WO1996039926A1 - Active pulse blood constituent monitoring - Google Patents
Active pulse blood constituent monitoring Download PDFInfo
- Publication number
- WO1996039926A1 WO1996039926A1 PCT/US1996/008505 US9608505W WO9639926A1 WO 1996039926 A1 WO1996039926 A1 WO 1996039926A1 US 9608505 W US9608505 W US 9608505W WO 9639926 A1 WO9639926 A1 WO 9639926A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- blood
- filter
- medium
- signal
- optical
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
- A61B5/14552—Details of sensors specially adapted therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/6813—Specially adapted to be attached to a specific body part
- A61B5/6825—Hand
- A61B5/6826—Finger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
- A61B5/683—Means for maintaining contact with the body
- A61B5/6838—Clamps or clips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
- A61B2560/04—Constructional details of apparatus
- A61B2560/0462—Apparatus with built-in sensors
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
- G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
- G01N21/1717—Systems in which incident light is modified in accordance with the properties of the material investigated with a modulation of one or more physical properties of the sample during the optical investigation, e.g. electro-reflectance
- G01N2021/1723—Fluid modulation
Definitions
- the present invention relates to noninvasive systems for monitoring blood glucose and other difficult to detect blood constituent concentrations, such as therapeutic drugs, drugs of abuse, carboxyhemoglobin, Methemoglobin, cholesterol.
- Example 2 Diabetic where natural pulse provides attenuation modulation of .1% at 1330 nm
- Example 3 Diabetic where natural pulse provides attenuation modulation of .01%
- a further aspect of the present invention involves a method of actively varying the attenuation of optical radiation due to blood in a fleshy medium.
- the method comprises a plurality of steps.
- Optical radiation is transmitted through the fleshy medium.
- a periodic change in the volume of blood is actively influenced in the medium.
- the optical radiation is detected after attenuation through the fleshy medium and an output signal indicative of the intensity of the attenuated signal is generated.
- Figure 2B depicts an embodiment of Figure 2 with added function for normalizing instabilities in emitters of Figure 2.
- Figure 2C illustrates a comparison between instabilities in selected emitters.
- Figure 4 illustrates further detail of the digital signal processing circuitry of Figure 2.
- FIG. 5 illustrates additional detail of the operations performed by the digital signal processing circuitry of Figure 2.
- Figure 7 illustrates additional detail regarding the decimation module of Figure 5.
- FIG 8 represents a more detailed block diagram of the operations of the glucose calculation module of Figure 5.
- Figure 9 illustrates the extinction coefficient versus wavelength for several blood constituents.
- Figure 10 - 12 depict one embodiment of a probe which can be used to induce an active pulse in accordance with the principals of the present invention.
- this unit can be made relatively inexpensively as a replaceable unit.
- the filter wheel is advantageously a conventional dichroic filter or filter made in accordance with the discussion of Figures 14-21.
- the monitor system 100 has a detector 140, such as a photodetector.
- the blood glucose monitor 100 also has a pressure inducing cuff 150 to physically squeeze a digit 130 in order to periodically induce a "pulse" in the fluid (i.e., actively vary the flow of fluid) in a digit 130.
- a device influences a change in the volume of blood in the digit or other fleshy medium.
- a window 111 is positioned to allow light from the emitter 110 to pass through the window 11 and transmit through the digit 130. This intentional active perturbation of the blood in the digit or medium under test is further referred to herein as an "active pulse.”
- the blood glucose monitor also has a display 160 which may be used to indicate such parameters as glucose concentration and signal quality.
- the blood glucose monitor also has a power switch 154, a start switch 156 and a trend data switch 158.
- the fleshy medium under test such as the patient's digit
- a pressure device 152 depicted in dotted lines in Figure 1
- Other methods of inducing a pulse could be utilized such as temperature fluctuations or other physiological changes which result in a fluctuation (modulation) of blood volume through the fleshy medium.
- All external methods actively vary the blood volume in the medium under test are collectively referred to herein as inducing an "active pulse.”
- 10% modulation in the total attenuation is obtained through the active induction of a pulse.
- the 10% modulation is selected as a level of minimal perturbation to the system. Too much perturbation of the medium will change the optical characteristics of the medium under test. For instance, with substantial modulation (e.g., 40 - 50%), the perturbation could impact scattering within the medium under test differently for different wavelengths, thus causing inaccurate measurements.
- Figure 24 depict a schematic block diagram of the blood glucose monitoring system 100 in accordance with the teachings of the present invention.
- Figure 2 illustrates a general hardware block diagram.
- a sensor 300 has multiple light emitters 301 - 305 such as LED's. In the present embodiment, each LED 301-305 emits light at a different wavelength.
- the sampling frequency is selected at 50 Khz so that the single full cycle at 625 Hz described above comprises 80 samples of data, eight samples relating to the first emitter wavelength plus ambient light, eight samples relating to ambient light, eight samples relating to the second emitter wavelength plus ambient light, eight more samples related to ambient light and so forth until there are eight samples of each emitter wavelength followed by eight samples of ambient light.
- a select signal synchronously controls the demultiplexing operation so as to divide the time-division multiplexed composite signal at the input of the demultiplexer 421 into its representative subparts or packets.
- the low-pass filter calculation is performed every ten samples, as represented in respective wavelength decimation by 10 modules 454, 456.
- a new low pass filter calculation is performed by multiplying the impulse response (coefficients) by the 519 filter taps.
- Each filter calculation provides one output sample for each respective emitter wavelength output buffers 458, 460.
- the output buffers 458, 460 are also continuous FIFO buffers that hold 570 samples of data.
- the 570 samples provide respective samples or packets (also denoted "snapshot" herein) of samples.
- the output buffers provide sample data for Glucose Calculation Module 408 for two wavelengths.
- I norm ⁇ 2 - ( ⁇ 1 ⁇ 2 C1 + ⁇ 2 ⁇ 2 C 2 + ⁇ 3 ⁇ 2 C 3 + ⁇ 4 ⁇ 2 C 4 + ⁇ 5 ⁇ 2 C 5
- a ratio is performed of the product of pathlength times concentration for glucose to the product of pathlength times the concentration of water as represented in a ratio block 487. Since the pathlength is substantially the same for each wavelength due to normalization (i.e., taking AC/DC) and due to minimal perturbation (e.g., 10%), the pathlength terms cancel, and the ratio indicates the concentration of glucose to water (preferably, this is scaled to mg/dL).
- the glucose concentration is provided to the display 336.
- the 310 is divided as represented by the division block 333 by the signal which represents the intensity of light from the LED 301b detected by the photodiode 301a.
- the signal emerging from the analog to digital conversion circuit 332 is as follows:
- 502 carries sufficient conductors to power the emitters 301• 305 and to receive a detector signal from the detector 320.
- Relief valve 510 enables manual and automatic release of pressure in the inflatable bladder 516.
- Relief valve 510 has a valve plate 522 which is spring biased to seal an aperture 524.
- the valve plate is connected to relief valve shaft 526.
- a valve button 530 is coupled to the valve shaft.
- the valve shaft extends through a valve housing 530 which forms a cylindrical sleeve shape.
- the valve housing is coupled to the upper surface 504 of sensor 500.
- the valve housing has an aperture 523 which allows air to readily escape from the relief valve.
- the relief valve is designed to ensure that the pressure is not high enough to cause damage to nerves. Accordingly, if the pressure increases beyond a certain point, the relief valve allows the excess fluid to escape, thereby reducing the pressure to the maximum allowable limit.
- Relief valve 510 could also be a spring-loaded needle-type valve.
- Figure 12 depicts a sectional view along line 12•12 of Figure 11 to illustrate the state of the sensor 500 when the inflatable bladder 516 is deflated.
- Figure 12a depicts the same sectional view as Figure 12 with the bladder 516 inflated.
- the blood glucose system can cycle fluid into and out of the inflatable bladder 516 at the selected rate to actively induce a pulse of sufficient magnitude as discussed above.
- a saturation transform may be applied to each 120 sample packet. It has been found that a second maxima representing venous oxygen saturation exists in the Master Power Curve during motion of the patient. In view of this, it is possible to utilize the inducement of a pulse disclosed herein through physically perturbing the medium under test in order to obtain the second maxima in the Master Power Curve, and thereby obtain the venous oxygen saturation if desired.
- the modulation may be lower than 10% because hemoglobin and oxyhemoglobin concentrations are higher than glucose and absorbtion at 660 nm and 905 nm are relatively strong. Thus, modulation from 1-5% may provide adequate results.
- a filter wheel 110A can be a conventional dichroic filter or a filter made in accordance with the following methods.
- Figure 14 shows an exemplary dichroic filter fabricated according to conventional methods. Previous methods employed to fabricate such optical filters typically involved laying out a circular substrate and then selectively increasing the coating thicknesses on the surface of the circular substrate.
- Such a filter 1150 is depicted in Figure 14 as having coating layers 1152, 1154, 1156, etc., of increasing thicknesses to form a spiral configuration as the filter 1150 is rotated. It should be understood that the coating thicknesses depicted in Figure 14 are exaggerated for ease of illustration.
- This method of optical coating is carried around substantially the entire circumference of the circular substrate so that as the coated substrate revolves, the thickness of the optical coating grows throughout the entire revolution and then suddenly drops back from the thickest coating to the thinnest coating at the end of one revolution.
- conventional filters of the type depicted in Figure 14 generally have many layers (e.g., 100 or more layers is common).
- the number of layers in conventional filters are provided to provide very precise pass bands (for a bandpass filter).
- Figure 18 depicts an exemplary transmission characteristic for a conventional rotational dichroic filter versus degrees of rotation for a selected wavelength.
- the pass band of the filter is very precise for the selected wavelength, generally without side-lobes, and also provides essentially zero transmission outside the pass band.
- a very high number of layers is required to obtain a filter with this near ideal precision. It should be understood, that this very narrow passband is in different rotational positions for different wavelengths.
- a conventional dichroic filter can be characterized as a monochrometer which passes a different wavelength at different rotational positions.
- a dichroic filter which differs significantly from conventional dichroic filters.
- Figure 15 depicts a filter 1120 along with the steps followed in the method of producing a filter.
- the dichroic filter has fewer layers than conventional filters. This provides for less precision in the transmission characteristic of the filter.
- Figure 4A• 4C depict the optical transmission characteristics for selected wavelengths of an exemplary rotational filter having only 17 optical coating layers. As illustrated in Figures 17A • 17C, the transmission characteristic is not as precise as the transmission characteristic of the filter represented in Figure 18. As depicted in Figures 17A•17C, the dichroic filter has several pass-bands for each wavelength depicted. In addition, outside the pass-bands, the transmission does not fall completely to zero, as with the conventional precision filters. The reduced precision in the passbands is due to the reduced number of layers in the filter.
- the reduced precision explained above is not limited to rotational dichroic filters, but could also be advantageous with dichroic filters that are vibrated (e.g., through oscillation or the like), and for any other optical filter which conventionally involves high precision in the pass-bands.
- the decreased precision of the filter of the present invention is accommodated with signal processing as further explained below to obtain the required precision. In this manner, the cost of the filter can be reduced.
- a conventional rotational filter could be fabricated with far fewer layers, but using conventional layering techniques such that the filter increases in thickness through the entire revolution of the filter.
- the method of fabrication disclosed herein could be used to form a rotational filter with conventional precision (e.g., many layers) at reduced manufacturing costs due to the improved manufacturing method.
- a cylindrical portion 1112 is cut from the wedge-shaped slab formed by the optical layer 1111 together with the substrate 1110.
- a cylindrical aperture is then formed in the center of the cylindrical portion 1112 to form a mounting hole.
- an optically opaque strip such as a brass strip 1122 over a portion of the optical filter disk 1120.
- the brass strip provides a zero-transmission reference portion of the disc 1120 which may be helpful for noise cancellation in certain signal processing applications.
- Figure 19 is a data flow diagram which details the method used to compensate for the imprecision of the filter made in accordance with the present invention. It should be understood, however, that prior to run-time, initialization is performed.
- the activity blocks 1830-1845 together with Figures 17A-17D, illustrate the method used in accordance with the present invention to construct the filter characteristics matrix.
- the filter 1120 reflects and transmits optical radiation in different proportions for different wavelengths at different places on the filter disk 1120. This is clearly illustrated in Figure 17A•17C, wherein Figure 17A represents the optical transmission of light at a wavelength of 850 nanometers plotted versus each of a possible 256 disk rotational positions (for one embodiment).
- Figure 16 illustrates the use of the filter 1120 in a system for monitoring blood constituents.
- Figure 6 illustrates a general flow diagram for the steps of accounting for the imprecision in the filter to obtain the characteristics of a medium under test.
- Figure 20 illustrates a general functional diagram of the process of accounting for filter imprecision through signal processing.
- the start of processing is represented in a begin block 1300.
- housekeeping and self-testing procedures are performed, as represented in an activity block 1305.
- housekeeping and self testing involves boot operations and conventional initialization a self testing. For example, the system first determines if there is a sufficient signal intensity to take an accurate reading.
- the medium 1131 under test is inserted as indicated in an activity block 1312.
- the filter 1120 is specially designed to include an opaque strip (i.e., the brass strip 1122).
- the digital signal processor 1145 detects when the opaque strip 1122 of the filter 1120 is interposed between the light 1115 and the detector 1140 by monitoring the intensity output from the detector 1140. This intensity is effectively zero when the light is blocked by the opaque strip 1122. Since the opaque strip 1122 blocks substantially all of the optical radiation transmitted from the source 1110, any signal output from the optical detector 1140 when the light is blocked (e.g., from ambient light, thermal effects, etc.), will be interpreted as electrical noise which is not due to either the spectral absorption characteristics of the medium under test 1131 or the spectral transmission characteristics of the filter 1120.
- control passes from the activity block 1315 to an activity block 1323.
- the signal is divided by l o to normalize the signal.
- the normalized signal is subsequently processed within an activity block 1325 to construct a signal intensity matrix, or vector, from the sample values obtained within the activity block 315 (taking into consideration the subtraction of the electrical noise, and the signal normalization performed in the activity block 1323)
- Figure 21 illustrates a signal intensity matrix l ⁇ m .
- the signal intensity matrix comprises a single column matrix having 256 digital values from l ⁇ 1 to l ⁇ 256 , which correspond to the optical intensities detected at each of the rotational positions of the filter 1120.
- the intensity values for several revolutions are averaged to form the signal intensity matrix.
- T( ⁇ ) the transmission through the test medium 1131
- the transmission of light through the test medium 1131 is defined as a function of the wavelength
- the combination, or convolution, of the optical absorption due to the test medium 1131 and the filter 1120 is designated over the same wavelengths by the function l( ⁇ ).
- T( ⁇ ) the intensity vector l( ⁇ ) and the filter transmission matrix F( ⁇ , ⁇ )
- the intensity vector l( ⁇ ) and the inverse F . 1 ( ⁇ ) are multiplied.
- the functions l( ⁇ ) and F( ⁇ ) may be represented by the signal intensity and filter characteristic matrices, respectively.
- T( ⁇ ) representative of optical transmission through the test medium 1131, may be represented as a one column matrix having values for each of the various wavelength values, ⁇ .
- the inverse transform is taken of the filter characteristic matrix, F -1 ( ⁇ , ⁇ ), and then this inverse matrix is multiplied by the signal intensity matrix, l( ⁇ ), within the activity block 1330 to obtain the frequency response of the test medium 1131 as expressed by the test medium characteristic matrix, or transmission vector T( ⁇ ).
- the signal intensity matrix 1000 is multiplied by the inverse of the filter characteristic matrix 1010 as indicated within a block 1005.
- the filter characteristic matrix 1010 is derived from an analysis of the filter 1120, as described above.
- the inverse transform of the filter characteristic matrix 1010 is multiplied by the signal intensity vector 1000 to obtain the optical frequency response matrix, or transmission vector,
- the dichroic filter 1120 is coated with optical layers of varying thickness so that different portions of the dichroic filter 1120 pass different wavelengths of light.
- the optical radiation 1125 output from the filter includes optical radiation of various wavelengths.
- a fiber optic is used to couple the optical radiation 1125 emitted from a portion of the filter 1120 to the patient's finger 1120 ???.
- the redundant half of the filter may be used for filter and source calibration.
- Each of the 128 samples represents a different portion of the filter 1120 having different optical transmission characteristics.
- the production specifications for the filter 1120 are as follows:
Abstract
Description
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002221864A CA2221864C (en) | 1995-06-07 | 1996-06-04 | Active pulse blood constituent monitoring |
DE69632320T DE69632320T2 (en) | 1995-06-07 | 1996-06-04 | ANALYSIS OF BLOOD COMPONENTS CONTROLLED BY ACTIVE IMPULSES |
AU59730/96A AU712825B2 (en) | 1995-06-07 | 1996-06-04 | Active pulse blood constituent monitoring |
JP50108497A JP3705817B2 (en) | 1995-06-07 | 1996-06-04 | Active pulse blood component monitoring system |
AT96917037T ATE265176T1 (en) | 1995-06-07 | 1996-06-04 | ANALYSIS OF BLOOD COMPONENTS CONTROLLED BY ACTIVE IMPULSES |
EP96917037A EP0831738B1 (en) | 1995-06-07 | 1996-06-04 | Active pulse blood constituent monitoring |
HK98110568A HK1009734A1 (en) | 1995-06-07 | 1998-09-10 | Active pulse blood constituent monitoring. |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/482,071 | 1995-06-07 | ||
US08/482,071 US5638816A (en) | 1995-06-07 | 1995-06-07 | Active pulse blood constituent monitoring |
Publications (1)
Publication Number | Publication Date |
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WO1996039926A1 true WO1996039926A1 (en) | 1996-12-19 |
Family
ID=23914533
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1996/008505 WO1996039926A1 (en) | 1995-06-07 | 1996-06-04 | Active pulse blood constituent monitoring |
Country Status (10)
Country | Link |
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US (3) | US5638816A (en) |
EP (1) | EP0831738B1 (en) |
JP (1) | JP3705817B2 (en) |
CN (1) | CN1192665A (en) |
AT (1) | ATE265176T1 (en) |
AU (1) | AU712825B2 (en) |
CA (1) | CA2221864C (en) |
DE (1) | DE69632320T2 (en) |
HK (1) | HK1009734A1 (en) |
WO (1) | WO1996039926A1 (en) |
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Also Published As
Publication number | Publication date |
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EP0831738B1 (en) | 2004-04-28 |
CA2221864A1 (en) | 1996-12-19 |
DE69632320T2 (en) | 2005-02-17 |
JPH11506652A (en) | 1999-06-15 |
AU712825B2 (en) | 1999-11-18 |
US6151516A (en) | 2000-11-21 |
ATE265176T1 (en) | 2004-05-15 |
AU5973096A (en) | 1996-12-30 |
JP3705817B2 (en) | 2005-10-12 |
US5638816A (en) | 1997-06-17 |
HK1009734A1 (en) | 1999-06-11 |
DE69632320D1 (en) | 2004-06-03 |
CA2221864C (en) | 2008-08-19 |
CN1192665A (en) | 1998-09-09 |
US5860919A (en) | 1999-01-19 |
EP0831738A1 (en) | 1998-04-01 |
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