JP2003508144A - Method and apparatus for combined measurement of hemoglobin and oxygen saturation - Google Patents

Abstract

(57) with the reflection of Abstract: at least Ichijo light beam, the SpO ₂ relates to a method for accurately measuring the measurement of blood characteristics, including hemoglobin in the liquid medium.

Description

Detailed Description of the Invention

[0001] (Technical field)   The present invention uses the orienting effect of red blood cells to produce a heap in a tube containing a mixture of liquid and blood cells.
SpO, including first measurement of blood properties (EVF / hematocrit) including moglobin _Two The present invention relates to a method for non-invasively measuring a. The present invention also implements the above method.
It relates to a device for applying.

BACKGROUND ART Various non-invasive methods for measuring hemoglobin are known. These measuring methods utilize the absorption of light energy of red blood cells (RBCs) at a specific wavelength. US Pat. No. 5,755,226 to Karim et al. Discloses a non-invasive direct method and apparatus for non-invasive direct prediction of hematocrit levels in mammalian blood using photoplethysmography (PPG) and data processing. ing. However, the method only utilizes the ability of red blood cells to absorb energy,
Further, in the above method, the formula used when calculating the predicted hematocrit value is extremely complicated. Therefore, the method is time consuming. Moreover, the above method does not consider the orientation and distribution of red blood cells in blood vessels.

Further, WO97 / 15229 discloses a method and an apparatus for measuring the hemoglobin concentration in blood. The method is used to introduce a measuring tip into the subject's mouth to detect hemoglobin in the submucosal microvasculature of the subject's inner lip. This means that the measuring tip of the device must have some sterile shell before it can be put into the mouth. The sterility of the measuring tip means that the device must be autoclaved before the measurement or a disposable plastic tip must be used when carrying out the method. Further, the method utilizes light reflection to measure hemoglobin concentration.

Photoplethysmography and pulse oximetry have been extensively studied by two of the inventors ("Photopletmysmography, methodological s").
tudies and applications ", Lars-Goeran, Lindberg Linkoeping Studies in Sc
ience and Technology Dissertation, No 262, 1991 and "Pulse oximetry-meth
odological considerations ", Magnus Vegfors, Linkoeping University Medica
l Dissertations, No 347 1992, both references are included for reference). What they found was that, for example, when the pulse oximeter was tested in an artificial bed, different flow conditions had a significant impact on the accuracy of the pulse oximeter. Different states of blood, diluted and hemolyzed blood changed the accuracy of the pulse oximeter. It showed that red blood cell orientation and blood viscosity as a whole may play important roles in the generation of the two PPG signals used for pulse oximetry (Lindberg, supra).

In addition, there is a reference in the Vegfors article above to some previous studies showing that the accuracy of pulse oximeters may depend on blood hematocrit. For ethical reasons it is not possible to study the accuracy of pulse oximetry in humans at extremely low hematocrit levels. Therefore, little data is available on humans in anemia. Some studies have documented an increasing negative bias in slightly anemia subjects.

Most pulse oximeters use transmitted light to measure oxygen saturation. This limits the application of the probe to, for example, fingertips, toes or ear lobes. Therefore, there is increasing interest in reflected pulse oximetry (see Vegfors, above).
). In addition, an example of a pulse oximeter is "History of Blood Gas Analy".
sis. VI. Oximetry ", JW Severinghaus and PB Astrup, Journal of Clinic
al Monitoring, Vol 2, No. 4, October 1986, pp 270-287 (described here for reference).

Since hematocrit values outside the normal range are known to affect the accuracy of combined measurements of pulse oximetry, hemoglobin and oxygen saturation, pay attention to erroneous pulse oximetry readings and use online It is desirable to have a method and apparatus capable of making the above modifications.

(Technical problem to be solved by the invention) [0008] Therefore, a new method for detecting SpO ₂ that can obtain a more accurate detection value in consideration of blood characteristics including hemoglobin and orientation of blood cells is provided. It has been demanded. Furthermore, a method that does not require an extra step of sterilizing the device before measurement or a disposable tip is desirable. The new method should also be one that is less sensitive to changes in blood pressure, eg, tightening pressure.

(Solution Method) As a means for solving the above problems, the present invention measures reflex and transmission in central arterial blood vessels that better reflect oxygenation than in peripheral vascular beds, and hematocrit values that affect accuracy. It is intended to improve the accuracy of pulse oximetry by the simultaneous online correction of blood oxygen values and the simultaneous results of blood values such as hematocrit, which improves the quality and safety of patient observations. is there.

The first aspect of the present invention is a novel non-invasive method for accurately measuring SpO ₂ from a mixture of liquid and blood cells contained in a light-transmitting tube, comprising: a) exposing the mixture to light. Directing a beam, b) measuring at least one blood characteristic of the mixture including hemoglobin other than SpO ₂ by analyzing the intensity of light reflected from the mixture in combination with the intensity of light transmitted through the mixture. And c) a method of measuring the oxygen saturation and SpO ₂ of the mixture by analyzing the intensity of light transmitted through the mixture.

In the novel method, step (b) and step (c) may be performed in reverse order or simultaneously.

According to the invention, the novel method further comprises the step of verifying whether the result of step c) is suitable for the result of step b).

Advantageously, step (c) is carried out by measuring the oxygen saturation by pulse oximetry.

Regarding the measurement of oxygen saturation, first, the step (a) directs at least one light beam having a wavelength in the red light region to the light-transmitting tube while This is done by directing at least one light beam having a wavelength in the infrared light region. Next, in step (c), the intensities of the red light and the infrared light transmitted through the mixture are detected, the ratio of the detected intensities of the transmitted light (red / infrared) is calculated, and the ratio is analyzed to determine Sp.
This is done by measuring O ₂ .

By analyzing the ratio of the detected intensities of the transmitted light, the pressure and flow of the liquid mixture,
In particular, the effect of pulsatile flow is compensated, and the advantage is that the measured SpO ₂ is accurate. Ratios are analyzed by comparing them to the ratios obtained previously for known values of SpO ₂ .

For the measurement of blood properties (ie at least hemoglobin), step (b) comprises: i) detecting the light intensity of the light beam reflected from the mixture and the light intensity of the light beam transmitted through the mixture, ii. ) By calculating the ratio between the detected intensity of transmitted light and the detected intensity of reflected light, or the ratio of the detected intensity of reflected light and the detected intensity of transmitted light, and iii) by analyzing the ratio to measure blood characteristics. Do it.

Analyzing the ratio of the detected intensities of transmitted and reflected light has the advantage that the effects of pressure and flow rate of the liquid mixture, in particular pulsating flow, are compensated for and the measured blood properties (hemoglobin) are accurate. To be The ratio is analyzed by comparing it to the ratio previously obtained for the known value of the blood property.

Alternatively, first step (a) is carried out by directing at least two light beams of different wavelengths towards said light-transmitting tube, then step (b) is i) said The light intensity of the light beam reflected from the transparent tube is detected, ii) the ratio of the detected intensity of the reflected light is calculated, and iii) the coefficient is analyzed to measure the blood characteristics.

A second aspect of the present invention is an apparatus for accurately measuring SpO ₂ from a mixture of liquid and blood cells contained in a light-transmitting tube, the light source directing a light beam to the light-transmitting tube, A means for measuring blood characteristics other than oxygen saturation (SpO ₂ ), which is capable of analyzing the intensity of light reflected from the light-transmitting tube in combination with the intensity of light transmitted through the mixture, and including hemoglobin; And a means for measuring the oxygen saturation and SpO ₂ of the mixture, preferably by pulse oximetry, and analyzing the intensity of light transmitted through the mixture.

According to the invention, the device further comprises means for verifying whether the measured SpO ₂ value is relevant with respect to the detected value of the blood characteristic.

The light source includes a first light source that emits a first light beam having a wavelength in a red light region to the light transmitting tube, and a second light beam having a wavelength in an infrared light region to the light transmitting tube. Of a second light source for emitting light.

The apparatus further includes a first detector that detects the intensity of the red first light beam that has passed through the transparent tube, and an infrared second light beam that has passed through the transparent tube. A second detector for detecting intensity may be included. The oxygen saturation measuring means may include a processing device configured to calculate a ratio of detection intensities of transmitted red light and infrared light and analyze the ratio to measure the value of oxygen saturation.

The light source optionally includes a third light source that emits a third light beam to the light-transmitting tube, and the apparatus further comprises a light intensity of the third light beam reflected from the light-transmitting tube. May be included, and a fourth detector that detects the intensity of the light of the third light beam that has passed through the light-transmitting tube may be included. The blood characteristic measuring means may include a processing device configured to calculate a ratio of detected intensities of reflected light and transmitted light of the third light beam, and analyze the ratio to measure the value of the blood characteristic. Good.

[0024] The apparatus may further ,, the measured blood property and measuring the recording means and optionally storing SpO ₂ blood characteristics and SpO ₂ may include means for visualizing.

A third aspect of the invention is the use of the device according to the second aspect of the invention in a dialysis machine.

The term “light source” should be understood to include one or more light emitting devices such as photodiodes.

In the present application, the expression “blood characteristics” refers to, for example, the concentration and viscosity of blood components such as hemoglobin, total hemoglobin, red blood cells, white blood cells, platelets, cholesterol, albumin, thrombocytes, lymphocytes, drugs and other substances. , Blood pressure, blood flow, blood volume, blood cell illnesses, appearance of abnormal blood cells, blood characteristics such as anemia, leukemia or lymphoma.

In the present application, the expression “hemoglobin” means oxyhemoglobin, reduced hemoglobin, carboxyhemoglobin, methemoglobin or sulfhemoglobin.

In the present application, the expression “red blood cells” means red blood cells containing hemoglobin, either completely or partially lysed.

In the present application, the expression “light-transmitting tube” means a blood vessel or a light-permeable pipe, tube or tubular article of an animal. The pipe, tube or tubing may be made of acrylonitrile butadiene styrene (ABS), polycarbonate or acrylic glass (polymethylmethacrylate; PMMA) which provides a non-flexible material, which provides a flexible material. Polyvinyl chloride (PVC), silicone rubber, soft P
It may also be made from VC, for example PVC plasticized with dioctyl phthalate, diethylhexyl phthalate or trioctyl trimellitate. PMMA is the most preferred inflexible material. The light-transmitting tube may be further used for infusion or blood transfusion. The elasticity of the material may vary widely. The animal containing the blood vessel is preferably a mammal, most preferably a human.

As used herein, “light” generally refers to the infrared of the spectrum,
Electromagnetic radiation at any wavelength, including visible and ultraviolet. Particularly preferred parts of the spectrum are those parts of the tissue that are transparent, such as visible and near infrared wavelengths. In the present invention, the light may be unpolarized light or polarized light, coherent light or incoherent light, and irradiation may be stationary light pulse, amplitude modulated light or continuous light. Needless to say.

The light source used in the method and apparatus according to the present invention may be, for example, a light emitting diode (LED).
), A laser diode or a combination thereof such as a vertical cavity surface emitting laser (VCSEL). It is preferable to use LEDs that are not very expensive. Current,
While there are new light emitting diodes with higher power, these light emitting diodes may be used in the method and apparatus of the present invention. It is also conceivable to use a strobe light source in the present invention. The light source may also be one capable of emitting monochromatic light, ie a monochromator. A quartz halogen lamp or a tungsten lamp may also be used as the light source. In addition, an optical fiber may be used to guide light to or from the measurement point, or to directly irradiate the measurement point.

Suitable detectors for use in performing the method of the present invention are phototransistors, photodiodes, photoelectron amplifier tubes, photocells, photodetectors, optical power meters, amplifiers, CCD arrays and others.

In the present application, the expression “means for measuring blood properties including hemoglobin” refers to all non-invasive devices for measuring blood properties including hemoglobin in a liquid consisting of blood cells. . Preferred examples of such non-invasive devices are set forth in the description and claims below.

In the present application, the expression “means for measuring SpO ₂ ” refers to all devices for non-invasively measuring oxygen saturation in a liquid consisting of blood cells. For example, the above-mentioned Feghols (Ve) which discloses a Minolta pulse oximeter.
gfors) and Severinghaus, and the like, a device for pulse oximetry measurements is preferred. The Minolta pulse oximeter uses 650 nm and 805 nm. As described below, the device described in Vegfors above is most preferred.

The mixture of liquid and blood cells according to the invention is preferably flowing, but may be stopped, for example in the case of a fluid medium in a blood bag. The mixture of liquid and blood cells may include plasma or other liquids such as water or dialysate. The plasma is preferably in or from a mammal. Said liquid should be any other fluid consisting of blood cells obtained during or after the treatment of blood.

Furthermore, the method according to the present application is also characterized in that it is carried out on mammals such as livestock or humans, preferably on humans.

The method according to the invention may be carried out on the human body, ie any part of the body which consists entirely of thick blood vessels, but is preferably a vein, arteriole or artery, most preferably of 0 diameter. It is performed in blood vessels larger than 1 mm. According to a preferred embodiment of the invention, the detection is done on the arm, toe or finger. The detection is most preferably performed on the wrist or a finger with the third phalanx.

The present invention, in particular the SpO ₂ measuring part thereof, is based on the principle that the individual wavelengths of light are differently absorbed by different components of arterial blood. One application of this principle is used to measure arterial blood oxygen saturation. In pulse oximetry, two wavelengths of light emitted from a suitable light source are used, one in the red light region and one in the infrared light region. The oximeter allows light to pass through the site of observation and provides relative absorption of red light (due to reduced hemoglobin, Hb) (preferably 660 nm) and infrared light (due to oxyhemoglobin, HbO ₂ ) (preferably 940 nm). taking measurement. Since HbO ₂ and Hb absorb different amounts of light at each of the two wavelengths, the oximeter can compare the ratio of each absorption and convert it to a SpO ₂ value. More specifically, this is preferably at a constant DC level (AC ₆₆₀ / DC ₆₆₀ ) / (AC ₉₄₀ / DC ₉₄₀ ).
Alternatively, it can be expressed as AC ₆₆₀ / AC ₉₄₀ . Pulse oximetry diminishes the effects of other absorbers by seeing only pulsatile absorption. The oximeter only considers absorbers in arterial blood. This is therefore similar to the current innovative global measurement principle, especially for hemoglobin, preferably 940n
m and 660 nm light sources and suitable detectors.

In a preferred embodiment of the method according to the invention, the detected intensity of one or more of the light beams of the light beam reflected from the transparent tube and the detected intensity of the light beam transmitted through the transparent tube are preferably wireless communication. By means of a module for wireless transmission to devices performing steps a), e) and f). The wireless communication is preferably performed by using a communication path conforming to the Bluetooth (registered trademark) standard.

In the method according to the invention, the light beam is directed essentially perpendicular to the measuring range of the tube.

In the method according to the present invention, the wavelength of the light in step (a) is 200 nm to 2000 nm, preferably 770 nm to 950 nm, and most preferably about 770, 800, 850, 940 or when the transmitted light is also detected. 950 nm is preferred.

In a preferred embodiment of the method according to the invention, at least two light beams of different wavelengths in step (a) are directed towards the mixture, the first light beam comprising:
The wavelength of the second light beam is such that when it passes through the red blood cells, the light absorption of the red blood cells is relatively high, while that of the second light beam is such that the light absorption of the red blood cells is relatively low. Selected to be.

In a preferred embodiment of the method according to the invention, preferably at least two light beams of different wavelengths in (a) are directed onto the light-transmitting tube, preferably essentially parallel to one another, while Is set to 770 to 950 nm and the other wavelength is set to 48
0 to 590 nm.

In a preferred embodiment of the method according to the invention, in step (a) the light is emitted from at least 4 light sources, preferably at least 6 light sources, which light source is one of said detectors. One of the light sources, preferably 2
Most preferably, three are arranged as a set, and most preferably when there are six light sources, the light sources form an "H" shape about the detector. The “H” is preferably about 9 when viewed from the direction of the arm or blood vessel during measurement on the wrist.
It is preferably tilted at 0 degrees. The measurement is more preferably performed inside the wrist.

In a preferred embodiment of the method according to the invention, the light in (a) is emitted from two light sources. The light sources are arranged and emerge on two different opposite sides of the tube containing the mixture. The detection of reflected light and transmitted light from the tube requires at least two detectors,
Preferably it is done with only two detectors.

In one preferred embodiment of the method according to the present invention, step (b) comprises the following steps: That is, I) In a time frame that is evenly divided left and right, and whose length is preferably about 60% of the cycle,
Sweep on the curve containing the detected values of transmission and / or reflection, II) If there is no value within the time frame that is greater than the median, specify that value as the maximum point and at the same time set the time frame to the time frame. If the value exceeds the median value by rapidly moving it by half the length, the step of moving the time frame by one step, III) For the minimum value instead of the maximum value, perform the minimum point as in II). IV) The step of obtaining the AC signal height by subtracting the value on the perpendicular of the minimum point between the two maximum points from the value on the connecting line including the two maximum points, V) The step IV) Repeating at least 8 times, adding the values obtained in IV) and dividing the sum by the number of observations to obtain an AC average value; and VI) calculating the total height of the minimum points in step IV) in step V ) D by adding to the average AC signal
Optionally comprising the step of obtaining a C signal, preferably using a computer program to obtain said AC signal and optionally a DC signal.

In a preferred embodiment of the method according to the invention, the wavelength of red light is about 660.
nm, and the wavelength of infrared light is about 940 nm.

In the method according to the present invention, it is preferable to simultaneously present the measured SpO ₂ containing hemoglobin and the measured blood characteristics.

In the method according to the above method, the measured SpO2 is preferably corrected by using the measured blood characteristic including hemoglobin.

The method according to the invention, according to a preferred embodiment, is for example a dialysis machine, a cell saver, an extracorporeal device including a dialysis monitor, a blood bag device including an assembly, a slaughterhouse device, a blood sorting device. May be used to measure blood characteristics including hemoglobin. Said light-transmitting tube, preferably a tube or pipe, has a diameter of more than 0.1 mm in this embodiment of the invention. In a dialysis machine, hemoglobin and S present in the fluid subjected to any type of dialysis, preferably hemodialysis
It is desirable to look at the value of pO ₂ . It is further desirable to measure hemoglobin concentration during dialysis to track changes in patient blood volume and SpO ₂ . With respect to the construction of blood bags and blood bag assemblies, the method according to the present invention is directed to a tubular body, bag, filter or other used in connection with a blood bag containing whole blood or buffy coat, i.e. white blood cell concentrate. You may apply to a component. The method may also be used during transfusion through a tubular body or likewise during blood donation. In a slaughterhouse, the method according to the present application, when collecting blood from slaughtered livestock, and further processing the collected blood,
It is useful when directly obtaining whole blood used for food or when fractionating to obtain blood components such as albumin and immunoglobulin. The method according to the present application may also be used when counting blood cells, ie in the process of counting red blood cells and white blood cells. This may be done with a hemocytometer, such as a Coulter Counter from Coulter Diagnostics, Inc. of Miami, Florida. Furthermore, the method according to the invention may be used in connection with blood analysis, blood group determination or blood gas analysis. Further, the method according to the present invention may be used when separating human blood with a blood separating apparatus. It is desirable to use the method according to the present application when obtaining plasma from a blood donor. The method is also useful when obtaining a buffy coat from a blood donor or when the buffy coat is further processed to produce cytokines such as interferon alpha. Finally, the method is useful for determining how RBC lysis occurs in leukocyte purification. Leukocytes are exposed to a virus, such as Sendai virus, during one or more steps of subsequently contacting the RBC lysate with, for example, ammonium chloride, while culturing in a suitable medium, such as Eagle's Minimum Essential Medium (EMEM).

The method according to the present application is preferably performed in a blood vessel, tube or pipe.

According to a preferred embodiment of the invention, the light beam is preferably directed essentially perpendicular to the measuring range of the tube containing the mixture.

According to a preferred embodiment of the invention, at least two light beams are directed onto the tube from two light sources and the detection of the intensity of the reflected light from said light-transmissive tube is detected by at least one detector, Preferably, only one detector is used.

According to yet another preferred embodiment of the method according to the invention, in step a) at least two light beams, preferably having two different wavelengths, are directed onto the tube from two light sources. The light sources may be incorporated in the same shell, for example a chip, arranged and exposed on one common side of the object to be measured. The light source is
When used simultaneously in a chip, they may be illuminated alternately. Light beam 1
The wavelength of the book is 770 nm to 950 nm, preferably 770, 800, 850, 9
40 or 950 nm, and the wavelength of the other light beam is 480 nm to 590 nm.
nm, preferably 500 nm.

A device according to one of the preferred embodiments of the invention may comprise at least 4 light sources and at least 2 detectors for reflected light. In that case, the two light sources that direct the two light beams appearing on the same side of the tube have different wavelengths. The wavelength of one light source is 770 to 950 nm, and the wavelength of the other light source is 480 to 590 nm.
Is preferred.

In a device according to one of the preferred embodiments of the invention, at least two components of said device may be in communication with each other by means of a wireless connection, preferably a module for wireless connection. The module for wireless communication may include at least one transmitter and one receiver.

In a device according to a preferred embodiment of the present invention, at least three components,
That is, there may be one wireless communication module between the light source, the photodetector and the processing device and / or one wireless communication module between the processing device and the recording means.

In the device according to the preferred embodiment of the present invention, the wireless communication may be performed using a communication path compliant with the Bluetooth (registered trademark) standard.

In a device according to a preferred embodiment of the invention, the light source may be arranged essentially perpendicular to the measuring range of the tube.

In a device according to a preferred embodiment of the invention, at least one wavelength of the light is 200 nm to 2000 nm, preferably 770 nm to 950 nm, most preferably about 770, 800, 850, 940 or 950 nm.

A device according to a preferred embodiment of the invention may comprise two light sources directing two light beams of different wavelengths on the same side of the light-transmitting tube, one wavelength of said light beam being provided. Is 770 nm to 950 nm, preferably 770, 800, 850, 940 or 950 nm, and the wavelength of the other light beam is 480 to 590 nm, preferably 500 nm.

A device according to a preferred embodiment of the invention comprises at least 4 light sources on one side, preferably at least 6 light sources, said light sources appearing on either side of said detector, preferably Are preferably arranged in pairs of two light sources, preferably in groups of three, and the light sources preferably form an "H" shape about the detector.

The device according to a preferred embodiment of the invention may take the form of a test device comprising a light source and a detector fitted to the wrist, fingers or toes.

In a device according to a preferred embodiment of the present invention, said test device comprises a thimble-like shell applied to a finger or toe. In that case, the light source and the detector are adapted to direct a light beam within the shell and detect the light intensity.

In a device according to a preferred embodiment of the invention, at least three light sources and detectors are arranged in the shell of the clamping part. Thereby, the light source and the detector are arranged and exposed in the clamping part, and the shell is preferably part of the thimble design covering the finger or toe.

A device according to a preferred embodiment of the invention comprises at least 4 on one common side.
Consisting of 6 light emitting diodes, preferably at least 6 light emitting diodes and 1 detector, which form an "H" around the detector, this time a part of the handcuff structure for measuring the wrist Fixed to the patch to make it suitable. In that case, the distance between the light source and the detector, based on the center of each component, is preferably 4 to 12 mm, most preferably the distance, in order to measure the blood properties including Hb and SpO _2. Is about 8 to 9 mm. When measuring thick parts of the body, such as the wrist or arm including the radial side, and regarding blood characteristics that also include Hb and SpO ₂ , the distance between fibers (light source and detector) should be 6 to 12 mm. Good. For thicker parts of the body, such as the upper arm, the distance is 12 to 3
It is good to set it to 0 mm. When measuring on the wrist or on the thicker part of the body, it is preferable to apply pressure to the measurement site. The method according to the invention may also be used for measurements on tubes located below the ankle, including the back of the foot. Therefore, the invention may comprise light sources and detectors arranged at different distances set as described above depending on the observed measuring range, in particular for measuring blood properties including Hb. By doing so, the target tube can be reached and thus the detection of blood characteristics including Hb is possible. The distance between the detector and the light source is therefore preferably 1 to 20 mm, depending on the measuring range, as set out above.

In a device according to one of the preferred embodiments of the invention, the light source and the detector for reflection may be fixed to the edge of the patch containing the finger, toe or wrist, preferably the wrist. In that case, the patch is preferably a flexible plastic patch with a strap for wrist fastening. The strap preferably comprises a locking device.

In a device according to one of the preferred embodiments of the present invention, a light source and a detector for reflection may be incorporated in the patch, and the electrical components are on one side of a printed circuit board card coated with black silicon. And the optical component is fixed to the other transparent silicon-coated surface.

In an apparatus according to one of the preferred embodiments of the present invention, the patch is 51x
A light source and detector, which is a rectangle with a size of 35 mm and placed at "H", is fixed at the corner of the patch.

In a device according to one of the preferred embodiments of the invention, the processing device is adapted to convert the reflection value into a concentration value of the measured blood characteristic, preferably by calculating the ratio of the detected reflection intensities. .

In a device according to one of the preferred embodiments of the invention, the processing device may comprise a computer program for carrying out the method according to the invention.

In the device according to one of the preferred embodiments of the present invention, the wavelength of the red light region in (I) is about 660 nm, and the wavelength of infrared light is about 940 nm.

One of the embodiments is a computer program stored on a data carrier for carrying out the method according to the invention.

Combining the method and apparatus of the present invention with communication that does not require a cable makes the method and apparatus easier to use and broadens its use. The cableless communication enables Internet billing, patient information tracking and statistics, software package updates and services. The user can obtain the code necessary for performing a certain number of times of the test by using the command via the modem, much like a mobile phone.

The wireless communication standard Bluetooth (registered trademark) has provided the opportunity to use devices that do not require cables in hospitals. Bluetooth (Bluetooth,
The registered trademark technology allows electronic devices to communicate with each other without a cable. Bluetooth modules, which consist of a transmitter and a receiver, may replace cables for many applications. FIG. 18 shows a system with a SpO ₂ detector that includes a computer and blood property measurements,
The system does not require a cable between the computer and detector using Bluetooth technology.

L. M. Developed by Ericsson, the Bluetooth technology uses ISM band 2.45 Ghz to ensure uninterrupted communication. The system can work with fast frequency hopping of 1.600 hops per second. The output from the transmitter may be reduced to work at a maximum distance of 10 meters. However, the distance between the components of the apparatus of the present invention capable of wireless communication is 1c.
It can be changed from m to 10,000,000 miles.

In the device according to the present application, at least one detector is capable of receiving reflected light and may be arranged next to said light source.

According to a preferred embodiment of the device according to the present application, the detectors capable of receiving reflected light are arranged side by side next to the light source.

According to a preferred embodiment of the device according to the present application, said device may take the form of a finger or toe-fitting test device or handcuffed device with a light source and a detector.

The test device according to the present application, according to a preferred embodiment, consists of a thimble-like shell in a short thimble which is preferably used for detecting SpO ₂ containing blood properties including hemoglobin in the finger or toe. ing. In that case, at least three light sources and detectors are arranged as part of the thimble structure. The thimble embodiment is also useful for the detection of hemoglobin in the paw of domestic animals.

The test device according to the present application, according to a preferred embodiment, is a finger, toe or arm,
Preferably it consists preferably handcuffs-like shell in short handcuffs used to detect the SpO ₂ including blood characteristics including hemoglobin in the wrist or finger. In that case, at least three light sources and detectors are arranged as part of the handcuff structure. The handcuff embodiments are also useful for the detection of Hemoglobin-containing SpO _{2 in} the paw of livestock.

According to a preferred embodiment of the present invention, said device, in particular its test device, is adapted to apply a thimble-like shell applied to a finger or toe, directing a light beam in said shell and detecting the light intensity. It may include a light source and a detector. Said embodiment may comprise at least three light sources and detectors arranged in the same shell,
It may optionally include a bent portion (tightening portion). Thereby, the light source and the detector are arranged in the bending portion (tightening portion) and appear there, and the shell covering the finger, toe or wrist becomes a part of the thimble or handcuff structure. Therefore, the test device may be shaped to fit on the wrist, toes, or fingers.

The thimble or handcuff embodiments include at least three light emitting diodes (LEDs) arranged on one side with at least one detector and two detectors for detecting transmitted light. It is basically characterized. Said component is (a) in proximity to said component, i.e. the diode and the detector, in a flexible means comprising a flexible material, preferably a polymeric material, most preferably silicone rubber. It may be contained in a shell comprising a first member to be contained, and (b) a flexible material, preferably a polymeric material, most preferably an optional second member also comprising silicone rubber. The first member is also a black plastic material,
Most preferably it may be made of epoxy resin or PMMA. The shell may be molded on an industrial scale or handmade by methods known to those skilled in the art. When molding the silicone rubber to manufacture the first member and optionally the second member, colored powder (dye)
Is preferably added to the rubber. The shorter the wavelength, the greater the problem of external light. Therefore, the problem may be minimized by adding a dye to the material.
The dye is preferably black, which minimizes interference from other light sources. Through joining the shell to the first member and, if present, the second member, by joining them, preferably by gluing them together, or by some other method of attaching them together, e.g. fingers, feet. It may be fixed to a place such as a finger or a wrist.
Further, the shell may preferably have an inner bent portion and an inner tightened portion formed on the first member thereof. In that case the fingers, toes or wrists are properly positioned during the measurement. The shell may take any shape and surrounds the internal bend or clamp. In this way, the fingers, toes or wrists are tightened and the blood vessels are easily accessible for the measurement method according to the invention. The tightening may be done by mechanical means or simply by pressing by hand. It is also possible to fasten the object to be measured by fixing the thimble-like or handcuff-like device by using a tightening machine consisting of a rubber band with a tightening ring or a banding machine.

The flexible material of the first member may also be made of natural rubber or pure flexible polymers or copolymers. Alternatively, the flexible material may include one or more polymers. The materials of the first part and the second part preferably do not contain allergen-inducing substances and the thimble-like device is very gentle on the skin of mammals. The shell allows the finger, toe or wrist to be measured to be clamped and preferably makes the blood vessel readily available for the measurement method according to the invention. The blood vessels are preferably arteries, veins or arterioles. The detection is preferably performed on the wrist or a finger with the third phalange.

A test device according to a preferred embodiment of the present invention comprises a thimble-like shell applied to a finger or toe, a light source and a detector adapted to direct a light beam in the shell and detect the light intensity. Become.

Another preferred embodiment of the invention is a device with an additional light source adapted to appear on either side of the detector for detecting reflected light on the common side.

Another preferred embodiment of the present invention is at least 3 additional light sources, preferably at least 5 additional light sources, thus a total of at least 4 light sources,
It is preferably a device having six light sources. In that case, the light sources appear on either side of the detector on the common side, preferably in groups of two, most preferably in groups of three. Thereby, the component preferably forms an "H" about the detector. The preferred embodiment with six light sources, preferably six light emitting diodes and one detector, forms an "H" around the detector.

This further embodiment, a handcuffed device, which is one of the preferred embodiments of the invention according to the present application, is illustrated by the design described in detail in Example 3 and also in FIG. In the handcuff embodiment of the present invention, the distance between the light source and the detector may be from 4 to 12 mm relative to the center of each component, and is preferably about 8 mm. In FIG. 16, this is the distance between the LED and the central photodetector. It is preferred that the component is fixed to a finger, toe or wrist, preferably to the edge of the bend that houses the wrist.

The handcuffed device according to one embodiment of the invention may be present as a flexible plastic patch, preferably secured to a strap for fastening to the wrist.
In that case the strap is locked this time using a locking device during the measurement to tighten the wrist. This embodiment can be seen in FIGS. 15 and 16. As can be seen in FIG. 16, the component has a “H” in the corner of a flexible, essentially rectangular patch.
". The patch has rounded corners and the size is 51x35.
It is preferably mm. The patch preferably has a raised side for contacting the measuring range, eg human skin, at which the light source and the detector appear. The patch is preferably 51x35 mm in size,
The raised portion is 31x47 mm in size and 2 m with respect to the outer dimension.
There is a margin of m. As can be seen in FIG. 16, the component, when placed in the “H”, is preferably fixed to the smaller rectangle, ie the shorter corner of 31 × 47 mm. The “H” is, for example, about 9 when viewed from the direction of the arm or blood vessel during measurement on the wrist.
It is preferable to tilt it by 0 degree. The measurements are preferably made inside and outside the wrist and the detectors for detecting the transmitted light (red and infrared) will be on the outside of the wrist.

The light source and detector may further be fixed to the edge of the patch containing a finger, toe or wrist, preferably a wrist. Most preferably, the patch is a flexible plastic patch secured to a strap for fastening to the wrist. The strap preferably comprises a locking device. In addition, the device comprises a light source and a detector integrated in a patch, fixing the electrical components on one side of a black silicon coated printed circuit board card and the optical components on the other transparent side. Fix on the surface covered with silicon. This ensures electrical shielding, reduction of stray light and the possibility of sterilization. The patch may be a rectangle, preferably measuring 51 x 35 mm, with the light source and detector fixed at the "H" corners of the patch.

The tube in which the blood characteristic is observed may be identified by an appropriate choice of separation between the light source and the detector. Theoretical analysis and experimental verification of the optical technology are described in I. Friedrin, K. Johansson and L.L. G. It was described in two papers by Lindberg. The article will be adopted and published in Physics in Medicine and Biology (Optical Non-Invasive Techniques I and II for Imaging the Tube, Faculty of Biomedical Engineering, Linkoping University, Sweden). The following is a summary of their analytical and experimental validation.

The reflection of light from human tissue depends on many parameters such as the wavelength of the light, the separation of the source and detector, the size and diameter of the source and detector, and the optical properties of blood and tissue. The separation between the light source and the detection fiber consists of five center distances (2, 3, 4,
5 and 6 mm). The analysis was consistent with the earlier conclusion that a larger source and detector separation should be chosen to increase the effect of deeper tissue on the measured signal.

The results of the mathematical analysis and the results of the proven analysis can be summarized as follows. At higher separation values, the photons forming the maximum photon path and detected at the photodetector come from a deeper layer than for short distance values. This is shown in FIG. FIG. 14 shows the separation of two different light sources and detectors and different FL (α) (FL (0)
And FL (π / 2)) are explanatory views of movement of photons. FL is the position of a set of fibers relative to the inside of the tube. Two positions of the fiber of the light source and the photodetector were considered in relation to the inside of the tube. The angle α is defined so as to show characteristics at different positions. The abbreviation FL (0) means that the light source and the photodetector are arranged in parallel, and
L (π / 2) means that the light source and photodetector are arranged perpendicular to the tube.
Monte Carlo simulations have shown that in the near infrared region for human tissue, photons penetrate about 2 mm before being detected if the separation between the light source and the detector is about 2 mm.

Blood vessels from a vascular perspective are measured at the level of 3 vessels in combination with a fixed fiber diameter (1 mm) using the probes and techniques summarized above, according to the following: Surface level of blood vessels (about 1 mm). The level is sufficient to set the minimum distance between the illumination and detection fibers (2 mm in the above experiment). Intermediate level of blood vessels (about 2 mm). The minimum distance between the illumination and the detection fiber is
It may be preferably 2 to 3 mm. Deep level of blood vessels (about 3 mm). The distance between the illumination and detection fibers may preferably be greater than 3 mm. The results of the above study summaries are capable of measuring blood properties and physiological parameters such as blood flow, blood constant, oxygen saturation, for example, in selected vascular beds of veins or arteries. Indicates that.

When measuring a thick part of the body such as the wrist or the upper arm of the arm including the radial side, H
For SpO ₂ and blood properties including b, the distance between the fibers (source and detector) may be 6 to 12 mm. For thicker parts of the body, such as the upper arm, the distance may be 12 to 30 mm. When measuring on the wrist or on the thicker part of the body, it is preferable to apply pressure to the measurement site. The method according to the invention may also be used for measurements on tubes located below the ankle, including the back of the foot.

The theoretical solution to light distribution in tissue, described in paper II, provides the basis for describing how hemoglobin can be measured in reflection mode. Equation 3 from the above paper
2 provides a general solution. In the formula, μ _a and μ _s represent the influence of the light coefficient, and H and B or Z represent the influence on the variation of the pulsation in the blood vessel diameter during the heartbeat.

The light source is connected to a power source which may be an oscillator with a cord or battery. The oscillator may be connected to the amplifier and the LED driver. Driver is one or more LE
You may connect to D. A detector for reflection, eg a photodiode, may be connected to at least one current / voltage converter. The converter may be connected to the amplifier as well. The signal passes through a bandpass filter and then becomes an analog output or passes through a μ-controller connected to the readout device.

One or more calibration curves may be used for carrying out the method according to the invention. A calibration curve stored in the memory of the processor, which is preferably part of the computer, obtains when the light beam is directed at the tube and then reflections and transmissions or only reflections are detected.
C _R / AC _T or _DC R / DC _T and may be expressed reflection / transmission ratio (%), or _AC R / AC _R or _DC R / DC _R and may be expressed reflected / reflection ratio (%) Can be easily converted into hemoglobin value (mmol / l). By analyzing the ratio of the detected intensities of the reflected or reflected and transmitted light, the influence from the pressure and the flow rate of the liquid mixture, especially in the pulsatile flow, is compensated for and the measured blood properties are correct, so SpO ₂ also The advantage is that it is accurate. The ratio is analyzed by comparing it to the coefficient obtained previously for the known value of the blood property in question. The calibration curve may be obtained by analyzing blood samples collected from spontaneously healthy subjects and patients, preferably with a Hemocue device or a blood gas analyzer, simultaneously with the method according to the present invention. In conjunction with the method, a spectrophotometric absorption curve in reflection mode or a recording curve in reflection mode may also be used. The values obtained for measuring SpO ₂ , preferably in the form of the above ratios, may be compared to existing calibration curves. As a result, Sp
An easy conversion to O ₂ value is possible.

Furthermore, the device according to the invention may comprise a large matrix probe which may be in the form of a ring, plate, cube, sphere, which comprises a plurality of light sources (6 or more) and detectors (1 or more). Good.

According to a further preferred embodiment, the device according to the present application may be included in a dialysis device, preferably for hemodialysis.

The device according to the invention may be divided by location on the body, for example a SpO2 measuring part used in the ear and optionally wirelessly connected and an Hb measuring part used in the fingers, wrists or toes. You may have it.

The device according to the present application, according to a further preferred embodiment, at least 2, preferably 4, and most preferably 6 appearing arranged and on the common side of the measuring object during detection.
Individual light sources may be provided. If two or more LEDs are used, they are preferably interchangeable. The LEDs more preferably emit light of different wavelengths. Independence of blood properties on blood flow and blood pressure is also achieved by measuring the intensity of reflected light at one or more wavelengths using a light source of suitable wavelength. Similar measurement techniques may be used to compensate for differences in tissue absorption on arteries between individuals. LED is the same handcuff type device
(The patch) or a thimble-like device.

The device according to the present application may, according to a further preferred embodiment, comprise at least two light sources. In that case, the first light source emits light of a wavelength that is relatively unabsorbed by red blood cells, and the second light source emits light of a wavelength that is relatively absorbed by red blood cells. The first and second light sources are preferably oriented substantially parallel to each other.

The device according to the present application, according to a further preferred embodiment, at least two light sources, preferably at least four, arranged and appearing on the same common side of the measuring object during detection.
It may comprise one light source, most preferably at least six light sources. In that case, at least one light source, preferably an LED, emits green light and at least another light source, preferably an LED, emits NIR light from 770 nm to 950 nm.
At least two light sources direct two light beams to the same side of the tube. One wavelength of the light beam is 770 nm to 950 nm, and the other wavelength of the light beam is 480 to 590 nm. The green light has a wavelength range of green, that is,
It is preferred to emit at 480-590 nm, preferably 500 nm.

By directing two light beams with a wavelength shorter than 1500 nm, the method becomes more sensitive. In a preferred embodiment of the invention described above, one light beam has a long wavelength, preferably NIR (near infrared red) light, and the other light beam has a short wavelength, preferably in the range 200-580 nm. With wavelengths within, most preferably green light, 400 or 500 nm. The use of green as the other light source is advantageous because the green light is significantly absorbed by red blood cells.

The processor for analyzing the intensities of the reflected and transmitted light detected by the detector and for measuring SpO ₂ containing blood characteristics including hemoglobin may be incorporated in a computer (CPU). Further, the recording means may also be incorporated in the computer. The visualization may also be performed by any visualization means, but is preferably performed by using a computer display and / or a printer device. The processing of the data obtained during the measurement also reflects / reflects / without AC and / or DC signals with or without multiplication of one or more of the obtained data.
Including calculating transmission, transmission / reflection (reflection / transmission for SpO ₂ ) ratios,
Compensate for volume and flow variations. Further light sources and detectors according to the invention are used according to the invention (especially in the measurement of blood properties including Hb) to calculate some ratios based on the detected intensities according to the number of available detected intensities. To be done. Especially when using a matrix of multiple light sources and detectors, search for the optimum measuring location of the tube, reliable signal strength control / certification, performing algorithmic operations, storing of data against stored standard curves Computer programs for evaluation and display and storage of results along with patient data and associated quality criteria may also be incorporated into the processor. The output of the results from the measurement using the present invention may be performed by the connected printer device. The printer device may optionally be connected using visualization means.

Of course, manually processing the reflected signal to obtain an S containing blood characteristics including hemoglobin.
It is possible to measure pO ₂ . The results may also be visualized manually, for example by plotting the results in a figure. The signal detected by the detector may be further analyzed, preferably using the following procedure. Since the PPG signal is composed of two parts, a constant signal and a pulsating signal superimposed on the constant signal, the first maximum and minimum points are calculated. The maximum point is calculated by searching a time frame (time zone) from the beginning to the end of the curve. The length of the time frame (time zone) is AC
Approximately 60% of the period divided equally into right and left depending on the frequency of the signal (pulse)
Is adjusted to. If none of the values in the time frame (time zone) is higher than the central value, that value is set as the maximum point. After that, in order to avoid that the plateau forming curve is recorded as many maximum points, the time frame is moved by jumping half the time length. If a certain value within the time frame exceeds the central value, the time frame is moved by one step. The minimum point is calculated by a method corresponding to this.

The AC height for each minimum point is calculated as the height from the minimum point between the maximum points closest to the left and right of the center point to the connecting line between the maximum points. The subsequent 9 A's are removed to eliminate artifacts that could cause falsely detected minimum or maximum points.
Of the C heights, the central height is selected as the representative value of the AC signal. The DC signal is then calculated as the total height to the reference minimum of the AC signal + the AC signal. FIG. 19 shows an example of the above procedure. The step d in the above summary of the invention is the following step:
That is, I) a step of searching on a curve having detection values of transmission and / or reflection in a time frame having a length of approximately 60% of the cycle time, II) values within the time frame are average (intermediate) values If there is nothing higher than this, specify this value as the maximum point and move the time frame by half the length of the time frame, or if the value exceeds the intermediate value, move the time frame by one step. Step III) Specifying the minimum point in the same way as II) for the minimum value instead of the maximum value, IV) Dropping the minimum point between the maximum points from the value on the connecting line including the two maximum points. AC value by repeating the steps of subtracting the value on the line to obtain the height of the AC signal, V) IV) at least 8 times, adding the values obtained in IV) and dividing the sum by the number of observations And VI) optionally add the total height of the minimum point of IV) to the average AC signal of step V) D
Preferably, the step of obtaining a C signal is included. Preferably, the above steps are performed using a computer program to obtain an AC signal and optionally a DC signal. The computer program for performing the above steps I) to IV) is preferably stored in a data storage medium. Preferably, the data storage medium is the processor shown in iv) or a part of the central processing unit (CPU), or a separate floppy disk inserted and used by the processor. The processing device may also include a method according to the invention, and / or a computer program for carrying out steps I to VI above, for example as shown in the Summary of the Invention and the Preferred Embodiments of the Invention. Good.

Another embodiment of the invention also carries out the method according to the invention and / or steps I to VI above, for example as shown in the summary of the invention and the preferred embodiments of the invention. Is a computer program stored in a data storage medium for.

When measured on the skin, the equations are the same, except that the light decreases in response to the absorption of light and the scattering of light on the tissue. Intensity may be compensated with different blood flows when practicing the invention, the method and using the device. When performing skin measurements, this is preferably done on thick blood vessels, for example on the wrist or fingers with the third phalange. The blood vessels contain a blood volume that is significantly different from the surrounding blood volume, which preferably consists of capillaries. The methods and apparatus of the present invention should preferably be noted that may be used to measure the SpO ₂ including major blood characteristic as represented by thick blood vessel such as an artery. This may be done by using the ratio between reflected and transmitted light to compensate for the effects of blood pressure and blood flow on the measured intensity of reflected and transmitted light. The effects used in the method and apparatus according to the present invention may also be used to measure changes in SpO ₂ and blood properties in an individual or an in vitro system when blood hemoglobin levels are constant. This is further described in Example 4. This was done there by using the device according to the invention. Therefore, it becomes possible to follow changes in SpO ₂ and blood volume as well as pathological changes in the body using the above method.

Using the method and apparatus, the present invention also provides a total oxygen content in human blood of 97 to 9%.
Since 8% is transported by hemoglobin molecules in blood, it may be used for detection of oxygen together with SpO ₂ . Of course, the method may be used to detect SpO ₂ and the red blood cells themselves, as hemoglobin is normally incorporated into the red blood cells unless the red blood cells are lysed. Since the viscosity of blood corresponds to the amount of red blood cells in blood, the method may be used to detect viscosity. The method and apparatus according to the present invention may also be used to measure hematocrit (HCT). The difference between hemoglobin, which is the number of hemoglobins per blood volume, and hematocrit, which is the amount of blood cells per blood volume, is measured by the intracellular hemoglobin concentration that determines the cell refractive index.

A variety of different blood constants are used for diagnosis. Some are interchangeable, and there is a generally accepted relationship between the constants. The generally accepted relationships are as follows:

[0114]   Constant index calculation RBC Number of red blood cells per unit volume of blood or EPC red blood cell particle concentration Hb hemoglobin concentration in blood Hct hematocrit or erythrocyte Hct = RBCxMCV EVF red blood cell volume fraction           Fraction of red blood cell volume in the total volume MCV Erythrocyte volume MCV = EVF / RBC           Abbreviation for mean blood cell volume MCH Weight of hemoglobin in red blood cells MCH = Hb / RBC           Abbreviation for mean spherical hemoglobin MCHC Hemoglobin concentration in erythrocytes MCHC = Hb / EVF           Abbreviation for average concentration of corpuscular haemoglobin

In addition, human blood is made up of morphological elements and plasma. There are three basic types of morphological blood cell components. Refers to red blood cells, white blood cells, and platelets. Red blood cells contain hemoglobin, which carries oxygen from the lungs to the tissues of the body. The normal hemoglobin concentration is
Changes between 132-163 gram / litre in males and 116-14 in females
Varies between 8 gram / litre. Hematocrit (Hct) usually varies between 39-49% in men (EVF 0.39-0.49) and 37-44% in women.
It varies between (EVF 0.37-0.44). White blood cells are about the same size as red blood cells, but do not contain hemoglobin. The human body has approximately 5 liters of blood, and a normal, healthy individual will have approximately 5,000,0 per cubic millimeter of blood.
It has 00 red blood cells and about 7,500 white blood cells per cubic millimeter of blood. Thus, a normal, healthy individual will have about 1 white blood cell for every 670 red blood cells circulating in the vasculature. White blood cells (WBCs) are responsible for the immune system of mammals, preferably humans. For example, some white blood cells swallow invading pathogens.

With respect to platelets, platelets are the smallest of the morphological blood cell components, typically 1 μm or less in diameter. Platelets are less numerous than red blood cells, but more numerous than white blood cells. A normal, healthy individual has about 1 platelet for every 17 red blood cells that circulate in the vascular system for a total of about 2 trillion.

In summary, the method and apparatus according to the present invention uses a known relationship between parameters for the case of indirectly measuring the amount of white blood cells and / or platelets to determine the Sp of the vascular system.
It may be used to measure O ₂ and various properties. For WBC, the coefficient is 1/670 of red blood cells and for platelets the coefficient is 1/17 of red blood cells. Therefore, each blood characteristic in step a) of the method according to the invention also comprises white blood cells and / or platelets. Cholesterol and albumin concentrations may also be measured using known hemoglobin concentrations in conjunction with the method described in GB 2329015 referenced herein. The method refers to non-invasive measurement of blood component concentrations.

The devices and methods of the present invention also allow for the determination of SpO ₂ and diagnosis of anomalies or diseases in mammals, such as red blood cell deficient anemia. Binge eating patients often suffer from anemia. In that case, the method and apparatus according to the present invention may be used to accurately measure SpO ₂ . In addition, congestive heart failure and cardiac rhythm disorders (cardiac
arythmies) may also be detected using the method and apparatus according to the present invention. Moreover, the method and device provide an indirect possibility to measure platelet disorders such as thrombocytopenia. This may indicate problems with temporary menopause and coagulation. A high concentration of certain white blood cells further indicates viral infection. Leukocytosis and leukocytopenia are also possible signs that are indirectly detectable. Phagocytosis and other diseases of the immune system are also detectable. Neonatal observation is another area of application of the invention. Surgical observation is also a possible application. The device is set at a "zero-level" at the beginning of surgery to compensate for stable and interactive effects (skin color, lipids etc.). Therefore, easy observation of blood properties including SpO ₂ and hemoglobin is achieved.

The present invention, methods and devices also include the risks associated with blood collection (eg, AIDS, type A,
It allows accurate measurement of SpO ₂ in the blood of patients without hepatitis B and C, etc.). Blood collection with a needle is also a painful method, especially for individuals who need to take large numbers of blood samples. The drawbacks can be eliminated by using the method and the device according to the invention. Moreover, the method and device according to the invention are particularly suitable for measurements in children.

[0120]   The invention also refers to the use of the device according to the present application in a dialysis machine.

The following examples illustrate embodiments of the present invention, but are not intended to limit the scope of the invention in any way.

Example 1 Detection was performed using the following apparatus. One tube with an inner diameter of 3 mm made of acrylic glass (PMMA). Two optical fibers with a diameter of 0.094 mm. One of the fibers was for transmitting light (light source) and the other was for receiving reflection of light (photodetector). One glass tube with an outer diameter of 0.210 mm for accommodating optical fibers arranged in parallel with each other. Whole blood from a blood donor pumped through a PMMA tube.

FIG. 1 schematically shows a flow model for the detection of light reflection. FIG. 2 shows the orientation of red blood cells at intermediate levels of shear rate. FIG. 3 shows the light absorption in blood by different absorbing substances. FIG. 4 shows light scattering by red blood cells.

The results from the above experiments show that the light spreads in a unique manner when it hits the red blood cells in the tube. This is probably due to the shape of the blood cells, the biconcave disc. Due to said shape, the blood cells will be oriented differently when traveling in a circular tube. This has been proven through the placement of two optical fibers in a small catheter using optical techniques. At that time, as described above, one of the optical fibers serves as a light source, and the other optical fiber serves as a photodetector. The pair of optical fibers is moved from one periphery to the other at the cut surface of the circular tube.

FIG. 5 and FIG. 6 show the outline of the experimental results, that is, the intensity of light transmitted through the red blood cells flowing through the acrylic glass tube. The experimental equipment is the same as that of the above experiment.

FIG. 5 shows the relative change in transmitted light with respect to blood flow for two different types of red blood cells. "Stiff cells" are treated with glutaraldehyde to produce stiff cells.
(stiff) red blood cells. That is, the red blood cells have lost the ability to change shape upon pressure from the flow.

The above results indicate that one of the important properties of red blood cells is flexibility. This results in a change in shape with increasing flow, as evidenced by a reduced permeation intensity for increasing flow, ie elongation and orientation. Inflexible, or stiff, red blood cells show little or no orientation effect on the flow as measured by changes in light transmission.

FIG. 6 shows the relative change in transmitted light intensity with respect to blood flow for two types of blood cells. "Globular blood cells" are red blood cells that have been treated with a non-isotonic buffer. By the above treatment, blood cells loosen the biconcave disc shape. This results in intimate contact and orientation for increasing flow, as evidenced by a reduced transmission intensity for increasing flow. As the measured light transmission changes, spherical red blood cells show reduced shear stress for increasing flow and little or no orientation effect for flow.

It can therefore be concluded that the orientation of red blood cells as a function of flow, such as in human and mammalian flexible or inflexible vessels or arteries, is mainly due to the unique biconcave disc shape and flexibility. .

Example 2 The second experimental equipment basically consisted of: Basically three main parts, a cylindrical disc oxygenator that also serves as a blood reservoir, a flow-controlled roller pump (peristaltic pump) and a rigid flow-through connected to the light source and photodetector via an optical fiber. There was a model.

The experimental setup is basically shown in FIG. However, one photodetector is missing because it measures both transmission and reflection. A corrugator regulated a roller pump that produced continuous blood flow. The pressure transducer is also one of the blood circulation circuits.
It was a department. The temperature of blood can be controlled by circulating hot air around the experimental equipment.
． It was kept constant at 0 ± 0.1 ° C.

The gas mixture was introduced into a reservoir and mixed with blood. Gas exchange was simulated with a disc oxygenator and the gas mixture consisted of 19% oxygen in nitrogen and 5.6% carbon dioxide. Oxygen saturation was kept at 98-99% and blood gas parameters (p
O ₂ , pCO ₂ and pH) were assumed not to deviate from normal physiological values.

A layered flow-through model was used to minimize hemolysis of red blood cells. The wavelength used was 800 nm, and the isosbestic point at which the minimum absorption of light occurs in red blood cells. Measurement
A tube made of acrylic glass having an inner diameter of 3.0 mm was used.

[0134] Figure 8 is a reflection / transmission ratio on the y-axis (%), i.e. shows a diagram that describes the relative change in AC R _/ AC _T and hemoglobin concentration on the x-axis (mol / l). The reflection / transmission ratio appears to be independent of blood flow, but appears to vary with hemoglobin concentration. Thus, optically registered hemoglobin (Hb) signal may be expressed as Hb ₌ AC R / AC _T. This is due to the fact that hemoc (Hemocue
) Confirmed by analyzing blood samples taken from spontaneously healthy subjects and patients in the device (Angeholm, Sweden) in combination with the method according to the invention. In this way, a calibration curve was obtained. This calibration curve may be stored in the memory of the processing unit, which is preferably part of the computer. As a result, direct the light beam in accordance with the above-described method, subsequent reflection and AC R _/ AC _T obtained when detecting the transmission, thereby enabling easy conversion to hemoglobin (mmol / l). The curve becomes a straight line under specific conditions.

FIG. 9 shows the reflection and transmission of light with respect to the hemoglobin concentration. When illuminating an intact blood cell in a circular pipe, the transmission and reflection of light follows the concentration of red blood cells. Light transmission decreases as hemoglobin increases, and light reflection increases as hemoglobin increases.

Example 3 A thimble-shaped test apparatus including a shell, which is one of the preferred embodiments of the present invention shown in FIG. 10, was used. This thimble-like device consists of i) two light sources (one green light emitting diode (LED), basically 110104 type, 5
40, diameter φ5mm, and 1 NIR LED, basically SFH 585 type, 880, diameter φ4.85mm. The light source is replaceable. ) ii) 2 detectors, basically SD 1420-002 and CFD respectively
It consists of type 10.

For the measurement of SpO ₂ , two additional light sources (red and infrared light) and corresponding detectors for detecting the transmitted light may preferably be incorporated in the thimble-like structure.

The thimble-like device comprises a hard part made of a hard material and a soft part made of a flexible material. The rigid portion is made of PMMA or other similar plastic material. The soft part is made of silicon rubber containing a black dye (non-conductive ceramic pigment). The hard and soft parts form, for example, a circular ring with a keyhole-shaped hole in the center, with bent parts for the fingers or toes. The hard part and the soft part may be attached to each other or may be joined by other means.

How to connect the thimble-like device to a power source or the like is shown in FIG. 11 through a block diagram schematically illustrating the connection. The numbers in the figure are for the following description. 1. Resonator 2. LED-driver λ1 3. LED-driver λ2 4. LED λ1 or 2 5. Reflection of photodiode 6. Target 7. Transmission of photodiode 9. Current / voltage converter 10. Current / voltage converter 11. Low pass filter 12. Low pass filter 13. Sample and hold amplifier 14. Sample and hold amplifier 15. Bandpass filter 16. Bandpass filter 17. Analog output 18. Analog output 19. μ-controller 20. A read-out device resonator, a sample and hold amplifier, an LED-driver λ1 and an LED
-Connect to driver λ2. These drivers are connected to one or in this case two LEDs and one photodiode for detecting the reflected light. A photodiode for detecting transmitted light is connected to at least one, in this case two current / voltage converters, which in turn are connected to the sample and hold amplifiers. The signal then goes to a bandpass filter and then either an analog output or to a μ-controller connected to the readout device.

Example 4 A handcuff-like test device comprising a shell, which is one of the preferred embodiments of the present invention shown in FIG. 16, was used. The handcuff-like device consists of i) 6 light sources (LED, λ = 875 nm), and ii) 1 detector.

At least one of the light sources may preferably have a different wavelength than the other light sources.

The handcuffs consist of a patch of flexible material and a strap. The flexible material consists of silicone rubber with black dye (non-conducting ceramic pigment).
The flexible material may form bends, for example for the wrist, fingers or toes. PP
G-sensors were designed specifically for use on the wrist. The optical geometry of the sensor was optimized to allow observation of blood properties, preferably blood flow deep into the tissue from the radial artery over the flat portion of the radius. The center-to-center distance between the LED and the photodetector is about 8-9 mm.

All components are built into the sensor, with the electronics on one side of the printed circuit board card coated with black silicon and the optics on the other side coated with transparent silicon. This ensures electrical insulation, reduction of stray light and the possibility of sterilization.

To measure SpO ₂ , the shackle-like structure may include two LEDs with wavelengths in the red and infrared ranges respectively. The handcuffs also appear on the opposite side of the wrist and consist of two detectors for detecting the intensity (red / infrared) of the transmitted SpO ₂ light.

The way of connecting the power source of the handcuff-like device and the battery eliminator is shown in FIG. 10 through a block diagram schematically illustrated. The handcuffs are further connected to a laptop computer which stores all measurement signals.

The measurement was performed using the probe (see FIG. 16) held on the subject's wrist. The probe was placed on the wrist above the radial artery. Saline was injected in the flow direction near the probe. The arterial needle was inserted 10 cm from the hand into the radial artery in the flow direction. The distance between the sensor and the tip of the needle was about 5 cm. Saline was infused at different volumes for 1-5 seconds. The PPG signal was recorded and the observation depth (monit
oring depth) was confirmed.

Clinically recorded PPG signals were recorded in heart failure patients at the same time as ECG recordings.
Only the intensity of the reflected light was recorded. The change in signal corresponded to the dilution effect in the blood. The result is that there are two components, in other words, the pulsatile component (AC) that is synchronous with the heartbeat.
And a PPG signal consisting of a slowly varying component (DC) can be seen in FIG. In the figure, the light reflection can be seen by the change in both AC and DC signals corresponding to the dilution effect in the blood after a delay of about 0.5 seconds. From this it can be seen that the device according to the invention can be used to extract information from the radial artery itself. The bottom two figures in Figure 17 are records for a patient with atrial fibrillation. AC and PPG
The signal (upper curve) was consistent with the irregular appearance of the QRS complex on the electrocardiogram. The DC component reflects different physiological features in the circulation, such as changes in total blood volume such as vasomotion, thermoregulation and respiration.

The device according to the invention is therefore useful, for example, for the observation of blood flow associated with the center as well as SpO _{2 on} the wrist. The changes in the signal in the amplitude, curve shape and frequency attributes may further reflect different pathological phenomena in the body corresponding to congestive heart failure and cardiac rhythm thms. Other telemetrical applications in telemedicine are envisaged for the device and method according to the invention.

As with other blood flow monitoring systems, the device of the present invention is also susceptible to patient hand movements. Loops may also be incorporated into the device to reduce artifacts. In addition to the blood flow parameters described above, means for observing blood pressure, heart rate and respiratory rate along with oxygen saturation, SpO ₂ may be incorporated into the device.

Another measurement was carried out using the device according to the invention. The relative pressure was observed and the result can be seen in FIG. The diagram in FIG. 13 shows the intensity of reflected pulsatile light for increasing systolic blood pressure. Diastolic blood pressure was kept constant. This represents a major measure of blood characteristics including Hb shown in thick blood vessels such as arteries. This is achieved by using the ratio of transmitted / reflected, reflected / transmitted or reflected / reflected value to light intensity to compensate for the effect of reflected and transmitted light on blood pressure and blood flow on the measured intensity. Using this effect, if the blood hemoglobin is constant, the individual or extracorporeal system with SpO ₂ may measure the change in blood characteristics including Hb.

Measurement was performed using the probe (see FIG. 16) held on the wrist of the subject, and only reflected light was detected. The probe was placed on the wrist above the radial artery. Saline was injected in the flow direction near the probe. The arterial needle was inserted 10 cm from the hand into the radial artery in the flow direction. The distance between the sensor and the tip of the needle was about 5 cm. Saline was infused at different volumes for 1-5 seconds. Record the PPG signal,
Confirmed the monitoring depth. Only the intensity of the reflected light was recorded. The change in signal corresponded to the dilution effect in the blood. The result, namely the PPG signal, which consists of two constituent components, in other words a pulsatile component (AC) and a slowly varying component (DC) in synchronism with the heartbeat, can be seen in FIG. In the figure, the light reflection is about 0.
It can be seen by the change in both AC and DC signals corresponding to the dilution effect in the blood after a delay of 5 seconds. The DC component reflects different physiological features in the circulation, such as changes in total blood volume such as vasomotion, thermoregulation and respiration.

While various embodiments of the invention have been described above, those of skill in the art will further recognize minor modifications that are within the scope of the invention. The breadth and scope of the present invention should not be limited by the exemplary embodiments described above, but should be defined only according to the claims and their equivalents.

[Brief description of drawings]

FIG. 1 is an explanatory diagram showing a flow model of light reflection detection.

FIG. 2 shows the orientation of red blood cells at intermediate or high levels of shear rate or blood flow.

FIG. 3 is a diagram showing light absorption in blood by different absorbing substances.

FIG. 4 is a diagram showing light scattering by red blood cells.

FIG. 5 is a diagram showing the relative change in transmitted light versus blood flow rate for two types of red blood cells.

FIG. 6 is a graph showing the relative change in transmitted light intensity versus blood flow rate for two types of red blood cells.

FIG. 7 is a diagram basically showing experimental equipment of an example (Example 2).

[8] ratio reflection / transmission (%), _i.e., the AC R / AC _T and y axis, FIG hemoglobin concentration (mol / l) represents the relative change in the x-axis

FIG. 9 is a diagram showing reflection and transmission with respect to hemoglobin concentration.

FIG. 10 shows a thimble-like shell structure consisting of two cordless light sources according to the device of the invention, viewed from four different directions. A-A, B-B and C-C
FIG. 4 is a sectional view of the thimble-like device.

FIG. 11 is a schematic block diagram showing a connection method of thimbles (only a light source and a shell are shown, not a shell is shown).

FIG. 12 is a block diagram schematically illustrating how to connect the thimble-like device (shell not shown; only light source and detector are shown) in another embodiment of the thimble-like device. FIG.

FIG. 13 is a diagram showing the intensity of reflected pulsating light with respect to increasing systolic blood pressure.

FIG. 14 is a diagram showing photons at a larger separation value that form a maximum photon path and are detected by a photodetector resulting from a deeper layer than for a smaller separation value.

FIG. 15 shows one probe of a preferred embodiment of the device according to the invention, fastened to the subject's wrist when detecting only reflected light. The probe was placed on the wrist above the radial artery.

FIG. 16 is a diagram showing a probe made of a patch made of a flexible material. The probe was placed on the radial artery on the wrist, inside the arm.

FIG. 17 is a diagram showing three sheets for explaining a case where physiological saline is injected in the flow direction close to the probe of FIGS. 15 and 16. Only the intensity of the reflected light was recorded, the change in signal corresponding to the dilution effect in blood. The bottom two figures in FIG. 17 show a recording of a patient with atrial fibrillation, ie PPG and ECG signals.

FIG. 18 shows a SpO2 measuring device including a computer and blood characteristics and a Bluetooth device which does not require a cable for wireless communication of data between remote components of the device according to the invention. It is a figure explaining the apparatus which concerns.

FIG. 19 is a diagram showing a PPG signal together with a DC signal, an AC signal, a minimum point and a maximum point.

[Explanation of symbols]

    The numbers in FIG. 10 indicate the following. 1. Green light emitting diode (LED) and NIR LED are replaceable. 2. Detector 3. Detector 4. Second member made of hard material 5. First member made of flexible material   The numbers in FIG. 11 indicate the following. 1. Resonator 2. LED-driver λ1 3. LED-driver λ2 4. LED λ1 or 2 5. Photodiode reflection 6. Target 7. Photodiode transmission 9. Current / voltage converter 10. Current / voltage converter 11. Low pass filter 12. Low pass filter 13. Sample and hold amplifier 14. Sample and hold amplifier 15. Bandpass filter 16. Bandpass filter 17. Analog output 18. Analog output 19. μ-Controller 20. Reader   The numbers in FIG. 12 indicate the following. 1. Resonator 2. LED-driver 3. LED 4. Photodiode reflection 5. Photodiode transmission 6. Target 7. Current / voltage converter 8. Current / voltage converter 9. Low pass filter 10. Low pass filter 11. Sample and hold amplifier 12. Sample and hold amplifier 13. Bandpass filter 14. Bandpass filter 15. Analog output 16. Analog output 17. μ-Controller 18. Reader

[Procedure for Amendment] Submission for translation of Article 34 Amendment of Patent Cooperation Treaty

[Submission date] December 14, 2001 (2001.12.14)

[Procedure Amendment 1]

[Document name to be amended] Statement

[Name of item to be amended] Claims

[Correction method] Change

[Contents of correction]

[Claims]

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), OA (BF, BJ , CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, K E, LS, MW, MZ, SD, SL, SZ, TZ, UG , ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AG, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, BZ, C A, CH, CN, CR, CU, CZ, DE, DK, DM , DZ, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, K E, KG, KP, KR, KZ, LC, LK, LR, LS , LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, MZ, NO, NZ, PL, PT, RO, R U, SD, SE, SG, SI, SK, SL, TJ, TM , TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW (72) Inventor Magnus Wegfosch             Sweden, S-582 45 Linchepi             Hungary's Gartan No. 15 F-term (reference) 4C038 KK00 KK01 KL03 KL05 KL07                       KM01 KX01

Claims (54)

[Claims] 1. A non-invasive method for measuring SpO ₂ of a mixture of liquid and blood cells, comprising: a) directing a light beam at the mixture; b) the intensity of light reflected from the mixture; or wherein by analyzing the intensity of the light reflected from the mixture said mixture in combination with the intensity of light transmitted through the, blood characteristics other than SpO ₂ containing hemoglobin of said mixture at least one measure, c) transmitting said mixture The oxygen saturation, SpO ₂ of the mixture by analyzing the intensity of the emitted light, and optionally d) demonstrating whether the results of step c) are relevant based on the results of step b). A method comprising the steps of: 2. The method according to claim 1, wherein step (c) is performed by measuring oxygen saturation by pulse oximetry. 3. Step (a) comprises directing at least one light beam having a wavelength in the red light region to the mixture, and at least one light beam having a wavelength in the infrared light region to the mixture. Method according to claim 1, characterized in that it is done by directing a light beam. 4. In step (c), the intensities of red and infrared light transmitted through the mixture are detected, the ratio of detected intensities of transmitted light (red / infrared) is calculated, and the ratio is analyzed. Sp
The method according to claim 3, wherein the method is performed by measuring O ₂ . 5. In step (b), i) detecting the light intensity of the light beam reflected from the mixture and the light intensity of the light beam transmitted through the mixture, ii) the detected intensity of the transmitted light and the reflected light 2. The ratio of the detection intensity of 1 or the ratio of the detection intensity of reflected light and the detection intensity of transmitted light is calculated, and iii) the ratio is analyzed to measure blood characteristics. The method described. 6. The step (a) comprises at least two different wavelengths for the mixture.
Method according to claim 1, characterized in that it is done by directing a light beam of a book. 7. Step (b) comprises: i) detecting the light intensity of the light beam reflected from the mixture, ii) calculating the ratio of the detected intensities of the reflected light, and iii) analyzing the ratio. The method according to claim 6, which is performed by measuring blood characteristics. 8. One or more values of the detected intensity of light of a light beam reflected from the mixture and the detected intensity of light of a light beam transmitted through the mixture, preferably using a module for wireless communication. Method according to claim 1, characterized in that the transmission is carried out wirelessly to the device performing (b), (c) or (d). 9. The wireless communication is Bluetooth (registered trademark).
9. The method according to claim 8, wherein the method is performed using a standard-compliant communication path. 10. Method according to claim 1, characterized in that the light beam is directed essentially perpendicular to the measuring range of the tube containing the mixture. 11. When the transmitted light is also detected, the wavelength of the light beam is set to 200 n.
m-2000 nm, preferably 770 nm-950 nm, most preferably about 77.
0, 800, 850, 940 or 950 nm.
The method described in. 12. At least two light beams of different wavelengths are directed towards the mixture, one of which has a wavelength of 770 to 950 nm,
The method according to claim 1, characterized in that the wavelength of the other light beam is between 480 and 590 nm. 13. A method according to claim 1, characterized in that the mixture of liquid and blood cells is flowing. 14. The method of claim 1, wherein the mixture of liquid and blood cells comprises plasma. 15. Method according to claim 1, characterized in that it is performed in mammals, preferably in humans. 16. Method according to claim 15, characterized in that it is carried out in a blood mixture with a diameter greater than 0.1 mm, preferably in veins, arteries or arterioles. 17. Method according to claim 15, characterized in that it is carried out on the arm, toe or finger, preferably on the wrist or on the finger with the third phalanx. 18. A dialysis machine, a blood bag assembly, a slaughterhouse device or a blood fractionation device, preferably a tube or pipe.
The method of claim 1. 19. In step (b), the light is emitted from at least 4 light sources, preferably 6 light sources, and the light sources are preferably such that they appear on either side of the detector. When arranged in a group composed of two, and most preferably six light sources are present, they are arranged in a group composed of three, most preferably the light sources are centered around one detector. H "is formed,
The method of claim 1. 20. The method according to claim 19, characterized in that said “H” is tilted by about 90 ° when measured from the direction of the arm, preferably during measurement on the wrist. 21. In step (b), the light is emitted from two light sources arranged and exposed on two different opposite sides of the tube containing the mixture, the reflected light from the transparent tube and the transmission of light. Method according to claim 1, characterized in that the light detection is carried out with at least two detectors, preferably with only two detectors. 22. The step (b) comprises the following steps, I) searching on a curve having detection values of transmission and / or reflection in a time frame having a length of approximately 60% of the cycle time, II. ) If there is no higher value than the average (intermediate) value in the time frame, specify this value as the maximum point, move the time frame by half the length of the time frame, or move the value to an intermediate value. If it exceeds, the step of moving the time frame by one step, III) the step of specifying the minimum point in the same way as II) for the minimum value instead of the maximum value, IV) on the connecting line including the two maximum points The step of obtaining the height of the AC signal by subtracting the value on the vertical line of the minimum point between both maximum points from the value, V) IV) step is repeated at least 8 times, and the value obtained in IV) is added. To obtain the AC mean value by dividing the sum by the number of observations, and VI) optionally the total height of the minimum point of IV) to the AC signal of step 2. Method according to claim 1, characterized in that it comprises the step of obtaining a DC signal in addition to the signal average value, preferably using a computer program for obtaining an AC signal and optionally a DC signal. 23. The method of claim 3, wherein the wavelength in the red light region is about 660 nm and the wavelength in the infrared light region is about 940 nm. 24. The method according to claim 1, characterized in that the measured SpO ₂ containing hemoglobin and the measured blood properties are presented simultaneously. 25. The method according to claim 1, characterized in that the measured SpO ₂ is corrected by using the measured blood characteristic including hemoglobin. 26. An apparatus for accurately measuring SpO ₂ from a mixture of liquid and blood cells contained in a light-transmitting tube, comprising a light source for directing a light beam to the light-transmitting tube, and oxygen saturation including hemoglobin. , Means for measuring blood characteristics other than SpO ₂ and analyzing the intensity of light reflected from the transparent tube by combining the intensity of light reflected from the transparent tube or the intensity of light transmitted through the mixture. Means for measuring the oxygen saturation, SpO ₂ , of the mixture, preferably by pulse oximetry, and analyzing the intensity of the light transmitted through the mixture, and optionally the measured SpO ₂ is of the blood characteristic An apparatus characterized in that it comprises means for proving whether or not there is a relationship with respect to a detected value. 27. A first light source, which emits a first light beam having a wavelength in a red light region with respect to the light-transmitting tube, and a light source having a wavelength in an infrared light region, with respect to the light-transmitting tube. 27. Device according to claim 26, characterized in that it comprises a second light source emitting two light beams. 28. A first detector for detecting the intensity of the red first light beam transmitted through the transparent tube, and a detector for detecting the intensity of the infrared second light beam transmitted through the transparent tube. 27. Device according to claim 26, characterized in that it comprises two detectors. 29. The oxygen saturation measuring means includes a processing device configured to calculate a ratio of detection intensities of transmitted red light and infrared light and analyze the ratio to measure an oxygen saturation value. 29. The device according to claim 28, characterized in that 30. The light source comprises a third light source that emits a third light beam to the light-transmitting tube, and further detects a light intensity of the third light beam reflected from the light-transmitting tube. 27. The apparatus according to claim 26, comprising three detectors and a fourth detector for detecting the intensity of the light of the third light beam transmitted through the light-transmitting tube. 31. A processing device, wherein the blood characteristic measuring means calculates a ratio of detected intensities of reflected light and transmitted light of a third light beam, and analyzes the ratio to measure a value of blood characteristic. 31. Apparatus according to claim 30, characterized in that it comprises: 32. The device according to claim 26, characterized in that it comprises recording means for storing the measured blood characteristics and SpO ₂ . 33. The device according to claim 26, further comprising means for visualizing the measured blood properties and SpO ₂ . 34. The light source directs at least two light beams on the same side of the light-transmitting tube, preferably one of the light sources emits light having a wavelength in the range of 770 to 950 nm, and 27. The device according to claim 26, characterized in that one light source emits light with a wavelength in the range of 480-590 nm. 35. At least two of the components of the device are wirelessly connected,
Preferably characterized by communicating with each other in a module for wireless communication,
The device according to claim 26. 36. The apparatus according to claim 35, wherein the module for wireless communication includes at least one transmitter and one receiver. 37. At least three of the components of the device, namely the light source,
32. Device according to claim 31, characterized in that there is one module for wireless communication between the detector and the processing unit. 38. The device according to claim 35, wherein the wireless communication is performed using a communication path conforming to the Bluetooth (registered trademark) standard. 39. Apparatus according to claim 26, characterized in that the light source is arranged essentially perpendicular to the measuring range of the light-transmitting tube. 40. The wavelength of at least one of the light beams is 200 nm.
~ 2000 nm, preferably 770 nm to 950 nm, most preferably about 770.
, 800, 850, 940 or 950 nm.
The device according to. 41. Two of said light sources direct two light beams to the same side of said light-transmitting tube, wherein one of said light beams has a wavelength of 800 nm to 940 nm and another The wavelength of the light beam is 480 to 590 nm,
The device according to claim 26. 42. At least 4 light sources, preferably at least 6
The light sources appear on either side of the detector, preferably the light sources are arranged in groups of two, preferably groups of three, and the light sources are 31. Device according to claim 30, characterized in that it forms an "H" shape, preferably around the detector. 43. Further comprising the light source and at least one photodetector,
27. Device according to claim 26, characterized in that it comprises a test device in the form of a wrist, finger or toe attachment device. 44. The test device includes a thimble-shaped shell worn on a finger or toe, and the light source and the detector are disposed in the shell to emit a light beam and detect a light intensity. 44. The device according to claim 43, characterized in that 45. At least one light source and said detector are arranged in said shell consisting of a clamping part, said light source and detector are arranged in said clamping part so that they emerge, said shell preferably being a finger. 45. Device according to claim 44, characterized in that it is also part of a thimble design covering the toes. 46. The light source comprises at least 4 light emitting diodes, preferably at least 6 light emitting diodes and further comprises a detector, the light emitting diodes being fixed to the patch about the detector. Forming an "H" shape, the patch forming part of a handcuff-shaped structure suitable for measuring the wrist, and the distance between the light source and the detector for measuring blood characteristics including Hb is such that each component 27. Device according to claim 26, characterized in that it is preferably 4 to 12 mm, most preferably the distance is about 8 to 9 mm, at the central origin of the. 47. The light source and detector arranged to detect reflected light are fixed to the rim of a patch containing a finger, toe or wrist, preferably a wrist, for fastening the patch to the wrist. 47. The device of claim 46, which is a flexible plastic patch secured to a strap of the strap, the strap preferably having a locking device. 48. The light source and detector are incorporated into the patch, the electrical components are secured to one side of a black silicon coated printed circuit board card, and the optical components are mounted on the transparent silicon coated card. 48. Device according to claim 47, characterized in that it is fixed on one side. 49. The patch is a rectangle measuring 51 × 35 mm,
48. Device according to claim 47, characterized in that the light source and detector arranged in "H" are fixed at the corners of the patch. 50. The device according to claim 31, characterized in that the processing device is adapted to convert a reflection value into a concentration value of a measured blood characteristic. 51. A processing device comprising a computer program for carrying out the method according to any one of claims 1 to 20.
6. The device according to 6. 52. The device of claim 27, wherein the wavelength of the red light is about 660 nm and the wavelength of the infrared light is about 940 nm. 53. A computer program stored on a data storage medium for carrying out the method according to claim 1. 54. Use of the device according to any one of claims 26 to 52 in a dialysis machine.