Method and means to measure oxygen saturation/concentration in animals
20230000378 · 2023-01-05
Assignee
Inventors
Cpc classification
A61B5/02416
HUMAN NECESSITIES
A61B5/11
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
Abstract
We disclose an improvement for oximeters, which makes oximeters more reliable when making measurements on patients of darker skin complexion. The device of our invention discloses a re-entrant cavity, inside which some of the tissues of the patient are forced into, by pressing the device of our invention against the skin of the patient. The probing electromagnetic radiation beams (typically deep red and infra-red radiation) are directed to propagate through said re-entrant cavity, inside which some of the outer tissues of the patient are forced, along a path that is approximately parallel to, and just under, the skin of the patient. This probed volume inside said re-entrant cavity contains more arterial and less venous blood, when compared with measurements made by perpendicular beams, that penetrate deep under the skin, which causes that the measurements made by our device are more accurate than many existing oximeters.
Claims
1. An apparatus for gathering information on a circulating blood of animals, including humans, said animals with a body, a skin, and a first surface of said skin of said animal, said apparatus comprising: a) a holding and containing device adapted to hold, contain and maintain in fixed position against said skin of said animal, a plurality of elements, where said plurality of elements are at least one or more from a set of elements composed of at least one radiation emitting device and at least one radiation detecting device, such that: a1) each said radiation emitting device, emitting radiation along a first propagation path characteristic to each of said at least one radiation emitting devices, and capable of emitting said radiation of one or more wavelengths, a2) each said radiation detecting device receiving said radiation from one or more of said radiation emitting devices, along a second propagation path, that is different than said first propagation path characteristic of each of said at least one radiation emitting device, and, furthermore, capable of detecting at least part of said radiation of one or more said wavelengths, a3) each said radiation detecting device receiving said radiation from one or more of said radiation emitting devices, is capable of measuring a intensity of said radiation along said second propagation path, originally emitted by said radiation emitting devices and which suffered one or more scattering events, b) where said first propagation path of said radiation emitted by said at least one radiation emitting device is different than said second propagation path to said at least one radiation detecting device that detects radiation emitted by said radiation emitting device, c) where said first propagation path of said radiation emitted by said radiation emitting device, said radiation that is propagating inside said animal, is a known said radiation beam propagating at a desired and known first propagation path, just under said first surface of said skin of said animal, propagating forward at depths ranging from 0.5 mm to 10 mm below said first surface of said skin SK of said animal, d) where said holding and containing device is formed with a re-entrant cavity such that, when said holding and containing device is fixed in position, a flesh of said animal, including human , is pressed to fill in a space of said re-entrant cavity.
2. The apparatus of claim 1 were said radiation is either infrared radiation or deep red radiation.
3. The apparatus of claim 1 where said holding and containing device is kept in fixed position against said skin of said animal, at some part of a first surface of said skin of said animal, including human, by a wrapping device adapted to keep said holding and containing device in fixed position against said skin of said animal.
4. The apparatus of claim 1 where said first propagation path inside said body of said animal of said radiation emitted by said radiation emitting device is just under said skin of said animal from 500 micrometers (0.5 mm) to 5 millimeters under said skin.
5. The apparatus of claim 1 where said first propagation path of said radiation emitted by said radiation emitting device, that is propagating inside said animal, is along a direction that makes an angle less than 30 degrees with said first surface of said skin SK of said animal.
6. The apparatus of claim 1 where said radiation detecting device is capable of detecting and measuring said intensity of said radiation that has suffered one or more scattering events inside said body of said animal, and propagates after said scattering event along said second propagation path that makes an angle with said first propagation path of said radiation emitted by said radiation emitting device, said angle being between 1 degree and 180 degrees.
7. The apparatus of claim 1, where said re-entrant cavity is created on said holding and containing device by a cavity on said holding and containing device, said cavity existing on a side of said holding and containing device, that is facing said flesh of said animal.
8. The apparatus of claim 1, where said re-entrant cavity is created on said holding and containing device by a pair of protruding elements on said holding and containing device, on a side of said holding and containing device that is facing said flesh of said animal.
9. The apparatus of claim 1, where said re-entrant cavity is created on said holding and containing device by a single protruding element on said holding and containing device, on a side of said holding and containing device that is facing said flesh of said animal.
10. The apparatus of claim 1 where said information on said circulating blood of said animals, including humans, is a measurement of said intensity of said radiation beam at two different wavelengths.
11. The apparatus of claim 1 where said information on said circulating blood of said animals, including humans, is a measurement of a volumetric change per unit of volume on said circulating blood of said animals, including humans.
12. The apparatus of claim 1 where a second surface of said holding and containing device is a flat second surface while said radiation emitted by said radiation emitter LE is positioned at a first shallow angle with said second surface of said holding and containing device and with said skin of said animal, and said radiation detector LD is at a second shallow angle with said second surface of said holding and containing device and with said skin of said animal.
13. The apparatus of claim 1 where a second surface of said holding and containing device is a flat second surface, while said radiation emitted by said radiation emitter LE is positioned at a first shallow angle with said second surface of said holding and containing device and with said skin of said animal, and said radiation detector LD is at a position making a second angle larger than 15 degrees and smaller than 165 degrees with said second surface of said holding and containing device and with said skin of said animal.
14. A method for gathering information on a circulating blood of an animal, including humans , where said animal has a body, a skin and said skin has a first surface, wherein said method comprises the following steps: 1) providing a holding and containing device kept in fixed position with respect to said skin of said animal, including humans adapted to hold, contain and maintain in fixed position one or more elements, where said elements are one or more elements from one or more groups of elements where said groups of elements are one or more groups from the set of groups: one radiation emitting group and one radiation detecting group, such that: 1a) one or more radiation emitting devices, which is a member of said group of radiation emitting group, adapted to emitting a radiation at one or more wavelengths, each said radiation emitting device emitting said radiation at one or more wavelengths along a first propagation path, which is characteristic of each said radiation emitting device, 1b) at least one said radiation detection device, which is a member of said radiation detection group, adapted to detecting said radiation at said first wavelength lambda1 and at said second wavelength lambda2, each said radiation detection device detecting said radiation along a second propagation path and within an acceptance angle, which are characteristic of each said radiation detection device, 2) where each of said at least one said radiation detection device is positioned so as to detect radiation emitted by said radiation emitting device that have suffered one or more than one scattering events inside said animal, and after said one or more scattering events, propagates along said second propagation path that makes an angle larger than zero degrees and less then 180 degrees with said first propagation path of said radiation emitted by said radiation emitting device, 3) fixing said one or more radiation emitting device at such locations with respect to said holding and containing device, that said radiation emitted by said radiation emitting device propagates inside said animal, including humans, along said known first propagation path, just below said first surface of said skin SK of said animal, located at a closest proximity to said known first propagation path and at a depth of less than 1 cm from said first surface of said skin of said animal located at said closest proximity to said known first propagation path of said radiation under said skin of said animal, 4) where said holding and containing device is formed with a re-entrant cavity such that, when said holding and containing device is fixed in position, a flesh of said animal, including human, is pressed to fill in a space of said re-entrant cavity.
15. The method of claim 14 with a further wrapping device adapted to keeping said holding and containing device in fixed position with respect to said skin of said animal.
16. The method of claim 14 where said radiation emitting device emitting said radiation at one or more said wavelengths is either a single device capable of emitting said radiation at a first wavelength lambda1 and at a second wavelength lambda2, or is a combination of two separate radiation emitting devices, capable of emitting said radiation at said first wavelength lambda1 and at said second wavelength lambda2 each.
17. A method for gathering information on a circulating blood of an animal, including humans, wherein said method comprises the following steps: 1) providing a holding and containing device in fixed position with respect to said animal, including humans, adapted to hold, contain and maintain in fixed position a minimum of one element, where said minimum of one element is at least one or more from a set of elements composed of: 1a) a minimum of one radiation emitting device emitting a radiation along a first propagation path, 1b) a minimum of one radiation detection device detecting radiation along a second propagation path and within a cone of acceptance, 1c) electronics circuits, 2) where each of said minimum of one radiation detection device is positioned so as to detect said radiation emitted by said radiation emitting device that have suffered one or more than one scattering events inside said animal and after said one or more scattering event, propagates along such propagation path that makes an angle larger than zero degrees and less then 180 degrees with said first propagation path of said radiation emitted by said radiation emitting device, 3) fixing said minimum of one radiation emitting device at such locations with respect to said holding and containing device, that said radiation emitted by said radiation emitting device propagates inside said animal, including humans, along a direction that makes an angle larger than 1 degree and smaller than 75 degrees with a skin of said animal located at the closest proximity to said propagating radiation and at a depth of less than 1 cm from said first surface of said skin of said animal located at said closest proximity to said propagating radiation of said animal, 4) where said holding and containing device is formed with a re-entrant cavity where said radiation emitted by said radiation emitting device propagates to be detected and measured by said radiation detecting device, such that, when said holding and containing device is fixed in position, a flesh of said animal, including human , is pressed to fill in a space of said re-entrant cavity.
18. The method of claim 17, where said re-entrant cavity is created on said holding and containing device by a cavity on said holding and containing device on a side of said holding and containing device that is facing said flesh of said animal.
19. The method of claim 17, where said re-entrant cavity is created on said holding and containing device by a pair of protruding elements on said holding and containing device, on a side of said holding and containing device that is facing said flesh of said animal.
20. The method of claim 17, where said re-entrant cavity is created on said holding and containing device by a single protruding element on said holding and containing device, on a side of said holding and containing device that is facing said flesh of said animal.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DRAWINGS—LIST OF REFERENCE NUMERALS
Brief Description of Labels
[0059] BOX=SS=holding and containing device, or box or container, or supporting structure SS, which contains the elements of our invention. [0060] infrared (IR)=infrared radiation (IRR). We are using the term as it is understood in physics, all radiation characterized by wavelengths longer than deep red, beyond the visible spectrum.
[0061] This is how Wikipedia defines it, as assessed on 2020 Nov. 29: [0062] Infrared—Wikipedia [0063] en.wikipedia.org>wiki>Infrared [0064] Infrared (IR), sometimes called infrared light, is electromagnetic radiation (EMR) with wavelengths longer than those of visible light. [0065] FPP=First propagation path or direction of propagation, or direction. [0066] LB=Light (radiation) Beam [0067] LD=Light (radiation) detector [0068] LE=Light (radiation) Emitter [0069] PB=Protruding block [0070] PB1=Protruding block1 [0071] PB2=Protruding block2 [0072] radiation=we are using this term as it is used in physics, a short for electromagnetic radiation
[0073] (EMR), which has nothing to do with cancer causing radiation, as it is assumed by most people. Don't be afraid of radiation here guys, this is physics radiation. [0074] RC=Re-entrant cavity [0075] RFitBit=Re-entrance on FitBit, [0076] SC=scattering center [0077] SC1=scattering center 1 [0078] SF=surface [0079] SFitBit=Surface of FitBit [0080] SK=skin [0081] SP=SC=Scattering point or scattering center [0082] SS=Supporting structure=holding and containing device [0083] ST=strap [0084] STH=strap holder [0085] WIN=window, optical window
DETAILED DESCRIPTION
[0086] Referring to figures
[0087] Figures
[0088] If it is desired to measure the decrease of radiation along the incident beam direction, then the exit window near the radiation emitter LE and the window near the radiation detector LD1 should preferably, though not necessarily, be made perpendicular to the propagation of the radiation. This is not necessary, but it is one of the options protected in this patent. This is the preferred embodiment, as shown in figures
[0089] It is possible to make the measurement of blood volume using either the scattered radiation or using the radiation that suffered neither scattering not absorption events, which I call transmitted radiation—a non-standard use of the word, my personal use here, not used by anyone anywhere else in my city, in the country where I live, in this planet, in our galaxy, or in the universe at large. Both of these are shown at figure
[0090] Preferred Embodiment—Figures
[0091] Figure
[0092] Referring now to figure
[0093] Such a design for the amazing FitBit of our invention causes that when the device is firmly attached on the wrist of the wearer, so as to be pressed against the meat, some of the wearer's meat penetrates the volume between the radiation emitter LE (radiation emitter) and the radiation detector LD1 (radiation detector), which are located at the two protruding blocks PB1 and PB2, which is the volume we call the re-entrant cavity. Of course that, as per above observations, the re-entrant cavity may also be a “hole” carved out from the inner surface of the supporting structure SS.
[0094] Figures
[0095] Figure
[0096] We want to warn here the reader that in all these figures the penetration of the probing “light” is small if compared with the other dimensions of interest in the drawings. To respect this, and also to simplify the drawings, the dashed lines that indicate the propagation of the “light” beams show a light bean propagating back into the light detector LD as being scattered at the outer surface of the skin, when in reality though some scattering occurs at the surface of the skin, what matters for the invention is scattering that occurred inside the body, as shown in figure
[0097] Referring now to figure
[0098] We will use figure
[0099] The preferred embodiment uses a light emitter LE that emits infrared radiation of wavelengths in the preferred range of 850 nm+−50 nm, that is wavelengths from 800 nm to 900 nm. Any chosen wavelength in this his range of 800 to 900 nm is best because of its higher penetration in animal cells, particularly its lower absorption and scattering cross-sections by the pigment melanin, which is more abundant in humans of darker skin, to the point that existing FitBits fail to work for darker skinned persons (REF 1).
[0100] The direction of propagation of the light beam LB is important for this invention to work because if the light beam LB is sent normally (perpendicularly into the skin) then the infrared photons penetrate too deep, into depths where there is less variation in blood irrigation that changes with each heart beat, resulting in that there is only a small variation in the intensity of the infrared back-scattered and the device does not work either, even if the light beam LB penetrate beyond the melanin layer. Note that my invention does not depend on this theory of the depth of penetration to be correct, but only in the experimental results from the inventors' experiments. Moreover, though the invention itself came from pure cerebration, the actual confirmation by experiment is all that matters for the patent application, not the theory of why it works, not the process of cerebration that brought the solution of the problem to the attention of the inventor.
[0101] When the light beam LB is propagating parallel to, and just below the skin SK, then the infra-red photons are mostly in a path where the change in blood irrigation suffers maximum variation with each heart beat. This is so even if some photons happen to penetrate deeper below the skin, due to both the initial beam angular divergence and also due to forward scattering. It then follows, from this geometrical configuration and maximum interaction that matters for the working of this invention, that the variation of scattered infra-red photons is larger than other paths of photon propagation, particularly larger than photons propagating perpendicularly into the and below the skin sk. Another advantage for using this path of propagation which is almost parallel to, and just below the skin SK, is that photons propagating along such path needs to be scattered by 90 degrees to be measured by the light detector LD, as opposed to be scattered by 180 degrees (completely backward), as is the case with most existing FitBits. It happens that the scattering cross section as a function of the angle of scattering is generally a monotonically decreasing function of the scattering angle, which then implies as per figure
[0102] The position of the light emitter LE is fixed with respect to the skin SK of the user by the surface of the mechanical support, which, in the preferred embodiment is a FitBit-type device, as shown at figures
[0103] The depth of the indentation on the FitBit surface, which is the width of the window WIN, is typically of the order of a fraction of a millimeter to a millimeter or two, and the corners of the indentation or almost-perpendicular surface are rounded to prevent scratching the skin of the FitBit user. Window WIN is, on the preferred embodiment of our invention, perpendicular to the direction of the light beam LB. This is another important feature to prevent causing discomfort on the FitBit wearer.
[0104] Light detector LD receives light scattered from the region under the skin of the wearer. The intensity of this light scattered into the light detector LD varies with the amount of blood in the region from where the light beam LB is scattered, causing a periodic variation of the light intensity detected (measured) by light detector LD. This periodic variation of the light intensity follows the heart beatings. This periodic variation can be measured, converted by an ordinary ADC (analog-to-digital converter), then the digital result can be transferred to a microcontroller and counted over any convenient time period, say, 15 seconds, or 30 seconds or any other time. After normalizing the number of variations to 60 seconds, this normalized counting is the number of heart beatings per minute (one minute is 60 seconds). Any ordinary microprocessor, which is already part of the existing FitBits, can do this process of “watching” the periodic variation of the light intensity at the light detector LD.
EXAMPLES OF INTENDED USES
[0105] One example of intended use is to monitor the heart beating rate of humans wearing FitBit-type devices intended to acquire data about their physical activity, either for health reasons or for the purpose of improving their physical performance or even just to show-off.
[0106] Another intended use of the device and method of our invention is to measure the oxygen saturation/concentration in blood.
[0107] Another intended use of the device and method of our invention is to improve on the data gathering for hospitals and similar health facilities, that may need to collect information on the oxygen concentration/saturation for health decisions. Our device, as similar, though not as good, oximeters, produce a number, which goes well with the current trend of “evidence-based” diagnostics, which deflects any possible lawsuits by the damn lawyers.
[0108] Another intended use of the device of our invention is to buy a home for the inventors and to pay-off Diane's farm.
DETAILED DESCRIPTION—OPERATION OF INVENTION
[0109] This first paragraphs of the section “detailed description” is from the mother patent, which is for FitBits; the part that matters for this current continuation-in-part patent application, the extention to oximeters, is at the section “conclusion, ramifications, and scope of invention”.
[0110] I am adding a theoretical analysis of the invention because it helps the reader to better understand the invention and also to reproduce it. It is my view that a clear understanding of the structure that will be described in the sequel is only complete with an understanding of the reasoning underlying it, as opposed of a simple and magic physical description of the device—amazing as it is!
[0111] The method of our amazing invention is to direct the energy probing beam to a propagating path just under the skin, for both the FitBit and the oxymeter wearer, that is, propagating generally parallel to the skin and just under the skin, say, from 500 micrometers (0.5 mm) to 10 millimeters under the skin, preferably 500+−200 micrometers under the skin, the 10 millimeters being an upper limit that is entering here only because of the damn lawyers. The probing beam is preferably either visible light, or even better, what is known as deep red (red near the end of the visible red, around 700 nm), or even better, near infrared radiation, preferably near 850 nm. The reasoning for this is discussed and explained in the theoretical analysis below, it has to do with the smaller absorption by flesh of photons of these wavelengths in the near infra red.
[0112] Our invention operates on the differential cross section between blood and other animal cells, particularly between blood and flesh. This statement, which is written in physics language can be re-stated in normal English as “Our invention operates on differences of scattering properties, or probabilities, between blood and other cells of animals”.
[0113] We note here that this detection/recognition using differential scattering cross-section is no difference between all our vision system that we use all the time for all things, and image detection hardware used by the hardware and the computer of our invention. It is what we do all the time from observing a painting on a museum or to read the letters in this funny written patent application, written by an unconventional retired professor of physics. We decide that something is a leaf and not a flower both using the form of them and also using their color, i.e., using the differences in scattering of each for different colors. For example, most leaves scatters green light, some of which enters our eyes, absorbing the rest (red, yellow, etc.), while most flowers scatters a particular color, say red (as a red rose does), some of which red eventually enters our eyes, absorbing the other colors (yellow, green, etc.). In the case of our invention, as long as blood has a different scattering cross section (this is technical language, meaning probability of scattering, or power to scatter, or capacity of scattering), then the scattered “light”, which is preferentially infrared “light” for the main embodiment of our invention, will show the difference, as detected by a camera, and later measured by a computer. It is this simple, no big deal! . . .
[0114] The preferred embodiment of our invention uses near infrared radiation, with wavelengths in the window from 800 nm to 900 nm, because this range of wavelengths penetrates more in flesh, being, therefore able to probe deeper than other “colors”. For example, many FitBits use green light, which is so much absorbed by melanin that it cannot penetrate (and come back out after scattering!) enough to show any change in absorption and scattering cause by any change in blood irrigation due to heart beatings. It is a known fact that these FitBits that use green light works from poorly to not at all for darker skinned people. But keep in mind the particular detail that allows the green-light FitBits to work on fair-skinned people, as discussed further down.
[0115] Besides using infrared “light”, our invention uses a “light” beam that propagates parallel to and just below the skin, as opposed to propagate into the body, especially as opposed to propagating perpendicularly to the skin at the penetration point, or, in other words, that propagates parallel to and just under the skin, as opposed to propagate perpendicularly to the skin. The reason for this is different than the depth of penetration. Our invention uses a beam propagating parallel to and just under the skin SK, because of two independent reasons. Firstly because it is just under the skin that occurs the largest change in blood irrigation with each heart beat, or with each increase in blood pressure at each systole (systole means the higher blood pressure, or the heart contraction). To say it in a different way, our invention uses a “light” beam parallel and under the skin because it is there, just under the skin, that occurs the largest change in blood irrigation with each heart pumping, and consequently there is the largest change of the measured quantity: the amount or intensity of scattered “light”. Secondly, our invention uses a “light” beam propagating parallel to and just below the skin because with this path of propagation the scattered “light” has to suffer a scattering event of between 0 (zero) to 90 degrees to be measured by a light detector LD out of the body, instead of a 180 degrees scattering event, as it is the case for a light beam propagating perpendicular into the body, as used by most existing poorly designed FitBits. This makes a sizable difference for the measurement, because in just about all cases, and it is true in this case, the scattering cross section (meaning, the scattering probability) is much larger for a 0-to-90 degrees scattering than for a 180 degrees scattering, so the geometric arrangement of our invention causes that more “light” reaches the light detector LD than the existing FitBits that illuminate the body of interest with perpendicular light then receives 180 degrees scattered light! It is this simple . . . . This is illustrated in figure
DETAILED DESCRIPTION—DESCRIPTION AND OPERATION OF ALTERNATIVE EMBODIMENTS
[0116] Figure
[0117] Variation of the Main Embodiment Applied to Oximeters
[0118] One interesting variation of the main embodiment of the mother patent (FitBit), is the application of the same principles of the FitBit to measure heart rates, to the related application of measurement of oxygen concentration/saturation in blood (oximeter), from now on referred simply as oxygen saturation. Both cases require measurement of blood properties with spectroscopy, emitting “light” into the body, then measuring either the scattered or the non-scattered “light” back out, after this “light” has suffered two passages through the skin (in-and-out), perhaps being partly absorbed by melanin (REF 1).
[0119] For a better understanding of the device, and how it works, we proceed describing a simple version of the device of our invention, which is good to highlight the principles of operation, which we will be followed by the section “main embodiment” where we will describe a real proposed main embodiment for the invention. This simpler device may be thought as a theoretical description, because it highlight the principles of operation detached from any practical implementation.
[0120] The re-entrant cavity RC may be made as a cavity carved out into the surface of the supporting structure SS which faces the skin of the animal, as shown at
[0121] Detailed explanation of a particular embodiment.
[0122] This variation to the mother patent (FitBit), applied to oximeters, may be implemented with a variety of supporting structures, all of which are small modifications/variations of the same basic design. Accordingly, we are going to use one particular incarnation of the main embodiment of this daughter application, which uses a supporting structure similar to a cloth pin, of the type used to hold in place clothes to dry on a cloth-line. We chose this particular incarnation because it is one of the most commonly used types of oximeters today, if not the most common. It is the cloth-pin-type device that the health practitioner clips to our index finger as soon as we enter the facility, since the COVID-19 invasion, approximately March 2019 in the Unites States.
[0123] What is known as oxygen saturation, is measured with a comparison of the readings at two different wavelengths, from which the amount of oxygen with a particular molecular structure in the blood, within the probed volume, can be determined (REF 2). The radiation measured can be either transmitted radiation or scattered radiation, both types are possible and exist, The words “probed volume” above are crucial for out invention, which may be described as a volume which is selected for measurements by the device, that causes that the blood volume probed, or measured, is just under the skin, as opposed to probe deep under the skin. There are reasons for this, as described before and after here, which are related to the blood circulation and distribution, starting from the heart's left ventricle, to the main arteries, arterioles, capillaries, venules, main veins then back to the heart's right atrium.
[0124] The two wavelengths are usually red, or deep-red, and infrared, or near-infrared. More precisely, 700 nm (red), let us call this wavelength lambda1, and 850-900 nm (near infrared), let us call this wavelength lambda2. These two wavelengths lambda1 and lambda2 are usually along the same direction of propagation, or along the same line of propagation, or along the same propagation path, which we will call first propagation path FPP, is the set formed by the two photon beams at lambda1 and lambda2 we will call first beam. Consequently the first beam is a compound beam of photons at two wavelengths lambda1 and lambda2. For the damn lawyers out there, these are just two examples for wavelengths, the invention can work with other wavelengths as well, these two wavelengths being just two of the most used currently and being here as examples, not the only possibilities, but other wavelengths are possible as well. There are devices on with 5 different wavelengths. Don't come to me later, you damn lawyer, representing a client that is marketing an oximeter using 699 nm and 849 nm, pretending that these are outside the scope of my invention! These two wavelengths are selected by the differential absorption and/or scattering cross section (probability) of oxygenated hemoglobin, as compared with the less oxygenated form of hemoglobin.
[0125] Both the FitBit and the oximeter are subjected to the same problems of melanin absorption, when used on darker-skinned persons (REF 1). Melanin absorbs the incident light, resulting that there is at least less photons, often not enough photons to make the desired measurement, or even none at all. Both devices work better on fair-skinned persons. This problem is well documented in the literature, e.g., John R Feiner, John W Severinghaus, Philip E Bickler, “Dark skin decreases the accuracy of pulse oximeters at low oxygen saturation: the effects of oximeter probe type and gender” Anesth Analg December 2007, Vol 105, Number 6 (suppl), pg 518 ff., and Sjoding, Michael W. M., D. Dickson, Robert P. M.D., Iwashyna, Theodore J. M.D., Ph.D., Gay, Steven E. M.D., Valley, Thomas S. M.D., “Racial Bias in Pulse Oximetry Measurement”, New Engl. J. Med. V 383 issue 25 pages 2477-2478.
[0126] From now on, when referring to this wonderful oximeter of our invention, it will be understood that the light emitter LE is made of the two beams at wavelengths lambda1 and lambda2, as described above, which are along the same line of propagation or first propagation path FPP. This beam composed of the two separate wavelengths will be either two light emitters, perhaps encapsulated in the same container, perhaps separate emitters with the necessary optics to cause that their radiation beams are along the direction we call the first propagation path FPP, emitting light (radiation) on two different wavelengths, which normally are deep red and near infrared, usually at a first wavelength lambda1 equal to 700 nm and a second wavelength lambda2 within the range 850 to 900 nm, but may be other wavelengths or colors as well. Two wavelengths are necessary. So again, for you damn lawyers out there, from now on, on all instances of the oximeter variation, when we refer to light emitter LE it will be understood that these are two light emitters LE, say LE1 referring to deep red, lambda1, say, 700 nm, and LE2 referring to near infrared, lambda2, say 850-900 nm, and that these two light emitters may be one single package, or even one single device capable of emitting these two wavelengths.
[0127] The oximeter of our invention uses the same method of keeping the “light”, or radiation, propagating just near, and under, the skin surface, as described in the specification of the mother applications for the FitBit. In both cases this is so in order to cause that the “light” path is confined to volumes inside which the circulating blood is near the skin and near the original pumping heart than the blood that is deeper under the skin. The probing light beam(s) is (are) forced to be just under and not deep under the skin by arranging the supporting structure to direct the probing light beam LE inside the re-entrant cavity of our invention.
[0128] One embodiment, among others, of the oximeter, extension-variation of our beautiful FitBit device, is a device to measure the oxygen concentration/saturation, which, for the main embodiment, built within a supporting structure that is in the shape of a cloth pin, of the style used to keep clothes to dry hanging on a rope on the sun. This is the most commonly shape of the existing oximeters currently in use. It is shaped and sized as to attach to a finger or an ear lobe, etc. of a human being, or other animal.
[0129] In
[0130] Such a device has two variations. Variation CPT (ClothesPinTransmission) is a clothespin with light emitter devices LE1 and LE2, usually referred in common as LE, which propagate along a first propagation path FPP, and a light (or radiation) detector LD aligned with the first propagation path FPP, detecting photons that have not suffered any scattering episode and therefore reach the light detector LD along the same direction as the photons were emitted by LE. In this variation, the propagation path of the photon that reaches the light detector LD is the same as the first propagation path, because there is no scattering, and the device working on the transmission mode. There may exist a collimator as well. Such variation CPT is used on the transmission mode, and it measures “light” that has suffered no scattering,
[0131] Another variation of the same device, is the variation CPS (ClothesPinScattering), which is the same clothespin CP with the light emitters LE1 and LE2, the set that we here call LE, and light detector LD out of alignment. For the CPS the emitted light is along a propagation path which we call first propagation path FPP, along which path the photon (the particle of light that is propagating along this first propagation path) suffers a scattering, the result of which being that the photon then propagates along a second, different radiation direction, which we will call second propagation path SPP.
[0132] The re-entrant cavity RC of our invention may be the result of a hole on the surface of the supporting structure SS, or it may be the result of the light emitter LE and light detector LD be inside separate protruding blocks PB1 and PB2, which then create a space in between them. The former case is shown at
[0133] Another possibility is a re-entrant cavity similar to the one used with the FitBit. This variation device for oximeter may easily be incorporated into a FitBit device.
[0134] The re-entrant cavities may be created either by a re-entrant slice or hole onto the inner surface of the supporting structure, as the clothpin CP, or the FitBit, or a blood pressure cuff, which is the surface that touches the skin of the finger (or whatever other part of the body), or the re-entrant cavity may be created by two protuberances PB or extrusions EXT, extending out from the inner surface of the clothpin CP, or the FitBit, or the blood pressure cuff, etc., which generate an re-entrant cavity between them. Either way is good, technically equivalent, I do not care, as long as I get the money for them. Incidentally, I will not get money for the invention applied to the exploited lands of South America, Africa, etc., but only from the exploiters from USA and Europe, and the money will be used to create and maintain research institutes, libraries, health clinics, etc . . . , for the benefit of the exploited people.
[0135] So, repeating it in other words, the re-entrant cavity RC may be made either as a cavity on the inner surface of the supporting structure, or there may exist instead two optional extrusions which we call protuberances PB, which create the equivalent of a re-entrant cavity between them; such two optional extrusions or protuberances PB are therefore already covered by the re-entrant cavity but we mention them protuberances PB because of the damn lawyers who will latter come with their non-sensical absurdities.
[0136] Another embodiment of the oximeter extension-variation of out wonderful FitBit invention, which already gave us one issued and one allowed patent (:)) is the use of the ordinary cuff used for blood pressure measurements as supporting structure for the light emitter LE and the light detector LD, the rest being the same. We call this extension-variation as the BP oximeter, or BPO. Such variations either would use the device on the scattering mode, which we call the BPOS, or on the transmission mode, which we call the BPOT. The former case, the scattering mode, has the light emitter LE and the light detector LD just laid on the surface of the cuff, in which case they are not aligned, as they need not be for the scattering mode. For the transmission mode, which we call Blood Pressure Oximetry Transmission (BPOT), there exists a solid supporting structure, preferably small, which may be as small as 5 mm, with two protruding blocks, a protruding block PB1, where a light emitter LE, emitting LE1 and LE2, is fixed and emitting light approximately parallel to and just under the skin SK of the animal, and a light detector LD is fixed on the opposite protruding block PB2, which creates a re-entrant cavity between the two protruding blocks. For this variation of the BloodPressure BP variation, the light emitter LE is aligned with the light detector LD and the device works on the transmission mode described for the beautiful FitBit device of our invention.
[0137] Naturally that the oximeter could also be used as part of the FitBit itself! In this case most of the physical difference is the use of two wavelengths (“colors”), LE1 and LE2, then the extra parts on the software to calculate the oxygen saturation from the two measurements.
[0138] Another variation is a cuff-type of support device that is worn on the neck of a person, or other animal, the rest being similar to the blood pressure BP variation described above.
[0139] Another variation is a cuff-type of support device that is worn on the leg of a person, or other animal, the rest being similar to the blood pressure BP variation described above.
[0140] Another variation is a free-standing device FS, which can be a flexible type of support or a rigid type support, which would be positioned by hand on the desired location, and pressed on the skin of the person, or animal under examination, causing the flesh to penetrate the re-entrant cavity and the rest is the same.
Conclusion, Ramifications, and Scope of Invention
[0141] It is worth to mention that another class of devices, to form images using infrared (mostly) in transmission and forward scattering is besieged by the same problem as the propagation of the infrared from the FitBit into the wrist, and both require similar solutions.
[0142] Thus the reader will see that the illuminator of our amazing invention that so much improves the data collection for FitBit-type devices provides a highly reliable, lightweight, yet economical device that can be used by persons of almost any age and skill. In particular the illuminator of our invention contributes for the device, FitBit or any of its variations, to be usable for individuals of darker skin complexion.
[0143] While my above and below description contains many specificities, these should not be construed as limitations on the scope of the invention, but rather as an exemplification of one preferred embodiment of the invention (words borrowed from a lawyer . . . ). Many other variations are possible. For example, the light source may be of other colors, as visible red, which, though being more absorbed by the skin, including melanin, is still less absorbed than other colors of shorter wavelengths, as green, etc. The shape of the light emitted by the light source may also be altered in many ways. For example, the light beam may be spread along one direction only by a cylindrical lens (also known as astigmatic lens and non-spherical lens), capable of illuminating the body with a light “sheet” so to say, or a light distributed spread along a sheet parallel to, and slightly under the skin of the individual. Such a light distribution has the advantage of producing scattering from a wider area, therefore reaching more capillaries that are capable of producing the required optical signal when compared with a beam that is narrow, or laser-like, which by necessity probes a smaller number of capillaries than the sheet-like light beam. When using such a light distribution, the plane that defines the light distribution should preferably be approximately parallel to the skin.
[0144] Accordingly, the scope of the invention should be determined by the embodiment(s) illustrated, by the appended claims and the figures, and any lawyer's future confusing talk and their legal and illegal equivalents (copied from a lawyer, with variations).
SEQUENCE LISTING
[0145] Not applicable.
REFERENCES
[0146] Ref 1=https://www.healthline.com/health/pulse-oximetry#whats-next accessed Nov. 11, 2022, 3:20 pm [0147] REF 2=https://en.wikipedia.org/wiki/Pulse_oximetry accessed Nov. 11, 2022, 3:35 pm [0148] Pulse oximetry is a noninvasive method for monitoring a person's oxygen saturation. Peripheral oxygen saturation (SpO2) readings are typically within 2% accuracy (within 4% accuracy in 95% of cases) of the more accurate (and invasive) reading of arterial oxygen saturation (SaO2) from arterial blood gas analysis.[1] But the two are correlated well enough that the safe, convenient, noninvasive, inexpensive pulse oximetry method is valuable for measuring oxygen saturation in clinical use.[citation needed] [0149] The most common approach is transmissive pulse oximetry. In this approach, a sensor device is placed on a thin part of the patient's body, usually a fingertip or earlobe, or an infant's foot. Fingertips and earlobes have higher blood flow rates than other tissues, which facilitates heat transfer.[1] The device passes two wavelengths of light through the body part to a photodetector. It measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbances due to the pulsing arterial blood alone, excluding venous blood, skin, bone, muscle, fat, and (in most cases) nail polish.[2] [0150] Reflectance pulse oximetry is a less common alternative to transmissive pulse oximetry. This method does not require a thin section of the person's body and is therefore well suited to a universal application such as the feet, forehead, and chest, but it also has some limitations. Vasodilation and pooling of venous blood in the head due to compromised venous return to the heart can cause a combination of arterial and venous pulsations in the forehead region and lead to spurious SpO2 results. Such conditions occur while undergoing anesthesia with endotracheal intubation and mechanical ventilation or in patients in the Trendelenburg position [0151] A pulse oximeter is a medical device that indirectly monitors the oxygen saturation of a patient's blood (as opposed to measuring oxygen saturation directly through a blood sample) and changes in blood volume in the skin, producing a photoplethysmogram that may be further processed into other measurements. [4] The pulse oximeter may be incorporated into a multiparameter patient monitor. Most monitors also display the pulse rate. Portable, battery-operated pulse oximeters are also available for transport or home blood-oxygen monitoring.[5]