Transcutaneous sound sensor

Abstract

To provide a favorable transcutaneous sound sensor.SOLUTION: There is provided a transcutaneous sound sensor. A transcutaneous sound sensor system comprises a mounting unit and a sound sensor. The mounting unit detachably connects to an electronics unit and mounts to skin on a body. The sound sensor senses sounds 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 and placed beneath the skin of the body. In addition, the in-vivo portion has a sound-sensing element configured to produce an electrical signal in response to a 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.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Provisional Application No. 63 / 021,753, filed May 8, 2020, which is incorporated by reference in its entirety for all purposes.

[0002] Field The present disclosure relates generally to minimally invasive implantable sensors for medical monitoring. More specifically, the present disclosure relates to the design and use of transcutaneous sound sensors for monitoring physiological events within the body. Targets can include sounds from organs such as the heart, lungs, and intestines. [Background technology]

[0003] background Traditionally, auscultation involves using a stethoscope against bare skin to listen to internal body sounds, such as heart, respiratory and bowel sounds, which can provide valuable information about the condition of the respective circulatory, respiratory or gastrointestinal (GI) systems. Summary of the Invention

[0004] Abstract The present disclosure relates to a transcutaneous sound sensor system. Exemplary embodiments include, but are not limited to, the following examples.

[0005] In Example 1, a transcutaneous sound sensor system includes an attachment unit configured to be removably connected to an electronics unit and configured to be attached to the skin of a body, and a sound sensor configured to sense sound generated from within the body, the sound sensor including an in vivo portion and an extra-vivo portion, the in vivo portion configured to be inserted through and positioned beneath the skin of the body, 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 extra-vivo portion configured to operably connect to the electronics unit when the electronics unit is connected to the attachment 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 of any one of Examples 1-2, wherein the mounting unit further comprises electrocardiograph (ECG) electrodes configured to measure one or more ECG signals of the body.

[0008] In Example 4, the transcutaneous sound sensor system of any one of Examples 1-3, wherein at least a portion of an exterior surface of the intra-vivo portion includes a hydrophilic coating.

[0009] In Example 5, the transcutaneous sound sensor system of any one of Examples 1-4, wherein the sound sensor has a coaxial structure including multiple layers.

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

[0011] In Example 7, the transcutaneous sound sensor system of Example 6, wherein a second layer of the coaxial structure disposed about the innermost layer is a polarized piezopolymer layer.

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

[0013] In Example 9, the transcutaneous sound sensor system of any one of Examples 7-8, wherein the second layer is a spiral layer wrapped around the innermost layer.

[0014] In Example 10, the transcutaneous sound sensor system of any one of Examples 7-8, wherein the second layer is a continuous solid layer disposed about the innermost layer.

[0015] In Example 11, the transcutaneous sound sensor system of any one of Examples 7 to 10, wherein a third layer disposed around the second layer is a conductor.

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

[0017] In Example 13, the transcutaneous sound sensor system of any one of Examples 11-12, wherein a fourth layer disposed around the third layer is a protective layer.

[0018] In Example 14, the transcutaneous sound sensor system of any one of Examples 1-13, further comprising an electronics unit.

[0019] In Example 15, a transcutaneous sound sensor is configured to be implanted under the skin of a subject and includes a sound sensing element configured to generate an electrical signal in response to mechanical stress or strain on the sound sensing element, a proximal end configured to be removably 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, wherein the sound sensing element surrounds the core conductor.

[0021] In Example 17, the transcutaneous sound sensor of Example 16, wherein the sound sensing element is spirally wrapped around the core conductor.

[0022] In Example 18, the transcutaneous sound sensor of any one of Examples 15-17, wherein a conductor layer is disposed around the sound sensing element.

[0023] In Example 19, the transcutaneous sound sensor of Example 18, wherein the conductor layer is spirally wrapped around the sound sensing element.

[0024] In Example 20, in the transcutaneous sound sensor of any one of Examples 18 to 19, the protective layer surrounds the conductor layer.

[0025] In Example 21, the transcutaneous sound sensor of any one of Examples 15-20, wherein at least a portion of an outer surface of the transcutaneous sound sensor includes a hydrophilic coating.

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

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

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

[0029] In Example 25, a method of treatment using a transcutaneous sound sensor system includes coupling an electronics unit to a sound sensor, the sound sensor configured to sense sound originating from within a subject, the sound sensor including an in vivo portion disposed below a skin surface of the subject and an extra vivo portion disposed outside the skin surface, receiving a signal from the electronics unit corresponding to a sound measurement sensed by the sound sensor, and processing the received signal to determine a characteristic of the sound measurement.

[0030] In Example 26, the method of Example 25 further comprises implanting the in vivo portion beneath a skin surface and the ex vivo portion exterior to a skin surface.

[0031] In Example 27, the method of Example 25, further comprising correlating the characteristics of the sound measurements with a particular portion of the subject.

[0032] The foregoing examples are merely illustrative and should not be read to limit or narrow the scope of any of the inventive concepts otherwise provided by this disclosure. While several examples have been disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive in nature. [Brief description of the drawings]

[0033] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the disclosure, are incorporated in and constitute a part of this specification, illustrate embodiments, and together with the description, serve to explain the principles of the disclosure.

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

[0035] [Diagram 2]FIG. 2 is a schematic diagram of a transcutaneous sound sensor in accordance with at least one embodiment of the present disclosure.

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

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

[0038] [Figure 4] FIG. 4 is a block diagram of the electronics unit shown in FIG. 2 and additional devices shown in FIG. 1 according to an embodiment of the subject matter disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] As the terms are used herein in relation to ranges of measurements, "about" and "approximately" may be used interchangeably to refer to measurements that include the stated measurement, and also to refer to any measurement that is reasonably close to the stated measurement, but that may vary by a reasonably small amount, as understood and readily ascertained by one of ordinary skill in the relevant art due to measurement errors, differences in calibration of measuring and / or manufacturing equipment, human error in reading and setting the measurements, adjustments made to optimize performance and / or structural parameters taking into account other components, differences in measurements associated with a particular implementation scenario, imprecise adjustment and / or manipulation of objects by humans or machines, and the like.

[0040] This disclosure is not intended to be read in a restrictive manner, for example, the terms used in this application should be read broadly with respect to the meaning that terms of the art are ascribed to such terms.

[0041] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements that include the stated measurement and also include any measurement that is reasonably close to the stated measurement. A measurement that is reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, as would be understood and readily ascertained by one of ordinary skill in the relevant art. Such deviations may be due, for example, to measurement error or small adjustments made to optimize performance. In cases where it is determined that such reasonably small difference values ​​are not readily ascertainable by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean plus or minus 10% of the stated value.

[0042] Detailed Description Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0043] As mentioned above, traditional auscultation uses a stethoscope on bare skin to listen to the internal sounds of a subject. However, auscultation has drawbacks. For example, auscultation is a skill that often requires substantial clinical experience, a good stethoscope, and good articulatory skills. This is because the sound volume produced by traditional acoustic stethoscopes is typically low. Ambient noise, individual hearing limitations, and variability in the auscultation point can all affect the sounds heard.

[0044] Various electronic stethoscopes have been developed to improve upon traditional stethoscopes. For example, electronic stethoscopes 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, problems can still arise when using these electronic stethoscopes to listen to a subject's internal sounds from the outside.

[0045] For example, sound may be easily and efficiently transmitted within the body due to the abundance of fluids within the body. However, sound waves may be reflected, attenuated and / or distorted by the skin before they reach the transducer surface of the stethoscope. Poor transmission of sound at the skin interface between the sound-generating organ and the stethoscope transducer surface may result in failure to obtain desired information. Furthermore, externally placed acoustic transducers may sense undesired ambient noise. Furthermore, variation in the point on the surface of the body where auscultation is performed may affect the sounds the sensor can hear, adding uncertainty to comparisons of sound patterns collected over time.

[0046] To reduce or avoid the problems associated with traditional auscultation, the embodiments disclosed herein describe a transcutaneous sound sensor.

[0047] FIG. 1 is a schematic diagram of a system 100 including a transcutaneous sound sensor 102. As shown in FIG. 1, the transcutaneous sound sensor 102 is configured to be placed on a body of a subject 104. The transcutaneous sound sensor 102 may be placed on different regions of the subject 104 based on different sounds sensed by the transcutaneous sound sensor 102. For example, the transcutaneous sound sensor 102 may be placed on a left portion of the chest of the subject 104 if heart sounds are sensed by the transcutaneous sound sensor 102. As another example, the transcutaneous sound sensor 102 may be placed on the chest (e.g., a right portion of the chest of the subject 104) if respiratory sounds are sensed by the transcutaneous sound sensor 102. As yet another example, the transcutaneous sound sensor 102 may be placed on the abdomen of the patient if digestive sounds are sensed by the transcutaneous sound sensor 102. In at least some embodiments, multiple transcutaneous sound sensors 102 may be placed on the subject to sense different types of sounds produced by the subject 104. In an embodiment, the subject 104 can be a human, a dog, a pig, and / or other animal that emits detectable sounds. For example, the subject 104 can be a human patient.

[0048] The transcutaneous sound sensor 102 is configured to sense sounds produced by the subject 104. For example, the transcutaneous sound sensor 102 may sense 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. In at least some embodiments, the transcutaneous sound sensor 102 may also include electrodes configured to sense electrocardiogram signals. Once sounds and / or ECG signals are sensed by the transcutaneous sound sensor 102, the transcutaneous sound sensor 102 may store and / or process the sounds and / or ECG signals to determine characteristics of the sensed sounds and / or ECG signals.

[0049] In an embodiment, 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 may also perform power management functions for the transcutaneous sound sensor 102. For example, the AD 106 may 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 subject 104. An embodiment of the AD 106 may be any type of device having computing capabilities, such as, for example, a smartphone, tablet, notebook, or other portable or non-portable computing device.

[0050] The communication link 108 may be or include a wired link (e.g., a link achieved via a physical connection) or a non-wired link, such as a short-range wireless link, such as Bluetooth™, IEEE 802.11, Near Field Communication (NFC), WiFi, Rights-Based Wireless Protocol, etc. The term "communication link" may refer to the ability to communicate any type of information at least unidirectionally between at least two devices and should not be understood as being limited to a direct, permanent or otherwise limited communication channel. That is, according to an embodiment, the communication link 108 may be a permanent communication link, an intermittent communication link, an ad-hoc communication link, etc. The communication link 108 may refer to a direct communication between the transcutaneous sound sensor 102 and the AD 106 and / or an indirect communication that runs between the transcutaneous sound sensor 102 and the AD 106 via at least one other device (e.g., a repeater, a router, a hub, etc.). The communication link 108 may facilitate unidirectional and / or bidirectional communication between the transcutaneous sound sensor 102 and the AD 106. Data and / or control signals can be transmitted between the transcutaneous sound sensor 102 and the AD 106 to adjust the function of the transcutaneous sound sensor 102 and / or the AD 106. In embodiments, subject data can be downloaded periodically or on command from one or more of the transcutaneous sound sensor 102 and the AD 106. The clinician and / or the subject 104 can communicate with the transcutaneous sound sensor 102 and / or the AD 106 to, for example, initiate, terminate and / or modify the sensing, storage, processing and / or transmission of signals.

[0051] The exemplary system 100 illustrated in Figure 1 is not intended to suggest limitations as to the scope or functionality of use of the embodiments of the present disclosure. The exemplary system 100 should not be interpreted as having dependencies or requirements relating to any single component or combination of components illustrated therein. Moreover, the various components illustrated in Figure 1 may be combined in embodiments with various of the other components illustrated therein (and / or components not illustrated), all within the scope of the subject matter disclosed herein.

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

[0053] As shown, the in vivo portion 110A is configured to be placed under the surface 114 of the skin of the subject 104 and is configured to sense the sound 112 generated by the subject 104. To place the in vivo portion 110A under the surface 114, the in vivo portion 110A can be a sensor wire, where the tip of the sensor wire is inserted into the subject 104. In an embodiment, the sensor wire can be inserted into the subject 104 with the aid of an insertion device (e.g., a needle). The insertion device is removed after the sensor wire is inserted into the subject 104. When placed under the surface 114, the in vivo portion 110A has minimal movement. Thus, the transcutaneous sound sensor 102 reduces a drawback of auscultation, namely, the variation of the point on the surface 114 where the medical professional can hear a particular sound. Thus, the in vivo portion 110A is more 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 auscultation. Continuous monitoring is particularly beneficial when recording sounds associated with chronic illnesses.

[0054] The sounds 112 sensed by the in vivo portion 110A include, but are not limited to, heart sounds and / or other sounds associated with the circulatory system of the subject 104, breathing sounds associated with the respiratory system of the subject 104, and digestive sounds associated with the digestive system of the subject 104. Because the in vivo 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 a sensor, such as a stethoscope, may be reflected, attenuated, and / or distorted due to the surface 114. Additionally, the in vivo portion 110A is less likely to sense ambient noise than if the in vivo portion 110A were disposed on the surface 114. Additional exemplary characteristics of the in vivo portion 110A are described in more detail below with respect to FIGS. 3A-3B.

[0055] The extracorporeal portion 110B is not disposed below the surface 114 of the skin of the subject 104, but is removably coupled to the mounting unit 116 and / or the electronics unit 118. Because the extracorporeal portion 110B is coupled to the electronics unit 118 disposed outside the surface 114, the transcutaneous sound sensor 102 does not have some of the disadvantages of a device disposed entirely in vivo, such as limited access, power, storage, processing and transmission capabilities. Instead, the processor, memory, communication components, etc. included in the electronics unit 118 are more easily accessible than if the transcutaneous sound sensor 102 were disposed entirely in vivo. Furthermore, by only a portion of the transcutaneous sound sensor 102 (i.e., the intracorporeal portion 110A) being disposed below the surface 114, the transcutaneous sound sensor 102 induces less of a foreign body response than if the entire transcutaneous sound sensor 102 were disposed below the surface 114.

[0056] The mounting unit 116 can be disposed on the surface 114 to allow movement of the surface 114 beneath the mounting unit 116. In some embodiments, the mounting unit 116 can be formed from a material and disposed on the surface 114 such that the mounting unit 116 moves with flexing of the surface 114. For example, the mounting unit 116 can be made from a flexible material and can be glued and / or sewn to the surface 114. Exemplary adhesives include, but are not limited to, silicone-based adhesives and / or acrylic-based adhesives. In other embodiments, the mounting unit 116 can be formed from a material and disposed on the surface 114 such that the mounting unit 116 allows bending and flexing movement of the surface 114 but does not change position on the surface with flexing of the surface 114.

[0057] In at least some embodiments, the electronics unit 118 is removably coupled to the in vivo portion 110B of the sound sensor 110 via a wired or non-wired connection. Due to the coupling between the electronics unit 118 and the in vivo portion 110B, the electronics unit 118 is configured to receive signals corresponding to sounds sensed by the in vivo portion 110A. Furthermore, the electronics unit 118 may be communicatively coupled to the AD 106. Thus, the electronics unit 118 may store, process and / or transmit the signals to the AD 106 after receiving the signals sensed by the in vivo portion 110A. In at least some embodiments, the AD 106 may instruct the electronics unit 118 to sense, store, process and / or transmit signals corresponding to sounds produced by the subject 104. Exemplary components of the electronics unit 118 are described in more detail below in connection with FIG. 4.

[0058] In at least some embodiments, the mounting unit 116 can be removably coupled to the in vivo portion 110B via a wired or non-wired connection, and the electronics unit 118 can be removably coupled to the mounting unit 116. Thus, the electronics unit 118 can receive signals from the in vivo portion 110B via the mounting unit 116. In embodiments, the electronics unit 118 can be removably 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 electrocardiograph ECG signals of the subject 104. The electronics unit 118 may be removably connected to the electrodes 120 directly or via the mounting unit 116. Thus, the electronics unit 118 may receive signals sensed by the electrodes 120 and store, process and / or transmit the signals to the AD 106. In at least some embodiments, the electronics unit 118 may match the ECG signals with heart sounds sensed by the in vivo portion 110A. The sensed ECG signals, matched with the heart sounds, may be used to identify and analyze certain physiological characteristics of the subject 104.

[0060] 3A illustrates a side cross-sectional view of a portion of sound sensor 110, and FIG. 3B illustrates a cross-sectional end view of sound sensor 110. As shown, sound sensor 110 includes an in vivo portion 110A disposed below surface 114, and an in vivo portion 110B connected to in vivo portion 110A and disposed outside surface 114. As mentioned above, in vivo portion 110B may be removably coupled to electronics unit 118 (of FIG. 2). Thus, electronics unit 118 is configured to receive sensed sound from in vivo portion 110A via in vivo portion 110B.

[0061] The in vivo portion 110A is inserted through the surface 114 at a location 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 generated by the subject 104 (shown in FIG. 2). For example, the sound sensing element 124 may include a diaphragm that distorts as the acoustic energy of the sound waves generated by the subject 104 passes through the diaphragm, mechanically stressing or straining the diaphragm. Sounds generated by various parts of the subject 104 may have different characteristics, such as different durations, frequencies, amplitudes, and / or qualities, and thus may generate different mechanical stresses or strains on the diaphragm, each of which may be correlated to a particular location of the subject 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 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 a stress or strain and in response generates an electrical signal that can be correlated to a portion of the object 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 piezopolymer layer formed from a material, such as, for example, a polyvinylidene fluoride (PVDF) film or a PVDF copolymer (such as PVDF-TrFE) film, which exhibits a piezoelectric effect when polarized.

[0062] The remaining portion 126 of the intra-vivo portion 110A separates the sound sensing element 124 from the surface 114 to reduce the possibility that ambient and / or reflected sound will interfere with sound sensed by the sound sensing element 124. In at least some embodiments, a hydrophilic coating may be disposed on the tip 128 of the intra-vivo portion 110A to improve the sensing capabilities of the sound sensing element 124.

[0063] 3A-3B, the sound sensor 110 can have a coaxial structure. For example, the sound sensor 110 can include a core 130 surrounded by multiple layers (e.g., the sound sensing element 124, the conductive layer 132, and / or the protective layer 134).

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

[0065] Surrounding the distal portion of the core 130 can be the sound sensing element 124. In the illustrated embodiment, the sound sensing element 124 can be formed around the core 130 by a circumferential arrangement. In an alternative embodiment, the sound sensing element 124 can be spirally wrapped around the core 130 using a single or multiple layers of piezopolymer tape.

[0066] The electrical insulation layer 136 may be adjacent to the ends 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 electrical insulation layer 136 may be formed around the core 130 by circumferential arrangement or may be spirally wrapped around the core 130 using a single or multiple layer of insulating tape. In some embodiments, the electrical insulation layer 136 is formed from an electrically 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 may be formed from an unpolarized piezoelectric polymer material.

[0067] Surrounding the sound sensing element 124 and the electrical insulation 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 from any suitable biocompatible conductive material, such as titanium, platinum, gold, etc. In some embodiments, the conductive layer 132 can be formed by circumferentially disposing a conductive material on the outer surface of the sound sensing element 124 and the electrical insulation layer 136. In alternative embodiments, the conductive layer 132 can be composed of braided strands of metal, a non-braided spiral wrap 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 an insulating material and function as an electrode 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 can be formed from any suitable biocompatible insulating material, such as parylene, silicone rubber, or ePTFE. Additionally or alternatively, the protective layer 134 can include a hydrophilic coating that improves the transmission of sound 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 mentioned above, the electronics unit 118 can be removably and / or communicatively connected to the mounting unit and / or can be removably and / or communicatively coupled to the sound sensor 110 and / or the electrodes 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 source 152.

[0071] The controller 140 may include, for example, a processing unit, a pulse generator, etc. The controller 140 may be any arrangement of electronic circuits, electronic components, processors, program components, 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 FIGS. 2-3B) to sense one or more sounds of an object (e.g., object 104), instruct the amplifier 144 to amplify any sound signals sensed by the sound sensor 110, instruct the ADC to convert any sound signals sensed by the sound sensor 110 from an analog signal to a digital signal, store any sensed data 143, instruct the communication component 150 to transmit any data corresponding to sounds sensed by the sound sensor 110, etc., and may be implemented in any combination of hardware, software, and / or firmware, for example.

[0072] In an embodiment, controller 140 can 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 special purpose processors (such as microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components. According to an embodiment, controller 140 can include a processing unit configured to communicate with a memory and execute computer-executable instructions stored in the memory. Although controller 140 is referred to in the singular herein, controller 140 may be implemented in multiple instances, distributed across multiple computing devices, instantiated in multiple virtual machines, etc.

[0073] 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 the computer-executable instructions stored in the memory 142.

[0074] In an embodiment, memory 142 includes computer-readable media in the form of volatile and / or non-volatile memory, which can 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 cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, data transmission, and / or any other media that can be used to store information and that can be accessed by a computing device, such as quantum state memory. In an embodiment, 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.

[0075] Computer-executable instructions may include, for example, computer code, digital signal processing, machine-usable instructions, etc., such as program components executable by one or more processors associated with a computing device. The program components may be programmed using any number of different programming environments, including a variety of languages, development kits, frameworks, etc. Some or all of the functionality contemplated herein may be, or alternatively be implemented in, hardware and / or firmware.

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

[0077] 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 shift can be applied to one or both signals as a correction. The time shift adjusts for the delay in propagation time to the sensor due to the finite speed of sound. After the signals are aligned, the aligned signals can be stored as sensed data 143.

[0078] The communication component 150 may be configured to communicate (i.e., transmit and / or receive signals) with the AD 106 and / or any other device. For example, the sensed data 143 may be transmitted to the AD 106 for processing and / or storage. In an embodiment, the communication component 150 may include circuitry, program components, an antenna, and one or more transmitters and / or receivers to wirelessly communicate with one or more other devices, such as, for example, the AD 106. 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, for example, radio frequency (RF) communication, microwave communication, infrared or visible spectrum communication, acoustic communication, inductive communication, conductive communication, etc. 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 source 152 can be any type of power source suitable for providing power to the other operating components (e.g., controller 140, memory 142, amplifier 144, ADC 146, co-registration component 148, and communication component 150) and for providing the desired performance and / or life requirements of the electronics unit 118. In various embodiments, the power source 152 can include one or more batteries that are rechargeable (e.g., using an external energy source). The power source 152 can include one or more capacitors, energy conversion mechanisms, and the like. Additionally or alternatively, the power source 152 can obtain energy from the subject (e.g., subject 104) (e.g., kinetic, thermal, biochemical) and / or from the environment (e.g., electromagnetic).

[0080] 2, the AD 106 is communicatively coupled to the electronics 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 source 164. Similar to the controller 140, the controller 154 may include, for example, a processing unit, a pulse generator, etc. The controller 154 may be any configuration of electronic circuits, electronic components, processors, program components, etc. configured to store and / or execute programming instructions, direct operation of other functional components of the AD 106, store data received by the AD 106 from the electronics unit 118, etc., and may be implemented in any combination of hardware, software, and / or firmware, for example.

[0081] In an embodiment, controller 154 can 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 special purpose 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 an embodiment, controller 154 can include a processing unit configured to communicate with memory 156 and execute computer-executable instructions stored in the memory. Although controller 154 is referred to in the singular herein, controller 154 may be implemented in multiple instances, distributed across multiple computing devices, instantiated in multiple virtual machines, etc.

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

[0083] In an embodiment, memory 156 includes computer readable media in the form of volatile and / or non-volatile memory, which can 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 cassettes, magnetic tapes, magnetic disk storage devices or other magnetic storage devices, data transmission, and / or any other media that can be used to store information and that can be accessed by a computing device, such as quantum state memory. In an embodiment, 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.

[0084] Computer-executable instructions may include computer code, machine-usable instructions, etc., such as, for example, program components executable by one or more processors associated with a computing device. The program components may be programmed using any number of different programming environments, including a variety of languages, development kits, frameworks, etc. Some or all of the functionality contemplated herein may be or alternatively be implemented in hardware and / or firmware.

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

[0086] I / O component 160, along with processing component 158, may include and / or be coupled to a user interface configured to present information to 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 component, such as a microphone, joystick, satellite dish, scanner, printer, wireless device, keyboard, pen, voice input device, touch input device, touch screen device, interactive display device, mouse, etc. As described above, I / O component 160 may be used to present and / or provide an indication of any of the sensed data 143. According to an embodiment, for example, I / O component 160 may include one or more visual indicators (e.g., single color LED lights, multi-color LED lights, flexible digital display devices, etc.) configured to provide information to a user (e.g., by illuminating, flashing, displaying data, etc.).

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

[0088] According to various embodiments, communications 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. Communications component 162 may include any combination of hardware, software, and / or firmware configured to facilitate the establishment, maintenance, and use of any number of communications links.

[0089] The power source 164 provides power to the other operating components (e.g., the controller 154, the memory 156, the processing component 158, the I / O component 160, and the communication component 162), and it can be any type of power source suitable to provide the desired performance and / or life requirements of the AD 106. In various embodiments, the power source 164 can include one or more batteries, which can be rechargeable (e.g., using an external energy source). The power source 164 can include one or more capacitors, energy conversion mechanisms, and the like. In embodiments, the power source 164 can transfer power to the power source 152 using a wireless or non-wireless connection (e.g., via conduction, induction, radio frequency, and the like). Because the electronics unit 118 can be a small device, the power source 152 may not be able to store a lot of power, and therefore the life of the electronics unit 118 can be increased via power transfer from the AD 106 to the electronics unit 118.

[0090] The diagram shown in Figure 4 is not intended to suggest limitations on the scope of use or functionality of the embodiments of the present disclosure, nor should the diagram be interpreted 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 be combined in embodiments with various of the other components shown therein (and / or components not shown), all within the scope of the present disclosure.

[0091] The embodiments disclosed herein have been described both generally and with reference 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 the present disclosure. Therefore, the embodiments are intended to cover the modifications and variations of the present disclosure provided they come within the scope of the appended claims and their equivalents.

Claims

1. a mounting unit configured to be removably connected to the electronics unit, the mounting unit configured to be attached to the skin of a body; and a sound sensor configured to sense sound generated from within the body; the sound sensor includes an in vivo portion and an ex vivo portion, the in vivo portion configured to be inserted through and positioned beneath the skin of a body, 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 ex vivo portion configured to operably connect to an electronics unit when the electronics unit is connected to the mounting unit.

2. The transcutaneous sound sensor system of claim 1 , further comprising 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 a device.

3. The transcutaneous sound sensor system of claim 1 , wherein the mounting unit further comprises electrocardiograph (ECG) electrodes 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 an outer surface of the internal body part includes a hydrophilic coating.

5. The transcutaneous sound sensor system according to claim 1 , wherein the sound sensor has a coaxial structure including multiple layers.

6. The transcutaneous sound sensor system according to claim 5 , wherein the innermost layer of the sensor is a core conductor.

7. The transcutaneous sound sensor system of claim 6 , wherein a second layer of the coaxial structure disposed about the innermost layer is a polarized piezopolymer layer.

8. The transcutaneous sound sensor system of claim 6 , wherein a second layer of the coaxial structure disposed about the innermost layer is a piezo-ceramic layer.

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

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

12. The transcutaneous sound sensor system of claim 11 , wherein the third layer is a spiral layer wound around the second layer.

13. The transcutaneous sound sensor system according to any one of claims 11 to 12, wherein a fourth layer disposed around the third 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 sound sensing element configured to be implanted beneath the skin of a subject, 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 removably and communicatively coupled to the electronics unit; and a protective layer disposed around the sound sensing element; a transcutaneous sound sensor comprising:

16. The transcutaneous sound sensor of claim 15 , wherein the sound sensing element surrounds a core conductor.

17. 17. The transcutaneous sound sensor of claim 16, wherein the sound sensing element is helically wrapped around the core conductor.

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

19. 20. The transcutaneous sound sensor of claim 18, wherein the conductor layer is spirally wrapped 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 of any one of claims 15 to 20, wherein at least a portion of an outer surface of the transcutaneous sound sensor includes a hydrophilic coating.

22. The transcutaneous sound sensor of any one of claims 15 to 21, wherein the sound sensing element is formed from a polarized polyvinylidene fluoride (PVDF) film, a PVDF copolymer (eg PVDF-TrFE) 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. 24. The transcutaneous sound sensor of claim 23, wherein the biocompatible insulating material is at least one of parylene, silicone rubber, or ePTFE.

25. A method of treatment using a transcutaneous sound sensor system, comprising: coupling the electronics unit to the sound sensor; receiving a signal from the electronics unit corresponding to a sound measurement sensed by the sound sensor; and processing the received signal to determine characteristics of the sound measurements; Including, 13. A method according to claim 12, wherein the sound sensor is configured to sense sound originating from within a subject, the sound sensor including an in vivo portion disposed below a skin surface of the subject and an in vivo portion disposed outside the skin surface.

26. 26. The method of claim 25, further comprising implanting the in vivo portion beneath the skin surface and the ex vivo portion exterior to the skin surface.

27. 26. The method of claim 25, further comprising correlating characteristics of the sound measurements to a particular portion of an object.

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