Ultrasonic transducer assembly

Abstract

An ultrasonic transducer assembly is connectable to an ultrasonic system and includes one or more ultrasonic transducer elements supported by a cap. The ultrasonic transducer elements are operable to direct ultrasonic energy toward brain tissue of a subject and / or receive return ultrasonic energy when the ultrasonic transducer assembly is mounted on the head of the subject. Some embodiments include a fillable sheath coupled to an inner surface of the cap and in acoustic contact with the one or more transducer elements.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Application No. 62 / 966348, filed January 27, 2020. For the purposes of the United States, this application claims the benefit of U.S. Application No. 62 / 966348, filed January 27, 2020, entitled “CONFORMABILITY FOR ULTRASOUND TRANSDUCERS,” pursuant to 35 U.S. SC § 119, which is incorporated herein by reference for all purposes. Technical Field

[0003] The present invention generally relates to ultrasonic transducers, and particularly to ultrasonic transducer assemblies that can be connected to an ultrasonic system to deliver ultrasonic energy to the brain tissue of a subject and / or receive echo ultrasonic energy from the brain tissue of a subject. Background Technology

[0004] Ultrasound is commonly used in medicine to detect abnormal lumps (such as tumors) and / or changes in the appearance of organs and tissues. In an ultrasound examination, an ultrasound transducer emits high-frequency sound waves and detects the echoes reflected from organs, tissues, etc. Ultrasound can be delivered to brain tissue for therapeutic and diagnostic purposes.

[0005] To establish good acoustic coupling between the ultrasound transducer element and the patient's tissue, a suitable acoustic coupling medium must be present between the ultrasound transducer element and the tissue to provide an effective path for ultrasound propagation. Therefore, physicians typically perform ultrasound examinations by manually pressing the ultrasound probe against the patient's skin.

[0006] The brain is contained within a hard, bony skull with curved surfaces. The contours of the skull or head are typically irregular and non-linear. The shape and size of the skull can also vary between objects.

[0007] In some cases, it is desirable to use multiple ultrasound transducer elements to deliver ultrasound to the brain of a subject. For example, it may be desirable to use multiple transducers to increase the signal-to-noise ratio and / or provide effective coverage of the target region. In such cases, multiple ultrasound transducer elements can be provided as part of an ultrasound transducer assembly.

[0008] Designing ultrasound transducer assemblies to deliver ultrasound energy to the brain is challenging due to the presence of the skull. The physical and acoustic properties of the skull present challenges to coupling ultrasound energy into and out of the brain. Some ultrasound transducer assemblies (e.g., those used for diagnostic imaging) are not designed to conform to the complex contours of the skull or head, leaving air gaps that can result in poor acoustic coupling between the transducer element and brain tissue. Other ultrasound transducer assemblies are incompatible with different patients or require lengthy setup times.

[0009] There remains a need for ultrasound transducer assemblies that can adapt to various sizes and shapes of patients' heads. There also remains a need for ultrasound transducer assemblies that provide good acoustic coupling between the ultrasound transducer and the subject's brain.

[0010] The foregoing examples and related limitations of the related art are intended to be illustrative rather than exclusive. Other limitations of the related art will become apparent to those skilled in the art upon reading the specification and studying the accompanying drawings. Summary of the Invention

[0011] The following embodiments and aspects thereof are described and illustrated in conjunction with systems, tools, and methods, which are intended to be exemplary and illustrative, and not to limit the scope. In various embodiments, one or more of the problems described above are reduced or eliminated, while other embodiments address other improvements.

[0012] This invention has many aspects. These include, but are not limited to:

[0013] • An ultrasonic transducer assembly used to deliver ultrasonic energy to the brain;

[0014] • Includes an ultrasonic transducer assembly with a fillable sheath for acoustic coupling to the head of the object;

[0015] • Fillable sheath for ultrasonic transducer assemblies;

[0016] • Includes ultrasonic transducer assemblies with positionable transducers; and

[0017] • Related methods.

[0018] One aspect of the invention relates to an ultrasonic transducer assembly connectable to an ultrasonic system. The assembly includes a mechanical substructure having an outer surface and an inner surface. The inner surface is shaped to define a cavity therein. The mechanical substructure supports one or more ultrasonic transducer elements. Each of the ultrasonic transducer elements is operable to direct ultrasonic energy toward the cavity and / or receive echo ultrasonic energy. The assembly also includes a fillable sheath coupled to the inner surface of the mechanical substructure and in acoustic contact with one or more transducer elements. The fillable sheath is liner-lined on the inner surface of the mechanical substructure. The fillable sheath includes: a deformable container for holding a volume of acoustic transmission fluid within a deformable chamber of the container; a port in fluid communication with the deformable chamber; and a valve for controlling fluid flow through the port, thereby controlling the volume of acoustic transmission fluid in the deformable chamber.

[0019] In some embodiments, the fillable sheath is acoustically coupled to the mechanical substructure. In some embodiments, a layer of acoustic coupling gel is located between the fillable sheath and the mechanical substructure.

[0020] Deformable containers can be made of materials selected from the group consisting of polyurethane, latex, and silicone. Acoustic transmission fluids can be selected from the group consisting of degassed water, mineral oil, and gel.

[0021] In some embodiments, the ultrasonic transducer assembly includes a second port in fluid communication with the deformable chamber and a second valve for controlling fluid flow through the second port. The first port may be positioned in fluid communication with the output of a hydraulic system via the first valve to receive acoustic transmission fluid in the deformable chamber. The second port may be positioned in fluid communication with the input of the hydraulic system via the second valve to return acoustic transmission fluid from the deformable chamber to the hydraulic system. The hydraulic system may include electronics configured to continuously pump acoustic transmission fluid into the deformable chamber through the first port and continuously extract acoustic transmission fluid from the deformable chamber through the second port. In some embodiments, the first and second valves include corresponding electronic sensors configured to detect the rate of fluid flow through the respective valves.

[0022] In some embodiments, the ultrasonic transducer assembly includes a bubble detector for detecting bubbles in the acoustic transmission fluid. The bubble detector may include at least one ultrasonic transducer element (i.e., an ultrasonic transducer element configured to deliver pulses of ultrasonic energy). A hydraulic system may be configured to pump the acoustic transmission fluid through a first port into a deformable chamber and extract the acoustic transmission fluid through a second port in response to the detection of bubbles in the acoustic transmission fluid. The hydraulic system may be configured to pump the acoustic transmission fluid into the deformable chamber at a rate faster than the rate at which the acoustic transmission fluid is extracted from the deformable chamber.

[0023] In some embodiments, the fillable sleeve includes an O-ring extending around the periphery of the deformable container. The fillable sleeve can be mechanically coupled to a mechanical substructure by inserting the edge portion of the fillable sleeve and the O-ring into a channel.

[0024] In some embodiments, the O-ring includes segments or strips of conductive material that, when the O-ring is inserted into the channel, make electrical contact with corresponding conductive portions of the channel. The segments of conductive material may extend partially around the periphery of the deformable container. The conductive portions of the O-ring may be applied to transmit signals to and / or from sensors on the fillable sheath.

[0025] In some embodiments, the O-ring further includes a conductive pad that is in electrical contact with a segment of conductive material. For example, the conductive pad may extend in a polar direction around a portion of the O-ring. Electrical conductors may be provided, for example, by printing, on the outer surface of the deformable container. When the O-ring mechanically couples the fillable sheath to the substructure, the conductive pad of the O-ring may contact the corresponding electrical conductor of the fillable sheath. In some embodiments, the O-ring includes a first conductive pad and a second conductive pad, which are in electrical contact with corresponding first and second segments of conductive material and corresponding first and second electrical conductors supported on the surface of the deformable container. The electrical conductors may be located on the inner outer surface of the deformable container. The electrical conductors may be electrically connected to a sensor (e.g., a temperature sensor).

[0026] In some embodiments, the ultrasonic transducer assembly further includes one or more baffles located within the deformable chamber. The baffles may be made of a material having an acoustic impedance substantially the same as that of the acoustic transmission fluid. The baffles may have a thickness less than the wavelength of sound in the acoustic transmission fluid. For example, the thickness of the baffles may be in the range of 0.5 mm to 1.5 mm. The baffles may include perforations located between the baffles and the outer surface of the deformable container.

[0027] In some embodiments, the fillable sheath includes a temperature sensor. The temperature sensor may be configured to measure the temperature of the acoustic transmission fluid in the deformable chamber and / or the skin temperature of the object wearing the ultrasonic transducer assembly. In some embodiments, the fillable sheath is detachably coupled to a mechanical substructure. In some embodiments, the fillable sheath is made of a disposable material. In some embodiments, the fillable sheath also includes one or more of the following: an electroencephalogram (EEG) sensor, a motion sensor, and an accelerometer.

[0028] In some embodiments, the mechanical substructure includes a retaining mechanism for securing the mechanical substructure and a padded sheath coupled thereto to the head of the object. In some embodiments, the mechanical substructure includes a rigid frame. In some embodiments, the frame includes a locking hinge mechanism that allows the frame to be pushed toward the head of the object to secure the frame tightly to the head of the object.

[0029] Another aspect of the invention relates to a fillable sheath connectable to the inner surface of a cap supporting one or more ultrasonic transducer elements. The fillable sheath includes a deformable container. The deformable container holds a volume of acoustic transmission fluid within a deformable chamber. The fillable sheath includes at least one port in fluid communication with the interior of the deformable chamber. A valve may be provided to control fluid flow through the port, thereby controlling the volume of acoustic transmission fluid within the deformable chamber. The deformable sheath may be held in place within the cap using O-rings. In some embodiments, one or more of the valve and O-rings are part of the fillable sheath.

[0030] In some embodiments, the inflatable sheath includes a sensor supported on or coupled to the deformable container. This sensor may include a temperature sensor configured to measure the temperature of the acoustic transmission fluid within the deformable chamber and / or the skin temperature of the object to whom the inflatable sheath is attached.

[0031] In some embodiments, the fillable sleeve includes one or more electrical conductors. These conductors may, for example, be printed on the outer surface of the deformable container. When the fillable sleeve is attached to the cap via an O-ring, the conductors may be designed to make electrical connections to conductive pads on the O-ring and / or in the cap. For example, an electrical conductor on the fillable sleeve may contact a corresponding conductive pad located on the O-ring. The O-ring may further include an electrical conductor connecting the conductive pad to a segment of conductive material extending circumferentially around a portion of the O-ring. The segment of conductive material can provide electrical connections to conductors on the cap. In some embodiments, the conductive pad is shaped to extend in a polar direction around a portion of the O-ring. In some embodiments, the deformable container is made of a disposable material. In some embodiments, the deformable container is made of a material with an elastic modulus in the range of 0.5 MPa to 10 MPa.

[0032] Another aspect of the invention relates to an ultrasonic transducer assembly having one or more housings supported by a cap made of a rigid material. Each of the one or more housings includes: an ultrasonic transducer element operable to deliver ultrasonic energy; a spring coupled to the ultrasonic transducer element; and a pivot support coupled to the ultrasonic transducer element. As the ultrasonic transducer element moves toward the housing, the spring applies a reaction force, which is directed to force the ultrasonic transducer element away from the housing along a first axis. The pivot support facilitates rotational movement of the ultrasonic transducer element about a second axis.

[0033] In some embodiments, the pivot support includes a gimbal structure that facilitates rotational movement of the ultrasonic transducer elements about a second axis and about a third axis. The first axis, second axis, and third axis may be orthogonal to each other. The gimbal structure may include a first ring coupled to the housing via a first rotation axis and a second ring coupled to the first ring via a second rotation axis.

[0034] In some embodiments, each of one or more housings further includes: a first rotary encoder configured to measure a first rotation angle relative to a second axis; and a second rotary encoder configured to measure a second rotation angle relative to a third axis. In some embodiments, each of one or more housings further includes a linear encoder configured to measure displacement of a transducer element along the first axis.

[0035] Another aspect of the invention relates to an ultrasonic transducer assembly comprising one or more housings coupled to a cap made of a flexible material. Each of the one or more housings includes: an ultrasonic transducer element operable to deliver ultrasonic energy; a positioner attached to the ultrasonic transducer element; and a positioning sensor. The positioning sensor is configured to detect the position and orientation of the positioner to determine the corresponding position and orientation of the ultrasonic transducer element.

[0036] In some embodiments, the locator includes a reflective surface, and the positioning sensor includes an infrared emitter, an infrared receiver, and a camera. In some embodiments, the positioning sensor also includes a light source for providing controlled illumination. In some embodiments, the locator includes a circular reflective surface. In some embodiments, the cover is made of silicone resin. In some embodiments, the housing is attached to the cap via an adhesive. In other embodiments, the housing is coupled to corresponding grommets attached to the cap. The housing can be threadedly coupled to their respective grommets.

[0037] In addition to the exemplary aspects and implementations described above, other aspects and implementations will become apparent by referring to the accompanying drawings and studying the following specific embodiments. Attached Figure Description

[0038] Exemplary embodiments are illustrated in the accompanying drawings. The embodiments and drawings disclosed herein are intended to be illustrative rather than limiting.

[0039] Figure 1 An ultrasonic transducer assembly according to an exemplary embodiment of the present invention is illustrated schematically. Figure 1A The connection between the ultrasonic system and the hydraulic system is shown. Figure 1 The ultrasonic transducer assembly. Figure 1B yes Figure 1 A three-dimensional view of an ultrasonic transducer assembly of the type shown. Figure 1C yes Figure 1 An exploded perspective view of a portion of an ultrasonic transducer assembly. Figure 1D It schematically shows what can be used as Figure 1 A baffle is provided as part of the ultrasonic transducer assembly. Figure 1E It shows the method for using Figure 1 A flowchart of a method for assembling and mounting an ultrasonic transducer assembly onto the head of an object.

[0040] Figure 2 An ultrasonic transducer assembly according to another exemplary embodiment of the invention is illustrated schematically. Figure 2A yes Figure 2 A front cross-sectional view of the transducer element of the ultrasonic transducer assembly. Figure 2B yes Figure 2A Top view of the transducer element.

[0041] Figure 3 An ultrasonic transducer assembly according to another exemplary embodiment of the invention is illustrated schematically. Figure 3A The transducer element of the ultrasonic transducer assembly is shown. Figure 3B It shows the method for determining Figure 3A An exemplary positioning sensor for the position and orientation of transducer elements. Figures 3C to 3E It shows the result of Figure 3B Various exemplary images captured by the camera device of the positioning sensor.

[0042] Figure 4A A subarray comprising multiple transducer elements is shown. Figure 4B It shows including Figure 4A The ultrasonic transducer assembly of the subarray shown.

[0043] Figures 5A to 5C An exemplary technique for achieving acoustic coupling between a transducer element and the head of an object is shown.

[0044] Figure 6 An exemplary technique for measuring the orientation of the head relative to a conformal ultrasound assembly is shown. Detailed Implementation

[0045] Specific details are set forth throughout the following description to provide a more thorough understanding to those skilled in the art. However, well-known elements may not be shown or described in detail to avoid unnecessarily obscuring the contents of this disclosure. Therefore, the specification and drawings should be regarded as illustrative rather than restrictive.

[0046] One aspect of the invention relates to an ultrasound transducer assembly that can be used to deliver ultrasound energy to brain tissue and is compatible with various objects (i.e., adaptable to objects with different head shapes and sizes). Such an assembly can be mounted on the head of different objects to deliver ultrasound energy to the object's brain tissue and / or receive echo ultrasound energy from the object's brain tissue. Because the shape and size of the head may vary between objects, the ultrasound transducer assembly described herein includes features that facilitate good ultrasound energy coupling between the transducer elements of the ultrasound transducer assembly and the object's brain tissue.

[0047] First Example Implementation

[0048] Figure 1 An ultrasonic transducer assembly 10 according to an exemplary embodiment is schematically shown. Assembly 10 is mounted on the head 2 of object 3. Figure 1A As shown, the ultrasonic transducer assembly 10 can be connected to the ultrasonic system 5 and / or the hydraulic system 6. The ultrasonic system 5 can be, for example, of the type described in PCT Publication WO2018 / 026738 entitled “ULTRASOUND GUIDED OPENING OF BLOOD-BRAIN BARRIER”, the entire contents of which are incorporated herein by reference for all purposes.

[0049] The ultrasound transducer assembly 10 includes a mechanical substructure 12 supporting one or more transducer elements 20. For example, the mechanical substructure 12 may support approximately 256 to 1024 transducer elements 20. When the ultrasound transducer assembly 10 is mounted on the head 2 of the subject 3, the transducer elements 20 may operate independently or jointly to deliver ultrasound energy to the brain tissue of the subject 3 and / or receive echo ultrasound energy. That is, some transducer elements 20 may be operated to deliver but not receive ultrasound energy, while some other transducer elements 20 may be operated to receive but not deliver ultrasound energy. Some other transducer elements 20 may be operated to both deliver and receive ultrasound energy. These various operating modes of the transducer elements 20 can be applied to achieve any one of treatment, imaging, or monitoring, as well as combinations of two or more of these.

[0050] Transducer element 20 can be operated to transmit or receive ultrasonic energy having various frequencies and / or frequency ranges. For example, some transducer elements 20 can be operated to deliver low-frequency ultrasonic energy (e.g., about 200 kHz to 400 kHz). As another example, some transducer elements 20 can be operated to deliver and receive low-frequency ultrasonic energy. As another example, some transducer elements 20 can be operated to deliver and receive high-frequency ultrasonic energy (e.g., 2 MHz or greater). As another example, some transducer elements 20 can be operated to receive both low-frequency and high-frequency ultrasonic energy.

[0051] In some embodiments, the ultrasonic transducer assembly 10 is connected to the ultrasonic system 5 and receives signals from the ultrasonic system 5 to operate the transducer element 20.

[0052] In some embodiments, each transducer element 20 is composed of, for example... Figure 1 The independent housing of the depicted mechanical substructure 12 is supported or housed within the independent housing of the mechanical substructure 12.

[0053] The mechanical substructure 12 has an inner surface 12A and an outer surface 12B. The inner surface 12A is shaped to define a cavity 16 for receiving the head 2 of the object 3 (see...). Figure 1B Although not mandatory, the mechanical substructure 12 typically has an overall construction of a hat or helmet. Therefore, for the sake of brevity, the mechanical substructure 12 may be described herein as, or referred to as, a hat or helmet.

[0054] The mechanical substructure 12 is made of a rigid material and / or coupled to a rigid frame 14. The frame 14 may be integrally formed with or detachably coupled to the mechanical substructure 12 (e.g., via a snap-fit ​​mechanism, hinge, etc.). The frame 14 may include a locking hinge mechanism that facilitates securing the mechanical substructure 12 to the head 2 of the object 3. For example, the frame 14 may include a locking hinge mechanism that allows the frame 14 to be pushed toward the head 2 and locked in place to secure the frame 14 tightly against the face of the object 3. When locked in place, the frame 14 applies pressure to the bony regions of the object 3's face (e.g., the region below the temporal region) to restrict movement of the ultrasonic transducer assembly 10 relative to the head 2.

[0055] In some embodiments, the frame 14 includes a liner 14A coupled to a portion of the inner surface of the frame 14 (see...). Figure 1B When the frame 14 presses against the face of the object 3, the pad 14A can provide more comfort for the object 3.

[0056] Fillable sheath

[0057] The ultrasonic transducer assembly 10 includes a fillable sheath 30 coupled to the inner surface 12A of the mechanical substructure 12. When the ultrasonic transducer assembly 10 is mounted on the head 2, the sheath 30 is located in the cavity 16 and between the mechanical substructure 12 and the head 2. The sheath 30 can be shaped to have an outer surface and an inner surface, the outer surface being shaped to mate with the inner surface 12A of the mechanical substructure 12, the inner surface being shaped to receive the head 2 of the object.

[0058] The sheath 30 is acoustically coupled to the transducer element 20. In some embodiments, the sheath 30 is in direct physical contact with the transducer element 30. The sheath 30 includes one or more chambers that may contain an acoustic transmission fluid 8. The acoustic transmission fluid 8 can provide a good acoustic coupling medium between the transducer element 20 and the head 2 (e.g., by eliminating or reducing the air gap between the transducer element 20 and the head 2). Examples of suitable acoustic transmission fluids 8 include, but are not limited to, water, mineral oil, and gels. The following properties of the acoustic transmission fluid 8 may resemble those of the tissue of the head 2: attenuation coefficient, reflection coefficient, transmission coefficient, and / or acoustic impedance.

[0059] When filled with the acoustic transmission fluid 8, the sheath 30 expands to contact the head 2 and apply pressure to the head 2. This provides good acoustic contact between the transducer element 20 and the head 2, and further restricts the movement of the ultrasonic transducer assembly 10 relative to the head 2. By using an appropriate amount of acoustic transmission fluid 8 to fill the fillable sheath 30, the ultrasonic transducer assembly 10 can be fitted to heads 2 of different sizes.

[0060] In some embodiments, the sheath 30 may be inflated (i.e., filled with the acoustic transmission fluid 8) until it conforms to the shape and / or contour of the head 2. This facilitates good ultrasonic energy coupling between the transducer element 20 of the ultrasonic transducer assembly 10 and the brain tissue of the subject 3. In some cases, establishing conformity and good acoustic coupling between the transducer element 20 and the skull of the head 2 may be particularly desirable. This allows ultrasonic energy to reach and propagate to the four lobes (frontal, parietal, temporal, and occipital lobes), the cerebellum, and the brainstem, and to propagate within the four lobes (frontal, parietal, temporal, and occipital lobes), the cerebellum, and the brainstem. Therefore, the sheath 30 may be shaped or otherwise designed to provide good conformity between the transducer element 20 and the skull of the head 2 when the sheath 30 is filled with the acoustic transmission fluid 8.

[0061] exist Figure 1In the illustrated example embodiment, the sheath 30 includes a deformable container 32 defining a deformable chamber 32C therein. The deformable container 32 has an outer surface 32A facing the mechanical substructure 12 and an inner surface 32B facing away from the mechanical substructure 12 (i.e., facing the cavity 16). The deformable container 32 may be made of materials such as polyurethane, latex, silicone, etc., or combinations thereof, such that the sealed chamber 32C prevents fluid 8 loss and has good acoustic transmission characteristics. The material constituting at least the inner surface 32B of the container 32 may be elastic, allowing the container 32 to expand or contract to accommodate heads of different sizes without forming a significant amount of creases.

[0062] like Figure 1 As shown, the sheath 30 may include several regions 50A, 50B, 50C, 50D, and 50E. The material properties (e.g., thickness, stiffness, elasticity, etc.) of certain portions of the deformable container 32 may vary between different regions 50. For example, the inner surface 32B of the deformable container 32 may be thinner at region 50C compared to region 50A or region 50E. For example, the material thickness of the inner surface 32B at region 50C may be in the range of approximately 1 mm to 2 mm, and the material thickness at regions 50A and 50E may be in the range of approximately 3 mm to 4 mm. As another example, the elasticity of the different regions 50 of the sheath 30 may range from 0.5 MPa to 10 MPa, including any value in between.

[0063] The deformable chamber 32C can be filled with a certain volume of acoustic transmission fluid 8 (such as water, mineral oil, gel, etc.).

[0064] In some embodiments, the deformable chamber 32C is pre-filled with a desired volume of acoustic transmission fluid 8. That is, the deformable chamber 32C may be filled with acoustic transmission fluid 8 before the sheath 30 is mechanically coupled to the mechanical substructure 12 and / or before the assembly 10 is mounted on the head 2 of the object 3. In such embodiments, the sheath 30 may include a system for adjusting the amount of acoustic transmission fluid 8 contained in a portion of the sheath 30 between the mechanical substructure 12 and the head 2, such that the ultrasonic transducer assembly 10 is fitted onto the head 2 of the object. Such a system may include a port 40 that allows the acoustic transmission fluid 8 to escape from the deformable chamber 32C when the ultrasonic transducer assembly 10 is placed on the head 2 of the person. In a simplified embodiment, the port 40 is connected to a one-way valve in fluid communication with the deformable chamber 32C. The one-way valve allows the acoustic transmission fluid 8 to drain from the deformable chamber 32C. For example, the deformable chamber 32C can be pre-filled with an excess of acoustic transmission fluid 8, and when the ultrasonic transducer assembly 10 is fitted onto the head 2 of the object, the excess acoustic transmission fluid 8 can be extracted from the deformable chamber 32C by a one-way valve (i.e., the excess acoustic transmission fluid 8 can be extracted from the deformable chamber 32C due to the force applied by the head 2).

[0065] In another example embodiment, the accumulator is connected to a port that allows the acoustic transmission fluid 8 to escape from the deformable chamber 32C. The accumulator can receive the acoustic transmission fluid discharged from the deformable chamber 32C and can apply a mild pressure to the discharged acoustic transmission fluid 8, thereby keeping the fillable sheath inflated to the contact head 2. When the ultrasonic transducer assembly 10 is fitted to the head 10, the acoustic transmission fluid 8 can flow back and forth between the accumulator and the deformable chamber 32C.

[0066] In other embodiments, the deformable chamber 32C remains empty or only partially filled before the sheath 30 is mechanically coupled to the mechanical substructure 12 and / or before the assembly 10 is mounted on the head 2 of the object 3. In such embodiments, after the assembly 10 is mounted on the head 2 of the object 3, the deformable chamber 32C can be filled with more acoustic transmission fluid 8 (e.g., by pumping fluid 8 through one or more ports 40, as described in more detail below). For example, the deformable chamber 32C can be filled with more acoustic transmission fluid 8 and expand until the deformable container 32 conforms to the shape and / or contour of the head 2 of the object 3.

[0067] In some embodiments, the hydraulic system 6 is connected to the ultrasonic transducer assembly 10 and is operable to pump the acoustic transmission fluid 8 into and / or extract the acoustic transmission fluid 8 from the deformable chamber 32C. The hydraulic system 6 may include an active hydraulic system (e.g., an electrically or manually operated system) and / or passive components. In some embodiments, the hydraulic system 6 includes a collection bag (e.g., for receiving excess fluid 8 flowing out of the deformable chamber 32C) and optionally includes a storage bag (e.g., for supplying additional fluid 8 to the deformable chamber 32C). In some embodiments, the hydraulic system 6 includes active devices such as pumps, computers, and controllers.

[0068] The outer surface 32A of the deformable container 32 is acoustically coupled to the transducer element 20. For ease of description, the two elements (e.g., transducer element 20 and head 2) are “acoustically coupled” if about 80% or more of the ultrasonic power is transmitted from the first element to the second element.

[0069] The outer surface 32A of the deformable container 32 can be connected via an acoustic coupling gel 33 (e.g., Aquasonic) located between the inner surface 12A and the outer surface 32A of the mechanical substructure 12. TM Gel, Bolx TM The layer acoustic coupling of gels and other materials is to the mechanical substructure 12 (especially the transducer 20).

[0070] The sheath 30 can be mechanically coupled to the mechanical substructure 12 via various mechanisms. For example, the sheath 30 can be integrally formed with the mechanical substructure 12. As another example, the outer surface 32A of the deformable container 32 can be adhered to the inner surface 12A of the mechanical substructure 12 using an adhesive.

[0071] exist Figure 1 In the example embodiment shown, the sheath 30 includes an O-ring 34 that can be pressed or otherwise inserted into a circumferentially extending channel 15 of the mechanical substructure 12. Inserting the O-ring 34 into the channel 15 mechanically couples the sheath 30 to the mechanical substructure 12 (e.g., see...). Figure 1C Advantageously, the O-ring 34 can be tightly fitted in the channel 15 to provide a seal between the inner surface 12A of the mechanical substructure 12 and the outer surface 32A of the deformable container 32. That is, the O-ring 34 can be tightly fitted in the channel 15 to prevent leakage of the acoustic coupling gel 33. In some embodiments, the O-ring 34 is integrally formed with the fillable sheath 30 (e.g., see...). Figure 1C In some embodiments, the O-ring 34 is a separate portion that holds the edge of the fillable sheath 30 in the channel 15.

[0072] In some embodiments, the sheath 30 can be detached from the mechanical substructure 12. For example, the sheath 30 can be detached from the mechanical structure 12 by pulling the O-ring 34 out of the channel 15. In these embodiments, the sheath 30 and its components can be made of disposable material. Different sheaths 30 can be used for different objects. In some embodiments, a set of different sheaths 30 can be provided, in which the different sheaths 30 have different volumes, with larger volumes used to accommodate smaller heads, or smaller volumes used to accommodate larger heads.

[0073] The sheath 30 may include a locking mechanism for securing the sheath 30 to the head 2 of the object 3. For example, as Figure 1 As shown, the sheath 30 may include an elastic band 35 extending around the inner surface 32B of the deformable container 32. The elastic band 35 may be formed together with or fused to the deformable container 32. Advantageously, the elastic band 35 may be secured around the head 2 of the object 3 to prevent leakage of any acoustic coupling gel 33 applied between the head 2 and the inner surface 32B of the deformable container 32.

[0074] Although not mandatory, the sheath 30 typically includes one or more ports 40 (i.e., openings) in fluid communication with the deformable chamber 32C. The ports 40 may be physically supported by the mechanical substructure 12. For example, the ports 40 may protrude through openings located on the mechanical substructure 12 (e.g., Figure 1 (As shown). Advantageously, port 40 allows the acoustic transmission fluid 8 to be pumped into and / or extracted from the deformable chamber 32C to control the volume of the deformable container 32.

[0075] Hydraulic system 6 can be connected to port 40 and operated to pump acoustic transmission fluid 8 into and / or extract acoustic transmission fluid 8 from deformable chamber 32C. Figure 1A In the example embodiment shown, the sheath 30 includes an inlet 40A connectable to the hydraulic system 6 to receive acoustic transmission fluid 8 and an outlet 40B connectable to the hydraulic system 6 to extract acoustic transmission fluid 8 from the deformable chamber 32C. The port 40 can be in fluid communication with the hydraulic system 6 via one or more flexible tubes or the like.

[0076] Port 40 may include or be in fluid communication with one or more valves 42. Valve 42 can be toggled between an open position allowing fluid to flow through and a closed position preventing fluid flow through. Figure 1AIn the example embodiment shown, inlet valve 42A can be switched to its open position and outlet valve 42B can be switched to its closed position, enabling hydraulic system 6 to pump acoustic transmission fluid 8 into deformable chamber 32C. That is, after flow is established between inlet valve 42A and outlet valve 42B, outlet valve 42B can be switched to its closed position to fill deformable chamber 32C with acoustic transmission fluid 8.

[0077] Similarly, the inlet valve 42A can be switched to its closed position, and the outlet valve 42B can be switched to its open position, so that the hydraulic system 6 can extract the acoustic transmission fluid 8 from the deformable chamber 32C.

[0078] In some embodiments, valve 42 is an electrically operated control valve and / or includes suitable electronics for receiving electronic signals to control valve 42. In these embodiments, valve 42 may be electrically connected to a control system and / or an external control system (not shown) provided as part of hydraulic system 6 to receive electronic signals controlling valve 42. Valve 42 may be electrically connected to hydraulic system 6 and / or another control system via cables or the like.

[0079] The valve 42 can be operated to control the pressure within the deformable container 32. For example, the valve 42 can be operated to maintain the pressure within the deformable chamber 32C at a level that provides good acoustic coupling between the transducer element 20 and the tissue within the head 2, and ensures the comfort of the subject 3. In some embodiments, the pressure within the deformable container 32 is maintained between 1 atmosphere and 3 atmospheres.

[0080] To determine whether the deformable chamber 32C has expanded sufficiently to fill the space between the head 2 and the inner surface 12A of the transducer assembly 10, one or more transducer elements 20 can be operated to deliver and receive pulses of ultrasonic energy. If a strong reflection is detected immediately upon the transmission of a pulse by a transducer element 20, this indicates the existence of an air gap between the inner surface 12A and the deformable container 32. In this case, valve 42 can be operated to increase the pressure inside the deformable container 32 until the intensity of the immediate reflection decreases. The ultrasonic system 5 can be connected to the transducer assembly 10 to coordinate pulse-echo integration and the pressure increase inside the deformable container 32. For example, the pressure inside the deformable container 32 can be increased incrementally, with pulse-echo measurements performed at each step. In some embodiments, the ultrasonic system 5 is configured to set a maximum pressure value to prevent the pressure inside the deformable container 32 from exceeding the maximum pressure value.

[0081] The sheath 30 may optionally include one or more baffles 36 located within the deformable chamber 32C. Advantageously, by preventing the acoustic transmission fluid 8 from flowing freely to certain areas, the baffles 36 can provide a more uniform distribution of the volume of the acoustic transmission fluid 8 within the deformable chamber 32. For example, the baffles 36 may be arranged to reduce the pooling of the acoustic transmission fluid 8 at the bottom of the deformable chamber 32C (e.g., due to gravity) when the object 3 is wearing the ultrasonic transducer assembly 10. Such pooling would undesirably lead to cavitation at the top of the deformable chamber 32C.

[0082] In some embodiments, baffle 36 includes one or more features that help prevent pooling. For example, baffle 36 may be configured to limit the separation of inner surface 32B from outer surface 32A. Baffle 36 may be made of a low-elasticity or inelastic material and may be physically coupled to outer surface 32A and inner surface 32B via an adhesive. When chamber 32C fills, baffle 36 may apply a force to prevent outer surface 32A and inner surface 32B from separating beyond a certain distance, thereby preventing excessive expansion of deformable chamber 32C.

[0083] The baffle 36 may be made of a material having an acoustic impedance that is the same as or nearly matched with the acoustic impedance of the acoustic transmission fluid 8, such that the baffle 36 is acoustically transparent or nearly acoustically transparent. For example, the baffle 36 may be made of silicone resin with an acoustic impedance of about 1.54 MRayl, and the acoustic transmission fluid 8 may be water with an acoustic impedance of about 1.48 MRayl.

[0084] Preferably, the thickness of the baffle 36 is significantly smaller than the wavelength of the ultrasound emitted by the transducer element 20 in the acoustic transmission fluid 8. For example, the baffle 36 may have a thickness of about 1 mm or less, wherein the transducer element 20 is configured to deliver ultrasound with frequencies up to about 220 kHz, and the acoustic transmission fluid 8 is water or another fluid in which the speed of sound is close to that in water.

[0085] In some embodiments, the baffle 36 is configured to extend between the outer surface 32A and the inner surface 32B. For example... Figure 1D As shown, the baffle 36 can be configured to leave a perforation 37 (e.g., a gap between the baffle 36 and the outer surface 32B). The perforation 37 allows some acoustically transportable fluid 8 to flow through the baffle 36. The perforation 37 can reduce the likelihood of air bubbles forming at the junction of the baffle 36 and the deformable container 32.

[0086] Additional features of the first example implementation

[0087] The ultrasonic transducer assembly 10 optionally includes one or more sensors 44 (e.g., electronic water pressure sensors, flow sensors, temperature sensors, etc.), one or more sensors being configured to measure the flow and / or pressure characteristics of the acoustic transmission fluid 8. Figure 1A As depicted, sensor 44 may be located between port 40 and hydraulic system 6. Sensor 44 may be electrically connected to a control system and / or an external control system (not shown) provided as part of hydraulic system 6. The control system may control sensor 44, supply power to sensor 44, read the output signal of sensor 44, process sensor values, etc.

[0088] The control system can be connected to the hydraulic system 6 and / or the ultrasonic system 5, or can be provided as part of the hydraulic system 6 and / or the ultrasonic system 5. For example, the hydraulic system 6 may include the control system and can be connected to the ultrasonic system 5 (e.g., via a system interface 7) Figure 1A (As shown).

[0089] Figure 1A An exemplary manner in which the ultrasonic transducer assembly 10 is electrically connected to the ultrasonic system 5 is shown. For example... Figure 1A As shown, the ultrasonic transducer assembly 10 includes a cable housing layer 60 that houses wires connected to the transducer element 20 and optionally wires connected to sensors 44, 46 (as described in more detail elsewhere herein). The wires may be bundled or individually routed through the cable housing layer 60 to a connector 62. Electrical connection between the transducer element 20 and the ultrasonic system 5 can be achieved via a detachable cable connector that mates with the connector 62. The cable housing layer 60 may include mechanical structures such as struts (not shown) to provide mechanical support for the cable housing layer 60. These struts may extend from the mechanical substructure 12 to the top of the cable housing layer 60. In some embodiments, flexible circuitry is used to connect the connector 62 to the transducer element 20.

[0090] Some embodiments employ one or more different methods for controlling the inflow and / or outflow of acoustic transmission fluid 8 into and / or outflow from the deformable chamber 32C when operating transducer element 20 to deliver ultrasonic energy to the head 2 of object 3. The ultrasonic system 5, hydraulic system 6, and ultrasonic transducer assembly 10 can operate, for example, in the following non-limiting manner:

[0091] The hydraulic system 6 may include electronic devices that receive signals from valve 42, sensor 44 and / or external control systems, and send corresponding signals to the ultrasonic system 5 (e.g., via system interface 7) to start and stop ultrasonic transmission, adjust the timing of certain aspects of ultrasonic transmission (e.g., timing between transmitted pulses), etc.

[0092] • The hydraulic system 6 can be manually or automatically controlled to regulate the flow rate of fluid 8 into and out of the sheath 30 and / or the pressure within the deformable chamber 32C.

[0093] The hydraulic system 6 can pump the acoustic transmission fluid 8 into the deformable chamber 32C and stop pumping when the sensor 44 detects a threshold pressure corresponding to the head 2 constrained by the sheath 30.

[0094] The hydraulic system 6 allows the acoustic transmission fluid 8 (e.g., degassed water) to flow continuously through the deformable chamber 32C. This reduces the likelihood of air bubbles accumulating inside the sheath 30. The circulating fluid 8 helps cool the transducer element 20. In some embodiments, the hydraulic system 6 continuously delivers fluid 8 into the deformable chamber 32C and regulates the pressure within the chamber 32C by one or more of the following: regulating the rate at which fluid 8 flows into the chamber 32C and adjusting a valve connected to regulate the flow of fluid 8 out of the deformable chamber 32C.

[0095] The ultrasonic transducer assembly 10 may optionally include one or more temperature sensors 46. Temperature sensors 46 may include, for example, thermistors, thermocouples, or other suitable temperature sensors. Temperature sensors 46 may be placed at one or more of the following locations and configured to measure the temperature of the acoustic transmission fluid 8 at one or more of the following locations:

[0096] • The position near the head 2;

[0097] • The location near the transducer element 20;

[0098] • The outlet port of Room 32C;

[0099] • The entrance port of chamber 32C;

[0100] • Top of chamber 32C.

[0101] In some embodiments, the fillable sheath 30 includes one or more temperature sensors 46. The temperature sensors 46 may be located outside the inner surface 32B of the deformable container 32 (i.e., between the deformable container 32 and the head 2). When the ultrasonic transducer assembly 10 is connected to the ultrasonic system 5, the temperature sensors 46 can send sensor readings to the ultrasonic system 5. This allows the ultrasonic system 5 to control the transducer element 20 (e.g., stop ultrasonic energy delivery) based on the measurements of the temperature sensors 46. For example, the transducer element 20 may be controlled to deliver ultrasonic energy until the temperature sensors 46 measure a threshold temperature. In some embodiments, the temperature sensors 46 are oriented to estimate the skin temperature of the subject 3. In such embodiments, the threshold temperature may be set to a value, for example, between 40°C and 43°C, to prevent discomfort to the subject 3.

[0102] In some embodiments, temperature sensor 46 is configured to measure the temperature of the acoustic transmission fluid 8. In these embodiments, the temperature measured by temperature sensor 46 can be sent to hydraulic system 6 (e.g., via ultrasonic system 5 and system interface 7). Hydraulic system 6 can be configured to control the flow rate and / or temperature of the acoustic transmission fluid 8 flowing into sheath 30 based on the temperature measurement results.

[0103] In some embodiments, the hydraulic system 6 includes a temperature control system operable to adjust the temperature of the fluid 8 delivered to the sheath 30. The temperature control system may include a heater and / or a cooler. In some embodiments, the temperature of the acoustic transmission fluid 8 is maintained in the range of approximately 35°C to 40°C.

[0104] In some embodiments, some or all of the temperature sensors 46 are interconnected with other systems (e.g., ultrasonic system 5, hydraulic system 6, etc.) via electrical conductors 47 supported on the inner surface 32B of the deformable container 32. For example, the electrical conductors can be formed by printing with conductive ink. The electrical conductors 47 can be printed, for example, on the outer surface of the inner surface 32B of the deformable container 32 or otherwise disposed on the outer surface of the inner surface 32B of the deformable container 32 (see [link to relevant documentation]). Figure 1C The electrical conductor 47 can provide an electrical connection between the sensor (e.g., temperature sensor 46) that can be filled with sheath 30 and an external system (e.g., ultrasonic system 5).

[0105] For example, conductor 47 can transmit signals to conductors supported on mechanical substructure 12, enabling temperature sensor 46 to receive signals from and / or transmit signals to ultrasonic system 5. For example, conductor 47 can transmit current to and from sensor 46. Current can power temperature sensor 46 (and / or other sensors) and / or transmit data in analog and / or digital form to ultrasonic system 5 (or another system outside sheath 30).

[0106] In some embodiments, the ultrasound system 5 is configured to modulate the ultrasound transmission sequence and / or control other operations of the ultrasound system 5 based on data received from the temperature sensor 46. For example, if the temperature sensor 46 detects a temperature value higher than a threshold, the transmission of ultrasound energy can be paused until the temperature sensor 46 detects a lower (preset) temperature value.

[0107] exist Figure 1CIn the illustrated embodiment, electrical conductors 47A and 47B are electrically connected to metal strips 34A and 34B via a conductive pad 48 located on the O-ring 34. The conductive pad 48 may be shaped to extend in the polar direction around a portion of the O-ring 34. Typically, at least a portion of the conductive pad 48 is oriented towards the deformable container 32 (i.e., towards the radial direction), as shown. Figure 1C As shown.

[0108] The O-ring 34 may include a first conductive pad and a second conductive pad 48 electrically connected to corresponding first conductor 47A and second conductor 47B. Figure 1C In the example embodiment shown, the first electrical conductor 47A is electrically connected to the first conductive (e.g., metal) strip 34A via the first conductive pad 48, while the second electrical conductor 47B is electrically connected to the second conductive strip 34B via the second conductive pad (not shown).

[0109] The first cable 34A and the second cable 34B are electrically insulated from each other. The first cable 34A may, for example, transmit signal current to and / or from the sensor 46. The second cable 34B may, for example, be connected to electrical ground.

[0110] Similar to O-ring 34, strips 34A and 34B can extend circumferentially around deformable container 32. When O-ring 34 is inserted into channel 15 of mechanical substructure 12, strips 34A and 34B of O-ring 34 contact corresponding conductive strips 15A and 15B located in channel 15. Strips 15A and 15B can extend circumferentially around channel 15.

[0111] In embodiments where the fillable sheath 30 includes multiple sensors (e.g., several temperature sensors 46), the strips 34A, 34B of the O-ring 34 and the strips 15A, 15B located in the channel 15 may be discontinuous (i.e., they may be segmented, with each segment electrically isolated from the other segment in the segment).

[0112] The ultrasonic transducer assembly 10 may include various variations and / or supplementary features. These variations and / or supplementary features may be suitably applied to all embodiments of the ultrasonic transducer assembly 10 described above, and include, but are not limited to:

[0113] • The inner surface 32B of the deformable container 32 (i.e., the surface of the sheath 30 near the head 2 of the object 3 when the ultrasonic transducer assembly 10 is mounted on the head 2 of the object 3) may be coated with a layer of acoustic coupling material (e.g., gel 33). In other words, a layer of acoustic coupling gel 33 may be applied between the inner surface 32B of the deformable container 32 and the head 2 of the object 3.

[0114] The ultrasonic transducer assembly 10 may include a bubble detector (e.g., a transducer element 20 configured to detect bubbles) that detects the presence of bubbles in the sheath 30. The hydraulic system 6 and / or the ultrasonic transducer assembly 10 may be configured to remove any detected bubbles from the sheath 30 (e.g., by evacuating and refilling the deformable chamber 32C and / or by increasing the flow rate of the acoustic transmission fluid 8 into the deformable chamber 32, etc.).

[0115] The ultrasonic transducer assembly 10 may include other sensors, including but not limited to EEG sensors, motion sensors, and accelerometers. Such sensors can be used, for example, to modulate the ultrasonic energy delivered by the ultrasonic transducer assembly 10.

[0116] Figure 1E This is a flowchart illustrating an exemplary method 1000 for assembling and mounting an ultrasonic transducer assembly 10 onto the head 2 of an object 3. At step 1100, acoustic coupling gel 33 is applied to the head 2. At step 1200, acoustic coupling gel 33 is applied to the inner surface 12A of the mechanical substructure 12. Step 1200 may occur before, after, or simultaneously with step 1100.

[0117] At step 1300, the sheath 30 is mechanically coupled to the mechanical substructure 12. For example, step 1300 may include inserting the O-ring 34 of the sheath 30 into the channel 15 of the mechanical substructure 12. Step 1300 may include mechanically coupling the sheath 30 to the mechanical substructure 12 in such a manner that the valve 42 extends from and passes through the mechanical substructure 12. Step 1300 may be performed before, during, or after step 1200.

[0118] After the sheath 30 is mechanically coupled to the mechanical substructure 12, the ultrasonic transducer assembly 10 is mounted on the head 2 of the object 3 at step 1400. Step 1400 may include pressing the frame 14 against the face of the object 3 to secure the ultrasonic transducer assembly 10 in place. At step 1500, the hydraulic system 6 is connected to the ultrasonic transducer assembly 10 (i.e., through port 40) and the acoustic transmission fluid 8 is pumped into the sheath 30. As the sheath 30 is filled with the acoustic transmission fluid 8, the sheath 30 expands until it conforms to the shape of the head 2. This facilitates good acoustic coupling between the transducer element 20 and the head 2 and helps reduce relative movement between the mechanical substructure 12 and the head 2.

[0119] Second Example Implementation

[0120] Another aspect of the invention relates to an ultrasonic transducer assembly including transducer elements that can take different positions and / or orientations based on the shape and size of the object's head. Since the position and / or orientation of such transducer elements can vary between objects, it is desirable to measure or at least estimate these positions and / or orientations of the transducer elements to reduce errors in beamforming. Beamforming errors can cause problems such as undesirable beam patterns and incorrect focusing.

[0121] In some embodiments, the ultrasonic transducer assembly is configured to measure or estimate: the position of the transducer elements, the orientation of the transducer elements, the position of the head, and / or the orientation of the head. The ultrasonic transducer assembly can transmit these measurements or estimates to an ultrasonic system. Advantageously, the ultrasonic system can calculate ultrasonic parameters (e.g., the group of transducer elements to be excited, the timing of the excitation of the transducer elements, the amplitude of the excitation of each transducer element, phase delay, etc.) based on the measurements performed by the ultrasonic transducer assembly.

[0122] For example, an ultrasound system (e.g., ultrasound system 5) can shut off a transducer element 20 that is not properly oriented (e.g., too tilted) in order to deliver ultrasound energy to the target area in a meaningful manner. This can happen because the radiation pattern of the transducer element 20 is not a uniform sphere. As an example, a circular planar transducer element 20 emits a radiation pattern that approximates a Jinc function (sometimes called a “sombrero function”). For target points positioned at an angle to the transducer element 20 (i.e., points in the tissue of object 3), the amount of ultrasound energy delivered to these points is less than the amount of ultrasound energy delivered to target points directly in front of the transducer element 20. The ultrasound system 5 can be configured to calculate the expected amount of ultrasound energy delivered to certain points based on the position and / or orientation of the transducer element 20, a pre-established radiation pattern of the transducer element 20, the size of the transducer element 20, etc. If the calculated expected amount is too low, the transducer element 20 can be shut off in some cases.

[0123] In another example, the position and orientation of transducer element 20 can be processed by the ultrasound system to calculate the acoustic path length between a specific transducer element 20 and the target region. For example, the acoustic path length can be calculated by creating a model of head 2 (which includes layers of head tissue such as the skull, brain tissue, etc.) and calculating the propagation path between transducer element 20 and the target region. After calculating the path length, the ultrasound system can cause transducer element 20 to deliver ultrasonic energy with a specific phase to focus the ultrasonic energy on the target region.

[0124] Figure 2An ultrasonic transducer assembly 10A according to a second exemplary embodiment is schematically shown. The transducer assembly 10A is mounted on the head 2 of the object 3. The ultrasonic transducer assembly 10A includes a rigid mechanical substructure 12 supporting one or more transducer element housings 120. The ultrasonic transducer assembly 10A optionally includes a sheath 30 as described above, but this is generally not required.

[0125] like Figure 2 As shown, the rigid mechanical substructure 12 includes a rigid frame 14. The frame 14 may include an elastic band 35 extending circumferentially around the head 2 of the object 3 for holding the acoustic coupling gel 33 onto the head 2. Figure 2 As shown, the band 35 can be fused or mechanically coupled to the bottom edge of the mechanical substructure 12.

[0126] Transducer element housing

[0127] Figure 2A A cross-section of an example transducer element housing 120 is schematically shown. The transducer element housing 120 includes a housing base 121 and a housing body 122. The housing base 121 is mechanically coupled to a mechanical substructure 12. The housing body 122 houses a spring-loaded shaft 125 (e.g., a shaft 125 loaded with a spring 124), which is coupled to a transducer element 20 at its first end 125A and to one or more pivot supports 130 at its second end 125B. The shaft 125 may optionally include a cap 126 located at the second end 125B to prevent the pivot supports 130 and / or the transducer element 20 from separating from the transducer element housing 120.

[0128] like Figure 2A As depicted, the transducer element 20 typically protrudes inward through a gap 121A in the housing base 121. When the object 3 wears the ultrasonic transducer assembly 10A, the head 2 contacts the transducer element 20. In some cases, the head 2 can push the transducer element 20 radially outward toward the mechanical substructure 12 along axis 101. As the transducer element 20 is pushed toward the mechanical substructure 12, a spring 124 applies a restoring force to the transducer element 20 toward the head 2 along the radial axis 101. The position of the transducer element 20 along axis 101 can be displaced based on the shape and / or size of the head 2.

[0129] The support 130 allows the shaft 125 and the transducer element 120 coupled thereto to rotate about one or more axes. Figure 2AIn the illustrated example embodiment, the pivot support 130 includes a gimbal structure that allows the transducer element 20 to adopt an orientation (e.g., pitch and yaw) consistent with the shape of the head 2. The gimbal structure includes a first ring 130A (i.e., outer ring) coupled to the transducer element housing 122 via a first rotation axis 132A and a second ring 130B (i.e., inner ring) coupled to the first ring 130A via a second rotation axis 132B (see...). Figure 2B The first rotation axis 132A allows the first ring 130A to pivot along axis B-B'. The second rotation axis 132B allows the second ring 130B to pivot along axis C-C'.

[0130] Shaft 125 is coupled to second ring 130B. Shaft 125 may be coupled to second ring 130B via two or more shaft ball bearings 123. For example, second ring 130B may include pockets cut within its body to receive ball bearings 123. Ball bearings 123 contact shaft 125 and provide rolling surfaces for shaft 125 to move up and down along shaft 101, for example, when head 2 pushes against transducer element 20.

[0131] In some embodiments, the transducer element housing 120 includes one or more linear encoders and / or rotary encoders. The encoder values ​​can be read by electronic devices such as microprocessors. Signals from the encoders can be carried, for example, by wiring that passes through channels in the transducer element housing 120 and / or channels in the mechanical substructure 12.

[0132] exist Figure 2B In the example embodiment shown, the transducer element housing 120 includes: a first rotary encoder 134A for measuring the orientation of the first ring 130A (i.e., the angle relative to the shaft B-B'); a second rotary encoder 134B for measuring the orientation of the second ring 130B (i.e., the angle relative to the shaft C-C'); and a linear encoder 134C for measuring the position of the shaft 125 along the shaft 101 (i.e., the displacement relative to the initial position).

[0133] In some implementations, such as Figure 2A As shown, the linear encoder 134C is mounted on the second ring 130B. The linear encoder 134C may be located near the shaft 125. The linear encoder 134C may include a magnet or magnetic sensor, and the shaft 125 may include a magnetic strip or other suitable markings that enable the linear encoder 134C to measure the displacement of the shaft 125 (along the shaft 101) from its initial position.

[0134] Advantageously, the linear encoders and / or rotary encoders described herein can be configured to measure reference positions (e.g., a “zero” state of the position and / or orientation of each transducer element 20). Before the ultrasonic transducer assembly 10A is mounted on the head 2, the spring 124 does not store restoring force, thus all transducer elements 20 are biased inward (i.e., biased in a direction away from the mechanical substructure 12). The zero state can be used to determine the new position and / or orientation of each transducer element 20 after the ultrasonic transducer assembly 10A is mounted on the head 2. When the ultrasonic transducer assembly 10A is mounted on the head 2, each transducer element 20 adopts a position and orientation corresponding to the position and orientation of the head 2 at the point of contact. The linear encoders and / or rotary encoders described herein can measure the position and / or orientation of the transducer elements 20 and transmit the measurement results to the ultrasonic system (e.g., ultrasonic system 5).

[0135] The transducer element 20 described herein, as well as the linear encoder and / or rotary encoder, can be powered via wires connected to a power outlet that can be connected to an ultrasonic system. As described above with respect to the ultrasonic transducer assembly 10, the wires may be located within a cable housing layer 60. The cable housing layer 60 may include a power outlet for connection to the ultrasonic system (e.g., via a detachable cable or connector).

[0136] Third Example Implementation

[0137] Figure 3 An ultrasonic transducer assembly 10B according to a third exemplary embodiment is schematically shown mounted on the head 2 of object 3. The ultrasonic transducer assembly 10B includes a non-rigid (i.e., conformal) substrate 12B supporting one or more transducer element housings 120B. The conformal substrate 12B may be flexible and / or stretchable. The conformal substrate 12B may be made of one or more materials, such as, but not limited to, silicone, Lycra... TM And elastic rubber.

[0138] Each transducer element housing 120B houses a transducer element 20. The transducer element housing 120B can be mechanically coupled to the conformal substrate 12B via various possible mechanisms. For example, the transducer element housing 120B can be glued or adhered to the conformal substrate 12B. As another example, the conformal substrate 12B may include a grommets 200, and the transducer element housing 120B can be coupled to the grommets 200. These coupling mechanisms and the conformal substrate 12B enable each transducer element 20 to take a position and orientation that matches the position and orientation at the contact point between the transducer element 20 and the head 2.

[0139] Figure 3AAn exemplary transducer element housing 120B is shown, coupled to a conformal substrate 12B via a grommets 200. The grommets 200 may include threads for receiving a corresponding thread of the transducer element housing 120B.

[0140] The transducer element housing 120B may include an electrical connection mechanism 210 that enables electrical connections to be wired from the conformal substrate 12B to the transducer element 20. Figure 3A In the illustrated example embodiment, the electrical connection mechanism 210 includes a service loop that enables the transducer element 20 to take a position and orientation at the contact point with the head 2. The conformal substrate 12B may also include a conformal channel 220 that allows wiring. The wires can be routed to the conformal substrate cable connector 260. The cable connector 260 can be located in a position that does not obstruct the optical path between the positioner 230 and the positioning sensor 250 of the transducer element 20 (as described in more detail below). A cable can be connected between the cable connector 260 and the ultrasonic system 5 to connect the ultrasonic transducer assembly 10B to the ultrasonic system 5.

[0141] In some embodiments, the transducer element 20 is mechanically coupled to the positioner 230. The positioner 230 may include a disk with a reflective surface, a disk with a different pattern, an object with a reflective surface, etc. The positioner 230 may be provided as part of the transducer element housing 120B. The positioner 230 may be configured to indicate the transducer element 20 relative to, for example, a positioning base 245 (see...). Figure 3 The position and / or orientation of the positioning sensor 250 on the transducer element 20. Measuring the position and / or orientation of the transducer element 20 can help increase the accuracy of beamforming (as described in more detail elsewhere herein). The positioning sensor 250 can be, for example, an optical (e.g., camera-based) positioning sensor, a magnetic positioning sensor, etc.

[0142] Figure 3B A portion of the positioning base 245, positioning sensor 250, and locator 230 is schematically shown. Figure 3B The depicted positioning sensor 250 may include an infrared (IR) transmitter 252, an infrared receiver 254, and a camera device 255. Optionally, the positioning sensor 250 may include a light source (not shown) for providing controlled illumination. In operation, the IR transmitter 252 may be configured to direct light toward the locator 230, and the IR receiver 254 may be configured to receive light reflected from the locator 230. For example, the position of the locator 230 may be determined by calculating the time of flight of the light traveling between the IR transmitter 252 and the IR receiver 254.

[0143] like Figure 3C , Figure 3D and Figure 3E As shown, the orientation of the transducer element 20 can be measured using a camera device 255. For example, the camera device 255 can capture an image of the surface of the positioner 230 and send the image to a computing device (not shown) for analysis. If the surface of the positioner 230 is circular and perpendicular to the camera axis of the camera device 255, the image will appear as shown. Figure 3C The disk shown. If the reflective surface of locator 230 is at a pitch angle and / or yaw angle, the image will show an ellipse. For example, if the surface of locator 230 is around... Figure 3C Rotating the E-E' axis allows the image captured by the camera device 255 to be displayed. Figure 3D An ellipse of the type shown. As another example, if the surface of locator 230 surrounds... Figure 3C Rotating the F-F' axis allows the image captured by the camera device 255 to be displayed. Figure 3E An ellipse of the type shown. The computing device can calculate or estimate the orientation of the transducer element 20 based on a photograph taken by the camera device 255.

[0144] In some embodiments, multiple positioning sensors 250 may be mounted on the positioning base 245 to measure the position and / or orientation of some or all of the transducer elements 20 of the ultrasonic transducer assembly 10B. In some embodiments, the positioning sensors 250 are mounted on a mechanical scanning platform that oscillates about an axis. The scanning platform may include an encoder that measures the orientation and / or position of the positioning sensors 250. This allows for the use of fewer positioning sensors 250.

[0145] The positioning sensor 250 may include the IR sensor and camera device as described above, and / or other types of sensors. For example, the positioning sensor 250 may also include electromagnetic sensors and / or radio frequency sensors to detect the position and / or orientation of the transducer element 20.

[0146] Supplementary features for all example implementations

[0147] The ultrasonic transducer assemblies described herein (e.g., ultrasonic transducer assemblies 10, 10A, 10B) may include transducer elements 20 grouped into one or more subarrays 21. Figure 4AA first subarray 21A and a second subarray 21B are schematically shown. The groups of transducer elements 20 forming the subarray 21 can share a common substrate or mechanical substructure. That is, the subarray 21 can be an independent unit with electronics (e.g., emitter drive electronics integrated within the structure of the subarray 21 to drive the transducer elements 20). Each transducer element 20 within the subarray 21 can be optimized differently and / or can perform different functions. For example, some transducer elements 20 in the subarray 21 can be optimized for emitting low-frequency ultrasonic energy, while other transducer elements 20 in the subarray 21 can be optimized for receiving only echo ultrasonic energy.

[0148] Advantageously, subarray 21 can reduce the number of cables and / or the wiring complexity required to electrically connect the ultrasound machine 5 to the transducer elements 20. For example, a single cable from the ultrasound system 5 can drive two or more transducer elements 20 in the subarray 21 via integrated electronics included in the subarray 21. The integrated electronics can receive input signals from the ultrasound system 5 and generate one or more control signals to control the transducer elements 20 within the subarray 21.

[0149] The type of electronics may depend on the type of transducer elements 20 included in subarray 21. For example, if subarray 21 includes only low-frequency transducer elements 20, the electronics may include: an ultrasonic transmitter driver circuit for each transducer element 20; digital electronics for sequencing the operation of the transducer elements 20 via the transmitter driver circuit; and digital electronics for receiving and transmitting information to the ultrasonic system. In this case, only a few DC power lines and a few digital signal lines are needed between the ultrasonic system and the subarray 21 containing multiple elements. If subarray 21 includes transducer elements 20 performing multiple functions (e.g., some delivering low-frequency ultrasonic energy, others receiving echo ultrasonic energy, etc.), the integrated electronics may include low-noise amplifiers (one for each transducer element 20, operating in receive mode) and / or other additional circuitry.

[0150] In some implementations, the number of positioners 230 in subarray 21 is less than the number of transducer elements 20. For example, subarray 21A may include three transducer elements 20 but only one positioner 230. In subarray 21A, each transducer element 20 has the same orientation but a different position. Since the position of each transducer element 20 in subarray 21A relative to each other is fixed and therefore known, the position and orientation of all three transducer elements 20 in subarray 21A can be calculated based on the position and orientation values ​​measured from the positioner 230.

[0151] Figure 4BAn example embodiment of an ultrasonic transducer assembly 10 having three subarrays 21A, 21B, and 21C is shown. The ultrasonic transducer assembly described herein may include any suitable number of subarrays 21.

[0152] Another aspect of the invention relates to a technique for achieving acoustic coupling between the transducer element 20 and the head 2. Figure 5A An object 3 with hair 4 is shown. (Example) Figure 5B As shown, the acoustic coupling gel layer can be applied to hair 4 (or scalp, if object 3 has no hair). After applying the acoustic coupling gel to head 2, as... Figure 5C As shown, the headgear 9 can be placed on the head 2. The headgear 9 can be made of elastic material and may also include a tight elastic band 35 at its bottom edge (such as...). Figure 5C (As shown). The elastic properties of the headgear 9 allow it to adapt to various head sizes and shapes. A tight elastic band at the bottom edge prevents or reduces gel leakage outside the headgear 9. (As shown) Figure 5C As shown, the hood 9 may also include one or more perforations 9A. The perforations 9A allow air to escape when the hood 9 is fitted onto the head 2. The perforations 9A can also be used to apply gel to the head 2 at locations where air may be present. The hood 9 may be made of various materials such as silicone, nylon, etc. The hood 9 may be a disposable item (e.g., made of disposable materials).

[0153] Another aspect of the invention relates to an imaging array that can be used in conjunction with the ultrasound transducer assembly described herein to measure the relative position of the head with respect to the ultrasound transducer assembly. In some cases, it is desirable to measure or estimate the position of the head 2 relative to the ultrasound transducer assembly 10. To measure or estimate the position of the head 2 relative to the ultrasound transducer assembly 10, at least some of the transducer elements 20 can be positioned adjacent to a thin portion (i.e., an acoustic window) of the skull of the subject 3. Ultrasound images of the anatomical structures (e.g., the circle of arteries) of the subject 3 are obtained using such transducer elements 20. The obtained images can then be aligned or registered with images of the subject 3 previously obtained using another modality, such as magnetic resonance imaging (MRI). Because MRI is capable of producing highly resolved and diagnostically high-quality images of the brain, qualified professionals can use these images to identify or select brain regions that require treatment (e.g., by opening the blood-brain barrier).

[0154] When the relative position of the area to be treated with respect to the anatomical structures imaged using ultrasound is known, this information can be relayed back to the ultrasound system 5. This information can be used to calculate a set of low-frequency therapeutic elements in the transducer assembly, which can be activated to perform treatment at the desired location.

[0155] Figure 6An example method for measuring the orientation of the head 2 relative to the ultrasonic transducer assembly 10 is shown. (e.g.) Figure 6 As depicted, some transducer elements 20 (i.e., the black transducer elements) are located adjacent to a thin region of the skull of the object 3 and are optimally positioned for imaging the anatomical structures within the skull. Other transducer elements 20 (i.e., the white transducer elements) are low-frequency therapeutic elements. Using the techniques described herein, the relative position and orientation of each transducer element 20 are calculated. In particular, the relative position and orientation of the therapeutic transducer elements 20 are calculated relative to the imaging elements. Since the location of the anatomical structures to be treated is known through ultrasound-MRI alignment, calculations can be performed to determine which set of therapeutic elements needs to be activated.

[0156] Terminology Explanation

[0157] Unless the context explicitly requires otherwise, in the specification and claims:

[0158] • The words “comprise” and “comprising” should be interpreted in terms of inclusion, not exclusion or exhaustiveness; that is, in terms of “including but not limited to”.

[0159] • “Connection,” “coupled,” “attached,” or any variation thereof means any direct or indirect connection or coupling between two or more elements; the coupling, connection, or attachment between elements can be physical, logical, or a combination thereof.

[0160] • When using words to describe this specification, “this text,” “above,” “below,” and similar terms should refer to this specification as a whole, and not to any particular part of this specification;

[0161] • In a list that refers to two or more items, “or” encompasses all of the following interpretations of the word: any item in the list, all items in the list, and any combination of items in the list.

[0162] • The singular forms (“a”, “an”) and “the” also include the meaning of any appropriate plural form.

[0163] The directional terms used in this specification and any appended claims (if any), such as “vertical,” “lateral,” “horizontal,” “upward,” “downward,” “forward,” “backward,” “inward,” “outward,” “vertical,” “lateral,” “left,” “right,” “front,” “backward,” “top,” “bottom,” “below,” “above,” “lower,” etc., depend on the specific orientation of the described and illustrated device. Various alternative orientations can be assumed for the subject matter described herein. Therefore, these directional terms are not strictly defined and should not be interpreted narrowly.

[0164] The present invention can be implemented using specially designed hardware, configurable hardware, a programmable data processor (configured by providing software (which may optionally include "firmware") capable of executing on the data processor), a dedicated computer or data processor (specifically programmed, configured, or constructed to perform one or more steps of the methods as detailed herein), and / or a combination of two or more of these. Examples of specially designed hardware are: logic circuits, application-specific integrated circuits ("ASICs"), large-scale integrated circuits ("LSIs"), very large-scale integrated circuits ("VLSIs"), etc. Examples of configurable hardware are: one or more programmable logic devices, such as programmable array logic ("PALs"), programmable logic arrays ("PLAs"), and field-programmable gate arrays ("FPGAs"). Examples of programmable data processors are: microprocessors, digital signal processors ("DSPs"), embedded processors, graphics processors, math coprocessors, general-purpose computers, server computers, cloud computers, mainframe computers, computer workstations, etc. For example, one or more data processors in the control circuitry of a control system for a device as described herein (which may include, for example, an ultrasonic system 5 and / or a hydraulic system 6) may implement the methods described herein by executing software instructions in a processor-accessible program memory and / or by processing data according to logic circuitry or a configurable device (such as an FPGA).

[0165] Processing can be centralized or distributed. In the case of distributed processing, information, including software and / or data, can be maintained centrally or distributed. Such information can be exchanged between different functional units via communication networks such as local area networks (LANs), wide area networks (WANs), or the Internet, wired or wireless data links, electromagnetic signals, or other data communication channels.

[0166] Although processes or blocks are presented in a given order, alternative examples may execute routines with steps in a different order or use a system with blocks, and some processes or blocks may be deleted, moved, added, subdivided, combined, and / or modified to provide alternatives or subcombinations. Each of these processes or blocks can be implemented in a variety of different ways. Furthermore, although processes or blocks are sometimes shown to be executed serially, they may alternatively be executed in parallel or at different times.

[0167] In the case of the components mentioned above (e.g., sheaths, valves, sensors, components, substructures, substrates, etc.), unless otherwise indicated, references to such components (including references to “devices”) should be interpreted to include equivalents of such components, any component that performs the function of the described component (i.e., is functionally equivalent), including components that are structurally different from the disclosed structure that performs the function in the exemplary implementation of the invention shown.

[0168] For illustrative purposes, specific examples of systems, methods, and devices have been described herein. These are merely examples. The techniques provided herein can be applied to systems other than the example systems described above. Many changes, modifications, additions, omissions, and substitutions are possible within the practice of this invention. This invention includes variations relating to the described implementations that will be apparent to those skilled in the art, including variations obtained by: replacing features, elements, and / or actions with equivalent features, elements, and / or actions; mixing and matching features, elements, and / or actions from different implementations; combining features, elements, and / or actions from implementations as described herein with features, elements, and / or actions from other technologies; and / or omitting combined features, elements, and / or actions from the described implementations.

[0169] Various features are described herein as existing in “some embodiments.” Such features are not mandatory and may not appear in all embodiments. Embodiments of the invention may include zero, any, or any combination of two or more such features. Even where such features are shown in different figures and / or described in different sections or paragraphs, all possible combinations of such features are considered in this disclosure. This is limited only to the fact that some features of such features are incompatible with others of such features, in a sense that it would be impossible for someone of ordinary skill in the art to construct a practical embodiment combining such incompatible features. Therefore, the description of “some embodiments” having feature A and “some embodiments” having feature B should be interpreted as explicitly indicating that the inventors have also considered embodiments combining features A and B (unless otherwise stated in the description or features A and B are substantially incompatible).

[0170] Therefore, claims intended to be introduced hereafter are to be interpreted as including all such modifications, substitutions, additions, omissions, and sub-combinations that can be reasonably inferred. The scope of the claims should not be limited to the preferred implementations set forth in the examples, but should be given the broadest interpretation consistent with the entire specification.

Claims

1. An ultrasonic transducer assembly capable of being connected to an ultrasonic system, the ultrasonic transducer assembly comprising: A mechanical substructure having an outer surface and an inner surface, the inner surface having a shape defining a cavity for receiving a head of an object; One or more ultrasonic transducer elements supported by the mechanical substructure; as well as A fillable sheath, detachably coupled to the inner surface of the mechanical substructure for acoustic contact with one or more transducer elements, the fillable sheath comprising: A deformable container for receiving an acoustically transporting fluid within a chamber, such that when the acoustically transporting fluid is introduced into the chamber, the deformable container deforms to liner the inner surface and conform to the shape of the head of the object.

2. The ultrasonic transducer assembly according to claim 1, wherein, The fillable sheath is acoustically coupled to the mechanical substructure.

3. The ultrasonic transducer assembly of claim 2, further comprising a first layer of acoustic coupling gel located between the fillable sheath and the mechanical substructure.

4. The ultrasonic transducer assembly according to claim 1, wherein, The deformable container is made of a material selected from the group consisting of polyurethane, latex, and silicone.

5. The ultrasonic transducer assembly according to claim 1, wherein, The acoustic transmission fluid is selected from the group consisting of: degassed water, mineral oil, and gel.

6. The ultrasonic transducer assembly according to claim 1, wherein, The fillable sheath includes: A port in fluid communication with the chamber; and A valve is used to control the flow of fluid through the port, thereby controlling the volume of the acoustic transmission fluid in the chamber.

7. The ultrasonic transducer assembly according to claim 6, comprising: A second port in fluid communication with the chamber and a second valve for controlling fluid flow through the second port; The second port is connected to the output fluid of the hydraulic system via the valve to receive the acoustic transmission fluid in the chamber, and the second port is connected to the input fluid of the hydraulic system via the second valve to allow the acoustic transmission fluid to return from the chamber to the hydraulic system.

8. The ultrasonic transducer assembly according to claim 7, wherein, The hydraulic system includes electronic components configured to continuously pump the acoustic transmission fluid into the chamber through the port, and the electronic components are also configured to continuously extract the acoustic transmission fluid from the chamber through the second port.

9. The ultrasonic transducer assembly according to claim 7, wherein, The valve and the second valve include corresponding electronic sensors configured to detect the rate at which fluid flows through the respective valve.

10. The ultrasonic transducer assembly of claim 1, further comprising a bubble detector for detecting bubbles in the acoustic transmission fluid.

11. The ultrasonic transducer assembly of claim 10, wherein, The bubble detector includes at least one of the one or more ultrasonic transducer elements, the at least one ultrasonic transducer element being configured to deliver pulses of ultrasonic energy.

12. The ultrasonic transducer assembly according to claim 7, comprising: A bubble detector for detecting bubbles in the acoustic transmission fluid; The hydraulic system is configured to: in response to the detection of air bubbles in the acoustic transmission fluid, pump the acoustic transmission fluid into the chamber through the port, and extract the acoustic transmission fluid from the chamber through the second port.

13. The ultrasonic transducer assembly according to claim 12, wherein, The hydraulic system is configured to pump the acoustic transmission fluid into the chamber at a rate faster than the rate at which the acoustic transmission fluid is drawn out of the chamber.

14. The ultrasonic transducer assembly according to any one of claims 1 to 13, wherein, The fillable sheath also includes an O-ring extending around the periphery of the deformable container, and wherein the fillable sheath is mechanically coupled to the mechanical substructure by inserting the edge portion of the fillable sheath including the O-ring into a channel of the mechanical substructure.

15. The ultrasonic transducer assembly according to claim 14, wherein, The O-ring includes a segment of conductive material, which makes electrical contact with a corresponding conductive portion of the channel when the O-ring is inserted into the channel.

16. The ultrasonic transducer assembly according to claim 15, wherein, The segment of the conductive material extends partially around the O-ring.

17. The ultrasonic transducer assembly according to claim 15, wherein, The O-ring also includes: A conductive pad that is in electrical contact with a segment of the conductive material and an electrical conductor on the outer surface of the deformable container.

18. The ultrasonic transducer assembly of claim 17, wherein, The conductive pad extends in the polar direction around a portion of the O-ring.

19. The ultrasonic transducer assembly of claim 17, wherein, The O-ring includes: A first conductive pad, the first conductive pad being in electrical contact with a first segment of the conductive material and a first electrical conductor printed on the outer surface of the deformable container; and The second conductive pad is electrically insulated from the first conductive pad and is in electrical contact with the second segment of the conductive material and the second electrical conductor printed on the outer surface of the deformable container.

20. The ultrasonic transducer assembly of claim 17, wherein, The electrical conductor is located on the inner outer surface of the deformable container.

21. The ultrasonic transducer assembly according to claim 17, wherein, The electrical conductor is electrically connected to the sensor.

22. The ultrasonic transducer assembly according to claim 21, wherein, The sensor includes a temperature sensor configured to measure the temperature of the acoustic transmission fluid in the chamber.

23. The ultrasonic transducer assembly according to claim 21, wherein, The sensor includes a temperature sensor configured to measure the temperature of the skin of an object wearing the ultrasonic transducer assembly.

24. The ultrasonic transducer assembly according to any one of claims 1 to 13, further comprising one or more baffles located in the chamber.

25. The ultrasonic transducer assembly according to claim 24, wherein, The baffle is made of a material having an acoustic impedance substantially the same as that of the acoustic transmission fluid.

26. The ultrasonic transducer assembly according to claim 24, wherein, The baffle has a thickness smaller than the wavelength of sound in the acoustic transmission fluid.

27. The ultrasonic transducer assembly according to claim 26, wherein, The thickness of the baffle is in the range of 0.5mm to 1.5mm.

28. The ultrasonic transducer assembly according to claim 24, wherein, The baffle includes a perforation located between the baffle and the outer surface of the deformable container.

29. The ultrasonic transducer assembly according to any one of claims 1 to 13, wherein, The fillable sheath also includes one or more of the following: an electroencephalogram (EEG) sensor, a motion sensor, and an accelerometer.

30. The ultrasonic transducer assembly according to any one of claims 1 to 13, wherein, The mechanical substructure includes a retaining mechanism for securing the mechanical substructure and a fillable sheath coupled to the mechanical substructure to the head of the object.

31. The ultrasonic transducer assembly according to any one of claims 1 to 13, wherein, The fillable sheath is made of disposable material.

32. The ultrasonic transducer assembly according to any one of claims 1 to 13, wherein, The mechanical substructure includes a rigid frame.

33. The ultrasonic transducer assembly according to claim 32, wherein, The frame includes a locking hinge mechanism that allows the frame to be pushed toward the head of the object to secure the frame firmly to the head of the object.

34. The ultrasonic transducer assembly according to any one of claims 1 to 13, wherein, The deformable container is made of a material with an elastic modulus in the range of 0.5 MPa to 10 MPa.

35. A fillable sheath detachably coupled to an inner surface of a cap, wherein the inner surface of the cap has a shape defining a cavity for receiving a head of an object, and wherein the cap supports one or more ultrasonic transducer elements, the fillable sheath comprising: A deformable container for holding a volume of acoustic transmission fluid in a chamber of the deformable container, the deformable container being able to deform in response to pressure applied between the cap and the head of the object housed in the chamber to conform to the shape of the head of the object; A port, in fluid communication with the chamber and extending through the cap, for introducing acoustic transmission fluid into the chamber and / or extracting acoustic transmission fluid from the chamber; as well as An O-ring extends around the periphery of the deformable container and can be detachably coupled to the cap to provide a seal between the infillable sheath and the cap.

36. The infillable sheath of claim 35, including the sensor on the deformable container.

37. The fillable sheath according to claim 36, wherein, The sensor includes a temperature sensor configured to measure the temperature of the acoustic transmission fluid in the chamber.

38. The fillable sheath according to claim 36, wherein, The sensor includes a temperature sensor configured to measure the temperature of the subject's skin.

39. The fillable sheath according to claim 36, further comprising: An electrical conductor printed on the outer surface of the deformable container, the electrical conductor being electrically connected to the sensor; A conductive pad located on the O-ring and electrically connected to the electrical conductor; as well as A segment of conductive material extends circumferentially around a portion of the O-ring and is electrically connected to the conductive pad.

40. The fillable sheath according to claim 39, wherein, The conductive pad has a shape that extends in the polar direction around a portion of the O-ring.

41. The fillable sheath according to any one of claims 35 to 40, wherein, The deformable container is made of disposable material.

42. The fillable sheath according to claim 35, wherein, The deformable container is made of a material with an elastic modulus in the range of 0.5 MPa to 10 MPa.

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