A wearable device that generates extracorporeal shock waves

Abstract

The present invention relates to a wearable device for generating extracorporeal shock waves in the chest region of a user, the wearable device comprising a shockwave converter unit configured to be placed on the skin of a user for generating extracorporeal shock waves and applying shockwave therapy, at least one proximity sensor for measuring the proximity of the shockwave converter unit to the skin of the user, a positioning mechanism configured to controllably position the shockwave converter unit, and a processor configured to transmit information to the shockwave converter unit to generate extracorporeal shock waves.

Description

[Technical field]

[0001] The present disclosure relates to the measurement of cardiac function for assessing cardiovascular health and the generation of ultrasonic shock waves for therapeutic applications, and more particularly, but not exclusively, to a wearable device for generating extracorporeal shock waves in the chest region of a user. [Background technology]

[0002] Cardiovascular diseases are the leading cause of death and disability worldwide. Many pharmacological and device-based therapies have been developed for cardiovascular diseases such as resistant hypertension and myocardial infarction, but most of them still have disappointing clinical results. The use of ultrasound for cardiovascular diagnosis has been widely applied and may be developed as a strategy for cardiovascular therapy as well due to its non-invasive and non-ionizing properties. Ultrasound therapy has been used as a resource for device-based treatment in neurosurgery, cancer, and cardiology, alone and / or in combination with other therapies.

[0003] However, existing systems and methods are costly and error prone due to the adhesiveness of the sensors / probes. This specification recognizes the need for a portable and efficient device to determine and measure cardiac function and generate extracorporeal shock waves without requiring special skills or training by the user and / or assistant.

[0004] Each person has different cardiac motion, respiratory motion, and blood circulation, which may reduce the targeting accuracy and acoustic energy deposition of ultrasound therapy. Interference in the acoustic path may reduce the required energy, induce non-target damage, and prevent the achievement of the treatment goal. Delivery of high intensity focused ultrasound to the human chest region may cause undesirable lesions and reduce the intensity of energy reaching the target. By administering lower intensity ultrasound over longer sessions and / or durations, ultrasound therapy may be performed more safely and undesirable side effects may be minimized. However, patients suffering from cardiovascular disease often have multiple comorbidities and precipitating factors that affect their health. Therefore, adaptive and / or personalized therapy is needed to make the treatment more effective. Treating multiple cardiac conditions simultaneously further requires devices that can continually adapt to new information about the user's cardiac health and adapt the treatment accordingly.

[0005] Ultrasound therapy typically requires a visit to a medical professional and clinical setting. Patients are often more susceptible to hospital-acquired infections, and preventing patients from entering a hospital may reduce the risk of contracting the disease. Reducing the need for hospital visits may further reduce the amount of hospital resources needed to treat patients.

[0006] In view of the above, therefore, there exists a long-standing need in the medical industry to address the aforementioned deficiencies and shortcomings. Summary of the Invention

[0007] It is an object of the present disclosure to provide a wearable device that generates extracorporeal shock waves to assess the cardiac function of a user's heart and to treat cardiac diseases of the heart and the blood vessels around and on the heart.

[0008] A further object of the present disclosure is to provide personalized ultrasound therapy to each patient according to their physical characteristics and / or disease characteristics, thereby helping to minimize adverse effects and reduce undesirable side effects.

[0009] In general, low-frequency ultrasound has good penetration that can reach deeper targets, and exerts mainly mechanical effects on cell membranes with very little temperature rise (less than 0.01°C), thereby depolarizing the membrane as much as possible, activating voltage-gated sodium channels and voltage-gated calcium channels, and affecting cell excitability. However, high-frequency ultrasound has shorter wavelengths and better spatial resolution than low-frequency ultrasound. High-frequency ultrasound is centrally integrated, which is useful for imaging. High-frequency ultrasound attenuates quickly, which can cause heat loss and poor penetration when applied to deliver skin treatments.

[0010] It is generally known that ultrasound can induce a wide range of biological effects in soft tissue. An advantage of the disclosed approach is the ability to non-invasively generate controlled biological effects. Depending on which biological tissue response is desired, the exposure parameters of magnitude and frequency can be adjusted. An additional advantage of the disclosed approach is that an adaptive ultrasound pulse system can be used to cost-effectively personalize cardiovascular ultrasound therapy.

[0011] The present disclosure relates to a device for generating extracorporeal shock waves in the chest region, the preferred embodiment being a wearable device. The device is preferably configured to receive cardiac health information. The device may include at least one cardiac sensor, such as an ultrasound sensor, e.g., an ultrasound receiver, for non-invasively acquiring cardiac data, and / or may be configured to receive information from an invasive cardiac sensor, e.g., a pacemaker. A shock wave converter unit or multiple shock wave converter units may be provided to generate extracorporeal shock waves. Through the control of the device, the shock wave converter unit(s) may be placed on the user's skin and shock wave therapy may be applied, e.g., in the form of ultrasound therapy.

[0012] The shockwave converter units may be arranged in an array of shockwave converter units.

[0013] The array of shock wave transducer units can function as a cardiac sensor to obtain cardiac health information of a user. The array of shock wave transducer units can function as a cardiac sensor so that the cardiac sensor can obtain cardiac health information regarding different parts of the heart without moving the wearable device. The array of shock wave transducer units can be a planar array and / or a linear array for phased array transducer units.

[0014] The wearable device may further comprise at least one proximity sensor. The proximity sensor may measure the proximity of the shockwave converter unit to the user's skin. The measured proximity is the distance between the shockwave converter unit and the user's skin, determining how tight the converter fits to the user's skin and thus the actual distance between the shockwave converter unit and the heart or various parts of the heart. The wearable device may further comprise a positioning mechanism configured to controllably position the shockwave converter unit and the at least one cardiac sensor against the user's skin. The at least one cardiac sensor is preferably part of the shockwave converter unit.

[0015] The wearable device may comprise a processor configured to transmit information to a shock wave converter unit for generating extracorporeal shock waves. The information may comprise information regarding treatment parameters, including but not limited to information regarding location, frequency, spatial average, temporal average, duty cycle and / or duration of shock wave treatment.

[0016] A pressure sensor is an example of a proximity sensor and may be configured to measure the proximity of the shockwave converter to the skin of a user. This means that a sensor capable of detecting the contact state between the shockwave converter unit and the skin of a user may be used. A pressure sensor may be any instrument or device that converts the amount of physical pressure applied to the sensor into an output signal that may be used to determine a quantitative value of the pressure.

[0017] Advantageously, the shockwave converter unit is adapted to generate extracorporeal shock waves and is adapted to be placed on the user's skin, preferably with an adhesion force selected to optimize the shockwave therapy. The adhesion force is the contact force between the shockwave converter unit and the user's skin. Advantageously, said contact force is predefined and can be measured by a proximity sensor. Based on the predefined value, an optimized shockwave therapy routine can be provided.

[0018] Shockwave therapy refers to any therapeutic ultrasound modality that includes piezoelectric crystals that are electrically stimulated and configured to emit high frequency sound waves that propagate through tissue, with some of the generated energy being absorbed and another portion being reflected by fluids, cells, and / or connective tissue. Ultrasound therapy can be tailored according to clinical applications and tissue characteristics using various parameters (including but not limited to frequency, amplitude, and / or pulse duration) and can be optimized to maximize absorption to enable therapeutic applications. The device of the present disclosure is preferably configured to perform multiple functions, thereby providing long-term in-home therapy without the need for specialist training.

[0019] The wearable device may comprise an array of shockwave converter units that may be independently controlled such that the direction and focus of the shockwaves generated from the array may be controlled, such that the position of the wearable device is sufficient in the chest area of ​​the user to treat the user's heart and any part of the heart without moving the wearable device.

[0020] The positioning mechanism may be configured to position the shockwave converter unit in an area in the chest region of the user. The positioning mechanism may improve position control of the shockwave converter on the user's skin. As a result, the shockwave therapy may be applied in a guided manner. In one embodiment, the positioning mechanism comprises a guide channel. The guide channel may be provided on a bottom surface of the device that faces the user's skin during shockwave therapy. The guide channel may guide the shockwave converter unit towards the user's skin in a plane defined by said bottom surface of the device. Advantageously, the shockwave converter unit may be guided through the guide channel on the plane, improving the guiding and positioning control of the shockwave converter unit. The bottom surface of the device is the surface of the device that is configured to face the user's skin.

[0021] The devices of the present disclosure may be equipped with multiple sensors that provide sensor data, for example cardiac data.

[0022] The continuous positioning of the shock wave converter unit and acquisition of sensor data can be automated and coupled with artificial intelligence based techniques such as case-based expert systems and / or implementing fuzzy logic control systems.

[0023] The personalized shockwave therapy parameters may be calculated by machine learning models, so that the device may be configured to continually identify, scan, and apply region-based shockwaves to regions of the heart in need of treatment.

[0024] The shock waves from the shock wave converter unit(s) have a maximum energy of 0.02 mJ / m 2 , or even higher.

[0025] The invention will now be described in more detail with reference to the accompanying drawings. [Brief description of the drawings]

[0026] [Figure 1] FIG. 1 shows a block diagram illustrating the connections between various components of a wearable device for generating extracorporeal shock waves in the chest region of a user, according to an embodiment of the present invention. [Diagram 2] FIG. 2 illustrates a bottom view of a wearable device according to one embodiment of the present disclosure. [Diagram 3] FIG. 1 illustrates a side view of a wearable device according to one embodiment of the present disclosure. [Figure 4] 1 illustrates a monitoring application installed in a handheld computing device according to one embodiment of the present disclosure. [Diagram 5] FIG. 1 illustrates a perspective view of a handheld computing device placed against a user's body or chest in accordance with at least one embodiment. [Figure 6] FIG. 1 illustrates a perspective view of the interaction between an ultrasound sensor and a user's heart in accordance with at least one embodiment. [Figure 7] FIG. 1 illustrates a first exploded view of a wearable device positioned against a user's chest, according to at least one embodiment. [Figure 8] FIG. 13 illustrates a second exploded view of a wearable device positioned against a user's chest, according to at least one embodiment. [Figure 9] 13 illustrates a third exploded view of a wearable device positioned against a user's chest, according to at least one embodiment. [Figure 10] FIG. 1 illustrates a perspective view of placing a wearable device within a pocket of a vest, according to at least one embodiment. [Figure 11] FIG. 1 illustrates a perspective view of an ultrasonic transducer matrix or array according to at least one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0027] From one aspect, the present disclosure relates to a device comprising a mobile device comprising a processor and a memory, and adapted to be configured as described herein.

[0028] The present disclosure further relates to a wearable device configured to carry out a set of instructions that, when executed by a computing device, causes the computing device to generate extracorporeal shock waves in the thoracic region of a user.

[0029] In one embodiment, the wearable device comprises a computing device. The computing device may be a handheld mobile computing device, for example a smartphone. Thus, in one embodiment, the wearable device comprises a handheld computing device. In a further embodiment, the wearable device comprises a display screen. Preferably, the handheld computing device may have a display screen.

[0030] In one embodiment, the wearable device is configured to control the user's smartphone, which adjusts the power mode of the phone to minimize the generation of electronic RF noise, thereby eliminating or at least reducing the impact or interruption caused by the phone call when the piezoelectric transducer is functioning normally.

[0031] Thus, one advantage of the present disclosure is that the wearable device can use both the processing and power of a handheld computing device, such as a smartphone, to perform measurements based on, for example, Doppler shift, and uses inexpensive existing carbon fiber technology in combination with side stickers and automated sensor positioning to ensure accurate positioning of the ultrasound sensor and avoid any external pressure on the vessel that may distort the vessel's shape or diameter and cause errors. Thus, from an aspect of one embodiment, the wearable device can function as a gadget for the computing device.

[0032] In one embodiment, the device of the present disclosure comprises a circuit board, such as a PCB, for connecting the electronic components of the device, such as the shock wave converter unit, the sensor, the positioning mechanism, and optionally the processor. PCB can refer to a printed wiring board, a printed wiring card, or a printed circuit board (PCB), which mechanically supports the electrical or electronic components of the device of the present disclosure using conductive tracks, pads, and other features etched from one or more layers of copper laminated on and / or between layers of a non-conductive substrate. The interface circuit board (PCB) can be connected to the handheld computing device described above.

[0033] The device comprises at least one data processor for executing program components for executing user-generated or system-generated requests. The processor may comprise specialized processing units such as an integrated system (bus) controller, memory management control unit, floating point unit, graphics processing unit, digital signal processing unit, and the like. The processor may further comprise a microprocessor such as an AMD® ATHLON® microprocessor, DURON® microprocessor or OPTERON® microprocessor, ARM application, embedded or secure processor, IBM®, POWERPC®, INTEL'S CORE® processor, ITANIUM® processor, XEON® processor, CELERON® processor, or other processor line. The processor may be implemented using mainframe, distributed processor, multi-core, parallel, grid, or other architectures. Some embodiments may utilize embedded technologies such as application specific integrated circuits (ASICs), digital signal processors (DSPs), field programmable gate arrays (FPGAs), AlazarTech controller systems, and the like.

[0034] The processor may be arranged to communicate with one or more I / O devices via an input / output (I / O) interface. The I / O interface may employ, but is not limited to, the following communications protocols / methods: audio, analog, digital, RCA, stereo, IEEE-1394, serial bus, universal serial bus (USB), infrared, PS / 2, BNC, coaxial, component, composite, digital visual interface (DVI), high definition multimedia interface (HDMI), RF antenna, S-video, VGA, IEEE 802.n / b / g / n / x, Bluetooth, cellular (e.g., code division multiple access (CDMA), high speed packet access (HSPA+), global system for mobile communications (GSM), long term evolution (LTE), WiMAX, etc.).

[0035] In one embodiment, the PCB is connected to one or more of an analog-to-digital converter (ADC) for converting analog ultrasound data to digital data, a microcontroller unit with power and data transmission ports, one or more high bandwidth op-amp circuits, multiple digital buffers, at least two signal mixers for precision Doppler calculations, multiple filters suitable for the operating range of the piezoelectric ultrasonic sensors, multiple bidirectional drivers for micro linear actuators and servo motors, multiple headers and multiple PWM lines for powering the micro linear actuators and servo motors.

[0036] In one embodiment, the PCB is connected to the handheld computing device via a cable and / or interface having data and power lines, and the cable / interface receives power from the handheld computing device. In a further embodiment, the wearable device receives power from an external power system via a cable.

[0037] In one embodiment, the wearable device comprises a boost circuit for providing power to the shockwave converter unit. In a further embodiment, the boost circuit comprises a low equivalent series resistance (ESR) capacitor and utilizes a high capacity stored charge. The stored charge can be obtained from the handheld computing device via the power supply and data transmission cable during idle times.

[0038] In one embodiment, the device further comprises a battery. Thus, the wearable device can receive power from an external battery that can power the PCB. The battery can be based on Lithium Polymer (Li-Poly) and Lithium Ion (Li-Ion). The battery can also be operated by a power management integrated circuit such as a power MOSFET. Alternatively, the wearable device can be powered by the handheld computing device.

[0039] In one embodiment, the wearable device can be powered by a power source, where the power source can be one or more batteries, an AC mains power source, or electromagnetic induction power transmission without physical contact. In the case of electromagnetic induction power transmission, the wearable device can be powered, for example, by an AC mains power source, an optical fiber power source. In the case of optical fiber power source, the wearable device can include, for example, an optical-to-electrical converter, such as a solar cell for providing electrical energy, a solar array for providing electrical energy, a winding hand system for providing electrical energy, such as a generator driven by a winding hand system, or an energy harvesting system for providing electrical energy from a magnetic field. In an embodiment where the electromagnetic induction power transmission relies on an AC mains power source, the wearable device can include a filter for blocking high frequency and / or large magnitude power transients.

[0040] The major advantages of adopting handheld computing device technology are that it provides cheap and reliable access to perform cardiac function measurements, and adds the feature of extracorporeal shock waves to treat heart failure using high intensity focused ultrasound (HIFU) and thermal and non-thermal effects of extracorporeal shock waves for relief and mobility restoration. Wearable devices can operate with automated precision sensor positioning and negligible error in sensor weight.

[0041] In one embodiment, the device further comprises a memory and / or a server for providing instructions. The memory may be a non-volatile memory or a volatile memory. Examples of non-volatile memory may include, but are not limited to, flash memory, read only memory (ROM), programmable duty cycle LE ROM (PROM), erasable PROM (EPROM), and electrical EPROM (EEPROM) memory. Examples of volatile memory may include, but are not limited to, dynamic random access memory (DRAM) and static random access memory (SRAM). Alternatively, the device may comprise a processor and memory and may be adapted to perform multiple events.

[0042] As used herein, cardiac health information may include cardiac sensor data and / or self-reported cardiac health data. The cardiac sensor data may include, but is not limited to, non-invasive cardiac sensor data such as electrocardiogram (ECG), photoplethysmography (PPG), ultrasound, phonocardiogram (PCG), myocardial perfusion by thallium scintigraphy, and / or data regarding ejection fraction. The cardiac sensor data may further include invasive cardiac sensor data from sensors such as implantable intracardiac pressure sensors, pacemaker defibrillators, and / or any other implantable cardiac devices. The self-reported cardiac health status data may include, but is not limited to, one or more self-reported symptom questionnaire(s) related to angina, Canadian Cardiovascular Society score, extent of cardiac medication use, self-administered 6-minute walk test, and / or any physical symptoms resulting from exercise testing.

[0043] Pressure sensors as used herein include, but are not limited to, potentiometer pressure sensors, inductive pressure sensors, capacitive pressure sensors, piezoelectric pressure sensors, strain gauge pressure sensors, variable reluctance pressure sensors, aneroid barometer sensors, manometer sensors, Bourdon tube pressure sensors, vacuum pressure sensors, and hermetic pressure sensors.

[0044] As previously mentioned, the cardiac sensor may be an ultrasound sensor for measuring cardiac function of the user's heart. The ultrasound sensor may be, for example, a piezoelectric ultrasound sensor. The ultrasound sensor may comprise a MEMS ultrasound sensor.

[0045] The cardiac sensor may be an electronic stethoscope, which may be any device configured to electronically amplify body sounds using acoustically transduced sound waves heard through a chestpiece into electrical signals that may then be amplified for optimal hearing. Electronic stethoscopes may include, but are not limited to, microelectromechanical system (MEMS) microphones, electret condenser microphones (ECM), accelerophones, and / or piezoelectric microphones.

[0046] The device further comprises one or more sensors selected from the following group: a photoplethysmography (PPG) sensor, an electrocardiogram (ECG) sensor, an inertial measurement unit (IMU) sensor, configured to determine, for example, whether the device is correctly positioned or not, which may be part of the cardiac sensor.

[0047] The shock wave converter unit may comprise an ultrasound transceiver that generates extracorporeal shock waves. However, in some embodiments, the extracorporeal shock waves may be infrasonic frequency shock waves.

[0048] In one embodiment, the device of the present disclosure is configured to receive analog data from a user.

[0049] The proximity sensor ensures that the device can receive information regarding a given proximity of the shockwave converter unit to the user's skin and / or the pressure applied to the user's skin, thereby minimizing errors due to pressing the shockwave converter unit against the skin.

[0050] In one embodiment, the wearable device is configured to be individually calibrated to the user.

[0051] The device of the present disclosure may comprise one or more rows of shock wave transducers, such as ultrasound transducers. The transducers may be activated depending on the area of ​​the heart to be analyzed and / or treated. The transducers may be electronically and / or mechanically adjusted to ensure a good fit with the skin of the user. The shock wave transducer unit may further comprise an electrohydraulic power source, a piezoelectric power source, an electromagnetic source with a flat coil, and / or an electromagnetic source with a cylindrical coil. Furthermore, the shock wave transducer unit may be configured as a signal generator attached to a concave transducer such that the ultrasound can be focused at one or more fixed focal lengths. The configuration may be used to emit or generate a beam to focus energy on the target tissue at a predefined depth from the tissue surface with minimal resolution and with minimal impact on the tissue between the surface and the target. The configuration may enable its use in exploiting the thermal effects of ultrasound.

[0052] The present disclosure describes deploying extracorporeal shock wave therapy, where a user receives shock wave therapy instructions, including the type of disease requiring treatment, such as, for example, coronary artery disease and / or myocardial sclerosis. These instructions may be predefined rules / instructions based on the user's characteristics, such as body size, age, type and / or severity of heart disease, e.g., in ischemic heart disease, the desired angiogenic effect that may be achieved by using shock wave therapy parameters.

[0053] In one embodiment, the transducer units may be independently controllable to control the direction and / or focal length of the generated extracorporeal shock waves.

[0054] The converter unit may be a shock wave converter unit.

[0055] The individual transducer units may be phase shifted relative to each other. Depending on the relative phase shift between the transducer units, the position of maximum of all superimposed waves in a plane for a one-dimensional or two-dimensional array may be positioned by adjusting the phase for each of the transducer units in the array. Using this method, shock waves can be directed to specific angles (and positions) without the use of moving mechanical parts. Similarly, ultrasound waves from the transducer units may be focused on specific regions of the heart, and shock waves may be controlled in angle and focus relative to the heart.

[0056] In one embodiment, the array can be one or two dimensional.

[0057] If the array is one-dimensional, the generated extracorporeal shock waves can be controlled in one dimension. If the array is two-dimensional, the generated extracorporeal shock waves can be controlled in two dimensions.

[0058] In one embodiment, at least one array of shock wave transducer units may be configured to generate an electrical signal in response to reflected ultrasound waves from the heart.

[0059] The fact that the transducer units can be bidirectional transducers means that an array of shock wave transducer units, in addition to extracorporeal shock waves for treating the heart, can also generate ultrasound waves and record reflected ultrasound waves to generate images and even videos of the heart. In this way, the heart can be (further) diagnosed and the diagnosis can be used to: Where on the patient's heart the transducer array should be focused; How much power should be used for the shock wave? How focused should the shock wave be? How large should the focal area on the heart be? Whether the shock waves should be continuous or pulsed, and if pulsed, the frequency of the pulses and / or the duration of each pulse, etc. It is possible to determine:

[0060] The same shock wave converter unit can generate extracorporeal shock waves for treating the heart and ultrasound for imaging the heart. The difference between the two waves is the energy density or intensity of the waves, shock waves have a higher intensity than ultrasound.

[0061] When the reflected ultrasound waves are incident on the array of shockwave transducer units, they create a voltage / current response from the shockwave transducer units depending on the strength of the vibration / pressure wave amplitude. This means that the array of shockwave transducer units can be used as an active sensor array to monitor the condition of the heart. As the reflected ultrasound waves reach different transducer units at different times, the array of shockwave transducer units can record the phase difference and build an image of the heart based on the reflected ultrasound. The array of shockwave transducer units can be used to locate the heart in the extrapolated actuator / sensor array plane by using the amplitude and time delay between each sensor / actuator in the array.

[0062] In general, a controller transmits electrical signals to control the transducer units, which are converted into ultrasonic waves. A phased array system is composed of an array of transducer units in a one-dimensional or two-dimensional array, and can transmit waves independently of different times or phase changes between the transducer units. To focus or steer the ultrasonic waves, time delays or phase changes are applied to the transducer units, creating constructive interference of the ultrasonic wavefronts from each transducer unit. This effect allows the ultrasonic waves to be steered to a specific angle and / or the energy to be focused at any location in the heart.

[0063] After transmitting the ultrasound waves, the transducer unit also receives reflected ultrasound waves from the heart as echoes. By using the transducer unit in reverse, the transducer unit can convert the received reflected ultrasound waves into electrical signals that can be registered by the controller. Just as the array of transducer units can steer and focus the generated ultrasound waves as described above, the array of transducer units can determine the direction and origin of the reflected ultrasound waves. All received waves are converted into electrical signals and can be evaluated by signal analysis to determine the health of the heart and / or the effectiveness of the shock waves transmitted to the heart.

[0064] Advantages of phased array systems, such as an array of transducer units, include the ability to perform ultrasonic scans, which shortens inspection times by eliminating or reducing the need to mechanically move the array of transducer units.

[0065] When an array of transducer units is used to generate images of the heart, the energy level of the ultrasound generated is 0.02 mJ / mm 2 It may be lower or much lower.

[0066] In one embodiment, the wearable device may be equipped with an acoustic transducer such as a microphone or accelerophone for detecting sound waves below 20 kHz or below 15 kHz, or the wearable device may be configured to detect cavitation using a shock wave transducer unit.

[0067] Under certain physical conditions, the use of ultrasound in a fluid (such as water) can cause cavitation, which can cause significant tissue damage as a secondary effect. If cavitation occurs in cardiac tissue, it must be stopped immediately to prevent damage to the cardiac tissue. Cavitation has a distinct sound that humans can hear that indicates its presence in the frequency range of 5 kHz to 20 kHz. Cavitation produces a sound that sounds like a collection of popping sounds. This is a distinct and unique sound.

[0068] Cavitation can be detected as a broadband popping sound above about 5 kHz. The time window of the measured sound is converted into a frequency window by signal processing, for example by Fourier transformation or any other transformation, and by comparing the amplitude at a frequency slightly above 5 kHz or at least within the frequency range of cavitation with the amplitude at another frequency outside the frequency range of cavitation (for example below 5 kHz or above 20 kHz). When cavitation occurs, the amplitude of the frequency in the frequency range of cavitation is relatively high compared to the amplitude of the frequency in the frequency range of cavitation. When such a high amplitude is detected, the array of shock wave converter units is switched off.

[0069] The acoustic transducer can be specially made to be sensitive only to the cavitation frequency range, and when the acoustic transducer registers a noise that would be a signature of cavitation, the array of shock wave transducer units is switched off.

[0070] Since the frequency of ultrasound is above 20 kHz, acoustic transducers such as microphones or accelerophones only react to sound waves below 20 kHz or below 15 kHz and cannot record ultrasound. In principle, the only noise is the heartbeat. Any recorded peaks during the heartbeat may be a sign of cavitation, after which the array of shock wave transducer units is switched off.

[0071] Since the frequency range of cavitation may vary from person to person and / or from shock wave transducer unit to shock wave transducer, the acoustic transducer may be adapted to function optimally - this is a simple design feature.

[0072] Cavitation produces a variety of noises, easily recognizable noises that a machine learning model can be trained to record by providing as input which noises are cavitation and which are not. When cavitation is recorded, the array of shock wave transducer units is switched off or the intensity or amplitude of the generated shock waves is reduced.

[0073] The acoustic transducer may preferably have a sensitivity in the range of 3-20 kHz, preferably in the range of 4-20 kHz, and most preferably in the range of 5-20 kHz.

[0074] The shock wave transducer unit may be sensitive to frequencies in the ranges of 3-20 kHz, 4-20 kHz, or 5-20 kHz, and the shock wave transducer unit may record cavitation in a manner similar to the acoustic transducers described above. When cavitation is detected by the shock wave transducer unit, the shock wave transducer unit stops generating ultrasonic shock waves to preserve cardiac tissue and avoid damage.

[0075] In one embodiment, the wearable device may be configured to emit extracorporeal shock waves to induce cardiac regeneration therapy. Cardiac regeneration therapy induced through extracorporeal shock waves is non-invasive, safe, non-cancerous, and in the embodiments of the wearable device described herein has the advantage of being less resource intensive than existing modalities for administering this form of therapy.

[0076] Cardiac regenerative therapies include, but are not limited to, therapies that positively affect cardiac function during ischemia through the induction of angiogenesis and postnatal angiogenesis.

[0077] In one embodiment, the wearable device may include one or more cardiac rhythm detection sensors.

[0078] The cardiac rhythm detection sensors may include, but are not limited to, electrocardiography (ECG), photoplethysmography (PPG), magnetocardiogram (MCG), oscillogram (SCG), phonocardiogram (PCG) and / or echocardiography sensors. These cardiac rhythm detection sensors may be used to enable cardiac gating of a patient and / or to detect adverse cardiac events. Examples of adverse events that may be detected via cardiac rhythm detection sensors may include, but are not limited to, cardiac arrhythmias, acute coronary syndromes, acute heart failure, pulmonary health, embolism, stroke, etc.

[0079] Cardiac gating protocols that may be used may include, but are not limited to, a prospective high-pitch dual source protocol, a prospective step-and-shoot protocol, and a retrospectively gated helical protocol. Common examples of cardiac gating include targeting cardiac shock wave therapy under an ECG-based R-wave gating protocol.

[0080] The cardiac rhythm detection sensor(s) may be a shock wave transducer unit or one or more external cardiac rhythm detection sensor(s) that listen to the heartbeat.

[0081] When a shockwave converter unit is considered to stimulate the heart, it may be advantageous to stimulate the heart at the same location in the cardiac cycle. This is advantageous, for example, when treating myocardial ischemia by targeting the area surrounding the left ventricle. In such a scenario, one would like to stimulate the myocardium at the cellular level to initiate a regenerative program at the cellular level. By controlling the delivery of this therapy at the same location, a more effective therapy can be delivered and less shockwave energy will leak into unwanted areas of the heart. This basic approach can be applied to many cardiac shockwave therapy modalities, including but not limited to the treatment of cardiac arrhythmias, heart failure and cardiomyopathies.

[0082] In one embodiment, the wearable device may include one or more breath detection sensors.

[0083] The breath detection sensor(s) may be a shock wave transducer unit that listens to the sounds produced by breathing in and out of the lungs.

[0084] The breath detection sensor may be used to allow shockwave therapy to be performed under breath gating, which may allow shockwave therapy to be performed in a more controlled manner, for example when the patient is breathing less intensely and / or exhaling and / or when the patient is not engaging in much potentially adverse movement.

[0085] The respiration detection sensors may include, but are not limited to, electrocardiogram (ECG), photoplethysmography (PPG), magnetocardiogram (MCG), oscilloscope (SCG), phonocardiogram (PCG), infrared camera and / or echocardiography sensors.

[0086] A breath detection model may be applied to the data from the breath detection sensor to distinguish between breathing and non-respiratory episodes. The breath detection model may be a classifier model trained on a number of annotated patient data points based on breathing and / or non-respiratory episodes.

[0087] In order to treat some diseases, such as coronary syndromes, which are aimed at regenerative therapy of the myocardium, it is advantageous to synchronize the shock waves with the user's breathing. Since the chest moves during the respiratory cycle, the distance between the wearable device and the heart may change during the respiratory cycle. By generating shock waves simultaneously with the respiratory cycle, the focus of the shock waves will be at the exact location of the heart, making the effect of the treatment as localized and effective as possible.

[0088] An array of shock wave transducer units can be used to generate an image of the heart, and the distance between the shock wave transducer units and the heart can be determined as a function of position in the respiratory cycle. With that knowledge, the breath detection sensor(s) can be used to vary the focus of the shock wave transducer units during the respiratory cycle so that the focus is always at the correct location on the heart.

[0089] Ultrasound An example of an extracorporeal shock wave is ultrasound. Generally, ultrasound has an energy of 1 W / cm 2 Ultrasound is defined as either low intensity or high intensity by determining whether it is less than or greater than 1 MHz. Low and high frequency ultrasound is also classified by determining whether the frequency is less than or greater than 1 MHz. Low frequency ultrasound has good penetration that can reach deeper targets and exerts mainly mechanical effects on cell membranes with negligible temperature rise (less than 0.01°C), thereby depolarizing the membrane, activating voltage-gated sodium channels and voltage-gated calcium channels, and affecting cell excitability. However, high frequency ultrasound has shorter wavelengths and better spatial resolution than low frequency ultrasound. High frequency ultrasound is centrally integrated, which is useful for imaging. High frequency ultrasound attenuates quickly, which can cause heat loss and poor penetration when applied to deliver skin treatments.

[0090] In one study comparing the sonic properties of bovine liver and myocardium, the velocity, impedance, and density of myocardial tissue were lower than those of liver in the frequency range of 20-40 MHz. Furthermore, loosely organized structures such as thrombi or atheromas that lack normal collagen and elastin fiber support can be easily destroyed by ultrasound, whereas the vascular wall is resistant to higher intensity and lower frequency ultrasound because it contains a thick collagen and elastin matrix. These characteristics are the basis of sonothrombolysis.

[0091] The present disclosure describes deploying ultrasound therapy, where a user receives ultrasound therapy instructions, including the type of disease requiring treatment, such as, for example, coronary artery disease and / or myocardial sclerosis. These instructions may be tailored to the user's characteristics, such as body size, age, type and / or severity of heart disease, e.g., for ischemic heart disease, a frequency of 1 / 1875 MHz; 15 / 25 mW / cm 2 may be predefined rules / instructions based on the desired angiogenic effect, which may be achieved by using ultrasound treatment parameters set to: spatial-averaged-temporal-averaged (SATA); 20% duty cycle, 20 min / day.

[0092] Another example is a frequency of 1.5 / 3 MHz or close to it; 30 / 200 mW / cm 2 One may wish to achieve an anti-inflammatory effect using parameters set as follows: SATA; 20% duty cycle; 15 / 20 min / day. In a further example, one may wish to achieve an anti-inflammatory effect using a frequency at or near 1 MHz; 50 / 110 mW / cm 2 One may wish to achieve an anti-degenerative effect using parameters set as follows: SATA; 20% / 50% duty cycle; 10 / 15 min / day. In a further example, one may wish to achieve an anti-degenerative effect using parameters set as follows: 1.5 / 1.6 MHz frequency or close to it; 30 / 50 / 90 mW / cm 2 One might want to achieve a regenerative effect using parameters set to SATA; 20% duty cycle; 20 minutes / day. In a further example, one might want to use a frequency of 1.5 / 1.6 MHz or close to it; 30 / 50 / 90 mW / cm 2 One may wish to achieve a differentiation effect using parameters set as follows: SATA; 20% duty cycle; 20 min / day.

[0093] The present disclosure also describes a semi-automated method of deploying ultrasound therapy. Additionally, the present disclosure describes an automated method of deploying ultrasound therapy where a user must perform various steps to first use an automatic calibration of a wearable device for mapping the position and size of the user's heart. Additionally, a user must perform various steps to first use a manual calibration of a wearable device for mapping the position and size of the user's heart.

[0094] Preferably, the automatic calibration of the wearable device, including the location and parameters of the shockwave therapy, can be determined through a mapping process using simultaneous acquisition of sensor data from two or more sensors, where the sensor data is collected from the user. The strength of the particular cardiac signal of interest can be compared between two or more sensors. This can then be visualized in the form of a heat map. The particular cardiac region of interest can be mapped based on the location of the sensor receiving the strongest cardiac signal. Taking into account knowledge about the patient, such as gender and size, the size and location of the various regions of the heart can be approximated from physiological basics of the human body (e.g., average dimensions of the heart for a particular patient group). Based on the desired treatment area, the shockwave therapy can be directed to the appropriate region of the heart.

[0095] For example, if the location of the patient's aorta has been correctly determined and the desired area of ​​treatment is the left ventricle, shockwave treatment for an adult male may be preferably performed based on coordinates that are 5 centimeters away from the aortic area located by the user (downward if the patient is standing) and 3 centimeters to the right of the location of the aorta located by the patient as viewed by a person facing the patient.

[0096] The cardiac data may be derived from sensor data based on a representative patient population, for example, sensor data known to be representative of a particular cardiac region.

[0097] The cardiac data can be any sensor data emanating from the patient's chest region.

[0098] The sensor data may comprise, but is not limited to, first sensor data from electrocardiogram, photoplethysmography, vibratory cardiogram, vibrocardiography, phonocardiogram, photoacoustics, cardiac imaging modalities (including, but not limited to, echocardiography, piezocardiography, CT scan, MRI, SPECT imaging, PET scan, etc.) Corresponding sensors for measuring the first sensor data are known in the art.

[0099] In one embodiment, the wearable device may be manually calibrated, whereby a medical professional determines the position of the shock wave converter to optimize the patient's treatment. The optimal position of the shock wave converter may be informed based on one or more imaging modalities, including, but not limited to, data from electrocardiogram, photoplethysmography, vibratory cardiogram, vibrocardiography, phonocardiogram, photoacoustics, cardiac imaging modalities (including, but not limited to, echocardiography, piezocardiography, CT scan, MRI, SPECT imaging, PET scan, etc.), to ensure that the shock wave therapy is administered within the optimal region of the patient. The optimal position of the shock wave converter may be determined by assessing the patient's anatomy and ensuring a tight fit so that shock waves can be transmitted through the patient's skin. This ensures that the position of the shock wave converter is within the same region every time the patient wears the wearable device. In this case, the positioning mechanism of the shock wave converter may be fixed until the next manual and / or automatic calibration of the wearable device is performed.

[0100] Positioning Mechanism Devices of the present disclosure may be configured such that the shock wave converter unit and / or cardiac sensor(s) are controllably moveable by a positioning mechanism, for example, allowing the shock wave converter unit, accompanied by the ultrasound sensor, to be moved across different regions of the user's chest region.

[0101] The positioning mechanism may comprise a guide channel defining a predetermined path of movement for guiding the movement of the shockwave converter unit, one advantage of which is that the channel allows the shockwave converter unit to be moved via an automatic control device searching for an optimal signal through the path of movement.

[0102] In one embodiment, the positioning mechanism may comprise a motor for engaging the shockwave converter unit and optionally a pulley engaging the motor. In a preferred embodiment, the device may be configured such that the motor and pulley are controllably moved to position the shockwave converter unit.

[0103] In one embodiment, the positioning mechanism comprises a micro linear actuator, which may comprise a drive side and a driven side, the driven side engaging the motor from the drive side and the shockwave converter unit from the driven side. Additionally, the positioning mechanism may comprise a spring-based mechanism for engaging the shockwave converter unit.

[0104] In one embodiment, the wearable device is configured such that the positioning mechanism provides pulse width modulation (PWM) control of the shockwave converter unit. The average delivered power to the device can be controlled via the PWM. The PWM can drive a motor in on and off modes obtainable by a micro linear actuator.

[0105] Shockwave Therapy The device may be configured to perform a number of events. The wearable device may be configured, for example, to scan the user's heart (utilizing cardiac sensor(s)), identify one or more regions of the user's heart, and possibly detect one or more cardiac disorders. The wearable device may be further configured to detect a number of acoustic properties of cardiovascular and external tissues to optimize ultrasound treatment. Thus, the wearable device may be configured to determine an effective ultrasound treatment for the user in one or more regions of the user's chest region based on the acoustic properties and / or demographic properties. The wearable device may be configured, for example, to move the shockwave transducer unit to one or more identified regions and perform ultrasound treatment in the one or more regions. Alternatively, ultrasound treatment may be performed at an optimal location and with optimal parameters for shockwave treatment.

[0106] In one embodiment, the device of the present disclosure is configured to analyze cardiac function of a user's heart and determine a location on the user's chest where the shockwave converter unit is to be positioned based on non-invasively acquired cardiac sensor data.

[0107] Cardiac function data can be collected to determine the cardiac function of a user. For example, if a patient is known to have coronary artery disease, imaging modalities such as ET ECG exercise test, CPET cardiopulmonary exercise test, DSE dobutamine stress echocardiography, PET positron emission tomography, SPECT single photon emission computed tomography, etc. can be used to obtain relevant cardiac function data. In addition to these monitoring methods, observational questionnaires and patient characteristics such as Canadian Cardiovascular Society Angina Class (CCS) angina class, nitroglycerin consumption (expressed as number of pills per day), New York Heart Association (NYHA) class, and Seattle Angina Questionnaire can be used to determine the cardiac function of the user's heart. If a patient is known to have, for example, heart failure with preserved systolic function (HFpEF), modalities such as echocardiography to assess ejection fraction and / or blood sample tests such as NT-proBNP and / or BNP to assess the patient's cardiac function are used. Similarly, for patients suffering from cardiomyopathy, signs of myocardial inflammation may be of greatest concern.

[0108] So that the shockwave converter unit can determine the optimal location on the user's chest to be positioned and the shockwave parameters to be transmitted, with regard to shockwave power and the number of shots to be administered to each spot, predefined treatment protocols from Tohoku University of Japan, as well as protocols developed by the University of Essen, Germany, can be used.

[0109] As described herein, the device may be configured to create a map of the user's heart, which is stored in memory and later used to more efficiently position the cardiac sensor(s) and / or shock wave converter unit.

[0110] In one embodiment, the wearable device is configured to scan the heart and collect data therefrom, for example by moving a shock wave transducer unit equipped with a cardiac sensor(s) over different areas of the user's chest region.

[0111] In one embodiment, the wearable device is configured to scan the heart, for example by using a shock wave transducer unit with cardiac sensor(s) to collect data across and from various regions of the user's chest region.

[0112] Scanning the heart can mean collecting cardiac function data from various regions of the user's chest region, which can include, but is not limited to, first sensor data and a technique for measuring the first sensor data.

[0113] In one embodiment, the wearable device is configured to compare the user's cardiac health in one or more regions to determine the effectiveness of the ultrasound treatment over time. The wearable device may then be configured to update the ultrasound treatment based on the observed effectiveness of the ultrasound treatment over time.

[0114] In one embodiment, the wearable device is configured to create a map of the user's heart, which map is stored, for example, in the device's memory.

[0115] In one embodiment, the extracorporeal shock wave converter unit is configured to take advantage of the non-thermal properties of ultrasound therapy.

[0116] In one embodiment, the wearable device is configured to collect information regarding the user's health status through questionnaires and / or a patient health database.

[0117] The present disclosure relates to existing manual methods of deploying ultrasound therapy. For example, a user can receive ultrasound therapy information including the type of disease that needs to be treated, such as coronary artery disease and / or myocardial sclerosis. The user can then position the shockwave generator or device disclosed herein on the treatment area (the treatment area can be estimated from the user's body size and demographics, e.g., if a person is small, the user can be given a small wearable structure (e.g., a vest) to hold the wearable device in place) based on the ultrasound therapy instructions. The wearable structure and / or device can include any device that can be worn by the user for a longer period of time, placed on the user's chest by the user himself, and / or held in place by the user for a period of time greater than 30 seconds. Finally, the user can apply (administer) the shockwave therapy based on the instructions. These instructions can be predefined rules / instructions based on the user's characteristics, e.g., body size, age, type of heart disease, and / or severity. In a further embodiment, a user can manually adjust the pressure of the shockwave converter unit against the user's skin to optimize contact with the user's skin for optimal ultrasound transmission. Such pressure adjustment may be performed using a pressure adjustment knob that moves the shockwave converter unit up and down. The pressure adjustment knob may be understood to be configured similarly to the coarse adjustment knob of a conventional microscope commonly used in clinical research.

[0118] The present disclosure further relates to a device configured to provide semi-automated ultrasound therapy. Initially, a user can receive ultrasound therapy information, such as disease type and treatment area that needs to be treated, e.g., coronary artery disease and / or myocardial sclerosis. The user can position the device in the treatment area using the previously mapped cardiac area from the first-use calibration process. The device can then provide the user with ultrasound data and / or electronic stethoscope data (and / or other non-invasive cardiac data of the user) from the treatment area. Thus, the user can analyze the severity of the disease. Risk analysis can be assessed by risk assessment machine learning models and / or measurements of cardiac function such as ejection fraction and / or patient self-report questionnaires, etc. The user can then specify ultrasound therapy parameters, such as intensity, duration, and / or pulsation frequency in one or more areas based on the user's characteristics, e.g., body size, age, type and / or severity of cardiac disease (myocardial sclerosis may require ultrasound therapy to relax muscles, and coronary artery disease may require ultrasound therapy to remove plaque). Finally, the user can administer shockwave therapy based on the identified treatment needs.

[0119] Ultrasound therapy information can be obtained from the patient, for example, using ET ECG exercise test, CPET cardiopulmonary exercise test, DSE dobutamine stress echocardiography, PET positron emission tomography, or SPECT single photon emission computed tomography. In addition to these monitoring methods, observational questionnaires and patient characteristics such as Canadian Cardiovascular Society Angina Class (CCS) angina class, nitroglycerin consumption (expressed as number of pills per day), New York Heart Association (NYHA) class, and Seattle angina questionnaire can be used. Ultrasound therapy information will provide information about the patient's heart.

[0120] The obtained ultrasound treatment information can be used to determine the patient's heart disease or disease type. The obtained ultrasound treatment information regarding the patient's heart disease or disease type can include the following information: Where on the patient's heart the transducer array should be focused; How much power should be used for the shock wave? How focused should the shock wave be? How large should the focal area on the heart be? Whether the shock waves should be continuous or pulsed, and if pulsed, the frequency of the pulses and / or the duration of each pulse, etc. can be provided.

[0121] For example, if the disease type is found to be end-stage coronary artery disease, the patient may be irradiated with up to 1200 impulses per session at the base, middle, and apical portions of the left ventricle, delivering 0.09 mJ / mm 2 Treatment with less than 100 impulses at one site with an energy flux of 100 Hz, three times a week for three weeks, reduces the ischemic burden.

[0122] If the disease type is found to be, for example, chronic ischemic heart failure, then preferably 300 impulses at a frequency of 4 Hz will produce 0.38 mJ / mm 2 can be delivered to the ischemic site with an energy flux density of

[0123] If the disease type is found to be, for example, calcified aortic valve cusps, the hardened mass can be destroyed by lithotripsy using two shock waves, one at 100 kHz and one at 3 MHz, with a time interval of 6 seconds. The combination of different frequencies will destroy the calcium deposits within the aortic valve cusps and avoid thermal damage.

[0124] The ultrasound treatment information obtained may include, instead of the patient's heart disease or disease type, the following information: Where on the patient's heart the transducer array should be focused; How much power should be used for the shock wave? How focused should the shock wave be? How large should the focal area on the heart be? Whether the shock waves should be continuous or pulsed, and if pulsed, the frequency of the pulses and / or the duration of each pulse, etc. can be provided directly.

[0125] The present disclosure further relates to a device configured to provide automated ultrasound therapy. A user can access sensor data, such as ultrasound data and / or electronic stethoscope data (and / or other non-invasive cardiac data of the user), from multiple regions of the user. Thus, the user can identify one or more diseases and analyze the severity of the one or more diseases in one or more regions. This can be done by employing disease type and severity machine learning models, e.g., classification models trained on gold standards such as calcification index, plaque accumulation in coronary arteries, cardiac function measurements such as ejection fraction, patient self-reported health outcomes / well-being questions, etc. The user can then identify shockwave treatment parameters (intensity, duration, and / or pulsation frequency) in one or more regions based on the user's characteristics, e.g., body size, age, type and / or severity of cardiac disease (myocardial sclerosis may require ultrasound treatment to relax muscles, coronary artery disease may require ultrasound treatment to cut away plaque). Finally, the user can administer shockwave treatment based on the identified treatment needs.

[0126] When mapping the location and size of the user's heart for the first use of the automatic calibration of the wearable device, the user typically performs various steps. The user can access the ultrasound sensor and / or electronic stethoscope data from multiple regions (data collection regions can be randomized and / or pre-defined). Furthermore, the user can identify unique markers and / or patterns in each region, for example by training a machine learning model to identify each region. Preferably, clustering methods can be used to segment the data into different groups / regions. Furthermore, the position data corresponding to the positioning of the sensor and / or shockwave converter unit relative to each region can be stored in memory and / or in the cloud so that the data can be accessed at a later time.

[0127] For the first use of manual calibration of the wearable device, the user will usually perform various steps to map the position and size of the user's heart. Based on the user characteristics (e.g., gender and body size), the device can navigate to the desired area by a pre-set formula / decision rule. For example, if the user is a 55 kg, 70-year-old woman, and the disease to be treated is mitral regurgitation, the shock wave converter unit will be positioned in the lower right quadrant of the device.

[0128] The devices disclosed herein can be configured to utilize the non-thermal properties of ultrasound therapy to produce stem cell differentiation, angiogenesis, and anti-inflammatory effects as a treatment for a number of diseases, including, but not limited to, ischemic heart disease and / or fibrosis. The non-thermal properties can be achieved by increasing pressure and / or amplitude to produce microstreaming (which can increase fluid movement to promote endothelial shear stress), jetting (which can increase vascular permeability), bubble expansion and / or compression (which can increase vascular permeability).

[0129] Specifically, the wearable device may be configured to harness the thermal effects of ultrasound through increasing the pulse length and / or power emitted by the shockwave converter unit to increase local tissue temperature, which may cause liquefactive necrosis.

[0130] Additionally, wearable devices may be configured to utilize molecular effects that may include, but are not limited to, upregulation of angiogenic factors, increased nitric oxide synthase activity, anti-inflammatory properties, promotion of differentiation of myocytes, endothelial cells, and / or vascular smooth muscle cells.

[0131] The pulsation frequency and intensity of the shock wave transducer can be targeted to inhibit hypertrophic cardiomyopathy and / or myocardial interstitial fibrosis.

[0132] Shockwave therapy can be aimed at enabling cardiac pacing. Alternatively, the disclosed device can be used to non-invasively reduce hypertension by affecting the nerves that control blood pressure. Additionally, low intensity ultrasound pulses can be used to produce an anti-inflammatory effect. Ultrasound pulses can also be configured to generate an anti-inflammatory effect that targets microvascular inflammation throughout the body.

[0133] Low intensity ultrasound pulses can be used to enhance angiogenesis and reduce left ventricular dysfunction. In addition, low intensity ultrasound pulses can be used to enhance angiogenesis and ameliorate myocardial infarction.

[0134] The devices of the present disclosure may be used to deliver ultrasound to liquefy blood clots, either alone or in combination with gas bubbles and anticoagulants, and in some cases may be used to restore blood flow to areas of the brain affected by stroke and / or to treat arterial and / or deep vein thrombosis.

[0135] Additionally, the disclosed devices can be targeted to increase myocardial blood flow in ischemic cardiomyocytes and cardiac endothelial cells. Ultrasound has a direct cardioprotective effect on tissue, which may result from ultrasound-induced increases in tissue blood flow and / or from metabolites released from endothelial cells that may increase blood flow and thereby confer cardioprotection.

[0136] The devices disclosed herein can also focus on utilizing the non-thermal properties of ultrasound therapy to produce stem cell differentiation, angiogenesis and anti-inflammatory effects as a treatment for multiple diseases, including, but not limited to, ischemic heart disease and / or fibrosis.

[0137] In some examples, the devices of the present disclosure focus on utilizing the non-thermal properties of ultrasound therapy to produce an anti-inflammatory effect that inhibits fibroblast proliferation.

[0138] The devices of the present disclosure may focus on utilizing the non-thermal properties of ultrasound therapy to induce stem cell differentiation, angiogenesis, and anti-inflammatory effects as a treatment for multiple diseases, including, but not limited to, pulmonary fibrosis, chronic obstructive pulmonary disease (COPD), respiratory syndrome, and / or pulmonary embolism.

[0139] In one embodiment, the device of the present disclosure focuses on utilizing the thermal properties of ultrasound therapy to target and destroy tumor cells.

[0140] In one embodiment, the disclosed device is focused on utilizing ultrasound therapy to target and destroy blood clots in multiple body regions of a user, including but not limited to the lower extremity regions.

[0141] In one embodiment, the device of the present disclosure is used to identify and / or treat deep vein thrombosis.

[0142] The devices disclosed herein may be applied to one or more cardiovascular disease areas, which may include, but are not limited to, the following: arteriovenous malformations (AVMs), atherosclerosis, atrial fibrillation, cardiac pacing, cardiac hypertrophy, aortic aneurysms, congestive heart failure, deep vein thrombosis (DVT), cardiac valve calcification, hematoma management, hypertension, hypoplastic left heart syndrome, mitral regurgitation, peripheral arterial disease, septal perforation, varicose veins, ventricular tachycardia, and fibrillation and heart failure with preserved systolic function (HFpEF).

[0143] Machine learning models The machine learning model underlying the machine learning system may be stored in the memory of the device and / or the handheld computing device. The machine learning model may be trained by adaptive clinical settings. The machine learning system may be integrated with the handheld computing device. Furthermore, the machine learning system may be executed remotely from an auxiliary handheld computing device. Additionally, the machine learning system may suggest treatment recommendations accessible to the patient's clinician. The clinician may confirm one or more recommended treatments, including, but not limited to, treatment location, intensity, and / or frequency.

[0144] In one embodiment, the machine learning system generates personalized ultrasound treatments for users. For each user (patient), the machine learning system can measure disease progression by comparing disease severity data in cycle "A" with disease severity data in cycle "B". Based on a dataset including all patients and / or all patients from multiple cycles, the machine learning system can train a machine learning model to correlate x-variables (such as patient data and ultrasound treatment specifications) with y-variables (disease progression). Based on the trained machine learning model, the ultrasound treatment specifications are adjusted to minimize predicted disease progression (or in other words, maximize the efficacy of the treatment) (while holding other x-variables, such as patient characteristics, constant). The machine learning system may include machine learning models based on decision trees, artificial neural networks, convolutional neural networks, logistic regression, naive Bayes, nearest neighbor, support vector machines, boosted tree learning methods, and / or generative neural networks.

[0145] The device of the present disclosure may be configured to receive a user's biological sample data. In operation, a user may receive his / her biological sample in the form of saliva from a salivary gland. The user may then place the biological sample on a reactant having one or more reaction properties related to the user's body's chemical information. The user may then take an image of the reactant as the biological sample is placed, and determine the biological sample data. The device may then be configured to process the biological sample data, which acts as one of the decision points for generating a personalized shockwave therapy. In an alternative embodiment, the device is configured to generate a personalized shockwave therapy based on the user's medical data.

[0146] The device may be configured to utilize a machine learning model underlying the machine learning system stored in a memory of the user's handheld computing device. The machine learning model may be trained, for example, by adaptive clinical settings. Furthermore, the machine learning system may be integrated with the handheld computing device. In addition, the handheld computing device may collect information regarding the user's health status via questionnaires and / or other patient health status databases.

[0147] An auxiliary handheld computing device may be connected to the wearable device to allow remote control of the wearable device. The machine learning system may be executed remotely from the auxiliary handheld computing device. Additionally, an external computing device, such as an auxiliary handheld computing device, may receive data representing the ultrasonic sensor data that is recorded as a video file.

[0148] Machine learning can essentially be expressed as a target variable T of data to be mathematically approximated as accurately as possible based on an unknown mathematical combination of input variables called response variables A, B, C, D, E, ..., where T=f(A, B, C, D, E, ...), where the function f is not known a priori. This is similar to using a data fitting program, but the functional form of the equation to be fitted must be known. The function f is called the machine learning model, and the function f should be judged by carefully selecting a recipe of different algorithms based on the problem at hand, or by testing a wide variety of machine learning algorithms and ranking their accuracy for each class of algorithm. Machine learning should find models with as few data requirements as possible, should produce models that can accurately estimate or infer new data scenarios, the model should be simple to analyze, refit, and reuse, and the structure of the model should give insight into the problem. Additionally, the model should be able to provide suggestions on how to affect the input variables to adjust the target variable T in a controllable manner. Adjustable input variables are called levers and are things that can be influenced or changed.

[0149] Casing In one embodiment, the wearable device further comprises a housing for housing at least a portion of the shock wave converter unit, the proximity sensor, the positioning mechanism, the cardiac sensor(s), and optionally the processor, the housing being made of carbon fiber material. Advantageously, the measurement error caused by the weight of the device can be minimized.

[0150] In a further embodiment, the wearable device may comprise a number of anchoring pads on a bottom surface of the wearable device to enable the wearable device to be attached to the skin of a user.

[0151] In an advantageous embodiment, the wearable device comprises a container with an acoustic impedance matching material or an acoustic impedance matching liquid, such as ultrasound gel. The housing may be designed to have an opening on the side of the housing for placing a small sheet of ultrasound gel. The amount of acoustic impedance matching material or acoustic impedance matching liquid may be sufficient for one-time use. Preferably, the acoustic impedance matching material or acoustic impedance matching liquid may be optimized for a certain intensity and / or duration of ultrasound treatment. Furthermore, the device is provided with a brush and cleaning detergent, allowing the acoustic impedance matching material or acoustic impedance matching liquid to be removed from the transducer and washed.

[0152] Additionally, the device may include a thin square sheet that connects to the shock wave converter unit. The thin square sheet may be configured for one-time use and may be connected by adhesive or mechanically attached to the converter, and an acoustic impedance matching material or liquid may be at the bottom of the sheet. The thin square sheet may be configured to be removable after use.

[0153] The acoustic impedance matching material or liquid may include an ultrasound gel to optimize the delivery of shock waves to the user's tissue, hi one embodiment, the acoustic impedance matching gel further includes an adhesive material that promotes a tight fit between the shock wave transducer and the user's skin.

[0154] In a further embodiment, the device is configured to prompt the user to apply acoustic impedance matching liquid evenly over the chest region before commencing ultrasound treatment.

[0155] The wearable device can be attached to a vest. The vest can be configured to ensure a good fit with the chest of the user. The vest can be available in a variety of sizes to ensure a good fit across a variety of patient populations. This can facilitate the wearable device being applied to areas of the user across a variety of user populations. The vest can be adjusted to increase pressure and / or improve contact of the sensors and / or transducers with the patient's skin. Thus, such a vest can be part of a kit that includes the vest of the present disclosure and the device of the present disclosure.

[0156] Detailed Description of the Drawings The present description is best understood with reference to the drawings and descriptions set forth herein. Various embodiments of the present system and method are described with reference to the drawings. However, those skilled in the art will readily appreciate that the detailed description provided herein with respect to the figures is merely for the purpose of illustration, and that the present system and method may be extended beyond the described embodiments. For example, the teachings presented and the needs of a particular application may result in multiple alternative and preferred ways of implementing the functionality of any details of the present system and method described herein. Thus, any way of implementing the present system and method may be extended beyond the specific implementation options in the following embodiments.

[0157] According to embodiments herein, the methods of the present disclosure may be implemented by performing or completing manual, automatic, and / or combinations thereof. The term "method" refers to, but is not limited to, ways, means, techniques, and procedures for accomplishing any task, which ways, means, techniques, and procedures are known to those of ordinary skill in the art or are readily developed from existing ways, means, techniques, and procedures by practitioners of the art to which the present disclosure pertains. Those skilled in the art will envision many other possible variations within the scope of the present systems and methods described herein.

[0158] FIG. 1 shows a block diagram 101 (assembly diagram shown and described in conjunction with FIGS. 2-4) of connections between various components of one exemplary embodiment of the presently disclosed device 100 for generating extracorporeal shock waves in the chest region of a user. The wearable device 100 includes a guide channel 104, a circuit board (PCB) 106, a cardiac sensor 108 in the form of an ultrasonic sensor, a micro linear actuator 110, a servo motor 111, and a processor 132. In some embodiments, the wearable device 100 functions as a gadget of handheld computing devices. Examples of gadgets may include, but are not limited to, a casing, cover, housing, or electrical housing. In some embodiments, the wearable device 100, or at least its housing / body, is made of carbon fiber material. Examples of handheld computing devices 112 include, but are not limited to, computing devices, smartphones, mobile devices, phablets, tablets, etc.

[0159] The guide channel 104 is disposed within the body of the wearable device 100. The PCB 106 is connected to one or more pressure sensors, the shock wave converter unit 114, and the processor 132. The pressure sensor is configured to measure the proximity of the shock wave converter to the user's skin. The pressure sensor may include any instrument or device that converts a magnitude of physical pressure applied on the sensor into an output signal that can be used to establish a quantitative value of the pressure. The pressure sensor may include, but is not limited to, a potentiometric pressure sensor, an inductive pressure sensor, a capacitive pressure sensor, a piezoelectric pressure sensor, a strain gauge pressure sensor, a variable reluctance pressure sensor, an aneroid barometer sensor, a manometer sensor, a Bourdon tube pressure sensor, a vacuum pressure sensor, and a hermetic pressure sensor.

[0160] The shockwave converter unit 114 is configured to generate extracorporeal shock waves and is configured to be placed on the skin of a user with an adhesion selected to optimize shockwave therapy. The processor 132 is configured to execute a number of instructions, the processor 132 being configured to send instructions to the shockwave converter unit to generate extracorporeal shock waves.

[0161] The guide channel 104 is configured to position the acoustic transducer unit within the area of ​​the user's chest region. In one embodiment, the PCB 106 further includes a cardiac sensor in the form of an ultrasonic sensor 108 that is connected to the circuit board (PCB) 106 via an analog sensor cable 126. In one embodiment, the ultrasonic sensor 108 includes a MEMS ultrasonic sensor. In one embodiment, the ultrasonic sensor 108 is a piezoelectric ultrasonic sensor.

[0162] The shockwave converter unit 114 is attached to the PCB 106 via a spring-based mechanism to generate extracorporeal shock waves. The pressure sensor measures the proximity of the shockwave converter unit and / or the ultrasonic sensor 108 to the skin. The ultrasonic sensor 108 is configured to detect different regions of the user's heart and determine the location on the chest where the shockwave converter unit 114 is placed. The micro linear actuator 110 is attached to the ultrasonic sensor 108 and gets pulse width modulation (PWM) control from the interface circuit board 106. The micro linear actuator 110 is configured to place the ultrasonic sensor 108 on the user's skin to determine analog data of an adhesion force selected to minimize errors resulting from pressing the ultrasonic sensor 108 against the skin.

[0163] The servo motor 111 is attached to the micro linear actuator 110 and gets PWM control from the interface circuit board 106 via a bidirectional PWM driver on the interface circuit board 106. In some embodiments, the micro linear actuator 110 includes a stationary side and a moving stroke, and is attached to the servo motor 111 from the stationary side, and the ultrasonic sensor 108 is attached to the moving stroke of the micro linear actuator 110. In some embodiments, the pressure sensor, the shock wave transducer 114, and the piezoelectric ultrasonic sensor are soldered to a slim printed circuit board (PCB).

[0164] In some embodiments, the servo motor 111 moves within a number of channels formed in the body of the wearable device 100. In some embodiments, the function of the servo motor 111 may be performed by a stepper motor. The servo motor 111 is powered and controlled by the interface circuit board (PCB) 106. In some embodiments, the servo motor 111 is attached to the micro linear actuator 110 and gets PWM control from the interface circuit board 106 via a bidirectional PWM driver located on the interface circuit board 106. In some embodiments, a hollow guide channel 104 is incorporated within the body of the wearable device 100 to guide and limit the movement of the servo motor 111.

[0165] The processor 132 is configured to execute instructions stored in the memory 130 of the handheld computing device 112. The memory 130 may be a non-volatile memory or a volatile memory.

[0166] The processor 132 is configured to estimate cardiac function from measurements of the cardiac sensor 108 and transmit instructions to the shockwave converter unit 114 to generate extracorporeal shock waves. According to embodiments herein, the processor 132 is configured to identify regions of the user's heart, control ultrasound therapy, adjust a plurality of acoustic properties of cardiovascular tissue to optimize penetration and effectiveness of ultrasound therapy, scan the user's heart to detect one or more cardiac diseases, determine an effective ultrasound therapy for the user in one or more regions of the user's body, move one or more shockwave generators to one or more regions and perform ultrasound therapy in the one or more regions, scan the heart by moving an ultrasound sensor and / or electronic stethoscope across various regions of the user's chest region and collecting data therefrom, adjust the ultrasound therapy based on physiological and / or demographic characteristics of the user, compare the user's cardiac health in one or more regions to determine the effectiveness of the ultrasound therapy over time, and update the ultrasound therapy based on the observed effectiveness of the ultrasound therapy over time.

[0167] In some embodiments, the interface circuit board 106 includes an analog-to-digital converter (ADC) for converting analog data to digital data, a microcontroller unit with power and data transmission ports, one or more wide bandwidth op-amp circuits, multiple digital buffers, at least two signal mixers for precision Doppler calculations, multiple filters suitable for the operating range of the piezoelectric ultrasonic sensor 108, multiple bidirectional drivers for the micro linear actuator 110 and the servo motor 111, multiple headers and multiple PWM lines for providing power to the micro linear actuator 110 and the servo motor 111. In some embodiments, the interface circuit board (PCB) is connected to the handheld computing device 112 via a power and data transmission cable 120 having data lines and power lines. The power and data transmission cable 120 receives power from the handheld computing device 112.

[0168] In some embodiments, the shockwave converter 114 derives power from a boost circuit 116. In some embodiments, the boost circuit 116 utilizes a stored charge in a high capacitance and low equivalent series resistance (ESR) capacitor 118. The stored charge is obtained from the handheld computing device 112 via a power and data transmission cable 120 during idle times.

[0169] In some embodiments, the wearable device 100 includes a pulley 122 attached to a servo motor 111 to move the shockwave converter unit within a hollow guide channel 104 in the body of the wearable device. In some embodiments, the wearable device 100 includes multiple arms with fixation pads 124 attached to the bottom of the case 102, allowing the gadget or device 100 to be attached to the user's skin.

[0170] In some embodiments, the wearable device 100 can be powered by the handheld computing device 112 or can obtain power from an external battery that can power the PCB 106.

[0171] Since impaired arterial endothelial function may indicate the onset of cardiovascular disease, the brachial artery is measured in diameter a few minutes before and a few minutes after either vasoconstriction or vasorelaxation, and when an ultrasonic signal is transmitted and received at the PCB of the ultrasonic sensor 108, a Doppler shift occurs between both the transmitted and received waves, which indicates the blood flow velocity, and any change in that velocity reflects a corresponding change in the arterial diameter. The delay between the application and detection of the pulse can be measured using a signal mixer. In this case, the RMS value of the multiplication of the signals indicates the shift between the two signals and can be used to measure the change in Doppler shift using an integrator circuit. In this case, the integration result for steady flow should be linear, but this nonlinearity is proportional to the change in flow velocity, so the degree of nonlinearity measures the Doppler shift.

[0172] To avoid measurement errors due to the weight of the measuring device, a hollow case made of carbon fiber similar to that of a handheld computing device is used to create a hollow space around the sensor, ensuring that there is no extra weight of the wearable device on the skin between the sensor and the artery, thus ensuring accurate results, so that the pressure applied to the skin by the wearable device 100 is exerted at a point far from the artery and does not affect the diameter or shape of the artery.

[0173] FIG. 2 is a bottom view of a wearable device according to an embodiment of the present disclosure. FIG. 2 will be described in relation to FIG. 1. An arm having a fixation pad 124 is configured to be placed on a patient's body. A hollow guide channel 104 is disposed within the body of the wearable device 100 and guides the shock wave converter unit through the movement of a stepper motor or servo motor 111 and a linear actuator 110 and a PCB of an ultrasonic sensor 108 attached thereto. The PCB of the ultrasonic sensor 108 is attached to the stepper motor 111 via the linear actuator 110.

[0174] FIG. 3 shows a side view 300 of a wearable device according to one embodiment of the disclosure. FIG. 3 will be described in relation to FIG. 1. A cardiac sensor in the form of a piezoelectric ultrasound transceiver 108, a shock wave converter unit with a highly directional extracorporeal ultrasound shock wave converter, and one or more pressure sensors are soldered onto a slim PCB (preferably a PCB of 0.4 millimeters or less). In some embodiments, the wearable device 100 includes a drive motor 302 for a linear actuator. The pulley 122 is attached to a stepper / servo motor 111 and is intended to move only within a hollow guide channel 104 in the body of the wearable device 100.

[0175] FIG. 4 illustrates a monitoring application 400 installed in the handheld computing device 112 according to one embodiment of the present disclosure. FIG. 4 is described in relation to FIG. 1. The monitoring application 400 can be based on one or more operating systems, including Android® and iOS®. The wearable device 100 requests a user to register with the monitoring application 400 installed or configured in the handheld computing device 112. The memory 130 is configured to register the user via the monitoring application 400 by receiving one or more authentication information from the user to provide access to the monitoring application 400. Examples of authentication information may include, but are not limited to, a username, a password, an age, a gender, a phone number, an email address, an address, and the like. In some embodiments, the monitoring application 400 is commercialized as a software or mobile application for cardiac health assessment, or a web application. The user may include a patient, a patient using a monitoring application using a handheld computing device 112 such as that included in the present invention, or the handheld computing device 112 itself. In some embodiments, the monitoring application 400 is a combination of a software program having a graphical user interface (GUI) 128 (shown in FIG. 1 ) running on the handheld computing device 112 that presents result data such as name, address, age, sex, height, weight, periodic target intensity, etc., and allows the user to make appropriate adjustments based on the result data. The resultant data is obtained by one or more ultrasonic sensors 108 configured with the wearable device 100.

[0176] According to embodiments herein, the processor 132 processes the captured / derived data and transmits it to an external computing device or as a server for further processing over a network. The processed data related to the user's cardiac health is presented on the monitoring application 400. The network may be a wired or wireless network, examples of which may include, but are not limited to, the Internet, Wireless Local Area Network (WLAN), Wi-Fi, Long Term Evolution (LTE), Worldwide Maximum Wireless Communications (WiMAX), and General Packet Radio Service (GPRS).

[0177] The monitoring application 400 allows a user to continually monitor for possible heart failure and aids in the treatment of heart failure with preserved systolic function (HFpEF). Typically, HFpEF occurs when the lower left ventricle (left ventricle) does not fill properly with blood during the diastolic (filling) phase. Less than normal amount of blood is pumped out to the body. Also referred to as diastolic heart failure. Additionally, the monitoring application 400 utilizes machine learning for automatic positioning and determination of ultrasound transducer strength.

[0178] FIG. 5 illustrates a perspective view of a handheld computing device 500 placed against a user's body or chest, according to at least one embodiment. FIG. 5 is described in conjunction with FIG. 4. The monitoring application 400 prompts the user through a GUI to begin measuring cardiac function. The user then places the handheld computing device on his or her chest, as shown in FIG. 5. The handheld computing device 112 can have a shape adapted to fit snugly against the user's chest. The shape of the handheld computing device 112 is bent or curved to fit snugly against the patient's chest.

[0179] In some embodiments, the cardiac sensor 108 is combined with one or more proximity sensors, such as pressure sensors, to allow a linear actuator to correctly position the shockwave transducer unit and / or cardiac sensor on the skin with a minimum and constant adhesion force to minimize errors resulting from pressing the skin with a probe. According to one embodiment herein, the wearable device 100 utilizes a closed loop control using a digital PID algorithm to ensure that the force applied to the skin does not introduce additional errors into the measurement process. Furthermore, the wearable device 100 utilizes a closed loop control using a digital PID algorithm to ensure that the position of the sensor is automatically optimized and that the applied measurements are not further optimized.

[0180] The signal coming from the pressure sensor is digitized and sent to the MCU to use its full processing power and use Fourier or other digital processing libraries to determine the Doppler shift accurately and in real-time with minimal additional hardware or cost. Signal processing of the array signal in the preferred enablement includes processing the signal as a complex number using an orthogonal representation, which should also include the Hilbert transform required for generating the analytic signal required for optimal processing and control of the phased array, and for matched filtering. Finally, highly directional extracorporeal ultrasound shock wave transducers can be used with high accuracy by precise ultrasound transceivers, so the wearable device 100 can provide treatment, not just detection or measurement. The accuracy of the Doppler shift for a wave is proportional to the frequency of the wave, so the optimal frequency is around 8 MHz, but the standard Doppler calculation estimates the pulse speed by dividing the distance between the sensors by the pulse transit time.

[0181] In some embodiments, the cardiac sensor 108 uses an integrator as part of the ultrasound computation circuitry. This is an ideal solution when sampling the output waveform directly can cause many problems since the output waveform does not have a precise waveform. The integrator, on the other hand, allows for the measurement of changes by determining the nonlinearity of the waveform obtained from the integrator. Finally, the use of an analog filter is essential to ensure that noise from external sources is ignored so that the input of the integrator is guaranteed to be from the ultrasound reading and not from ambient EM waves at the integrator input. FIG. 6 shows a perspective view 600 of the interaction between the ultrasonic sensor 108 and the user's heart 602, according to at least one embodiment. In operation, an interface circuit board (PCB) 106 picks up the audio signal from the PCB of the ultrasonic sensor 108. The audio signal informs the microcontroller unit (MCU) of the interface circuit board (PCB) 106 about the optimal XY position to place the ultrasonic sensor 108, as the automatic control uses the audio level as a means to select the optimized position of the sensor, in this case the feedback obtained from the voice recognition of the arterial pulse helps the MCU to recognize the position that allows maximum voice retrieval of the pulse, and generates PWM power to control the servo / stepper motor based on the feedback from the audio signal. The process of attaching the ultrasonic sensor 108 to the skin is provided by a positioning mechanism that uses a linear actuator attached to a stepper motor / servo motor, the positioning process is performed with the help of a pressure sensor designed to limit the attachment force to a fixed value to reduce errors due to excess pressure on the skin that may affect the diameter or shape of the artery. The interface circuit board (PCB) 106 generates PWM power pulses to control the linear actuator based on measurements from a proximity sensor. Optimizing the shockwave therapy may include placing the shockwave transducer unit on the user's skin with an attachment force selected to minimize errors resulting from pressing the skin with the shockwave transducer.

[0182] In further embodiments, the wearable device may be individually calibrated for each user such that ultrasound treatment parameters are determined based on a number of factors, including, but not limited to, one or more ailments being targeted, demographic information of the user, health information of the user, the penetration of ultrasound 603 through the user's skin, tissue, bones, and / or organs, the environment in which the ultrasound treatment is administered, the time of day the ultrasound treatment is administered, and / or the risk of the user experiencing an adverse health event. Individual calibration of the wearable device may further include adjusting the size of the device to accommodate different physiological characteristics of different body types and / or different genders.

[0183] The cardiac sensor and the shock wave converter may be separate solid objects or may be integrated into a shock wave converter unit. The cardiac sensor may be equipped with a high voltage ultrasonic transceiver and generate highly directional shock waves, which are delivered to the user via the shock wave converter. Although the power of the handheld computing device may provide a voltage limited to only 5V level, a highly efficient boost circuit may be added to the PCB 106, allowing the boost circuit to provide a high current for a very short period (i.e., 1 or 2 milliseconds), i.e., a high voltage sufficient for shock waves, if the boost circuit uses a low ESR and high capacity capacitor, i.e., a supercapacitor. Since the shock wave converter does not need to be precisely affixed to the skin without pressure, the shock wave converter may be an independent PCB statically attached to the bottom of the hollow case in a manner that does not collide with the movement trajectory of the cardiac sensor 108, and a simple spring mechanism may be used to ensure that it is affixed to the skin with sufficient pressure.

[0184] The interface circuit board (PCB) 106 filters and mixes the signal used to transmit the ultrasonic pulse with the signal picked up during ultrasonic sensing, integrates the result, and transmits the sampled / digitized result to the CPU of the handheld computing device via power and data transmission cables, for which the handheld computing device can minimize programming development costs by using inexpensive and existing digital signal processing libraries, i.e., Fast Fourier Transform libraries for Android®, IOS®, Windows® and Linux®, and calculate the Doppler shift based on the non-linearity of the integrated signal, thereby determining the flow velocity and changes.

[0185] The interface circuit board (PCB) 106 collects data from the ultrasonic sensor 108 and sends it back to the handheld computing device. Finally, the handheld computing device gets back the ultrasonic data in digitized form and uses this data to analyze the Doppler shift to determine the blood flow velocity and so-called arterial changes, and presents the resulting data in readable, graphical or audio form, i.e., GUI. Thus, the wearable device 100 utilizes the thermal and non-thermal effects of high intensity focused ultrasound (HIFU) and extracorporeal shock waves to treat cardiac diseases.

[0186] 7 illustrates a first exploded view 700 of the wearable device 100 positioned against a user's chest, according to at least one embodiment. According to embodiments herein, the wearable device 100 includes a container 702 that stores an acoustic impedance matching liquid.

[0187] 8 shows a second exploded view 800 of the device positioned against a user's chest, according to at least one embodiment. The pulsating frequency and intensity of the shock waves generated by the shock wave converter unit 114 are directed towards inhibiting hypertrophic cardiomyopathy and / or myocardial interstitial fibrosis.

[0188] 9 shows a third exploded view 900 of a wearable device positioned against a user's chest, according to at least one embodiment. In one embodiment, the shockwave converter unit 114 includes an electrohydraulic power source, and / or a piezoelectric power source, and / or an electromagnetic source with a flat coil, and / or an electromagnetic source with a cylindrical coil.

[0189] FIG. 10 illustrates a perspective view 1000 of a wearable device 100 placed in a pocket of a vest 1002 along with a handheld computing device, according to at least one embodiment. The wearable device 100 is placed in the pocket of the vest 1002, which allows the wearable device 100 to be controlled and stabilized during ultrasound treatment. In one embodiment, the vest 1002 is configured to ensure a good fit with the chest of a user. The vest 1002 is available in a variety of sizes to ensure a good fit across a variety of patient populations. The various sizes of the vest 1002 facilitate the use of the wearable device 100 in areas of users across a variety of user populations. Additionally, the vest 1002 may be adjusted to increase pressure and improve contact of the sensors and / or transducers with the patient's skin.

[0190] FIG. 11 shows a perspective view 1100 of a matrix or array of ultrasonic transducers or transducer units 1102 according to at least one embodiment. In another embodiment, the wearable device 100 of the present invention includes a matrix of ultrasonic transducers 1102 instead of linear actuators and guide channels. According to embodiments herein, different transducers 1102 are activated depending on which area of ​​the heart requires treatment. In one embodiment, shock wave transducers are activated according to the area of ​​the heart to be analyzed and / or treated. The shock wave transducers may be electronically and / or mechanically adjusted to ensure a good fit with the user's skin.

[0191] In one embodiment, the array of transducer units may be configured to generate ultrasound signals or pulses for ultrasound therapy and may additionally be configured to provide electrical signals in response to input ultrasound signals or pulses.

[0192] In the above specification, the embodiments of the present invention are described with reference to numerous specific details that may vary from implementation to implementation. Therefore, the specification and drawings are to be regarded in an illustrative sense, not a restrictive sense. The sole and exclusive indication of the scope of the present invention, and what the applicant intends to be the scope of the present invention, is the literal scope and equivalent scope of the set of claims issued from this application, in the particular form in which such claims issue, including any subsequent amendments.

[0193] Terms Article 1. 1. A wearable device for generating extracorporeal shock waves in a chest region of a user, comprising: a shock wave converter unit configured to generate extracorporeal shock waves and to be placed on the skin of the user to apply shock wave therapy; at least one proximity sensor for measuring the proximity of the shock wave converter unit; the one or more shockwave converter units are arranged in an array or the wearable device further comprises a positioning mechanism configured to controllably position the shockwave converter units; The wearable device, wherein the device is configured to receive cardiac health information and transmit the information to the shock wave converter unit to generate extracorporeal shock waves.

[0194] Article 2. 2. The wearable device of claim 1, comprising a cardiac sensor.

[0195] Article 3. The wearable device of clause 2, wherein the cardiac sensor is configured to non-invasively acquire cardiac data of the user.

[0196] Article 4. The wearable device of clause 2, wherein the cardiac sensor is an invasive cardiac sensor.

[0197] Article 5. 2. The wearable device of any one of the preceding clauses, wherein the cardiac health information comprises cardiac sensor data and / or self-reported cardiac health data.

[0198] Article 6. A wearable device as described in any one of the preceding clauses, wherein the positioning mechanism comprises a guide channel for guiding the shock wave converter unit and / or the cardiac sensor towards the user's skin within a plane defined by a bottom surface of the device.

[0199] Article 7. The wearable device of any one of the preceding clauses, further comprising a circuit board, such as a PCB, for connecting the shock wave converter unit, the proximity sensor(s), the cardiac sensor(s), the positioning mechanism, and a processor.

[0200] Article 8. A wearable device as described in any one of the preceding clauses, wherein the proximity sensor is a pressure sensor for measuring the pressure that the shock wave converter applies to the user's skin.

[0201] Article 9. 2. A wearable device as described in any one of the preceding clauses, wherein the cardiac sensor comprises an ultrasound sensor for measuring cardiac function of the user's heart.

[0202] Article 10. 2. The wearable device of any one of the preceding clauses, wherein the cardiac sensor comprises an electronic stethoscope.

[0203] Article 11. 13. The wearable device of any one of the preceding clauses, further comprising a photoplethysmography (PPG) sensor.

[0204] Article 12. 7. The wearable device of any one of the preceding clauses, further comprising an electrocardiogram (ECG) sensor.

[0205] Article 13. Further comprising an inertial measurement unit (IMU) sensor; 2. A wearable device as described in any one of the preceding clauses, configured to determine whether the device is correctly positioned.

[0206] Article 14. 2. A wearable device as described in any one of the preceding clauses, wherein the positioning mechanism comprises a spring-based mechanism for engaging the shock wave converter unit.

[0207] Article 15. A wearable device as described in any one of the preceding clauses, wherein the positioning mechanism comprises a motor for engaging the shock wave converter unit.

[0208] Article 16. 16. The wearable device of claim 15, wherein the positioning mechanism comprises a pulley that engages with the motor.

[0209] Article 17. The wearable device of claim 16, wherein the device is configured such that the motor and pulley are controllably moved to position the shock wave converter unit and / or the cardiac sensor(s).

[0210] Article 18. 2. The wearable device of any one of the preceding clauses, wherein the positioning mechanism comprises a micro linear actuator.

[0211] Article 19. The wearable device of claim 18, wherein the micro linear actuator has a drive side and a driven side, and engages with a motor from the drive side and engages with the shockwave unit from the driven side.

[0212] Article 20. A wearable device as described in any one of the preceding clauses, wherein the positioning mechanism is configured to provide pulse width modulation (PWM) control of the shock wave transformation unit.

[0213] Article 21. The wearable device of clause 20, further comprising a bidirectional PWM driver for said PWM control.

[0214] Article 22. a housing for enclosing at least a portion of the shockwave converter unit, the proximity sensor, the positioning mechanism, and the processor; 2. The wearable device of any one of the preceding clauses, wherein the housing is made of carbon fiber material.

[0215] Article 23. 2. A wearable device according to any one of the preceding clauses, wherein the device is configured to receive analog data from the user.

[0216] Article 24. A wearable device as described in any one of the preceding clauses, wherein the device is configured to analyze cardiac function of the user's heart and determine a position on the user's chest where the shock wave converter unit is positioned based on sensor data of the shock wave converter unit.

[0217] Article 25. The PCB, an analog-to-digital converter (ADC) for converting the analog ultrasound data into digital data; a microcontroller unit having a power supply and a data transmission port; One or more high bandwidth op amp circuits, Multiple digital buffers, At least two signal mixers for precision Doppler calculations; A plurality of filters suitable for the operating range of the piezoelectric ultrasonic sensor; Multiple bidirectional drivers for micro linear actuators and servo motors, a plurality of headers and a plurality of PWM lines for supplying the power to the micro linear actuators and the servo motors; 5. The wearable device of claim 1, wherein the wearable device is connected to one or more of the following:

[0218] Article 26. The interface circuit board (PCB) is connected to a mobile computing device via a cable having data lines and power lines; 2. The wearable device of any one of the preceding clauses, wherein the cable receives power from the mobile computing device.

[0219] Article 27. 10. A wearable device as described in any one of the preceding clauses, comprising a boost circuit for providing power to the shock wave converter unit.

[0220] Article 28. 28. The wearable device of claim 27, wherein the boost circuit comprises a low equivalent series resistance (ESR) capacitor and utilizes a high capacity of stored charge.

[0221] Article 29. A wearable device as described in any one of the preceding clauses, comprising a plurality of fixing pads on the bottom surface of the wearable device to enable the wearable device to be attached to the skin of the user.

[0222] Article 30. 13. A wearable device according to any one of the preceding clauses, comprising a container having an acoustic impedance matching liquid.

[0223] Article 31. 7. A wearable device according to any one of the preceding clauses, further comprising a memory and / or a server for providing instructions to the device.

[0224] Article 32. 2. A wearable device as described in any one of the preceding clauses, wherein the information comprises information regarding ultrasound treatment parameters, including but not limited to information regarding location, frequency, spatial average, temporal average, duty cycle and / or duration of treatment.

[0225] Article 33. 13. The wearable device of any one of the preceding clauses, comprising a display screen.

[0226] Article 34. 7. The wearable device of any one of the preceding clauses, comprising a battery.

[0227] Article 35. 2. The wearable device of any one of the preceding clauses, configured to be individually calibrated for the user.

[0228] Article 36. 2. The wearable device of any one of the preceding clauses, configured to scan the user's heart, identify one or more regions of the user's heart, and detect one or more cardiac diseases.

[0229] Article 37. 2. A wearable device as described in any one of the preceding clauses, configured to determine an effective ultrasound treatment for the user in one or more areas of the user's chest region.

[0230] Article 38. A wearable device as described in any one of the preceding clauses, configured to move the shock wave converter unit to the one or more areas and perform the ultrasound treatment in the one or more areas.

[0231] Article 39. The wearable device of any one of the preceding clauses, configured to scan the heart by moving the ultrasound sensor and / or the electronic stethoscope over different areas of the user's chest area and collecting data from the ultrasound sensor and / or the electronic stethoscope.

[0232] Article 40. The wearable device of any one of the preceding clauses, configured to compare the user's cardiac health in the one or more regions to determine the effectiveness of the ultrasound therapy over time.

[0233] Article 41. 2. A wearable device as described in any one of the preceding clauses, configured to update the ultrasound treatment based on the effectiveness of the ultrasound treatment observed over time.

[0234] Article 42. 2. The wearable device of any one of the preceding clauses, configured to create a map of the user's heart, the map being stored in the memory.

[0235] Article 43. 2. The wearable device of any one of the preceding clauses, wherein the wearable device is configured to collect information regarding the user's health status through questionnaires and / or a patient health database.

[0236] Article 44. 13. The wearable device of any one of the preceding clauses, wherein the wearable device is connected to a vest.

[0237] Article 45. A wearable device as described in any one of the preceding clauses, wherein the wearable device is provided with a manual pressure adjustment knob configured to move the shock wave converter unit up and down.

[0238] Article 46. 13. A wearable device as described in any one of the preceding clauses, wherein the wearable device receives power from an external power system via a cable.

Claims

1. 1. A wearable device for generating extracorporeal shock waves in a chest region of a user, the wearable device comprising: an array of at least one shock wave converter unit configured to be placed on the user's skin to generate extracorporeal shock waves and apply shock wave therapy; at least one proximity sensor configured to measure the proximity of the one or more shockwave converter units; Equipped with The wearable device is configured to receive cardiac health information and transmit therapy information to the array of shock wave transducer units to generate extracorporeal shock waves.

2. The wearable device of claim 1 , comprising a cardiac sensor configured to generate the cardiac health information.

3. The wearable device of claim 1 , wherein the cardiac health information includes cardiac sensor data and / or self-reported cardiac health data.

4. The wearable device of claim 1 , wherein the proximity sensor comprises a pressure sensor configured to measure the pressure that the array of shockwave transducer units applies to the user's skin.

5. The wearable device of claim 1 , wherein the cardiac sensor comprises an ultrasound sensor or an electronic stethoscope for measuring cardiac function of the user's heart.

6. The wearable device of claim 2 , wherein the cardiac sensor is an array of the shock wave transducer units.

7. 2. The wearable device of claim 1, wherein the wearable device is configured to scan the heart by collecting data using the cardiac sensor over various regions of the user's chest region, the wearable device is configured to analyze cardiac function of the user's heart, and the array of shock wave converter units is configured to determine locations on the user's chest to deliver extracorporeal shock waves based on the cardiac sensor data.

8. The wearable device of claim 1 , comprising a plurality of anchoring pads on a bottom surface of the wearable device to enable the wearable device to be attached to the skin of the user.

9. 10. The wearable device of claim 1, comprising a container for containing acoustic impedance matching liquid for use during shock wave therapy.

10. The wearable device of claim 1 , wherein the transducer units are independently controllable to control the direction and / or focal length of the generated extracorporeal shock waves.

11. The wearable device of claim 1 , wherein the array is one-dimensional or two-dimensional.

12. The wearable device of claim 1 , wherein the array of at least one shock wave transducer unit is configured to generate an electrical signal in response to reflected ultrasound waves from the heart.

13. The wearable device of claim 1, wherein the wearable device comprises an acoustic transducer, such as a microphone, such as an axerophone, for detecting sound waves below 20 kHz or below 15 kHz, or the wearable device is configured to detect cavitation using the shock wave transducer unit.

14. The wearable device of claim 1 , wherein the wearable device is configured to emit extracorporeal shock waves to induce cardiac regenerative therapy.

15. The wearable device of claim 1 , wherein the wearable device comprises one or more cardiac rhythm detection sensors.

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