Acoustic coupling device and method of using the same

Abstract

The acoustic coupling device includes a base tape member including a hole and a sensor side and a skin side, each having an adhesive material thereon. The device further includes a tray removably attached to cover the skin side of the base tape member. The tray includes a recessed portion defining a concave surface facing the hole and a flat portion surrounding the recessed portion. The device further includes ultrasound transmission gel disposed within the recessed portion and a removable protective liner configured to cover the sensor side of the base tape member.

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Patent Application No. 17 / 899,226, filed August 30, 2022, the disclosure of which is incorporated herein by reference in its entirety.

[0002] (Technical field) The present disclosure describes an acoustic coupling device and methods of using the same, and more particularly, an acoustic coupling device for securing the coupling of an ultrasound transceiver to the skin of a patient for ultrasound-based diagnostic imaging techniques, and methods of using the same. [Background technology]

[0003] (background) 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 pathology or lesions. Obstetric ultrasound is commonly used during pregnancy and is widely recognized by the public. Various other diagnostic and therapeutic applications are also implemented in medicine.

[0004] To obtain good quality images of body structures of interest, it is necessary for the sound pulses emitted by the ultrasound transceiver to pass into and be received from the body without interference. The material forming the transceiver surface is selected to allow sound to be efficiently transmitted into the body. Traditionally, 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 desired.

[0005] For example, U.S. Patent No. 9,211,106 discloses using tape to secure an ultrasound probe to a patient's skin. However, further improvements have been found to be necessary for acoustic coupling between the tape and the patient's skin. To ensure reliable acoustic coupling, the tape requires the user to manually place a small amount of ultrasound gel, which is inconvenient for the user and susceptible to user error. Furthermore, it has proven difficult to consistently manufacture the tape.

[0006] 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.

[0007] Therefore, a need exists for improved devices and methods for securing the coupling of an ultrasound transceiver to a patient's skin for ultrasound-based diagnostic imaging techniques while reducing user operation error and time. [Prior art documents] [Patent documents]

[0008] [Patent Document 1] U.S. Patent No. 9,211,106 Summary of the Invention [Means for solving the problem]

[0009] (overview) Aspects of the present disclosure are directed to securely attaching ultrasound sensors to a patient's skin to observe internal body organ activity using a simple device, and 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 a non-limiting aspect, the device may include a base tape member having a sensor side and a skin side, each having an adhesive material thereon, and an aperture; a tray removably attached to cover the skin side of the base tape member, the tray including 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 configured to cover the sensor side of the base tape 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 connectable to a patient's skin surface. In a non-limiting aspect, the device may include a base tape member having a sensor side and a skin side, each having an adhesive thereon, and an aperture; a tray removably attached to cover the skin side of the base tape member, the tray including a recess defining a concave surface facing the aperture and a flat portion surrounding the recess; ultrasound transmission gel disposed in the recess; and a removable protective liner configured to cover the sensor side of the base tape member. A method of using the acoustic coupling device may include removing the protective liner from the base tape member; attaching an ultrasound sensor to the sensor side of the base tape member; applying pressure on the recess to allow the ultrasound transmission gel to pass through the aperture of the base tape member and directly contact the surface of the ultrasound sensor; removing the tray from the base tape member to expose the skin side of the base tape member; and attaching the skin side of the base tape member to the patient.

[0012] Yet another aspect of the present disclosure is directed to a method of using an acoustic coupling device to enable an ultrasound sensor to be connectable to a patient's skin surface. In a non-limiting aspect, the device may include a base tape member having a sensor side and a skin side, each having an adhesive thereon, a fenestrated hole, and a window configured to cover the fenestrated hole and made of a material having acoustically transparent properties; a tray removably attached to cover the skin side of the base tape member, the tray including a recessed portion defining a concave surface facing the fenestrated hole 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 tape member. A method of using the acoustic coupling device may include removing a protective liner from a base tape member, attaching a sensor to the sensor side of the base tape member, applying pressure on the recessed portion of the tray to allow a first ultrasound transmission gel to contact the window, removing the tray from the base tape member to expose the skin side of the base tape member, and attaching the skin side of the base tape member to a patient.

[0013] Acoustic coupling devices according to various embodiments configured as tape assemblies may achieve the following advantages: 1. Adhesiveness: 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 the patient's skin by using one acoustic coupling device. 2. Biocompatibility: The adhesive material of the acoustic coupling device can be compatible with the patient's skin while preventing irritation and other effects. 3. Biocompatible Barrier: The acoustic coupling device may provide a barrier that prevents direct contact between the sensor surface and the patient's skin, preventing irritation and other effects. 4. Acoustically transparent: The acoustic coupling device can transmit and receive ultrasonic pulses without introducing significant interference, so that an acceptable acoustic response can be obtained from the body structure(s) of interest. The designs and materials used can be selected not only for their own acoustic transmission capabilities, but also to reduce or eliminate echoes and / or interference created 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. Adhesive compositions can be selected for their acoustic impedance to provide an appropriate acoustic impedance match with adjacent skin or the sensor surface.

[0014] Further features and advantages, as well as the structure and operation of various embodiments, are described in detail below with reference to the accompanying drawings. It should be noted that the specific embodiments described herein are not intended to be limiting. Such embodiments are presented herein for illustrative purposes only. Additional embodiments will be apparent to those skilled in the relevant art(s) based on the teachings contained herein. [Brief explanation of the drawings]

[0015] The accompanying drawings, which are incorporated in and form a part of this specification, illustrate aspects and, together with the description, further serve to explain the principles and to enable one skilled in the relevant art to make and use the present disclosure.

[0016] [Figure 1] FIG. 1 illustrates an exploded view of an acoustic coupling device according to an embodiment of the present disclosure.

[0017] [Figure 2] FIG. 2 illustrates a top view of an acoustic coupling device in an assembled state according to an embodiment of the present disclosure.

[0018] [Figure 3] FIG. 3 illustrates a perspective view of one side of an exposed acoustic coupling device according to an embodiment of the present disclosure.

[0019] [Figure 4] FIG. 4 illustrates a perspective view of securing an ultrasonic sensor onto an exposed side of an acoustic coupling device according to an embodiment of the present disclosure.

[0020] [Figure 5] FIG. 5 illustrates a perspective view of applying ultrasound transmitting gel onto the transceiver side of an ultrasound sensor according to an embodiment of the present disclosure.

[0021] [Figure 6] FIG. 6 illustrates a perspective view of another side of an exposed acoustic coupling device according to an embodiment of the present disclosure.

[0022] [Figure 7] FIG. 7 illustrates an ultrasound sensor attached to a patient's body by attaching an acoustic coupling device to the patient's skin according to an embodiment of the present disclosure.

[0023] [Figure 8] FIG. 8A illustrates a cross section of an acoustic coupling device according to a first embodiment when assembled, and FIG. 8B illustrates a cross section of the acoustic coupling device according to the first embodiment secured to an ultrasonic sensor.

[0024] [Figure 9] FIG. 9A illustrates a cross section of an acoustic coupling device according to a second embodiment when assembled, and FIG. 9B illustrates a cross section of an acoustic coupling device according to the second embodiment secured to an ultrasonic sensor.

[0025] [Figure 10] FIG. 10A illustrates a cross-sectional view of an acoustic coupling device according to a third embodiment when assembled, and FIG. 10B illustrates a cross-sectional view of the acoustic coupling device according to the third embodiment secured to an ultrasonic sensor.

[0026] [Figure 11]11A and 11B illustrate an acoustic coupling device packaged in a pouch according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0027] (Detailed explanation) The following detailed description refers to the accompanying drawings to illustrate exemplary embodiments consistent with this disclosure. References in the detailed description to "one exemplary embodiment," "an exemplary embodiment," "an example exemplary embodiment," etc. indicate that the described exemplary embodiment may include a particular feature, structure, or characteristic, but that not all exemplary embodiments may necessarily include that particular feature, structure, or characteristic. Moreover, such phrases do not necessarily refer to the same exemplary embodiment. Also, when a particular feature, structure, or characteristic is described in connection with an exemplary embodiment, it is within the knowledge of one of ordinary skill in the relevant art(s) to affect such feature, structure, or characteristic in connection with other exemplary embodiments, whether or not explicitly described.

[0028] The exemplary embodiments described herein are provided for purposes of illustration and not limitation. Other exemplary embodiments are possible, and modifications may be made to the exemplary embodiments within the spirit and scope of the present disclosure. Therefore, the detailed description is not intended to limit the present disclosure. Rather, the scope of the present disclosure is defined only by the following claims and their equivalents.

[0029] The following detailed description of exemplary embodiments will fully clarify the general nature of the present disclosure so that others, by applying the knowledge of those skilled in the relevant art(s), may readily modify and / or adapt such exemplary embodiments for various applications without departing from the spirit and scope of the disclosure and without undue experimentation. Accordingly, such adaptations and modifications are intended to be within the meaning and range of equivalents of the exemplary embodiments based on the teaching and guidance presented herein. It should be understood that the phraseology or terminology herein is for purposes of description and not of limitation, and that the terminology or terminology herein should be interpreted by one of ordinary skill in the relevant art(s) in light of the teachings herein.

[0030] FIG. 1 illustrates, as a non-limiting embodiment, an exploded view of an acoustic coupling device according to an aspect of the present disclosure, and FIG. 2 illustrates a plan view of an assembled acoustic coupling device according to an aspect of the present disclosure. An acoustic coupling device according to an aspect of the present disclosure may include a base tape member 1 including a plastic substrate with adhesive material on both sides. As shown in FIG. 1, base tape member 1 has a ring shape at its center surrounding hole 1a. Hole 1a may be passable or windowed, as described with reference to FIGS. 9 and 10. It will be understood that base tape member 1 may have a shape other than a ring shape, such as a polygonal or hexagonal shape. Furthermore, hole 1a does not necessarily have to be located at the center of base tape member 1. A ring 1b containing adhesive on both sides surrounds hole 1a, and an adhesive-free edge region (or skirt region) 1c surrounds ring 1b. One side of the base tape member 1 is a skin side 1d (see FIG. 6), and the tray 3 can be removably attached thereon as a protective liner to protect the adhesive on the skin side 1d before attachment to the skin surface of a patient 7 (see FIG. 7). The tray 3 can be formed with a shallow depression or blister portion 3a. The tray 3 can be suitably made from a plastic material (e.g., a semi-rigid plastic sheet), but the material selection is not limited thereto. The depression portion 3a can be made to be elastic, flexible, or elastic and flexible.

[0031] Alternatively or additionally, the recessed portion 3a has a thickness thin enough to be deformable when a user applies a small amount of pressure. Furthermore, the tray 3 may be made entirely or partially of a flexible material. The tray 3 may be manufactured by a thermoforming process commonly used for manufacturing blister packs for tablets, for example. In a non-limiting embodiment, the diameter of the recessed portion 3a may be, for example, within a range of 10 to 25 mm, or more preferably 15 mm, although such ranges should not be construed as limiting the embodiment. For example, the diameter and depth of the recessed portion 3a may be varied based on the amount of ultrasound gel 2 deposited in the recessed portion 3a (described in detail later in this disclosure), the size of the ultrasound transceiver, and the patient's imaging location (e.g., the abdomen or other body part). The recessed portion 3a may be in the shape of a truncated cone or a partial sphere. The angle can be manufactured in different sizes relative to the diameter and depth of the depression 3a to provide a sufficient amount of ultrasound gel 2 without forming any air bubbles inside the depression 3a when the device of this embodiment is attached to the ultrasound sensor. The depression 3a can include a central region that is substantially flat and substantially parallel to the base tape member 1, as shown in, for example, FIGS. 3A, 5, and 8A-10B. Alternatively, the central region of the depression 3a can have a slightly rounded shape with a higher sloped region arranged between the central region and the surrounding base tape. The shape and dimensions of the depression can be related to the amount of gel required and can vary depending on the ultrasound sensor, ultrasound probe, or patient measurement position.

[0032] The acoustic coupling device according to the embodiment may further include a pair of flexible liners 4 and 5 for protecting the ring 1b and hole 1a in 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 with bent folds 4a and 5a, respectively, for easy grasping by a user for removal. In a non-limiting embodiment, the two halves 4 and 5 may each have a surface area greater than the surface area of ​​the bent folds 4a and 5a. In an alternative embodiment, the acoustic coupling device may include a single liner covering the entire sensor-side adhesive, with or without the bent folds. Additionally, the two halves 4 and 5 may be joined along their adjacent edges, and the folds 4a and 5a may form a joined, unified single fold.

[0033] The substrate of the base tape member 1 may be made from, for example, silicone, polyethylene, polyester, acrylic, polyvinyl chloride, or other suitable plastic material, elastomer, or a combination thereof. The adhesive of the base tape member 1 may be made from, for example, but not limited to, silicone, acrylic, or other types of suitable adhesive. Of particular importance, but not limiting, is that the base tape member 1 and its adhesive include a biocompatible material to prevent or reduce allergic reactions (if any) to the patient. Furthermore, the tray 3 may be made from a variety of materials, such as, but not limited to, polyamide, polyethylene, or other suitable plastic, elastomer, or a combination thereof.

[0034] As previously mentioned, the depressions or blisters 3a have a shape that allows a small amount of standard ultrasound gel or hydrogel 2 to be securely contained therein. In a non-limiting embodiment, the gel 2 can be dispensed into the depressions 3a either prior to mounting the base tape member 1 on the tray 3 or through the holes 1a after mounting the base tape member 1 on the tray 3. The ultrasound gel 2 can include, for example, glycerin, propylene glycol, water, or other suitable ingredients for use in ultrasound scanning.

[0035] 3-7 illustrate application of the tape member of an acoustic coupling device according to an embodiment of the present disclosure in clinical use. First, a user can remove the acoustic coupling device from the pouch-shaped package (see FIGS. 11A and 11B). Then, the user peels off liners 4 and 5 (or the single liner described above as an alternative embodiment) by pulling bent folds 4a and 5a outward, as shown in FIG. 3.

[0036] 4, the user then attaches an ultrasound probe, or more specifically, an ultrasound sensor 6 of the probe, to the sensor side (exposed by removing liners 4 and 5) of base tape member 1. Because base tape member 1 has a hole 1a passing through it in the axial direction, ultrasound gel 2 can be exposed to the outside and can come into direct contact with probe surface 6a of sensor 6.

[0037] Referring now to FIG. 5 , a user applies pressure to the recess 3a using the fingers 7b of the user's hand 7a, or by using an equivalent tool, to squeeze the gel 2 from the recess 3a onto the surface 6a of the sensor 6. This wets the surface 6a of the sensor 6 and provides improved acoustic coupling between the sensor 6 and the gel 2. Due to the hardness of the gel 2 and the surface characteristics of the recess 3a, a sufficient amount of the gel 2 can be squeezed out of the recess 3a to wet the surface 6a of the sensor. When the user peels the tray 3 off as shown in FIG. 6 , the tray 3 may have a surface to which the gel 2 does not substantially adhere, but some of the gel 2 may still remain on the tray 3. However, this residual amount of gel 2 on the tray 3 is small, and as a result, the gel 2 remaining on the transceiver surface 6a of the sensor 6 provides sufficient gel to provide contact with the patient's skin. Thus, the gel 2 provides direct coupling from the sensor 6, and more specifically, from the transceiver surface 6a to the skin of the patient 7.

[0038] The user can then peel the tray 3 from the base tape member 1 to expose the skin side 1d. Finally, the user can couple the skin side 1d to the patient's skin, for example, the patient's abdomen as shown in FIG. 7, to scan a particular body structure of interest. However, the scanning location is not limited thereto. As described above, the user can place the sensor 6 with the tape base member 1 on any location on the body for scanning, such as the head, chest, or neck, using an appropriate ultrasound sensor. That is, the acoustic coupling device according to various embodiments can be used for any ultrasound sensor having dimensions and a surface to which the base tape member 1 of the acoustic coupling device can be attached. In addition, the acoustic coupling device according to various embodiments can be used for an ultrasound probe having an ultrasound transceiver coupled to the patient's body such that the ultrasound beam angle emitted from the ultrasound transceiver can be non-perpendicular, for example, at an angle of 45° or less, relative to the motion vector of an internal structure inside the patient's body (see FIGS. 8B, 9B, and 10B). However, acoustic coupling devices according to various embodiments can be used for any ultrasound beam angle, such as, for example, greater than or less than 45°, and may be within the range of 0 to 90°.

[0039] In an alternative embodiment, the base tape member 1 may have a sandwiched construction of multiple double-sided adhesives instead of the single double-sided adhesive described above. The double-sided adhesive may include a film that acts as a substrate, with a layer of adhesive on each side. In a further alternative embodiment, two double-sided adhesive films may be attached to each other. Thus, if each film has an adhesive layer on each side of the substrate, the base tape member 1 may include a total of six or more layers. In this case, commercially available adhesive layers may be used to form the layered structure, thus reducing manufacturing costs and time.

[0040] 9A and 9B illustrate a second embodiment of the present disclosure, or an alternative embodiment to the first embodiment. In this second embodiment, the hole 1a of the base tape member 1 has a window 8 of a material having acoustically transparent properties therein, thereby providing an acoustically transparent path from the ultrasonic transceiver surface 6a of the sensor 6 through the window 8 to the gel 2 (for contacting the skin), without direct contact between the surface 6a and the gel 2. The term "sound transparent" can be understood as an inherent property that allows the passage of ultrasound waves without the generation of echoes due to reflection, attenuation, diffraction, or other perturbations of the wave. The material having acoustically transparent properties can be any ultrasonically transparent material commonly used in ultrasound scanning. Therefore, a detailed description of materials with acoustically transparent properties is omitted herein.

[0041] The window 8 may be an area on one of the base tape member layers, or the entire base tape member 1 itself may be made of a sound-transmitting material, so that the hole 1 a is no longer a pass-through hole but is instead covered or blocked by the window 8. Thus, the gel 2 may be fixed in the recess 3 a and prevented from contacting the liners 4 and 5 without losing any gel when the liners 4 and 5 are removed. Alternatively, the window 8 may be created by removing a specific material (e.g., by omitting an adhesive layer on the hole 1 a area during the manufacturing process of the base tape member 1 or by removing the adhesive layer from the base tape member 1 in a subsequent manufacturing step) to retain only the sound-transmitting properties. Alternatively, or in addition to the above embodiment, the base tape member 1 may have a layered structure. The number of layers that the base tape member 1 may have is not limited to the example given herein (e.g., three layers) and may be any number. Each layer may have adhesive on both sides to adhere to each other.

[0042] 10A and 10B , an additional small amount of ultrasound-propagating gel or hydrogel 2a may be packed or placed between the window 8 and the liners 4 and 5 of the base-type member 1 to provide ultrasound gel directly on the surface 6a of the sensor 6. That is, when the sensor 6 is applied onto the adhesive sensor side of the base-type member 1, an air pocket (e.g., air bubble or space) may form or be trapped between the window 8 located proximal to the sensor side and the surface 6a, so the additional gel 2a is provided on top of the window 8 to provide direct gel contact with the surface of the surface 6a. In this case, it will be understood that the window 8 and the additional gel 2a may be in a central or dedicated portion of the sensor-side layer of the base tape member 1, corresponding to the hole 1a. Thus, the additional small amount of gel 2a may reduce air between the sensor 6 and the window 8.

[0043] 11A and 11B illustrate a pouch into which an acoustic coupling device according to various embodiments is packaged for shipping. The pouch 9 can reliably seal and maintain the acoustic coupling device as originally packaged without any damage during transportation and storage. Furthermore, a user can easily open and remove an acoustic coupling device according to various embodiments without damaging the device. The pouch 9 can be made of a combination of plastic, metal foil, and paper. In a non-limiting embodiment, the acoustic coupling device can be packaged in a single package or a double package, as shown in FIGS. 11A and 11B. FIG. 11B illustrates, as a non-limiting embodiment, that the sealed pouch 9 can include a pouch portion 9a for storing one acoustic coupling device, while the pouch portion 9b can store a different coupling device 10 or another acoustic device according to various embodiments.

[0044] For example, when a dual package is used, a user can open and remove each coupling device by peeling the left corner of the liner for the left pouch portion 9a and the right corner of the liner for the right pouch portion 9b, as shown in FIG. 11B. However, this is merely an example, as a user may peel the middle portion between pouches 9a and 9b to open. The various embodiments of the acoustic coupling device described above may be used for an anterior position on a patient. On the other hand, a different coupling device 10 may be a commercially available coupling device or another coupling device for use on the posterior side of a patient to cooperate with a sensor 6 to provide a motion-compensated transceiver (e.g., U.S. Pat. Nos. 10,398,351 and 10,505,821). Alternatively, an embodiment of the acoustic coupling device may be packaged within each pouch portion, such that one device of various embodiments may be used for an anterior position and the other device of various embodiments may be used for a posterior position. It will be understood that the base tape member 1 of that embodiment may be sold separately with a different bonding device 10, in which case no dual packaging is provided. As noted from the front of the dual packaging, a visual user manual may be provided on the front of the package.

[0045] It should be understood that the Detailed Description section, and not the Abstract and Summary sections, is intended to be used to interpret the claims. While the Abstract and Summary sections may describe one or more example aspects of the disclosure contemplated by the inventor(s), they do not describe every example aspect of the disclosure and thus are not intended to limit the disclosure and the appended claims in any way.

[0046] Aspects of the present disclosure have been described above with the aid of functional components illustrating the implementation of specific functions and their relationships. The boundaries of these functional components have been arbitrarily defined herein for the convenience of description. Alternative boundaries may be defined so long as the specific functions and their relationships are appropriately performed.

[0047] The foregoing description of specific embodiments so fully clarifies the general nature of the present disclosure that others may easily modify and / or adapt such specific embodiments for various applications without departing from the general concepts of the present disclosure and by applying knowledge within the skill of the art without undue experimentation. Such adaptations and modifications are therefore intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for purposes of description and not of limitation, and that the terminology or terminology herein should be interpreted in light of the teaching and guidance by the skilled artisan.

[0048] The breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

1. 1. An acoustic coupling device for securing an ultrasound sensor to a patient, the device comprising: a base tape member, the base tape member including a sensor side and a skin side each having an adhesive material thereon, the base tape member including a hole; a tray removably attached to cover the skin side of the base tape member, the tray including a recessed portion, the recessed portion defining a concave surface facing the hole and a flat portion surrounding the recessed portion; a first ultrasound transmission gel disposed in the recess; a removable protective liner configured to cover the sensor side of the base tape member; Including, the device.

2. The base tape member is The device of claim 1 , further comprising a window arranged to correspond to and cover the hole, the window being positioned proximal to the sensor side of the base tape member.

3. 3. The device of claim 2, wherein the first ultrasound transmission gel is disposed in the recess and adjacent a surface of the window remote from the removable protective liner.

4. The device of claim 3 , wherein a second ultrasound transmission gel is disposed between the window and the removable protective liner.

5. The device of claim 2 , wherein the base tape member has a multi-layer structure.

6. The device of claim 5 , wherein each layer in the multi-layer structure has an adhesive material on each side, the adhesive material configured to adhere the layers in the multi-layer structure to one another.

7. The device of claim 6 , wherein at least one layer of the multi-layer structure having the window includes a sound-transmitting material axially aligned with the hole in the base tape member.

8. The device of claim 7 , wherein one or more layers of the structure other than the one layer having the acoustically transparent material have through holes axially aligned with the holes in the base tape member.

9. The device according to claim 1 , wherein the recessed portion is disposed corresponding to the hole in the base tape member.

10. The base tape member is 10. The device of claim 1, further comprising a border region surrounding the base tape member at an outer edge, the border region being positioned without adhesive material to surround the sensor side and the skin side of the base tape member having the adhesive material thereon.

11. The device of claim 1 , wherein the base tape member comprises at least one of a plastic material, an elastomeric material, a biocompatible material, or a silicone-based material.

12. The device of claim 1 , wherein the tray comprises at least one of a plastic material or an elastomeric material.

13. The device of claim 1 , wherein the recess is configured to be flexible.

14. 14. The device of claim 13, wherein the recess has a diameter in the range of 10 to 25 millimeters and a depth in the range of 1 to 20 millimeters.

15. The device of claim 14 , wherein the recess has a frusto-conical or spherical crown shape.

16. The device of claim 1 , wherein the removable protective liner comprises plastic liner members, each of the plastic liner members having a gripping flaps.

17. The device of claim 1 , wherein the adhesive material on the skin side of the base tape member comprises a biocompatible material.

18. 1. A method of utilizing an acoustic coupling device for securing an ultrasound sensor to a patient, the acoustic coupling device comprising: a base tape member, the base tape member including a sensor side and a skin side each having an adhesive material thereon, the base tape member including a hole passing through the base tape member from the sensor side to the skin side; a tray removably attached to cover the skin side of the base tape member, the tray including a recessed portion, the recessed portion defining a concave surface facing the hole and a flat portion surrounding the recessed portion; an ultrasound transmission gel disposed in the recess; a removable protective liner configured to cover the sensor side of the base tape member; Including, The method comprises: removing the protective liner from the base tape member; attaching the ultrasonic sensor to the sensor side of the base tape member; applying pressure onto the recess of the tray to allow the ultrasound transmission gel to pass through the hole in the base tape member and to come into direct contact with a surface of the ultrasound sensor; removing the tray from the base tape member to expose the skin side of the base tape member; applying the skin side of the base tape member to the patient; A method comprising:

19. 1. A method of utilizing an acoustic coupling device for securing an ultrasound sensor to a patient, the acoustic coupling device comprising: a base tape member, the base tape member including a sensor side and a skin side each having an adhesive material thereon, the base tape member including a windowed hole; a window made of a material having sound-transmitting properties and arranged to cover the windowed hole; a tray removably attached to cover the skin side of the base tape member, the tray including a recessed portion, the recessed portion defining a concave surface facing the windowed hole and a flat portion surrounding the recessed portion; a first ultrasound transmission gel disposed in the recess; a removable protective liner configured to cover the sensor side of the base tape member; Including, The method comprises: removing the protective liner from the base tape member; attaching the sensor to the sensor side of the base tape member; applying pressure to the recess of the tray to allow the first ultrasound transmission gel to contact the window; removing the tray from the base tape member to expose the skin side of the base tape member; attaching the skin side of the base tape member to the patient; A method comprising:

20. the acoustic coupling device further includes a second ultrasound transmission gel between the protective liner and the window; 20. The method of claim 19, further comprising, after the step of attaching the sensor to the sensor side of the base tape member, providing ultrasonic transmitting contact between the sensor surface of the sensor and the window by use of the second ultrasonic transmitting gel.

Images