Transdermal sound sensor

Abstract

Embodiments of the present disclosure relate to a transcutaneous sound sensor. In at least one embodiment, a transcutaneous sound sensor system includes a mounting unit and a sound sensor. The mounting unit is detachably connected to an electronics unit and mounted to skin on a body. The sound sensor senses sound originating from inside the body. The sound sensor includes an in-vivo portion and an ex-vivo portion. The in-vivo portion is configured to be inserted through the skin of the body and placed under the skin of the body. Further, the in-vivo portion has a sound sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element. The ex-vivo portion is configured to be operatively connected to the electronics unit when the electronics unit is connected to the mounting unit.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of Provisional Application No. 63 / 021,753, filed on May 8, 2020, which is incorporated herein by reference in its entirety for all purposes. Technical Field

[0003] This disclosure generally relates to minimally invasive implantable sensors for medical monitoring. More specifically, this disclosure relates to the design and use of percutaneous sound sensors for monitoring physiological events in the body. Targets may include sound from organs such as the heart, lungs, and intestines. Background Technology

[0004] Traditionally, auscultation involves using a stethoscope over bare skin to listen to internal sounds of the body, such as heart sounds, respiratory sounds, and bowel sounds. These sounds can provide valuable information about the state of the corresponding circulatory, respiratory, or gastrointestinal (GI) systems. Summary of the Invention

[0005] This disclosure relates to transdermal sound sensor systems. Exemplary embodiments include, but are not limited to, the following examples.

[0006] In Example 1, the transdermal sound sensor system includes: an mounting unit configured for detachable connection to an electronic unit and configured for mounting on the skin of a body; and a sound sensor configured to sense sound originating from within the body, the sound sensor including an internal portion and an external portion, the internal portion being configured for insertion through the skin of the body and positioned beneath the skin, wherein the internal portion has a sound sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element, wherein the external portion is configured for operatively connecting to the electronic unit when the electronic unit is connected to the mounting unit.

[0007] In Example 2, the transcutaneous sound sensor system of Example 1 further includes a device configured to receive and process sound measurements from the electronic unit via a wired or wireless communication link between the device and the electronic unit.

[0008] In Example 3, a transcutaneous sound sensor system of any of Examples 1-2, wherein the mounting unit further includes an electrocardiogram (ECG) electrode configured to measure one or more ECG signals of the body.

[0009] In Example 4, a transdermal sound sensor system of any of Examples 1-3, wherein at least a portion of the outer surface of the in vivo portion includes a hydrophilic coating.

[0010] In Example 5, a transdermal sound sensor system of any of Examples 1-4, wherein the sound sensor has a coaxial structure comprising multiple layers.

[0011] In Example 6, a transdermal sound sensor system of any of Examples 1-5, wherein the innermost layer of the sensor is a core conductor.

[0012] In Example 7, the transdermal sound sensor system of Example 6, wherein the second layer arranged around the innermost layer of the coaxial structure is a polarized piezoelectric polymer layer.

[0013] In Example 8, the transdermal sound sensor system of Example 6, wherein the second layer arranged around the innermost layer of the coaxial structure is a piezoelectric ceramic layer.

[0014] In Example 9, a transdermal sound sensor system of any of Examples 7-8, wherein the second layer is a spiral layer wound around the innermost layer.

[0015] In Example 10, a transdermal sound sensor system of any of Examples 7-8, wherein the second layer is a continuous solid layer arranged around the innermost layer.

[0016] In Example 11, a transdermal sound sensor system of any of Examples 7-10, wherein the third layer arranged around the second layer is a conductor.

[0017] In Example 12, the transdermal sound sensor system of Example 11, wherein the third layer is a spiral layer wrapped around the second layer.

[0018] In Example 13, a transdermal sound sensor system of any of Examples 11-12, wherein the fourth layer arranged around the third layer is a protective layer.

[0019] In Example 14, the transdermal sound sensor system of any of Examples 1-13 further includes an electronic unit.

[0020] In Example 15, the percutaneous sound sensor includes: a sound sensing element configured for implantation under the skin of a subject and configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element; a proximal end configured for releasable and communicatively coupled to an electronic unit; and a protective layer disposed around the sound sensing element.

[0021] In Example 16, the transcutaneous sound sensor of Example 15 is used, wherein the sound sensing element surrounds the core conductor.

[0022] In Example 17, the percutaneous sound sensor of Example 16 is used, wherein the sound sensing element is spirally wound around the core conductor.

[0023] In Example 18, a transdermal sound sensor of any of Examples 15-17 is used, wherein a conductor layer is arranged around the sound sensing element.

[0024] In Example 19, the percutaneous sound sensor of Example 18 is used, wherein a conductor layer is spirally wound around the sound sensing element.

[0025] In Example 20, a transdermal sound sensor of any of Examples 18-19, wherein a protective layer surrounds a conductor layer.

[0026] In Example 21, a transdermal sound sensor of any of Examples 15-20, wherein at least a portion of the outer surface of the transdermal sound sensor includes a hydrophilic coating.

[0027] In Example 22, a transdermal sound sensor of any of Examples 15-21 is provided, wherein the sound sensing element is formed of a polarized polyvinylidene fluoride (PVDF) film, a PVDF copolymer (e.g., a PVDF-TrFE) film, or a piezoelectric ceramic material.

[0028] In Example 23, a transdermal sound sensor of any of Examples 15-22, wherein the protective layer is formed of a biocompatible insulating material.

[0029] In Example 24, the transdermal sound sensor of Example 23, wherein the biocompatible insulating material is at least one of the following: parylene, silicone rubber, or ePTFE.

[0030] In Example 25, a method of treatment using a percutaneous sound sensor system includes: coupling an electronic unit to a sound sensor configured to sense sound originating from within a subject, the sound sensor including an in vivo portion disposed below the subject's skin surface and an ex vivo portion disposed outside the skin surface; receiving from the electronic unit a signal corresponding to a sound measurement sensed by the sound sensor; and processing the received signal to determine characteristics of the sound measurement.

[0031] In Example 26, the method of Example 25 further includes: implanting the in vivo portion below the skin surface and implanting the ex vivo portion outside the skin surface.

[0032] In Example 27, the method of Example 25 further includes: associating the characteristics of the sound measurement with a specific part of the subject.

[0033] The examples above are limited to these and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by this disclosure. While several examples have been disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates and describes exemplary examples. Therefore, the drawings and detailed description are to be regarded in an illustrative rather than restrictive manner. Attached Figure Description

[0034] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and form part of this specification, illustrating embodiments and serving, together with the description, to explain the principles of the present disclosure.

[0035] Figure 1 This is a schematic diagram of a system including a transdermal sound sensor according to an embodiment of the present disclosure.

[0036] Figure 2 This is a schematic diagram of a transdermal sound sensor according to at least one embodiment of the present disclosure.

[0037] Figure 3A According to at least one embodiment of this disclosure Figure 2 A side sectional view of a portion of the sound sensor depicted in the image.

[0038] Figure 3B According to at least one embodiment of this disclosure Figure 2 The end of the sound sensor depicted in the cross-sectional view.

[0039] Figure 4 This is an embodiment based on the subject matter disclosed herein. Figure 2 The electronic units depicted in Figure 1 A block diagram depicting the additional equipment.

[0040] Since the terms “about” and “approximately” used herein with respect to measurement range are used interchangeably to refer to any measurement that includes the stated measurement and also includes quantities that are reasonably close to the stated measurement but may differ reasonably little from it (such as those that can be understood and readily determined by a person of ordinary skill in the relevant field, which may be due to measurement errors, differences in measurement and / or manufacturing equipment calibration, human error in reading and / or setting the measurement, and adjustments made to optimize performance and / or structural parameters in view of measurement differences associated with other components, specific implementation scenarios, imprecise adjustments, and / or objects manipulated by humans or machines).

[0041] This disclosure is not intended to be read in a restrictive manner. For example, terminology used in the application should be read broadly within the context in which those skilled in the art would interpret such terms as attributes.

[0042] Regarding the terminology of imprecision, the terms "approximately" and "approximately" are used interchangeably to refer to a measurement that includes the stated measurement, as well as any measurement that reasonably approximates the stated measurement. A measurement that reasonably approximates the stated measurement deviates from it by a considerably small margin, as understood and readily determined by one of ordinary skill in the art. For example, such deviation could be attributed to measurement error or minor adjustments made to optimize performance. If it is determined that a person of ordinary skill in the art would not readily determine the value of such a reasonably small difference, then the terms "approximately" and "approximately" can be understood as plus or minus 10% of the stated value. Detailed Implementation

[0043] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced in this disclosure are not necessarily drawn to scale but may be exaggerated to illustrate various aspects of this disclosure, and in this respect, the drawings should not be construed as limiting.

[0044] As mentioned above, conventional auscultation involves using a stethoscope on exposed skin to listen to the internal sounds of a subject. However, auscultation has drawbacks. For example, it is a skill that typically requires considerable clinical experience, a fine stethoscope, and good hearing techniques. This is because traditional acoustic stethoscopes usually produce a low volume. Ambient noise, individual hearing limitations, and variations in the auscultation point can all affect the sounds that can be heard.

[0045] Various electronic stethoscopes have been developed to improve upon conventional stethoscopes. For example, electronic stethoscopes can electronically amplify faint sounds from the body, improve sound pickup through advanced transducer designs, and apply computer-aided processing techniques such as noise cancellation and digital analysis. However, using these electronic stethoscopes to listen to a subject's internal sounds from the outside may still present challenges.

[0046] For example, sound can be easily and efficiently transmitted within the body due to the abundance of bodily fluids. However, sound waves can be reflected, attenuated, and / or distorted by the skin before reaching the stethoscope transducer surface. Poor sound transmission at the skin boundary between the sound-producing organ and the stethoscope transducer surface can result in the failure to capture the desired information. Furthermore, externally placed sound transducers can sense unwanted ambient noise. Additionally, variations in points on the body surface where auscultation is performed can affect the sound that the sensor can hear, which can increase the uncertainty in comparing sound patterns collected over long periods.

[0047] To reduce or avoid problems associated with routine auscultation, embodiments disclosed herein describe a transcutaneous sound sensor.

[0048] Figure 1This is a schematic diagram of a system 100 including a transdermal sound sensor 102. (See diagram below.) Figure 1 As shown, a transcutaneous acoustic sensor 102 is configured to be disposed on the body of a subject 104. The transcutaneous acoustic sensor 102 may be disposed on different areas of the subject 104 based on the different sounds to be sensed by the transcutaneous acoustic sensor 102. For example, in the case of sensing heart sounds via the transcutaneous acoustic sensor 102, the transcutaneous acoustic sensor 102 may be disposed on the left side of the subject 104's chest. As another example, in the case of sensing respiratory sounds via the transcutaneous acoustic sensor 102, the transcutaneous acoustic sensor 102 may be placed on the chest (e.g., the right side of the subject 104's chest). As yet another example, in the case of sensing digestive sounds via the transcutaneous acoustic sensor 102, the transcutaneous acoustic sensor 102 may be placed on the abdomen of the subject 104. In at least some embodiments, multiple transcutaneous acoustic sensors 102 may be disposed on the subject to sense different types of sounds produced by the subject 104. In embodiments, the subject 104 may be a human, dog, pig, and / or any other animal that produces senseable sounds. For example, the subject 104 may be a human patient.

[0049] The transcutaneous acoustic sensor 102 is configured to sense sounds generated by the subject 104. For example, the transcutaneous acoustic sensor 102 can sense heart sounds and / or other sounds associated with the subject 104's circulatory system, respiratory sounds associated with the subject 104's respiratory system, digestive sounds associated with the subject 104's digestive system, and so on. In at least some embodiments, the transcutaneous acoustic sensor 102 may also include electrodes configured to sense electrocardiogram (ECG) signals. Once the sound and / or ECG signals are sensed by the transcutaneous acoustic sensor 102, the transcutaneous acoustic sensor 102 can store and / or process the sound and / or ECG signals to determine the characteristics of the sensed sound and / or ECG signals.

[0050] In embodiments, the transcutaneous acoustic sensor 102 is configured to be communicatively coupled to another device (AD) 106 via a communication link 108. The AD 106 may be configured to receive, store, and / or process signals (e.g., sound and / or ECG signals) sensed by the transcutaneous acoustic sensor 102. In at least some embodiments, the AD 106 may also perform power management functions for the transcutaneous acoustic sensor 102. For example, the AD 106 may wake the transcutaneous acoustic sensor 102, put it into sleep mode, and / or instruct the transcutaneous acoustic sensor 102 to sense, store, process, and / or transmit signals corresponding to the sound generated by the subject 104. Embodiments of the AD 106 may be any type of device with computing capabilities, such as, for example, a smartphone, tablet, laptop, or other portable or non-portable computing device.

[0051] Communication link 108 may be or include wired links (e.g., links established via physical connections) or wireless links, such as short-range radio links, such as Bluetooth, IEEE 802.11, Near Field Communication (NFC), WiFi, proprietary wireless protocols, etc. The term "communication link" may refer to the ability to transmit some type of information between at least two devices in at least one direction and should not be construed as being limited to a direct, persistent, or otherwise restricted communication channel. That is, according to embodiments, communication link 108 may be a persistent communication link, an intermittent communication link, a self-organizing communication link, etc. Communication link 108 may refer to direct communication between transcutaneous acoustic sensor 102 and AD 106, and / or indirect communication traversed between transcutaneous acoustic sensor 102 and AD 106 via at least one other device (e.g., a repeater, router, hub, etc.). Communication link 108 may facilitate unidirectional and / or bidirectional communication between transcutaneous acoustic sensor 102 and AD 106. Data and / or control signals can be transmitted between the percutaneous acoustic sensor 102 and the AD 106 to coordinate the functions of the percutaneous acoustic sensor 102 and / or the AD 106. In embodiments, subject data can be downloaded periodically or on command from one or more of the percutaneous acoustic sensor 102 and the AD 106. Clinicians and / or subjects 104 can communicate with the percutaneous acoustic sensor 102 and / or the AD 106 to, for example, initiate, terminate, and / or modify sensing, storing, processing, and / or transmitting signals.

[0052] Figure 1 The exemplary system 100 shown is not intended to imply any limitation on the scope or functionality of the embodiments of this disclosure. The exemplary system 100 should not be construed as having any dependency or requirement associated with any individual component or combination of components shown therein. Furthermore, Figure 1The various components depicted herein can be integrated with various components of other components (and / or components not shown) depicted herein in embodiments, all of which are within the scope of the subject matter disclosed herein.

[0053] Figure 2 This is a schematic diagram of a transdermal acoustic sensor 102. In at least some embodiments, the transdermal acoustic sensor 102 includes an acoustic sensor 110, which includes an in vivo portion 110A communicatively coupled to an ex vivo portion 110B. Therefore, any signal sensed by the in vivo portion 110A can be transmitted to the ex vivo portion 110B.

[0054] As shown, the in vivo portion 110A is configured to be positioned beneath the surface 114 of the skin of the subject 104 and is configured to sense sound 112 generated by the subject 104. To position the in vivo portion 110A beneath the surface 114, it can be a sensor wire with its tip inserted into the body of the subject 104. In embodiments, the sensor wire can be inserted into the body of the subject 104 using an insertion device (e.g., a needle), which is then removed after the sensor wire has been inserted. Once positioned beneath the surface 114, the in vivo portion 110A will have minimal movement. Therefore, the percutaneous sound sensor 102 reduces the disadvantages of auscultation, where a medical professional can only listen for changes in points on the surface 114 for a specific sound. Consequently, the in vivo portion 110A is more likely to sense changes in the waveform of the sound 112. Furthermore, the sound 112 can be continuously sensed and recorded, rather than only periodically as with auscultation. Continuous monitoring can be particularly beneficial when recording sounds associated with chronic diseases.

[0055] The sounds 112 sensed by the in-body portion 110A include, but are not limited to: heart sounds and / or other sounds associated with the circulatory system of the subject 104, respiratory sounds associated with the respiratory system of the subject 104, digestive sounds associated with the digestive system of the subject 104, etc. Because the in-body portion 110A is disposed below the surface 114 of the skin, the surface 114 does not interfere with (e.g., reflect, attenuate, and / or distort) the sounds 112 generated by the subject 104. Conversely, sounds sensed by sensors (such as a stethoscope) may be reflected, attenuated, and / or distorted due to the surface 114. Furthermore, the in-body portion 110A is less likely to sense ambient noise than if it were located on the surface 110A. (The following is a continuation of the previous paragraph.) Figures 3A-3B Additional exemplary characteristics of the in vivo portion 110A are described in more detail.

[0056] The ex vivo portion 110B is not disposed beneath the surface 114 of the subject's skin and is detachably coupled to the mounting unit 116 and / or the electronic unit 118. Because the ex vivo portion 110B is coupled to the electronic unit 118 disposed outside the surface 114, the transdermal acoustic sensor 102 does not have some of the disadvantages of devices that are entirely located within the body, such as limited access, power, storage, processing, and transmission capabilities. Instead, the processor, memory, communication components, etc., included in the electronic unit 118 are more easily accessible compared to a case where the transdermal acoustic sensor 102 is entirely located within the body. Furthermore, by disposing only a portion of the transdermal acoustic sensor 102 beneath the surface 114 (i.e., the in vivo portion 110A), the transdermal acoustic sensor 102 will cause less foreign body reaction than if the entire transdermal acoustic sensor 102 were located beneath the surface 114.

[0057] Mounting unit 116 may be arranged on surface 114 in a manner that allows surface 114 to move beneath mounting unit 116. In some embodiments, mounting unit 116 may be formed of a material and arranged on surface 114 such that mounting unit 116 moves with bending of surface 114. For example, mounting unit 116 may be made of a flexible material and may be adhered to and / or sewn to surface 114. Exemplary adhesives include, but are not limited to, silicone-based adhesives and / or acrylic-based adhesives. In other embodiments, mounting unit 116 may be formed of a material and arranged on surface 114 such that mounting unit 116 allows bending and flexing movement of surface 114 without changing its position on surface 114 with bending of surface 114.

[0058] In at least some embodiments, electronic unit 118 is detachably coupled to the detached portion 110B of sound sensor 110 via a wired or wireless connection. Through the coupling between electronic unit 118 and the detached portion 110B, electronic unit 118 is configured to receive a signal corresponding to a sound sensed by the in-body portion 110A. Additionally, electronic unit 118 may be communicatively coupled to AD 106. Therefore, electronic unit 118 can store, process, and / or transmit a signal to AD 106 after receiving a signal sensed by the in-body portion 110A. In at least some embodiments, AD 106 can instruct electronic unit 118 to sense, store, process, and / or transmit a signal corresponding to a sound generated by subject 104. The following is in conjunction with… Figure 4 Exemplary components of electronic unit 118 are described in more detail below.

[0059] In at least some embodiments, mounting unit 116 can be detachably coupled to detached portion 110B via a wired or wireless connection, and electronic unit 118 can be detachably coupled to mounting unit 116. Therefore, electronic unit 118 can receive signals from detached portion 110B via mounting unit 116. In embodiments, electronic unit 118 can be releasably coupled to mounting unit 116 via snap-fit, connector, and / or other types of fasteners.

[0060] Additionally, or alternatively, the mounting unit 116 may include one or more electrodes 120 configured to sense one or more electrocardiogram (ECG) signals from the subject 104. An electronic unit 118 may be directly or detachably connected to the electrodes 120 via the mounting unit 116. Thus, the electronic unit 118 may receive and store signals sensed by the electrodes 120, process signals, and / or transmit signals to the AD 106. In at least some embodiments, the electronic unit 118 may align the ECG signals with heart sounds sensed by the body portion 110A. The heart sound-aligned sensed ECG signals can be used to identify and analyze certain physiological characteristics of the subject 104.

[0061] Figure 3A A side sectional view of a portion of the sound sensor 110 is depicted, and Figure 3B The image depicts the end portion of the sound sensor 110 in cross-section. As shown, the sound sensor 110 includes a body portion 110A disposed below a surface 114 and a detached portion 110B connected to the body portion 110A and disposed outside the surface 114. As described above, the detached portion 110B can be detachably coupled to (…). Figure 2 The electronic unit 118 is thus configured to receive sensed sound from the in-body portion 110A via the detached portion 110B.

[0062] The internal portion 110A is inserted through the surface 114 at the insertion site 122. As described above, the internal portion 110A can be inserted through the surface 114 using an insertion device (such as a needle). The internal portion 110A inserted below the surface 114 includes a sound sensing element 124. The sound sensing element 124 is configured to sense sounds generated by the subject 104 (such as...). Figure 2(As shown). For example, the sound sensing element 124 may include a diaphragm that twists when the acoustic energy of sound waves generated by the subject 104 is transferred through the diaphragm and causes mechanical stress or strain. The sound generated by different parts of the subject 104 may have different characteristics, such as different durations, frequencies, amplitudes, and / or masses, thus generating different mechanical stresses or strains on the diaphragm, each of which may be associated with a specific part of the subject 104. The sound sensing element 124 may also include a transducer that generates different electrical signals in response to the different twists of the diaphragm caused by the different mechanical stresses or strains. Thus, when a sound wave (e.g., sound 112) contacts the sound sensing element 124, the sound sensing element 124 experiences stress or strain and responsively generates an electrical signal that may be associated with a part of the subject 104 and transmitted by the sound sensor 110 to the electronics unit 118. In at least some embodiments, the sound sensing element 124 is a piezoelectric polymer layer formed of a material such as, for example, a polyvinylidene fluoride (PVDF) film or a PVDF copolymer (e.g., a PVDF-TrFE film) film, which exhibits a piezoelectric effect when polarized.

[0063] The remaining portion 126 of the body portion 110A separates the sound sensing element 124 from the surface 114 to reduce the possibility of ambient noise and / or reflected sound interfering with the sound sensing element 124 sensing sound. In at least some embodiments, a hydrophilic coating may be disposed on the tip 128 of the body portion 110A to improve the sensing capability of the sound sensing element 124.

[0064] like Figures 3A-3B As shown, the sound sensor 110 may have a coaxial structure. For example, the sound sensor 110 may include a core 130 surrounded by multiple layers (e.g., sound sensing element 124, conductive layer 132, and / or protective layer 134).

[0065] In at least some embodiments, the core 130 may be an elongated conductor, which may be a tube, a solid wire, or a stranded wire to obtain flexibility. For example, the core 130 may include platinum, titanium, MP35N alloy, and / or any other type of conductive material.

[0066] The tip portion surrounding the core 130 may be a sound sensing element 124. In the illustrated embodiment, the sound sensing element 124 may be formed circumferentially around the core 130. In an alternative embodiment, the sound sensing element 124 may be spirally wound around the core 130 using a single or multiple layer of piezoelectric polymer tape.

[0067] The electrically insulating layer 136 may abut an end of the sound sensing element 124 and / or separate the core 130 from the conductive layer 132. Similar to the sound sensing element 124, the electrically insulating layer 136 may be formed circumferentially around the core 130, or it may be spirally wound around the core 130 using a single or multiple layers of insulating tape. In some embodiments, the electrically insulating layer 136 is formed of an electrically insulating material such as an ePTFE film. In alternative embodiments, the electrically insulating layer 136 is simply an extension of the sound sensing element 124 and may be formed of a piezoelectric polymer material without polarization.

[0068] Surrounding the sound sensing element 124 and the electrically insulating layer 136 is another conductive layer 132. In some embodiments, the conductive layer 132 is a thin metal layer, which can be a thin film layer formed of any suitable biocompatible conductive material (such as, for example, titanium, platinum, gold, etc.). In some embodiments, the conductive layer 132 can be formed by circumferentially distributing a conductive material on the outer surface of the sound sensing element 124 and the electrically insulating layer 136. In alternative embodiments, the conductive layer 132 can consist of metal braided strands, non-woven spiral windings of metal strips, or a conductive polymer layer. In some embodiments, the proximal end 138 of the core 130 and the conductive layer 132 is not covered by insulating material and serves as an electrode for connecting the sound sensor 110 to the electronics unit 118.

[0069] In at least some embodiments, the protective layer 134 may surround the conductive layer 132. In some embodiments, the protective layer 134 may be formed of any suitable biocompatible insulating material, such as parylene, silicone rubber, or ePTFE. Additionally, or alternatively, the protective layer 134 may include a hydrophilic coating that improves sound transmission to the sound sensing element 124.

[0070] Figure 4 yes Figure 2 The electronic unit 118 of the transdermal sound sensor depicted in the image and Figure 1 The block diagram depicts the auxiliary device (AD) 106. As described above, the electronic unit 118 can be releasably and / or communicatively connected to the mounting unit and / or can be releasably and / or communicatively coupled to the sound sensor 110 and / or the electrode 120.

[0071] In at least some embodiments, the electronic unit 118 includes a controller 140, a memory 142 including sensing data 143, an amplifier 144, an analog-to-digital converter (ADC) 146, a common registration component 148, a communication component 150, and / or a power supply 152.

[0072] The controller 140 may include, for example, a processing unit, a pulse generator, etc. The controller 140 can be any arrangement of electronic circuitry, electronic components, processors, program components, etc., configured to store and / or execute programming instructions to instruct the operation of other functional components of the electronic unit 118. For example, the controller 140 can instruct ( Figures 2-3B The sound sensor 110 senses one or more sounds of a subject (e.g., subject 104), instructs the amplifier 144 to amplify any sound signal sensed by the sound sensor 110, instructs the ADC 146 to convert any sound signal sensed by the sound sensor 110 from an analog signal to a digital signal, stores any sensed data 143, instructs the communication component 150 to transmit any data corresponding to the sound sensed by the sound sensor 110, and so on, and the controller 140 may be implemented, for example, in any combination of hardware, software and / or firmware.

[0073] In embodiments, controller 140 may be, include, or be included in: one or more field-programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components. According to embodiments, controller 140 may include a processing unit configured to communicate with memory to execute computer-executable instructions stored in the memory. Although controller 140 is mentioned herein in the singular, controller 140 may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, etc.

[0074] The controller 140 may also be configured to store information (e.g., sensed data 143) in the memory 142 and / or access information (e.g., sensed data 143) from the memory 142. The controller 140 may execute instructions and perform desired tasks specified by computer-executable instructions stored in the memory 142.

[0075] In embodiments, memory 142 includes computer-readable media in the form of volatile and / or non-volatile memory, and may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM); read-only memory (ROM); electronically erasable programmable read-only memory (EEPROM); flash memory; optical or holographic media; magnetic tape cassettes, magnetic tape, disk storage, or other magnetic storage devices; data transfer; and / or any other medium that can be used to store information and is accessible by a computing device (such as, for example, quantum state memory, etc.). In embodiments, the memory stores computer-executable instructions for causing a processor to implement aspects of embodiments of the system components discussed herein and / or perform aspects of embodiments of the methods and procedures discussed herein.

[0076] Computer-executable instructions may include, for example, computer code, digital signal processing, machine-usable instructions, etc., such as, for example, program components that can be executed by one or more processors associated with a computing device. The program components can be programmed using any number of different programming environments, including various languages, development kits, frameworks, etc. Some or all of the functionality envisioned herein may also be implemented in hardware and / or firmware, or alternatively, in hardware and / or firmware.

[0077] As described above, amplifier 144 can amplify any sound sensed by sound sensor 110, and ADC 146 can convert any sound sensed by sound sensor 110 from an analog signal to a digital signal. Additionally, or alternatively, amplifier 144 can amplify any ECG signal sensed by electrode 120, and ADC 146 can convert any ECG signal sensed by electrode 120 from an analog signal to a digital signal. Furthermore, memory 142 can store any such sensing data 143.

[0078] In at least some embodiments, the co-registration component 148 can align the sensed sound with the sensed ECG signal. For example, the signals can be sampled synchronously and a time offset can be applied as a correction for one or both signals. Due to the finite speed of sound, the time offset is adjusted to the delay of the sensor's propagation time. After signal alignment, the aligned signal can be stored as sensing data 143.

[0079] Communication component 150 can be configured to communicate with AD 106 and / or any other device (i.e., transmit and / or receive signals). For example, sensed data 143 can be transmitted to AD 106 for processing and / or storage. In embodiments, communication component 150 may include, for example, circuitry, program components, antennas, and one or more transmitters and / or receivers for wireless communication with one or more other devices (such as, for example, AD 106). According to various embodiments, communication component 150 may include one or more transmitters, receivers, transceivers, transducers, etc., and may be configured to facilitate any number of different types of wireless communication, such as, for example, radio frequency (RF) communication, microwave communication, infrared or visible spectrum communication, acoustic communication, inductive communication, conducted communication, etc. Communication component 150 may include any combination of hardware, software, and / or firmware configured to facilitate the establishment, maintenance, and use of any number of communication links.

[0080] Power source 152 supplies power to other operating components (e.g., controller 140, memory 142, amplifier 144, ADC 146, co-registration component 148, and communication component 150) and can be any type of power source suitable for providing the desired performance and / or lifespan requirements of electronics 118. In various embodiments, power source 152 may include one or more batteries, which may be rechargeable (e.g., using an external power source). Power source 152 may include one or more capacitors, energy conversion mechanisms, etc. Additionally, or alternatively, power source 152 may harvest energy (e.g., motion, heat, biochemical) from a subject (e.g., subject 104) and / or harvest energy (e.g., electromagnetic) from the environment.

[0081] like Figure 2 As shown, AD 106 is communicatively coupled to the electronic unit via communication link 108 and includes a controller 154, a memory 156 including sensed data 143, a processing component 158, an I / O component 160, a communication component 162, and a power supply 164. Similar to controller 140, controller 154 may include, for example, a processing unit, a pulse generator, etc. Controller 154 can be any arrangement of electronic circuitry, electronic components, processor, program components, etc., configured to store and / or execute programming instructions, instruct the operation of other functional components of AD 106, store data received by AD 106 from electronic unit 118, etc., and can be implemented in any combination of hardware, software, and / or firmware.

[0082] In embodiments, controller 154 may be, include, or be included in: one or more field-programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components. According to embodiments, controller 154 may include a processing unit configured to communicate with memory 156 to execute computer-executable instructions stored in the memory. Although controller 154 is mentioned herein in the singular, controller 154 may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, etc.

[0083] The controller 154 may also be configured to store information (e.g., sensed data 143) in the memory 156 and / or access information (e.g., sensed data 143) from the memory 156. The controller 154 may execute instructions and perform desired tasks specified by computer-executable instructions stored in the memory 156. In embodiments, for example, the controller 154 may be configured to instantiate by executing instructions stored in the memory 156.

[0084] In embodiments, memory 156 includes computer-readable media in the form of volatile and / or non-volatile memory, and may be removable, non-removable, or a combination thereof. Examples of media include random access memory (RAM); read-only memory (ROM); electronically erasable programmable read-only memory (EEPROM); flash memory; optical or holographic media; magnetic tape cassettes, magnetic tape, disk storage, or other magnetic storage devices; data transfer; and / or any other medium that can be used to store information and is accessible by a computing device (such as, for example, quantum state memory, etc.). In embodiments, the memory stores computer-executable instructions for causing a processor to implement aspects of embodiments of the system components discussed herein and / or perform aspects of embodiments of the methods and procedures discussed herein.

[0085] Computer-executable instructions may include, for example, computer code, machine-usable instructions, and such as, for example, program components that can be executed by one or more processors associated with a computing device. The program components can be programmed using any number of different programming environments, including various languages, development kits, frameworks, etc. Some or all of the functionality envisioned herein may also be implemented in hardware and / or firmware, or alternatively, in hardware and / or firmware.

[0086] Processing component 158 ​​may be configured to process sensing data 143 received from electronics 118 and cause I / O component 160 to present a representation of the sensing data 143. According to embodiments, processing component 158 ​​may be configured to interpret, analyze, and / or otherwise process the sensing data 143 before presenting a representation of the sensing data 143. In embodiments, processing component 158 ​​may provide an interactive representation of the sensing data 143 via a graphical user interface (GUI). The representation of the sensing data 143 may include, for example, parameter values, diagnostic indications, graphs, charts, anatomical diagrams, images (e.g., ECG images), etc. According to embodiments, processing component 158 ​​may also be configured to receive input from a user via the GUI, indicating parameter settings for a specific sensing task. That is, for example, the GUI may facilitate user control of any number of operational aspects of AD 106.

[0087] I / O component 160, together with processing component 158, may include and / or be coupled to a user interface configured to present information to a user or receive instructions from a user. For example, I / O component 160 may include and / or be coupled to a display device, speaker, printing device, etc., and / or input components (such as, for example, a microphone, joystick, satellite dish, scanner, printer, wireless device, keyboard, pen, voice input device, touch input device, touchscreen device, interactive display device, mouse, etc.). As described above, I / O component 160 may be used to present and / or provide indications of any sensed data in sensed data 143. According to embodiments, for example, I / O component 160 may include one or more visual indicators (e.g., monochrome LEDs, multicolor LEDs, flexible digital display devices, etc.) configured to provide information to a user (e.g., through illumination, flashing, displaying data, etc.).

[0088] Communication component 162 may be configured to communicate with electronic unit 118 and / or any other device (i.e., send and / or receive signals). For example, communication component 162 may be configured to receive sensing data 143 from electronic unit 118. Additionally, or alternatively, communication component 162 may be configured to send commands to electronic unit 118 and / or send sensing data 143 to another device (not shown) for processing and / or storage.

[0089] According to various embodiments, communication component 162 may include one or more transmitters, receivers, transceivers, transducers, etc., and may be configured to facilitate any number of different types of wireless communications, such as, for example, radio frequency (RF) communications, microwave communications, infrared or visible spectrum communications, acoustic communications, inductive communications, conducted communications, etc. Communication component 162 may include any combination of hardware, software, and / or firmware configured to facilitate the establishment, maintenance, and use of any number of communication links.

[0090] Power source 164 supplies power to other operating components (e.g., controller 154, memory 156, processing component 158, I / O component 160, and communication component 162) and can be any type of power source suitable for providing the desired performance and / or lifespan requirements of AD 106. In different embodiments, power source 164 may include one or more batteries, which may be rechargeable (e.g., using an external power source). Power source 164 may include one or more capacitors, energy conversion mechanisms, etc. In embodiments, power source 164 may use wireless or non-wireless connections (e.g., via conduction, induction, radio frequency, etc.) to transfer power to power source 152. Because electronic unit 118 may be a small device, power source 152 may not be able to store large amounts of power; therefore, the lifespan of electronic unit 118 can be increased by transferring power from AD 106 to electronic unit 118.

[0091] Figure 4 The schematic diagrams shown are not intended to imply any limitation on the scope or functionality of the embodiments of this disclosure. The schematic diagrams should not be construed as having any dependency or requirement relating to any individual component or combination of parts shown therein. Additionally, Figure 4 The various components depicted herein can be integrated with various components of other components depicted herein (and / or components not shown) in embodiments, all of which are within the scope of this disclosure.

[0092] The embodiments disclosed herein have been described above in a general and specific manner. It will be apparent to those skilled in the art that various modifications and variations may be made to the embodiments without departing from the scope of this disclosure. Therefore, this disclosure is intended to cover the embodiments with a variety of modifications and variations provided herein, provided that such modifications and variations are within the scope of the appended claims and their equivalents.

Claims

1. A transdermal acoustic sensor system, the transdermal acoustic sensor system comprising: The mounting unit is configured for detachably connecting to the electronic unit and is configured for mounting on the skin of the body; as well as A sound sensor configured to sense sound originating from within the body, the sound sensor comprising an internal portion and an external portion, the internal portion being configured to be inserted through the skin of the body and positioned beneath the skin, wherein the internal portion has a sound sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element, wherein the external portion is configured to be operatively connected to the electronic unit when the electronic unit is connected to the mounting unit. The sound sensor has a coaxial structure comprising multiple layers, the innermost layer of the sound sensor being a core conductor, and in the internal portion of the sound sensor, a second layer of the coaxial structure arranged around the innermost layer comprising at least one of a polarized piezoelectric polymer layer or a piezoelectric ceramic layer, and in the external portion of the sound sensor, the second layer of the coaxial structure arranged around the innermost layer comprising an electrically insulating material.

2. The transcutaneous sound sensor system of claim 1, further comprising a device configured to receive and process sound measurements from the electronic unit via a wired or wireless communication link between the device and the electronic unit.

3. The transdermal sound sensor system as described in claim 1, characterized in that, The mounting unit further includes an electrocardiogram (ECG) electrode configured to measure one or more ECG signals of the body.

4. The transcutaneous sound sensor system as described in claim 1, characterized in that, At least a portion of the outer surface of the in vivo portion includes a hydrophilic coating.

5. The transdermal sound sensor system as described in claim 2, characterized in that, The second layer is a spiral layer wrapped around the innermost layer.

6. The transdermal sound sensor system as described in claim 2, characterized in that, The second layer is a continuous solid layer arranged around the innermost layer.

7. The transdermal sound sensor system as described in any one of claims 1-6, characterized in that, The third layer, arranged around the second layer, is a conductor.

8. The transcutaneous sound sensor system as described in claim 7, characterized in that, The third layer is a spiral layer that is wrapped around the second layer.

9. The transdermal sound sensor system as described in claim 7, characterized in that, The fourth layer, which is arranged around the third layer, is a protective layer.

10. The transdermal sound sensor system as described in any one of claims 1-6, characterized in that, It further includes electronic units.

11. A transdermal acoustic sensor, the transdermal acoustic sensor comprising: A sound sensing element, the sound sensing element being configured to be implanted under the skin of a subject and configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element; The proximal end, which is disposed outside the skin of the implanted subject and configured to be releasably and communicatively coupled to an electronic unit, includes an electrically insulating layer disposed at the end of the sound sensing element; as well as A protective layer is disposed around the sound sensing element.

12. The transcutaneous sound sensor as described in claim 11, characterized in that, The sound sensing element and the electrical insulating layer surround the core conductor.

13. The transdermal sound sensor as described in claim 12, characterized in that, The sound sensing element is spirally wound around the core conductor.

14. The transcutaneous sound sensor as described in any one of claims 11-13, characterized in that, A conductor layer is arranged around the sound sensing element and the electrical insulating layer.

15. The transcutaneous sound sensor as described in claim 14, characterized in that, The conductor layer is spirally wound around the sound sensing element.

16. The transcutaneous sound sensor as described in claim 14, characterized in that, The protective layer surrounds the conductor layer.

17. The transcutaneous sound sensor as described in any one of claims 11-13, characterized in that, At least a portion of the outer surface of the transdermal sound sensor includes a hydrophilic coating.

18. The transcutaneous sound sensor as described in any one of claims 11-13, characterized in that, The sound sensing element is formed from a polarized polyvinylidene fluoride (PVDF) film, a PVDF copolymer film, or a piezoelectric ceramic material.

19. The transcutaneous sound sensor as described in any one of claims 11-13, characterized in that, The protective layer is formed of a biocompatible insulating material.

20. The transdermal sound sensor as claimed in claim 19, characterized in that, The biocompatible insulating material is at least one of the following: parylene, silicone rubber, or ePTFE.

21. A transdermal sound sensor system, comprising: Electronic unit, used for coupling to the sound sensor, The sound sensor is configured to sense sound originating from within a subject. The sound sensor includes an in vivo portion disposed below the skin surface of the subject and an ex vivo portion disposed outside the skin surface. The sound sensor has a coaxial structure comprising multiple layers. The innermost layer of the sound sensor is a core conductor. In the in vivo portion of the sound sensor, a second layer of the coaxial structure disposed around the innermost layer comprises at least one of a polarized piezoelectric polymer layer or a piezoelectric ceramic layer. In the ex vivo portion of the sound sensor, the second layer of the coaxial structure disposed around the innermost layer comprises an electrically insulating material. as well as The processor is configured to be used for: Receives from the electronic unit a signal corresponding to the sound measurement sensed by the sound sensor; and The received signal is processed to determine the characteristics of the sound measurement.

22. The system of claim 21, wherein the in vivo portion is implanted below the skin surface and the ex vivo portion is implanted outside the skin surface.

23. The system of claim 21, wherein the processor is further configured to associate the characteristics of the sound measurement with a specific portion of the subject.

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