response to the signal; and Including, the system.

2. The system of claim 1 , wherein the electromagnetic unit includes at least one light emitting diode.

3. 2. The system of claim 1, wherein the electromagnetic unit includes at least one light emitting diode configured to generate at least one wavelength in a range of about 400 nm to 900 nm and having a first intensity, and at least one wavelength in a range of about 400 nm to 900 nm and having a second intensity less than the first intensity.

4. The system of claim 1 , wherein the electromagnetic unit includes at least one light emitting diode each configured to generate at least one wavelength in the range of 400 to 900 nm.

5. The system of claim 1 , wherein the electromagnetic unit comprises a linear arrangement of a plurality of light emitting diodes.

6. The electromagnetic unit comprises: A light emitting diode; a driver circuit configured to selectively activate and power the light emitting diodes; The system of claim 1 , comprising:

7. The electromagnetic unit comprises: A light emitting diode; a temperature control circuit configured to maintain a respective temperature of each of said light emitting diodes within a temperature range; The system of claim 1 , comprising:

8. the optical sensor includes a spectrometer; The spectrometer comprises: receiving the redirected portion of the electromagnetic energy; and generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; The system of claim 1 configured to:

9. further comprising a housing configured to be attached directly to the body; The system of claim 1 , wherein the electromagnetic unit, the optical sensor, and the computing circuitry are disposed within the housing.

10. 2. The system of claim 1, wherein the operational circuitry is configured to determine an oxygenation level of one or more of the at least one muscle cell in response to a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy.

11. The arithmetic circuit includes: implementing a machine learning algorithm; determining an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented machine learning algorithm; The system of claim 1 configured to:

12. The arithmetic circuit includes: Conducting a locally weighted regression model; determining an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented local weighted regression model; The system of claim 1 configured to:

13. Attachment to the housing and to the body. directing the electromagnetic energy from the electromagnetic unit into the body; providing the portion of the electromagnetic energy redirected by the body to an optical sensor; The system of claim 1 , further comprising a probe configurable to:

14. A probe configurable for attachment to the housing and the body, comprising: a plurality of illumination optical fibers having a plurality of first ends configurable to receive the electromagnetic energy from the electromagnetic unit and having a plurality of second ends configurable to direct the electromagnetic energy into a plurality of locations of the body; and a collecting optical fiber having a first end for receiving the portion of the electromagnetic energy redirected by the body and having a second end for providing the portion of the electromagnetic energy redirected by the body to the optical sensor; The system of claim 1 further comprising a probe.

15. A probe configurable for attachment to the housing and the body, comprising: a plurality of illumination optical fibers having a plurality of first ends configurable to receive the electromagnetic energy from the electromagnetic unit and having a plurality of second ends configurable to direct the electromagnetic energy into a plurality of locations of the body; and a collecting optical fiber having a first end for receiving the portion of the electromagnetic energy redirected by the body and having a second end for providing the portion of the electromagnetic energy redirected by the body to the optical sensor; Further comprising a probe, The system of claim 1 , wherein for each of the plurality of illumination optical fibers, the electromagnetic unit is configured to generate the electromagnetic energy for a respective duration dependent on a position of the second end of the illumination optical fiber.

16. a generator configured to provide wavelength electromagnetic energy in a range of approximately 400 nm to 900 nm to a probe, the probe being configurable to: direct the electromagnetic energy into a body having at least one muscle cell; and collect a portion of the electromagnetic energy redirected by the body over a period of time that the generator provides the electromagnetic energy; a computing circuit configured to determine an oxygenation level of one or more of the at least one muscle cell in response to a portion of the redirected electromagnetic energy; 13. An apparatus comprising:

17. 17. The apparatus of claim 16, wherein the generator includes at least one light emitting diode configured to generate at least one wavelength having a first intensity and at least one wavelength having a second intensity less than the first intensity.

18. the generator includes a light emitting diode; 17. The apparatus of claim 16, wherein the light emitting diodes are each configured to generate electromagnetic energy over a respective spectrum that is approximately equal to a respective spectrum generated by another one or more of the light emitting diodes.

19. the generator includes a light emitting diode; 17. The apparatus of claim 16, further comprising a receptacle configured to receive a probe connector that accommodates ends of optical fibers and align each of the ends of the optical fibers with a respective one of the light emitting diodes.

20. the generator includes a light emitting diode; The apparatus comprises: a receptacle configured to receive a probe connector that accommodates an end of an optical fiber; A latch and a motor configured to engage the latch with the probe connector to thereby align each of the ends of the optical fibers with a respective one of the light emitting diodes; 20. The apparatus of claim 16, further comprising:

21. the generator includes a light emitting diode; The apparatus comprises: a receptacle having a contact area configured to accommodate an end of an optical fiber and to receive a probe connector including a latch engagement area; A latch and a motor configured to align each of the ends of the optical fibers with a respective one of the light emitting diodes by engaging the latch with the latch engagement region to press the probe connector against the contact region; 20. The apparatus of claim 16, further comprising:

22. 22. The apparatus of claim 21, wherein the motor is further configured to disengage the latch from the latch engagement region, thereby releasing the probe connector for removal from the receptacle.

23. receiving the redirected portion of the electromagnetic energy from a probe; generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; 20. The apparatus of claim 16, further comprising a spectrometer configured to:

24. receiving the redirected portion of the electromagnetic energy from a probe; generating, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electrical signal related to a combined intensity of one or more wavelengths present in the at least one wavelength range; 20. The apparatus of claim 16, further comprising a spectrometer configured to:

25. the generator includes a light emitting diode; The apparatus comprises: a spectrometer having an input configured to receive the redirected portion of the electromagnetic energy from the probe, the spectrometer configured to generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; a receptacle configured to receive a probe connector housing ends of optical fibers, to align each of the ends of some of the optical fibers with a respective one of the light emitting diodes, and to align each of the ends of at least one other of the optical fibers with the spectrometer input; 20. The apparatus of claim 16, further comprising:

26. the generator includes a light emitting diode; The apparatus comprises: a spectrometer having an input configured to receive the redirected portion of the electromagnetic energy from the probe, the spectrometer configured to generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; a receptacle configured to receive a probe connector accommodating an end of an optical fiber, the receptacle being configured to align each of the ends of one of the optical fibers with a respective one of the light emitting diodes and each of the ends of at least one other of the optical fibers with the spectrometer input, the receptacle including an electromagnetic radiation shielding material configured to be disposed between one of the optical fibers while aligned with the light emitting diode and the at least one other of the optical fibers while aligned with the spectrometer input; 20. The apparatus of claim 16, further comprising:

27. the generator includes a light emitting diode; The apparatus comprises: a spectrometer having an input configured to receive the redirected portion of the electromagnetic energy from the probe, the spectrometer configured to generate, for each of at least one wavelength range of the redirected portion of the electromagnetic energy, a respective electronic signal related to a value of a characteristic of the at least one wavelength range; a receptacle configured to receive ends of optical fibers and having a slot between the first set of optical fibers and the at least one second set of optical fibers, the receptacle configured to align each of the ends of the optical fibers of the first set with a respective one of the light emitting diodes and each of the ends of the at least one optical fiber of the second set with the spectrometer input, the receptacle including an electromagnetic radiation shielding material configured to be disposed within the slot; 20. The apparatus of claim 16, further comprising:

28. The apparatus of claim 16 , wherein the operational circuitry is configured to control the generator.

29. 17. The apparatus of claim 16, wherein the operational circuitry is configured to determine an oxygenation level of one or more of the at least one cell in response to a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy.

30. The arithmetic circuit includes: implementing a machine learning algorithm; determining an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented machine learning algorithm; The apparatus of claim 16 , configured to:

31. The arithmetic circuit includes: implementing a mathematical algorithm; determining an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented mathematical algorithm; The apparatus of claim 16 , configured to:

32. The arithmetic circuit includes: Conducting a mathematical model; determining an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented mathematical model; The apparatus of claim 16 , configured to:

33. The arithmetic circuit includes: Conducting a locally weighted regression model; determining an oxygenation level of one or more of the at least one muscle cell by providing a respective value of a characteristic of each of at least one wavelength range of the portion of the redirected electromagnetic energy as at least one input to the implemented local weighted regression model; The apparatus of claim 16 , configured to:

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