Multi-layer housing seal for ultrasonic transducers

Abstract

Systems, devices, and methods useful in preventing and / or detecting liquid intrusion into ultrasonic equipment are described. Ultrasonic transducers and associated ultrasonic circuitry, which may be located inside an ultrasonic system or device, may be adversely affected by exposure to liquid. As described herein, ultrasonic systems and devices may include a multi-layer seal, for example, the multi-layer seal includes one or more layers for preventing liquid intrusion and one or more layers for detecting liquid intrusion (e.g., the one or more layers for detecting liquid intrusion include an indicator material capable of changing color when exposed to liquid).

Description

[Technical field]

[0001]

[0001] Disinfection of ultrasound equipment is crucial to minimize risks to patients and to maintain a clean environment in which the equipment is used. In particular, it is important to thoroughly clean the exterior surface of the ultrasound probe head to reduce or eliminate the microbial load. Some existing strategies for disinfecting ultrasound equipment include exposing the exterior surface of the equipment to ultraviolet light. However, prolonged and / or repeated exposure to ultraviolet (UV) light can embrittle the plastic materials often used in making ultrasound probe housings and can also reduce the lifespan of the ultrasound equipment. Furthermore, UV light has limited line-of-sight efficacy, which can make the task of thoroughly disinfecting all surfaces of ultrasound system components difficult. In some cases, liquid-based disinfectants can be used to reduce the microbial load on ultrasound equipment. In many cases, it may be necessary to immerse one or more ultrasound system components, including the ultrasound transducer head, in a liquid disinfectant to achieve thorough disinfection of the component surfaces. Repeated or extended exposure of ultrasonic equipment to liquid disinfectants (e.g., immersing an ultrasonic equipment in a liquid-based disinfectant) can be detrimental to the continued function of the equipment. Therefore, improved ultrasonic devices and systems are needed to facilitate thorough disinfection of ultrasonic equipment surfaces while reducing the risk of damage to the equipment. Summary of the Invention [Means for solving the problem]

[0002]

[0002] Sensitive components of an ultrasound transducer head may be at risk of damage if the transducer head housing is not adequately sealed against liquid intrusion. Liquid-based disinfectants and gels pose significant risks to the internal components of ultrasound imaging devices because they are applied to the ultrasound transducer head during and / or between uses of the ultrasound system. High-level disinfectants that may require extended contact with the transducer head, e.g., where the transducer head must be immersed in the disinfectant, are of particular concern. Furthermore, the threat of liquid intrusion may be complicated by the transducer head geometry and fabrication process, which may make the task of sealing the outer shell of the transducer device difficult.

[0003]

[0003] Transducer devices and systems that are compromised by liquid intrusion can often suffer partial or complete failure, for example, due to electrical shorting and / or physical interference between the liquid and the ultrasonic transmission, propagation, or transmission within the components of the ultrasonic transducer (e.g., microelectromechanical systems (MEMS)). In some cases, partial or complete failure of all or a portion of the components of the ultrasonic device due to liquid intrusion can require replacement of the ultrasonic device, which can be extremely costly. Therefore, detection and / or prevention of liquid intrusion into ultrasonic devices can be critical to the economic viability of ultrasonic technology in many medical settings. The devices and systems described herein can be effective in reducing the risk of liquid intrusion into ultrasonic transducer devices and facilitating the identification and / or repair of ultrasonic equipment compromised by liquid intrusion.

[0004] In some aspects, the ultrasound device includes an outer barrier surrounding the ultrasound transducer, the outer barrier including a lens, a housing, and a multi-layer seal in contact with the lens and the housing, the multi-layer seal including a first layer and a second layer, the first layer including an indicator material and the second layer including a first sealant. In some cases, the multi-layer seal further includes a third layer, the third layer including a second sealant. In some cases, the first sealant has a higher viscosity than the second sealant. In some cases, the first sealant is a thixotropic material. In some cases, the first sealant is a silicone-based sealant. In some cases, the outer barrier is impermeable to liquids. In some cases, the second sealant is a silicone-based sealant. In some cases, the first sealant is an adhesive. In some cases, the second sealant is an adhesive. In some cases, the multi-layer seal is disposed in a gap between a lens of the device and a housing of the device. In some cases, the multi-layer seal is in contact with the entire perimeter of the lens. In some cases, the multi-layer seal is in contact with the entire perimeter of the aperture of the housing. In some cases, the second layer is in contact with the housing and the lens. In some cases, the second layer is in contact with the entire perimeter of the lens. In some cases, the second layer is in contact with the entire perimeter of the aperture of the housing. In some cases, the second layer is disposed proximal to the first layer with respect to the ultrasound transducer. In some cases, the third layer is disposed distal to the first layer with respect to the ultrasound transducer. In some cases, the third layer is in contact with the entire perimeter of the lens. In some cases, the third layer is in contact with the entire perimeter of the aperture of the housing. In some cases, the third layer is in contact with the entire distal surface of the second layer. In some cases, the interface of the distal surface of the third layer and the distal surface of the lens is smooth. In some cases, the interface of the distal surface of the third layer and the distal surface of the lens is flat. In some cases, the indicator material includes a material that undergoes a color change after contacting a liquid. In some cases, the indicator material changes from a first color to a second color upon contacting a liquid. In some cases, the liquid is a disinfectant. In some cases, the liquid includes water.In some cases, the ultrasound transducer is coupled to a proximal surface of the lens. In some cases, the lens is an ultrasound acoustic lens. In some cases, the ultrasound transducer comprises a microelectromechanical system (MEMS) array. In some cases, the multi-layer seal has a thickness between 1 μm and 1000 μm. In some cases, the multi-layer seal has a constant thickness. In some cases, the multi-layer seal has a non-constant thickness. In some cases, the first layer has a thickness between 1 μm and 125 μm. In some cases, the first layer has a thickness between 1 μm and 100 μm. In some cases, the first layer has a constant thickness. In some cases, the first layer has a non-constant thickness. In some cases, the second layer has a thickness between 100 μm and 1000 μm. In some cases, the second layer has a thickness less than 750 μm. In some cases, the second layer has a constant thickness. In some cases, the second layer has a non-constant thickness. In some cases, the multi-layer seal has a width between 100 μm and 1000 μm. In some cases, the second layer has a constant width. In some cases, the second layer has a non-constant width. In some cases, the lens is coupled to the ultrasonic transducer. In some cases, the indicator material includes an adhesive. In some cases, the indicator material is adhered to a surface of the ultrasonic transducer. In some cases, the indicator material is adhered to a surface of an ASIC of the ultrasonic device. In some cases, the indicator material is adhered to a surface of a MEMS wafer of the ultrasonic device. In some cases, the indicator material is disposed between the second layer and a third layer.

[0005]

[0005] In some aspects, a method of manufacturing an ultrasonic device includes assembling a housing and a lens to substantially enclose an ultrasonic transducer, where the lens is coupled to the ultrasonic transducer, and applying a multi-layer seal to fill a gap between the housing and the lens, where applying the multi-layer seal includes applying a second layer of the multi-layer seal to one or more inner surfaces of the gap whereby the second layer contacts the entirety of a periphery of the housing facing the gap and the entirety of a periphery of the lens facing the gap, applying a first layer of the multi-layer seal to a distal surface of the second layer, whereby the first layer includes an indicator material, and applying a third layer of the multi-layer seal to the distal surface of the first layer whereby the third layer contacts the entirety of a periphery of the housing facing the gap and the entirety of a periphery of the lens facing the gap. In some embodiments, a method of manufacturing an ultrasonic device includes assembling a housing and a lens to substantially enclose a plurality of internal components, the plurality of internal components including an ultrasonic transducer coupled to the lens, and applying a multi-layer seal to fill a gap between the housing and the lens, where applying the multi-layer seal includes applying a first layer of the multi-layer seal to a distal surface of one or more of the internal components, the first layer including an indicator material, and applying a second layer of the multi-layer seal to one or more inner surfaces of the gap, whereby the second layer contacts the entirety of the periphery of the housing facing the gap and the entirety of the periphery of the lens facing the gap. In some cases, the method further includes applying a third layer of the multi-layer seal to a distal surface of the first layer, whereby the third layer contacts the entirety of the periphery of the housing facing the gap and the entirety of the periphery of the lens facing the gap. In some cases, the method further includes coupling the lens to the ultrasonic transducer. In some cases, the method further includes smoothing a distal surface of the multi-layer seal at the interface of the third layer and the housing.In some cases, the method further includes smoothing a distal surface of the multi-layer seal at the interface of the third layer and the lens. In some cases, the second layer is thixotropic. In some cases, the third layer is self-leveling. In some cases, the second layer includes a material having a higher viscosity than the material that makes up the third layer. In some cases, the second layer is applied using a dispensing needle. In some cases, the indicator material undergoes a color change after contacting a liquid. In some cases, the liquid includes a disinfectant. In some cases, the liquid includes water. In some cases, the first layer has a thickness of 150 micrometers or less. In some cases, the multi-layer seal has a thickness of 1,000 micrometers or less.

[0006] In some aspects, a method of detecting liquid intrusion in an ultrasonic device includes contacting a distal surface of an outer barrier of an ultrasonic device with a liquid, the outer barrier comprising a multi-layer seal disposed in a gap between a lens and a housing and coupled to the lens and the housing, the multi-layer seal comprising a first layer and a second layer, the first layer comprising an indicator material and the second layer comprising a sealant, and observing a color change in the indicator material of the first layer. In some cases, the distal surface of the outer barrier is contacted with the liquid for between 0.1 hours and 1 hour. In some cases, the liquid comprises water. In some cases, the liquid comprises a low-level disinfectant. In some cases, the distal surface of the outer barrier is contacted with the liquid for between 1 hour and 24 hours. In some cases, the liquid comprises water. In some cases, the liquid comprises a high-level disinfectant. In some cases, the method further includes replacing all or a portion of the outer barrier.

[0007] A better understanding of the features and advantages of the present subject matter will be obtained with reference to the following detailed description, which sets forth illustrative embodiments and the accompanying drawings. [Brief description of the drawings]

[0008] [Figure 1] 1 is a schematic diagram of an ultrasonic device according to an embodiment. [Diagram 2]

[0009] 1 is a schematic diagram of an ultrasonic device comprising a housing, a multi-layer seal, and a lens, according to an embodiment. [Diagram 3]

[0010] 1 is a cross-sectional view of an ultrasonic device including a housing, a multi-layer seal, and a lens, according to an embodiment. [Figure 4]

[0011] 1 is a schematic diagram of a distal end of an ultrasound device comprising a housing, a multi-layer seal, and a lens, according to an embodiment. [Diagram 5]

[0012] FIG. 1 illustrates a portion of an ultrasonic device including a housing, a multi-layer seal, and a lens, according to an embodiment. [Figure 6]

[0013] FIG. 1 illustrates a portion of an ultrasonic device including a housing, a multi-layer seal, and a lens, according to an embodiment. [Figure 7]

[0014] FIG. 1 illustrates a portion of an ultrasonic device including a housing, a multi-layer seal, and a lens, according to an embodiment. [Figure 8]

[0015] 1 is an image of an indicator material showing color change after exposure to a high-level disinfectant for 24 hours, according to an embodiment. [Figure 9A]

[0016] 1A-1D illustrate steps of a method for making an outer barrier of an ultrasonic device that includes a multi-layer seal, according to an embodiment. [Figure 9B]

[0017] 1A-1D illustrate steps of a method for making an outer barrier of an ultrasonic device that includes a multi-layer seal, according to an embodiment. [Figure 10]

[0018] FIG. 1 is a schematic diagram of a computer system, according to an embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009]

[0019] Systems, devices, and methods for improved barrier function in ultrasound imaging applications are described herein. Ultrasonic devices 100, 200 and systems are frequently brought into contact with liquids during use, and intrusion of such liquids into the interior of the ultrasonic device can adversely affect the function of the device and possibly destroy sensitive electronic components located within the housing 231 of the device 100, 200 (e.g., ultrasonic transducers 102, 202, and / or associated electrical circuitry 106, as shown in Figs. 1 and 2). In addition to direct contact with ultrasonic imaging media such as acoustic gel and / or bodily fluids, ultrasonic devices and systems used in medical settings may require prolonged and / or repeated disinfection to protect patients from pathogens that may be present on the outer surface of the ultrasonic device. As described herein, ultrasonic devices with a multi-layer seal 240 can have increased protection against liquid intrusion, for example, compared to devices and systems that use some existing sealing techniques. In many cases, the devices, systems, and methods disclosed herein can significantly improve detection of liquid intrusion and / or compromised liquid barriers of ultrasonic devices and systems. In some cases, detection of liquid intrusion and / or a compromised liquid barrier of an ultrasound device or system can reduce the risk that an ultrasound system or device that malfunctions due to liquid intrusion is used to collect data in a medical setting. In some cases, detection of liquid intrusion and / or a compromised liquid barrier of an ultrasound device or system can enable repair of the device or system before one or more components (e.g., the ultrasound transducer or electronic device) are damaged or destroyed. overview

[0020] The ultrasonic system 100 or a component thereof, for example, an ultrasonic device 200, such as an ultrasonic probe, can include a multi-layer seal 240. Ultrasonic systems and devices with a multi-layer seal 240 can have improved resistance to liquid intrusion. As shown in FIG. 2, the ultrasonic system 100 can include an outer barrier. The outer barrier of the ultrasonic system or device can be placed in contact with one or more liquids, such as ultrasonic acoustic gel, bodily fluids, and / or one or more disinfectants (e.g., liquid disinfectants), during or between uses. In many cases, the outer barrier of the ultrasonic system or device can be the primary barrier against liquid intrusion into the interior of the ultrasonic system or device. One or more components located inside the ultrasonic system or device (e.g., ultrasonic transducer 202 (which may comprise a microelectromechanical system (MEMS) array), application specific integrated circuit (ASIC), printed circuit board, analog processing components (e.g., analog front end 228 (AFE)), electronic memory 236, computer processor 226, battery 238, communication circuitry 232, and / or communication port 234) may be sensitive to exposure to liquids and, in some cases, may be damaged by liquids breaching the outer barrier. In many cases, the multi-layer seal 240 may form an integral part of the outer barrier of the ultrasonic system or device. In some cases, the outer barrier comprising the multi-layer seal 240 may reduce (e.g., prevent) the possibility of damage to the internal components (e.g., including the ultrasonic transducer and / or ASIC of the system or device), for example, as a result of liquid intrusion. In some cases, the multi-layer seal 240 may improve maintenance and / or error diagnosis of the ultrasonic system or device.For example, the multi-layer seal 240 can, in some cases, provide an indication (e.g., a visual indication) that a liquid (e.g., water or a disinfectant such as a high-level disinfectant) has crossed the outer surface of the outer barrier and / or that liquid intrusion into the interior of the ultrasound system or device has occurred.

[0010]

[0021] An outer barrier of an ultrasonic system component or device can include a multi-layer seal 240. In some cases, the outer barrier of an ultrasonic system or device can include a housing 231 and a lens 222 (e.g., the lens optionally includes a coating layer). In some cases, the multi-layer seal 240 can be in contact with the housing 231 and the lens 222 of the ultrasonic system 100 or device 200, for example, to establish an uninterrupted outer barrier surrounding one or more internal components of the ultrasonic system 100 or device 200 (e.g., including the ultrasonic transducer 202). In some cases, the multi-layer seal 240 can be in contact with the entire outer periphery (e.g., circumferential periphery) of the lens 222 (e.g., as shown in FIG. 4). In some cases, the multi-layer seal 240 can be in contact with the entire outer periphery of the housing 231 (e.g., the inner periphery of the aperture of the housing, as shown in FIG. 4). In some cases, the multi-layer seal 240 may be disposed in a gap 301 between the lens 222 of an ultrasonic device and the housing 231 of an ultrasonic device, as shown, for example, in FIG. 3. Some embodiments of the multi-layer seal 240 disposed in the gap 301 of an ultrasonic device may be seen in FIGS. 5, 6, and 7, which are enlarged views of the area of ​​FIG. 3 indicated by the dotted line box. In some cases, the gap 301 of an ultrasonic device or system may have a thickness 302 (e.g., in the z-direction, as shown in FIGS. 5, 6, 7) of 1 micrometer (μm) to 1,000 micrometers. In some cases, the gap 301 of an ultrasonic device or system may have a thickness 302 of 1 micrometer to 25 micrometers, 1 micrometer to 50 micrometers, 1 micrometer to 100 micrometers, 1 micrometer to 150 micrometers, 1 micrometer to 200 micrometers, 1 micrometer to 250 micrometers, 1 micrometer to 500 micrometers, 1 micrometer to 750 micrometers, 1 micrometer to 1,000 micrometers, 1 micrometer to 250 micrometers, 1 micrometer to 30 ...250 micrometers, 1 micrometer to 300 micrometers, 1 micrometer000 micrometers, 25 micrometers to 50 micrometers, 25 micrometers to 100 micrometers, 25 micrometers to 150 micrometers, 25 micrometers to 200 micrometers, 25 micrometers to 250 micrometers, 25 micrometers to 500 micrometers, 25 micrometers to 750 micrometers, 25 micrometers to 1,000 micrometers, 50 micrometers to 100 micrometers, 50 micrometers to 150 micrometers, 50 micrometers to 200 micrometers, 50 micrometers to 250 micrometers, 50 micrometers to 500 micrometers, 50 micrometers to 750 micrometers, 50 micrometers to 1,000 micrometers, 100 micrometers to 150 micrometers, 100 micrometers to 200 micrometers, 100 micrometers to 250 micrometers, 00 micrometers to 500 micrometers, 100 micrometers to 750 micrometers, 100 micrometers to 1,000 micrometers, 150 micrometers to 200 micrometers, 150 micrometers to 250 micrometers, 150 micrometers to 500 micrometers, 150 micrometers to 750 micrometers, 150 micrometers to 1,000 micrometers, 200 micrometers to 250 micrometers, 200 micrometers to 500 micrometers, 200 micrometers to 750 micrometers, 200 micrometers to 1,000 micrometers, 250 micrometers to 500 micrometers, 250 micrometers to 750 micrometers, 250 micrometers to 1,000 micrometers, 500 micrometers to 750 micrometers, 500 micrometers to 1,000 micrometers, or 750 micrometers to 1,In some cases, the gap 301 of the ultrasonic device or system may have a thickness 302 of 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a thickness 302 of at least 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system can have a thickness 302 of at most 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system can have a thickness 302 (e.g., in the z-direction, as shown in Figures 5, 6, and 7) of between 1 micrometer (μm) and 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may be between 1 micrometer and 1,250 micrometers, between 1 micrometer and 1,500 micrometers, between 1 micrometer and 1,700 micrometers, between 1 micrometer and 2,000 micrometers, between 1,000 micrometers and 1,250 micrometers, between 1,000 micrometers and 1,500 micrometers, between 1,000 micrometers and 1,750 micrometers, between 1,000 micrometers and 2,000 micrometers, between 1,250 micrometers and 1,500 micrometers, between 1,250 micrometers and 1,750 micrometers, between 1,250 micrometers and 2,000 micrometers, between 1,500 micrometers and 1,750 micrometers, between 1,In some cases, the gap 301 of the ultrasonic device or system may have a thickness 302 of 500 micrometers to 2,000 micrometers, or 1,750 micrometers to 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a thickness 302 of 1,250 micrometers, 1,500 micrometers, 1,750 micrometers, or 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a thickness 302 of at least 1,250 micrometers, 1,500 micrometers, 1,750 micrometers, or 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a thickness 302 of at most 1 micrometer, 1,250 micrometers, 1,500 micrometers, 1,750 micrometers, or 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system can have a width 303 (e.g., in the x- or y-direction, as shown in Figures 4, 5, 6, 7) between 1 micrometer (μm) and 1,000 micrometers. In some cases, the thickness 302 can be a minimum thickness 302a, a maximum thickness 302b, or an average thickness (e.g., at a particular location of the gap 301 or evaluated over all or a portion of the length of the gap 301, e.g., the length being perpendicular to the thickness and width of the gap 301). In some cases, the gap 301 of the ultrasonic device or system can have a width between 1 micrometer and 25 micrometers, between 1 micrometer and 50 micrometers, between 1 micrometer and 100 micrometers, between 1 micrometer and 150 micrometers, between 1 micrometer and 200 micrometers, between 1 micrometer and 250 micrometers, between 1 micrometer and 500 micrometers, between 1 micrometer and 750 micrometers, between 1 micrometer and 1,000 micrometers, 25 micrometers to 50 micrometers, 25 micrometers to 100 micrometers, 25 micrometers to 150 micrometers, 25 micrometers to 200 micrometers, 25 micrometers to 250 micrometers, 25 micrometers to 500 micrometers, 25 micrometers to 750 micrometers, 25 micrometers to 1,000 micrometers, 50 micrometers to 100 micrometers, 50 micrometers to 150 micrometers, 50 micrometers to 200 micrometers, 50 micrometers to 250 micrometers, 50 micrometers to 500 micrometers, 50 micrometers to 750 micrometers, 50 micrometers to 1,000 micrometers, 100 micrometers to 150 micrometers, 100 micrometers to 200 micrometers, 100 micrometers to 250 micrometers, 00 micrometers to 500 micrometers, 100 micrometers to 750 micrometers, 100 micrometers to 1,000 micrometers, 150 micrometers to 200 micrometers, 150 micrometers to 250 micrometers, 150 micrometers to 500 micrometers, 150 micrometers to 750 micrometers, 150 micrometers to 1,000 micrometers, 200 micrometers to 250 micrometers, 200 micrometers to 500 micrometers, 200 micrometers to 750 micrometers, 200 micrometers to 1,000 micrometers, 250 micrometers to 500 micrometers, 250 micrometers to 750 micrometers, 250 micrometers to 1,000 micrometers, 500 micrometers to 750 micrometers, 500 micrometers to 1,000 micrometers, or 750 micrometers to 1,In some cases, the gap 301 of the ultrasonic device or system may have a width 303 of 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a width 303 of at least 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a width 303 of at most 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. The gap 301 of the ultrasonic device or system can have a width 303 (e.g., in the x or y direction, as shown in Figures 4, 5, 6, and 7) of 1 micrometer (μm) to 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system can have a width 303 between 1 micrometer and 1,250 micrometers, between 1 micrometer and 1,500 micrometers, between 1 micrometer and 1,700 micrometers, between 1 micrometer and 2,000 micrometers, between 1,000 micrometers and 1,250 micrometers, between 1,000 micrometers and 1,500 micrometers, between 1,000 micrometers and 1,750 micrometers, between 1,000 micrometers and 2,000 micrometers, between 1,250 micrometers and 1,500 micrometers, between 1,250 micrometers and 1,750 micrometers, between 1,250 micrometers and 2,000 micrometers, between 1,500 micrometers and 1,750 micrometers, between 1,500 micrometers and 2,000 micrometers, or between 1,750 micrometers and 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a width 303 of 1,250 micrometers, 1,500 micrometers, 1,750 micrometers, or 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a width 303 of at least 1,250 micrometers, 1,500 micrometers, 1,750 micrometers, or 2,000 micrometers. In some cases, the gap 301 of the ultrasonic device or system may have a width 303 of at most 1 micrometer, 1,250 micrometers, 1,500 micrometers, 1,750 micrometers, or 2,000 micrometers.

[0011]

[0022] In many cases, an outer barrier (e.g., a continuous outer barrier surrounding one or more internal components of the ultrasonic system 100 or device 200) can resist or prevent ingress of liquid (e.g., water and / or liquid disinfectant) into the interior of the ultrasonic system 100 or device 200. In some cases, an interface 251 (e.g., a watertight interface) between the multi-layer seal 240 and the lens 222 can prevent liquid from passing between the multi-layer seal 240 and the lens 222. In some cases, an interface 252 (e.g., a watertight interface) between the multi-layer seal 240 and the housing 231 can prevent liquid from passing between the multi-layer seal 240 and the housing 231. In some cases, the outer surface (e.g., distal surface) of the outer barrier at interface 251 between multi-layer seal 240 and lens 222 can be smooth (e.g., the tangent to the distal surface of multi-layer seal 240 at interface 251 has an angle equal to or substantially equal to (e.g., differs by less than 5 degrees) the angle of the tangent to the distal surface of lens 222 at interface 251), as shown, for example, in Figures 5 and 6. In some cases, the outer surface (e.g., distal surface) of the outer barrier at interface 252 between multi-layer seal 240 and housing 231 can be smooth (e.g., the tangent to the distal surface of multi-layer seal 240 at interface 252 has an angle equal to or substantially equal to (e.g., differs by less than 5 degrees) the angle of the tangent to the distal surface of housing 231 at interface 252), as shown, for example, in Figures 5 and 6. Matching the angle of the tangent of the distal surface of the multi-layer seal 240 with the angle of the tangent of the distal surface of the housing 231 and / or lens 222 (e.g., to create a smooth distal surface of the outer barrier) can help reduce the likelihood of water ingress (e.g., reduce the likelihood of adhesive failure at the interfaces 251, 252 that could result in water ingress), can make low-level disinfection (e.g., including the use of disinfectant wipes) easier to perform correctly, and can make the ultrasonic device more comfortable for the patient's skin during use. In some cases, the distal surface of the outer barrier (or a portion thereof) can be curved, for example, as shown in FIG. 5.In some cases, the distal surface of the outer barrier (or a portion thereof) may be flat, for example as shown in FIG.

[0012]

[0023] In some cases, the multi-layer seal 240 can enable detection of liquid intrusion into or through the outer barrier. In some cases, detection of liquid intrusion into an ultrasonic device (e.g., an ultrasonic probe head) can enable identification of an ultrasonic device that may require maintenance (e.g., due to liquid intrusion) or replacement (e.g., due to damage to one or more internal components due to liquid intrusion) of all or a portion of the device (e.g., all or a portion of the device's outer barrier). In some cases, detection of liquid intrusion can prevent inadvertent use of an ultrasonic system or device that is no longer calibrated and / or no longer capable of functioning accurately (e.g., as a result of liquid intrusion). In some cases, the first layer 242 of the multi-layer seal 240 can be useful in detecting liquid intrusion. For example, the first layer 242 of the multi-layer seal 240 can comprise an indicator material (e.g., an indicator film). In some cases, the indicator material (e.g., an indicator film) of the first layer 242 of the multi-layer seal 240 can undergo a color change upon contact with a liquid (e.g., the liquid includes a disinfectant or the liquid includes water). For example, the indicator material of the first layer 242 can undergo a color change upon contact with a disinfectant (e.g., a low-level disinfectant or a high-level disinfectant). In some cases, the indicator material of the first layer 242 can undergo a color change upon contact with a first liquid and cannot undergo a color change upon contact with a second liquid. In some cases, the indicator material of the first layer 242 can undergo a color change upon contact with water. For example, in some cases, the indicator material of the first layer 242 can undergo a color change upon contact with a first disinfectant (e.g., a high-level disinfectant) and cannot undergo a color change upon contact with a second disinfectant (e.g., a low-level disinfectant). In some cases, the indicator material of the first layer 242 can undergo a color change upon contact with a low-level disinfectant and cannot undergo a color change upon contact with a high-level disinfectant. In some cases, the indicator material of the first layer 242 may undergo a color change upon contact with a first liquid (e.g., a high-level disinfectant or a low-level disinfectant) and may not undergo a color change upon contact with a second liquid (e.g., water).For example, the indicator material of the first layer 242 may undergo a color change upon contact with a first liquid (e.g., water) and may not undergo a color change upon contact with a second liquid (e.g., high-level or low-level disinfectant). In some cases, the indicator material of the first layer 242 may change from a first color to a second color upon contact with a liquid (e.g., a specific liquid such as water or a specific disinfectant) or upon contact with any liquid. In some cases, the indicator material of the first layer 242 may change from a first shade of a first color to a second shade of a second color upon contact with a liquid (e.g., a specific liquid such as water or a specific disinfectant) or upon contact with any liquid. In some cases, the color change of the first layer (e.g., an indicator film or strip) may be due to wetting of the first layer by a liquid (e.g., a liquid placed in contact with an exterior surface of the ultrasound system or device during or during use). In some cases, the color change of the first layer (e.g., an indicator film or strip) can result from a chemical reaction between the material of the first layer and a liquid or component of a liquid (e.g., a liquid or component of a liquid placed in contact with an exterior surface of the ultrasound system or device during or between uses). In some cases, the first color can be white, yellow, or brown. In some cases, the second color can be yellow, brown, or black. For example, the indicator material can change from a first color, white, to a second color, yellow, in some cases (e.g., when the indicator material comes into contact with or is incubated in contact with a liquid, such as a disinfectant). In some cases, the first color can be clear (e.g., colorless). In some cases, the second color can be clear (e.g., colorless). In some cases, the first layer 242 and / or the indicator material of the first layer 242 (e.g., comprising the indicator film or strip) can include a silicone or silicone-based material.In some cases, first layer 242 and / or the indicator material of first layer 242 can include one or more silicone-based materials selected from ASI 505 (American Sealants, Inc.), ASI 306 (American Sealants, Inc.), ASI 388 (American Sealants, Inc.), Dow 734 (Dow Corning DOWSIL™ 734 Flowable Sealant), SS-154 (Silicone Solutions, Inc.), SS-265 (Silicone Solutions, Inc.), SS-6604 (Silicone Solutions, Inc.), or SS-18 (Silicone Solutions, Inc.). For example, the first layer can include a silicone-based material including SS-18 (e.g., the silicone-based material includes an indicator material (e.g., an indicator film or strip) of the first layer 242) (e.g., as shown in FIG. 8, the second color is yellow after the silicone-based material is contacted with a high-level disinfectant, such as, for example, a disinfectant including benzene-1,2-dicarbaldehyde (e.g., a phthalaldehyde, which can be ortho-phthalaldehyde (OPA)). In some cases, the first layer 242 can include a silicone-based material including SS-6604 (e.g., the silicone-based material includes an indicator material (e.g., an indicator film or strip) of the first layer 242) (e.g., the second color is yellow after the silicone-based material is contacted with a high-level disinfectant, such as, for example, a disinfectant including benzene-1,2-dicarbaldehyde (e.g., OPA)). In some cases, the first layer 242 can include a silicone-based material including SS-265 (e.g., the silicone-based material includes an indicator material (e.g., an indicator film or strip) of the first layer 242) (e.g., the second color is brown after the silicone-based material contacts a high-level disinfectant, such as a disinfectant including benzene-1,2-dicarbaldehyde (e.g., OPA)).In some cases, the first layer 242 can include a silicone-based material that includes ASI 306 (e.g., the silicone-based material includes an indicator material (e.g., an indicator film or strip) of the first layer 242) (e.g., the second color is yellow after the silicone-based material is contacted with a high-level disinfectant, such as a disinfectant that includes benzene-1,2-dicarbaldehyde (e.g., OPA)). In some cases, the first layer 242 can include a silicone-based material that includes ASI 388 (e.g., the silicone-based material includes an indicator material (e.g., an indicator film or strip) of the first layer 242) (e.g., the second color is yellow after the silicone-based material is contacted with a high-level disinfectant, such as a disinfectant that includes benzene-1,2-dicarbaldehyde (e.g., OPA)). In some cases, the silicone-based materials described herein (e.g., including components of first layer 242, second layer 244, and / or third layer 246) can include a "one-part" silicone material (e.g., a one-part silicone-based adhesive or sealant) that can comprise a first part (e.g., a rubber base) and a second part (e.g., a curing agent). In some cases, a one-part silicone material can be advantageous for use as a component of first layer 242 (or second layer 244 or third layer 246), for example, because in some cases, the one-part silicone material (e.g., a one-part silicone-based adhesive or sealant) can be translucent or transparent when cured and / or because the one-part silicone material can cure quickly and / or without the need for mixing. In some cases, the silicone-based materials described herein (e.g., including components of first layer 242, second layer 244, and / or third layer 246) can include a "two-part" silicone that can comprise a first part (e.g., a silicone rubber base) and a second part (e.g., a curing agent). In some cases, first layer 242 and / or the indicator material of first layer 242 can include a self-leveling adhesive, e.g., a silicone-based self-leveling adhesive such as SS-18.In some cases, the first layer 242 and / or the indicator material of the first layer 242 may include a thixotropic adhesive, e.g., a silicone-based thixotropic adhesive such as SS-19. In some cases, the silicone-based material (e.g., including the components of the first layer 242, the second layer 244, and / or the third layer 246) may utilize one or more of a moisture cure system, an ultraviolet UV cure system, a heat cure system, and / or a room-temperature-vulcanizing (RTV) silicone cure system. For example, a one-part silicone-based material may use moisture in the air to cure in some embodiments.

[0013]

[0024] In some cases, the first layer 242 (e.g., the first layer includes an indicator material) can be in direct contact with an internal component of an ultrasonic system or device. In some cases, the first layer 242 can be the most proximal layer of the multi-layer seal 240. For example, the first layer 242 of the multi-layer seal 240 can be in direct contact with a proximal surface of the second layer 244 of the multi-layer seal 240 and a distal surface of an internal component of the ultrasonic system or device, as shown, for example, in FIGS. 5 and 6. In some cases, the first layer 242 of the multi-layer seal 240 can be in direct contact with a proximal surface of the second layer 244 of the multi-layer seal 240 and not in direct contact with the third layer 246 of the multi-layer seal 240 (e.g., as shown in FIGS. 5 and 6). In some cases, the first layer 242 of the multi-layer seal 240 can be in direct contact with the second layer 244 of the multi-layer seal 240 (e.g., a distal surface of the second layer 244) and in direct contact with the third layer 246 of the multi-layer seal 240 (e.g., a proximal surface of the third layer 246) (e.g., as shown in FIG. 7, for example). In some cases, positioning the first layer 242 of the multi-layer seal 240 between the second layer 244 and the third layer 246 of the multi-layer seal 240 can provide an indication of liquid intrusion when liquid has crossed some but not all layers of the multi-layer seal 240 that can prevent liquid flow across the outer barrier that comprises the multi-layer seal 240, which can facilitate repair of a partially compromised outer barrier before internal components are affected (e.g., damaged) by the liquid intrusion.

[0014]

[0025] The first layer 242 may be in contact with an internal component of an ultrasonic system or device. For example, the first layer 242 may be in contact with a MEMS transducer array 202, a MEMS wafer, or an ASIC 106, or a thermal management component 268 of an ultrasonic system or device. In some cases, the first layer 242 may be placed in contact with (e.g., adhered to) an internal component of an ultrasonic system or device before the second layer 244 (or third layer 246) of the multi-layer seal 240 is placed in contact with the first layer 242. In some cases, the first layer 242 may include an adhesive. In some cases, the first layer 242 is applied to the internal component of the ultrasonic system or device such that there are no wrinkles or gaps between the first layer and the internal component and / or the housing and / or the lens. In some cases, even when one or more wrinkles or gaps (e.g., due to wrinkling, perforation, or tearing of the first layer 242) exist between the first layer 242 and the internal components and / or housing and / or lens, the multi-layer seal can still effectively reduce the possibility of liquid intrusion (and / or provide an indication of liquid intrusion) into the interior of the ultrasound system or device, for example, because the second layer 244 (and, in some cases, the third layer 246) can provide the liquid barrier function of the multi-layer seal 240. This can be an advantage over other approaches, such as the use of a rubber or plastic gasket instead of the multi-layer seal 240. In some cases, the second layer 244, which can be a thixotropic material, can be in contact with the entire (e.g., distal) surface of the first layer 242, for example, even when the first layer 242 is wrinkled, perforated, or torn.

[0015]

[0026] In some cases, the first layer 242 (eg, including the indicator material) can have a thickness (eg, in the z-direction, as shown in Figures 5 and 6) of between 1 micrometer (μm) and 150 micrometers. In some cases, the first layer (e.g., including the indicator material) can have a thickness of 1 micrometer to 25 micrometers, 1 micrometer to 50 micrometers, 1 micrometer to 75 micrometers, 1 micrometer to 100 micrometers, 1 micrometer to 125 micrometers, 1 micrometer to 150 micrometers, 25 micrometers to 50 micrometers, 25 micrometers to 75 micrometers, 25 micrometers to 100 micrometers, 25 micrometers to 125 micrometers, 25 micrometers to 150 micrometers, 50 micrometers to 75 micrometers, 50 micrometers to 100 micrometers, 50 micrometers to 125 micrometers, 50 micrometers to 150 micrometers, 75 micrometers to 100 micrometers, 75 micrometers to 125 micrometers, 75 micrometers to 150 micrometers, 100 micrometers to 125 micrometers, 100 micrometers to 150 micrometers, or 125 micrometers to 150 micrometers. In some cases, the first layer (e.g., including the indicator material) can have a thickness of 1 micrometer, 25 micrometers, 50 micrometers, 75 micrometers, 100 micrometers, 125 micrometers, or 150 micrometers. In some cases, the first layer (e.g., including the indicator material) can have a thickness of at least 1 micrometer, 25 micrometers, 50 micrometers, 75 micrometers, 100 micrometers, 125 micrometers, or 150 micrometers. In some cases, the first layer (e.g., including the indicator material) can have a thickness of at most 1 micrometer, 25 micrometers, 50 micrometers, 75 micrometers, 100 micrometers, 125 micrometers, or 150 micrometers.In some cases, the first layer (e.g., including the indicator material) can have a width that is 10 percent to 100 percent (e.g., in the x-direction and / or y-direction, as shown in FIG. 4 ) of the width 303 of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a width that is 10 percent to 25 percent, 10 percent to 50 percent, 10 percent to 75 percent, 10 percent to 100 percent, 25 percent to 50 percent, 25 percent to 75 percent, 25 percent to 100 percent, 50 percent to 75 percent, 50 percent to 100 percent, or 75 percent to 100 percent of the width of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a width that is 10 percent, 25 percent, 50 percent, 75 percent, or 100 percent of the width of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a width that is at least 10 percent, 25 percent, 50 percent, 75 percent, or 100 percent of the width of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a width that is at most 10 percent, 25 percent, 50 percent, 75 percent, or 100 percent of the width of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a thickness that is between 5 percent and 100 percent of the thickness 302 of the gap 301.In some cases, the first layer (e.g., including the indicator material) can have a thickness of 5 percent to 12 percent, 5 percent to 25 percent, 5 percent to 37 percent, 5 percent to 50 percent, 5 percent to 75 percent, 5 percent to 100 percent, 12 percent to 25 percent, 12 percent to 37 percent, 12 percent to 50 percent, 12 percent to 75 percent, 12 percent to 100 percent, 25 percent to 37 percent, 25 percent to 50 percent, 25 percent to 75 percent, 25 percent to 100 percent, 37 percent to 50 percent, 37 percent to 75 percent, 37 percent to 100 percent, 50 percent to 75 percent, 50 percent to 100 percent, or 75 percent to 100 percent of the thickness 302 of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a thickness of 5 percent, 12 percent, 25 percent, 37 percent, 50 percent, 75 percent, or 100 percent of the thickness 302 of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a thickness of at least 5 percent, 12 percent, 25 percent, 37 percent, 50 percent, 75 percent, or 100 percent of the thickness 302 of the gap 301. In some cases, the first layer (e.g., including the indicator material) can have a thickness of at most 5 percent, 12 percent, 25 percent, 37 percent, 50 percent, 75 percent, or 100 percent of the thickness 302 of the gap 301.

[0016]

[0027] The multi-layer seal 240 can include a second layer 244. In some cases, the second layer 244 can function as a barrier against liquid intrusion into an internal compartment or space of an ultrasonic system or device. In some cases, the second layer 244 can be disposed in a gap 301 between the lens 222 and the housing 231 (e.g., at the distal end of the ultrasonic device). In some cases, the second layer 244 of the multi-layer seal 240 can be an adhesive. For example, the second layer 244 of the multi-layer seal 240 can be adhered (e.g., strongly adhered) to a sidewall of the housing 231 of the ultrasonic device (e.g., a sidewall of an aperture of the housing 231). In some cases, the second layer 244 of the multi-layer seal 240 can be adhered (e.g., strongly adhered) to a sidewall of the lens 222 of the ultrasonic device. In some cases, the second layer 244 of the multi-layer seal 240 can be adhered (e.g., strongly adhered) to a surface of an internal component of the ultrasonic device. In some cases, the second layer 244 can include a material that can flow under pressure (e.g., a material having a high viscosity, such as a thixotropic material). In some cases, the second layer 244 can include a highly viscous material. In some cases, the second layer 244 can include a material that will deform under pressure, but will not flow in the absence of applied pressure. In some cases, a material that will deform under pressure allows the material to be deposited over a desired area. In some cases, a material that will deform under pressure allows the material to fill gaps, crevices, wrinkles, or undulations in the surface to which the material is applied. In some cases, a material that will not flow in the absence of applied pressure is useful as a second layer material, for example, because the material will not flow inside the ultrasonic device after it is deposited in the gap 301. In some cases, the second layer 244 can include a silicone or silicone-based material. For example, the material of the second layer 244 can include silicone. In some cases, the second layer can include a sealant (eg, a silicone-based sealant) or adhesive (eg, a silicone-based adhesive).In some cases, the second layer 244 can include a thixotropic silicone-based material (e.g., to allow complete filling of wrinkles, holes, undulations, and / or gaps where the material is deposited or applied, optionally while reducing spontaneous flow from the site of application or deposition, e.g., to allow flow under pressure but limit flow of material when the pressure is removed). In some cases, the second layer 244 can include a self-leveling silicone-based material. In some cases, the second layer 244 (e.g., the second layer silicone-based sealant or silicone-based adhesive) can include one or more silicone-based materials selected from ASI 505 (American Sealants, Inc.), ASI 306 (American Sealants, Inc.), ASI 388 (American Sealants, Inc.), Dow 734 (Dow Corning DOWSIL™ 734 Flowable Sealant), SS-154 (Silicone Solutions, Inc.), SS-265 (Silicone Solutions, Inc.), SS-6604 (Silicone Solutions, Inc.), or SS-18 (Silicone Solutions, Inc.). In some cases, the second layer 244 can include a one-part silicone material. In some cases, the material of the second layer 244 can be translucent. In some cases, the material of the second layer 244 can be transparent (e.g., clear).

[0017]

[0028] In some cases, the second layer 244 (e.g., a proximal surface of the second layer 244) may be in contact with all or a portion of a surface of the first layer 242 (e.g., a distal surface of the first layer 242), for example, as shown in Figures 5 and 6. In some cases, the second layer 244 (e.g., a proximal surface of the second layer 244) may be in contact with all or a portion of a surface (e.g., a distal surface) of an internal component of an ultrasonic device (e.g., an ultrasonic transducer, a MEMS wafer, a MEMS array, or an ASIC), for example, as shown in Figure 7. In some cases, the distal surface of the second layer 244 may be in contact with all or a portion of a surface of the first layer (e.g., as shown in Figure 7). In some cases, the distal surface of the second layer 244 may be in contact with all or a portion of a surface of a third layer (e.g., as shown in Figures 5 and 6).

[0018]

[0029] In some cases, the second layer 244 of the multi-layer seal 240 can have a thickness (eg, in the z-direction, as shown in FIGS. 5 and 6) of between 1 micrometer (μm) and 1,000 micrometers. In some cases, the second layer 244 may have a thickness of 1 micrometer to 25 micrometers, 1 micrometer to 50 micrometers, 1 micrometer to 100 micrometers, 1 micrometer to 150 micrometers, 1 micrometer to 200 micrometers, 1 micrometer to 250 micrometers, 1 micrometer to 500 micrometers, 1 micrometer to 750 micrometers, 1 micrometer to 1,000 micrometers, 25 micrometers to 50 micrometers, 25 micrometers to 100 micrometers, 25 micrometers to 150 micrometers, 25 micrometers to 200 micrometers, 25 micrometers to 250 micrometers, 25 micrometers to 500 micrometers, 25 micrometers to 750 micrometers, 25 micrometers to 1,000 micrometers, 50 micrometers to 100 micrometers, 50 micrometers to 150 micrometers, 50 micrometers to ... 0.0 to 200 micrometers, 50 micrometers to 250 micrometers, 50 micrometers to 500 micrometers, 50 micrometers to 750 micrometers, 50 micrometers to 1,000 micrometers, 100 micrometers to 150 micrometers, 100 micrometers to 200 micrometers, 100 micrometers to 250 micrometers, 100 micrometers to 500 micrometers, 100 micrometers to 750 micrometers, 100 micrometers to 1,000 micrometers, 150 micrometers to 200 micrometers, 150 micrometers to 250 micrometers, 150 micrometers to 500 micrometers, 150 micrometers to 750 micrometers, 150 micrometers to 1,000 micrometers, 200 micrometers to 250 micrometers, 200 micrometers to 500 micrometers, 200 micrometers to 750 micrometers,The second layer 244 may have a thickness of 200 micrometers to 1,000 micrometers, 250 micrometers to 500 micrometers, 250 micrometers to 750 micrometers, 250 micrometers to 1,000 micrometers, 500 micrometers to 750 micrometers, 500 micrometers to 1,000 micrometers, or 750 micrometers to 1,000 micrometers. In some cases, the second layer 244 may have a thickness of 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the second layer 244 can have a thickness of at least 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the second layer 244 can have a thickness of at most 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the second layer 244 can have a thickness of between 5 percent and 100 percent of the thickness 302 of the gap 301. In some cases, the second layer 244 may be between 5 percent and 10 percent, 5 percent and 25 percent, 5 percent and 50 percent, 5 percent and 63 percent, 5 percent and 75 percent, 5 percent and 87 percent, 5 percent and 100 percent, 10 percent and 25 percent, 10 percent and 50 percent, 10 percent and 63 percent, 10 percent and 75 percent, 10 percent and 87 percent, 10 percent and 100 percent, 25 percent and 50 percent, 25 percent and 63 percent, 25 percent and 75 percent,The second layer 244 may have a thickness of 25 percent to 87 percent, 25 percent to 100 percent, 50 percent to 63 percent, 50 percent to 75 percent, 50 percent to 87 percent, 50 percent to 100 percent, 63 percent to 75 percent, 63 percent to 87 percent, 63 percent to 100 percent, 75 percent to 87 percent, 75 percent to 100 percent, or 87 percent to 100 percent. In some cases, the second layer 244 may have a thickness of 5 percent, 10 percent, 25 percent, 50 percent, 63 percent, 75 percent, 87 percent, or 100 percent of the thickness 302 of the gap 301. In some cases, the second layer 244 may have a thickness of at least 5 percent, 10 percent, 25 percent, 50 percent, 63 percent, 75 percent, 87 percent, or 100 percent of the thickness 302 of the gap 301. In some cases, the second layer 244 can have a thickness that is at most 5 percent, 10 percent, 25 percent, 50 percent, 63 percent, 75 percent, 87 percent, or 100 percent of the thickness of the gap 301. In some cases, the second layer 244 can have a width that is at most 100 percent, at least 100 percent, or exactly 100 percent (e.g., in the x-direction and / or y-direction, as shown in FIG. 4 ) of the width 303 of the gap 301.

[0019]

[0030] The multi-layer seal 240 can include a third layer 246. In some cases, the third layer 246 can function as a barrier against liquid intrusion into an interior compartment or space of the ultrasound system or device. In some cases, the third layer 246 can be disposed in the gap 301 between the lens 222 and the housing 231 (e.g., at the distal end of the ultrasound device). In some cases, the third layer 246 of the multi-layer seal 240 can be an adhesive. For example, the third layer 246 of the multi-layer seal 240 can be adhered (e.g., strongly adhered) to a sidewall of the housing 231 of the ultrasound device (e.g., a sidewall of an aperture of the housing 231). In some cases, the third layer 246 of the multi-layer seal 240 can be adhered (e.g., strongly adhered) to a sidewall of the lens 222 of the ultrasound device. In some cases, the third layer 246 can include a material (e.g., a silicone-based substance) that is self-leveling (e.g., a self-leveling silicone adhesive or sealant). In some cases, the third layer 246 can include a material that can flow under pressure (e.g., a material having a high viscosity, such as a thixotropic material). In some cases, the third layer 246 can include a highly viscous material. In some cases, the third layer 246 can include a material that can deform under pressure, but will not flow in the absence of applied pressure. In some cases, a material that can deform under pressure allows the material to be deposited over a desired area. In some cases, a material that will deform under pressure allows the material to fill gaps, crevices, wrinkles, or undulations in a surface to which the material is applied. In some cases, the third layer 246 can include a silicone or silicone-based material. For example, the material of the third layer 246 can include silicone. In some cases, the third layer 246 can include a sealant (e.g., a silicone-based sealant) or an adhesive (e.g., a silicone-based adhesive).In some cases, the third layer 246 can include a thixotropic silicone-based material (e.g., to allow complete filling of wrinkles, holes, undulations, and / or gaps where the material is deposited or applied, optionally while reducing spontaneous flow from the site of application or deposition, e.g., to allow flow under pressure but limit flow of material when the pressure is removed). In some cases, the third layer 246 can include a self-leveling silicone-based material. In some cases, the third layer 246 (e.g., a silicone-based sealant or silicone-based adhesive of the third layer) can include one or more silicone-based materials selected from ASI 505 (American Sealants, Inc.), ASI 306 (American Sealants, Inc.), ASI 388 (American Sealants, Inc.), Dow 734 (Dow Corning DOWSIL™ 734 Flowable Sealant), SS-154 (Silicone Solutions, Inc.), SS-265 (Silicone Solutions, Inc.), SS-6604 (Silicone Solutions, Inc.), or SS-18 (Silicone Solutions, Inc.). In some cases, the third layer 246 can include a one-part silicone material. In some cases, the third layer 246 includes one or more of the same materials as the third layer 246. In some cases, the third layer 246 includes a different ratio of the same materials as the second layer 244 (e.g., to provide a lower viscosity to the material of the third layer 246). In some cases, the third layer 246 can include a material having a lower viscosity than the viscosity of the second layer 244 of the multi-layer seal 240. For example, the third layer 246 of the multi-layer seal 240 can include a self-leveling silicone-based material and the second layer 246 of the multi-layer seal 240 can include a thixotropic silicone-based material.In some cases, the low viscosity of the third layer 246 material (e.g., relative to the viscosity of the second layer material) can help establish a smooth distal (e.g., exterior) surface of the third layer even in situations where the third layer is applied to an uneven surface (e.g., as shown in FIG. 5 ), for example, because the third layer material (which can include a self-leveling silicone-based material) can have a lower viscosity than the surface to which the material is applied or deposited. In some cases, the third layer 246 material can be translucent. In some cases, the third layer 246 material can be transparent (e.g., clear). In some cases, a translucent or transparent third layer 246 can allow for observation of a color change (or the absence of a color change) in the first layer 242 material through the third layer 246 material. In some cases, the material for the third layer 246 can be selected for its chemical interaction with the sidewall of the lens or the sidewall of the housing. For example, the material for third layer 246 may be selected such that the material will settle (e.g., flow slowly) such that the wetting angle of the material decreases over time, e.g., to approach (or equal) the angle of the sidewall (e.g., housing sidewall or lens sidewall) without changing the height of the highest contact point between the material and the sidewall. In some cases, the material of multi-layer seal 240 (e.g., the material of third layer 246 or, in some cases, the material of second layer 244) may be polished, ground, cut, or otherwise smoothed to match the angle of one or both of the distal surface of housing 231 at material-housing interface 252 or the distal surface of lens 222 at material-lens interface 251.In some cases, the risk of delamination (e.g., during disinfection cleaning) of the outer barrier (e.g., the exterior surface, which may include the distal surface) of the ultrasonic device or system may be reduced when the distal layer of the multi-layer seal (e.g., the third layer 246, which may be a self-leveling layer, or the second layer 244, which may be a thixotropic layer in some cases) has an angle (e.g., measured by a tangent) at the interface 251, 252 that matches or nearly matches the angle of the distal surface of the lens 222 or housing 231 at the interface 251, 252.

[0020]

[0031] In some cases, the third layer 246 (e.g., a proximal surface of the third layer 246) can be in contact with all or a portion of a surface of the first layer 242 (e.g., a distal surface of the first layer 242), for example, as shown in Figure 7. In some cases, the third layer 246 (e.g., a proximal surface of the third layer 246) can be in contact with all or a portion of a surface of the second layer 244 (e.g., a distal surface of the second layer 244), for example, as shown in Figures 5 and 6. In some cases, the distal surface of the third layer 246 can comprise a portion of a distal surface of the outer barrier (e.g., as shown in Figures 5, 6, and 7).

[0021]

[0032] In some cases, the third layer 246 of the multi-layer seal 240 can have a thickness (eg, in the z-direction, as shown in FIGS. 5 and 6) of between 1 micrometer (μm) and 1,000 micrometers. In some cases, the third layer 246 may have a thickness of 1 micrometer to 25 micrometers, 1 micrometer to 50 micrometers, 1 micrometer to 100 micrometers, 1 micrometer to 150 micrometers, 1 micrometer to 200 micrometers, 1 micrometer to 250 micrometers, 1 micrometer to 500 micrometers, 1 micrometer to 750 micrometers, 1 micrometer to 1,000 micrometers, 25 micrometers to 50 micrometers, 25 micrometers to 100 micrometers, 25 micrometers to 150 micrometers, 25 micrometers to 200 micrometers, 25 micrometers to 250 micrometers, 25 micrometers to 500 micrometers, 25 micrometers to 750 micrometers, 25 micrometers to 1,000 micrometers, 50 micrometers to 100 micrometers, 50 micrometers to 150 micrometers, 50 micrometers to ... 0.0 to 200 micrometers, 50 micrometers to 250 micrometers, 50 micrometers to 500 micrometers, 50 micrometers to 750 micrometers, 50 micrometers to 1,000 micrometers, 100 micrometers to 150 micrometers, 100 micrometers to 200 micrometers, 100 micrometers to 250 micrometers, 100 micrometers to 500 micrometers, 100 micrometers to 750 micrometers, 100 micrometers to 1,000 micrometers, 150 micrometers to 200 micrometers, 150 micrometers to 250 micrometers, 150 micrometers to 500 micrometers, 150 micrometers to 750 micrometers, 150 micrometers to 1,000 micrometers, 200 micrometers to 250 micrometers, 200 micrometers to 500 micrometers, 200 micrometers to 750 micrometers,The third layer 246 can have a thickness of 200 micrometers to 1,000 micrometers, 250 micrometers to 500 micrometers, 250 micrometers to 750 micrometers, 250 micrometers to 1,000 micrometers, 500 micrometers to 750 micrometers, 500 micrometers to 1,000 micrometers, or 750 micrometers to 1,000 micrometers. In some cases, the third layer 246 can have a thickness of 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the third layer 246 can have a thickness of at least 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the third layer 246 can have a thickness of at most 1 micrometer, 25 micrometers, 50 micrometers, 100 micrometers, 150 micrometers, 200 micrometers, 250 micrometers, 500 micrometers, 750 micrometers, or 1,000 micrometers. In some cases, the third layer 246 can have a thickness of between 5 percent and 100 percent of the thickness 302 of the gap 301. In some cases, the third layer 246 may be between 5 percent and 10 percent, 5 percent and 25 percent, 5 percent and 50 percent, 5 percent and 63 percent, 5 percent and 75 percent, 5 percent and 87 percent, 5 percent and 100 percent, 10 percent and 25 percent, 10 percent and 50 percent, 10 percent and 63 percent, 10 percent and 75 percent, 10 percent and 87 percent, 10 percent and 100 percent, 25 percent and 50 percent, 25 percent and 63 percent, 25 percent and 75 percent,The third layer 246 may have a thickness of 25 percent to 87 percent, 25 percent to 100 percent, 50 percent to 63 percent, 50 percent to 75 percent, 50 percent to 87 percent, 50 percent to 100 percent, 63 percent to 75 percent, 63 percent to 87 percent, 63 percent to 100 percent, 75 percent to 87 percent, 75 percent to 100 percent, or 87 percent to 100 percent. In some cases, the third layer 246 may have a thickness of 5 percent, 10 percent, 25 percent, 50 percent, 63 percent, 75 percent, 87 percent, or 100 percent of the thickness 302 of the gap 301. In some cases, the third layer 246 may have a thickness of at least 5 percent, 10 percent, 25 percent, 50 percent, 63 percent, 75 percent, 87 percent, or 100 percent of the thickness 302 of the gap 301. In some cases, the third layer 246 can have a thickness that is at most 5 percent, 10 percent, 25 percent, 50 percent, 63 percent, 75 percent, 87 percent, or 100 percent of the thickness of the gap 301. In some cases, the third layer 246 can have a width that is at most 100 percent, at least 100 percent, or exactly 100 percent (e.g., in the x-direction and / or y-direction, as shown in FIG. 4 ) of the width 303 of the gap 301.

[0022]

[0033] In some cases, an ultrasonic system 100 or device 200 without a multi-layer seal may be less effective in preventing liquid intrusion into the interior of the ultrasonic system 100 or device 200 than an ultrasonic system 100 or device 200 with a multi-layer seal. For example, it may be a challenge to properly seat a gasket (e.g., a rubber or polymer-based gasket) disposed between and in contact with the housing 231 and the lens 222 (and / or on a substrate inside the device 200, such as a MEMS array or ASIC) (e.g., completely or partially filling the gap 301). In some cases, the gasket may be prefabricated with other components of the outer barrier during assembly of the ultrasonic device and manipulated into place. In some cases, the prefabricated gasket may have a specific shape and / or specific dimensions. In some cases, the specific shape and / or set of specific dimensions of the prefabricated gasket may not match one or more shapes and dimensions of the gap 301 of the ultrasonic device 200. For example, the shape and / or dimensions of the gap 301 may not match the nominal values ​​included in the device design (e.g., due to inaccuracies in the lens and / or housing shape and / or dimensions, the temperature of the components during assembly, and / or the pressure used to assemble the device). In some cases, the gasket (e.g., a prefabricated gasket) cannot be easily modified to fit the actual dimensions of the gap 301 (e.g., as opposed to the expected dimensions of the gap 301 from the device design), which may lead to incomplete and / or ineffective contact between the gasket and the lens and / or between the gasket and the housing. In some cases, it may be difficult to apply the gasket to a surface of the device (e.g., during device assembly) such that the gasket lies flat (e.g., without wrinkles) on the surface to which it is applied. In some cases, manipulation of the gasket during assembly may result in puncturing or tearing of the gasket, which may adversely affect the barrier function of the gasket.In some cases, incomplete or ineffective contact between the gasket and one or more other components of the outer barrier of the ultrasonic device may adversely affect the barrier function of the outer barrier and may also render the device susceptible to liquid intrusion. In some cases, compressing the gasket between the lens and / or housing and / or between internal components (e.g., ASIC wafer or MEMS wafer) may improve the contact of the gasket with one or both of the lens and housing; however, compression may be ineffective or even harmful in some cases. For example, compressing a gasket (e.g., a prefabricated rubber or plastic gasket) may not provide sufficient deformation of the gasket to completely fill the width of the gap 301 (e.g., from the side of the lens 222 to the side of the housing 231). Additionally, adjusting the pressure by which the components of the ultrasonic device are assembled (and / or compressed) may possibly adversely affect the alignment and / or bending of one or more other components of the device (e.g., the ultrasonic transducer). In contrast, the multi-layer seal 240 can allow for a large tolerance for the shape and size of the ultrasonic device components without significantly affecting the barrier function of the outer barrier. For example, the viscous second layer 244 of the multi-layer seal 240 can be formed in the gap 301 after assembly of the housing and lens 222 (and, optionally, one or more inner components of the device). In some cases, the second layer 244 (or a third layer) that is capable of flowing (e.g., the degree of flow is at least partially governed by the viscosity of the layer material) can conform to variations (e.g., imperfections or undulations) in the shape or dimensions of the gap. In some cases, this can establish a watertight or water-tight seal even when the gap shape or dimensions are not consistent with the expected shape or dimensions.

[0023]

[0034] The housing 231 can substantially enclose (e.g., spatially surround) one or more internal components of an ultrasonic system or device (e.g., comprising an ultrasonic transducer (e.g., comprising a MEMS array), an ASIC, and / or a computer processor or controller). In some cases, the housing can comprise all or a portion of an outer barrier of an ultrasonic system or device. For example, the housing 231 can comprise a side surface 262 that spatially surrounds one or more internal components of the ultrasonic system or device about a longitudinal axis "z", as shown, for example, in FIG. 2. In some cases, the housing 231 can comprise one or more proximal surfaces 264 that spatially surround all or a portion of one or more internal components of the ultrasonic system or device at a proximal end of the longitudinal axis "z" of the ultrasonic device, as shown, for example, in FIG. 2. In some cases, the housing 231 can comprise one or more distal surfaces 260 that spatially surround all or a portion of one or more internal components of the ultrasonic system or device at a distal end of the longitudinal axis "z" of the ultrasonic device, as shown, for example, in FIG. 2. In some cases, one or more internal components of the ultrasonic system or device may be spatially surrounded (e.g., bounded) by an outer barrier comprising the multi-layer seal 240, the lens 222, and at least a portion of the housing 231 at the distal end of the ultrasonic device. As described herein, the lens may be coupled to the multi-layer seal 240 (e.g., at an interface 252, which may comprise a side circumferential surface of the housing 231 at the distal end, e.g., the entire side surface of the aperture of the housing 231 at the distal end of the ultrasonic device) to, for example, prevent liquid intrusion around the housing 231 and into the interior of the ultrasonic system or device. The housing may be a single piece of material (e.g., a single segment). In some cases, the housing comprises multiple pieces of material (e.g., multiple segments) coupled together, for example, in one or more watertight or waterproof joints.In some cases, the housing 231 of the ultrasound system or device may include plastic (e.g., polycarbonate, polyester, polyethylene terephthalate, polybutylene terephthalate, or combinations thereof), resin, and / or metal. In some cases, the housing 231 of the ultrasound system or device may be added to the ultrasound system or device after assembly of the lens and one or more internal components (e.g., including the ultrasound transducer). In some cases, it may be more cost effective to fabricate the housing 231 to have a shape and / or dimensions such that a small gap 301 remains between the housing 231 and the lens 222, for example, to allow for greater tolerance when attaching the housing to the assembled lens and ultrasound transducer. In some cases, it may be advantageous to incorporate a seal (e.g., a multi-layer seal as described herein) between the assembled housing 231 and the lens 222, for example, to reduce water ingress between the housing 231 and the lens 222.

[0024]

[0035] The lens 222 (e.g., the acoustic lens 222) can include an acoustically and / or optically translucent or transparent material. In many cases, the lens 222 can function to transmit ultrasonic energy waves to and / or from an ultrasonic transducer of an ultrasonic system or device. In many cases, the lens 222 can be located at a distal end of the ultrasonic system or device. In some cases, all or a portion of the lens 222 can form a part of an outer barrier of the ultrasonic system or device. For example, the distal surface (e.g., the outer surface) of the lens 222 can function to prevent liquids from penetrating into the interior of the ultrasonic device (e.g., the ultrasonic probe head). In some cases, the lens 222 can include an outer coating that can form a part of the outer barrier (e.g., to improve the acoustic impedance transition from the transducer to an acoustic gel or the patient's tissue and / or to reduce the susceptibility of the lens 222 to scratches). As described herein, the lens 222 may be bonded to a multi-layer seal 240 (e.g., at an interface 251, which may comprise the entirety of a lateral peripheral surface of the lens 222) to, for example, prevent liquid intrusion around the lens 222 and into the interior of the ultrasound system or device. In some cases, the lens 222 may be bonded to an ultrasound transducer (e.g., at a proximal surface of the lens 222). In some cases, the lens 222 may be bonded (e.g., directly) to a MEMS array, MEMS wafer, or ASIC wafer (e.g., at a proximal surface of the lens 222). Multi-layer seal

[0036] The multi-layer seal can include multiple layers. In some embodiments, the multi-layer seal 240 can include 2, 3, 4, 5, 6, 7, 8, 9, 10, 10-20, or 21 or more layers. In some cases, the multi-layer seal 240 can include multiple first layers. For example, the multi-layer seal 240 can include 2, 3, 4, 5, or 6 or more first layers. In some cases, the first first layer can include a material that undergoes a color change when placed in contact with water. In some cases, the first first layer can include a material that undergoes a color change when placed in contact with a disinfectant. In some cases, the multi-layer seal 240 can include a second first layer, for example, the second first layer includes a material that undergoes a color change when placed in contact with a liquid different from the liquid capable of causing the color change of the first first layer. For example, the multi-layer seal 240 may include a first first layer capable of undergoing a color change when placed in contact with water, and a second first layer capable of undergoing a color change when placed in contact with a disinfectant (e.g., a high-level disinfectant). In some cases, the multi-layer seal 240 may include a second first layer including a material that undergoes a color change (e.g., a different color change) when placed in contact with the same liquid that can cause a color change in the first first layer of the multi-layer seal 240. In some cases, the second first layer may be in contact with the first first layer of the multi-layer seal 240. In some cases, the second first layer may not be in direct contact with the first first layer of the multi-layer seal 240. For example, the second first layer may be disposed between (e.g., in contact with) the second layer 244 of the multi-layer seal 240 and the third layer 246 of the multi-layer seal 240, while the first first layer of the multi-layer seal 240 may be disposed proximal to the second layer 244 of the multi-layer seal (e.g., to indicate the degree of liquid intrusion into the ultrasonic device).

[0025]

[0037] 9A shows example steps of a method 900 of making an ultrasonic system or device with a multi-layer seal. In some cases, the lens 222 may be coupled (e.g., the lens 222 is directly or indirectly coupled to one or more internal components of the ultrasonic device (e.g., an ultrasonic transducer, etc.) (e.g., as shown in step 902). In some cases, a housing may be assembled (e.g., partially) around the coupled lens and internal components (e.g., as shown in step 904). The second layer 244 (e.g., an adhesive thixotropic second layer) of the multi-layer seal 240 may be applied to the inner surface (e.g., the distal surface of the internal component) of the gap 301 between the housing 231 and the lens 222, for example, by using a needle (e.g., a dispensing needle) to dispense the second layer 244 onto the inner surface, as shown in step 906 (e.g., the second layer 244 is applied so as to be in contact with the entire perimeter of the sidewall of the housing 231, in contact with the entire perimeter of the sidewall of the lens 222, and in contact with the entire distal surface of the inner surface). In some cases, the first layer 242 of the multi-layer seal 240 may be applied to the distal surface of the second layer 244 of the multi-layer seal 240 after the second layer 244 has been applied within the gap 301 (e.g., as shown in step 908). In some cases, a third layer 246 (e.g., an adhesive third layer that can include the same materials as the second layer 244 in the same or different proportions as the second layer) may be applied to the distal surface of the first layer within the gap 301, for example, as shown in step 910 of FIG. 9A (e.g., the third layer 246 is applied so as to be in contact with the entire outer periphery of the sidewall of the housing 231, in contact with the entire outer periphery of the sidewall of the lens 222, and in contact with the entire distal surface of the first layer 242).In some cases, the outer (e.g., distal) surface of the multi-layer seal 240 (e.g., the outer surface of the second layer 244 or the third layer 246 of the multi-layer seal 240) may be smooth (e.g., flush or nearly flush) at a first interface 251 with respect to the outer (e.g., distal) surface of the lens 222 and / or at a second interface 252 with respect to the outer (e.g., distal) surface of the housing 231. In some cases, a first surface (e.g., the outer surface of multi-layer seal 240) can be considered smooth with respect to a second surface (e.g., the outer surface of lens 222 or housing 231) when an angle tangent to all or a portion of the first surface matches (e.g., is equal to or complementary to) or nearly matches (e.g., within 1%, 5%, 10%, 15%, 20%, 25%, or 30% of) an angle tangent to all or a portion of the second surface at the interface (e.g., interface 251 or interface 252) between the first and second surfaces. In some cases, a first surface (e.g., the outer surface of multi-layer seal 240) can be considered smooth with respect to a second surface (e.g., the outer surface of lens 222 or housing 231) when there is no separation (e.g., a gap) between the first and second surfaces or when there are no surface irregularities or roughness of the first and second surfaces at the interface (e.g., interface 251 or interface 252) of the first and second surfaces. In some cases, the outer (e.g., distal) surface of the third layer 246 may be smoothed (e.g., as shown in step 912 of FIG. 9A ), e.g., by cutting, grinding, or polishing the distal surface of the third layer 246 until the tangent angle of the third layer 246 matches (or approximately matches, e.g., within 10% or within 25%) the tangent angle of the lens 222 at the first interface 251 and / or until the tangent angle of the distal surface of the third layer 246 matches (or approximately matches, e.g., within 10% or within 25%) the tangent angle of the distal surface of the housing 231 at the second interface 252.

[0026]

[0038] 9B shows example steps of a method 901 of making an ultrasonic system or device with a multi-layer seal. In some cases, the lens 222 may be coupled (e.g., the lens 222 is directly or indirectly coupled to one or more internal components of the ultrasonic device, such as an ultrasonic transducer) (e.g., as shown in step 903). In some cases, a housing may be assembled (e.g., partially) around the coupled lens and internal components (e.g., as shown in step 905). A first layer 242 of the multi-layer seal 240 (e.g., an adhesive thixotropic first layer including an indicator material) may be applied to the inner surface (e.g., the distal surface of an internal component) of the gap 301 between the housing 231 and the lens 222, for example, by using a needle (e.g., a dispensing needle) to dispense the first layer 242 onto the inner surface, as shown in step 907 (e.g., the first layer 242 is applied so that it is in contact with the entire outer periphery of the sidewall of the housing 231, in contact with the entire outer periphery of the sidewall of the lens 222, and in contact with the entire distal surface of the inner surface). In some cases, the second layer 244 of the multi-layer seal 240 may be applied to the distal surface of the first layer 242 of the multi-layer seal 240 after the first layer 242 is applied within the gap 301 (e.g., as shown in step 909) (e.g., the second layer 244 is applied so as to be in contact with the entire outer periphery of the sidewall of the housing 231, in contact with the entire outer periphery of the sidewall of the lens 222, and in contact with the entire distal surface of the first layer 242). In some cases, a third layer 246 (e.g., an adhesive third layer that can include the same materials as the second layer 244 in the same or different proportions as the second layer) may be applied to the distal surface of the first layer within the gap 301, for example, as shown in step 911 of FIG. 9B (e.g., the third layer 246 is applied so as to be in contact with the entire periphery of the sidewall of the housing 231, in contact with the entire periphery of the sidewall of the lens 222, and in contact with the entire distal surface of the first layer 242).In some cases, the outer (e.g., distal) surface of the third layer 246 may be smoothed (e.g., as shown in step 913 of FIG. 9B ), e.g., by cutting, grinding, or polishing the distal surface of the third layer 246 until the tangent angle of the third layer 246 matches (or approximately matches, e.g., within 10% or within 25%) the tangent angle of the lens 222 at the first interface 251 and / or until the tangent angle of the distal surface of the third layer 246 matches (or approximately matches, e.g., within 10% or within 25%) the tangent angle of the distal surface of the housing 231 at the second interface 252.

[0027]

[0039] In some cases, all or a portion of the layers of the multi-layer seal (e.g., the first layer, the second layer, or the third layer) can be created or applied to or within the gap of the surface of the ultrasonic system or device using a needle, such as a discharge needle (e.g., with a syringe or pump). In some cases, all or a portion of the layers of the multi-layer seal (e.g., the first layer, the second layer, or the third layer) can be applied using a needle (e.g., a discharge needle) oriented at a low angle relative to the surface on which the layer is deposited, for example, to allow for the deposition of a flatter, uninterrupted bead of layer material. This can be particularly advantageous for the deposition of thixotropic materials, which may retain an uneven surface if applied too quickly or using a large needle angle. In some cases, adding an additional layer (e.g., a third layer) containing a self-leveling material on top of the layers (e.g., the first layer and / or the second layer) containing a thixotropic material can help establish a smooth or flat exterior surface of the outer barrier that comprises the multi-layer seal 240 (e.g., as shown in FIG. 5). liquid

[0040] An ultrasonic device (e.g., the distal surface of an outer barrier of an ultrasonic probe head) may be placed in direct contact with one or more liquids during or between use of the ultrasonic device. In some cases, contacting a surface of an ultrasonic device (e.g., all or a portion of the distal surface of the outer barrier) may present a risk of the liquid crossing the outer barrier of the ultrasonic device into an internal compartment of the ultrasonic device. In some cases, liquid that has crossed the outer barrier of the ultrasonic device may adversely affect one or more internal components (e.g., ultrasonic transducers, MEMS arrays, circuitry of a printed circuit board (PCB), or ASICs of a device that may include a processor or memory) or the function of the ultrasonic device as a whole. In some cases, the accuracy or precision of the ultrasound may be adversely affected if one or more internal components of an ultrasonic device or system are contacted with a liquid (e.g., that has crossed the outer barrier of the device or system). In some cases, one or more internal components of an ultrasonic device or system may be damaged or destroyed as a result of being contacted by a liquid (e.g., that has crossed the outer barrier of the device or system). In some cases, the outer barrier of an ultrasonic device or system may or must be placed in contact with a liquid (e.g., an acoustic medium or a bodily fluid) during use of the device or system (e.g., to improve acoustic energy transmission and / or to access the area of ​​the patient's body being assayed by the ultrasonic device or system). In some cases, the outer barrier of an ultrasonic device or system may or must be placed in contact with a liquid (e.g., a disinfectant or rinse solution) during use of the device or system (e.g., to disinfect or sterilize the device or system to prevent, for example, the transfer of one or more pathogens to a subsequent patient).In some cases, the outer barrier of an ultrasonic device or system may or must be in contact with liquid repeatedly over the life of the ultrasonic device or system (e.g., over multiple instances of exposure to liquid during use and / or disinfection during use). In some cases, the outer barrier of an ultrasonic device or system may be in contact with liquid for extended periods of time (e.g., during use and / or disinfection). In some cases, such repeated direct contact with liquid may lead to or increase the risk of liquid ingress into the interior of the ultrasonic system or device, which may result in or increase the possibility of damage to one or more internal components of the ultrasonic system or device (e.g., as a result of short circuits, chemical reactions, fracturing of mechanical MEMS membranes, fracturing of electrical connections, and / or unintended modulation of acoustic impedance within the acoustic path of the device, e.g., as a result of condensation or fogging). In some cases, prolonged contact with liquid (e.g., immersing all or a portion of an ultrasonic device or system in liquid during treatment of the device or system with a high-level disinfectant) can lead to or increase the risk of liquid intrusion into the interior of the ultrasonic system or device, which may result in or increase the possibility of damage to one or more internal components of the ultrasonic system or device (e.g., as a result of short circuits, chemical reactions, fracturing of mechanical MEMS membranes, fracturing of electrical connections, and / or unintended modulation of acoustic impedance within the acoustic path of the device, e.g., as a result of condensation or fogging). In some cases, an outer barrier of an ultrasonic system or device comprising a multi-layer seal 240 as described herein can reduce the possibility of or prevent liquid intrusion into an internal compartment of the ultrasonic system or device, for example, even when contact with liquid is prolonged or the liquid is water-based or alcohol-based.

[0028]

[0041] The liquid may include water or a water-based (e.g., aqueous) material. In some cases, the liquid may include an ultrasound gel (e.g., sonogel). In some cases, the ultrasound gel may include water, polyols (e.g., propane-1,2,3-triol or glycerin), glycol ethers (e.g., 2-phenoxyethan-1-ol or phenoxyethanol), propylene glycol (e.g., propane-1,2-diol), and / or petroleum-based materials such as synthetic dyes. In some cases, the use of the ultrasound device may include contacting an outer surface of the ultrasound device with an imaging medium, such as sonogel, which may be a water-based material. In some cases, the liquid may include a saline solution (e.g., saline, which may include exactly or approximately 0.90% w / v of sodium chloride in water, or lactated Ringer's solution, which may include sodium chloride, sodium lactate, potassium chloride, and / or calcium chloride in water). In some cases, the liquid may include a bodily fluid. In some cases, the use of the ultrasound device may include contacting an outer surface of the ultrasound device with a bodily fluid. In some cases, water molecules (e.g., alone or in combination with components of an aqueous solution) can cause, for example, a color change in an indicator material (e.g., of the first layer 242 of the multi-layer seal 240) after contacting the indicator material. In some cases, solutes or compounds (e.g., inorganic compounds, organic compounds, or biological substances such as proteins, enzymes, lipids, or nucleic acids) mixed with water in an aqueous solution (e.g., alone or in combination with water) can cause, for example, a color change in an indicator material (e.g., of the first layer 242 of the multi-layer seal 240) after contacting the indicator material.

[0029]

[0042] The liquid can include a disinfectant. In some cases, the disinfectant can include an organic compound (e.g., an alcohol or an aldehyde). In some cases, the disinfectant can include an inorganic compound (e.g., chlorine, hypochlorite, hypochlorous acid, hydroxide, or iodide). In some cases, the disinfectant can be water-based (e.g., an aqueous solution). In some cases, the disinfectant can include an alcohol (e.g., ethyl alcohol, isopropyl alcohol, or a combination thereof). In some cases, the disinfectant can include an aldehyde. For example, the disinfectant can include formaldehyde, glutaraldehyde, or phthalaldehyde (e.g., ortho-phthaladehyde (OPA)). In some cases, the disinfectant can include an oxidizing agent, such as hydrogen peroxide. In some cases, the disinfectant can include an ammonium-based compound, such as a quaternary ammonium cation. In some cases, the disinfectant may include chlorine, hypochlorite (e.g., sodium hypochlorite or calcium hypochlorite), or hypochlorous acid (e.g., in an aqueous solution). In some cases, the disinfectant may include a phenolic, such as phenol, thymol, o-phenylphenol, or chloroxylenol. In some cases, the disinfectant may be an enzymatic cleaner (e.g., containing an enzyme). In some cases, the water molecules of the disinfectant (e.g., alone or in combination with components of an aqueous solution) may cause, for example, a color change in the indicator material (e.g., of the first layer 242 of the multi-layer seal 240) after the disinfectant contacts the indicator material. In some cases, the solutes or compounds of the disinfectant (e.g., inorganic compounds, organic compounds, or biological substances such as proteins, enzymes, lipids, or nucleic acids) may cause, for example, a color change in the indicator material (e.g., of the first layer 242 of the multi-layer seal 240) after contacting the indicator material.

[0030]

[0043] In some cases, disinfection of ultrasonic equipment can include low-level disinfection, which can include application of a disinfectant (e.g., using a disinfectant wipe) to the outer surface of an ultrasonic device or component of an ultrasonic system, such as an ultrasonic probe head, before, after, or during use. In some cases, the low-level disinfectant can include a compound that includes ammonium (e.g., a quaternary ammonium compound). In some cases, ultrasonic devices and systems must undergo high-level disinfection. High-level disinfection of the outer surface of an ultrasonic system or device can include contacting the outer surface of the ultrasonic device (e.g., the outer surface of the outer barrier of the ultrasonic device) with a liquid (e.g., a high-level disinfectant) for an extended period of time. In some cases, high-level disinfection of the surface of an ultrasonic system or device (e.g., all or a portion of the outer surface, such as an outer barrier, which can include a multi-layer seal) can include contacting the surface of the ultrasonic system or device with a liquid (e.g., a disinfectant) for a longer period of time than during a low-level disinfection process. For example, high-level disinfection of a surface of an ultrasonic system or device can include contacting all or a portion of the surface with a liquid (e.g., a disinfectant such as phthalaldehyde) for a period of time between 20 minutes to 1 hour, between 1 hour to 2 hours, between 2 hours to 3 hours, between 3 hours to 4 hours, between 4 hours to 6 hours, between 6 hours to 12 hours, between 12 hours to 24 hours, or more than 24 hours. In some cases, low-level disinfection of a surface of an ultrasonic system or device can include contacting all or a portion of the surface with a liquid (e.g., a disinfectant such as a quaternary ammonium compound) for less than 5 minutes, between 5 minutes to 10 minutes, between 10 minutes to 20 minutes, between 20 minutes to 1 hour, between 1 hour to 2 hours, or more than 2 hours.

[0031]

[0044] In some cases, all or a portion of the outer barrier (e.g., including the exterior surface) of the ultrasound system or device may be placed in contact with the liquid for between 0.1 hours and 24 hours. In some cases, all or a portion of the outer barrier (e.g., including the exterior surface) of the ultrasound system or device may be placed in contact with the liquid for between 0.1 hours and 0.2 hours, 0.1 hours and 0.4 hours, 0.1 hours and 0.5 hours, 0.1 hours and 0.8 hours, 0.1 hours and 1 hour, 0.1 hours and 2 hours, 0.1 hours and 3 hours, 0.1 hours and 4 hours, 0.1 hours and 6 hours, 0.1 hours and 12 hours, 0.1 hours and 24 hours, 0.2 hours and 0.4 hours. , 0.2 hours to 0.5 hours, 0.2 hours to 0.8 hours, 0.2 hours to 1 hour, 0.2 hours to 2 hours, 0.2 hours to 3 hours, 0.2 hours to 4 hours, 0.2 hours to 6 hours, 0.2 hours to 12 hours, 0.2 hours to 24 hours, 0.4 hours to 0.5 hours, 0.4 hours to 0.8 hours, 0.4 hours to 1 hour, 0.4 hours to 2 hours, 0.4 hours to 3 hours, 0.4 hours to 4 hours, 0.4 hours to 6 hours, 0.4 hours to 12 hours, 0 .4 hours to 24 hours, 0.5 hours to 0.8 hours, 0.5 hours to 1 hour, 0.5 hours to 2 hours, 0.5 hours to 3 hours, 0.5 hours to 4 hours, 0.5 hours to 6 hours, 0.5 hours to 12 hours, 0.5 hours to 24 hours, 0.8 hours to 1 hour, 0.8 hours to 2 hours, 0.8 hours to 3 hours, 0.8 hours to 4 hours, 0.8 hours to 6 hours, 0.8 hours to 12 hours, 0.8 hours to 24 hours, 1 hour to 2 hours, 1 hour to 3 hours, 1 The ultrasound system or device may be placed in contact with the liquid for 0.1, 0.2, 0.4, 0.5, 0.8, 1, 2, 3, 4, 6, 12, or 24 hours.In some cases, all or a portion of the outer barrier (e.g., including the exterior surface) of the ultrasound system or device may be placed in contact with the liquid for at least 0.1 hours, 0.2 hours, 0.4 hours, 0.5 hours, 0.8 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, or 12 hours. In some cases, all or a portion of the outer barrier (e.g., including the exterior surface) of the ultrasound system or device may be placed in contact with the liquid for no more than 0.2 hours, 0.4 hours, 0.5 hours, 0.8 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, or 24 hours.

[0032]

[0045] In some cases, the multi-layer seal can reduce the risk of liquid intrusion in an ultrasonic system or device, where the system or device has been in contact with liquid for between 0.1 hours and 24 hours. In some cases, the multi-layer seal can reduce the risk of liquid intrusion in an ultrasonic system or device, where the system or device has been in contact with liquid for between 0.1 hours and 0.2 hours, 0.1 hours and 0.4 hours, 0.1 hours and 0.5 hours, 0.1 hours and 0.8 hours, 0.1 hours and 1 hour, 0.1 hours and 2 hours, 0.1 hours and 3 hours, 0.1 hours and 4 hours, 0.1 hours and 6 hours, 0.1 hours and 12 hours, 0.1 hours and 24 hours, 0.1 hours and 0 hours. .2 hours to 0.4 hours, 0.2 hours to 0.5 hours, 0.2 hours to 0.8 hours, 0.2 hours to 1 hour, 0.2 hours to 2 hours, 0.2 hours to 3 hours, 0.2 hours to 4 hours, 0.2 hours to 6 hours, 0.2 hours to 12 hours, 0.2 hours to 24 hours, 0.4 hours to 0.5 hours, 0.4 hours to 0.8 hours, 0.4 hours to 1 hour, 0.4 hours to 2 hours, 0.4 hours to 3 hours, 0.4 hours to 4 hours, 0.4 hours to 6 hours, 0.4 hours 0.4-12 hours, 0.4-24 hours, 0.5-0.8 hours, 0.5-1 hour, 0.5-2 hours, 0.5-3 hours, 0.5-4 hours, 0.5-6 hours, 0.5-12 hours, 0.5-24 hours, 0.8-1 hour, 0.8-2 hours, 0.8-3 hours, 0.8-4 hours, 0.8-6 hours, 0.8-12 hours, 0.8-24 hours, 1 hour-2 hours, 1 hour ~3 hours, 1 hour-4 hours, 1 hour-6 hours, 1 hour-12 hours, 1 hour-24 hours, 2 hours-3 hours, 2 hours-4 hours, 2 hours-6 hours, 2 hours-12 hours, 2 hours-24 hours, 3 hours-4 hours, 3 hours-6 hours, 3 hours-12 hours, 3 hours-24 hours, 4 hours-6 hours, 4 hours-12 hours, 4 hours-24 hours, 6 hours-12 hours, 6 hours-24 hours, or 12 hours-24 hours. In some cases, the multi-layer seal can reduce the risk of liquid ingress in an ultrasonic system or device, where the system or device has been in contact with the liquid for 0.1 hours, 0.2 hours, 0.4 hours, 0.5 hours, 0.8 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, or 24 hours.In some cases, the multi-layer seal can reduce the risk of liquid intrusion in an ultrasonic system or device where the system or device has been in contact with liquid for at least 0.1 hours, 0.2 hours, 0.4 hours, 0.5 hours, 0.8 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, or 24 hours. In some cases, the multi-layer seal can reduce the risk of liquid intrusion in an ultrasonic system or device where the system or device has been in contact with liquid for at most 0.1 hours, 0.2 hours, 0.4 hours, 0.5 hours, 0.8 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, or 24 hours.

[0033]

[0046] In some cases, a method of disinfecting an ultrasound system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a low-level disinfectant) for a period of between 0.1 hours and 48 hours. In some cases, the method of sterilizing an ultrasound system or device may include 0.1 hours to 0.5 hours, 0.1 hours to 1 hour, 0.1 hours to 2 hours, 0.1 hours to 4 hours, 0.1 hours to 6 hours, 0.1 hours to 8 hours, 0.1 hours to 12 hours, 0.1 hours to 24 hours, 0.1 hours to 36 hours, 0.1 hours to 48 hours, 0.5 hours to 1 hour, 0.5 hours to 2 hours, 0.5 hours to 4 hours, 0.5 hours to 6 hours, 0.5 hours to 8 hours, 0.5 hours to 12 hours, 0.5 hours to 24 hours, 0.5 hours to 36 hours, 0.5 hours to 48 hours, 1 hour to 2 hours, 1 hour to 4 hours, 1 hour to 6 hours, 1 hour to 8 hours, 1 hour to 12 hours, 1 hour to 24 hours, 1 hour to 36 hours, 1 hour to 48 hours, 2 hours to 4 hours, 2 hours to This can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a low-level disinfectant) for 6 hours, 2 hours to 8 hours, 2 hours to 12 hours, 2 hours to 24 hours, 2 hours to 36 hours, 2 hours to 48 hours, 4 hours to 6 hours, 4 hours to 8 hours, 4 hours to 12 hours, 4 hours to 24 hours, 4 hours to 36 hours, 4 hours to 48 hours, 6 hours to 8 hours, 6 hours to 12 hours, 6 hours to 24 hours, 6 hours to 36 hours, 6 hours to 48 hours, 8 hours to 12 hours, 8 hours to 24 hours, 8 hours to 36 hours, 8 hours to 48 hours, 12 hours to 24 hours, 12 hours to 36 hours, 12 hours to 48 hours, 24 hours to 36 hours, 24 hours to 48 hours, or 36 hours to 48 hours. In some cases, a method of disinfecting an ultrasonic system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a low-level disinfectant) for 0.1 hour, 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, or 48 hours.In some cases, a method of disinfecting an ultrasonic system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a low-level disinfectant) for at least 0.1, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, or 48 hours. In some cases, a method of disinfecting an ultrasonic system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a low-level disinfectant) for at most 0.1, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, or 48 hours.

[0034]

[0047] In some cases, a method of disinfecting an ultrasound system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a high-level disinfectant) for a period of between 0.1 hours and 48 hours. In some cases, the method of sterilizing the ultrasound system or device may be 0.1 hours to 0.5 hours, 0.1 hours to 1 hour, 0.1 hours to 2 hours, 0.1 hours to 4 hours, 0.1 hours to 6 hours, 0.1 hours to 8 hours, 0.1 hours to 12 hours, 0.1 hours to 24 hours, 0.1 hours to 36 hours, 0.1 hours to 48 hours, 0.5 hours to 1 hour, 0.5 hours to 2 hours, 0.5 hours to 4 hours, 0.5 hours to 6 hours, 0.5 hours to 8 hours, 0.5 hours to 12 hours, 0.5 hours to 24 hours, 0.5 hours to 36 hours, 0.5 hours to 48 hours, 1 hour to 2 hours, 1 hour to 4 hours, 1 hour to 6 hours, 1 hour to 8 hours, 1 hour to 12 hours, 1 hour to 24 hours, 1 hour to 36 hours, 1 hour to 48 hours, 2 hours to 4 hours, 2 hours to 6 ... The method can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a high-level disinfectant) for a period of time between 8 hours, 2 hours and 12 hours, 2 hours and 24 hours, 2 hours and 36 hours, 2 hours and 48 hours, 4 hours and 6 hours, 4 hours and 8 hours, 4 hours and 12 hours, 4 hours and 24 hours, 4 hours and 36 hours, 4 hours and 48 hours, 6 hours and 8 hours, 6 hours and 12 hours, 6 hours and 24 hours, 6 hours and 36 hours, 6 hours and 48 hours, 8 hours and 12 hours, 8 hours and 24 hours, 8 hours and 36 hours, 8 hours and 48 hours, 12 hours and 24 hours, 12 hours and 36 hours, 12 hours and 48 hours, 24 hours and 36 hours, 24 hours and 48 hours, 36 hours and 48 hours, or 48 hours and 96 hours. In some cases, a method of disinfecting an ultrasound system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a high-level disinfectant) for 0.1 hour, 0.5 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 ​​hours, 72 hours, or 96 hours.In some cases, a method of disinfecting an ultrasonic system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a high-level disinfectant) for at least 0.1, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, or 96 hours. In some cases, a method of disinfecting an ultrasonic system or device can include contacting all or a portion of the outer barrier of the system or device with a liquid (e.g., a disinfectant such as a high-level disinfectant) for at most 0.1, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, or 96 hours.

[0035]

[0048] In some cases, the indicator material of the multi-layer seal 240 can undergo a color change when placed in contact (e.g., direct contact) with a liquid (e.g., water, disinfectant, or bodily fluid) for between 0.1 hours and 24 hours. ...0.2 hours, 0.1 hours and 0.4 hours, 0.1 hours and 0.5 hours, 0.1 hours and 0.8 hours, 0.1 hours and 1 hour, 0.1 hours and 2 hours, 0.1 hours and 3 hours, 0.1 hours and 4 hours, 0.1 hours and 6 hours, 0.1 hours and 12 hours, 0.1 hours and 24 hours, 0.2 hours and 0.4 hours, 0.2 hours and 0.5 hours, 0.2 hours and 0.8 hours, 0.2 hours and 1 hour. hours, 0.2 hours to 2 hours, 0.2 hours to 3 hours, 0.2 hours to 4 hours, 0.2 hours to 6 hours, 0.2 hours to 12 hours, 0.2 hours to 24 hours, 0.4 hours to 0.5 hours, 0.4 hours to 0.8 hours, 0.4 hours to 1 hour, 0.4 hours to 2 hours, 0.4 hours to 3 hours, 0.4 hours to 4 hours, 0.4 hours to 6 hours, 0.4 hours to 12 hours, 0.4 hours to 24 hours, 0.5 hours to 0.8 hours, 0.5 hours to 1 hour, 0.5 hrs~2 hrs, 0.5 hrs~3 hrs, 0.5 hrs~4 hrs, 0.5 hrs~6 hrs, 0.5 hrs~12 hrs, 0.5 hrs~24 hrs, 0.8 hrs~1 hr, 0.8 hrs~2 hrs, 0.8 hrs~3 hrs, 0.8 hrs~4 hrs, 0.8 hrs~6 hrs, 0.8 hrs~12 hrs, 0.8 hrs~24 hrs, 1 hrs~2 hrs, 1 hrs~3 hrs, 1 hrs~4 hrs, 1 hrs~6 hrs, 1 hrs~12 hrs, 1 hrs~24 hrs, 2 hrs~3 hour, 2 hours to 4 hours, 2 hours to 6 hours, 2 hours to 12 hours, 2 hours to 24 hours, 3 hours to 4 hours, 3 hours to 6 hours, 3 hours to 12 hours, 3 hours to 24 hours, 4 hours to 6 hours, 4 hours to 12 hours, 4 hours to 24 hours, 6 hours to 12 hours, 6 hours to 24 hours, or 12 hours to 24 hours. In some cases, the indicator material of the multi-layer seal 240 can undergo a color change when placed in contact (e.g., direct contact) with a liquid (e.g., water, disinfectant, or bodily fluid) for 0.1 hour, 0.2 hours, 0.4 hours, 0.5 hours, 0.8 hours, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 12 hours, or 24 hours.In some cases, the indicator material of the multi-layer seal 240 can undergo a color change when placed in contact (e.g., direct contact) with a liquid (e.g., water, disinfectant, or bodily fluid) for at least 0.1, 0.2, 0.4, 0.5, 0.8, 1, 2, 3, 4, 6, 12, or 24 hours. In some cases, the indicator material of the multi-layer seal 240 can undergo a color change when placed in contact (e.g., direct contact) with a liquid (e.g., water, disinfectant, or bodily fluid) for at most 0.1, 0.2, 0.4, 0.5, 0.8, 1, 2, 3, 4, 6, 12, or 24 hours. Ultrasonic Transducers

[0049] In some cases, the systems, devices, or methods described herein may include one or more ultrasonic transducers (e.g., ultrasonic transducers). In some cases, the ultrasonic transducers may include a wafer that may include a printed circuit board (PCB). In many cases, the one or more ultrasonic transducers (e.g., as well as one or more other internal components of an ultrasonic system or device, such as a MEMS array, a MEMS wafer, an ASIC, a thermal management component, and / or a processor) may be located within an internal compartment (e.g., an internal space) of the ultrasonic system or device. In some cases, the internal compartment or space of the ultrasonic system, which may include the housing 231, the multi-layer seal 240, and / or the lens 222, may be surrounded (e.g., spatially enclosed) by an outer barrier. In some cases, the internal compartment or space of the ultrasonic system may be defined by an outer barrier that surrounds (e.g., spatially enclosed) it. In some cases, the systems, devices, or methods described herein may include a piezoelectric micromachine ultrasound transducer (pMUT). In some cases, the systems, devices, or methods described herein may include one or more capacitive micromachine ultrasonic transducers (cMUTs). Piezoelectric micromachined ultrasonic transducers (pMUTs) may be formed on a substrate such as a semiconductor wafer (e.g., a printed circuit board, PCB). pMUT elements built on a semiconductor substrate may provide a smaller size profile than bulky conventional transducers having bulkier piezoelectric materials. In some cases, pMUTs may also be less expensive to manufacture and / or may enable less complex and higher performance interconnects between the transducer and additional electronic components of an ultrasonic device or system.

[0036]

[0050] Micromachined ultrasonic transducers (MUTs), which may include pMUTs and / or cMUTs, may include a diaphragm (e.g., a thin film attached, e.g., to a membrane edge, for one or more portions of the interior of an imaging device (e.g., an ultrasound probe). In contrast, traditional bulk piezoelectric (PZT) elements typically consist of a single solid piece of material. Such traditional PZT ultrasonic systems and devices can be expensive to fabricate, for example, because of the high precision required to cut and mount the PZT or ceramic materials that make up the PZT ultrasonic systems and devices with appropriate spacing. Additionally, traditional PZT ultrasonic systems and devices can have a transducer impedance that is significantly higher than the impedance of the transmit / receive electronics of the PZT systems and devices, which can adversely affect performance.

[0037]

[0051] In some cases, one or more transducer elements may be configured to transmit and / or receive signals at a particular frequency or bandwidth (e.g., the bandwidth is related to the center frequency). In some cases, one or more transducer elements may be further configured to transmit and / or receive signals at additional center frequencies and bandwidths. Such multiple frequency transducer elements may be referred to as multimodal elements and may be used in some embodiments to extend the bandwidth of the imaging system or device 100. The transducer elements or pixels may be configured to emit (e.g., transmit) and / or receive ultrasound energy (e.g., ultrasound waveforms, patterns, or pressure waves) at an appropriate center frequency, for example, between 0.1 megahertz (MHz) and 100 MHz. In some cases, the transducer or pixel may be 0.1MHz to 1MHz, 0.1MHz to 1.8MHz, 0.1MHz to 3.5MHz, 0.1MHz to 5.1MHz, 0.1MHz to 10MHz, 0.1MHz to 25MHz, 0.1MHz to 50MHz, 0.1MHz to 100MHz, 1MHz to 1.8MHz, 1MHz to 3.5MHz, 1MHz to 5.1MHz, 1MHz to 10MHz, 1MHz to 25MHz, 1MHz to 50MHz, 1MHz to 100MHz, 1.8MHz to 3.5MHz, 1.8MHz to 5.1MHz, 1.8MHz to 10MHz, 1.8MHz to 25MHz, The ultrasonic transducer may be configured to transmit or receive ultrasonic energy at a center frequency of 1.8 MHz, 1.8 MHz to 50 MHz, 1.8 MHz to 100 MHz, 3.5 MHz to 5.1 MHz, 3.5 MHz to 10 MHz, 3.5 MHz to 25 MHz, 3.5 MHz to 50 MHz, 3.5 MHz to 100 MHz, 5.1 MHz to 10 MHz, 5.1 MHz to 25 MHz, 5.1 MHz to 50 MHz, 5.1 MHz to 100 MHz, 10 MHz to 25 MHz, 10 MHz to 50 MHz, 10 MHz to 100 MHz, 25 MHz to 50 MHz, 25 MHz to 100 MHz, or 50 MHz to 100 MHz.In some cases, the transducer or pixel may be configured to transmit or receive ultrasonic energy at a center frequency of 0.1 MHz, 1 MHz, 1.8 MHz, 3.5 MHz, 5.1 MHz, 10 MHz, 25 MHz, 50 MHz, or 100 MHz. In some cases, the transducer or pixel may be configured to transmit or receive ultrasonic energy at a center frequency of at least 0.1 MHz, 1 MHz, 1.8 MHz, 3.5 MHz, 5.1 MHz, 10 MHz, 25 MHz, 50 MHz, or 100 MHz. In some cases, the transducer or pixel may be configured to transmit or receive ultrasonic energy at a center frequency of at most 0.1 MHz, 1 MHz, 1.8 MHz, 3.5 MHz, 5.1 MHz, 10 MHz, 25 MHz, 50 MHz, or 100 MHz. Computing Systems

[0052] An ultrasound system or device described herein may comprise or interface with a computer system. Figure 10 is a block diagram illustrating an example machine including a computer system 1000 (e.g., a processing or computing system) in which a set of instructions may be executed to cause a device to implement or execute any one or more of the aspects and / or methodologies for static code scheduling of the present disclosure. The components of Figure 10 are merely examples and do not limit the scope of use or functionality of any hardware, software, embedded logic components, or combinations of two or more such components to implement a particular embodiment.

[0038]

[0053] The computer system 1000 may include one or more processors 1001, memory 1003, and storage 1008, which communicate with each other and with other components via a bus 1040. The bus 1040 may also link to a display 1032, one or more input devices 1033 (which may include, for example, a keypad, keyboard, mouse, stylus, etc.), one or more output devices 1034, one or more storage devices 1035, and various tangible storage media 1036. All of these elements may interface to the bus 1040 directly or through one or more interfaces or adapters. For example, the various tangible storage media 1036 may interface with the bus 1040 through a storage media interface 1026. The computer system 1000 may have any suitable physical form, including, but not limited to, one or more integrated circuits (ICs), a printed circuit board (PCB), a mobile handheld device (such as a mobile telephone or PDA), a laptop or notebook computer, a distributed computer system, a computing grid, or a server.

[0039]

[0054] The computer system 1000 includes one or more processors 1001 (e.g., a central processing unit (CPU), a general purpose graphics processing unit (GPGPU), or a quantum processing unit (QPU)) that perform functions. The processor 1001 optionally includes a cache memory unit 1002 for temporary local storage of instructions, data, or computer addresses. The processor 1001 is configured to assist in the execution of computer-readable instructions. The computer system 1000 may provide functionality for the components illustrated in FIG. 10 as a result of the processor 1001 executing non-transitory processor-executable instructions embodied in one or more tangible computer-readable storage media, such as memory 1003, storage 1008, storage device 1035, and / or storage medium 1036. The computer-readable medium may store, and the processor 1001 may execute, software that implements a particular embodiment. The memory 1003 may read software from one or more other computer-readable media (such as mass storage devices 1035, 1036) or from one or more other sources through an appropriate interface, such as the network interface 1020. The software may cause the processor 1001 to perform one or more processes or one or more steps of one or more processes described or illustrated herein. Performing such a process or step may include defining data structures stored in the memory 1003 and modifying the data structures as directed by the software.

[0040]

[0055] The memory 1003 may include various components (e.g., machine-readable media) including, but not limited to, random access memory components (e.g., RAM 1004) (e.g., static RAM (SRAM), dynamic RAM (DRAM), ferroelectric random access memory (FRAM), phase-change random access memory (PRAM), etc.), read-only memory components (e.g., ROM 1005), and any combination thereof. The ROM 1005 may serve to communicate data and instructions unidirectionally to the processor 1001, and the RAM 1004 may serve to communicate data and instructions bidirectionally with the processor 1001. The ROM 1005 and the RAM 1004 may include any suitable tangible computer-readable media as described below. In one example, a basic input / output system 1006 (BIOS), containing the basic routines that help transfer information between elements within the computer system 1000, such as during start-up, may be stored in the memory 1003.

[0041]

[0056] Persistent storage 1008 is optionally bidirectionally connected to processor 1001 through storage control unit 1007. Persistent storage 1008 provides additional data storage capacity and may include any suitable tangible computer-readable media described herein. Storage 1008 may be used to store operating system 1009, executables 1010, data 1011, applications 1012 (application programs), and the like. Storage 1008 may also include an optical disk drive, a solid-state memory device (e.g., a flash-based system), or a combination of any of the above. Information in storage 1008 may be incorporated as virtual memory in memory 1003, where appropriate.

[0042]

[0057] In one example, storage device 1035 may be removably interfaced to computer system 1000 via storage interface 1025 (e.g., via an external port connector (not shown)). In particular, storage device 1035 and associated machine-readable media may provide non-volatile and / or volatile storage of machine-readable instructions, data structures, program modules, and / or other data for computer system 1000. In one example, software may reside, completely or partially, within the machine-readable media on storage device 1035. In another example, software may reside, completely or partially, within processor 1001.

[0043]

[0058] Bus 1040 connects a wide variety of subsystems. As used herein, references to a bus may, where appropriate, include one or more digital signal lines providing a common function. Bus 1040 may be any of several types of bus structures including, but not limited to, a memory bus, a memory controller, a peripheral bus, a local bus, and any combination thereof using any of a variety of bus architectures. By way of example, and not by way of limitation, such architectures include an Industry Standard Architecture (ISA) bus, an Enhanced ISA (EISA) bus, a Micro Channel Architecture (MCA) bus, a Video Electronics Standards Association local bus (VLB), a Peripheral Component Interconnect (PCI) bus, a PCI-Express (PCI-X) bus, an Accelerated Graphics Port (AGP) bus, a HyperTransport (HTX) bus, a serial advanced technology attachment (SATA) bus, and any combination thereof.

[0044]

[0059] The computer system 1000 may also include input devices 1033. In one example, a user of the computer system 1000 may input commands and / or other information into the computer system 1000 via the input devices 1033. Examples of the input devices 1033 include, but are not limited to, an alphanumeric input device (e.g., a keyboard), a pointing device (e.g., a mouse or touchpad), a touchpad, a touch screen, a multi-touch screen, a joystick, a stylus, a gamepad, an audio input device (e.g., a microphone, a voice response system, etc.), an optical scanner, a video or still image capture device (e.g., a camera), and any combination thereof. In some embodiments, the input device is a Kinect, Leap Motion, or the like. The input devices 1033 may be interfaced to the bus 1040 via any of a variety of input interfaces 1023 (e.g., input interface 1023), including, but not limited to, serial, parallel, game port, USB, FIREWIRE®, THUNDERBOLT®, or any combination of the above.

[0045]

[0060] In a particular embodiment, the computer system 1000, when connected to the network 1030, may communicate with other devices connected to the network 1030, particularly mobile devices and enterprise systems, distributed computing systems, cloud storage systems, cloud computing systems, and the like. Communications to and from the computer system 1000 may be transmitted through the network interface 1020. For example, the network interface 1020 may receive incoming communications (such as requests or requests from other devices) in the form of one or more packets (such as Internet Protocol (IP) packets) from the network 1030, and the computer system 1000 may store the incoming communications in the memory 1003 for processing. The computer system 100 may similarly store outgoing communications (such as requests or requests to other devices) in the form of one or more packets communicated from the network interface 1020 to the network 1030 in the memory 1003. The processor 1001 may access these communication packets stored in the memory 1003 for processing.

[0046]

[0061] Examples of network interfaces 1020 include, but are not limited to, network interface cards, modems, and any combination thereof. Examples of networks 1030 or network segments 1030 include, but are not limited to, distributed computing systems, cloud computing systems, wide area networks (WANs) (e.g., the Internet, enterprise networks), local area networks (LANs) (e.g., networks associated with an office, building, campus, or other relatively small geographic space), telephone networks, direct connections between two computing devices, peer-to-peer networks, and any combination thereof. Networks such as network 1030 may use wired and / or wireless communication modes. In general, any network topology may be used.

[0047]

[0062] Information and data may be displayed through a display 1032. Examples of the display 1032 include, but are not limited to, a cathode ray tube (CRT), a liquid crystal display (LCD), a thin film transistor liquid crystal display (TFT-LCD), an organic liquid crystal display (OLED) such as a passive-matrix OLED (PMOLED) or active-matrix OLED (AMOLED) display, a plasma display, and any combination thereof. The display 1032 may interface with the processor 1001, memory 1003, and fixed storage 1008, as well as other devices such as input device 1033, via a bus 1040. The display 1032 is linked to the bus 1040 via a video interface 1022, and the transmission of data between the display 1032 and the bus 1040 may be controlled by a graphics control 1021. In some embodiments, the display is a video projector. In some embodiments, the display is a head-mounted display (HMD), such as a VR headset. In further embodiments, suitable VR headsets include, by way of non-limiting example, HTC Vive, Oculus Rift, Samsung Gear VR, Microsoft HoloLens, Razer OSVR, FOVE VR, Zeiss VR One, Avegant Glyph, Freefly VR headsets, and the like. In still further embodiments, the display is a combination of devices, such as those disclosed herein.

[0048]

[0063] In addition to the display 1032, the computer system 1000 may include one or more other peripheral output devices 1034, including, but not limited to, audio speakers, printers, storage devices, and any combination thereof. Such peripheral output devices may be connected to the bus 1040 via an output interface 1024. Examples of output interface 1024 include, but are not limited to, a serial port, a parallel connection, a USB port, a FIREWIRE port, a THUNDERBOLT port, and any combination thereof.

[0049]

[0064] Additionally or alternatively, computer system 1000 may provide functionality as a result of logic hardwired or otherwise embodied in circuitry, which may operate in place of or together with software to perform one or more processes or one or more steps of one or more processes described or illustrated herein. References to software in this disclosure may encompass logic, and references to logic may encompass software. Furthermore, references to computer-readable media may encompass, where appropriate, circuitry (such as an IC) that stores software for execution, circuitry that embodies logic for execution, or both. This disclosure encompasses any appropriate combination of hardware, software, or both.

[0050]

[0065] Those skilled in the art will appreciate that the various illustrative logical blocks, modules, circuits, and algorithmic steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or a combination of both. To clearly illustrate this interchangeability of hardware and software, the various illustrative components, blocks, modules, circuits, and steps have been described above generally in terms of their functionality.

[0051]

[0066] The various illustrative logic blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed by a general purpose processor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0052]

[0067] The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by one or more processors, or in a combination of both. The software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor. The processor and the storage medium may reside in an ASIC. The ASIC may reside in a user terminal. In the alternative, the processor and the storage medium may reside as discrete components in a user terminal.

[0053]

[0068] In accordance with the description herein, suitable computing devices include, by way of non-limiting examples, server computers, desktop computers, laptop computers, notebook computers, handheld computers, Internet appliances, mobile smart phones, and tablet computers. Those skilled in the art will also recognize that select televisions, video players, and digital music players with optional computer network connectivity are suitable for use with the systems described herein. Suitable tablet computers, in various embodiments, include computers having booklet, slate, and convertible configurations known to those skilled in the art.

[0054]

[0069] In some embodiments, the computing device includes an operating system configured to execute executable instructions. An operating system is software, including programs and data, that, for example, manages the device's hardware and provides services for the execution of applications. Those skilled in the art will recognize that suitable server operating systems include, by way of non-limiting examples, FreeBSD, OpenBSD, NetBSD, Linux, Apple Mac OS X Server, Oracle Solaris, Windows Server, and Novell NetWare. Those skilled in the art will recognize that suitable personal computer operating systems include, by way of non-limiting examples, Microsoft Windows, Apple Mac OS X, UNIX, and UNIX-like operating systems, such as GNU / Linux. In some embodiments, the operating system is provided by cloud computing. Those skilled in the art will similarly recognize that suitable mobile smartphone operating systems include, by way of non-limiting examples, Nokia® Symbian® OS, Apple® iOS®, Research In Motion® BlackBerry OS®, Google® Android®, Microsoft® Windows Phone® OS, Microsoft® Windows Mobile® OS, Linux®, and Palm® WebOS®. application

[0070] In some cases, the imaging system or device 100 described herein may be used in (e.g., non-invasive) medical imaging, lithotripsy, localized tissue heating for therapeutic intervention, highly intensive focused ultrasound (HIFU) surgery, and / or non-medical flow measurement in pipes (or speaker and microphone arrays). In some cases, the imaging system or device described herein may be used to determine the direction and / or velocity of fluid flow (e.g., blood flow) in arteries and / or veins, for example, using Doppler mode imaging. In some cases, the imaging system or device described herein may be used to measure tissue stiffness.

[0055]

[0071] In some cases, the imaging system or device 100 described herein may be configured to perform one-dimensional imaging (e.g., A-scan imaging). In some cases, the imaging system or device 100 described herein may be configured to perform two-dimensional imaging (e.g., B-scan imaging). In some cases, the imaging system or device 100 described herein may be configured to perform three-dimensional imaging (e.g., C-scan imaging). In some cases, the imaging system or device 100 described herein may be configured to perform Doppler imaging. In some cases, the imaging system or device 100 described herein may be switched into (e.g., between) different modes, including a linear mode or a sector mode. In some cases, the imaging system or device 100 may be electronically configured under program control (e.g., by a user).

[0056]

[0072] In many cases, the imaging system or device 100 (e.g., a probe of the imaging system or device 100) can be portable. For example, the imaging system or device 100 can include a handheld casing (e.g., it can be housed within a housing) that can house one or more transducer elements, pixels or arrays, ASICs, control circuitry, and / or computing devices. In some cases, the imaging system or device 100 can include a battery. Some definitions

[0073] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this subject matter belongs.

[0057]

[0074] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. Any reference to "or" herein is intended to include "and / or" unless stated otherwise.

[0058]

[0075] Throughout this specification, references to "some embodiments," "further embodiments," or "a particular embodiment" mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in some embodiments," "in further embodiments," or "in a particular embodiment" in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0059]

[0076] While preferred embodiments of the present subject matter have been shown and described herein, it will be apparent to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the present subject matter. It should be understood that various alternatives to the embodiments of the present subject matter described herein may be used in practicing the present subject matter.

Claims

1. 1. An ultrasonic device comprising: an outer barrier surrounding the ultrasonic transducer, the outer barrier comprising: Lenses and Housing and a multi-layer seal in contact with the lens and the housing, the multi-layer seal comprising a first layer and a second layer, the first layer comprising an indicator material and the second layer comprising a first sealant; Ultrasonic devices.

2. The device of claim 1 , wherein the multi-layer seal further comprises a third layer, the third layer comprising a second sealant.

3. The device of claim 2 , wherein the first sealant has a higher viscosity than the second sealant.

4. The device of any one of claims 1 to 3, wherein the first sealant is a thixotropic material.

5. The device according to any one of claims 1 to 4, wherein the first sealant is a silicone-based sealant.

6. The device according to any one of claims 1 to 5, wherein the outer barrier is impermeable to liquids.

7. The device according to any one of claims 2 to 6, wherein the second sealant is a silicone-based sealant.

8. The device of any one of claims 1 to 7, wherein the first sealant is an adhesive.

9. The device of any one of claims 1 to 8, wherein the second sealant is an adhesive.

10. The device of any one of claims 1 to 9, wherein the multi-layer seal is disposed in a gap between the lens of the device and the housing of the device.

11. The device of any one of claims 1 to 10, wherein the multi-layer seal is in contact with the entire periphery of the lens.

12. A device according to any preceding claim, wherein the multi-layer seal is in contact with the entire periphery of the aperture in the housing.

13. The device of any one of claims 1 to 12, wherein the second layer is in contact with the housing and the lens.

14. The device of any one of claims 1 to 13, wherein the second layer is in contact with the entire periphery of the lens.

15. A device according to any preceding claim, wherein the second layer is in contact with the entire periphery of the aperture in the housing.

16. The device of any one of claims 1 to 15, wherein the second layer is disposed proximal to the first layer relative to the ultrasound transducer.

17. The device of any one of claims 2 to 16, wherein the third layer is disposed distal to the first layer relative to the ultrasound transducer.

18. A device according to any one of claims 2 to 17, wherein the third layer is in contact with the entire periphery of the lens.

19. A device as claimed in any one of claims 2 to 18, wherein the third layer is in contact with the entire periphery of the aperture in the housing.

20. The device of any one of claims 2 to 19, wherein the third layer is in contact with the entire distal surface of the second layer.

21. The device of any one of claims 2 to 20, wherein the interface of the distal surface of the third layer and the distal surface of the lens is smooth.

22. The device of any one of claims 2 to 21, wherein the interface of the distal surface of the third layer and the distal surface of the lens is flat.

23. A device according to any preceding claim, wherein the indicator material comprises a material that undergoes a colour change after coming into contact with a liquid.

24. 24. The device of claim 23, wherein the indicator material changes from a first color to a second color upon contact with the liquid.

25. 25. The device of claim 23 or 24, wherein the liquid is a disinfectant.

26. The device of any one of claims 23 to 25, wherein the liquid comprises water.

27. The device of any one of claims 1 to 26, wherein the ultrasound transducer is coupled to a proximal surface of the lens.

28. The device according to any one of claims 1 to 27, wherein the lens is an ultrasonic acoustic lens.

29. A device according to any preceding claim, wherein the ultrasonic transducer comprises a micro-electro-mechanical system (MEMS) array.

30. The device according to any one of claims 1 to 29, wherein the multi-layer seal has a thickness of from 1 μm to 1000 μm.

31. The device according to any one of claims 1 to 30, wherein the multi-layer seal has a thickness that is constant.

32. The device of any one of claims 1 to 31, wherein the multi-layer seal has a non-constant thickness.

33. The device of any one of claims 1 to 32, wherein the first layer has a thickness of from 1 μm to 125 μm.

34. The device of any one of claims 1 to 33, wherein the first layer has a thickness of from 1 μm to 100 μm.

35. The device of any one of claims 1 to 34, wherein the first layer has a thickness that is constant.

36. The device of any one of claims 1 to 35, wherein the first layer has a non-constant thickness.

37. The device of any one of claims 1 to 36, wherein the second layer has a thickness of from 100 μm to 1000 μm.

38. The device of any one of claims 1 to 37, wherein the second layer has a thickness of less than 750 μm.

39. A device according to any preceding claim, wherein the second layer has a thickness that is constant.

40. The device of any one of claims 1 to 39, wherein the second layer has a non-constant thickness.

41. The device according to any one of claims 1 to 40, wherein the multi-layer seal has a width of from 100 μm to 1000 μm.

42. The device of any one of claims 1 to 41, wherein the second layer has a width that is constant.

43. A device according to any preceding claim, wherein the second layer has a non-constant width.

44. The device of any one of claims 1 to 43, wherein the lens is coupled to the ultrasound transducer.

45. A device according to any preceding claim, wherein the indicator material comprises an adhesive.

46. 46. ​​The device of claim 45, wherein the indicator material is adhered to a surface of the ultrasonic transducer.

47. 47. The device of claim 46, wherein the indicator material is adhered to a surface of an ASIC of the ultrasonic device.

48. 48. The device of claim 47, wherein the indicator material is adhered to a surface of a MEMS wafer of the ultrasonic device.

49. A device according to any preceding claim, wherein the indicator material is disposed between the second and third layers.

50. 1. A method of manufacturing an ultrasonic device, comprising: assembling a housing and a lens to substantially enclose an ultrasound transducer, the lens being coupled to the ultrasound transducer; and applying a multi-layer seal to fill a gap between the housing and the lens, the applying of the multi-layer seal comprising: applying a second layer of the multi-layer seal to one or more inner surfaces of the gap, whereby the second layer contacts the entire periphery of the housing facing the gap and the entire periphery of the lens facing the gap; applying a first layer of the multi-layer seal to a distal surface of the second layer, the first layer including an indicator material; applying a third layer of the multi-layer seal to a distal surface of the first layer, whereby the third layer contacts the entire periphery of the housing facing the gap and the entire periphery of the lens facing the gap. method.

51. 1. A method of manufacturing an ultrasonic device, comprising: assembling a housing and a lens to substantially enclose a plurality of internal components, the plurality of internal components including an ultrasound transducer coupled to the lens; applying a multi-layer seal to fill a gap between the housing and the lens; The step of applying the multi-layer seal comprises: applying a first layer of the multi-layer seal to a distal surface of one or more of the internal components, the first layer including an indicator material; applying a second layer of the multi-layer seal to one or more inner surfaces of the gap, whereby the second layer contacts the entire periphery of the housing facing the gap and the entire periphery of the lens facing the gap; method.

52. 52. The method of claim 51, further comprising applying a third layer of the multi-layer seal to a distal surface of the first layer, whereby the third layer contacts the entire periphery of the housing facing the gap and the entire periphery of the lens facing the gap.

53. 52. The method of claim 50 or 51, further comprising the step of coupling the lens to the ultrasound transducer.

54. 54. The method of any one of claims 50, 52, or 53, further comprising smoothing a distal surface of the multi-layer seal at an interface of the third layer and the housing.

55. The method of any one of claims 50 to 53, further comprising smoothing a distal surface of the multi-layer seal at the interface of the third layer and the lens.

56. The method of any one of claims 50 to 54, wherein the second layer is thixotropic.

57. The method of any one of claims 50 to 55, wherein the third layer is self-leveling.

58. 57. The method of any one of claims 50 to 56, wherein the second layer comprises a material having a higher viscosity than a material comprising the third layer.

59. A method according to any one of claims 50 to 57, wherein the second layer is applied using a dispensing needle.

60. The method of any one of claims 50 to 58, wherein the indicator material undergoes a colour change after contact with a liquid.

61. 61. The method of claim 60, wherein the liquid comprises a disinfectant.

62. 61. The method of claim 60, wherein the liquid comprises water.

63. The method of any one of claims 50 to 61, wherein the first layer has a thickness of less than or equal to 150 micrometers.

64. The method of any one of claims 50 to 62, wherein the multi-layer seal has a thickness of 1,000 micrometers or less.

65. 1. A method for detecting liquid intrusion in an ultrasound device, comprising: contacting a distal surface of an outer barrier of the ultrasonic device with a liquid, the outer barrier comprising a multi-layer seal disposed in a gap between a lens and a housing and coupled to the lens and the housing, the multi-layer seal comprising a first layer and a second layer, the first layer comprising an indicator material and the second layer comprising a sealant; observing a color change in the indicator material of the first layer; A method comprising:

66. 66. The method of claim 65, wherein the distal surface of the outer barrier is contacted with the liquid for between 0.1 hours and 1 hour.

67. 67. The method of claim 66, wherein the liquid comprises water.

68. 67. The method of claim 66, wherein the liquid comprises a low-level disinfectant.

69. 66. The method of claim 65, wherein the distal surface of the outer barrier is contacted with the liquid for between 1 hour and 24 hours.

70. 70. The method of claim 69, wherein the liquid comprises water.

71. 70. The method of claim 69, wherein the liquid comprises a high-level disinfectant.

72. 72. The method of any one of claims 65 to 71, further comprising replacing all or part of the outer barrier.

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