CA1331483C

CA1331483C - User-wearable hemoglobinometer for measuring the metabolic condition of a subject

Info

Publication number: CA1331483C
Application number: CA000607792A
Authority: CA
Inventors: Britton Chance
Original assignee: NIM Inc
Current assignee: Non Invasive Technology Inc
Priority date: 1988-11-02
Filing date: 1989-08-08
Publication date: 1994-08-16
Anticipated expiration: 2011-08-16
Also published as: JPH04502563A; WO1990004941A1; KR900701214A; EP0441791A1; DE68928348D1; KR0144010B1; EP0441791A4; JP2603350B2; EP0441791B1; US5167230A; DE68928348T2

Abstract

ABSTRACT
A system for non-invasively determining the oxygenation state of tissue located beneath the surface of the skin, such as muscle tissue, of an exercising person or other subject is disclosed. In a preferred embodiment, a user-wearable detector array and related circuitry which use near-infrared radiation to collect oxygenation data are provided. The apparatus also includes displays for information regarding the oxygenation state in several ways. In one embodiment a user wearable wristband indicator connected to the detector array which is located at another location, such as on the leg, and provides information directly to the user. In another embodiment, a telemetry device allows remote monitoring of a subject during an activity, the oxygenation information being displayed to a coach or other observer. A separate, user-wearable battery pack, which is preferably designed to provide power for the duration of the activity being monitored, is also provided.

Description

1 331 4~3 lol~-q NIM-l PAT13NT

BACRGROUND OF THE: INVEN~ION
The present invention relates to wearable apparatus for noninvasive deter~inations of the concentration of oxygen in a specific target region of tissue. M3re specifically, the present invention discloses a user-wearable system for monitoring the oxygen concentration in the tissue of a subject undergoing aerobic stress, such as an exercising person.
The increasing popularity of all forms of exercise over the last several decades has also lead to an increased interest in the measurement of individual athletic performance. However, at the present time, athletes are limited to obtaining heartbeat and blood pressure data while theiy are exercising. Although of some use, these data do no~ reflect peripheral circulatory capacity or the oxygenation state of specific muscle tissue.
In order to ~easure oxygen delivery to the capillary bed of the musclei~, an athlete must ~e tethered to-electrocardiogram apparatus and have blood samples drawn while running on a treadmill. These are essentially operating room apparatus and ~;~

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procedures, which do not simulate the actual conditions of exercise. The measurement of aerobic efficiency by analyzing the oxygenation state of a particular muscle while exercising is important to a variety of persons. For example, as a casual jogger strives to become a marathon runner, the efficiency at which they use oxygen can severely impact performance; data reflecting the utilization o~ oxygen can provide information which allows an athlete to change pacing strategies or otherwise adjust their activity to produce better results. Other athletes, such as swimmers, cyclists and rowers would also find this information useful for evaluating performance. However, the use of blood oxygenation data is not limited to competitive athletes; even geriatrics who undergo mild aerobic exercise to maintain and improve their health can benefit from data concerning the changes in blood oxygenation brought about by exercise or other activity.
other animalst such as racehorses, can also benefit form this type of performance data. By measuring the oxyg~n delivery to the muscles, both the quality of training and the natural ability to exercise may be evaluated.
In addition to monitoring and maximizing athletic performance, information pertaining to the delivery of oxygen to the limbs and the brain is important in military and spaoe applications where changes in gravity and other stresses may result in fatigue, and ultimately, blackouts.

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1 331 4~3 NIM-l PATENT

Although apparatus are available which measure the oxygenation content of blood using data collected from a fingertip or ear lobe, these devicas do not actually measure the oxygenation state o~ nearby muscle groups or the brain. To monitor athletic performance, or the condition of exerl:ed muscle6, data collection ~ust be performed at the site of interest. For example, runners will wish to know the condition of the muscles in their legs, and further wish to be provided with this information during a race, not in a laboratory. Therefore, for an apparatus measuring the metabolic condition of an athlete to be truly useful, a rugged, lightweight, user-wearable system must be provided. -One method by whi~h the oxygen level in a muscle may be -~
measured by tissue spectrometry. For example, red and near-red light, having wavelengths between about 600-~00 nanometers (nm), ~ ~ ;
will harmlessly penetrate body tissues. As the light penetrates `~
the tissue, it migrates and is absorbed by deoxygenated hemoglobin in small blood vessels. No~mally, tissue receives oxygen from hemoglobin contained in red blood cells, which circulate in the -major blood vessels and eventually into the capillary bed, ;~
supplying muscle tissue with oxygen~ Aerobic activity can cause ;~
the level of oxygen use to rise, causing a commensurate rise in the level of deoxyhemoylobin which is.compensated for by increased ..
blood flow in train~d individuals. Near-red light is absorbed by tissue that is not xeceiving as much oxygen as the surrounding tissue due to increased levels of deoxyhemoglobin in less trained -3- ``:~

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individuals~ Thus, by deter~ining the amount of incident radiation a~sorbed, the oxygenation 6tate of a specific area of tissue, and the training level of an i.ndividual, can be determined.
SUMMARY OF TH~ INVENTIO~
The present invention provides a novel, wearable 6ystem for determining the metabolic condition oiE an aerobically stressed portion of the muscle tissue of an exercising person. The system comprises a lightweight rugged detector, woxn against the skin surface of the subject, adjacent the muscle being monitored. The system of the present invention thus minimizes any performance impairment. The prefer~d system further comprises a wearable power pack and a wearable display means for displaying information indicative of the aerobic meta~olic condition of the region being monitored. In a preferred embodiment intended for use while running or engaged in ~imilar athletic activities, the display is a worn on the wris~ and display~ information from a leg-mounted detector. In another embodiment, intended to provide information to coaches, a telemetry system is employed to transmit a ~ignal carrying the data from the detector to a remote location, for processing and di~splay.
The detector of the pr~sent invention preferably employs a continuous wave spectrophot~meter having one or more sources of electromagnetic rad:iation with wavelengths between about 760 nanometers and about 800 nanometers directed into tbe tissue of ' ' .' ' ' .:~

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tha 6ubject. The detector i6 efficiently coupled to the body ti~sue and utilizes the principle of photon migration to detect the portion of the transmitted radiation arriving at an adjacent ~kin region.
The present invention al60 discloses methods for displaying the aerobic metabolic condition of a subject. The percentage of deoxyhemoglobin in the blood of the subject i6 determined, and a signal representative o~ this percentage iB converted into a graphic representation. The display may preferably be a digital display, a bar graph or a series of deoxyhemoglobin levels, placed on a time scale.
OBJECTS OF THE INV~NTION ;-~
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It is an object of the present invention to provide methods ~ ~-and apparatus which allow a rapid determination of the oxygenation state of tissue, such as muscle tissue, located beneath the surface of the skin of a subject, such as an athlete, without requiring the sub~ect to be tethered or physically connected to `~
laboratory or operating room monitoring equipment.
It is also an object of the present invention to provide .~ ~.. ..
apparatus which may be attached to a user which would determine ~ ~
, .:
the oxygenation state of a portion of the user's body and provide that informat~on in a readily understandable form.
It is a further object of certain embodiments of the present ;~
invention to provide information pertaining to the oxygenation -5~

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state of tis~ue directly to a user wearing the apparatus o~ the present invention.
It is another object of certain embodiments of the present invention to transmit infor~ation pertaining to the oxygenation state of tissue to a remote observer.
BRI~F D~SCRIPTION OF THE DR~WINGS
Figure 1 is a depiction of a preEerred configuration of an embodiment of the present invention.
Figure 2 is a partially diagrammatic, partially schematic representation of a preferred embodiment detector.
Figure 3 illustrates another preferred configuration of an embodiment of the present invention.
Figure 4 is a partially dia~rammatic, partial schematic representation of an alternate preferred embodiment detector.
DETAILED DESCRIPTION
A preferred embodiment of thè apparatus of the present invention is illustrated in Figure 2. In this embodiment an electro-optical pickoff detector unit 10 is worn on the leg of the exercising sub~ect 50. It is preferred that the weight of the detector be kept to a minimum so that hindrance to a competing athlete is negligible. In a preferred embodiment, the detector will be housed in a flexible array constructed from a suitable non-irritating, lightweight material.
Power is provided to the detector unlt 10 from a replaceable battery pack 30. The replaceable power pack 30 is preferably ~ . ... , , ~ . ~

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designed to be of minimal dimensions and weight. Most preferably,the battery pack 30 would be designed to last only for the duration of the activity, e.g., ~everal minutes of sprinting, several hours for a marathon runner, etc. In competitive sports applications, the life of the battery pack is preferably based upon the interval between substitutions or ~ther interruptions between period~ ~f competition.
The embodiment illustrated in Figure 1 further comprises an arm indicator 40, which is preferably worm on the arm in the manner of a wristwatch. The arm indicator 40 displays the percentage of deoxyhemoglobin (~Hb) as a measure of the subject's ~ -. . . ~
metabolic s~ate. As seen in Figure lA, such a display may comprise a simple readout of this information, such as a bar graph. Alternatively, the information displayed may be placed on a time scale, to graphically illustrate the change in ~Hb concentration over the course of the activity, as illustrated by Figure lB. In a most)preferred embodiment, the graphic displays illustrated by Figures lA and lB are comprised of liquid crystal -~
displays (LCD's~, although other electrical or electronic display ~ -~
means may also be used. The amplitude interval of this embodiment `~
is preferably divided into 6-10 levels, each aovering a portion of j the designated %Hb scale.
It will be appreciated that the ranye of the %Hb scale may be adjusted depending upon the range expected to occur during the activity. Since the precision of the present invention is limited -7- ~
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by that of the indicator, the range which is displayed is an important variable parameter. In the most accurate embodiment oP
the present invention, with the endpoint6 of the %Hb ~cale set at 20% and 4~%, the apparatus would have an accuracy of about 6%, which is about the limit of precision which can be obta$ned from a moving limb. One of ordinary skill w:ill realize that the gain of the apparatus is preset, depending upon the intensity of the intensity o~ the activity expected. :Cn a most preferred embodiment, a button placed on the arm indicator 40 allows the gain to be set.
Referring now t~ Figure 2, there is illustrated a partially schematic, partially diagrammatic representation of a preferred embodiment of a circuit which comprises the optical pickoff component of a DC tissue spectrophotometer detector 10 contemplated $or use in the system of the present invention. The detector 10 is shown for illustrative purposes mounted against a skin surface 25 of a subject. In a typical configuration, the detector is mounted against either large, homogeneous muscles, such as the gastrocnemius or the quadriceps or against the forehead o~ an adult. Two lamps 12,14 and two detectors 16,18 are contained in a flexible waterproof array. Also contained in the array is an opaque specular barrier, which i6 a concentric ring of material 11 between the lamps 12,14 and the detectors 16,18 which acts as a barrier zone to light of a specified wavelength. Most preferably, the material which comprises the barrier zone will not .

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1331~83 NIM-l PATENT

only be opaque to light within a specified region, but will further act as an absorber o~.
Thus, superficial light rays from the skin are, in effect, blocked by the opaque ~arrier 11 from entering the detectors 16,18. This blocking action by the barrier 11 of these superficial rays enables the system to determine the oxygenation state of hemoglobin within the muscle rather than at the skin surface. The rays that migrate deep within the tissue are received by the detectors 16,18. The light rays that migrate superficially ~escapen through the skin surface and will be absorbed by the opaque barrier 11. When, for example, a 760 nm impulse is applied, the deoxygenated hemoglobin (Hb) within the muscle is detected and when an 800 nm signal is applied, the oxygenated and deoxygenated hemoglobin (HbO2 and Hb) within the tissue region are detected. The system is able to ignore the `~`
oxygenation state at the skin surface and determine that within ~ -the tissue.
The lamps 12,14 may be, for example, 1/2 W flashlight bulbs that are periodically illuminated in the NR region. The lamps are -~
pxovided with cuto~f filters 13,15 so that only energy of a ~`~
specified wavelength illuminates the tissu~. The silicon diode , _g_ . .,;., ~
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detectors 16,18 are sensitive to 760 ~ 20 nm and B00 ~ 20 nm wavelengths respectively.
In a preferred embodiment, the lamps 12,14 are light emitting diode (LED) ~ources, which emit light having a wavelength of about 760 nanometers and about 800 nanometers respectively. In either embodiment, the lampis are ~lashed or pulsed at a predetermined repetition rate. The repetition rate of 6ampling, i.e., the rate at which the lamps are flashed determine~ the rate at which data may be collected. Thus, for a long distance runner, the lamps are flashed slowly; the output is commensurately changed for a sprinter, the lamps flashed rapidly to produce sufficient data to evaluate an exercise having a duration on the order of seconds.
The selection of LEDs as sources of electromagnetic radiation provides a ~urther advantage, since these sources produce a signal-to-noise ratio (S/N) approximately one order of magnitude greater than previously disclosed optical coupling systems using optical light fiber sources.
Referring now t~ Flgure 4, an alternate embodiment of a circuit for use with the present invention is illustrated. In this case a single detector 17 responding to separate light flashes collects and transmits signals to an amplifier 24, which has bipolar outputs that are connected intermitkently to an integrator 27 by a switch 25. Another switch 26 adjusts the relative duration of the two light pulses to equalize the two signals. One of ordinary skill will understand that those portions of Figure 2 and Figure 4 having the same reference numerals perform substantially similar functions. Many details of the particular circuits comprising the present inYention need not be set forth with particularity as they are well known or will be obvious to those of ordinary ~kill.
Referring to Figure 2, it can be seen that the detectors 16,18 are also protected by a transmit:ting filter 19 to minimize the effect of background light. The filter 19 may be comprised of a separate member, a coating or integrated into the housing of the circuit. The DC output of each of the detectors 16,18 is time-shared into its respective differential amplifier 20,22. The amplifiers are connected in opposite polarity, one non-inverting, the other inverting. The dwell time of the switch 23 connecting the amplifiers 20,22 i~ adjusted to equalize the response of the ;
two signals by appropriate circuitry 28. Th~ signal from the ~-integrator is coupled to a recorder (not illustrated). As shown in Figure 4, the signal from the 800 nm lamp 12 may be simultaneously employed to vary the gain of the amplifier 24 so as to correct the fiignals for changes of blood volume and to produce the ratio of the two signals, and thus maintaining ~
constant sensitivity for difference detection. One of ordinary ~ ;
skill will appreciate that a similar gain compensation circuit can be incorporated into the circuitry of the 800 nm detector amplifier 22, shown in Figure 2. Whether incorporated into the circuits of Figure ;' or Figure 4, the 800 nm signal is also ~ ~;

1 331 4~33 NIM-l PATENT

coupled to a second recorder channel to collect data reflecting total absor~tion or blood volume.
Another configuration of th~ pre~ent invention is illustrated in Figure 3. In this embodiment, a radio-linked telemet~y system comprised of a transmitter 60 attached to the subject and a receiver 62, allows the re~ote monitoring of the subject. A
supervisor, coach, or clinician is thereby enabled to monitor the performance of the subject. The data display is remote, one of ordinary skill will appreciate that the displays utilized may be similar to those illustrated in Figures lA and lB, or may be more complex, displaying data using various scales, time overlays, colors, etc. In a most preferred embodiment the telemetry signal would be carried on the 220-400 MHz band, using a transmitter in ~ :
the 1~0 ~W range.
The configuration illustrated by Figure 3 allows tbe present invention to monitor athletes in competition or workers and military/space personnel located in remote locations. For ~;
example, the apparatus of the present invention may be used in training to determine the duration of peak performance and the ;~
appropriate times for the substitution of fresh players or other adjustments. This configuration would also be preferred for monitoring the metabolic condition of an animal such as a~ ;
racehorse, racing dog, or any animal whose metabolic condition i8 ;-;
being studied for clinical or other purposes.

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In any of the emb~diment~ of the present invention, it is preferred that the data be integrated over at least about ten sieconds to smooth out irregularities which normally occur in the concentration of deQxyhemoglobin during exercise. However, it will be understood that the period integration can be varied, .:, .
depending upon the duration of the act~vity being monitored.
Although manual balancing of the apparatus of the present invention is required, in a preferred embodiment, the balancing is accomplished by depressing a button, which will normalize the output of the two wavelengths.
one of ordinary skill in the art will appreciate that the present invention is not limited to the particular embodiments described in detail. Modifications to the circuitry disclosed, and other aspects of the spectrophotometer configurations disclosed, as well as other modifications to the physical arrangement of the present apparatus will be obvious to those of ordinary skill. Further, the present invention is not limited to any of the uses described herein. In order to fully appreciate the scope of the present invention, reference should be made to the following claims.

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Claims

1. A multiple wavelength oximeter useful, by comparison of light absorption at different specific wavelengths, for determining oxygenation state of a relatively deep-lying tissue region of a relatively large body part of a subject, said region not practically targetable with optical transmission techniques, said oximeter comprising:
an assembly of lamp and detector active elements located in an arrangement establishing, for each wavelength, at least two adjacent, substantially symmetric photon lateral-scatter paths through the tissue of interest, for each wavelength said arrangement comprising the detector centrally located with respect to at least two laterally spaced-apart lamp elements, the lamp-to-detector spacing along a surface of the subject several centimetres, said assembly of lamp and detector active elements being mounted on a flexible, water-proof, body-conformable array capable of simultaneously maintaining said active elements adjacent to the skin of the subject to enable, for each given wavelength, photon migration through each of the respective photon lateral-scatter paths, pulsing means for pulsing said lamps in a plurality of pulses having a known duration at a rate unrelated to the pulse rate of the subject, a substantially opaque barrier, mounted on said body-conformable array, disposed between said lamp and said detector, substantially blocking superficial photons migrating in the skin from entering said detector while allowing for each said wavelength photon migration through each of the respective photon lateral-scatter paths, and the detector output for each wavelength, responsive, to light from each of the respective lamps, serving as input for oxygenation determination.

2. The oximeter of claim 1 wherein said assembly of infrared source and detector active elements comprises:

several laterally spaced-apart light sources mounted on said support member; and several wavelength specific light detectors mounted side by side, centrally with respect to said spaced-apart light sources.

3. The oximeter of claim 1 wherein said assembly of infrared source and detector active elements comprises:
several light sources mounted on a support member capable of producing two selected wavelengths and oriented to direct said light to said tissue of interest; and a light detector centrally mounted on said support member adapted to receive light from said sources.

4. The oximeter of claim 1 further comprising means constructed to flash said light sources at a selected frequency unrelated to a frequency of heart beats of a user.

5. The oximeter of claim 1, 2 or 3 further comprising a barrier, mounted on said support member and being conformable with the skin, adapted to prevent detection of light migrating laterally in subcutaneous layers.

6. The oximeter of claim 2 including control means for simultaneously flashing the light sources to enable each detector to pick up light energy at the detector's specific wavelength simultaneously from each light source.

7. The oximeter of claim 2 wherein said light sources are light emitting diodes (LEDs).

8. The oximeter of claim 1 further including a real-time readout device constructed to be worn by the user and having a display responsive to said oximeter disposed for viewing by the user.

9. The oximeter of claim 8 further comprising telemetry means adapted to transmit data comprising the detector output for each wavelength to said display means.

10. The oximeter of claim 7 further adapted to indicate the oxygenation state of said target region.

11. A method of monitoring the aerobic metabolic condition of a tissue target region of an exercising subject comprising the steps of:
(a) providing an oximeter as claimed in claim 1;
(b) activating said oximeter during the exercise of said subject; and (c) displaying information indicative of the aerobic metabolic condition of said target area of said tissue of said subject responsive to said signal produced by said oximeter means.

12. The method of claim 11, wherein said display is created upon demand.

13. A method of monitoring the metabolic condition within a relatively deep-lying tissue region of a relatively large body part of a subject comprising the steps of:
(a) providing the oximeter of claim 1;
(b) activating the oximeter lamps to direct electromagnetic radiation into a relatively deep-lying tissue region of a relatively large body part;
(c) sensing, at the oximeter detector, the scattered portion of the electromagnetic radiation which has migrated through said target region;
(d) determining oxygenation and therefrom metabolic condition in said target region; and ` (e) monitoring information indicative of the metabolic condition in said target region.

14. The method of claim 13 wherein said target region of said body part is in the leg, arm or head.

15. The method of claim 13 or 14 further comprising the step of transmitting said information indicative of the metabolic condition in said target region to a remote location by telemetry.

16. The method of claim 13 or 14 wherein said monitoring of the metabolic condition of said target region is performed on athlete, worker, military personnel, space personnel or animal.

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