WO2005016129A2 - Dispositif d'auscultation du type « multigated » - Google Patents
Dispositif d'auscultation du type « multigated » Download PDFInfo
- Publication number
- WO2005016129A2 WO2005016129A2 PCT/US2004/026438 US2004026438W WO2005016129A2 WO 2005016129 A2 WO2005016129 A2 WO 2005016129A2 US 2004026438 W US2004026438 W US 2004026438W WO 2005016129 A2 WO2005016129 A2 WO 2005016129A2
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- WIPO (PCT)
- Prior art keywords
- timer
- signal
- heart sound
- modifying
- wave detector
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B7/00—Instruments for auscultation
- A61B7/02—Stethoscopes
- A61B7/04—Electric stethoscopes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
- A61B5/316—Modalities, i.e. specific diagnostic methods
- A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
- A61B5/346—Analysis of electrocardiograms
- A61B5/349—Detecting specific parameters of the electrocardiograph cycle
- A61B5/352—Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
Definitions
- This invention relates to a method and device for gating electronic stethoscopes and heart sound teaching equipment.
- Auscultation is a common part of the physical examination in which the health care provider listens to the heart with a stethoscope. Training and experience are required to develop auscultatory skills for accurate clinical assessments. Auscultatory findings must be interpreted within the context of physiological events within the cardiac cycle. There are two periods within a cardiac cycle that must be appreciated during auscultation: 1 ) the period of systole when the heart contracts and blood is ejected from the main pumping chambers of the heart and 2) the period of diastole when the heart relaxes and the main pumping chamber fills.
- the standard clinical stethoscope relies on the interpreter's skill to define the timing and duration of abnormal heart sounds including murmurs, clicks, snaps, rubs, galloping sounds and splitting.
- experienced cardiologist may have a sensitivity of 70-80% for identifying isolated cardiac lesions by auscultation.
- physician sensitivity decreases to 20%.
- Sensitivity decreases further when assessments involve more complex auscultatory findings and are especially difficult in patients with disturbances of cardiac rhythm (e.g., tachyarrhythmias - abnormally fast heart rates).
- phonocardiographic recording systems include sound transducers (microphones or other sensor device), an amplifier, a reproduction system (paper recorder or computer display) and an audio speaker.
- sound transducers microphones or other sensor device
- amplifier amplifier
- reproduction system paper recorder or computer display
- audio speaker audio speaker
- Temporal discrimination of acoustic events with existing phonographic recording systems depends on either the paper speed of the recorder or the data sampling rate of the computer. These systems have historically been used clinically to define the timing and duration of normal and abnormal heart sounds. They rely on visual rather than auscultatory skills for measurement of timing and duration of heart sounds.
- the invention includes an apparatus for listening to a patient's heart having means for detecting a trigger, means for selecting systole or diastole, and means for modifying a heart sound signal.
- the invention includes an apparatus for listening to a patient's heart having an R-wave detector, a S/D controller connected to said R-wave detector, and means for modifying a heart sound signal.
- the invention includes a method for selecting the portion of a heart sound signal to listen to based on user selected inputs, the method including analyzing a physiological signal for a trigger indicating the start of a cardiac cycle, beginning a count until starting a gate, gating the heart sound and providing the gated heart sound to the user when gating is selected by the user, and when gating is not selected by the user providing an ungated heart sound to the user.
- the invention includes a device that allows a person listening to heart sounds to 1 ) rapidly determine whether sounds are systolic or diastolic and 2) provides means to quickly and accurately determine the timing and duration of acoustic events.
- Figure 1 illustrates a sample ECG signal and a sample heart sound signal.
- Figure 2 depicts a sample set of signals that can be inputted and outputted from at least one embodiment of the invention.
- Figure 3 illustrates a functional diagram of an exemplary embodiment of the invention.
- Figures 4A and 4B depict an exemplary circuit diagram for the embodiment illustrated in Figure 3.
- Figure 4C illustrates an exemplary interface for use with the illustrated circuit of
- Figure 5 depicts a table showing a variety of dial settings and the corresponding gate time that results from the dial settings using the circuit illustrated in Figures 4A and 4B.
- Figure 6 illustrates a functional diagram of another exemplary embodiment of the invention.
- Figures 7A, 7B and 7D depict an exemplary circuit diagram for the embodiment illustrated in Figure 6.
- Figures 7C and 7E illustrate exemplary interfaces for use with the illustrated circuit of
- Figures 8A and 8B depict another exemplary circuit diagram according to an embodiment of the invention.
- Figure 9 illustrates an exemplary circuit for an ECG input, an amplification circuit, an
- ECG output ECG output
- R-wave tracker an R-wave tracker
- Figure 10 depicts an exemplary circuit for an ECG input, an ECG output, and an R- wave tracker according to an embodiment of the invention.
- Figure 11 illustrates a block diagram according to an exemplary embodiment of the invention.
- Figures 12-13C depict exemplary implementations of the embodiment illustrated in
- Figure 14 illustrates a method according to at least one embodiment of the invention.
- Figure 15 depicts an exemplary embodiment according to the invention.
- the invention preferably is a device that interfaces with electronic stethoscopes or other types of heart sound recording equipment and allows the health care provider (1 ) to listen to heart sounds during all periods of the cardiac cycle as he/she would with a regular stethoscope (normal use) and (2) to selectively listen to specific parts of the cardiac cycle.
- the invention in at least one embodiment includes a stethoscope (or other heart sound listening equipment) with a gated auscultatory device.
- the invention allows health care providers or trainees to listen to either systole or diastole or shorter intervals within these periods to facilitate identification of normal and abnormal heart sounds. This preferably is accomplished by physiological gating, timing, switching and display circuits developed to be integrated with an electronic stethoscope or heart sound recording systems.
- the health care provider or student learning heart sounds listens to heart sounds as he/she would with a normal stethoscope then selects periods within the cardiac cycle to listen to by turning the audio output of electronic stethoscope (or other heart sound recording devices) on or off during systole or diastole or periods of interest.
- the device is gated by a predefined physiological event and allows the listener to control the timing and duration of what they hear during each heart beat (cycle).
- default settings based on heart rate are use to quickly identify whether the heart sound of interest occurs during systole or diastole.
- the device in at least one embodiment allows the listener to control the intervals of silence and sound.
- displays are provided to indicate a) that gating was successfully achieved and b) to allow the listener to determine the timing and duration of the cardiac acoustic events in milliseconds.
- the health care provider or student can employ standard clinical criteria (timing and duration) to identify anomalous heart sounds.
- Figure 1 demonstrates the relationship between ECG and S1 and S2 showing that the low frequency components (often inaudible) in S1 begin approximately 30 ms after the onset of QRS complex. Higher frequency and more audible components of S1 begin between 35 and 70 ms after the onset of the QRS complexes.
- the medical professional can selectively focus on different parts of the cardiac cycle.
- Normal QS1 interval is less than 100 ms except during MS.
- an embodiment of the invention would turn on a listening mode for auscultation at the onset of the Q wave and off within 120 ms. This would allow the medical professional to selectively listen to S1. It would also be reliable from the standpoint that as long as the onset of the R-wave in an ECG was detected, S1 from arrhythmias and premature beats would also be ausculted.
- Ejection sounds are heard 50-120 ms after S1. By permitting the medical professional to adjust the listening interval, he/she will be able to more easily discern ES from S1.
- systole is defined after a physiological trigger is established and the medical professional adjusts the interval of systole to a point in time when the onset of S2 is first heard or approximated by established HR algorithms for QS2.
- S4's are late diastolic, low frequency sounds occurring after the onset of the P-wave and just before the QRS complex. By selectively prolonging the period of the diastole window (with the diastole terminated by the onset of the next QRS complex), S4 could be detected as the last diastolic sound.
- Murmurs are categorized by their timing within the cardiac cycle and their duration.
- the invention preferably includes a detector (or means for detecting a trigger) 130, a selector (or controller or means for selecting systole or diastole) 160, and a PCG module (or means for modifying a PCG (or heart sound) signal) 180.
- Figure 2 illustrates an exemplary display showing what the various waveforms look like using the invention.
- Figure 2 shows an input ECG and PCG signals, an amplified ECG signal outputted from an exemplary device, gating pulses triggered by an R-wave in the ECG signal, and the resulting PCG output that is the portion of the input PCG signal that falls within the gating pulse.
- FIG. 3-5 illustrate an analog exemplary embodiment of the invention.
- the inputs into the system include an ECG signal, an S/D control signal(s), a gate timer signal, and a phonocardiogram and/or a heart sound input.
- the illustrated system includes an ECG connector 110, an AC/DC coupling switch 120, an R-wave detector 130, an S/D control 160, and a switch matrix (or means for modifying a PCG signal) 180.
- the AC/DC coupling switch (or means for modifying an ECG signal) 120 provides two options with the operation of switch 122.
- the first option is a by-pass and direct connection 124 between the ECG signal input (or connector) 110 and the R-wave detector 130.
- the second option provides an AC coupling that includes a high pass filter 126 as illustrated in Figure 4A.
- the R-wave detector 130 in this embodiment includes a reference voltage source 132, a reference offset 134, a rectifier 136, a charging pump 138, a reference sum 140, and a voltage comparator 142.
- the reference voltage source could be replaced with a voltage divider (or other voltage adjustment circuitry) connected to a power source for the device.
- the ECG signal is typically ⁇ 1 V with a 0 V baseline, and as a result preferably is increased to allow for detection of the R-wave.
- the rectifier 136 which may for example be a half-bridge rectifier, removes from the signal anything below 5 volts.
- the charging pump 138 is a sample and hold circuit that holds the peak voltage of the modified ECG signal for a period of time.
- the reference sum 140 provides the comparison point by adding a low reference voltage to the output of the rectifier 136.
- the low reference voltage may be, for example, obtained by using a voltage divider 1402 to lower the reference voltage of 5 V from the reference voltage source 132 down to 50 mV or a similar magnitude voltage to prevent hysteresis in the comparator 142.
- the comparator 142 compares the outputs from the charging pump 138 and the reference sum 140 to determine when the modified ECG signal becomes lower than the signal from the charging pump 138, and when this occurs providing a trigger signal.
- the trigger signal is provided to the S/D control (or means for selecting systole or diastole) 160, which provides the S/D selection based upon which way the S/D switch 162, which in the illustrated embodiment is a toggle switch although a variety of other switch mechanism may be used instead, is set. If the S/D switch 162 is set for the systole, then the trigger signal bypasses the delay on timer. If the S/D switch is set for the diastole, then the trigger signal passes through the delay on timer 164, which in the illustrated example has a delay that is adjustable and settable between 10 and 560 ms inclusive of the endpoints.
- the delay on timer 164 delays the trigger signal from reaching the gate on timer 168 and thus activating the switch matrix 180.
- the gate on timer (or means for setting gate length) 168 provides the length of the window for sound to be heard, and in the illustrated example includes a gate adjust that can be set between 10 and 560 ms inclusive of the endpoints as a gating pulse.
- Both of the timers are illustrated in Figure 4C as dials 166, 170 controlling a variable resistor, but as one of ordinary skill in the art will appreciate based on this disclosure a variety of input mechanisms may be used in place of dials.
- the illustrated dials are linear and have settings between 0 and 10. The length of the delay/gate can be calculated by multiplying the dial setting by 55 and adding 10 to the result.
- the illustrated implementation has a tolerance of about +/- 2%, which as one of ordinary skill in the art will appreciate based on this disclosure is a characteristic that can be impacted by the quality of the components used. For example, if the dial setting is set to 1.0, then the result is 65 ms. Another example is if the dial setting is set to 2.5, then the result is 147.5 ms.
- Figure 5 illustrates a table showing gate time for a variety of settings.
- the illustrated switch matrix 180 includes four analog switches 182, a buffer gate 181 , resistor 185, a bypass switch 184, and a sound input (phono in) connector 186 and sound output (phono out) connector 188 as illustrated in Figures 3 and 4B.
- Analog switches 182 operate substantially in unison and are control by the gating pulse, which in the illustrated embodiment is a digital signal, received from buffer gate 181.
- the bypass switch 184 is in the illustrated ON position, then the phono in 186 is connected directly to the phono out 188 and bypasses the analog switches 182.
- the analog switches 182 When the bypass switch 184 is in the OFF position, the analog switches 182 when activated by the gate pulse connect the sound input (phono in) 186 to the sound output (phono out) 188, otherwise while the gating pulse disables the analog switches 182 by opening them and only a small (if any) amplitude/volume of sound is outputted through the volume resistor 185 to the phono out 188.
- FIG. 5-7E Another exemplary embodiment is the above exemplary embodiment with the addition of a lock out timer (or means for preventing false triggering) 150 between the R-wave detector 130 and the S/D control 160 as illustrated in Figures 5-7E.
- the lock out timer 150 may be incorporated into the R-wave detector 130 or the S/D control 160.
- the lock out timer 150 is triggered by the trigger signal to begin a counter that while it is running, a T-wave in an ECG signal will not trigger the gating pulse, i.e., this component locks out a false T-wave trigger.
- the counter in one embodiment is set at 250 ms, which should be sufficient time after the R-wave trigger to cover the time during which a T-wave may occur while not preventing a trigger signal from the next R-wave in the ECG signal.
- This exemplary embodiment also illustrates the option of including a variety of LED indicators and outputs.
- Figures 7D and 7E illustrate a lock LED 152, a delay LED 172, and a gate LED 176. Also illustrated in these figures are the optional outputs: a lock output 154, a delay output 174, and a gate output 178.
- FIG. 7E also illustrates a faceplate with the phono in and phono out connectors 184, 188 and the bypass switch 186.
- the interface shown in Figure 7E provides the physical connection 110 for the ECG source and the switch for activating AC/DC coupling.
- FIGs 8A-8B Another exemplary embodiment is similar to the previous exemplary embodiments and is illustrated in Figures 8A-8B. In place of the DC/AC coupling in the previous exemplary embodiments, a gain amplifier (or means for modifying an ECG signal) 220 is provided.
- the illustrated gain amplifier 220 includes a set of four poll dip switches to allow the user to select the amplifier gain for the ECG input.
- the illustrated inverter 222 is an R-wave inverter that works in conjunction with the R-wave switch 224 to invert the R-wave from the amplifier 226 from a typical negative polarity, because the amplifier 226 inverts the typically inputted positive polarity ECG signal to a negative polarity ECG signal. However, if the placement of the ECG lead is not exact, then the original ECG signal may have negative polarity that will become the needed positive polarity signal output from the amplifier 226 and switch 224 can be positioned in the down position.
- Figure 8B illustrates a lock out timer 150 that includes optional connectors to the S/D controller 160 illustrated in Figure 4B.
- Pin 7 provides a negative trigger signal for an implementation that uses digital thumb wheels (or other digital selection mechanism in place of the dials illustrated, for example, in Figures 4C and 5C).
- Pin 6 provides a positive trigger signal for use with analog timing/gate circuits using analog dials such as 166, 170.
- analog dials such as 166, 170.
- FIG. 9 illustrates an ECG output circuit connected to a feedback on amplifier 2302 that includes an exemplary buffer 114 that can be used to buffer the ECG signal prior to be outputted at ECG output 112.
- Figure 9 also illustrates another exemplary amplifier 230 for the ECG signal prior to the reference offset 132.
- Figure 10 illustrates another exemplary ECG output circuit after the rectifier 134 that includes a buffer 1 14' and ECG output 112. Another exemplary embodiment is also illustrated in Figure 10, and this embodiment removes the AC/DC coupling switch at the input 110 for the ECG signal with a direct connection to the reference offset 134. The two illustrated exemplary modifications can be done separately.
- Figure 11 illustrates a block diagram illustrating the modules that are a part of this exemplary embodiment.
- the inputs include a bypass signal from a bypass switch, an ECG signal, an S/D selection signal, a time selected input signals, and a phonocardiogram (PCG) signal.
- the output is a modified PCG signal.
- the components preferably include an R-wave detector module (or means for detecting a trigger) 130', an S/D control module (or means for selecting systole or diastole) 160', and a modified PCG module (or means for modifying the PCG signal) 180'.
- Figures 12 and 13A illustrate an exemplary R-wave detector module 130' that receives as an input 1 10 of the ECG signal and detects when the R-wave occurs, although the R-wave detector 130' could be replaced by a detector set to detect an alternative physiological trigger that is indicative of when systole or diastole occur.
- An alternative embodiment is illustrated in Figure 12 that includes a T-wave blocking circuit 150'.
- the R-wave detector 130' produces a signal (or R pulse) for triggering the S/D control module 160'.
- Figure 12 illustrates an exemplary S/D control module 160' that receives as additional inputs the selection of systole (S) or diastole (D) from the S/D selection switch 162' and the gated time length to be used from the time selected input (or window control or means for setting gate length) 165', which as illustrated in Figures 12 and 13B may include multiple leads running between the time select input 165' and the S/D control module 160' such as the illustrated sixteen leads.
- Figure 13B illustrates an enlarged view of the integrated circuit and the leads connected to it within this exemplary embodiment.
- the time selected input 165' is illustrated as a binary coded decimal input, but could be other types of time or gating entry devices.
- the S/D control module 160' produces a signal that is high for the period of time selected. While if diastole is selected, then the S/D control module 160' produces a signal that is low for the period of time during systole portion of the heartbeat and the signal is high for the period around the diastole portion of the heartbeat.
- An alternative embodiment would reverse the high and low signal levels and make corresponding changes in the modified PCG module 180' to take into account the reversal of the control signal.
- the S/D control module 160' outputs a gating pulse control signal that controls the output from the modified PCG module 180' in conjunction with the input provided by the bypass switch 184'.
- FIG 13C illustrates an exemplary modified PCG module 180'.
- the bypass switch 184' controls whether there is any gating or not, i.e., whether the listener hears systole or diastole or both systole and diastole. If the bypass switch 184' is set to pass the PCG signal through unmodified, then the output will be the inputted PCG signal irrespective of the gating pulse signal. If the bypass switch 184' is set to modify the PCG signal, then a gating controller 182' will gate the portion of the PCG signal based on the gating pulse to be produced as illustrated in Figure 2 where the systole has been selected and is then produced as represented by Phono (out).
- a LED connected to the QRS detection that could be pulsed during the detection time, which would allow the medical professional to verify that the gate mechanism is on and working properly.
- a display can be provided to display at least one of the current settings of the device such as the gate and delay times being used.
- Another add-on feature is a RR interval detection circuit attached to the ECG input for calculating the beat-by-beat heart rate for display.
- a recording and marking system can be provided to allow the medial professional to mark for later review events of interest.
- the exemplary stethoscope embodiment includes any of the above described embodiments with the addition of stethoscope components.
- the transducer 412 would provide the phono in input into the means for modifying the PCG signal 180 and at least one electrode 414 proximate to the transducer 412 on the bell 410 for providing an ECG signal to the R-wave detector 130 as illustrated in Figure 15.
- the ear pieces 420 of the stethoscope would receive the output from the phono out in the means for modifying the PCG signal 180.
- the stethoscope 400 houses all of the components including, for example, the R-wave detector 130, the S/D control 160, and the means for modifying the PCG signal 180.
- the invention includes a method for performing the functional aspects discussed above.
- Figure 14 illustrates an exemplary method.
- the physiological parameter is analyzed for the triggering event, S310.
- An example of a physiological parameter is an ECG signal that includes a triggering event of an R-wave.
- S320 Upon detecting the triggering event, beginning a count until the window is to open for listening to the heart sound, S320. Opening the window and keeping it open for a period of time to pass the windowed (or gated) heart sound to the listener when gating is selected by the user, S330.
- the window is not open, providing minimal sound transmission to the listener, more preferably muting the heart sound.
- S340 When the user has selected to bypass the gating function, providing an ungated heart sound to the user.
- An exemplary addition to the above method is the inclusion of a locking step (or prevention of false triggering), because there are times when a false triggering event will occur such as a T-wave in an ECG signal that ideally would not restart either the wait period or the window over.
- This step may be incorporated into the detecting the triggering event or be a separate step.
- the window (or gating) steps in an exemplary embodiment are based upon settings either preset and/or received from the user.
- the selection of the wait period can be as simple as receiving an indication of systole or diastole with a delay time amount.
- the length of the window may be provided in a variety of ways including the illustrated device embodiments above.
- the window steps may include receiving the settings from the user. The settings may be adjusted on the fly by the user to allow the user to select periods of interest in the heart sound.
- Another exemplary embodiment includes providing outputs and/or indicators for the variety of signals and activation of different aspects. For example, providing a physiological parameter signal after some processing has occurred for comparison to the original and/or the concurrent phonocardiogram. Another example is outputting the trigger signal or window control signal. The indicator lights may be activated when a particular module is performing its corresponding part of the method.
- Another exemplary embodiment adds the receiving a bypass signal or indicator from the user, and providing the heart sound in a pure form without windowing (or gating) the signal.
- This exemplary method also includes receiving a signal or indicator to gate the heart sound based on the current settings.
- Another exemplary when the physiological parameter used as the trigger source is an ECG signal includes preparation steps. First, taking the patient's heart rate. Using the heart rate calculating the intervals for QS2 to better setup the gating time.
- an implementer may opt for a hardware and/or firmware vehicle; alternatively, if flexibility is paramount, the implementer may opt for a solely software implementation; or, yet again alternatively, the implementer may opt for some combination of hardware, software, and/or firmware.
- any vehicle to be utilized is a choice dependent upon the context in which the vehicle will be deployed and the specific concerns (e.g., speed, flexibility, or predictability) of the implementer, any of which may vary.
- a signal bearing media include, but are not limited to, the following: recordable type media such as floppy disks, hard disk drives, CD ROMs, digital tape, and transmission type media such as digital and analogue communication links using TDM or IP based communication links (e.g., packet links).
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Abstract
Dans des modes de réalisation à titre d'exemples, cette invention permet à un utilisateur de choisir s'il souhaite écouter un cycle cardiaque entier ou une partie du cycle cardiaque d'un patient. On délimite par la méthode dite «multigated» la partie du cycle cardiaque ainsi choisie en détectant un déclencheur physiologique et en délimitant par cette méthode les bruits du coeur sur la base des réglages ainsi établis, afin de fournir juste la partie souhaitée du cycle cardiaque.
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US49512603P | 2003-08-15 | 2003-08-15 | |
US60/495,126 | 2003-08-15 |
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WO2005016129A3 WO2005016129A3 (fr) | 2005-08-04 |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11357471B2 (en) | 2006-03-23 | 2022-06-14 | Michael E. Sabatino | Acquiring and processing acoustic energy emitted by at least one organ in a biological system |
Citations (2)
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USRE27042E (en) * | 1968-10-24 | 1971-01-26 | Method and apparatus for automatic screening op cardiac signals | |
US5025809A (en) * | 1989-11-28 | 1991-06-25 | Cardionics, Inc. | Recording, digital stethoscope for identifying PCG signatures |
-
2004
- 2004-08-16 WO PCT/US2004/026438 patent/WO2005016129A2/fr active Application Filing
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
USRE27042E (en) * | 1968-10-24 | 1971-01-26 | Method and apparatus for automatic screening op cardiac signals | |
US5025809A (en) * | 1989-11-28 | 1991-06-25 | Cardionics, Inc. | Recording, digital stethoscope for identifying PCG signatures |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11357471B2 (en) | 2006-03-23 | 2022-06-14 | Michael E. Sabatino | Acquiring and processing acoustic energy emitted by at least one organ in a biological system |
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