Ultrasound imaging device

Abstract

An ultrasonic imaging apparatus (100) includes: a base layer (1); an echo layer (2) covering the base layer (1) and bonded to the base layer (1) at least by a separate lower adhesive (4); and an outer layer (3) covering the echo layer (2) and bonded to the echo layer (2) at least by a separate upper adhesive (5). The ultrasonic imaging apparatus (100) is configured such that the echo material of the echo layer (2) has a rough interface at locations where it contacts at least the upper surfaces of the upper adhesive (5) and the lower adhesive (4), and that the outer surface of the outer layer (3) at least partially follows the undulations of the rough interface. An ultrasonic imaging apparatus (100) with a simple structure and easy to form is obtained.

Description

[0001] This application claims the benefit of Chinese application No. 202021026053.8, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This application also relates to an ultrasound imaging apparatus. Such an ultrasound imaging apparatus may be included in and / or formed in a balloon dilation catheter or other polymer medical device, for example, as an echo wall or echo layer. Background Technology

[0003] In medical procedures using ultrasound devices and ultrasound detection methods, it is usually necessary for the medical device to be visualized in ultrasound imaging. This requires at least a portion of the medical device to have echo characteristics, that is, to be able to effectively reflect the ultrasound waves used for detection, such as B-mode ultrasound.

[0004] Echo components are typically dispersed in a polymer solution or matrix, and their echo properties are primarily impeded by the surrounding polymer. As a result, high concentrations of echo components are required to obtain satisfactory echo properties in the final product, and this mixing or embedding increases structural and process complexity, altering the properties of the original polymer.

[0005] US6506156B1 discloses a method for forming an echo layer from a polymer matrix having multiple voids and / or glass microspheres. Multiple void spaces are formed to dissolve a portion of the phase in the polymer matrix while retaining another phase after curing. This method is inefficient because only the dissolved phase on the surface rapidly forms voids, while the component at the center of the matrix is ​​difficult to dissolve. The glass microspheres used in this technology adhere to the polymer matrix via electrostatic adhesion, which requires the base layer to be insulating.

[0006] US2013 / 0053770A1 discloses an echo balloon formed by two layers, one being a polymer layer and the other being a polymer having 60% to 80% radiopaque material by weight. Due to the high concentration of filler, the blowing process of the second balloon wall becomes difficult, and the filler reduces certain mechanical properties of the balloon wall, such as flexibility and elongation. Summary of the Invention

[0007] This disclosure aims to provide an ultrasonic imaging apparatus and related methods, with the goal of conveniently forming a final product with a relatively simple construction, a low amount of echo material added, and good echo properties.

[0008] According to one aspect of this disclosure, an ultrasonic imaging apparatus includes: a base layer; an echo layer covering the base layer, the echo layer being adhered to the base layer at least by a separate lower adhesive; and an outer layer covering the echo layer, the outer layer being adhered to the echo layer at least by a separate upper adhesive. The ultrasonic imaging apparatus is configured such that the echo material of the echo layer has a rough interface (uneven interface) at locations where it contacts at least the upper adhesive of the upper and lower adhesives, and that the outer surface of the outer layer at least partially, and substantially follows, the undulations of the rough interface. Therefore, this differs from mixing and / or encapsulating the echo material in a polymer. The ultrasonic imaging apparatus according to this disclosure is constructed as a multilayer structure, particularly a film structure obtained through layer-by-layer coating, in which the echo material is substantially only located within a specific echo layer.

[0009] According to some embodiments, the total thickness of the outer and upper adhesive layers is less than 20 μm, such as less than 10 μm, for example less than 5 μm. Therefore, the outer and upper adhesive layers can be sufficiently thin to avoid masking the rough interface. In other words, the upper adhesive can be as thin as possible while maintaining adhesion to prevent the rough interface of the echo layer from being filled with excessive adhesive. Furthermore, the outer surface of the outer layer will not deviate from the aforementioned interface roughness due to excessive thickness.

[0010] According to some embodiments, the hardness of the outer and upper adhesive layers is lower than that of the echo material in the echo layer. Therefore, the outer and upper adhesive layers can be sufficiently soft to have good compliance.

[0011] According to some embodiments, the ultrasonic imaging apparatus can be formed into a planar structure or a columnar structure.

[0012] According to some embodiments, the echo material of the echo layer is substantially not embedded in the base layer. According to some embodiments, the echo material of the echo layer is substantially not embedded in the outer layer. Therefore, the ultrasonic imaging apparatus is formed as a layered structure in the thickness direction. According to some embodiments, the echo material of the echo layer is substantially only located between the interfaces with the upper adhesive and the lower adhesive. For example, at least 90%, or even 95%, of the echo material of the echo layer is located between the interfaces with the upper adhesive and the lower adhesive. In other words, at most 10%, or even 5%, of the echo material of the echo layer is located outside the interfaces with the upper adhesive and the lower adhesive. Therefore, the multilayer structure of the ultrasonic imaging apparatus is substantially non-nested, and the boundaries of the aggregation regions where most of the echo material of the echo layer is located are uneven.

[0013] According to some embodiments, the echoing material of the echo layer covers 30%-100% of the extended area of ​​the base layer. According to some embodiments, the outer layer covers at least the entire extended area of ​​the echoing material, such as the entire extended area of ​​the base layer. Thus, in locations where no echoing material is provided in the echo layer, the outer layer and the base layer may be directly bonded together using existing adhesives.

[0014] According to some embodiments, the echo material of the echo layer can form one or more patterned regions, such as lines, spirals, squares, spots, or combinations thereof. According to some embodiments, the minimum dimensional dimension of the patterned region can be greater than 0.8 mm. According to some embodiments, the spacing between patterned regions can be greater than 0.5 mm. In particular, both the minimum dimensional dimension of the patterned region and the spacing between patterned regions can be no less than 1 mm. Therefore, the presence, location, and / or orientation of the ultrasound imaging device can be more easily identified in the image.

[0015] According to some embodiments, the thickness of the echo layer can be less than 100 μm. Here, due to the unevenness of the interface, the thickness of the echo layer can be defined as the average thickness of the area occupied by the echo material of the echo layer.

[0016] According to some embodiments, the echo material of the echo layer can be glass beads, such as organic or inorganic glass beads. According to some embodiments, the glass beads can be spheres or ellipsoids (i.e., spherical or subspherical) with a size of less than 100 μm, for example, between 40-50 μm.

[0017] According to some embodiments, the echo material of the echo layer can be a metal powder, such as titanium, nitinol, silver, gold, and tungsten. According to some embodiments, the particle size of the metal powder is between 800 mesh and 180 mesh, for example, between 400 mesh and 240 mesh.

[0018] According to some embodiments, the echo material of the echo layer can be distributed in a structure of no more than four sublayers. In the case of non-single sublayers, each sublayer can be bonded together with an additional adhesive. Preferably, the thickness of the echo layer is still less than 100 μm.

[0019] According to some embodiments, the base layer can be made of polymeric materials, such as polyethylene terephthalate (PET) base layers.

[0020] According to some embodiments, the outer layer may be made of a polymeric material, such as a polypropylene (PP) or polyetheramide (Pebax) outer layer.

[0021] According to some embodiments, the adhesive may be water-based or solvent-based.

[0022] According to some embodiments, the adhesive may be thermoplastic or thermosetting.

[0023] According to some embodiments, the adhesive material type may be epoxy resin, acrylate, polyurethane, or polyvinyl acetal.

[0024] According to some embodiments, the adhesive may be a one-component or a two-component adhesive.

[0025] According to some embodiments, the adhesive may be selected as a pressure-sensitive adhesive.

[0026] According to some embodiments, the curing or drying temperature of the adhesive does not exceed 120°C. In particular, the adhesive may be a water-based polyurethane pressure-sensitive adhesive.

[0027] According to some embodiments, the lower adhesive for adhesion can be pre-applied to the surface of the substrate facing the echo layer (i.e., the outer surface). Therefore, echo materials, such as the aforementioned glass beads or metal powder, can be conveniently arranged on the lower adhesive with a certain coverage and / or a certain pattern.

[0028] According to some embodiments, the upper adhesive for adhesion can be pre-applied to at least one of the echo layer and the outer layer facing each other, such as pre-applied to the outer layer facing the echo layer (i.e., the inner surface).

[0029] According to another aspect of this disclosure, a method for forming an ultrasound imaging apparatus is provided. The method includes providing a substrate. The substrate may be independent or may be derived from the surface of a medical device. The method includes adhering an echo layer to the substrate using at least a lower adhesive. As described above, the lower adhesive for adhesion may be pre-applied to the surface of the substrate facing the echo layer. When adhering the echo layer, the echo layer may be applied over the lower adhesive in a manner having one or more of the aforementioned characteristics such as thickness, coverage, pattern, material, etc. The method includes adhering an outer layer to the echo layer using at least an upper adhesive. As described above, the upper adhesive for adhesion may be pre-applied to at least one of the echo layer and the outer layer facing each other, such as pre-applied to the surface of the outer layer facing the echo layer. The method includes forming a rough interface (uneven interface) at the location where the echo material of the echo layer contacts the adhesive, such as at least the upper adhesive, and the upper adhesive of the lower adhesive, and causing the outer surface of the outer layer to at least partially, substantially, follow the undulations of the rough interface. According to some embodiments, the ultrasonic imaging apparatus can be formed into a planar structure or a columnar structure.

[0030] According to some embodiments, the properties of the base layer, echo layer, outer layer, and adhesive can be configured as described above.

[0031] According to this disclosure, an ultrasound imaging device with a simple structure and easy fabrication has been obtained. This ultrasound imaging device can be applied to a variety of medical devices, and can even be directly fabricated on the corresponding devices.

[0032] According to this ultrasonic imaging apparatus, good ultrasonic imaging properties are achieved by adding a small amount of echoing material. Specifically, the echoing material (such as the aforementioned metal powder / glass beads) is set as a thin layer in a layered structure, almost entirely distributed on the same layer (i.e., aggregated distribution), and forms a rough interface (e.g., so that the outer surface of the outer layer undulates accordingly), thereby providing effective echoing properties while essentially maintaining the original process / performance of the substrate. Attached Figure Description

[0033] Other features of this application will become apparent from the following description of exemplary embodiments with reference to the accompanying drawings.

[0034] Figure 1A-1B This is a schematic illustration of a portion of the ultrasonic imaging apparatus according to this application.

[0035] Figures 2A-2D It is based on this application Figure 1A A schematic diagram illustrating the construction of an ultrasonic imaging device.

[0036] Figures 3A-3D It is based on this application Figure 1B A schematic diagram illustrating the construction of an ultrasonic imaging device.

[0037] Figure 4 This is a schematic diagram illustrating the principle of the ultrasonic imaging apparatus according to this application.

[0038] Figures 5A-5B This is a schematic illustration of a portion of the ultrasonic imaging apparatus according to this application.

[0039] Figures 6A-6C This is a comparison of ultrasound images from a device according to a comparative example and a portion of an ultrasound imaging apparatus according to this application.

[0040] Figures 7A-7D This is a schematic illustration of a portion of the ultrasonic imaging apparatus according to this application.

[0041] Figures 8A-8B It is based on the pattern identification of a part of the ultrasonic imaging apparatus of this application in an ultrasonic image. Detailed Implementation

[0042] This application is described with reference to the accompanying drawings, in which certain embodiments of the application are illustrated. However, this application may be embodied in many different forms and should not be construed as limited to the embodiments depicted and described herein; rather, these embodiments are provided so that this disclosure will be thorough and complete and will fully convey the scope of the application to those skilled in the art. It will also be understood that the embodiments disclosed herein can be combined in any manner and / or in any combination to provide many other embodiments.

[0043] Unless otherwise defined, all technical and scientific terms used in this disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. The terminology used in the foregoing description is for the purpose of describing particular embodiments only and is not intended to limit the scope of this application.

[0044] Unless otherwise expressly stated in the contents, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” all include plural references. It should also be noted that, unless otherwise expressly stated in the contents, the term “or” is generally used in the sense that it includes “and / or.”

[0045] For ease of explanation, the same reference numerals refer to the same modules, units and / or components in the various figures.

[0046] The embodiments described below are merely specific examples. However, this application is not limited to the embodiments described in the specification.

[0047] refer to Figure 1A-1B A schematic illustration of a portion of an ultrasonic imaging apparatus according to this application is shown. Figure 1A In the process, a portion of the ultrasonic imaging device 100 is formed as a planar structure; in Figure 1B In the process, a portion of the ultrasonic imaging device 100' is formed as a columnar structure.

[0048] According to this disclosure, the ultrasonic imaging apparatus 100, 100' generally comprises three layers: a base layer 1, 1', an echo layer 2, 2', and an outer layer 3, 3'. As shown, the echo layer 2, 2' covers the base layer 1, 1' and is adhered to the base layer 1, 1' at least by separate lower adhesives 4, 4'. The outer layer 3, 3' covers the echo layer 2, 2' and is adhered to the echo layer 2, 2' at least by separate upper adhesives 5, 5'. In this application, the ultrasonic imaging apparatus 100, 100' is configured such that the echo material 20, 20' of the echo layer 2, 2' has a rough interface (uneven interface) at the location where it contacts at least the upper adhesive 5, 5' of the upper adhesive 5, 5' and the lower adhesive 4, 4', and the outer surface of the outer layer 3, 3' can at least partially, substantially follow the undulations of the rough interface.

[0049] like Figure 1A-1B As shown, the echo materials 20 and 20' are located at different heights along the thickness direction. Here, the rough interface extends approximately perpendicular to the thickness direction of the ultrasonic imaging apparatus 100 and 100', that is, in Figure 1A It extends roughly horizontally in the middle, while Figure 1BThe middle extends roughly circumferentially. Although not explicitly drawn, the outer surfaces of the outer layers 3, 3' will at least partially, and can substantially, vary with the height of the echo materials 20, 20'.

[0050] Now for reference Figures 2A-2D 3A-3D respectively show the following according to this disclosure Figure 1A-1B A schematic diagram of the construction of the ultrasonic imaging apparatus 100, 100'.

[0051] In this exemplary construction method for forming ultrasonic imaging devices 100, 100', reference is first made to... Figure 2A , 3A Substrates 1 and 1' are provided. Here, substrates 1 and 1' are shown as independent; however, substrates can also originate from the surface of the medical device. See below for further details. Figure 2B , 3B Apply the lower adhesive 4 and 4' to the surface of the substrate facing the echo layer. Next, refer to... Figure 2C , 3C At least the lower adhesive layer 2 and 2' should be bonded to the substrate. Next, refer to... Figure 2D , 3D The outer layers 3 and 3' are adhered to the echo layer using at least the upper adhesives 5 and 5'. Before adhering to the echo layer, the upper adhesive is applied to at least one of the face-to-face surfaces of the echo layer and the outer layers, with the upper adhesive applied to the surface of the outer layer facing the echo layer. During construction, a rough interface (uneven interface) is formed at the location where the echo material of the echo layer contacts at least the upper adhesive of the upper and lower adhesives, and the outer surface of the outer layer at least partially and substantially follows the undulations of the rough interface.

[0052] It should be pointed out that, Figure 1A-3D This is highly illustrative. In order to clearly show the structure and construction of the ultrasonic imaging devices 100 and 100', the dimensions and shapes of some features may not be drawn to scale and may be exaggerated.

[0053] It should be noted that the ultrasound imaging apparatus according to this application is not limited to the shape shown in the figure, but may have other suitable shapes not shown as needed without departing from the spirit and scope of this application, and may even be attached to the exterior of a medical device.

[0054] According to the illustrated embodiment, the echo materials 20, 20' of echo layers 2, 2' are substantially not embedded in the base layers 1, 1', and also substantially not embedded in the outer layers 3, 3'. Therefore, the echo materials 20, 20' of echo layers 2, 2' are substantially only located between the interfaces with the upper adhesives 5, 5' and the lower adhesives 4, 4'. Specifically, at least 90%, or even 95%, of the echo materials 20, 20' of echo layers 2, 2' are located between the interfaces with the upper adhesives 5, 5' and the lower adhesives 4, 4'. In other words, at most 10%, or even 5%, of the echo materials 20, 20' of echo layers 2, 2' are located outside the interfaces with the upper adhesives 5, 5' and the lower adhesives 4, 4'.

[0055] This forms the majority of the acoustic materials 20 and 20' in the echo layers 2 and 2', where the boundaries of these acoustic regions are irregular, such as the rough interface described above, and the outer surface of the outer layer advantageously follows this rough interface. In some cases, the total thickness of the outer layer and the upper adhesive is less than 20 μm, such as less than 10 μm, for example less than 5 μm. In some cases, the hardness of the outer layer and the upper adhesive is lower than that of the acoustic materials in the echo layers.

[0056] refer to Figure 4 A schematic diagram illustrating the principle of the ultrasonic imaging apparatus according to this application is shown. Generally, during ultrasonic imaging, the ultrasonic probe receives the reflected sound of the ultrasonic waves it emits, converts this reflected sound into an electrical signal, and displays it on a screen in grayscale. The stronger the reflected sound received by the probe, the better the imaging of the object it detects. To enhance the imaging properties of the ultrasound, the ultrasonic probe needs to receive more reflected sound. As shown in the figure, when the roughness of the outer surface of the outer layer 3* increases, the diffuse reflection of sound waves at the interface increases, thereby increasing the energy returning to the ultrasonic probe. This diffuse reflection... Figure 4 outer layer 3 * The diagram above is schematic. Of course, diffuse reflection can also occur here because some sound waves may be transmitted to the rough interface of the echo material 20* of the echo layer 2*.

[0057] It should be noted that, for clarity, only the base layer 1 of the planar ultrasonic imaging device is shown here very schematically. * Echo layer 2 * (Echo Material 20) * The dimensions and shapes of some features are not necessarily drawn to scale and may be exaggerated. However, the principles described can be applied to appropriate constructions without departing from the spirit and scope of this application.

[0058] refer to Figures 5A-5BA schematic illustration of a portion of the ultrasonic imaging apparatus 100”, 100”' according to this application is shown. Figure 1A Similarly, in Figure 5A In the process, a portion of the ultrasonic imaging device 100 is formed as a planar structure; and with Figure 1B Similarly, in Figure 5B In the process, a portion of the ultrasonic imaging device 100”’ is formed as a columnar structure.

[0059] The ultrasonic imaging devices 100” and 100”' are constructed in a basically similar manner to the ultrasonic imaging devices 100 and 100’, and also include base layers 1” and 1”', echo layers 2” and 2”', outer layers 3” and 3”', and upper adhesives 5” and 5”' and lower adhesives 4” and 4”' for adhesion. The difference lies in the coverage of the echo layers 2” and 2”', and especially the echo materials 20” and 20”'.

[0060] exist Figure 1A-1B In the embodiments, it can be considered that the echo materials 20, 20' of the echo layers 2, 2' substantially cover 100% of the extended areas of the base layers 1, 1'; while Figures 5A-5B In the embodiments described, it can be seen that the echo materials 20”, 20”’ of the echo layers 2”, 2”’ do not completely cover the extended areas of the base layers 1”, 1”’. In other words, the coverage can be less than 100%. In some cases, the coverage can be between 30% and 100%.

[0061] In the illustrated embodiment, the outer layers 3, 3', 3"', 3"' cover the entire extended area of ​​the echo materials 20, 20', 20"', 20"', and also cover the entire extended area of ​​the underlying base layers 1, 1', 1"'. Thus, in the echo layers 2"', 2"' where the echo materials 20"', 20"' are not present, the outer layers 1"', 1"' and the base layers 1"', 1"' can be directly bonded using existing adhesives (e.g., upper adhesive 5"', 5"', lower adhesive 4"', 4"'). However, in other embodiments not shown, the outer layers only cover the entire extended area of ​​the echo materials.

[0062] It should be pointed out that, Figures 5A-5B This is illustrative. In order to clearly show the structure of the ultrasonic imaging devices 100” and 100”’, the dimensions and shapes of some features may not be drawn to scale and may be exaggerated.

[0063] According to the above and other embodiments, the thickness of the echo layer can be less than 100 μm.

[0064] According to the above and other embodiments, the echo material of the echo layer can be glass beads, such as organic or inorganic glass beads. In some cases, the glass beads can be spheres or ellipsoids with a size of less than 100 μm, such as those between 40-50 μm.

[0065] According to the above and other embodiments, the echo material of the echo layer can be a metal powder, such as titanium, nitinol, silver, gold, and tungsten. Of course, other common metals or alloys that also have good biocompatibility can be selected. In some cases, the particle size of the metal powder is between 800 mesh and 180 mesh, such as between 400 mesh and 240 mesh.

[0066] According to some embodiments, the echo material of the echo layer can be distributed in a structure of no more than four sub-layers. In the case of non-single sub-layers, each sub-layer can be bonded to each other by an additional adhesive (e.g., the same adhesive as the upper adhesive and / or lower adhesive).

[0067] The applicant found that, among other things, the echo layer formed by the echo material of the above dimensions and / or construction can achieve particularly good echo properties.

[0068] It should be noted that, in the above Figure 1A-5B And the following Figures 7A-7D In this work, for clarity, echo materials are depicted as spheres of a specific, relatively large diameter, distributed relative to each other and / or clustered in a certain number to form a pattern. However, as stated above, these are merely illustrative and do not necessarily represent actual echo materials of the aforementioned dimensions and / or configurations, but are intended to better illustrate the spirit and scope of this disclosure.

[0069] According to the above and other embodiments, the base layer can be made of a polymer material, which may be polyethylene terephthalate (PET).

[0070] According to the above and other embodiments, the outer layer may be made of a polymer material, which may be polypropylene (PP) or polyetheramide (Pebax).

[0071] According to the above and other embodiments, the adhesive can be water-based or solvent-based. In some cases, the adhesive can be thermoplastic or thermosetting. In some cases, the material type of the adhesive can be epoxy resin, acrylate, polyurethane, or polyvinyl acetal. In some cases, the adhesive can be one-component or two-component, such as one-component. In some cases, the adhesive can be selected as a pressure-sensitive adhesive. In some cases, the curing or drying temperature of the adhesive does not exceed 120°C. Pressure-sensitive adhesives are advantageous, for example, as they can prevent excessive flow of the adhesive from filling and masking the aforementioned uneven and rough interfaces. Lower curing or drying temperatures are advantageous, for example, as they can avoid affecting the properties of the substrate and / or outer layer. In particular, the adhesive can be a water-based polyurethane pressure-sensitive adhesive.

[0072] According to the above and other embodiments, the lower adhesive for adhesion can be pre-applied to the surface of the substrate facing the echo layer (i.e., the outer surface).

[0073] According to the above and other embodiments, the upper adhesive for adhesion can be pre-applied to at least one of the mutually facing surfaces of the echo layer and the outer layer, such as pre-applied to the surface of the outer layer facing the echo layer (i.e., the inner surface).

[0074] Now for reference Figures 6A-6C The comparison shows an ultrasound image of the device according to the comparative example and the ultrasound imaging apparatus according to the present application, wherein the ultrasound images (B-mode images) were obtained under the same measurement conditions and parameters.

[0075] Figure 6A : Baseline example, original polymer device without additional layers.

[0076] Figure 6B Example 1: A columnar ultrasonic imaging device with three layers: PET as the base layer; 325-mesh titanium powder as the echo layer, bonded to the base layer using a water-based polyurethane pressure-sensitive adhesive, with the titanium powder evenly distributed and covering approximately 70% of the entire base layer; and an outer layer bonded to the top using a water-based polyurethane pressure-sensitive adhesive. The total thickness of the device is 90 μm.

[0077] Figure 6C Example 2: A columnar ultrasonic imaging device with three layers: PET as the base layer; 180-mesh glass beads as the echo layer, bonded to the base layer using a water-based polyurethane pressure-sensitive adhesive, with the glass beads evenly distributed and covering approximately 90% of the entire base layer; and an outer layer bonded to the top using a water-based polyurethane pressure-sensitive adhesive. The total thickness of the device is 100 μm.

[0078] Comparing the ultrasound images, it can be seen that... Figure 6A compared to, Figure 6C , 6BA portion of the sample appears whiter and brighter, indicating improved radioactivity. Therefore, the ultrasonic imaging apparatus according to this application demonstrates better echogenicity under B-mode ultrasound diagnosis.

[0079] refer to Figures 7A-7D A schematic illustration of a portion of an ultrasonic imaging apparatus according to this application is shown. As shown, the echo material of the echo layer can also advantageously form one or more patterned regions. Figure 7A In this process, linear patterned areas are formed within a planar ultrasonic imaging device. Figure 7B In this process, a spiral pattern region is formed within a columnar ultrasonic imaging device. Figure 7C In this process, square-shaped patterned regions are formed within a planar ultrasonic imaging device. Figure 7D In this process, the dotted pattern area is formed in the columnar structure of the ultrasonic imaging device.

[0080] In some cases, the minimum dimensional dimension of the pattern area (e.g., the width of the line portion 200 in the pattern area, the width of the spiral portion 200' in the pattern area, the minimum dimensional dimension of the block 200" in the pattern area and / or the outer diameter of the spot 200"' in the pattern area) can be greater than 0.8 mm, and the interval between pattern areas (e.g., the interval between the line portions 200 in the pattern area, the interval between the spiral portions 200' in the pattern area, the interval between the blocks 200" in the pattern area and / or the interval between the spots 200"' in the pattern area) can be greater than 0.5 mm.

[0081] It should be noted that, for clarity, the base layer and echo layer (particularly the patterned area 200-200"' formed by the echo material) of the ultrasonic imaging apparatus are shown only schematically here, and the dimensions and shapes of some features are not necessarily drawn to scale and may be exaggerated. Furthermore, the given patterned area 200-200"' is depicted and illustrated in a specific form combined with a specific apparatus structure. However, the ultrasonic imaging apparatus according to this application is not limited thereto. Without departing from the spirit and scope of this application, each of the aforementioned patterned areas may have different orientations, distributions, etc., and other suitable forms of patterned areas, not shown, are also possible. Therefore, it is possible to have a suitable combination of patterned areas (e.g., the specific form, other suitable forms, or combinations thereof described above) and apparatus structures (e.g., the planar structure, columnar structure, and other suitable shapes described above).

[0082] refer to Figures 8A-8B The image shows pattern recognition in an ultrasound image of a portion of the ultrasound imaging apparatus according to this application, wherein the ultrasound image (B-mode image) is obtained under the same measurement conditions and parameters.

[0083] In addition to the patterned area Figures 8A-8B The ultrasonic imaging devices used for measurement were essentially the same. Both ultrasonic imaging devices tested employed line pattern regions, but with different sizes and spacing. For the former and the latter, the width of the lines in the pattern region was 1 mm and 0.8 mm, respectively. Similarly, for the former and the latter, the spacing between the lines in the pattern region was 1 mm and 0.5 mm, respectively.

[0084] Comparing the ultrasound images, it can be seen that... Figure 8B In region B, lines can be vaguely seen, while from... Figure 8A In region A, the lines are clearly visible, which means improved discernibility. Therefore, it is particularly preferable that the minimum dimensional dimension of the patterned region and the spacing between patterned regions are both no less than 1 mm.

[0085] Therefore, according to this disclosure, the requirements for echo characteristics can be substantially achieved with a simple structure and means using an ultrasonic imaging apparatus and related methods.

[0086] The foregoing description is a description of the present disclosure and should not be construed as limiting it. While exemplary embodiments of the present disclosure have been described, those skilled in the art will readily understand that many modifications may be made to the exemplary embodiments without substantially departing from the novel teachings and advantages of the present disclosure; for example, features relating to the system and features relating to the method may be combined in any manner to form other embodiments. Therefore, all such modifications are intended to be included within the scope of the present disclosure as defined in the claims. The present disclosure is defined by the appended claims, including equivalents of the claims.

Claims

1. An ultrasonic imaging device, characterized in that, The ultrasonic imaging device includes: grassroots level; An echo layer is placed over the substrate and is adhered to the substrate at least by a separate underlay adhesive. The outer layer covers the echo layer and is adhered to the echo layer at least by a separate upper adhesive. The ultrasonic imaging apparatus is configured such that the echo material of the echo layer has a rough interface at the location where it contacts at least the upper adhesive of the upper adhesive and the lower adhesive, and the outer surface of the outer layer at least partially follows the undulation of the rough interface. The ultrasonic imaging device forms a planar structure or a columnar structure; and The echo material of the echo layer is not embedded in the base layer, and / or the echo material of the echo layer is not embedded in the outer layer.

2. The ultrasonic imaging apparatus according to claim 1, characterized in that, The total thickness of the outer and upper adhesive layers is less than 20 μm.

3. The ultrasonic imaging apparatus according to claim 2, characterized in that, The total thickness of the outer and upper adhesive layers is less than 10 μm.

4. The ultrasonic imaging apparatus according to claim 3, characterized in that, The total thickness of the outer and upper adhesive layers is less than 5 μm.

5. The ultrasonic imaging apparatus according to claim 1, characterized in that, The hardness of the outer and upper adhesive layers is lower than that of the echo material in the echo layer.

6. The ultrasonic imaging apparatus according to claim 1, characterized in that, At least 90% of the echo material in the echo layer is located between the interface with the upper adhesive and the lower adhesive.

7. The ultrasonic imaging apparatus according to claim 6, characterized in that, At least 95% of the echo material in the echo layer is located between the interface with the upper adhesive and the lower adhesive.

8. The ultrasonic imaging apparatus according to claim 1, characterized in that, The echo material of the echo layer covers 30%-100% of the extended area of ​​the base layer.

9. The ultrasonic imaging apparatus according to claim 1, characterized in that, The outer layer should at least cover the entire extended area of ​​the echo material.

10. The ultrasonic imaging apparatus according to claim 9, characterized in that, The outer layer covers the entire extended area of ​​the base layer.

11. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The echo material of the echo layer forms one or more patterned areas.

12. The ultrasonic imaging apparatus according to claim 11, characterized in that, The pattern area is composed of lines, spirals, squares, spots, or combinations thereof.

13. The ultrasonic imaging apparatus according to claim 11, characterized in that, The minimum dimension of the pattern area is greater than 0.8 mm, and / or the spacing between pattern areas is greater than 0.5 mm.

14. The ultrasonic imaging apparatus according to claim 13, characterized in that, The minimum dimension of the pattern area and the spacing between pattern areas are both no less than 1 mm.

15. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The thickness of the echo layer is less than 100 μm.

16. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The echo material in the echo layer is glass beads.

17. The ultrasonic imaging apparatus according to claim 16, characterized in that, Glass beads are spheres or ellipsoids with an outer dimension of less than 100 μm.

18. The ultrasonic imaging apparatus according to claim 16, characterized in that, The dimensions of glass beads are between 40-50 μm.

19. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The echo material of the echo layer is metal powder.

20. The ultrasonic imaging apparatus according to claim 19, characterized in that, The metal powder is selected from titanium, nickel-titanium, silver, gold, or tungsten.

21. The ultrasonic imaging apparatus according to claim 19, characterized in that, The particle size of the metal powder is between 800 mesh and 180 mesh.

22. The ultrasonic imaging apparatus according to claim 21, characterized in that, The particle size of the metal powder is between 400 mesh and 240 mesh.

23. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The echo material of the echo layer is distributed in a structure of no more than 4 sub-layers. In the case of non-single sub-layers, each sub-layer is bonded together by an additional adhesive.

24. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The base layer includes polymer materials.

25. The ultrasonic imaging apparatus according to claim 24, characterized in that, The base layer includes polyethylene terephthalate.

26. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The outer layer consists of polymer materials.

27. The ultrasonic imaging apparatus according to claim 26, characterized in that, The outer layer consists of polypropylene or polyetheramide.

28. The ultrasonic imaging apparatus according to claim 1, characterized in that, The adhesive is a pressure-sensitive adhesive.

29. The ultrasonic imaging apparatus according to claim 1, characterized in that, The curing or drying temperature of the adhesive shall not exceed 120°C.

30. The ultrasonic imaging apparatus according to claim 28 or 29, characterized in that, The adhesive is a water-based polyurethane pressure-sensitive adhesive.

31. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The lower adhesive for bonding is pre-applied to the surface of the substrate facing the echo layer.

32. The ultrasonic imaging apparatus according to any one of claims 1 to 9, characterized in that, The top adhesive for bonding is pre-applied to the outer surface facing the echo layer.

33. A method for manufacturing an ultrasonic imaging device, characterized in that, The method includes: Provide for the grassroots; The echo layer of the echo material is bonded to the base layer using a lower adhesive; The outer layer is bonded to the echo layer using a separate top adhesive; Provide a rough interface at the location where the echo material contacts at least the upper adhesive; and The outer surface of the outer layer is provided, which at least partially follows the undulations of the rough interface.

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