Patent Description:
One known construction is disclosed in <CIT>, which discloses a hand-held heart monitoring device that, when held against a chest of a subject by the subject's right hand, is capable of recording heart activity. Another known construction is disclosed in <CIT>, which discloses a system for measuring vital signs using bilateral pulse transit time, where a hand-held vital signs monitoring device measures blood pressure from a patient's fingers.

According to the present invention as defined in independent claim <NUM>, a stethoscope includes a housing that has a first surface and a second surface. The first surface defines a first groove on a first side of the housing and a second groove on a second side of the housing. The stethoscope also includes a controller. A photoplethysmogram sensor assembly is operably coupled to the housing and configured to obtain and push photoplethysmogram data to the controller. The photoplethysmogram sensor assembly includes a first optical sensor operably coupled to the housing within the first groove and a second optical sensor operably coupled to the housing within the second groove. A phonocardiogram sensor is coupled to the second surface of the housing and configured to obtain and push phonocardiogram data to the controller. An electrocardiogram sensor assembly is coupled to the housing. The electrocardiogram sensor assembly includes a first electrode disposed in the first groove and a second electrode disposed in the second groove. The electrocardiogram sensor assembly is configured to obtain electrocardiogram data and send the electrocardiogram data to the controller. A power supply is configured to provide an electric current to be applied by the first electrode and detected by the second electrode. The controller is configured to determine an impedance signal based on a variance in the electric current detected by the second electrode.

The present illustrated embodiments reside primarily in combinations of method steps and apparatus components related to an active stethoscope. Accordingly, the apparatus components and method steps have been represented, where appropriate, by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Further, like numerals in the description and drawings represent like elements.

For purposes of description herein, the terms "upper," "lower," "right," "left," "rear," "front," "vertical," "horizontal," and derivatives thereof, shall relate to the disclosure as oriented in <FIG>. Unless stated otherwise, the term "front" shall refer to a surface closest to an intended viewer, and the term "rear" shall refer to a surface furthest from the intended viewer. It is also to be understood that the specific structures and processes illustrated in the attached drawings, and described in the following specification are simply exemplary embodiments of the inventive concepts defined in the appended claims.

The terms "including," "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element preceded by "comprises a. " does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

Referring to <FIG> reference numeral <NUM> generally designates a medical device, such as a stethoscope that includes a housing <NUM> that has a first surface <NUM> and a second surface <NUM>. The first surface <NUM> defines a first groove <NUM> on a first side <NUM> of the housing and a second groove <NUM> on a second side <NUM> of the housing <NUM>. A photoplethysmogram (PPG) sensor assembly <NUM> is configured to obtain and push or communicate data. The PPG sensor assembly <NUM> includes a first optical sensor <NUM> disposed in the first groove <NUM> and a second optical sensor <NUM> disposed in the second groove <NUM>. Each of the first optical sensor <NUM> and the second optical sensor <NUM> includes an emitter <NUM> and a detector <NUM>. A phonocardiogram (PCG) sensor <NUM> is coupled to the second surface <NUM> of the housing <NUM> and is configured to obtain and push or transmit data. A controller <NUM> is configured to receive the data from each of the PPG sensor assembly <NUM> and the PCG sensor <NUM>.

Referring to <FIG>, the stethoscope <NUM> is generally a handheld device. The stethoscope <NUM> includes a housing <NUM>, which may be elongated and flat. The generally small, elongated, and flat housing <NUM> may allow a user to conveniently move the stethoscope <NUM> to certain positions to obtain physiological data. Additionally, the size and portability of the stethoscope <NUM> may be advantageous for providing convenient at-home health monitoring for the user.

The first surface <NUM>, which may be a top surface, of the housing <NUM> defines the first groove <NUM> and the second groove <NUM>. The first groove <NUM> can be at least partially defined by the first surface <NUM> and by a side surface <NUM>. Similarly, the second groove <NUM> can be at least partially defined by the first surface <NUM> and partially defined by an opposing side surface <NUM>. In examples where the housing <NUM> is elongated, the first groove <NUM> and the second groove <NUM> are generally positioned along a longitudinal extent <NUM> and on opposing sides of the housing <NUM>.

Each of the first groove <NUM> and the second groove <NUM> are generally contoured to fit a finger (any finger, including a thumb) of the user. Accordingly, the user can hold the stethoscope <NUM> in both hands with a single finger from one hand disposed in the first groove <NUM> and a single finger from the other hand disposed in the second groove <NUM>. When grasping the stethoscope <NUM> to have a finger positioned in each of the first groove <NUM> and the second groove <NUM>, the stethoscope <NUM> may obtain physiological data as described further herein.

Referring to <FIG>, the stethoscope <NUM> includes the PPG sensor assembly <NUM>. The PPG sensor assembly <NUM> is configured to obtain PPG data (e.g., the physiological data) using the first optical sensor <NUM> and the second optical sensor <NUM>. The first optical sensor <NUM> is coupled to the housing <NUM> within the first groove <NUM>. The second optical sensor <NUM> is coupled to the housing <NUM> in the second groove <NUM>. When the stethoscope <NUM> is held by the user, the first optical sensor <NUM> engages the finger of one hand of the user, and the second optical sensor <NUM> engages the finger of the other hand of the user.

Each of the first optical sensor <NUM> and the second optical sensor <NUM> includes the emitter <NUM> and the detector <NUM>. In a non-limiting example, the emitter <NUM> includes a light-emitting diode (LED) <NUM>, and the detector <NUM> is configured as a photodiode. The emitter <NUM> may include one or more LED light sources <NUM>. For example, the emitter <NUM> may include a first LED light source 76A configured to emit visible light (e.g., having a wavelength in a range between about <NUM> and about <NUM>), which can be white light (e.g., having a wavelength in a range between about <NUM> and about <NUM>) or red light (e.g., having a wavelength in a range between about <NUM> and about <NUM>) and a second LED light source 76B configured to emit infrared light (e.g., having a wavelength in a range between about <NUM> and about <NUM>). The two light sources 76A, 76B may be advantageous as red light may be primarily absorbed by deoxygenated blood and infrared light may be primarily absorbed by oxygenated blood. The first and second light sources 76A, 76B are collectively referred to herein as the light sources <NUM>.

The light sources <NUM> may include any form of light source. For example, fluorescent lighting, light-emitting diodes (LEDs), organic LEDs (OLEDs), polymer LEDs (PLEDs), laser diodes, quantum dot LEDs (QD-LEDs), solid-state lighting, a hybrid, and/or any other similar device. Any other form of lighting may be utilized within the stethoscope <NUM> without departing from the teachings herein. Further, various types of LEDs are suitable for use within the stethoscope <NUM>, including, but not limited to, top-emitting LEDs, side-emitting LEDs, and others.

According to various aspects, the light sources <NUM> of the emitter <NUM> are generally configured to generate pulse profile signals based on the light received by the detector <NUM> and, consequently, the amount of light absorbed or reflected by the blood. The pulse profile signals may be used to calculate additional physiological data, such as blood oxygen saturation or SpO<NUM> levels, including, for example, capillary oxygen saturation levels. The SpO<NUM> level is generally an indication of a profusion of oxygen into the blood. Additionally or alternatively, the data from the PPG sensor assembly <NUM> may be utilized to determine blood volume changes in a microvascular bed of tissue. The light emitted by the emitter <NUM> is configured to pulse through the finger of the user and be received by the detector <NUM>. The light received by the detector <NUM> can be converted into an electrical pulse by the detector <NUM>. The detector <NUM> is configured to send the PPG data (e.g., the electrical pulse) to the controller <NUM>. Further, an amount of light reflected or absorbed by the blood may be determined. The amount of infrared light versus the amount of red light received by the detector <NUM> may indicate an absorption ratio. The controller <NUM> is configured to utilize the PPG data, including the peaks and averages of the pulse profile signals and/or the absorption ratio, to calculate the SpO<NUM> levels of the user. Accordingly, the controller <NUM> utilizes the PPG data to determine the percentage of oxygen in the blood (e.g., <NUM>%, <NUM>%, etc.).

The data received from the PPG sensor assembly <NUM> by the controller <NUM> may be utilized to measure or determine pulse transit time (PTT) and pulse velocity time (PVT) or pulse wave velocity (PWV) between different locations of the body of the user. The PTT and/or the PVT may be calculated based on the timing in the pulse profile signals and/or the SpO<NUM> measurements. The controller <NUM> may measure the time delay between critical points of the PPG data signal. The critical points are characteristic identification points of the blood pulse wave. The PTT and/or the PVT may be indicative of the time it takes the pulse pressure waveform to propagate through a length of the arterial tree. Generally, PTT is the propagation time of a pulse wave going from the heart to the peripheral arteries and may be calculated as time between R-peaks of an electrocardiogram (ECG) to the time to the pulse wave peaks of a photoplethysmogram (PPG). Alternatively, the PTT may be calculated as the time from the pulse wave peaks of the PPG on a finger of one hand to the pulse wave peaks of the PPG on a finger of the other hand. The PVT may be calculated as the time the pulse wave from the heart to the selected artery divided by the distance and multiplied by a constant (e.g., <NUM>).

The PVT and/or the PTT may be utilized to calculate the blood pressure of the user. Generally, PTT is inversely proportional to blood pressure. Additionally, PVT is generally inversely related to PTT. PVT may be utilized to determine arterial stiffness, which may indicate cardiovascular disease. The PTT and PVT measurements may be utilized to monitor cardiovascular concerns or disease in the user.

Referring to <FIG>, and <FIG>, the stethoscope <NUM> has a recessed region <NUM> on the second surface <NUM> that defines a space or recess <NUM>. An ECG sensor assembly <NUM> is at least partially coupled to the second surface <NUM> adjacent to the recess <NUM>. The ECG sensor assembly <NUM> is utilized to measure ECG data (e.g., physiological data), such as the six (<NUM>) lead ECG values. Additionally, the ECG sensor assembly <NUM> may be coupled with a capacitor-sensing circuit <NUM> for activating the stethoscope <NUM> to obtain the physiological data, as described further herein.

The ECG sensor assembly <NUM> includes a first electrode 86A disposed within the first groove <NUM>, a second electrode 86B is disposed within the second groove <NUM>, and a third electrode 86O may be disposed in an annular ring surrounding the recess <NUM>. The first, second, and third electrodes 86A-86C are collectively referred to herein as electrodes <NUM> or metal electrodes <NUM>. The ECG sensor assembly <NUM> is coupled to the first surface <NUM> and the second surface <NUM> of the housing <NUM> for convenient use for the user.

The electrodes 86A, 86B disposed in each of the first groove <NUM> and the second groove <NUM> may be flat contact surfaces. Alternatively, the electrodes 86A, 86B in the first and second grooves <NUM>, <NUM> may be contoured to the shape of the first and second grooves <NUM>, <NUM>. As illustrated in <FIG>, the electrodes 86A, 86B can cover a portion of the surfaces of the first groove <NUM> and the second groove <NUM>. It is also contemplated that the electrodes 86A, 86B may be contoured to cover a substantial portion, or all, of the surface of each of the first groove <NUM> and the second groove <NUM> (as best illustrated in <FIG>).

The ECG sensor assembly <NUM> may provide a passive differential voltage measuring system to the stethoscope <NUM>. The ECG sensor assembly <NUM> is configured to obtain the ECG data and send the ECG data to the controller <NUM>. The ECG data may include the six (<NUM>) lead ECG measurements, which include Lead I, Lead II, Lead III, aVR, aVL, and aVF measurements. The Lead I, Lead II, and Lead III measurements are bipolar limb leads using electrodes <NUM> of opposite polarity, and the aVR, aVL, and aVF measurements are unipolar limb leads. The six (<NUM>) lead ECG measurements measure approximately <NUM>° around the heart, which allows the stethoscope <NUM> to generally pinpoint a location of a heart issue.

Referring still to <FIG>, the third electrode 86C of the ECG sensor assembly <NUM> is disposed proximate to and extends around the recess <NUM> on the second surface <NUM> of the housing <NUM>. The third electrode 86C is generally a metal contact annular ring on the second surface <NUM> of the stethoscope <NUM>. The third electrode 86C is positioned and shaped to come into contact with skin in a generally flat area of the body, such as the chest, leg, or knee. The generally flat annular ring configuration of the third electrode 86C provides for proper contact between the electrode 86C and the skin of the user. The stethoscope <NUM> generally has three electrodes <NUM> with one electrode 86A, 86B in each of the first groove <NUM> and the second groove <NUM> on the first surface <NUM> of the stethoscope <NUM> and one electrode 86C around the recess <NUM> on the second surface <NUM> of the stethoscope <NUM>.

In use, it is generally contemplated that the user can hold the stethoscope <NUM> with a single finger from each hand in contact with the electrodes 86A, 86B within the first groove <NUM> and the second groove <NUM>. When the user is in contact with the electrodes 86A, 86B, the stethoscope <NUM> can measure the voltage across the chest of the user for the Lead I ECG measurement. While maintaining contact with the electrodes 86A, 86B, the user can move the stethoscope <NUM> to place the third electrode 86C on the second surface <NUM> in contact with another part of the body. For example, when the third electrode 86C is in contact with the left knee of the user, the stethoscope <NUM> can measure the voltage for the Lead II and Lead III ECG measurement. When measuring the Lead II and Lead III ECG measurements, the stethoscope <NUM> connects a voltage circuit from the hands of the user through the left or right shoulder to the left or right knee to obtain and measure diagonal heart signals.

The ECG data is communicated to the controller <NUM>. The controller <NUM> may calculate the heart rate of the user utilizing the ECG data. Additionally, controller <NUM> may detect cardiac abnormalities using the ECG data. The location of a potential cause of the cardiac abnormality may be determined through the six (<NUM>) lead ECG measurements.

Referring to <FIG> and <FIG>, the PPG sensor assembly <NUM> and the ECG sensor assembly <NUM> are both included in the stethoscope <NUM> to provide both types of physiological data to the user. The PPG sensor assembly <NUM> and the ECG sensor assembly <NUM> may sense the physiological data concurrently, independently, or a combination thereof depending on the position of the stethoscope <NUM> relative to the user. The electrodes 86A, 86B of the ECG sensor assembly <NUM> may be separate from the emitter <NUM> and the detector <NUM> of the PPG sensor assembly <NUM>. As best illustrated in <FIG>, the first optical sensor <NUM> may extend into the space defined by the first groove <NUM>. The finger of the user can be in contact with each of the emitter <NUM> and detector <NUM>. It is also contemplated that the first optical sensor <NUM> may be disposed within the housing <NUM>, such that the first optical sensor <NUM> may not impinge the space defined by the first groove <NUM>. The first optical sensor <NUM> may be flush with or behind the surface of the first groove <NUM>. The flush configuration of the PPG sensor assembly <NUM> may be advantageous for combining the PPG sensor assembly <NUM> with the ECG sensor assembly <NUM> (<FIG>). While the first optical sensor <NUM> in the first groove <NUM> is illustrated, it is contemplated that the second optical sensor <NUM> in the second groove <NUM> (<FIG>) may have a substantially similar configuration.

As best illustrated in <FIG>, the electrodes 86A, 86B may be contoured to correspond with the shape of each of the first groove <NUM> and the second groove <NUM> and extend over an increased surface area within the first and second grooves <NUM>, <NUM>. In such configurations, the electrodes 86A, 86B and/or the housing <NUM> may define optically clear windows <NUM> that align with the emitter <NUM> and the detector <NUM> of each of the first optical sensor <NUM> and the second optical sensor <NUM>. The optically clear windows <NUM> allow the light to be emitted through the windows <NUM> by the emitter <NUM> and received through the windows <NUM> by the detector <NUM>.

Additionally or alternatively, the electrodes 86A, 86B may not define the windows <NUM>. In such examples, the housing <NUM> defines the optically clear windows <NUM>. The emitter <NUM> and the detector <NUM> are aligned with the windows <NUM> defined by the housing <NUM>. The emitter <NUM> and the detector <NUM> may be positioned within the housing <NUM> and emit or detect light, respectively, through the windows <NUM>.

Referring again to <FIG>, and <FIG>, the electrodes <NUM> of the ECG sensor assembly <NUM> may be utilized to measure an impedance signal through the body of the user. Impedance is generally a measure of restriction applied to the electrical circuit of the heart. The impedance signal may be utilized to measure body mass index, body fat levels, and fluid levels within the body. When the user has a finger in contact with each of the electrodes 86A, 86B within the first groove <NUM> and the second groove <NUM>, the stethoscope <NUM> may measure the impedance across the chest of the user.

According to the claimed invention, one of the electrodes 86A applies a small electric current to be detected by the other electrode 86B. A power supply <NUM> of the stethoscope <NUM> provides the current for impedance measurement. The voltage received by the second electrode 86B varies based on the biological material through which the current passes (e.g., bone, muscle, fat, etc.). The variance in the voltage received is utilized by the controller <NUM> to determine the impedance signal.

In various aspects, the user can touch the third electrode 86C disposed around the recess <NUM> to the right knee or the left knee. When the third electrode 86C contacts the knee while the fingers remain in contact with the electrodes 86A, 86B within the first groove <NUM> and the second groove <NUM>, the stethoscope <NUM> can measure a portion of the impedance of the arms of the user and down to the leg. The measurements may be utilized to measure the sub-impedance for each arm and each leg of the user.

The sub-impedance measurements may indicate the fluid level within each arm and each leg for the particular measurements taken through the body. The body can act as a resistor to calculate the impedance signal. The various vectors between the chest, the left leg, and the right leg can be utilized to calculate sub-impedance measurements for a leg portion, an entire leg, an arm proportion, or an entire arm of the user. The impedance circuit (e.g., using the electrodes <NUM>) can drive a current into the fingers of the user and into the body that can be utilized to measure the body fat content and the body water content. Measuring the fluid levels within the body may be advantageous for various patients, including patients with lymphedema. The user of the stethoscope <NUM> can measure impedance daily, weekly, or at regular or irregular intervals, and compare the obtained data to a baseline to determine variations in the body mass index, the body fat level, and the body fluid level.

Referring still to <FIG> and <FIG>, the PCG sensor <NUM> may be coupled to the second surface <NUM> of the housing <NUM>. The second surface <NUM> of the housing <NUM> defines the recess <NUM>, and the PCG sensor <NUM> generally includes a microphone <NUM> positioned at a bottom of the recessed region <NUM>. The microphone <NUM> is generally centrally located within the recess <NUM>. The recess <NUM> is contoured to direct sound to the microphone <NUM> or other acoustic sensors. In various examples, the recess <NUM> may be bell-shaped, parabolic, arcuate, hemispherical, partially ovoid, etc. to direct sounds to the microphone <NUM>.

The recess <NUM> is generally centrally located on the second surface <NUM>. It is contemplated that the recess <NUM> may be located in any practicable location and/or be any shape, such that the recess <NUM> can engage various parts of the body of the user. For example, the recessed region <NUM> can be contoured to engage a chest, a knee, and/or an ankle of the user. It is contemplated that an edge between the recessed region <NUM> and the remainder of the second surface <NUM> may be rounded or beveled to assist in better aligning the recess <NUM> with more bony prominences.

The recess <NUM> may be defined on an opposing surface relative to the first groove <NUM> and the second groove <NUM>. In various examples, though on the opposing surface, the recess <NUM> is positioned between and generally equidistant from each of the first groove <NUM> and the second groove <NUM>. This configuration may be advantageous for convenient handling by the user to obtain one of both or the PPG data and the ECG data concurrently with the PCG data.

The PCG sensor <NUM> is generally utilized to measure the heart sounds of the user. The user can place the stethoscope <NUM> against the chest with the second surface <NUM> of the housing <NUM> in contact with the chest. The recessed region <NUM> and the recess <NUM> direct the sounds of the heart to the microphone <NUM>. The PCG sensor <NUM> can measure the S1 and S2 heart sounds. Generally, the S1 and S2 heart sounds mark valve closings. The S1 heart sound represents the closure of the atrioventricular valves and corresponds with the pulse of the user. The S2 heart sound represents the closure of the semilunar valves. The PCG data is communicated to the controller <NUM> (<FIG>). The measured heart sounds may be utilized to calculate at least one of PTT, PVT, and SpO<NUM> levels.

Additionally, the S1 and S2 sounds may be utilized to monitor cardiac conditions of the user. For example, abnormal S2 sounds may be indicative of various cardiac conditions, such as, for example, pulmonary hypertension. It is also contemplated that the PCG sensor <NUM> may also sense S3 heart sounds and S4 heart sounds. When sensed, the S3 and S4 heart sounds may be associated with ventricular dilation (e.g., ventricular systolic failure) or a stiff and low compliance ventricle (e.g., ventricular hypertrophy), respectively. Moreover, any additional sounds, such as heart murmurs, may be sensed and monitored using the stethoscope <NUM>.

Referring again to <FIG>, the sensed data may be utilized to determine various physiological data or vital sign parameters of the user. For example, the PTT is the interval between the peak of the R-wave in an ECG measurement and the fingertip PPG measurement. The S1 and S2 heart sounds measured by the PCG sensor <NUM> may contribute to the calculation of PTT. The controller <NUM> may measure the time delay between the R-peak and any one critical point of the PPG signal to calculate the PTT.

The PCG data and the PPG data, along with the PVT and the PTT, may be utilized to measure the blood pressure of the user. PTT may be used to estimate systolic blood pressure and diastolic blood pressure. PVT, related to arterial stiffness, may be modulated by blood pressure. The data obtained by the stethoscope <NUM> may be utilized to calibrate a blood pressure measurement and obtain blood pressure deltas. The stethoscope <NUM> may then calculate blood pressure over a predetermined amount of time using the calibration. The predetermined amount of time (i.e., hours, days, etc.) may differ depending on signal quality and various other factors.

Referring to <FIG>, the stethoscope <NUM> includes the controller <NUM>. The controller <NUM> includes a processor <NUM>, a memory <NUM>, and other control circuitry. Instructions or routines <NUM> are stored within the memory <NUM> and executable by the processor <NUM>. The controller <NUM> disclosed herein may include various types of control circuitry, digital or analog, and may include the processor <NUM>, a microcontroller, an application specific circuit (ASIC), or other circuitry configured to perform the various input or output, control, analysis, or other functions described herein. The memory <NUM> described herein may be implemented in a variety of volatile and nonvolatile memory formats. The routines <NUM> include operating instructions to enable various methods and functions described herein.

The controller <NUM> generally includes at least one routine <NUM> related to receiving the physiological data from each of the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM>. The routines <NUM> may also include instructions for utilizing the data received to calculate additional vital sign parameters or physiological data, including, but not limited to, blood oxygen saturation levels (SpO<NUM>), PVT, PTT, heart rate, blood pressure, impedance, body composition, and fluid levels in the body.

The controller <NUM> is configured to receive the physiological data from each of the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM> and communicate the physiological data through a data line or wirelessly to a remote device <NUM>. The remote device <NUM> may utilize the data to determine additional data or parameters, store the data, and/or compare the data over a period of time. The stethoscope <NUM> and the remote device <NUM> may be included in a health monitoring system <NUM> that measures and tracks vital sign parameters or physiological data of the user. The stethoscope <NUM> is configured to obtain physiological data, which is conveyed to the remote device <NUM> by the controller <NUM>. The physiological data includes each type of data received by the controller <NUM> (e.g., the PPG data, the PCG data, the ECG data, the impedance data, etc.) and the physiological data calculated therefrom.

The controller <NUM> includes communication circuitry <NUM> configured to communicate with the remote device <NUM> and/or remote servers (e.g., cloud servers, Internet-connected databases, computers, etc.) via a communication interface <NUM>. The communication interface <NUM> may be a network having one or more various wired or wireless communication mechanisms, including any combination of wired (e.g., cable and fiber) or wireless communications and any network topology or topologies. Exemplary communication networks include wireless communication networks, such as, for example, a Bluetooth® transceiver, a ZigBee® transceiver, a Wi-Fi transceiver, an IrDA transceiver, an RFID transceiver, etc. The controller <NUM> of the stethoscope <NUM> and the remote device <NUM> may include circuitry configured for bidirectional wireless communication. Additional exemplary communication networks include local area networks (LAN) and/or wide area networks (WAN), including the Internet and other data communication services. It is contemplated that the stethoscope <NUM> and the remote device <NUM> may communicate by any suitable technology for exchanging data.

The remote device <NUM> may be a remote handheld unit such as, for example, a phone, a tablet, a portable computer, a wearable device, etc. In a non-limiting example, the remote device <NUM> can be associated with a medical professional through a patient database system <NUM>. The remote device <NUM> may include an application or software for communicating information between the medical professional and the user. The physiological or vital sign data may be communicated from the stethoscope <NUM> through the communication interface <NUM> to the patient database system <NUM>. The remote device <NUM> may also be in communication with the patient database system <NUM> to transfer data therebetween.

Referring still to <FIG>, as well as <FIG>, the controller <NUM> may be configured to generate an alert notification <NUM> in response to the physiological or vital sign data received from the stethoscope <NUM>. The controller <NUM> is configured to communicate the alert notification <NUM> to the remote device <NUM> for viewing by one of the user and the medical professional or caregiver. In certain aspects, the controller <NUM> of the stethoscope <NUM> may compare the sensed and calculated physiological data to predefined values or baseline values specific to the user. For example, if the physiological data is outside a predefined range, then the alert notification <NUM> may be generated. The alert notification <NUM> may indicate a certain condition or abnormal data to the user, as illustrated in <FIG>, or to the medical professional or caregiver, as illustrated in <FIG>.

As best illustrated in <FIG>, the remote device <NUM> may belong to the user of the stethoscope <NUM>, thereby allowing the user to monitor the obtained vital sign parameter data in a home environment. In such examples, the alert notification <NUM> may be communicated to the remote device <NUM>, notifying the user of a certain condition or abnormal data. The user may contact the caregiver or schedule an appointment in response to the alert notification <NUM>. As best illustrated in <FIG>, when the alert notification <NUM> is generated for the medical professional, the alert notification <NUM> may be communicated to the patient database system <NUM>, which may be a centralized records database accessible by the caregiver. Once communicated to the patient database system <NUM>, the alert notification <NUM> may be viewed by the medical professional or caregiver associated with the user of the stethoscope <NUM>. The medical professional may contact the user of the stethoscope <NUM> regarding the condition detected by the stethoscope <NUM> in response to the alert notification <NUM>.

The alert notification <NUM> may provide the physiological data, an indication of the condition, a tip or prompt to contact the medical professional, etc. The alert notification <NUM> may also include selectable features to view additional data or imaging, as well as schedule appointments. The information illustrated in the alert notification <NUM> of <FIG> is merely exemplary and not meant to be limiting. Moreover, the alert notification <NUM> can be any practicable alert (e.g., visual, haptic, audible, etc.) configured to convey information to the medical professional and/or the user.

Referring to <FIG>, to use the stethoscope <NUM>, the user can grasp and hold the stethoscope <NUM> with one finger disposed in each of the first groove <NUM> and the second groove <NUM>. For example, the thumbs of the user can be disposed in the first groove <NUM> and the second groove <NUM> and the index fingers of the user can contact the second surface <NUM> to hold the stethoscope <NUM>. The emitter <NUM> of each of the first optical sensor <NUM> and the second optical sensor <NUM> of the PPG sensor assembly <NUM> emit light, which can be received by the detectors <NUM> to calculate or measure the pulse profile, the SpO<NUM>, the absorption ration, etc. of the user. Additionally or alternatively, the thumbs or index fingers of the user can be in contact with the electrodes 86A, 86B within the first groove <NUM> and the second groove <NUM>, providing electrical contact to the body to measure the voltage (e.g., the ECG signal) across the chest of the user for the Lead I ECG measurement. The user can then place the third electrode 86C disposed around the recess <NUM> on the kneecap to get the Lead II and the Lead III ECG measurements. The user can obtain the Lead I, the Lead II, the Lead III ECG measurements, the pulse profile, and the SpO<NUM> measurements simultaneously by holding the stethoscope <NUM> and placing the stethoscope <NUM> in contact with the kneecap.

When the user holds the stethoscope <NUM> and contacts the second surface <NUM> with the chest of the user, the user can simultaneously obtain the Lead I ECG measurement across the chest, the pulse profile, the SpO<NUM> measurements, and the heart rate using the PCG sensor <NUM> simultaneously. The stethoscope <NUM> can be used to diagram the heart ECG QRS bundles when the heart is contracting. When the heart is beating, peaks and specific points on the waveform of the ECG signal can be compared to a point of the pulse profile signal (e.g., the PPG or SpO<NUM> signal) to calculate the PTT, the PVT, and the blood pressure. Accordingly, using the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM>, the stethoscope <NUM> may be advantageous for obtaining a variety of physiological or vital sign data simultaneously.

The stethoscope <NUM> can include one or more buttons <NUM> on the housing <NUM> to activate or deactivate the stethoscope <NUM> or certain aspects of the stethoscope <NUM>. The buttons <NUM> can correspond with measuring the PCG data, the ECG data, and/or the PPG data. Accordingly, the user can press one of the buttons <NUM>, position the stethoscope <NUM>, and the stethoscope <NUM> can take the selected measurement or measurements. The user may obtain certain measurements and not others based on the selected buttons <NUM> or may obtain all measurements based on the selected buttons <NUM>. It is contemplated that the controller <NUM> may analyze or process the physiological data and which buttons <NUM> were selected. If a certain button <NUM> was selected but the sensed physiological data does not match the type of physiological data to be obtained, the controller <NUM> may generate the alert notification <NUM> to inform the user to obtain a subsequent measurement or contact the medical professional. For example, if the PCG sensor <NUM> is activated but the user does not place the stethoscope <NUM> against his or her chest, the PCG data may not be sensed and the controller <NUM> may indicate the misalignment between the activated PCG sensor <NUM> and the sensed data to the user.

In a specific example, the stethoscope <NUM> may be advantageous for lymphedema patients. Cancer patients that have their lymph nodes removed are more susceptible to lymphedema. Lymphedema is generally swelling of the arms and the legs of the patient. The measurements obtained by the stethoscope <NUM> can alert the medical professional and/or the user that the patient should schedule a physical therapy session to manage the lymphedema. The impedance circuit that measures the fluid level within the body may also be advantageous to monitor lymphedema patients. The stethoscope <NUM> may provide a long-term health monitoring system <NUM> for those with chronic medical concerns.

According to various aspects, the stethoscope <NUM> can be preprogrammed based on the specific condition and/or diagnosis of the user. The user may determine a change in health over time by using daily, weekly, or periodic measurements. The frequency of the measurements may depend on a risk level or a level of attention for the specific condition. The user and the medical professional associated with the remote device <NUM> can monitor any significant changes in the condition of the user of the stethoscope <NUM>.

Referring still to <FIG>, the medical device, such as the stethoscope <NUM>, may include any combination or each of the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM>. Based on the various configurations of the medical device, different types of physiological data may be measured.

Referring to <FIG>, as well as <FIG>, a method <NUM> of monitoring health or medical conditions of the user includes step <NUM> of providing the medical device or the stethoscope <NUM>. Such a method does not fall within the scope of the claimed sbject-matter. The stethoscope <NUM> may have any one or more of the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM>. In certain aspects, the sensors included in the stethoscope <NUM> may be customized to the user. Alternatively, the stethoscope <NUM> may include each of the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM> to provide flexible at-home monitoring of various conditions.

In step <NUM>, the PPG sensor assembly <NUM> may be activated to obtain the PPG data. The user may position one finger in the first groove <NUM> and a second finger of the other hand in the second groove <NUM>. The user may then press one of the buttons <NUM> to activate the PPG sensor assembly <NUM>.

Additionally or alternatively, the ECG electrodes 86A, 86B in the first and second grooves <NUM>, <NUM> (e.g., right and left grooves) may be coupled to the capacitor-sensing circuit <NUM>. The controller <NUM> may activate the PPG sensor assembly <NUM>, the ECG sensor assembly <NUM>, and/or the PCG sensor <NUM> to obtain the PPG, ECG, and PCG measurements, respectively, when the electrodes 86A, 86B are touched by the patient (e.g., touch activation). The capacitor-sensing circuit <NUM> may provide a voltage to one or both of the electrodes 86A, 86B to generate at least one electric field. The capacitor-sensing circuit <NUM> is configured to sense a change in capacitance that occurs when the user brings his or her finger into contact or close proximity with one or both of the electrodes 86A, 86B, which affects the generated electric fields. Upon the capacitor-sensing circuit <NUM> sensing the change in capacitance, the controller <NUM> is configured to activate one or more of the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM>. Accordingly, the stethoscope <NUM> may activate and obtain data automatically upon the user contacting the ECG sensor assembly <NUM>. It is contemplated that the electrodes 86A, 86B and the capacitor-sensing circuit may be configured to operate as any practicable type of capacitor (e.g., self-capacitance or mutual capacitance between the electrodes 86A, 86B or with additional electrodes) without departing from the teachings herein.

Upon activation, the emitter <NUM> transmits light toward the detector <NUM> through the fingers of the user. The emitter <NUM> may emit at least one of red light and infrared light. The light received by the detector <NUM> may be converted to an electrical signal and communicated to the controller <NUM>.

In step <NUM>, the ECG sensor assembly <NUM> may be activated to obtain at least some of the ECG data. The user may press at least one button <NUM> to activate the ECG sensor assembly <NUM> to begin obtaining data across the chest of the user. When the user positions his or her fingers in the first and second grooves <NUM>, <NUM>, the user contacts the electrodes 86A, 86B, allowing the ECG data to be measured. The ECG data may then be communicated to the controller <NUM>.

In step <NUM>, the PCG sensor <NUM> may be activated via at least one of the buttons <NUM> to initiate sensing of the PCG data. The user may place the second surface <NUM> of the stethoscope against his or her chest and activate the PCG sensor <NUM>. Once activated, the microphone <NUM> is configured to sense the heart sounds of the user. The heart sounds (e.g., the PCG data) are communicated to the controller <NUM>.

In step <NUM>, additional data may be sensed by the stethoscope <NUM>. For example, the user may reposition the stethoscope <NUM> to obtain additional ECG data. The user may position the stethoscope <NUM> so the electrode 86C on the second surface <NUM> abuts the knee or ankle of the user. Additionally or alternatively, in step <NUM>, a voltage may be provided to the electrode 86A to measure resistance within the user to obtain impedance data. The user may also reposition the stethoscope <NUM> to obtain sub-impedance data for his or her arms and legs.

In step <NUM>, the controller <NUM> may utilize the obtained data to calculate additional physiological or vital sign data. For example, the controller <NUM> may utilize the data to obtain blood oxygen saturation (SpO<NUM>), PTT, PVT, blood pressure, body composition, and other related information. In step <NUM>, the sensed data and the calculated data or information are communicated to at least one of the remote device <NUM> and the patient database system <NUM> to be viewed by the user or the medical professional. Additionally, when the information is communicated to the patient database system <NUM>, the information may be stored within an electronic medical record associated with the user.

In step <NUM>, the controller <NUM> may compare the sensed and calculated data with predefined data. The predefined data may be an upper threshold, a lower threshold, or a range. The predefined data may be defined by the medical professional and may be based on the user (age, gender, etc.). Additionally or alternatively, the predefined data may be baselines values specific to the user. In certain aspects, the baseline values may be based on certain conditions of the patient.

In step <NUM>, the controller <NUM> may generate the alert notification <NUM>. The alert notification <NUM> may be communicated to at least one of the medical professional and the user via the remote device <NUM>. The alert notification <NUM> may include a variety of information helpful to the treatment and monitoring of the user. The alert notification <NUM> may include the sensed and calculated data. Additionally or alternatively, the alert notification <NUM> may indicate abnormal data. Further, based on the sensed or calculated data, the alert notification <NUM> may include steps to be taken for treatment, such as contacting the medical professional, scheduling an appointment, etc. It is understood that the steps of the method <NUM> may be performed in any order, simultaneously and/or omitted without departing from the teachings provided herein.

Use of the present device may provide for a variety of advantages. For example, the stethoscope <NUM> may include one or more of the PPG sensor assembly <NUM>, the PCG sensor <NUM>, and the ECG sensor assembly <NUM>. Additionally, the stethoscope <NUM> can be customized based on the condition of the user of the stethoscope <NUM>. Accordingly, the stethoscope <NUM> may be preprogrammed to monitor certain data based on the condition of the user. Further, after a patient is released from a hospital or other medical facility, the user can utilize the stethoscope <NUM> to monitor a current health status, including episodic vital sign parameters, while at home. Also, the stethoscope <NUM> can be utilized to monitor vital sign parameters and physiological data over longer periods of time. Accordingly, the stethoscope <NUM> may be utilized for overall health assessments in the home on a self-serve basis and a continuous basis. Further, the stethoscope <NUM> may provide a low-cost device for users to monitor vital sign and physiological data and provide indications to a medical professional and the user of any significant changes to the condition of the user. These and other benefits or advantages may be realized and/or achieved.

It is also important to note that the construction and arrangement of the elements of the disclosure, as shown in the exemplary embodiments, is illustrative only. Although only a few embodiments of the present innovations have been described in detail in this disclosure, those skilled in the art who review this disclosure will readily appreciate that many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes, and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.) without materially departing from the novel teachings and advantages of the subject matter recited. For example, elements shown as integrally formed may be constructed of multiple parts, or elements shown as multiple parts may be integrally formed, the operation of the interfaces may be reversed or otherwise varied, the length or width of the structures and/or members or connector or other elements of the system may be varied, the nature or number of adjustment positions provided between the elements may be varied. It should be noted that the elements and/or assemblies of the system may be constructed from any of a wide variety of materials that provide sufficient strength or durability, in any of a wide variety of colors, textures, and combinations. Accordingly, all such modifications are intended to be included within the scope of the present innovations. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the desired and other exemplary embodiments without departing from the present innovations.

Claim 1:
A stethoscope (<NUM>), comprising:
a housing (<NUM>) having a first surface (<NUM>) and a second surface (<NUM>), wherein the first surface (<NUM>) defines a first groove (<NUM>) on a first side (<NUM>) of the housing (<NUM>) and a second groove (<NUM>) on a second side (<NUM>) of the housing (<NUM>);
a controller (<NUM>);
a photoplethysmogram sensor assembly (<NUM>) operably coupled to the housing (<NUM>) and configured to obtain and push photoplethysmogram data to the controller (<NUM>), the photoplethysmogram sensor assembly (<NUM>) including:
a first optical sensor (<NUM>) operably coupled to the housing (<NUM>) within the first groove (<NUM>); and
a second optical sensor (<NUM>) operably coupled to the housing (<NUM>) within the second groove (<NUM>);
a phonocardiogram sensor (<NUM>) coupled to the second surface (<NUM>) of the housing (<NUM>) and configured to obtain and push phonocardiogram data to the controller (<NUM>);
an electrocardiogram sensor assembly (<NUM>) coupled to the housing (<NUM>), wherein the electrocardiogram sensor assembly (<NUM>) includes a first electrode (86A) disposed in the first groove (<NUM>) and a second electrode (86B) disposed in the second groove (<NUM>), wherein the electrocardiogram sensor assembly (<NUM>) is configured to obtain electrocardiogram data and send the electrocardiogram data to the controller (<NUM>); and
a power supply (<NUM>) configured to provide an electric current to be applied by the first electrode (86A) and detected by the second electrode (86B), wherein the controller (<NUM>) is configured to determine an impedance signal based on a variance in the electric current detected by the second electrode (86B).