This application includes subject matter, and claims the priority date of Israel Patent Application No 167401, filed on Mar. 13, 2005, the contents of which are incorporated herein by reference.
The present invention relates to an ear probe for detecting and/or measuring various physiological conditions of a subject. The invention is particularly useful for measuring body temperature, blood pressure and/or respiration of a subject, and is therefore described below with respect to such applications.
The accurate measurement of various physiological conditions, particularly body temperature and blood pressure, is frequently necessary or even critical in many medical situations. The most accurate way of making such measurements is by inserting an arterial catheter into the subject's artery; but such a method is highly invasive, requires a high degree of expertise, and runs a number of risks, e.g., infection, occlusion of an artery, or damage to an artery. Such highly invasive techniques are therefore used only when absolutely necessary, e.g., during major operating procedures or during intensive care where a precise blood-pressure measurement and/or temperature measurement is continuously needed.
Accordingly, many non-invasive procedures for making measurements of various physiological conditions are generally used even though less accurate compared to an invasive procedure. Several ear probes have been developed for this purpose since relatively accurate temperature and pressure measurements can be made non-invasively from the carotid artery which is close to the ear canal. Examples of ear probes for measuring temperature are described in U.S. Pat. Nos. 6,556,852 and 6,773,405, and for measuring blood pressure are described in U.S. Pat. Nos. 5,237,997 and 6,004,274. However efforts are continually being made to improve the sensitivity and accuracy of such ear probes.
An object of the present invention is to provide an ear probe which enables the accurate, non-invasive measurement of various physiological conditions, particularly temperature and/or blood pressure, in addition to various blood-pressure and respiration parameters, as will be described more particularly below.
According to one aspect of the present invention, there is provided an ear probe for detecting and/or measuring at least one predetermined physiological condition of a subject, comprising: an ear plug shaped and dimensioned for insertion into an ear of the subject; and a sensor carried by the earplug for sensing the predetermined physiological condition of the subject; the sensor including an acoustical transmitter and an acoustical receiver spaced from the transmitter and defining an acoustical channel therebetween; and a processor for monitoring changes in the transit time, caused by the predetermined physiological condition, of an acoustical wave transmitted from the transmitter to the receiver through the acoustical channel.
As indicated above, the invention is particularly useful for detecting and/or measuring body temperature and/or blood pressure, as well as various blood-pressure and respiration parameters, and is therefore described below with respect to such applications.
Thus, the present invention also utilizes the ear, and particularly the carotid artery accessible non-invasively from the ear canal, for sensing the respective physiological conditions to be measured, as in the prior art. However, instead of using conventional techniques, such as thermistors for making temperature measurements and strain gauges for making blood-pressure measurements as in the prior art, the present invention uses instead an acoustical technique, wherein what is measured is the influence of the respective condition on the transit time of an acoustical wave transmitted through an acoustical channel from a transmitter to a receiver. Thus, the condition being measured (e.g. temperature, pressure, etc.) influences the transit velocity and/or the transit distance of such an acoustical wave, and therefore by precisely measuring the transit time of such an acoustical wave, the respective physiological condition can be precisely measured.
In the preferred embodiments of the invention described below, the processor measures changes in transit time in accordance with the method described in U.S. Pat. No. 6,621,278 (Israel Patent 129,651) and International Application PCT/IL2004/000138, International Publication No WO2004/072658, published Aug. 26, 2004, both assigned to the same assignee as the present application, the contents of which are expressly incorporated herein by reference. As described therein, the processor measures such changes in the transit time by controlling the frequency of the transmitter to produce and maintain a whole integer number of waves in a loop including the acoustical channel irrespective of changes in the physiological condition being measured. This is done by detecting a fiducial point of each wave received by the receiver in the respective acoustical channel, and utilizing the detected fiducial point to trigger the transmission of the next wave by the transmitter in the respective acoustical channel.
In the preferred embodiments of the invention described below, one measured physiological condition is the temperature of the blood in the subject's carotid artery as such a temperature measurement is considered to be a very accurate representation of the subject's body temperature.
A second physiological condition measured in accordance with the present invention as described below is the blood pressure in the subject's carotid artery. Such a pressure measurement is also considered to be a very accurate representation of the patient's blood pressure. Measuring the blood pressure in the carotid artery in accordance with the present invention enables a large number of cardiac conditions to be detected and/or measured, including heart rate, systolic pressure, diastolic pressure, mean arterial pressure, continuous blood pressure, stroke volume and cardiac output.
A third physiological condition accurately measured by the described probe is a respiratory condition of the subject, such as respiration rate, respiration volume, sleep apnea and snoring. As further described below, the ear probe could also be used for measuring various body movements, such as walking or running by the subject.
In the described preferred embodiments, the earplug includes at least two such sensors for accurately measuring two or more physiological conditions of the subject.
According to another aspect of the present invention, there is provided an ear probe for detecting and/or measuring a plurality of physiological conditions of a subject, comprising: an earplug shaped and dimensioned for insertion into the ear canal of the subject; a temperature sensor carried by the earplug for sensing the temperature of the blond in the subject's carotid artery; and a pressure sensor carried by the earplug for sensing changes in, blood pressure in the carotid artery of the subject.
According to further features in the described preferred embodiments, the earplug is of a flexible material shaped and dimensioned to seal the ear canal and to produce a sealed air chamber between the end of the earplug and the subject's ear-drum. The temperature sensor is exposed to the sealed air chamber to sense the temperature thereof; and the pressure sensor is also exposed to the sealed air chamber to sense changes in the pressure therein.
In one described preferred embodiment, the pressure sensor includes a body of elastomeric material which is compressed by the pressure in the sealed air chamber. In a second described embodiment the pressure sensor includes a membrane which is deformed by the pressure in the sealed air chamber. A further embodiment is described wherein the ear probe includes an external pump which controllably pressurizes the sealed air chamber, and thereby the carotid artery, to enable blood pressure measurements to be made according to the oscillometric technique or other techniques involving the controlled application of pressure to an artery.
As will be described more particularly below, an ear probe constructed in accordance with one or more of the foregoing features enables highly accurate measurements of various physiological conditions, particularly body temperature, blood pressure and various respiratory activities, to be made in a convenient and non-invasive manner.
Further features and advantages of the invention will be apparent from the description below.
The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:
It is to be understood that the foregoing drawings, and the description below, are provided primarily for purposes of facilitating understanding the conceptual aspects of the invention and various possible embodiments thereof including what is presently considered to be a preferred embodiment. In the interest of clarity and brevity, no attempt is made to provide more details than necessary to enable one skilled in the art, using routine skill and design, to understand and practice the described invention. It is to be further understood that the embodiments described are for purposes of example only, and that the invention is capable of being embodied in other forms and applications than described herein.
The Embodiment of
Thus, ear probe 10 illustrated in
Earplug 11 is shaped and dimensioned to seal the subject's ear canal EC and to produce a sealed air chamber 13 between the end of the earplug and the subject's ear-drum. ED. The inner end of earplug 11 carries a temperature sensor 14 which is directly exposed to the sealed air chamber 13 and thereby measures its temperature. As shown in
The pulsatile pressure of the blood flowing through the carotid artery will also be applied to the sealed air chamber 13. This pressure is sensed by a pressure sensor 15 also carried at the inner end of the earplug.
As indicated earlier, each of the sensors 14 and 15 is of the acoustical type. Each includes an acoustical channel having an acoustical transmitter T (
In
The pressure sensor 15 includes a transmission channel (ACP) defined by the portion 15a of the material of earplug 11 between its transmitter T and receiver R. Portion 15a of earplug 11, or the complete earplug, is preferably made of a soft, deformable, elastomeric material having high transmissivity and low attenuation with respect to acoustical waves. Examples of materials that can be used for this purpose are described in the above-cited International Application No. PCT/IL2004/000138.
The transmitters and receivers in each of the two acoustical channels ACT and ACP are controlled by a control and measuring system 20 in the form of a microprocessor (
The Control and Measuring System
Initially, the transmitter T in each acoustical channel, therein designated AC, is activated by an oscillator 25 under the control of a switch SW until the acoustical waves are received by the receiver R in the respective channel. Once these waves are received, switch SW is opened, so that the received waves are thereafter used for triggering the transmitter T in the respective channel.
Thus, as shown in
The output from comparator 26 is fed to a monostable oscillator 27 which is triggered to produce an amplified output signal at each fiducial point in the signal from the receiver R. The signals from monostable oscillator 27 are fed via an OR-gate 28 to trigger the transmitter T in the respective acoustical channel AC.
It will thus be seen that transmitter T in each acoustical charnel is activated at a frequency such as to maintain the number of waves in the respective channels as a whole integer irrespective of changes in the condition (e.g. temperature, pressure) being monitored. This produces a precise measurement of the changes in transit time of the waves in the respective channel, and thereby of the condition influencing the change in the transit time, whether resulting from a change in the transit velocity, and/or the transit distance, of the wave through the respective channel.
Further details of the construction, use, and other possible applications of the system illustrated in
The Ear Probe of
Thus, as shown in
The inner tip of earplug 41 carries a temperature sensor 44, corresponding to temperature sensor 14 in
Pressure sensor 45, however, is of a substantially different construction from pressure sensor 15 in the ear probe of
As shown in
The deformations of membrane 46 in response to the differential pressure on its opposite faces is measured by pressure sensor 45. Thus, as shown in
It will be seen that the pressure within compartment 47b can be preset, as desired, by manually manipulating plunger 51 of syringe 50, such that membrane 46 will deform in accordance with the pressure in compartment 47a communicating, via passageway 48, with the sealed air chamber 43 at the inner end of the earplug. Deformations of membrane 46 produce corresponding deformations of elastomeric strip 52, and thereby, corresponding changes in the transit distance of the acoustical waves from transmitter T to receiver R. The transit times of the waves through the acoustical channel of elastomeric strip 52 are thus changed in accordance with changes in the pressure within chamber 43.
As pointed out above, the pressure in chamber 43 follows the changes in the blood pressure within the carotid artery CA produced by the pulsatile blood flow therethrough. Accordingly, a measurement of the changes in the transit times of the acoustical waves from transmitter T to the receiver R within the acoustical channel defined by elastomeric strip 52, caused by deformations of membrane 46, will produce a measurement of the changes of blood pressure within the carotid artery CA.
Further details of the construction of pressure sensor 45, as well as possible variations thereof, are set forth in the above-cited International Application PCT/IL2004/000138.
Both the temperature sensor 44 and the pressure sensor 45 in the ear probe 40 of
It will thus be seen that the sensor illustrated in
The pressure sensor in the ear probe of
The Ear Probe of
Thus, one known method for non-invasively measuring blood pressure is according to the “oscillometric” technique. The conventional oscillometric technique uses the conventional occluding cuff and pressure sensors for monitoring the pressure inside the occluding cuff to detect pressure oscillations in the artery between the systolic and diastolic arterial pressures. Detecting these pressure oscillations enables various parameters of blood pressure to be determined, including systolic pressure, diastolic pressure, and mean pressure.
The ear probe illustrated in
Thus, the ear probe illustrated in
As in the previously-described embodiments, the earplug 61 is received within the ear canal so as to define a sealed air chamber 63 between the inner tip of the earplug and the subject's ear-drum ED. Earplug 61 carries a temperature sensor 64 at its inner face, and a pressure sensor 65 spaced from its inner face and communicating with the air sealed chamber 63 by passageways 66 and 67. Temperature sensor 64 and pressure sensor 65 may be of the same construction as temperature sensor 14 and pressure sensor 15 in
The external head 62 of ear probe 60 carries a pump 70 having a pressurized output 71 communicating, via one-way valve 72, with passageway 66 leading to the air-sealed chamber 63, as well as with passageway 67 leading to the pressure sensor 65. Pump 70 is a manual pump and includes a depressable finger-piece 73 formed with a vent opening 74. The construction is such that when finger-piece 73 is engaged by the user's finger and is manually depressed, the air within pump chamber 75 is forced via outlet 71 and one-way valve 72, through passageway 66 to thereby pressurize chamber 63; and when finger-piece 73 is released to uncover vent opening 74, one-way valve 72 blocks the reverse flow of air such that pump chamber 75 is refilled with air via the vent opening.
The external head 62 of ear probe 60 includes a further valve 77 communicating with passageway 66. Valve 77 serves two functions: It prevents over-pressurization of the air sealed chamber 63 to prevent possible injury to the ear-drum. It also permits release of the pressure within chamber 63, and for this purpose it may be provided with a manual release element, such as a plunger 78, for controllably opening the valve to permit a controlled or a complete depressurization of chamber 63.
It will thus be seen that pump 70 may be operated to produce the initial overpressurization of chamber 63, and then valve 77 may be operated to reduce this pressure such as to produce pressure oscillations within the carotid artery CA. Such pressure oscillations are detected and measured by pressure sensor 65 to thereby enable the determination of various parameters of blow-pressure measurements according to the oscillometric technique.
It will be appreciated that whereas pump 70 is illustrated as being manually-actuated, it could be automatically actuated to produce a precise control of the pressurization and depressurization of the air-sealed chamber 63.
Other techniques are known to provide a continuous measurement of blood pressure, and various parameters thereof, by controllably pressurizing an artery. One such other technique is the “Penaz” technique, as described for example in Penaz U.S. Pat. No. 4,869,261, the contents of which are incorporated herein by reference. According to this method, the external pump 70 would be controlled so as to cause the externally-applied pressure to be equal to the arterial blood pressure at all times, and the pressure used for this purpose would be measured by the pressure sensor 65.
The probe illustrated in
The probe may also be used during the nighttime to monitor and record not only cardiac activity, but also respiratory activity of the subject, in order to detect sleep apnea, snoring, etc. For the latter purpose, the ear probe illustrated in
The illustrated ear probe may include a removable memory unit to monitor and record all cardiac and respiratory activities, body movements, sleep apnea, snoring, etc. of the subject during the nighttime for later evaluation. The electrical control and measuring system may be wire-connected to the ear probe, or may communicate therewith in a wireless manner as known in the art.
While the invention has been described with respect to several preferred embodiments, it will be appreciated that these are set forth merely for purposes of example, and that many other variations, modifications and applications of the invention may be made.
Number | Date | Country | Kind |
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167401 | Mar 2005 | IL | national |