Infrasonic Stethoscope for Monitoring Physiological Processes
20170296138 · 2017-10-19
Inventors
- Qamar A. SHAMS (YORKTOWN, VA, US)
- ALLAN J. ZUCKERWAR (WILLIAMSBURG, VA, US)
- ALBERT L. DIMARCANTONIO (WILLIAMSBURG, VA, US)
Cpc classification
H04R1/46
ELECTRICITY
A61B7/023
HUMAN NECESSITIES
A61B8/5207
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
H04R1/46
ELECTRICITY
A61B8/00
HUMAN NECESSITIES
Abstract
An infrasonic stethoscope for monitoring physiological processes of a patient includes a microphone capable of detecting acoustic signals in the audible frequency bandwidth and in the infrasonic bandwidth (0.03 to 1000 Hertz), a body coupler attached to the body at a first opening in the microphone, a flexible tube attached to the body at a second opening in the microphone, and an earpiece attached to the flexible tube. The body coupler is capable of engagement with a patient to transmit sounds from the person, to the microphone and then to the earpiece.
Claims
1-20. (canceled)
21. A microphone for use in an infrascope for monitoring physiological processes of a patient, said microphone comprising: a body comprising a proximal end, a distal end, a body side wall extending between the proximal end and the distal end, an end wall at the proximal end, and an aperture at the distal end; a body coupler attached to the distal end and over the aperture so as to form a substantially air-tight seal, wherein the body coupler is capable of engagement with the patient; a cavity surrounded by the body side wail, the end wall and the body coupler; a conductive backplate within the cavity and defining a backchamber between the conductive backplate and the end wall; a conductive membrane within the cavity, the conductive backplate and the conductive membrane being spaced apart from each other to form a capacitor; and a preamplifier board in electrical connection with the conductive backplate, the preamplifier board (i) being capable of measuring a capacitance between the conductive membrane and the conductive backplate and converting the measured capacitance into a voltage signal, and (ii) being parallel to each of the conductive backplate and the conductive membrane, said microphone being capable of detecting acoustic signals in a frequency range of 0.03 Hertz to 1000 Hertz.
22. The microphone of claim 21, further comprising: a conductive support plate attached to an internal surface of the body side wall within the cavity, the conductive support plate (i) comprising a base wall that divides the cavity into a distal chamber between the base wall and the distal end of the body and a proximal chamber between the base wall and the proximal end of the body, (ii) a base wall aperture within the base wall, and (iii) at least one aperture or slot within the base wall to allow air to flow from the distal chamber to the proximal chamber; an insulating member extending through the base wall aperture in the conductive support plate; a conductor extending through the insulating member and extending therefrom, the conductive member being electrically connected to the conductive backplate and to the preamplifier board, wherein the conductive backplate is on one side of the conductive support plate and the preamplifier board is on an opposite side of the conductive support plate.
23. The microphone of claim 21, wherein (i) the conductive backplate defines a plurality of holes, (ii) a slot is defined between an outer diameter of the conductive backplate and an inner wall of the body, and (iii) locations and sizes of the holes and a size of the slot are selected such that membrane motion is substantially critically damped.
24. The microphone of claim 23, wherein the conductive bookplate is seated on the insulating member.
25. The microphone of claim 21, wherein a slot is defined between the preamplifier board and the body side wall, and extends around the preamplifier board.
26. The microphone of claim 21, wherein the preamplifier board defines a first proximal chamber between the preamplifier board and the end wall, and a second distal chamber between the preamplifier board and the base wall of the conductive support plate.
27. The microphone of claim 26, wherein the first proximal chamber has a volume of approximately 0.1287 cubic inch, and the second distal chamber has a volume of approximately 0.6 cubic inch.
28. The microphone of claim 21, wherein the body coupler is formed of an outer ring having a flexible, non-conductive diaphragm attached thereto, and the outer ring is attached to the body.
29. The microphone of claim 21, further comprising a sealed electrical connection extending though the body side wall, said sealed electrical connection enabling electrical connection of said microphone to an electronics board.
30. The microphone of claim 21, further comprising a digitizer board which is remote from the microphone, said digitizer bond being capable of digitizing the voltage signal from the preamplifier.
31. The microphone of claim 21, wherein the voltage signal is digitized and electronically transmitted to a remote location.
32. An infrascope for monitoring physiological processes of a patient, said infrascope comprising the microphone of claim 21.
33. A method of using the microphone of claim 21, said method comprising: positioning the microphone to detect sound pressure from one or more locations within a patient's body.
34. A method of using two microphones of claim 1, said method comprising: positioning the two microphones to detect sound pressure from one or more locations within a patient's body.
35. A method of using the microphone of claim 21, said method comprising: generating a physiological process signal from detected sound pressure from one or more locations within a patient's body within a frequency range of 0.03 Hertz to 1000 Hertz, the physiological process signal being transmittable in real time.
36. A method of using the microphone of claim 21, said method comprising: generating a digitized signal from detected sound pressure from one or more locations within a patient's body within a frequency range of 0.03 Hertz to 1000 Hertz, the digitized signal being transmittable to a remote workstation.
37. A method of using the microphone of claim 21, said method comprising: generating a digitized signal from detected sound pressure from one or more locations within a patient's body within a frequency range of 0.03 Hertz to 1000 Hertz, the digitized signal being transmittable to a remote workstation comprising a laptop computer, a personal computer, a remote computer monitor, a smartphone, or a tablet.
38. A method of using the microphone of claim 21, said method comprising: using the microphone in (i) a stress phonocardiography test, (ii) for fetal heart monitoring during pregnancy, labor and delivery, (iii) for Doppler phonocardiography, (iv) for biometric identification, or (v) for polygraphs.
39. A method of using the microphone of claim 21 said method comprising: using the microphone to generate a spectrogram.
40. A method of using the microphone of claim 21, said method comprising: using the microphone to monitor respiratory, cardiac, or fetal heart physiological processes.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0020] The organization and manner of the structure and operation of the disclosed embodiments, together with further objects and advantages thereof, may best be understood by reference to the following description, taken in connection with the accompanying drawings, which are not necessarily drawn to scale, wherein like reference numerals identify like elements in which:
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
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[0028]
[0029]
[0030]
DETAILED DESCRIPTION OF THE INVENTION
[0031] While the disclosure may be susceptible to embodiment in different forms, there is shown in the drawings, and herein will be described in detail, a specific embodiment with the understanding that the present disclosure is to be considered an exemplification of the principles of the disclosure, and is not intended to limit the disclosure to that as illustrated and described herein. Therefore, unless otherwise noted, features disclosed herein may be combined together to form additional combinations that were not otherwise shown for purposes of brevity. It will be further appreciated that in some embodiments, one or more elements illustrated by way of example in a drawing(s) may be eliminated and/or substituted with alternative elements within the scope of the disclosure.
[0032] As shown in
[0033] The infrascope 20 contains a microphone 22, a body coupler 24 or 24a attached to the microphone 22, a flexible tube 26 attached to the microphone 22 and earpiece 28 connected to the flexible tube 26. For internal fetal monitoring, as shown in
[0034] The microphone 22 is substantially the same as the microphone described in U.S. Pat. No. 8,401,217, with the modifications described herein. The contents of U.S. Pat. No. 8,401,217 is incorporated by reference in its entirety.
[0035] The microphone 22 is best shown in
[0036] The body 30 has a cylindrical side wall 44 having a proximal end and a distal end, an end wall 46 at the proximal end of the body 30, and a connection port 48 extending proximally from the end wall 46. The body 30 is formed of metal, such as a stainless steel or aluminum. The side wall 44 and the end wall 46 define an internal cavity 50 within the body 30. The distal end of the body 30 is open such that an aperture 52 is defined in the body 30. A thread form 54 is provided on the exterior surface of the side wall 44 at the distal end. The end wall 46 substantially closes the proximal end of the body 30, with the exception of an aperture 56 therethrough, and may extend perpendicularly relative to the side wall 44. The aperture 56 may be centrally located in the end wall 46 and is communication with the connection port 48. The connection port 48 extends proximally from the end wall 46 and has a passageway 58 therethrough which is communication with the cavity 50 via the aperture 56. The exterior surface of the connection port 48 has a thread form 60 thereon. An aperture 62 is provided through the side wall 44 at a position spaced from the proximal end of the side wall 44.
[0037] The support plate 32 is attached to the internal surface of the side wall 44 and seats within the cavity 50. The support plate 32 is formed of metal, and has a circular base wall 64 which spans the diameter of the side wall 44 and is parallel to the end wall 46, and a depending side wall 66 which extends distally from the base wall 64. The side wall 66 terminates in a free end. The side wall 66 engages against the internal surface of the side wall 44 of the body 30, such that the free end of the side wall 66 is proximate to the distal end of the body 30, and the base wall 64 is spaced from the distal end of the body 30. The support plate 32 is affixed to the body 30 by suitable means, such as welding, in such a way that whole assembly can be connected to the ground of preamplifier board 42. As a result of this arrangement, a distal chamber 68 is formed between the base wall 64 and the distal end of the body 30, and a proximal chamber 70 is formed between the base wall 64 and the proximal end of the body 30. The base wall 64 has an aperture 72 therethrough, which may be centrally located. The base wall 64 also has at least one aperture 74 or slot therethrough to allow air to flow from the distal chamber 68 to the proximal chamber 70.
[0038] The insulating member 34, which may be formed of plastic, ceramic, wood or any suitable insulating material, seats within the aperture 72 in the support plate 32 and is used to electrically isolate the conductor 36, the backplate 38 and the preamplifier board 42 from the support plate 32. As shown, the insulating member 34 has a central portion 76 which extends through the aperture 72, a proximal portion 78 which extends radially outwardly from the central portion 76 on the distal side of the base wall 64, and a distal portion 80 which extends radially outwardly from the central portion 76 on the proximal side of the base wall 64. A passageway 82 extends through the central portion 76.
[0039] The backplate 38 is formed of a conducting material, and is formed from a base wall 88 and may further be formed of a proximal extending portion 90 which extends perpendicularly from the base wall 88. The backplate 38 may be formed of, for example, from conducting ceramics, brass, or stainless steel. A passageway 89 extends through the base wall 88, and extending portion 90 if provided, from its proximal surface to its distal surface. A permanently polarized thin polymer film 91 is coated on the distal surface of the backplate 38. The polarized thin polymer film 91 operates without the need for an external power supply. As described in U.S. Pat. No. 8,401,217, the backplate 38 has a plurality of spaced apart holes 92 therethrough (two holes are visible in
[0040] The conductor 36 extends through the passageways 82, 89 and extends into the proximal chamber 70. The conductor 36 is electrically connected to backplate 38. As shown, the conductor 36 is formed of a conducting rod or wire 84 which extends through the passageways 82, 89, and a conductive rod 86 extending proximally from the conducting rod or wire 84 and the insulating member 34. If formed of two components, the components are suitably connected to each other to form an electrical connection. The rod or wire 84 and rod 86 may be formed of brass, or may be formed of differing conductive materials. The proximal end of the conductor 46 is proximate, to but spaced from, the end wall 46 such that a gap is defined therebetween.
[0041] The membrane 40 is formed of a flexible conductive material and is seated at the distal free end of the side wall 66 of the support plate 32 such that the membrane 40 is positioned within the distal chamber 68 and is proximate to, but spaced from, the distal end of the body 30.
[0042] The diameter of the membrane 40 is selected so that the membrane 40 stays within side wall 66. The membrane 40 is parallel to the end wall 46 of the body 30 and to the base wall 64 of the support plate 32. As a result, the membrane 40 is in electrical communication with the support plate 32. The tension of the membrane 40 may be less than about 400 Newton per meter.
[0043] The backplate 38 is proximate to, but spaced from the membrane 40, such that an air gap 98 is formed between the membrane 40 and the backplate 38 to create a capacitor in the microphone 22 as is described in U.S. Pat. No. 8,401,217. As described in U.S. Pat. No. 8,401,217, the number, locations and sizes of the holes 92, the size of the slot 94, and the inner volume of the backchamber are selected such to allow enough air flow to provide proper damping of the motion of the membrane 40. As described in U.S. Pat. No. 8,401,217, the backchamber serves as a reservoir for the airflow through the holes 92 in the backplate.
[0044] In an exemplary embodiment, the membrane 40 has a diameter of approximately 1.05 inches (0.0268 meter). The membrane 40 may have the following characteristics/dimensions: [0045] radius=0.0134 meter; [0046] thickness=2.54×10.sup.−5 meter; [0047] density=8000 kilogram/meter.sup.3; [0048] tension=400 N/meter; [0049] surface density=0.1780 kilogram/meter.sup.2; and [0050] stress=47.4045 PSI.
The microphone 22 may comprises an air layer which may have the following characteristics/dimensions: [0051] air gap=2.54×10.sup.−5 meter; [0052] density=1.2050 kilogram/meter.sup.3; [0053] viscosity=1.8×10.sup.−5 Pascal-second; [0054] sound velocity through the air gap=290.2 meters per second; and [0055] gamma=1.4
The microphone 22 may also comprise a slot 94 which may have the following characteristics/dimensions: [0056] distance from the center of the backplate=0.0117 meter; [0057] width=0.00351 meter; [0058] depth=0.00114 meter; and [0059] area=0.000258 meter.sup.2.
The backplate 38 may define six holes 92, and each hole 92 may have the following characteristics/dimensions: [0060] distance from center of backplate to center of hole=0.00526 meter; [0061] radius=0.002 meter; [0062] depth=0.045 meter; [0063] angle between two lines going from center of backplate to either side edge of [0064] hole=43.5 degrees; and [0065] area=1.26×10.sup.−5 meter.sup.2.
The microphone 22 may also have the following further characteristics/dimensions: [0066] volume of the backchamber=5×10.sup.−5 meter.sup.3; [0067] membrane mass=480 kilogram/meter.sup.4; [0068] membrane cornpliance=3.2×10.sup.−11 meter.sup.5/Newton; and air gap compliance=3.5×10.sup.10 meter.sup.5/Newton.
[0069] In one embodiment, the resonant frequency of the microphone 22 may be 3108.01 Hertz.
[0070] The preamplifier board 42 is planar and extends radially outwardly from the proximal end of the conductor 36. The preamplifier board 42 is connected to the proximal end of the conductor 36 by suitable means such that there is an electrical connection between the preamplifier board 42 and the conductor 36, such as a brass screw 99. The preamplifier board 42 is parallel to the end wall 36 of the body 30, the base wall 64 of the support plate 32 and the base wall 88 of the backplate 38. The position of the preamplifier board 42 defines a first proximal chamber 100 which has a volume V1 between the preamplifier board 42 and the end wall 46 of the body 30, and a second distal chamber 102 which has a volume V2 between the preamplifier board 42 and the base wall 64 of the support plate 32. A slot 104 is defined between the outer diameter of the preamplifier board 42 and the side wall 44 of the body 30 to allow air to flow from the distal chamber 102 to the proximal chamber 100. In an embodiment, volume V1 is approximately 0.1287 cubic inch, and volume V2 is approximately 0.6 cubic inch. The air can only flow from the distal chamber 102 to the proximal chamber 100 through the slot 104. In an embodiment, this slot 104 has a clearance distance between the outer diameter of the preamplifier board 42 and the side wall 44 of approximately 0.025″, which slot 104 extends around the preamplifier board 42.
[0071] An electrical connection 106 extends through the aperture 62 in the side wall 44 and is sealed to the side wall 44 by suitable means. The electrical connection 106 is electrical communication with the preamplifier board 42 via wires 108, 110. The preamplifier board 42 is also electrically connected to the body 30 via a wire 110, which provides a ground to the preamplifier board 42. The preamplifier board 42 contains known components for measuring the capacitance between the membrane 40 and the backplate 38, and converting this measured capacitance into voltage.
[0072] The connection port 48 is connected to a distal end of the flexible tube 26, which may be formed of latex or rubber, which has an earpiece 28 at the proximal end of the tube 26. Such a flexible tube 26 and earpiece 28, like a typical stethoscope, are known in art for transmitting sound. The flexible tube 26 is attached to the connection port 48, such that there is no air exchange between the flexible tube 26 and the body 30, and such that the passageway through the tube 26 is in communication with the distal chamber 100 via the passageway 58 and aperture 56. When the earpiece 28 is inserted into the ears of the medical personnel, this allows substantially no air exchange between the cavity 50 of the microphone 22 and the outside the microphone 22. The length of the flexible tube 26 is adjusted so that maximum audible sound is received at the earpiece 28, which are used by medical personnel to hear the desired sounds in real time.
[0073] The combination of volumes V1 and V2 and the slot 104 around the preamplifier board 42 provide sufficient acoustic resistance for pressure equalization, and lowers the low frequency threshold. When the flexible tube 26 is connected to the earpiece 28, due to increased acoustic resistance and longer required period for pressure equalization, this lowers the low −3 dB frequency to 0.03 Hertz.
[0074] As described herein, the microphone may differ from U.S. Pat. No. 8,401,217 in that the body 30 is not completely sealed in that a connection port 48 is provided for connecting the microphone 22 to the flexible tube 26 and the earpiece 28, in that the preamplifier board 42 is mounted horizontally in the body 30 to divide the backchamber into two lower chambers 100 and 102 and that the preamplifier board 42 is parallel to the membrane 40, rather than being positioned vertically that is perpendicular to the membrane 40 as is positioned in U.S. Pat. No. 8,401,217, and in that the grid of U.S. Pat. No. 8,401,217 is eliminated and instead body 30 includes threads 54 for connection of the body coupler 24 or 24a to the distal end of the body 30.
[0075] The body coupler 24, 24a threadedly attaches to the thread form 54 at the distal end of the body 30 such that there is no air exchange between the body coupler 24, 24a and the body 30. In one embodiment, as shown in
[0076] As discussed herein, the preamplifier board 42 is installed parallel to the base wall 54 and to the membrane 24. The slot 104 between the edge of the preamplifier board 42 and the side wall 44 is small, for example 0.025″, to increase acoustic resistance. The combined volumes V1 and V2 and the volume in the flexible tube 26 is 5×10−5 meter.sup.3. Because of increased acoustic resistance, pressure equalization takes longer which aids in lower −3 dB frequency to 0.03 Hertz.
[0077] In use, the body coupler 24 or catheter tube 23 detects incident sound pressure from the heart, the uterus, or from any other location of the body where it is placed. For example as shown in
[0078] The microphone 22 provides damping of the motion of the membrane 40 for flat frequency response over a desired range by using the air gap 98 and the holes 92 in the backplate 38. When the membrane 40 vibrates, the membrane 40 compresses and expands the air layer in the air gap 98 and creates a reaction pressure, which opposes the motion of the membrane 40. The reaction pressure generates airflow which introduces damping primarily at two places: in the air gap 98 between the membrane 40 and the backplate 38, and in the holes 92 in the backplate 38 which provide large surface areas for viscous boundary layer damping.
[0079] As described in U.S. Pat. No. 8,401,217, in a 3 inch diameter infrasonic microphone 22, the tension of the membrane 40 may be less than about 1500 Newton per meter. For example, where the radius of the membrane 40 is about 0.0342 meter, the tension of the membrane 40 may be less than about 1000 Newton per meter. Further, the resonance frequency of the microphone 22 may be less than about 1000 Hertz. Still further, the volume of the backchamber may be selected to produce a low-frequency air compliance that exceeds the compliance of the membrane 40 by a factor of at least 3. In one example, the radius of the membrane 40 is about 0.0342 meter. In this example, the backplate 38 defines six holes 92, each having a radius of about 0.00302 meter. The holes 92 are evenly spaced along an imaginary circle on the backplate 38 and a center of each hole 92 is aligned with the imaginary circle. The center of the imaginary circle is located coincident with a center of the backplate 38, and the radius of the imaginary circle is about 0.0105 meter. The width of the slot 94 is about 0.0144 meter and the area of the slot 94 is about 0.00179 m.sup.2.
[0080] In an approximately 1.5 inch diameter infrasonic microphone 22, where the radius of the membrane 40 is about 0.0134 meter, the tension of the membrane 40 may be less than about 400 Newton per meter. Further, the resonance frequency of the microphone 22 may be less than about 1500 Hertz. Still further, the volume of the backchamber may be selected to produce a low-frequency air compliance that exceeds the compliance of the membrane 40 by a factor of at least 10. In another example, the radius of the membrane 40 is about 0.0134 meter. In this example, the radius of each of the six holes 92 is about 0.002 meter and the radius of the imaginary circle is about 0.0117 meter. The width of the slot 94 is about 0.00351 meter and the area of the slot 94 is about 0.000258 m.sup.2. The volume of the backchamber is about 0.00005 m.sup.3.
[0081] As shown in the block diagram of
[0082]
[0083] The infrascope 20 can be used for a stress phonocardiography test. Some heart problems occur only during physical activity. Stress phonocardiography test can be accomplished using the signals from the infrascope 20 immediately before and after walking on a treadmill or riding a stationary bike.
[0084] The infrascope 20 may be used for fetal heart monitoring during pregnancy, labor, and delivery to keep track of the heart rate of a fetus and the strength and duration of the contractions of uterus. External fetal heart monitoring which involves placing the body coupler 24 against the abdomen of the patient, keeps track of the baby's heart rate while at rest and while moving; measures the number of contractions and how long contractions last during labor and delivery; determines if there is preterm labor. Internal fetal heart monitoring, as shown in
[0085] The infrascope 20 can be used for Doppler phonocardiography as shown in
[0086] The infrascope 20 can be used for biometric identification. Fingerprints have been used for identification for more than 100 years, but using heartbeat for biometric identification has some advantages such as convenience and security. The heartbeat signatures can be extracted using either ECG/EKG or by using the infrascope 20 at remote locations. The security feature is preserved from the fact that a user's ECG or acoustic signatures cannot be captured without a person's consent. Another disadvantage of fingerprints are that these can be replicated by using samples left behind. The infrasonic bandwidth signals provide better and higher signal to noise ratio values and another tool for biometric identification.
[0087] The infrascope 20 can be used for polygraphs. Physiological processes measured by polygraphs are; cardiovascular, electrodermal, and respiratory, The direction and extent of cardiovascular reactivity may be different across individuals in response to stimuli that may be considered arousing. Electrodermal activity in terms of skin resistance or conductance is measured by passing a current through the skin. In response to controlled and relevant questions, variations from basal levels are called electrodermal or EDR responses or electrodermal activity levels and is used for polygraph interpretation. Variations in respiration which also produce changes in heart rate and electrodermal activity is monitored to determine of responses to relevant and control questions are artifacts. Currently, the rate and depth of respiration during polygraph are measured by changes measured using strain gauges positioned on chest and abdomen. Extreme low frequency signal measurements can be made by positioning the infrascope 20 at a subject's chest and abdomen is a relatively inexpensive tool to measure variation in respiratory and cardiovascular activity.
[0088] The infrascope 20 of the present disclosure enables medical personnel to look at the audible bandwidth as well as infrasonic bandwidth, thus providing medical personnel with another tool to analyze physiological processes. The infrascope 20 can be used for respiratory, cardiac, and for fetal heart monitoring. The infrascope 20 enables physiological process signals to be transferred to any place in the world in real time. Ambulances can be equipped with the infrascope 20 and medical personnel are able to obtain a patient's physiological information in real time. The infrascope 20 is a relatively inexpensive tool to diagnose abnormality at early stage.
[0089] The terms “patient” is used throughout the disclosure, which includes humans and animals, as it is anticipated that the present invention would also be capable of monitoring physiological processes for veterinary practices.
[0090] All references disclosed herein are hereby incorporated by reference in their entirety.
[0091] While particular embodiments are illustrated in and described with respect to the drawings, it is envisioned that those skilled in the art may devise various modifications without departing from the spirit and scope of the appended claims. It will therefore be appreciated that the scope of the disclosure and the appended claims is not limited to the specific embodiments illustrated in and discussed with respect to the drawings and that modifications and other embodiments are intended to be included within the scope of the disclosure and appended drawings. Moreover, although the foregoing descriptions and the associated drawings describe example embodiments in the context of certain example combinations of elements and/or functions, it should be appreciated that different combinations of elements and/or functions may be provided by alternative embodiments without departing from the scope of the disclosure and the appended claims.