Acoustic coupling device and method of using acoustic coupling device

By designing an acoustic coupling device including a baseband member, a tray, an ultrasonic transmission gel and a removable protective liner, the problems of unstable skin coupling between the ultrasonic transceiver and the patient and inconvenient operation in the prior art are solved, and a stable and simple coupling process is achieved.

CN119836267APending Publication Date: 2025-04-15РЕСПИНОР АС
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Patent Information

Application Number
CN202380062883.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-08-30
Filing Date
2023-08-29
Publication Date
2025-04-15

AI Technical Summary

Technical Problem

In the prior art, when the ultrasonic transceiver is firmly coupled to the patient's skin, the user is inconvenient to operation and errors are prone to, and the consistency of the manufacturing belt is difficult to ensure.

Method used

An acoustic coupling device is designed, including a baseband member, a tray, an ultrasonic transmission gel and a removable protective liner. By removing the protective liner, an ultrasonic sensor is attached, a pressure is applied to allow the gel to pass through the hole and contact the sensor surface, and finally the skin side of the baseband member is attached to the patient's skin.

Benefits of technology

The stable coupling of the ultrasound sensor and the patient's skin is achieved, reducing the complexity and error of user operation, and the design of the device improves the feasibility of manufacturing consistency.

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Abstract

The present application relates to an acoustic coupling device comprising a base band member having an aperture and a sensor side and a skin side, the sensor side and the skin side each having an adhesive material thereon. The acoustic coupling device also includes a tray removably attached to cover the skin side of the base band member. The tray includes a recessed portion defining a recessed surface facing the aperture, and a flat portion surrounding the recessed portion. The acoustic coupling device further includes an ultrasound transmission gel disposed in the recess, and a removable protective liner configured to cover the sensor side of the base band member.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. patent application US17 / 899,226, filed on August 30, 2022, the disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure describes an acoustic coupling device and a method of using the acoustic coupling device, and more particularly, relates to an acoustic coupling device and a method of using the acoustic coupling device for firmly coupling an ultrasound transceiver to a patient's skin for use in ultrasound-based diagnostic imaging techniques. Background Art

[0004] Ultrasound imaging or sonography is an ultrasound-based diagnostic imaging technique used to visualize subcutaneous body structures including tendons, muscles, joints, blood vessels, and internal organs for possible pathologies or lesions. Obstetric sonography is commonly used during pregnancy and is widely accepted by the general public. Various other diagnostic and therapeutic applications are implemented in medicine.

[0005] In order to obtain good quality images of the body structures of interest, it is necessary that the pulses of sound emitted by the ultrasound transceiver be transmitted into the body and received from the body without interference. The materials forming the surface of the transceiver are selected to enable the sound to be effectively transmitted into the body. Conventionally, a water-based gel (e.g., hydrogel) is placed between the patient's skin and the transceiver to ensure good acoustic coupling. The gel allows the transceiver to be moved over the skin while maintaining the desired acoustic coupling so that different areas can be imaged as needed.

[0006] For example, U.S. Pat. No. 9,211,106 discloses the use of a strap to secure an ultrasound probe to a patient's skin. However, it was found that further improvements were necessary for acoustic coupling between the strap and the patient's skin. To ensure reliable acoustic coupling, the strap requires the user to manually place a drop of ultrasound gel, which is inconvenient for the user and susceptible to user error. Furthermore, it has proven challenging to manufacture the strap consistently.

[0007] As another example, electrode pads may be used to assist in performing an electrocardiogram (ECG or EKG). However, conventional electrode pads require an electrical connector or snap ring for cable connection.

[0008] Therefore, there exists a need for improved apparatus and methods for securely coupling an ultrasound transceiver to a patient's skin while reducing user manipulation errors and time for ultrasound-based diagnostic imaging techniques. Summary of the invention

[0009] Various aspects of the present disclosure are directed to securely attaching an ultrasound sensor to a patient's skin to observe organ activity inside the body using a simple device, and to methods of using the device.

[0010] One aspect of the present disclosure is directed to an acoustic coupling device for coupling an ultrasound sensor to a patient's skin surface. In non-limiting aspects, the acoustic coupling device may include: a baseband member having a sensor side, a skin side, and a hole, each of the sensor side and the skin side having an adhesive material thereon; a tray removably attached to cover the skin side of the baseband member, the tray including a recessed portion and a flat portion, the recessed portion defining a concave surface facing the hole, the flat portion surrounding the recessed portion; a first ultrasound transmission gel disposed in the recessed portion; and a removable protective liner configured to cover the sensor side of the baseband member.

[0011] Another aspect of the present disclosure is directed to a method of using an acoustic coupling device to enable an ultrasound sensor to be connected to a patient's skin surface. In non-limiting aspects, the acoustic coupling device may include: a baseband member having a sensor side, a skin side, and a hole, each of the sensor side and the skin side having an adhesive material thereon; a tray removably attached to cover the skin side of the baseband member, the tray including a recessed portion and a flat portion, the recessed portion defining a concave surface facing the hole, the flat portion surrounding the recessed portion; an ultrasound transmission gel disposed in the recessed portion; and a removable protective liner configured to cover the sensor side of the baseband member. The method of using the acoustic coupling device may include the following steps: removing the removable protective liner from the base band member; attaching an ultrasound sensor to the sensor side of the base band member; applying pressure to the recessed portion of the tray to allow the ultrasound transmission gel to travel through the holes of the base band member and directly contact the surface of the ultrasound sensor; removing the tray from the base band member to expose the skin side of the base band member; and attaching the skin side of the base band member to the patient.

[0012] Another aspect of the present disclosure is directed to a method of using an acoustic coupling device to enable an ultrasound sensor to be connected to a patient's skin surface. In non-limiting aspects, the acoustic coupling device may include: a baseband member having a sensor side, a skin side, and a hole that cooperates with a window, each of the sensor side and the skin side having an adhesive material; and a window, the window is configured to cover the hole that cooperates with the window and is composed of a material having acoustic permeability; a tray, the tray is removably attached to cover the skin side of the baseband member, the tray includes a recessed portion and a flat portion, the recessed portion defines a concave surface facing the hole that cooperates with the window, and the flat portion surrounds the recessed portion; a first ultrasound transmission gel, the first ultrasound transmission gel is disposed in the recessed portion; and a removable protective liner, the removable protective liner is configured to cover the sensor side of the baseband member. The method of using the acoustic coupling device may include the following steps: removing the removable protective liner from the base band member; attaching the ultrasound sensor to the sensor side of the base band member; applying pressure to the recessed portion of the tray to allow the first ultrasound transmission gel to contact the window; removing the tray from the base band member to expose the skin side of the base band member; and attaching the skin side of the base band member to the patient.

[0013] The acoustic coupling device according to various aspects configured as a belt assembly can achieve the following advantages:

[0014] 1. Adhesion: By using an acoustic coupling device, the adhesive material of the acoustic coupling device allows one side of the acoustic coupling device to adhere to the sensor surface of the ultrasound sensor and the other side of the acoustic coupling device to adhere to the patient's skin.

[0015] 2. Biocompatibility: The adhesive material of the acoustic coupling device should be compatible with the patient's skin to avoid irritation and other effects.

[0016] 3. Biocompatible barrier: The acoustic coupling device can provide a barrier to avoid direct contact between the sensor surface and the patient's skin, thereby avoiding irritation and other effects.

[0017] 4. Acoustic Transparency: The acoustic coupling device can transmit and receive ultrasound pulses without introducing significant interference, so that an acceptable acoustic response can be obtained from one or more body structures of interest. The design and materials used can be selected not only for their own acoustic wave transmission capabilities, but also to reduce or remove echoes and / or interference generated by transitions between different layers within the acoustic coupling device, between the acoustic coupling device and body tissue, and / or between the acoustic coupling device and the sensor surface. The adhesive formulation can be selected for its acoustic impedance to provide an appropriate acoustic impedance match with the adjacent skin or sensor surface.

[0018] Other features and advantages and the structure and operation of various aspects are described in detail below with reference to the accompanying drawings. It should be noted that the specific aspects described herein are not intended to be limiting. These aspects are presented herein for illustrative purposes only. Based on the teachings contained herein, other aspects will be apparent to those skilled in the relevant art. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate various aspects and, together with the description, further serve to explain principles and enable one skilled in the relevant art to make and use the present disclosure.

[0020] Figure 1 An exploded view of an acoustic coupling device according to aspects of the present disclosure is shown.

[0021] Figure 2 A top view of an acoustic coupling device in an assembled state according to aspects of the present disclosure is shown.

[0022] Figure 3 A perspective view showing one side of an acoustic coupling device according to aspects of the present disclosure is shown.

[0023] Figure 4 A perspective view of securing an ultrasound sensor to an unexposed side of an acoustic coupling device is shown in accordance with aspects of the present disclosure.

[0024] Figure 5 A perspective view of applying ultrasound transmission gel to the transceiver side of an ultrasound sensor is shown in accordance with aspects of the present disclosure.

[0025] Figure 6 A perspective view showing the exposed other side of an acoustic coupling device according to aspects of the present disclosure is shown.

[0026] Figure 7 An ultrasound sensor is shown attached to a patient's body by attaching an acoustic coupling device to the patient's skin in accordance with aspects of the present disclosure.

[0027] FIG. 8A shows a cross section of the acoustic coupling device according to the first aspect after assembly, and FIG. 8B shows a cross section of the acoustic coupling device according to the first aspect being fixed to an ultrasonic sensor.

[0028] FIG. 9A shows a cross section of the acoustic coupling device according to the second aspect after assembly, and FIG. 9B shows a cross section of the acoustic coupling device according to the second aspect being fixed to an ultrasonic sensor.

[0029] FIG. 10A shows a cross section of an assembled acoustic coupling device according to the third aspect, and FIG. 10B shows a cross section of the acoustic coupling device according to the third aspect being fixed to an ultrasonic sensor.

[0030] 11A and 11B illustrate an acoustic coupling device packaged in a bag according to aspects of the present disclosure. DETAILED DESCRIPTION

[0031] The following detailed description refers to the accompanying drawings to illustrate exemplary aspects consistent with the present disclosure. References in the detailed description to "an exemplary aspect," "exemplary aspects," "exemplary aspects of an example," etc. indicate that the exemplary aspects described may include specific features, structures, or characteristics, but each exemplary aspect may not necessarily include the specific features, structures, or characteristics. In addition, such phrases do not necessarily refer to the same exemplary aspects. In addition, when specific features, structures, or characteristics are described in conjunction with exemplary aspects, whether or not explicitly described, such features, structures, or characteristics affecting combination with other exemplary aspects are within the knowledge of a person skilled in the relevant art.

[0032] The exemplary aspects described herein are provided for illustrative purposes and are not limiting. Other exemplary aspects are possible, and the exemplary aspects may be modified within the spirit and scope of the present disclosure. Therefore, the detailed description is not meant to limit the present disclosure. Rather, the scope of the present disclosure is limited only by the following claims and their equivalents.

[0033] The following detailed description of the exemplary aspects will so fully reveal the general nature of the present disclosure that others can, by applying the knowledge of those skilled in the relevant art, readily modify and / or adapt the exemplary aspects for various applications without departing from the spirit and scope of the present disclosure without undue experimentation. Therefore, such adaptations and modifications are intended to be within the meaning and multiple equivalents of the exemplary aspects based on the teachings and guidance set forth herein. It should be understood that the wording or terminology herein is for descriptive and not limiting purposes, so that the terms or wording of this specification are interpreted by those skilled in the relevant art in accordance with the teachings herein.

[0034] As a non-limiting example, Figure 1 shows an exploded view of an acoustic coupling device according to aspects of the present disclosure, and Figure 2 1 shows a top view of an acoustic coupling device according to various aspects of the present disclosure in an assembled state. The acoustic coupling device according to various aspects of the present disclosure may include a base strip member 1, which includes a plastic substrate with adhesive material on both sides. Figure 1As shown, the baseband member 1 has an annular shape surrounding a hole 1a in the center. As will be discussed with reference to Figures 9 and 10, the hole 1a can be a through hole or a hole that cooperates with a window. It should be appreciated that the baseband member 1 can have other shapes besides an annular shape, such as a polygonal or hexagonal shape. In addition, the hole 1a does not necessarily need to be located in the center of the baseband member 1. A ring 1b including a double-sided adhesive surrounds the hole 1a, and an edge area (or skirt area) 1c without adhesive surrounds the ring 1b. One side of the baseband member 1 is a skin side 1d (see Figure 6 ), the tray 3 can be removably attached to the skin side 1d, as a device for attaching to the skin surface of the patient 7 (see Figure 7 ) before the adhesive on the skin side 1d is protected. The tray 3 may be formed with a shallow depression or blister 3a. The tray 3 may be suitably made of a plastic material, such as a semi-rigid plastic sheet, although the choice of material is not limited thereto. The depression 3a may be made elastic, flexible, or elastic and flexible.

[0035] Alternatively or additionally, the recessed portion 3a has a sufficiently thin thickness to be deformable when a user applies slight pressure. In addition, the tray 3 can be made of a flexible material in whole or in part. The tray 3 can be manufactured by a thermoforming process commonly used to manufacture blister packages of, for example, pills. In non-limiting aspects, the diameter of the recessed portion 3a can be in the range of, for example, 10-25 mm, or more preferably 15 mm, although such a range should not be interpreted as limiting these aspects. For example, the diameter and depth of the recessed portion 3a can vary based on the amount of ultrasound gel 2 to be deposited in the recessed portion 3a (which will be described in detail later in this disclosure), the size of the ultrasound transceiver, and the imaging site of the patient (e.g., the abdomen or any other body part), etc. The recessed portion 3a can be in the form of a truncated cone or in the form of a partial sphere. The angle can be manufactured in different sizes in relation to the diameter and depth of the recessed portion 3a to provide a sufficient amount of ultrasound gel 2 without forming any air bubbles inside the recessed portion 3a when the acoustic coupling device according to various aspects is attached to the ultrasound sensor. As Figure 3 A. Figure 5 As shown in FIGS. 8A-10B , the recessed portion 3a may include a central region that is substantially flat and parallel to the base member 1. Alternatively, the central region of the recessed portion 3a may have a slightly rounded shape, with a region having a higher slope arranged between the central region and the surrounding base. The shape and size of the recessed portion may be related to the amount of gel required, and may vary according to the shape and size of the ultrasound sensor, ultrasound probe, or measurement site of the patient.

[0036] The acoustic coupling device according to the aspect may also include a pair of flexible liners 4 and 5, which are used to protect the ring 1b and the protection hole 1a at the sensor side adhesive of the base tape member 1. The pair of flexible liners 4 and 5 may include two halves 4 and 5, which have folded fins 4a and 5a, respectively, to be easily grasped by the user for removal. In non-limiting aspects, the two halves 4 and 5 may have a surface area larger than the surface area of ​​the folded fins 4a and 5a, respectively. In alternative aspects, the acoustic coupling device may include a single liner without or with a folded fin covering the entire sensor side adhesive. In addition, the two halves 4 and 5 may be combined along their adjacent edges, wherein the fins 4a and 5a form a combined, integrated single fin.

[0037] The substrate of the base strip member 1 can be made of, for example, silicone, polyethylene, polyester, acrylic, polyvinyl chloride or any other suitable plastic material, elastomer or combination thereof. The adhesive of the base strip member 1 can be made of, for example, silicone, acrylic or any other type of suitable adhesive, but is not limited thereto. In particular and importantly, without limitation to these aspects, the base strip member 1 and its adhesive include biocompatible materials to prevent or reduce allergic reactions (if any) in the patient. In addition, the tray 3 can be made of a variety of materials, such as polyamide, polyethylene or any other suitable other plastic, elastomer or combination thereof, but is not limited thereto.

[0038] As previously described, the recess or blister 3a has a shaped body in which a drop of standard ultrasound gel or hydrogel 2 can be securely contained. In non-limiting aspects, the gel 2 can be dispensed into the recess 3a before the base strip member 1 is attached to the tray 3, or dispensed into the recess 3a through the hole 1a after the base strip member 1 is attached to the tray 3. The ultrasound gel 2 may contain, for example, glycerin, propylene glycol, water, or other suitable ingredients for ultrasound scanning.

[0039] Figures 3 to 7 The application of the base band member of the acoustic coupling device according to various aspects of the present disclosure in clinical use is shown. First, the user can take out the acoustic coupling device from the packaging in the form of a bag (see Figures 11A and 11B). Then the user can open the base band member of the acoustic coupling device by opening it outward (such as Figure 3 ) by pulling the folded flaps 4a and 5a to peel off the liners 4 and 5, or peel off a single liner as described above as an alternative.

[0040] Reference Figure 4 , the user then attaches the ultrasonic probe, or more specifically the ultrasonic sensor 6 of the probe, to the sensor side of the base member 1, which is exposed by removing the liners 4 and 5. Since the base member has the hole 1a extending axially therethrough, the ultrasonic gel can be exposed to the outside and directly contact the probe face 6a of the sensor 6.

[0041] Next, refer to Figure 5 , the user can apply pressure on the recessed portion 3a using the finger 7b of the user's hand 7a or by using an equivalent tool to squeeze the gel 2 from the recessed portion 3a onto the face 6a of the sensor 6. This wets the face 6a of the sensor 6, thereby providing improved acoustic coupling between the sensor 6 and the gel 2. Due to the firmness of the gel 2 and the surface properties of the recessed portion 3a, a sufficient amount of gel 2 can be squeezed out of the recessed portion 3a to wet the face 6a of the sensor. When the user Figure 6 When the tray 3 is peeled off as shown, although the tray 3 may have a surface to which the gel 2 is substantially non-adherent, a portion of the gel 2 may still remain on the tray 3. However, the residual amount of gel 2 on the tray 3 is negligible, so that the gel 2 remaining on the transceiver face 6a of the sensor 6 provides sufficient gel to provide contact with the patient's skin. The gel 2 thus provides direct coupling from the sensor 6, more specifically from the transceiver face 6a, to the patient's 7 skin.

[0042] The user can then peel the tray 3 off the base member 1 to expose its skin side 1d. Finally, the user can couple the skin side 1d to the patient's skin, e.g. Figure 7 As shown, the acoustic coupling device is coupled to the abdomen of the patient for scanning a body structure of particular interest. However, the scanning site is not limited thereto, so that the user can place the sensor 6 together with the base band member 1 at any part of the body to be scanned using a suitable ultrasonic sensor as also described above, such as the head, chest, neck, etc. That is, the acoustic coupling device according to various aspects can be used for any ultrasonic sensor having a size and surface of the base band member 1 to which the acoustic coupling device can be adhered. In addition, the acoustic coupling device according to various aspects can be used for an ultrasonic probe having an ultrasonic transceiver coupled to the patient's body, so that the angle of the ultrasonic beam emitted from the ultrasonic transceiver may not be perpendicular to the motion vector of the internal structure inside the patient's body, for example, at an angle of 45° or less (see Figures 8B, 9B, and 10B). However, the acoustic coupling device according to various aspects can be used for any ultrasonic beam angle, so that the angle can be greater or less than, for example, 45° within the range of 0-90°.

[0043] In alternative aspect, instead of the baseband member consisting of a single double-sided adhesive as described above, the baseband member 1 can have a sandwiched configuration of multiple double-sided adhesives. The double-sided adhesive can include a film used as a substrate, with an adhesive layer on each face. In another alternative aspect, two double-sided adhesive films can be attached to each other. Therefore, if each film has an adhesive layer on each face of the substrate, the baseband member 1 can include a total of six or more layers. In this case, a commercially available adhesive layer can be used to form a layered structure, so that manufacturing costs and time can be reduced.

[0044] 9A and 9B illustrate a second aspect or first alternative aspect of the present disclosure. In the second aspect, a window 8 made of a sound-transmitting material is provided in the hole 1a of the base member 1, thereby providing a sound-transmitting path from the ultrasonic transceiver surface 6a of the sensor 6 to the gel 2 to be in contact with the skin via the window 8, without direct contact between the ultrasonic transceiver surface 6a and the gel 2. The term "sound-transmitting" can be understood as a unique property that allows ultrasound to pass without generating echoes, which are generated due to reflection, attenuation, diffraction or any other disturbance of some waves, and the material having the sound-transmitting property can be any ultrasound-transmitting material commonly used for ultrasound scanning. Therefore, a detailed description of the material having the sound-transmitting property is omitted herein.

[0045] The window 8 can be an area on one of the layers of the baseband member, or the entire baseband member 1 itself can be made of a sound-permeable material, so that the hole 1a can no longer be a hole passing through the window 8, but is covered or interrupted by the window 8. Therefore, the gel 2 can be fixed in the recessed portion 3a and can be prevented from contacting the liner 4 and 5, and no gel will be lost when the liner 4 and 5 are removed. Alternatively, the window 8 can be manufactured by removing a specific material to only maintain the sound-permeable property, for example, by omitting the adhesive layer on the hole 1a area during the manufacturing process of the baseband member 1 or removing the adhesive layer from the baseband member 1 in a subsequent manufacturing step. As another alternative or in addition to the above-mentioned aspects, the baseband member 1 can have a layered structure. The number of layers that the baseband member 1 can have is not limited to the examples (e.g., three layers) of this article, but can be any number. Each layer can have an adhesive on both sides to adhere to each other.

[0046] In a third aspect or second alternative aspect, as shown in Figures 10A and 10B, additional drops of ultrasound delivery gel or hydrogel 2a can be packaged or disposed between the window 8 of the base member 1 and the liners 4 and 5 to provide ultrasound gel directly on the face 6a of the sensor 6. That is, the additional gel 2a can be disposed on the top of the window 8 so that the gel directly contacts the surface of the face 6a, because when the sensor 6 is applied to the adhesive sensor side of the base member 1, air pockets (e.g., bubbles or spaces) can be formed or captured between the window 8 and the face 6a disposed near the sensor side. It should be appreciated that in this case, the window 8 and the additional gel 2a can be at the center or dedicated portion of the sensor side layer of the base band member 1 corresponding to the hole 1a. Therefore, the additional drops of gel 2a can reduce the air between the sensor 6 and the window 8.

[0047] 11A and 11B show a bag in which an acoustic coupling device according to various aspects is packaged in a bag to be shipped. The bag 9 can firmly seal and maintain the acoustic coupling device in the original package without any damage during transportation and storage. In addition, the user can easily open and take out the acoustic coupling device according to various aspects without damaging the acoustic coupling device. The bag 9 can be made of a combination of plastic, metal foil and paper. In non-limiting aspects, the acoustic coupling device can be packaged in one package or two packages as shown in FIGS. 11A and 11B. As a non-limiting example, FIG. 11B shows that the sealed bag 9 can include a bag portion 9a for storing one acoustic coupling device, while the bag portion 9b can store a different coupling device 10 or another acoustic device according to various aspects.

[0048] For example, when using a double package, the user can open and remove each acoustic coupling device by peeling off the left corner of the liner for the left bag portion 9a and the right corner of the liner for the right bag portion 9b as shown in FIG. 11B. However, this is only an example that allows the user to peel off the middle portion between the bag portions 9a and 9b to open. The acoustic coupling device according to various aspects as described above can be used for the front part of the patient. On the other hand, the different acoustic coupling device 10 can be a commercially available coupling device or another coupling device for the back side of the patient to provide a transceiver based on movement compensation that cooperates with the sensor 6 (for example, U.S. Patent No. 10,398,351 and U.S. Patent No. 10,505,821). Alternatively, there can be an acoustic coupling device according to various aspects packaged in each bag portion, so that one acoustic coupling device according to various aspects can be used for the front part, and another acoustic coupling device according to various aspects can be used for the back part. It should be appreciated that the base band member 1 of various aspects can be sold separately from the different acoustic coupling devices 10, and in this case, double packaging will not be provided. As noted from the front of the twin pack, a visual user manual may be provided on the front side of the pack.

[0049] It should be appreciated that the Detailed Description section, rather than the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary aspects of the present disclosure as contemplated by the inventors, and thus, are not intended to limit the present disclosure and the appended claims in any way.

[0050] The above aspects of the present disclosure have been described by means of functional building blocks that illustrate the implementation of specified functions and their relationships. For the convenience of description, the boundaries of these functional building blocks are arbitrarily defined in this article. As long as the specified functions and their relationships are properly performed, alternative boundaries can be defined.

[0051] The foregoing description of specific aspects will so fully reveal the general nature of the present disclosure that others can, by applying knowledge within the technical scope of the art, easily modify and / or adapt various applications of these specific aspects without departing from the overall concept of the present disclosure without undue experimentation. Therefore, based on the teachings and guidance set forth herein, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed aspects. It should be understood that the wording or terminology herein is for the purpose of description rather than limitation, so that the terms or wording of this specification should be interpreted by those skilled in the art based on the teachings and guidance.

[0052] The breadth and scope of the present disclosure should not be limited by any of the above-described exemplary aspects, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. An acoustic coupling device, the acoustic coupling device being used to fix an ultrasound sensor to a patient, the acoustic coupling device comprising: a base band member including a sensor side and a skin side, the sensor side and the skin side each having an adhesive material thereon, wherein the base band member includes an aperture; a tray removably attached to cover the skin side of the base band member, the tray comprising a recessed portion defining a concave surface facing the aperture and a flat portion surrounding the recessed portion; a first ultrasound transmission gel disposed in the recessed portion; and A removable protective liner is configured to cover the sensor side of the base strip member.

2. The acoustic coupling device according to claim 1, wherein: The baseband component also includes: A window is arranged to correspond to the hole and cover the hole, wherein the window is provided close to the sensor side of the base member.

3. The acoustic coupling device according to claim 2, wherein: The first ultrasound transmission gel is disposed in the recess and adjacent a surface of the window distal from the removable protective liner.

4. The acoustic coupling device according to claim 3, wherein: A second ultrasound transmission gel is disposed between the window and the removable protective liner.

5. The acoustic coupling device according to claim 2, wherein: The base tape member has a multi-layer structure.

6. The acoustic coupling device according to claim 5, wherein: Each layer in the multi-layer structure has an adhesive material on each side, the adhesive material being configured to bond the layers in the multi-layer structure to each other.

7. The acoustic coupling device according to claim 6, wherein: At least one layer of the multi-layer structure having the window includes an acoustically transparent material axially aligned with the aperture of the base tape member.

8. The acoustic coupling device according to claim 7, wherein: One or more layers of the multilayer structure other than the layer having the acoustically transparent material have through holes axially aligned with the holes of the base tape member.

9. The acoustic coupling device according to claim 1, wherein: The recessed portion is provided to correspond to the hole of the base belt member.

10. The acoustic coupling device according to claim 1, wherein: The baseband component also includes: An edge region surrounds the base strip member at an outer edge, wherein the edge region is free of adhesive material to surround the sensor side and the skin side of the base strip member having the adhesive material thereon.

11. The acoustic coupling device according to claim 1, wherein: The base band member includes at least one of a plastic material, an elastomeric material, a biocompatible material or a silicone-based material.

12. The acoustic coupling device according to claim 1, wherein: The tray includes at least one of a plastic material or an elastomeric material.

13. The acoustic coupling device according to claim 1, wherein: The recessed portion is configured to be flexible.

14. The acoustic coupling device according to claim 13, wherein: The recess has a diameter in the range of 10-25 mm and a depth in the range of 1-20 mm.

15. The acoustic coupling device according to claim 14, wherein: The recessed portion has a frustoconical shape or a spherical cap shape.

16. The acoustic coupling device according to claim 1, wherein: The removable protective liner includes plastic liner components, each of which has a retaining tab.

17. The acoustic coupling device according to claim 1, wherein: The adhesive material on the skin side of the base strip member comprises a biocompatible material.

18. A method of fixing an ultrasound sensor to a patient using an acoustic coupling device, wherein: The acoustic coupling device comprises: a base band member including a sensor side and a skin side, the sensor side and the skin side each having an adhesive material thereon, wherein the base band member includes an aperture that penetrates the base band member from the sensor side to the skin side; a tray removably attached to cover the skin side of the base band member, the tray comprising a recessed portion defining a concave surface facing the aperture and a flat portion surrounding the recessed portion; an ultrasound transmission gel disposed in the recessed portion; and a removable protective liner configured to cover the sensor side of the base strip member, The method comprises the following steps: removing the removable protective liner from the base strip member; attaching an ultrasonic sensor to the sensor side of the base tape member; applying pressure to the recessed portion of the tray to allow the ultrasound transmission gel to travel through the apertures of the base strip member and into direct contact with the surface of the ultrasound sensor; removing the tray from the base strip member to expose the skin side of the base strip member; and The skin side of the base belt member is attached to the patient.

19. A method of securing an ultrasound sensor to a patient using an acoustic coupling device, wherein the acoustic coupling device comprises: a base band member including a sensor side and a skin side, the sensor side and the skin side each having an adhesive material thereon, wherein the base band member includes an aperture that mates with the window; a window, the window being arranged to cover the hole matched with the window and being made of a sound-permeable material; a tray removably attached to cover the skin side of the base band member, wherein the tray includes a recessed portion defining a concave surface facing the aperture that cooperates with the window and a flat portion surrounding the recessed portion; a first ultrasound transmission gel disposed in the recessed portion; and a removable protective liner configured to cover the sensor side of the base strip member; The method comprises the following steps: removing the removable protective liner from the base strip member; attaching an ultrasonic sensor to the sensor side of the base tape member; applying pressure to the recessed portion of the tray to allow the first ultrasound transmission gel to contact the window; removing the tray from the base strip member to expose the skin side of the base strip member; and The skin side of the base belt member is attached to the patient.

20. The method according to claim 19, wherein: The acoustic coupling device further includes a second ultrasound transmission gel between the removable protective liner and the window, and Wherein, the method further comprises: after the step of attaching the ultrasonic sensor to the sensor side of the base strip member, providing ultrasonic transmission contact between the sensor face of the ultrasonic sensor and the window by using the second ultrasonic transmission gel.

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