Transcutaneous sound sensor

Abstract

An embodiment of the present disclosure relates to a transcutaneous sound sensor. In at least one embodiment, the transcutaneous sound sensor system includes a mounting unit and a sound sensor. The mounting unit is detachably connected to an electronics unit and attached to the skin of a body. The sound sensor senses sounds originating from within 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 and positioned beneath 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 operably connect to the electronics unit when the electronics unit is connected to the mounting unit.

Description

Technical Field

[0001] Cross - Reference to Related Applications This application claims the benefit of Provisional Application No. 63 / 021,753, filed on May 8, 2020, and is hereby incorporated by reference in its entirety for all purposes.

[0002] Field The present disclosure generally relates to minimally invasive implantable sensors for medical monitoring. More specifically, the present disclosure relates to the design and use of a percutaneous acoustic sensor for monitoring physiological events within the body. Target sounds can include those from organs such as the heart, lungs, and intestines.

Background Art

[0003] Background Traditionally, auscultation involves using a stethoscope on the skin to listen to internal body sounds such as heart sounds, breath sounds, and bowel sounds. These sounds can provide valuable information about the state of the respective cardiovascular, respiratory, or gastrointestinal (GI) systems.

Summary of the Invention

[0004] Summary The present disclosure relates to a percutaneous acoustic sensor system. Exemplary embodiments include, but are not limited to, the following examples.

[0005] In Example 1, the transcutaneous sound sensor system includes a mounting unit configured to be attached to the skin of a body and to be detachably connected to an electronics unit, and a sound sensor configured to sense sounds originating from within the body, wherein the sound sensor includes an in vivo portion and an external portion, the in vivo portion being inserted through the skin of a body and positioned beneath it, the in vivo portion having a sound sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element, and the external portion being configured to be operably connected to the electronics unit when the electronics unit is connected to the mounting unit.

[0006] In Example 2, the transcutaneous sound sensor system of Example 1 further includes a device configured to receive and process sound measurements from the electronics unit via a wired or non-wired communication link between the electronics unit and the device.

[0007] In Example 3, the transcutaneous sound sensor system is one of Examples 1 to 2, wherein the mounting unit further includes an electrocardiograph (ECG) electrode configured to measure one or more ECG signals of the body.

[0008] In Example 4, the transcutaneous sound sensor system is one of the systems described in Examples 1 to 3, wherein at least a portion of the outer surface of the in-vivo part includes a hydrophilic coating.

[0009] In Example 5, the transcutaneous sound sensor system is one of the systems described in Examples 1 to 4, wherein the sound sensor has a coaxial structure comprising multiple layers.

[0010] In Example 6, the transcutaneous sound sensor system of Example 5 is used, wherein the innermost layer of the sensor is a core conductor.

[0011] In Example 7, the transcutaneous sound sensor system of Example 6 is used, and the second coaxial layer arranged around the innermost layer is a polarizing piezoelectric polymer layer.

[0012] In Example 8, the transcutaneous sound sensor system of Example 6 is used, wherein the second coaxial layer arranged around the innermost layer is a piezoelectric ceramic layer.

[0013] In Example 9, the transcutaneous sound sensor system is one of the systems described in Examples 7 to 8, wherein the second layer is a helical layer wrapped around the innermost layer.

[0014] In Example 10, the transcutaneous sound sensor system is one of the systems described in Examples 7 to 8, wherein the second layer is a continuous solid layer arranged around the innermost layer.

[0015] In Example 11, the transcutaneous sound sensor system is one of the systems described in Examples 7 to 10, wherein the third layer, which is positioned around the second layer, is a conductor.

[0016] In Example 12, the transcutaneous sound sensor system of Example 11 is used, wherein the third layer is a helical layer wound around the second layer.

[0017] In Example 13, the transcutaneous sound sensor system is one of the systems described in Examples 11 to 12, wherein the fourth layer, positioned around the third layer, is a protective layer.

[0018] In Example 14, a transcutaneous sound sensor system is provided according to any one of Examples 1 to 13, further comprising an electronics unit.

[0019] In Example 15, the transcutaneous sound sensor includes a sound-sensing element configured to be implanted under the skin of a target and configured to generate an electrical signal in response to mechanical stress or strain on the sound-sensing element, a proximal end configured to be detachably and communicatively coupled to an electronics unit, and a protective layer disposed around the sound-sensing element.

[0020] In Example 16, the transcutaneous sound sensor of Example 15 is used, wherein the sound sensing element surrounds the core conductor.

[0021] In Example 17, it is the transcutaneous sound sensor of Example 16, and the sound sensing element is wound helically around the core conductor.

[0022] In Example 18, it is any one of the transcutaneous sound sensors of Examples 15 to 17, and the conductor layer is disposed around the sound sensing element.

[0023] In Example 19, it is the transcutaneous sound sensor of Example 18, and the conductor layer is wound helically around the sound sensing element.

[0024] In Example 20, it is any one of the transcutaneous sound sensors of Examples 18 to 19, and the protective layer surrounds the conductor layer.

[0025] In Example 21, it is any one of the transcutaneous sound sensors of Examples 15 to 20, and at least a part of the outer surface of the transcutaneous sound sensor includes a hydrophilic coating.

[0026] In Example 22, it is any one of the transcutaneous sound sensors of Examples 15 to 21, and the sound sensing element is formed from a polarized polyvinylidene fluoride (PVDF) film, a PVDF copolymer (e.g., PVDF-TrFE) film, or a piezoceramic material.

[0027] In Example 23, it is any one of the transcutaneous sound sensors of Examples 15 to 22, and the protective layer is formed from a biocompatible insulating material.

[0028] In Example 24, it is the transcutaneous sound sensor of Example 23, and the biocompatible insulating material is at least one of parylene, silicone - rubber, or ePTFE.

[0029] Example 25 provides a treatment method using a transcutaneous sound sensor system, comprising coupling an electronics unit to a sound sensor, wherein the sound sensor is configured to sense sounds originating from within a target, the sound sensor receiving a signal from the electronics unit corresponding to a sound measurement value sensed by the sound sensor, including an in vivo portion located beneath the skin surface of the target and an ex vivo portion located outside the skin surface, and processing the received signal to determine the characteristics of the sound measurement value.

[0030] In Example 26, the method of Example 25 is further comprising implanting the in vivo portion below the skin surface and the extra vivo portion outside the skin surface.

[0031] In Example 27, the method of Example 25 is further comprising correlating the characteristics of the sound measurement values ​​with those of a specific part of the object.

[0032] The examples described above are merely embodiments and should not be read to limit or narrow the scope of any of the inventive concepts provided otherwise by this disclosure. Although several examples are disclosed, other embodiments will still become apparent to those skilled in the art from the following detailed description, which illustrates and describes exemplary examples. Accordingly, the drawings and detailed description should be considered illustrative, not restrictive, in their essence. [Brief explanation of the drawing]

[0033] Brief explanation of the drawing The accompanying drawings are included to provide a further understanding of this disclosure, are incorporated herein, constitute part of this specification, illustrate embodiments, and help illustrate the principles of this disclosure together with the description.

[0034] [Figure 1] Figure 1 is a schematic diagram of a system including a transcutaneous sound sensor according to an embodiment of the present disclosure.

[0035] [Figure 2]Figure 2 is a schematic diagram of a transcutaneous sound sensor according to at least one embodiment of the present disclosure.

[0036] [Figure 3A] Figure 3A is a side cross-sectional view of a portion of the sound sensor shown in Figure 2, according to at least one embodiment of the present disclosure.

[0037] [Figure 3B] Figure 3B is a cross-sectional view of the end of the sound sensor shown in Figure 2, according to at least one embodiment of the present disclosure.

[0038] [Figure 4] Figure 4 is a block diagram of the electronics unit shown in Figure 2 and additional devices shown in Figure 1, according to embodiments of the subject matter disclosed herein. [Modes for carrying out the invention]

[0039] When the terms are used herein in relation to the range of measurements, “about” and “near” are used interchangeably and may be used to refer to measurements including the stated measurements, and also to any measurements that are reasonably close to the stated measurements but may have reasonably small differences, such as those that are understood and readily verifiable by a person skilled in the art, due to measurement errors, differences in calibration of measuring and / or manufacturing equipment, human error in reading and setting of measurements, other components, adjustments made to optimize performance and / or structural parameters taking into account differences in measurements related to a particular implementation scenario, or inaccurate adjustment and / or handling of the object by a person or machine.

[0040] This disclosure is not intended to be read restrictively. For example, the terms used in this application should be read broadly in relation to the semantic relationships to which other terms in the art belong.

[0041] With regard to the terminology of inaccuracy, the terms “approximately” and “nearly” may be used interchangeably to refer to measurements that include the stated measurement and any measurement that is reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates by a reasonably small amount from the stated measurement, such that it can be understood and readily verified by a person skilled in the art. Such deviations may result, for example, from measurement errors or small adjustments made to optimize performance. If it is determined that a person skilled in the art cannot readily verify the value of such a reasonably small difference, the terms “approximately” and “nearly” may be understood to mean plus or minus 10% of the stated value.

[0042] Detailed explanation Those skilled in the art will readily understand that various aspects of this disclosure can be realized by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to a fixed scale and may be exaggerated to illustrate various aspects of this disclosure; therefore, the drawings should not be construed as limiting.

[0043] As mentioned above, traditional auscultation involves using a stethoscope directly against the skin to listen to internal sounds. However, auscultation has its drawbacks. For example, auscultation is often a skill that requires substantial clinical experience, a good stethoscope, and excellent articulation skills. This is because the volume produced by traditional acoustic stethoscopes is typically low. Ambient noise, individual hearing limitations, and variations in the auscultation point can all affect the sounds heard.

[0044] Various electronic stethoscopes have been developed to improve upon conventional stethoscopes. For example, electronic stethoscopes electrically amplify faint sounds from the body, improve sound pickup through advanced transducer design, and apply computer-aided processing technologies such as noise cancellation and digital analysis. However, problems can still arise when using these electronic stethoscopes to listen to internal sounds from the outside.

[0045] For example, because the body is rich in fluids, sound can be transmitted easily and efficiently within the body. However, sound waves can be reflected, attenuated, and / or distorted by the skin before they reach the transducer surface of the stethoscope. Poor sound transmission at the skin boundary between the sound-producing organ and the stethoscope transducer surface may prevent the acquisition of desired information. Furthermore, externally placed acoustic transducers may detect unwanted ambient noise. In addition, variations in the point on the body surface where auscultation is performed can affect the sounds that the sensor can hear, potentially adding uncertainty to the comparison of sound patterns collected over long periods.

[0046] To mitigate or avoid problems associated with conventional auscultation, embodiments disclosed herein describe transcutaneous sound sensors.

[0047] Figure 1 is a schematic diagram of a system 100 including a transcutaneous sound sensor 102. As shown in Figure 1, the transcutaneous sound sensor 102 is configured to be positioned on the body of a subject 104. The transcutaneous sound sensor 102 may be positioned in different areas of the subject 104 based on different sounds detected by the transcutaneous sound sensor 102. For example, the transcutaneous sound sensor 102 may be positioned on the left side of the chest of the subject 104 if heart sounds are detected by the transcutaneous sound sensor 102. As another example, the transcutaneous sound sensor 102 may be positioned on the chest (e.g., the right side of the chest of the subject 104) if respiratory sounds are detected by the transcutaneous sound sensor 102. As yet another example, the transcutaneous sound sensor 102 may be positioned on the patient's abdomen if digestive sounds are detected by the transcutaneous sound sensor 102. In at least some embodiments, multiple transcutaneous sound sensors 102 may be positioned on the subject to detect different types of sounds produced by the subject 104. In embodiments, subject 104 can be a person, a dog, a pig, and / or other animal that emits a perceptible sound. For example, subject 104 can be a human patient.

[0048] The transcutaneous sound sensor 102 is configured to sense sounds generated by the object 104. For example, the transcutaneous sound sensor 102 can sense heart sounds and / or other sounds related to the circulatory system of the object 104, respiratory sounds related to the respiratory system of the object 104, digestive sounds related to the digestive system of the object 104, and so on. In at least some embodiments, the transcutaneous sound sensor 102 may also include electrodes configured to sense electrocardiogram signals. Once the transcutaneous sound sensor 102 senses sounds and / or ECG signals, the transcutaneous sound sensor 102 can store and / or process the sounds and / or ECG signals to determine the characteristics of the sensed sounds and / or ECG signals.

[0049] In some embodiments, the transcutaneous sound 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 sound sensor 102. In at least some embodiments, the AD 106 can also perform power management functions for the transcutaneous sound sensor 102. For example, the AD 106 can wake up the transcutaneous sound sensor 102, put the transcutaneous sound sensor 102 to sleep, and / or instruct the transcutaneous sound sensor 102 to sense, store, process, and / or transmit signals corresponding to sounds generated by the object 104. Embodiments of the AD 106 can be any type of device having computing capabilities, such as a smartphone, tablet, notebook, or other portable or non-portable computing device.

[0050] The communication link 108 may be a wired link (e.g., a link achieved via a physical connection) or a non-wired link such as Bluetooth®, IEEE 802.11, Near Field Communication (NFC), Wi-Fi, or a short-range wireless link, or may include these. The term “communication link” may refer to the ability to communicate some type of information between at least two devices in at least one direction and should not be understood as being limited to direct, persistent, or another limited communication channel. That is, according to the embodiment, the communication link 108 may be a persistent communication link, an intermittent communication link, an ad-hoc communication link, etc. The communication link 108 may refer to direct communication between the transcutaneous sound sensor 102 and the AD 106, and / or indirect communication between the transcutaneous sound sensor 102 and the AD 106 via at least one other device (e.g., a repeater, router, hub, etc.). The communication link 108 can facilitate unidirectional and / or bidirectional communication between the transcutaneous sound sensor 102 and the AD 106. To adjust the functions of the transcutaneous sound sensor 102 and / or AD106, data and / or control signals can be transmitted between the transcutaneous sound sensor 102 and AD106. In the embodiment, target data may be downloaded periodically or by command from one or more of the transcutaneous sound sensors 102 and AD106. The clinician and / or target 104 can communicate with the transcutaneous sound sensor 102 and / or AD106 to, for example, start, stop and / or modify the sensing, storage, processing and / or transmission of signals.

[0051] The exemplary system 100 shown in Figure 1 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 relating to any single component or combination of components shown therein. Furthermore, the various components shown in Figure 1 may, in embodiments, be integrated with various other components shown therein (and / or components not shown), all of which fall within the scope of the subject matter disclosed herein.

[0052] Figure 2 is a schematic diagram of the transcutaneous sound sensor 102. In at least some embodiments, the transcutaneous sound sensor 102 includes a sound sensor 110 which includes an intracellular portion 110A that is communicatively coupled to an external portion 110B. Thus, any signal sensed by the intracellular portion 110A can be transmitted to the external portion 110B.

[0053] As shown in the figure, the in vivo portion 110A is configured to be positioned beneath the surface 114 of the skin of the object 104 and is configured to sense the sound 112 produced by the object 104. To position the in vivo portion 110A beneath the surface 114, the in vivo portion 110A can be a sensor wire whose tip is inserted into the object 104. In embodiments, the sensor wire may be inserted into the object 104 with the help of an insertion device (e.g., a needle). The insertion device is removed after the sensor wire has been inserted into the object 104. When positioned beneath the surface 114, the in vivo portion 110A has minimal movement. Thus, the transcutaneous sound sensor 102 reduces the drawback of auscultation, namely the variation in the point on the surface 114 where a medical professional can hear a particular sound. Thus, the in vivo portion 110A is likely to be able to sense changes in the waveform of the sound 112. Furthermore, the sound 112 can be sensed and recorded continuously, not just periodically as in the case of auscultation. Continuous monitoring is particularly beneficial when recording sounds associated with chronic diseases.

[0054] Sounds 112 perceived by the in vivo portion 110A include, but are not limited to, heart sounds and / or other sounds related to the circulatory system of the subject 104, respiratory sounds related to the respiratory system of the subject 104, and digestive sounds related to the digestive system of the subject 104. Since the in vivo portion 110A is located beneath the surface 114 of the skin, the surface 114 does not interfere with (e.g., reflect, attenuate, and / or distort) the sounds 112 produced by the subject 104. Conversely, sounds perceived by sensors such as stethoscopes may be reflected, attenuated, and / or distorted due to the surface 114. Furthermore, the in vivo portion 110A is less likely to perceive ambient noise than if the in vivo portion 110A were located on the surface 114. Additional exemplary characteristics of the in vivo portion 110A are described in more detail below with respect to Figures 3A and 3B.

[0055] The external component 110B is not located beneath the surface 114 of the skin of the subject 104, but is detachably coupled to the mounting unit 116 and / or the electronics unit 118. Because the external component 110B is coupled to the electronics unit 118 located outside the surface 114, the transcutaneous sound sensor 102 does not have some of the drawbacks of a fully intracellular device, such as limited access, power, storage, processing, and transmission capabilities. Instead, the processor, memory, communication components, etc., contained in the electronics unit 118 are more easily accessible than if the transcutaneous sound sensor 102 were fully intracellular. Furthermore, by having only a portion of the transcutaneous sound sensor 102 (i.e., the intracellular portion 110A) located beneath the surface 114, the transcutaneous sound sensor 102 elicits less of a foreign body reaction than if the entire transcutaneous sound sensor 102 were located beneath the surface 114.

[0056] The mounting unit 116 may be positioned on the surface 114 such that it allows movement of the surface 114 beneath the mounting unit 116. In some embodiments, the mounting unit 116 may be formed from a material such that it moves with the bending of the surface 114 and positioned on the surface 114. For example, the mounting unit 116 may be made from a flexible material and may be bonded to and / or sutured to the surface 114. Exemplary adhesives include, but are not limited to, silicone. - Examples include concrete-based adhesives and / or acrylic-based adhesives. In other embodiments, the mounting unit 116 may be formed from a material that allows bending and flexing of the surface 114, but does not change its position on the surface due to the bending of the surface 114, and may be positioned on the surface 114.

[0057] In at least some embodiments, the electronics unit 118 is detachably coupled to the external bio-part 110B of the sound sensor 110 via a wired or non-wired connection. The coupling between the electronics unit 118 and the external bio-part 110B configures the electronics unit 118 to receive signals corresponding to sounds sensed by the internal bio-part 110A. Furthermore, the electronics unit 118 may be communicatively coupled to the AD 106. Thus, after receiving signals sensed by the internal bio-part 110A, the electronics unit 118 can store, process, and / or transmit the signals to the AD 106. In at least some embodiments, the AD 106 can instruct the electronics unit 118 to sense, store, process, and / or transmit signals corresponding to sounds generated by the object 104. Exemplary components of the electronics unit 118 are described below in more detail in relation to Figure 4.

[0058] In at least some embodiments, the mounting unit 116 can be detachably coupled to the external biomedical component 110B via a wired or non-wired connection, and the electronics unit 118 can be detachably coupled to the mounting unit 116. Thus, the electronics unit 118 can receive signals from the external biomedical component 110B via the mounting unit 116. In embodiments, the electronics unit 118 can be detachably coupled to the mounting unit 116 via snaps, connectors and / or other types of fasteners.

[0059] Additionally or alternatively, the mounting unit 116 may include one or more electrodes 120 configured to sense one or more electrocardiogram (ECG) signals of the subject 104. The electronics unit 118 can be detachably connected to the electrodes 120 directly or via the mounting unit 116. Thus, the electronics unit 118 can receive signals sensed by the electrodes 120, store, process and / or transmit the signals to AD 106. In at least some embodiments, the electronics unit 118 can coordinate the ECG signals with heart sounds sensed by the in vivo portion 110A. The sensed ECG signals, coordinated with heart sounds, can be used to identify and analyze specific physiological characteristics of the subject 104.

[0060] Figure 3A shows a partial side cross-sectional view of the sound sensor 110, and Figure 3B shows an end cross-sectional view of the sound sensor 110. As shown, the sound sensor 110 includes an in vivo portion 110A located beneath the surface 114, and an external portion 110B connected to the in vivo portion 110A and located outside the surface 114. As described above, the external portion 110B can be detachably coupled to the electronics unit 118 (in Figure 2). Thus, the electronics unit 118 is configured to receive sound sensed from the in vivo portion 110A via the external portion 110B.

[0061] The in vivo portion 110A is inserted through the surface 114 at site 122. As described above, the in vivo portion 110A may be inserted through the surface 114 using an insertion device such as a needle. The in vivo portion 110A inserted beneath the surface 114 includes a sound sensing element 124. The sound sensing element 124 is configured to sense sounds produced by the object 104 (shown in Figure 2). For example, the sound sensing element 124 may include a diaphragm that distorts as the acoustic energy of sound waves produced by the object 104 passes through the diaphragm, mechanically stressing or straining the diaphragm. Sounds produced by different parts of the object 104 may have different characteristics such as different durations, frequencies, amplitudes and / or qualities, and thus may generate different mechanical stresses or strains in the diaphragm. Each of these may correlate with a particular site of the object 104. The sound sensing element 124 may also include a transducer that generates a variable electrical signal in response to different strains of the diaphragm as a result of different mechanical stresses or strains. Therefore, when a sound wave (e.g., sound 112) comes into contact with the sound sensing element 124, the sound sensing element 124 is subjected to stress or strain, and in response generates an electrical signal which is correlated with a portion of the object 104 and can be transmitted to the electronics unit 118 by the sound sensor 110. In at least some embodiments, the sound sensing element 124 is a piezopolymer layer formed from a material such as a polyvinylidene fluoride (PVDF) film or a PVDF copolymer (PVDF-TrFE, etc.) film, which exhibits a piezoelectric effect when polarized.

[0062] The remaining portion 126 of the in vivo portion 110A separates the sound-sensing element 124 from the surface 114, reducing the possibility of ambient and / or reflected sound interfering with the sound sensed by the sound-sensing element 124. In at least some embodiments, a hydrophilic coating can be placed on the tip 128 of the in vivo portion 110A to improve the sensing ability of the sound-sensing element 124.

[0063] As shown in Figures 3A-3B, 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., a sound sensing element 124, a conductive layer 132, and / or a protective layer 134).

[0064] In at least some embodiments, the core 130 can be a long conductor, which is a tube, a single wire, or a stranded wire for flexibility. For example, the core 130 may include platinum, titanium, MP35N alloy, and / or any other type of conductive material.

[0065] The tip portion of the core 130 may be surrounded by a sound-sensing element 124. In the illustrated embodiment, the sound-sensing element 124 may be formed around the core 130 by periphery arrangement. In an alternative embodiment, the sound-sensing element 124 may be spirally wrapped around the core 130 using a single or multilayer piezopolymer tape.

[0066] The electrical insulation layer 136 is adjacent to the ends of the sound sensing element 124 and / or can separate the core 130 from the conductive layer 132. Similar to the sound sensing element 124, the electrical insulation layer 136 can be formed around the core 130 by periphery arrangement, or it can be helically wrapped around the core 130 using single-layer or multi-layer insulating tape. In some embodiments, the electrical insulation layer 136 is formed from an electrical insulating material such as an ePTFE film. In another embodiment, the electrical insulation layer 136 is simply an extension of the sound sensing element 124 and can be formed from a non-polarized piezopolymer material.

[0067] Another conductive layer 132 surrounds the sound sensing element 124 and the electrical insulating layer 136. In some embodiments, the conductive layer 132 is a thin metal layer, which can be a thin film layer formed from any suitable biocompatible conductive material, such as titanium, platinum, or gold. In some embodiments, the conductive layer 132 can be formed by circumferentially arranging the conductive material on the outer surfaces of the sound sensing element 124 and the electrical insulating layer 136. In alternative embodiments, the conductive layer 132 can consist of a braided strand of metal, an unbraided helical winding of metal tape, or a layer of conductive polymer. In some embodiments, the core 130 and the proximal end 138 of the conductive layer 132 are not covered by insulating material and function as electrodes for connecting the sound sensor 110 to the electronics unit 118.

[0068] In at least some embodiments, the protective layer 134 can surround the conductive layer 132. In some embodiments, the protective layer 134 is made of parylene, silicone - It may be formed from any suitable biocompatible insulating material such as rubber or ePTFE. Additionally or alternatively, the protective layer 134 may include a hydrophilic coating to improve sound transmission to the sound sensing element 124.

[0069] Figure 4 is a block diagram of the electronics unit 118 of the transcutaneous sound sensor shown in Figure 2 and the additional device (AD) 106 shown in Figure 1. As described above, the electronics unit 118 can be detachably and / or communicatively connected to the mounting unit and / or detachably and / or communicatively coupled to the sound sensor 110 and / or electrode 120.

[0070] In at least some embodiments, the electronics unit 118 includes a controller 140, a memory 142 containing sensed data 143, an amplifier 144, an analog-to-digital component (ADC) 146, a co-registration component 148, a communication component 150, and / or a power supply 152.

[0071] The controller 140 may include, for example, a processing unit, a pulse generator, etc. The controller 140 can be any configuration such as an electronic circuit, an electronic component, a processor, a program component, etc., configured to store and / or execute programming instructions to direct the operation of other functional components of the electronics unit 118. For example, the controller 140 may instruct the sound sensor 110 (of Figures 2-3B) to sense one or more sounds of an object (e.g., object 104), instruct the amplifier 144 to amplify any sound signal sensed by the sound sensor 110, instruct the ADC to convert any sound signal sensed by the sound sensor 110 from an analog signal to a digital signal, store any sensed data 143, and instruct the communication component 150 to transmit any data corresponding to the sound sensed by the sound sensor 110, and may be implemented in any combination of hardware, software and / or firmware, for example.

[0072] In embodiments, the controller 140 may be, and may include, one or more field-programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more composite PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more dedicated processors (such as microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination thereof and / or other components. According to embodiments, the controller 140 may include processing units configured to communicate with memory and execute computer executable instructions stored in memory. Although the controller 140 is referred to in the singular form herein, the controller 140 may be implemented in multiple instances, distributed across multiple computing devices, and instances may be created within multiple virtual machines, etc.

[0073] The controller 140 may also be configured to store information (e.g., sensed data 143) in memory 142 and / or to access information (e.g., sensed data 143) from memory 142. The controller 140 can execute instructions and perform desired tasks specified by computer-executable instructions stored in memory 142.

[0074] In embodiments, the memory 142 includes a computer-readable medium in the form of volatile and / or non-volatile memory, which may be removable, non-removable, or a combination thereof. Examples of the medium include random access memory (RAM), read-only memory (ROM), electronically erasable programmable read-only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, any other medium that can be used for data transmission and / or information storage and is accessible by a computing device, such as quantum state memory. In embodiments, the memory stores computer-executable instructions for causing a processor to implement embodiments of the system components discussed herein and / or perform embodiments of the methods and procedures discussed herein.

[0075] Computer executable instructions can include, for example, computer code, digital signal processing, machine-usable instructions, and program components that can be executed by one or more processors associated with a computing device. Program components can be programmed using any number of different programming environments, including various languages, development kits, frameworks, etc. Some or all of the functions conceivable herein may also be implemented in hardware and / or firmware, or instead.

[0076] As described above, the amplifier 144 can amplify the sound sensed by the sound sensor 110, and the ADC 146 can convert the sound sensed by the sound sensor 110 from an analog signal to a digital signal. Additionally or alternatively, the amplifier 144 can amplify any ECG signal sensed by the electrode 120, and the ADC 146 can convert any ECG signal sensed by the electrode 120 from an analog signal to a digital signal. The memory 142 can then store such sensed data 143.

[0077] In at least some embodiments, the co-registration component 148 can match the sensed sound with the sensed ECG signal. For example, the signals can be sampled synchronously, and a time shift can be applied as a correction to one or both signals. The time shift adjusts for the delay in propagation time to the sensor due to a finite speed of sound. After the signals are matched, the matched signals can be stored as sensed data 143.

[0078] The communication component 150 may be configured to communicate with AD106 and / or any other devices (i.e., to transmit and / or receive signals). For example, sensed data 143 may be transmitted to AD106 for processing and / or storage. In embodiments, the communication component 150 may include circuits, program components, antennas and one or more transmitters and / or receivers to communicate wirelessly with one or more other devices, such as AD106. According to various embodiments, the 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 radio frequency (RF) communication, microwave communication, infrared or visible spectrum communication, acoustic communication, inductive communication, and conducted communication. The 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.

[0079] The power supply 152 can be any type of power supply suitable for providing power to other operating components (e.g., controller 140, memory 142, amplifier 144, ADC 146, co-registration component 148, and communication component 150) and providing the desired performance and / or life requirements of the electronics unit 118. In various embodiments, the power supply 152 may include one or more rechargeable batteries (e.g., using an external energy source). The power supply 152 may include one or more capacitors, energy conversion mechanisms, etc. Additionally or alternatively, the power supply 152 may obtain energy from an object (e.g., object 104) (e.g., kinetic, thermal, biochemical) and / or from the environment (e.g., electromagnetic).

[0080] As shown in Figure 2, the AD106 is communicably coupled to the electronics unit via a communication link 108 and includes a controller 154, a memory 156 containing sensed data 143, a processing component 158, an I / O component 160, a communication component 162, and a power supply 164. Similar to the controller 140, the controller 154 may include, for example, a processing unit, a pulse generator, etc. The controller 154 can be any configuration of electronic circuits, electronic components, processors, program components, etc., configured to store and / or execute programming instructions, direct the operation of other functional components of the AD106, and store data received by the AD106 from the electronics unit 118, and can be implemented, for example, in the form of any combination of hardware, software and / or firmware.

[0081] In embodiments, the 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 composite 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 thereof and / or other components. According to embodiments, the controller 154 may include processing units configured to communicate with memory 156 and execute computer executable instructions stored in memory. Although the controller 154 is referred to in the singular form herein, the controller 154 may be implemented in multiple instances, distributed across multiple computing devices, and instances may be created within multiple virtual machines, etc.

[0082] The controller 154 may also be configured to store information (e.g., sensed data 143) in memory 156 and / or to access information (e.g., sensed data 143) from memory 156. The controller 154 can perform a desired task by executing instructions as specified by the computer execution instructions stored in memory 156. In an embodiment, for example, the controller 154 may be configured to create an instance by executing instructions stored in memory 156.

[0083] In embodiments, the memory 156 includes a computer-readable medium in the form of volatile and / or non-volatile memory, which may be removable, non-removable, or a combination thereof. Examples of the medium include random access memory (RAM), read-only memory (ROM), electronically erasable programmable read-only memory (EEPROM), flash memory, optical or holographic media, magnetic cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, any other medium that can be used for data transmission and / or for storing information and is accessible by a computing device, such as quantum state memory. In embodiments, the memory stores computer-executable instructions for causing a processor to implement embodiments of the system components discussed herein and / or perform embodiments of the methods and procedures discussed herein.

[0084] Computer executable instructions can include computer code, machine-readable instructions, and so on, such as program components that can be executed by one or more processors associated with a computing device. Program components can be programmed using any number of different programming environments, including various languages, development kits, frameworks, and so on. Some or all of the functions conceivable herein may be hardware and / or firmware, or may be implemented therein.

[0085] The processing component 158 ​​can be configured to receive and process the sensed data 143 from the electronics unit 118, and to cause the I / O component 160 to present a display of the sensed data 143. According to one embodiment, the processing component 158 ​​can be configured to interpret, analyze, and / or otherwise process the sensed data 143 before presenting its display. In one embodiment, the processing component 158 ​​can provide an interactive display of the sensed data 143 via a graphical user interface (GUI). Examples of displays of the sensed data 143 include parameter values, diagnostic displays, graphs, charts, anatomical maps, and images (e.g., ECG images). According to another embodiment, the processing component 158 ​​can also be configured to receive input from a user via the GUI instructing the parameter settings for a particular sensing task. That is, for example, the GUI can facilitate user control of any number of modes of operation of the AD 106.

[0086] The I / O component 160, together with the processing component 158, includes and / or may be coupled to a user interface configured to present information to the user or receive instructions from the user. For example, the I / O component 160 may include and / or be coupled to input components such as a display device, speaker, printing device, etc., and / or input components such as a microphone, joystick, satellite receiving antenna, scanner, printer, wireless device, keyboard, pen, voice input device, touch input device, touchscreen device, interactive display device, mouse, etc. As described above, the I / O component 160 may be used to present and / or provide instructions for any of the sensed data 143. According to an embodiment, for example, the I / O component 160 may include one or more visual indicators (e.g., monochromatic LED lights, multichromatic LED lights, flexible digital display devices, etc.) configured to provide information to the user (e.g., by illumination, flashing, displaying data, etc.).

[0087] The communication component 162 may be configured to communicate with the electronics unit 118 and / or any other device (i.e., to transmit and / or receive signals). For example, the communication component 162 may be configured to receive data 143 sensed from the electronics unit 118. Additionally or alternatively, the communication component 162 may be configured to transmit commands to the electronics unit 118 and / or transmit the sensed data 143 to another device (not shown) for processing and / or storage.

[0088] According to various embodiments, the 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 communication, such as radio frequency (RF) communication, microwave communication, infrared or visible spectrum communication, acoustic communication, inductive communication, and conducted communication. The 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.

[0089] Power supply 164 provides power to other operating components (e.g., controller 154, memory 156, processing component 158, I / O component 160, and communication component 162), and it can be any type of power supply suitable for providing the desired performance and / or lifespan requirements of AD106. In various embodiments, power supply 164 may include one or more batteries that can be rechargeable (e.g., using an external energy source). Power supply 164 may include one or more capacitors, energy conversion mechanisms, etc. In embodiments, power supply 164 may transmit power to power supply 152 using wireless or non-wireless connections (e.g., via conduction, induction, radio frequency, etc.). Since the electronics unit 118 may be a small device, power supply 152 may not be able to store much power, and therefore the lifespan of the electronics unit 118 may be increased through power transmission from AD106 to the electronics unit 118.

[0090] The diagram shown in Figure 4 is not intended to imply any limitation on the scope or functionality of the embodiments of this disclosure. Furthermore, the diagram should not be construed as having any dependency or requirement relating to any single component or combination of components shown therein. Moreover, the various components shown in Figure 4 may, in embodiments, be integrated with various other components shown therein (and / or components not shown), all of which are within the scope of this disclosure.

[0091] The embodiments disclosed herein are described both in general terms and in relation to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments without departing from the scope of this disclosure. Accordingly, the embodiments are intended to cover modifications and variations of this disclosure, insofar as they fall within the scope of the appended claims and their equivalents. (Appearance) (Aspect 1) Mounting units configured to be detachably connected to electronics units, mounting units configured to be attached to the skin of a body, and A sound sensor configured to detect sounds originating from within the body. A transcutaneous sound sensor system comprising, the sound sensor comprising an in vivo portion and an external portion, wherein the in vivo portion is configured to be inserted through the skin of the body and positioned beneath it, the in vivo portion having a sound-sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound-sensing element, and the external portion is configured to be operably connected to the electronics unit when the electronics unit is connected to the mounting unit. (Aspect 2) The transcutaneous sound sensor system according to embodiment 1, further comprising a device configured to receive and process sound measurement values ​​from the electronics unit via a wired or non-wired communication link between the electronics unit and the device. (Aspect 3) The transcutaneous sound sensor system according to any one of embodiments 1 to 2, wherein the mounting unit further includes an electrocardiograph (ECG) electrode configured to measure one or more ECG signals of the body. (Aspect 4) The transcutaneous sound sensor system according to any one of embodiments 1 to 3, wherein at least a portion of the outer surface of the in-vivo portion includes a hydrophilic coating. (Appendix 5) The sound sensor is a transcutaneous sound sensor system according to any one of embodiments 1 to 4, wherein the sound sensor has a coaxial structure including multiple layers. (Aspect 6) The transcutaneous sound sensor system according to embodiment 5, wherein the innermost layer of the sensor is a core conductor. (Aspect 7) The transcutaneous sound sensor system according to embodiment 6, wherein the second layer of the coaxial structure arranged around the innermost layer is a polarizing piezoelectric polymer layer. (Pattern 8) The transcutaneous sound sensor system according to embodiment 6, wherein the second layer of the coaxial structure arranged around the innermost layer is a piezoelectric ceramic layer. (Aspect 9) The transcutaneous sound sensor system according to any one of embodiments 7 to 8, wherein the second layer is a helical layer wrapped around the innermost layer. (Aspect 10) The transcutaneous sound sensor system according to any one of embodiments 7 to 8, wherein the second layer is a continuous solid layer arranged around the innermost layer. (Aspect 11) A transcutaneous sound sensor system according to any one of embodiments 7 to 10, wherein the third layer arranged around the second layer is a conductor. (Aspect 12) The transcutaneous sound sensor system according to embodiment 11, wherein the third layer is a helical layer wrapped around the second layer. (Aspect 13) The transcutaneous sound sensor system according to any one of embodiments 11 to 12, wherein the fourth layer arranged around the third layer is a protective layer. (Aspect 14) A transcutaneous sound sensor system according to any one of embodiments 1 to 13, further comprising the aforementioned electronics unit. (Aspect 15) A sound-sensing element configured to be implanted under the skin of a target, the sound-sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound-sensing element, and A proximal end configured to be detachably and communicatively coupled to an electronics unit, and A protective layer arranged around the sound sensing element, Transcutaneous sound sensors, including (Aspect 16) The sound sensing element surrounds a core conductor, as described in embodiment 15, for a transcutaneous sound sensor. (Aspect 17) The transcutaneous sound sensor according to embodiment 16, wherein the sound sensing element is spirally wound around the core conductor. (Aspect 18) A transcutaneous sound sensor according to any one of embodiments 15 to 17, wherein the conductive layer is arranged around the sound sensing element. (Aspect 19) The transcutaneous sound sensor according to embodiment 18, wherein the conductive layer is spirally wound around the sound sensing element. (Aspect 20) The skin sound sensor according to any one of embodiments 18 to 19, wherein the protective layer surrounds the conductor layer. (Aspect 21) The transcutaneous sound sensor according to any one of embodiments 15 to 20, wherein at least a portion of the outer surface of the transcutaneous sound sensor includes a hydrophilic coating. (Aspect 22) The transcutaneous sound sensor according to any one of embodiments 15 to 21, wherein the sound sensing element is formed from a polarized polyvinylidene fluoride (PVDF) film, a PVDF copolymer (e.g., PVDF-TrFE) film, or a piezoceramic material. (Aspect 23) The transcutaneous sound sensor according to any one of embodiments 15 to 22, wherein the protective layer is formed from a biocompatible insulating material. (Aspect 24) The transcutaneous sound sensor according to embodiment 23, wherein the biocompatible insulating material is at least one of parylene, silicone rubber, or ePTFE. (Aspect 25) A treatment method that uses a transcutaneous sound sensor system, To combine an electronics unit with a sound sensor, Receiving a signal from the electronics unit corresponding to the sound measurement value detected by the sound sensor, and Processing the received signal to determine the characteristics of the sound measurement. Includes, The sound sensor is configured to detect sounds originating from within an object, and the sound sensor includes an in vivo portion located beneath the skin surface of the object and an ex vivo portion located outside the skin surface. (Aspect 26) The method according to embodiment 25, further comprising implanting the in vivo portion below the skin surface and the extra vivo portion outside the skin surface. (Aspect 27) The method according to embodiment 25, further comprising correlating the characteristics of the sound measurement values ​​with those of a specific part of the object.

Claims

1. A mounting unit configured to be detachably connected to an electronics unit, comprising a mounting unit configured to be attached to the skin of a body, and a sound sensor configured to detect sounds originating from within the body, The sound sensor includes an in-biological portion and an external portion. The in vivo portion includes the distal end of the sound sensor and is configured to be inserted through the skin of the body and positioned beneath it, the in vivo portion includes a sound sensing element positioned near the distal end of the sound sensor, the sound sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element, and a separation portion that separates the sound sensing element from the surface of the skin. The extracellular portion is configured to be positioned outside the skin and to be operably connected to the electronics unit when the electronics unit is connected to the mounting unit. The separated portion and the extracorporeal portion have an electrically insulating layer arranged adjacent to the sound sensing element in the longitudinal direction. The aforementioned sound sensor is a transcutaneous sound sensor system having a coaxial structure including multiple layers.

2. The transcutaneous sound sensor system according to claim 1, further comprising a device configured to receive and process sound measurement values ​​from the electronics unit via a wired or non-wired communication link between the electronics unit and the device.

3. The transcutaneous sound sensor system according to any one of claims 1 to 2, wherein the mounting unit further includes an electrocardiograph (ECG) electrode configured to measure one or more ECG signals of the body.

4. The transcutaneous sound sensor system according to any one of claims 1 to 3, wherein at least a portion of the outer surface of the in-vivo portion includes a hydrophilic coating.

5. The transcutaneous sound sensor system according to any one of claims 1 to 4, wherein the electrical insulating layer is an extension of the sound sensing element and is formed from a non-polarized piezoelectric polymer material.

6. The transcutaneous sound sensor system according to any one of claims 1 to 4, wherein the sound sensor includes an innermost layer, and the innermost layer is a core conductor.

7. The transcutaneous sound sensor system according to claim 6, wherein the sound sensor includes a second layer disposed around the innermost layer, the second layer being a polarizing piezoelectric polymer layer.

8. The transcutaneous sound sensor system according to claim 6, wherein the sound sensor includes a second layer disposed around the innermost layer, the second layer being a piezoelectric ceramic layer.

9. The transcutaneous sound sensor system according to any one of claims 7 to 8, wherein the second layer is a helical layer wrapped around the innermost layer.

10. The transcutaneous sound sensor system according to any one of claims 7 to 8, wherein the second layer is a continuous solid layer arranged around the innermost layer.

11. The transcutaneous sound sensor system according to any one of claims 7 to 10, wherein the sound sensor includes a third layer disposed around the second layer, and the third layer is a conductor.

12. The transcutaneous sound sensor system according to claim 11, wherein the third layer is a helical layer wrapped around the second layer.

13. The transcutaneous sound sensor system according to any one of claims 11 to 12, wherein the sound sensor includes a fourth layer disposed around the third layer, and the fourth layer is a protective layer.

14. The transcutaneous sound sensor system according to any one of claims 1 to 13, further comprising the electronics unit.

15. A transcutaneous sound sensor configured to detect sounds generated from within the body, The aforementioned transcutaneous sound sensor is A sound sensing element positioned near the distal end of the transcutaneous sound sensor and configured to be implanted under the skin of a target, the sound sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element, A separation portion configured to be implanted under the skin and separating the sound-sensing element from the surface of the skin, A proximal end configured to be positioned outside the skin and to be detachably and communicatively coupled to an electronics unit, An electrical insulating layer is arranged adjacent to the sound sensing element in the longitudinal direction, and A protective layer disposed around the sound sensing element and the electrical insulating layer, Includes, The transcutaneous sound sensor is a transcutaneous sound sensor having a coaxial structure including multiple layers.

16. The sound sensing element surrounds a core conductor, as described in claim 15.

17. The transcutaneous sound sensor according to claim 16, wherein the sound sensing element is spirally wound around the core conductor.

18. The transcutaneous sound sensor according to any one of claims 15 to 17, wherein the conductive layer is arranged around the sound sensing element.

19. The transcutaneous sound sensor according to claim 18, wherein the conductive layer is spirally wound around the sound sensing element.

20. The transcutaneous sound sensor according to any one of claims 18 to 19, wherein the protective layer surrounds the conductor layer.

21. The transcutaneous sound sensor according to any one of claims 15 to 20, wherein at least a portion of the outer surface of the transcutaneous sound sensor includes a hydrophilic coating.

22. The transcutaneous sound sensor according to any one of claims 15 to 21, wherein the sound sensing element is at least partially formed from a polarized polyvinylidene fluoride (PVDF) film, a PVDF copolymer film, or a piezoceramic material.

23. The transcutaneous sound sensor according to any one of claims 15 to 22, wherein the protective layer is formed from a biocompatible insulating material.

24. The transcutaneous sound sensor according to claim 23, wherein the biocompatible insulating material is at least one of parylene, silicone rubber, or ePTFE.

Images