Single PEEL ultrasound coupling patch with GEL capture feature

Abstract

An ultrasound coupling device includes a gel component effective to conduct acoustic energy and a coupling compartment effective for holding the gel component. The coupling compartment includes a wall-like structure, a top seal, and a bottom seal. An adhesive fabric interfaces the device with a subject and includes a bottom facing removable adhesive retainer liner. The bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action. The bottom seal can be preformed to hold a desired volume of the gel material. In some embodiments, the bottom seal is expandable or formed to hold a known volume in a defined location. An ultrasound coupling system and methods for performing physiotherapy or applying ultrasound energy to a subject are also described. Methods of making the ultrasound coupling device are disclosed.

Description

PATENT Attorney Docket No.: 6381.023WO1 (AKG) SINGLE PEEL ULTRASOUND COUPLING PATCH WITH GEL CAPTURE FEATURE CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority benefit of U.S. Provisional Patent Application Serial No. 63 / 740,736, filed December 31, 2024, the disclosure of which is hereby incorporated by reference herein in its entirety.FIELD

[0002] The present disclosure generally relates to, inter alia, the field of ultrasound therapy and ultrasound coupling devices, ultrasound coupling systems, and methods for applying ultrasound energy to a subject on a daily and long-duration basis, as desired. More specifically, the present disclosure relates to an ultrasound coupling patch having an improved single peel structure and gel coupling for use with ultrasound transducers, systems containing the single peel patch, and methods of using the single peel patch in daily application by users.BACKGROUND

[0003] Ultrasound technologies are used in a variety of imaging and therapeutic applications. For example, ultrasound is a widely recognized therapy used for the reduction of pain and inflammation and for acceleration of healing in patients with a wide range of injuries and other medical conditions. Until recently, the delivery of ultrasound therapy was limited to delivery by a medical professional in a professional healthcare setting. Smaller or more portable ultrasound devices (e g., portable low intensity therapeutic ultrasound devices) can allow patients to self-administer ultrasound therapy outside the professional healthcare setting.

[0004] In ultrasound therapy applications, ultrasonic waves are produced by a transducer of a portable low intensity therapeutic ultrasonic device. The transducer is applied to the skin in the area of treatment. In order for the ultrasonic waves to leave the transducer and penetrate the skin, an acoustic gel has commonly been used as a coupling agent. The acoustic gel, which is applied between the target area, specifically the skin, and the transducer, tends to be applied in unmeasured amounts. Due to the unknown application amounts it is difficult to estimate the actual amount of acoustic energy that is delivered to the target area, and the efficiency of energy coupling from the transducer to the skin. Additionally, the current methods of applying the acoustic gel tend to be messy for daily long term use and inappropriate for patient self-PATENT Attorney Docket No.: 6381.023WO1 (AKG) administered low intensity therapeutic ultrasound treatment. The current gels tend to be thin, thereby not providing for multi-hour coupling and leaving unwanted and messy fdms on transducers when not cleaned immediately after treatment.

[0005] With the advent of patient self-administered low intensity therapeutic ultrasound, a method is required that assures the proper amount of an ultrasonic coupling agent is available between the transducer of the low intensity therapeutic ultrasound device and the target area and that such method of application of the coupling agent is sufficiently simple for a patient to use during the treatment period.

[0006] Further, therapeutic ultrasound devices are not able to be used for long periods, due to the non-portable size of the devices or the need for external power sources.

[0007] Previous attempts to provide bandages and other coupling devices for use with therapeutic ultrasound technologies have been reported. See, e.g., U.S. Pat. No. 4,787,888, U.S. Pat. No. 7,211,060, and U.S. Patent Application Publication No. US-2008 / 0200810. However, the ultrasound bandages or coupling devices provided in the art to date are insufficient for use with portable therapeutic ultrasound systems that are able to deliver ultrasound energy deep within tissue and that can be used for long periods of time.

[0008] There is also a need for ultrasound coupling devices that can be used with all types of ultrasound transducers, not just therapeutic ultrasound transducers, and that can enhance the efficiency of ultrasound transmission to a subject.

[0009] Furthermore, after use of such a device the system should be easily removed, cleaned and prepped for another treatment. In the case that the device is not cleaned immediately after treatment, it should still be easy to clean for another use the following day or several days later. However, the current state of the art does not provide for such features.

[0010] The present disclosure is directed to overcoming these and other deficiencies in the art of ultrasound coupling for long-duration therapeutic ultrasound treatment.SUMMARY OF THE DISCLOSURE

[0011] The present disclosure generally relates to, inter alia, an ultrasound coupling patch having an improved single peel structure for use with ultrasound transducers, and more particularly to ultrasound coupling patches having the improved single peel structure along with a gel capture feature.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0012] Moreover, in certain aspects, the present disclosure also provides a new gel formulation that includes a special formulation for improved coupling of the ultrasound to the body and cleaning after long duration ultrasound delivery. This is novel since the present disclosure provides long duration ultrasound treatment daily and facilitates cleaning and better human factors for treatment compliance and ease of use.

[0013] In certain aspects, the present disclosure provides a single-peel ultrasound coupling patch that structurally integrates the adhesive retainer liner and bottom gel seal into a single removable element, while preserving a controlled gel capture compartment. This enables removal of both components in one action, followed by directional gel displacement toward the transducer face upon applicator insertion. This differs from prior art that requires multiple peel steps, higher removal force, and lacks controlled gel displacement.

[0014] In certain aspects, the present disclosure provides a single-peel ultrasound coupling patch for long-duration wearable ultrasound systems that incorporates a pre-formed gel capture compartment and an integrated liner / bottom seal. The design reduces application steps and peel force, improves usability for patients with limited dexterity, enables consistent gel volume and acoustic coupling, and improves manufacturing yield and packaging efficiency. In certain aspects, the present disclosure provides for the optional inclusion of pharmaceutical agents (e.g., diclofenac) within the coupling gel.

[0015] In certain aspects, the present disclosure provides an integrated single-peel liner / seal structure, pre-formed or expandable gel capture region, controlled gel volume, and compatibility with wearable therapeutic ultrasound systems.

[0016] The present disclosure allows for a new coupling agent capture feature to be added to the ultrasound coupling patch having the single peel structure and features, thereby providing improved control of the movement of coupling agent during the insertion of the device into the patch for preferable coupling.

[0017] In a first aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; and (ii) a coupling compartment effective for holding the gel component in place. The coupling compartment includes: a wall-like structure having a sidewall, a top portion, and a bottom portion; a top seal removably integrated to the top portion of the wall-like structure; and a bottom seal removably integrated to the bottom portion of the wall-like structure. The bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducerPATENT Attorney Docket No.: 6381.023WO1 (AKG) and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure. The gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0018] In one aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; (ii) a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and (iii) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner. In certain embodiments, the bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action. In certain embodiments, the bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure. In certain embodiments, the gel component is contained at least within a portion of a sidewall of the walllike structure of the coupling compartment and at least a portion outside of the wall-like stmcture.

[0019] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) an ultrasound coupling device as contemplated and / or disclosed herein; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0020] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0021] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying ultrasound energy to a surfacePATENT Attorney Docket No.: 6381.023WO1 (AKG) of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0022] In another aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; (ii) a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and (iii) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner, wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, wherein a bottom seal is expandable to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure, and wherein said gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0023] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) an ultrasound coupling device as contemplated and / or disclosed herein; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0024] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0025] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0026] In another aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; (ii) a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and (iii) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner, wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, and wherein the top and bottom seals are formed to hold a known volume of gel in a defined location within the coupling compartment.

[0027] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) an ultrasound coupling device as contemplated and / or disclosed herein; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0028] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0029] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0030] In certain embodiments, the ultrasound coupling device is referred to herein as an ultrasound coupling patch that secures an ultrasound transducer to a patient for extended treatment periods and also acts to couple the ultrasound produced from the device into the patient. A portion of the ultrasound coupling patch maintains a coupling agent (e.g., ultrasound gel, hydrogel or equivalent) between the ultrasound emitting surface of the ultrasound transducer) and the part of the body to which ultrasound is being applied. Another portion of thePATENT Attorney Docket No.: 6381.023WO1 (AKG) patch provides adhesive properties to secure the device onto a location of the body. Current versions of the ultrasound coupling patch work well for this purpose (see US-2013 / 0144193-A1 and EP 2519322-A2), however there are some challenges in using the ultrasound coupling patch devices currently known in the art.

[0031] For example, with existing ultrasound coupling patches, when the ultrasound device is secured into the patch, excess coupling agent in the patch does not move in a controlled direction. In some cases, the ultrasound gel can move out the sides / top of the device away from the device / body interface in which it is intended. This creates an unwanted mess and loss of coupling gel between the ultrasound transducer and patient. Further, because the seal on the bottom of the patch is flat, it does not allow for a measured amount of gel to form outside of the patch between the device and body, to allow for ample coupling agent to fill various forms of the human body. The ultrasound coupling device is effective to remedy these and other deficiencies in the art.

[0032] In certain aspects, the present disclosure provides a single peel patch that is a new and improved technology over gel capture patches, with one advantage being a simplified application process that reduces steps and inefficiencies of prior gel capture patches, including, without limitation, allowing for a single-step peeling off of the adhesive retainer and bottom seal.

[0033] In certain aspects, the present disclosure provides a single peel patch that utilizes a new foil composition and dimensions to improve the seal of the bottom foil. This improvement allows for the removal of both the bandage liner and the bottom foil in a single movement / step which increases the accessibility of the patch for arthritis users and simplifies the process for all users. In certain aspects, the present disclosure improves application of the patch, including, without limitation, enabling the addition of more coupling medium, expanding access to the patch, and easing the use of the patch for users thereof.

[0034] In certain aspects, the present disclosure provides a single peel patch having a new and improved bottom seal with three layers (adhesive, foil printed white, external plastic film), expanded dimensions of the bottom foil / seal, changed contour of the bottom foil sealing head (wider diameter, changed step), improved step of sealing head - inner ring contacts the plastic gel cup, outer ring contacts the paper liner of the fabric, and increased gel filling volume to increase overall coupling medium.

[0035] In certain aspects, the bottom seal is an important improvement and feature since the layers allow for the seal to be formed in a desired shape and heat-sealed in a simultaneousPATENT Attorney Docket No.: 6381.023WO1 (AKG) step without tearing of the seal. Prior art and technologies would normally tear during the formation / sealing process making this new foil a critical element in the teaching of ultrasound coupling devices

[0036] As discussed in the present disclosure, there is provided a novel heat-sealing head with offsets to enable the use of staged pressures and temperatures to combine the two components to assure proper sealing and adhesion at the multiple locations required of the present disclosure.

[0037] Moreover, another important improvement and feature of the present disclosure over the prior art is the gel formulations described herein. In certain embodiments, the gel material is effective to enhance, improve, and facilitate cleaning and removal of the gel material by enabling removal of a polymer layer of the gel material formulation used with the ultrasound coupling device. In one embodiment, the gel material is a form 4 gel formulation as described herein, which is effective to provide easier cleaning and does not leave a thick polymer residual layer when it dries. In certain embodiments, the present disclosure provides an ultrasound coupling device containing such an improved gel material such as, but not limited to, the form 4 gel formulation described herein.

[0038] These and other objects, features, and advantages of this disclosure will become apparent from the following detailed description of the various aspects of the disclosure taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0039] For the purpose of illustrating aspects of the present disclosure, there are depicted in the drawings certain embodiments of the disclosure. However, the disclosure is not limited to the precise arrangements and instrumentalities of the embodiments depicted in the drawings. Further, if provided, like reference numerals contained in the drawings are meant to identify similar or identical elements.

[0040] FIG. 1 illustrates the front (top) and back (bottom) of one embodiment of an ultrasound coupling device of the present disclosure. Top seal 25 and bottom seal 26 are shown, as well as other portions described in the present disclosure.

[0041] FIGS. 1A-1D illustrate various portions of an embodiment of an ultrasound coupling device of the present disclosure.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0042] FIG. 1 A is a top view of an embodiment of an ultrasound coupling device of the present disclosure, with gel component 10, coupling compartment 20, and top portion 23 being shown, as well as other portions described in the present disclosure.

[0043] FIG. IB is a bottom view of an embodiment of an ultrasound coupling device of the present disclosure, with bottom portion 24 and vacant area 32 being shown, as well as other portions described in the present disclosure.

[0044] FIG. 1C is a side view of an embodiment of an ultrasound coupling device of the present disclosure, with wall-like structure 21 and sidewall 22 being shown, as well as other portions described in the present disclosure.

[0045] FIG. ID is a bottom view of an embodiment of an ultrasound coupling device of the present disclosure, with adhesive fabric 30 and bottom facing removable adhesive retainer liner 34 being shown, as well as other portions described in the present disclosure.

[0046] FIGS. 2A-2D illustrate how to use one embodiment of an ultrasound coupling device of the present disclosure.

[0047] FIG. 2A shows removal of the top seal of an ultrasound coupling device of the present disclosure.

[0048] FIG. 2B shows attachment of an ultrasound transducer into the ultrasound coupling device after removal of the top seal of an ultrasound coupling device of the present disclosure.

[0049] FIG. 2C shows how to use care not to push on the bottom seal after insertion of the ultrasound transducer and prior to removing the bottom seal of an ultrasound coupling device of the present disclosure.

[0050] FIG. 2D shows removal of removable adhesive retainer liner and the bottom seal in a single action prior to placement of the ultrasound coupling device with the ultrasound transducer to the target treatment site of the subject.

[0051] FIG. 3 are photographs illustrating improved bottom seal foil / dimensions in certain embodiments of the ultrasound coupling device of the present disclosure.

[0052] FIG. 4 is a table illustrating certain features and improvements relating to embodiments of the ultrasound coupling device of the present disclosure, or testing of examples thereof.

[0053] FIG. 5 is a graph illustrating gel capture patch gel volume displacement data.

[0054] FIG. 6 is a graph illustrating single peel patch gel volume displacement data.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0055] FIG. 7 is a photograph illustrating 5 patches graded as passing a dye ingress test (Generation 1), confirming no discoloration of blue transparent ultrasound gel.

[0056] FIG. 8 is a photograph illustrating 5 patches graded as passing a dye ingress test (Generation 2), confirming no discoloration of blue transparent ultrasound gel.

[0057] FIG. 9A, FIG. 9B, FIG. 9C, and FIG. 9D are photographs showing all 20 single peel patches passing the leak test, confirming that no water leaked out and colored the bandages.

[0058] FIG. 10A and FIG. 10B are photographs showing all 5 single peel patches passing the dye ingress test, confirming that there was no discoloration of blue transparent ultrasound gel.

[0059] FIG. 11 is a diagram showing healthy subjects found the single peel patch easy to use and could use the device normally. Subjects filled out surveys while using the device in the office with assistance or at home, alone, n=28-30.

[0060] FIG. 12A and FIG. 12B are diagrams showing that SAM was easy to use with no pain for arthritic patients. Through normal usage steps, arthritic patients gave (FIG. 12A) a high Ease of Use rating on the Likert scale and (FIG. 12B) a low pain rating on the Wong-Baker scale, n=8.DETAILED DESCRIPTION

[0061] The present disclosure relates to an ultrasound coupling device, as further described herein. The present disclosure also relates to various ultrasound kits and ultrasound transducer systems configured to include the ultrasound coupling device of the present disclosure. Further, the present disclosure relates to various methods of using and making the ultrasound coupling device of the present disclosure.Overview of the Ultrasound Coupling Device

[0062] An ultrasound coupling device is provided that facilitates efficient transmission of acoustic energy between an ultrasound transducer and a subject's body surface. The device addresses challenges associated with maintaining proper acoustic coupling during ultrasound procedures, including therapeutic ultrasound treatments and diagnostic applications.The ultrasound coupling device includes a gel component that comprises a gel material effective to conduct acoustic energy. The device also includes a coupling compartment that is effective for holding the gel component in place during operation. An adhesive fabric is provided forPATENT Attorney Docket No.: 6381.023WO1 (AKG) interfacing the coupling device with a subject, enabling hands-free operation and consistent positioning during ultrasound procedures.Structure of the Coupling Compartment

[0063] The coupling compartment includes a wall-like structure having a sidewall, a top portion, and a bottom portion. The wall-like structure defines the spatial boundaries within which the gel component is contained and provides structural support for the device during use.

[0064] A top seal is removably integrated to the top portion of the wall-like structure. A bottom seal is removably integrated to the bottom portion of the wall-like structure. The top and bottom seals can be made from aluminum foil, which provides suitable barrier properties to retain the gel material prior to use. Alternatively, the top seal and / or bottom seal can be made from a plastic part of the wall-like structure material.

[0065] The gel component is contained at least within a portion of the sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure. This configuration allows for optimal distribution of the gel material to ensure adequate acoustic coupling across the interface between the transducer and the subject's skin.Adhesive Fabric and Integrated Liner System

[0066] The adhesive fabric includes a vacant area in which the coupling compartment is situated for operation. This vacant area allows the gel component to directly contact the subject's skin surface while the surrounding adhesive fabric secures the device in place. The adhesive fabric includes a bottom facing removable adhesive retainer liner that protects the adhesive surface prior to application.

[0067] A key feature of the device is that the bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action. This integrated design simplifies the preparation process and reduces the number of steps required to ready the device for use, thereby improving efficiency and reducing the potential for user error.Preformed Bottom Seal Configuration

[0068] In one configuration, the bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when the ultrasoundPATENT Attorney Docket No.: 6381.023WO1 (AKG) transducer is attached at the top portion of the wall-like structure. The preformed configuration creates a predetermined space that accommodates a specific quantity of gel material in a defined geometry optimized for acoustic coupling.

[0069] The preformed bottom seal can be shaped to accommodate the ultrasound transducer, ensuring that when the transducer is inserted into the device, the gel material is distributed appropriately beneath the transducer face. The gel material can be provided so as to have a thickness of between 0.25 mm and about 20 mm, with the shape of the preformed seal designed to accommodate the specific ultrasound transducer being used.Expandable Bottom Seal Configuration

[0070] In another configuration, the bottom seal is expandable to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when the ultrasound transducer is attached at the top portion of the wall-like structure. The expandable bottom seal can be made from an elastic material which expands outward upon insertion of the ultrasound transducer. Alternatively, the expandable bottom seal can be made from an aluminum foil seal which expands outward upon insertion of the ultrasound transducer.

[0071] The expandable design allows the bottom seal to dynamically conform to the shape and volume of the gel material as the transducer is inserted, creating a custom-fit acoustic coupling interface. This configuration provides flexibility to accommodate different transducer sizes and shapes while maintaining optimal gel distribution.Seal Design for Volume Optimization

[0072] In a further configuration, the top and bottom seals are formed to hold a known volume of gel in a defined location within the coupling compartment. This design approach provides precise control over gel quantity and positioning, which directly impacts the quality of acoustic coupling achieved during use.

[0073] The top and bottom seals can be configured to reduce non-gel volume within the device to less than 50%. By minimizing empty space within the coupling compartment, this design maximizes the proportion of the internal volume occupied by acoustically conductive gel material, thereby improving coupling efficiency and reducing the potential for air pockets that could interfere with acoustic transmission.PATENT Attorney Docket No.: 6381.023WO1 (AKG) Gel Material Composition

[0074] The gel material can be selected from the group consisting of a gel, a gel-like composition, a hydrogel, a low density cross-linked polymer hydrogel, and the like. A particular gel material can comprise a water-based acoustic coupling gel with one or more ingredient selected from the group consisting of humectants, viscosity modifiers, preservatives, buffering agents, and optionally pharmaceutical agents. In certain embodiments, the gel material is effective to enhance, improve, and facilitate cleaning and removal of the gel material by enabling removal of a polymer layer of the gel material formulation used with the ultrasound coupling device. In one embodiment, the gel material is a form 4 gel formulation as described herein, which is effective to provide easier cleaning and does not leave a thick polymer residual layer when it dries. In certain embodiments, the present disclosure provides an ultrasound coupling device containing such an improved gel material such as, but not limited to, the form 4 gel formulation described herein.

[0075] Humectants can be included to maintain moisture content and prevent drying of the gel during storage and use. Viscosity modifiers control the flow characteristics of the gel, ensuring it maintains appropriate consistency for acoustic coupling without being too fluid or too viscous. Preservatives extend shelflife by preventing microbial growth. Buffering agents maintain pH stability. Pharmaceutical agents can be optionally included when the device is intended for therapeutic applications where transdermal delivery of medication is desired.Optimized Dimensions and Gel Volume

[0076] The dimensions of the gel component can be configured to provide increased gel filling volume and other improvements over existing ultrasound coupling devices. The device can enable a gel material weight of less than or at least between about 3.0 and 3.5 grams, which represents an optimized quantity that balances adequate acoustic coupling with efficient material usage and compact device dimensions.

[0077] The bottom seal can have a diameter prior to sealing of less than or at least 43 mm, and a bottom seal diameter after sealing of less than or at least 37 mm. These dimensional specifications reflect a design that accommodates standard ultrasound transducer sizes while maintaining a compact footprint suitable for application to various body locations.Ultrasound Coupling SystemPATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0078] An ultrasound coupling system is provided that includes the ultrasound coupling device described above and an ultrasound transducer configured for operable attachment to the ultrasound coupling device. The ultrasound transducer can be any suitable transducer capable of generating and / or receiving ultrasound energy, including transducers used for therapeutic applications and diagnostic imaging applications.

[0079] The transducer is configured to attach at the top portion of the wall-like structure, creating an integrated assembly in which the transducer, gel component, and coupling device function together as a complete acoustic coupling system. When the transducer is operably attached to the coupling device, acoustic energy generated by the transducer is efficiently transmitted through the gel component to the subject's tissue.Methods of Use for Physiotherapy

[0080] A method for performing physiotherapy on a subject includes providing an ultrasound coupling system as described above and applying therapeutic ultrasound energy to a subject. The therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0081] Therapeutic ultrasound can be used to treat various musculoskeletal conditions, promote tissue healing, increase local blood flow, and reduce inflammation. The ultrasound coupling device facilitates consistent and reliable delivery of therapeutic ultrasound energy by maintaining stable acoustic coupling throughout the treatment session. The hands-free design enabled by the adhesive fabric allows the device to remain securely positioned without requiring manual handling of the transducer during treatment.Methods of Use for Ultrasound Energy Application

[0082] A method for applying ultrasound energy to a subject includes providing an ultrasound coupling system as described above and applying ultrasound energy to a surface of a subject. The ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0083] Applying the ultrasound energy to the surface of the subject can be effective to alleviate pain in tissue of the subject in and around the surface. The method can be used for pain management applications where localized ultrasound energy application provides therapeutic benefit. The coupling device ensures that ultrasound energy is efficiently transmitted from thePATENT Attorney Docket No.: 6381.023WO1 (AKG) transducer into the target tissue, maximizing therapeutic efficacy while minimizing energy loss at the transducer-skin interface.Methods of Making the Ultrasound Coupling Device

[0084] Methods of making an ultrasound coupling device of the present disclosure are described. In one embodiment, this method involves assembling the ultrasound coupling device using a heat seal head that is contoured to create a step feature, where the ultrasound coupling device provided by the method includes the following: a gel component having a gel material effective to conduct acoustic energy; a coupling compartment effective for holding the gel component in place, where the coupling compartment includes a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and where the adhesive fabric includes a bottom facing removable adhesive retainer liner, where the bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, where the bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure, and where the gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0085] In another embodiment, this method of making an ultrasound coupling device of the present disclosure involves assembling the ultrasound coupling device using a heat seal head that is contoured to create a step feature, where the ultrasound coupling device provided by the method includes the following: a gel component having a gel material effective to conduct acoustic energy; a coupling compartment effective for holding the gel component in place, where the coupling compartment includes a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and an adhesive fabric for interfacing the coupling device with a subject, where the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherePATENT Attorney Docket No.: 6381.023WO1 (AKG) the adhesive fabric includes a bottom facing removable adhesive retainer liner, where the bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, where a bottom seal is expandable to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when the ultrasound transducer is attached at the top portion of the wall-like structure, and where the gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0086] In another embodiment, this method of making an ultrasound coupling device of the present disclosure involves assembling the ultrasound coupling device using a heat seal head that is contoured to create a step feature, where the ultrasound coupling device provided by the method includes the following: a gel component having a gel material effective to conduct acoustic energy; a coupling compartment effective for holding the gel component in place, where the coupling compartment includes a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and an adhesive fabric for interfacing the coupling device with a subject, where the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and where the adhesive fabric includes a bottom facing removable adhesive retainer liner, where the bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, and where the top and bottom seals are formed to hold a known volume of gel in a defined location within the coupling compartment.Technical Advantages

[0087] The ultrasound coupling device addresses several problems associated with conventional ultrasound coupling approaches. Traditional methods often require manual application of coupling gel directly to the skin and / or transducer, which can be messy, inconsistent, and difficult to control. The self-contained gel component eliminates the need for separate gel application, providing a cleaner and more convenient solution.

[0088] The integrated removal of the bottom seal and adhesive retainer liner in a single action simplifies device preparation and reduces setup time. The preformed and / or expandablePATENT Attorney Docket No.: 6381.023WO1 (AKG) bottom seal configurations ensure consistent gel volume and distribution, improving coupling reliability across different operators and clinical settings.

[0089] The adhesive fabric enables hands-free operation, allowing clinicians to perform other tasks during ultrasound procedures and enabling patients to receive treatment while remaining mobile. The optimized gel volume and seal design minimize wasted material while ensuring adequate acoustic coupling for effective ultrasound energy transmission.Additional Aspects

[0090] The ultrasound coupling device of the present disclosure has various attributes, as described more fully herein. Without meaning to limit the present disclosure to a particular embodiment, provided below are various attributes of the present disclosure.

[0091] The present disclosure provides a simple and disposable means to connect an ultrasound transducer or low profile ultrasound transducer or ultrasound therapy device to a specific region of a patient without having the need to manually hold the ultrasound transducer in place on the body. The disclosure makes the application of ultrasound therapy or ultrasound in combination with a topical pharmaceutical to be a simple and self-delivered process.

[0092] In one aspect, the present disclosure provides an affordable, highly adaptable and ergonomic means to secure ultrasound coupling gel to the face of an ultrasound transducer, and couple it to a patient or other object.

[0093] The ultrasound coupling device of the present disclosure may be used for ultrasound therapy, imaging, monitoring, industrial measurements and testing, anywhere ultrasound would be applied and requires attachment to some type of object or subject.

[0094] As referred to herein, the ultrasound coupling device may also be referred to as a specific embodiment for use as a hydrogel low-intensity ultrasound (LIUS) coupling patch device or variants thereof. However, the ultrasound coupling device of the present disclosure is useful for all types of ultrasound applications (e.g., imaging and therapeutic applications), and the gel is not limited to a hydrogel, but can include any type of gel or gel-like substance that can be used with ultrasound. Further, the ultrasound coupling device of the present disclosure can be used with various types of ultrasound transducers. In one embodiment, a suitable ultrasound transducer or ultrasound system for use with the ultrasound coupling device of the present disclosure can include, without limitation, a portable, low-profile type of ultrasound transducer.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0095] Examples of portable ultrasound systems that can be used with the ultrasound coupling device of the present disclosure are provided in WO2011 / 082407, the entire disclosure of which is incorporated by reference herein.

[0096] Examples of low-profde ultrasound transducers that can be used with the ultrasound coupling device of the present disclosure are provided in WO2011 / 082408, the entire disclosure of which is incorporated by reference herein.

[0097] As provided herein, the gel component can be a hydrogel or any type of gel or gel-like substance that can be used with ultrasound. Therefore, in describing the various aspects and embodiments of the present disclosure, the term “hydrogel” can be used to refer to a hydrogel or any gel or gel-like substance that can be used with ultrasound.

[0098] In various embodiments, the gel component can be a hydrogel that is made of polymer materials that can absorb large amounts of water without dissolving due to physical or chemical cross-linkage of the hydrophilic polymer chains. Hydrogels which have low density cross-linking are more suitable conducting acoustic energy but low density cross-linking causes the hydrogel to be less ridged. The present disclosure is effective for using such hydrogels (as well as any other gel or gel-like material) for conducting acoustic energy from a low intensity ultrasound device to a subject.

[0099] In one aspect, the present disclosure provides a hydrogel LIUS coupling patch device that is designed to serve as an efficient acoustic conductive vehicle for the transmission of low intensity ultrasound between the portable low intensity therapeutic ultrasound device and the skin.

[0100] In one aspect, the present disclosure relates to the manufacture, composition, and use of biocompatible hydrogel acoustic coupling patches for transfer of low intensity therapeutic ultrasound to achieve pain relief, reduction of inflammation and healing.

[0101] A suitable gel component can include, for example, a hydrogel material effective to conduct acoustic energy. In one embodiment, the hydrogel material, gel material, or gel-like material is effective to conduct acoustic energy across the entire therapy range, e.g., from about 10 to about 100,000,000 mW / cm2. The acoustic energy can be in the form of low-intensity ultrasound waves. As stated above, the hydrogel material, gel material, or gel-like material is effective to conduct low-intensity ultrasound waves ranging from about 10 to about 100,000,000 mW / cm2. The present disclosure also contemplates that suitable hydrogel materials, gel materials, or gel-like materials are effective to conduct low-intensity ultrasound waves at anyPATENT Attorney Docket No.: 6381.023WO1 (AKG) value within the range of 10 to about 100,000,000 mW / cm2. While not meaning to limit the present disclosure, examples of various suitable ranges of low-intensity ultrasound waves can include, without limitation, a range selected from the group consisting of between about 10 mW / cm2 to about 50,000,000 mW / cm2, between about 10 mW / cm2 to about 1,000,000 mW / cm2, between about 10 mW / cm2 to about 500,000 mW / cm2, between about 10 mW7cm2 to about 250,000 mW / cm2, between about 10 mW / cm2 to about 100,000 mW / cm2, between about 10 mW7cm2 to about 50,000 mW / cm2, between about 10 mW / cm2 to about 40,000 mW / cm2, between about 10 mW / cm2 to about 30,000 mW7cm2, between about 10 mW / cm2 to about 20,000 mW / cm2, between about 10 mW / cm2 to about 10,000 mW / cm2, between about 10 mW / cm2 to about 6,000 mW7cm2, between about 10 mW / cm2 to about 5,750 mW / cm2, between about 10 mW / cm2 to about 5,500 mW / cm2, between about 10 mW / cm2 to about 5,250 mW / cm2, between about 10 mW / cm2 to about 5,000 mW / cm2, between about 10 mW / cm2 to about 4,750 mW7cm2, between about 10 mW7cm2 to about 4,500 mW / cm2, between about 10 mW / cm2 to about 4,250 mW / cm2, between about 10 mW / cm2 to about 4,000 mW / cm2, between about 10 mW / cm2 to about 3,750 mW7cm2, between about 10 mW / cm2 to about 3,500 mW / cm2, between about 10 mW / cm2 to about 3,250 mW7cm2, between about 10 mW / cm2 to about 3,000 mW / cm2, between about 10 mW / cm2 to about 2,750 mW / cm2, between about 10 mW / cm2 to about 2,500 mW7cm2, between about 10 mW / cm2 to about 2,250 mW / cm2, between about 10 mW / cm2 to about 2,000 mW / cm2, between about 10 mW7cm2 to about 1,750 mW / cm2, between about 10 mW / cm2 to about 1,500 mW / cm2, between about 10 mW7cm2 to about 1,250 mW7cm2, between about 10 mW7cm2 to about 1,000 mW / cm2, between about 10 mW / cm2 to about 750 mW / cm2, between about 10 mW / cm2 to about 500 mW / cm2, between about 10 mW / cm2 to about 250 mW / cm2, between about 10 mW / cm2 to about 200 mW / cm2, between about 10 mW / cm2 to about 150 mW7cm2, and between about 10 mW / cm2 to about 100 mW / cm2.

[0102] The present disclosure generally relates to, inter alia, an ultrasound coupling patch having an improved single peel structure for use with ultrasound transducers, and more particularly to ultrasound coupling patches having the improved single peel structure along with a gel capture feature. The present disclosure allows for a new coupling agent capture feature to be added to the ultrasound coupling patch, thereby controlling the movement of coupling agent during the insertion of the device into the patch for preferable coupling. As used herein, the term “ultrasound coupling device” can be used to refer to the ultrasound coupling patch of the presentPATENT Attorney Docket No.: 6381.023WO1 (AKG) disclosure. The present disclosure also generally relates to an ultrasound coupling device, an ultrasound coupling system, and related methods of the present disclosure.

[0103] Provided below are various embodiments of an ultrasound coupling device, ultrasound coupling system, and related methods of the present disclosure. The ultrasound coupling device, ultrasound coupling system, and related methods of the present disclosure involve improvements over the “Ultrasound Coupling Patch with Gel Capture Feature” disclosed in WO2018 / 102828A1 and US2020 / 0061393A1, the entire disclosures of which are incorporated by reference herein. The ultrasound coupling device, ultrasound coupling system, and related methods of the present disclosure can involve the use of various elements, components, and methods described in W02015 / 130841, US2013 / 0144193, WO2011 / 082407, andWO2011 / 082408, the entire disclosures of which are incorporated by reference herein.Single Peel Ultrasound Coupling Patch with Gel Capture Feature and Related Systems and Methods Thereof

[0104] In a first aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; and (ii) a coupling compartment effective for holding the gel component in place. The coupling compartment includes: a wall-like structure having a sidewall, a top portion, and a bottom portion; a top seal removably integrated to the top portion of the wall-like structure; and a bottom seal removably integrated to the bottom portion of the wall-like structure. The bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure. The gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0105] In one aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; (ii) a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and (iii) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein thePATENT Attorney Docket No.: 6381.023WO1 (AKG) adhesive fabric includes a bottom facing removable adhesive retainer liner. In certain embodiments, the bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action. In certain embodiments, the bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure. In certain embodiments, the gel component is contained at least within a portion of a sidewall of the walllike structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0106] In one embodiment, without limitation, the top and bottom seals are made from aluminum foil.

[0107] In one embodiment, without limitation, the gel material is selected from the group consisting of a gel, a gel-like composition, a hydrogel, a low density cross-linked polymer hydrogel, and the like.

[0108] In one embodiment, without limitation, the gel material is provided so as to have a thickness of between 0.25 mm and about 20 mm, and a shape of the performed seal to accommodate the ultrasound transducer.

[0109] In one embodiment, without limitation, the dimensions of the gel component are such to provide increased gel filling volume and other improvements over existing ultrasound coupling devices, including, without limitation, enabling a gel material weight of less than or at least between about 3.0 and 3.5 grams, a bottom seal diameter prior to sealing of less than or at least 43 mm, and / or a bottom seal diameter after sealing of less than or at least 37 mm.

[0110] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) an ultrasound coupling device as contemplated and / or disclosed herein; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0111] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0112] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. The method involves: (i) providing an ultrasound couplingPATENT Attorney Docket No.: 6381.023WO1 (AKG) system as contemplated and / or disclosed herein; and (ii) applying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0113] In one embodiment, without limitation, applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.

[0114] In another aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; (ii) a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and (iii) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner, wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, wherein a bottom seal is expandable to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure, and wherein said gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0115] In one embodiment, without limitation, the expandable bottom seal is made from an elastic material which expands outward upon insertion of the ultrasound transducer.

[0116] In one embodiment, without limitation, the expandable bottom seal is made from an aluminum foil seal which expands outward upon insertion of the ultrasound transducer.

[0117] In one embodiment, without limitation, the gel material is selected from the group consisting of a gel, a gel-like composition, a hydrogel, a low density cross-linked polymer hydrogel, and the like.

[0118] In one embodiment, without limitation, the gel material is provided so as to have a thickness of between 0.25 mm and about 20 mm, and a shape of the performed seal to accommodate the ultrasound transducer.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0119] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) an ultrasound coupling device as contemplated and / or disclosed herein; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0120] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0121] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0122] In one embodiment, without limitation, applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.

[0123] In another aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; (ii) a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; and (iii) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner, wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, and wherein the top and bottom seals are formed to hold a known volume of gel in a defined location within the coupling compartment.

[0124] In one embodiment, without limitation, the top and bottom seals are made from aluminum foil.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0125] In one embodiment, without limitation, the top and / or bottom seal is made from a plastic part of the wall-like structure material.

[0126] In one embodiment, without limitation, the top and bottom seals reduce non-gel volume within the device to less than 50%.

[0127] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) an ultrasound coupling device as contemplated and / or disclosed herein; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0128] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0129] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. The method involves: (i) providing an ultrasound coupling system as contemplated and / or disclosed herein; and (ii) applying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0130] In one embodiment, without limitation, applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.

[0131] The ultrasound coupling device, ultrasound coupling system, and related methods provide various improvements. Without intending to limit the scope of the present disclosure, but only for purposes of example, provided below are some improvements of the present disclosure:• Improved removal of the bottom foil seal - The patch design in the art requires a two- step process and a significant amount of force to remove the back side (bandage liner and bottom foil seal) of the patch. In some instances, the bottom foil seal or liner may rip into multiple smaller pieces, increasing the time taken and difficulty in applying the patch. The modifications of the present disclosure of the bottom seal materials and dimensions would result in a combined removal of the back side of the patch into one singular peeling motion that removes both the liner and bottom foil in one steady pull.PATENT Attorney Docket No.: 6381.023WO1 (AKG) • Enhanced product line branding - The fabric component is being altered from white fabric with green print to white fabric with blue print. The packaging can also align with the blue theme (or other color scheme) for the Single Peel Patch for consistent branding. This can help differentiate product lines and better cater to our customer markets.• Thermal seal - Using the sam® gel capture patch as a reference, the new patch will also be thermally sealed. The new design requires different contours, dimensions, and parameters to achieve the same level of seal integrity specifications set by both previous sam® coupling patches. The bottom seal foil also has different thickness ratios of adhesive to foil to liner to achieve the seal that adheres to both the plastic gel cup and paper liner.

[0132] In certain aspects, the present disclosure provides an improved ultrasound coupling device effective to maintain gel capture contour for appropriate gel volume at application, maintain airtight sealed pocket to hold ultrasound gel, remove paper backing and bottom foil seal in one step, and reduce force required to remove bottom seal without compromising previous requirements.

[0133] FIG. 1, FIG. 1 A, FIG. IB, FIG. 1C, and FIG. ID illustrate various views of an example of one embodiment of an ultrasound coupling device of the present disclosure, illustrating front (top), back (bottom), and side views of the device prior to use by a subject.

[0134] More specifically, FIG. 1 illustrates an ultrasound coupling system including an ultrasound coupling device 1. The ultrasound coupling device 1 includes a gel component 10 including a gel material effective to conduct acoustic energy.

[0135] As shown in FIG. 1, there is illustrated the front (top) and back (bottom) of one embodiment of an ultrasound coupling device of the present disclosure. Top seal 25 and bottom seal 26 are shown, as well as other portions described in the present disclosure.

[0136] FIGS. 1A-1D illustrate various portions of an embodiment of an ultrasound coupling device of the present disclosure.

[0137] As shown in FIG. 1 A, there is illustrated a top view of an embodiment of an ultrasound coupling device of the present disclosure, with gel component 10, coupling compartment 20, and top portion 23 being shown, as well as other portions described in the present disclosure.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0138] As shown in FIG. IB, there is illustrated a bottom view of an embodiment of an ultrasound coupling device of the present disclosure, with bottom portion 24 and vacant area 32 being shown, as well as other portions described in the present disclosure.

[0139] As shown in FIG. 1C, there is illustrated a side view of an embodiment of an ultrasound coupling device of the present disclosure, with wall-like structure 21 and sidewall 22 being shown, as well as other portions described in the present disclosure.

[0140] As shown in FIG. ID, there is illustrated a bottom view of an embodiment of an ultrasound coupling device of the present disclosure, with adhesive fabric 30 and bottom facing removable adhesive retainer liner 34 being shown, as well as other portions described in the present disclosure.

[0141] As shown in FIG. 1, FIG. 1A, FIG. IB, FIG. 1C, and / or FIG. ID, the ultrasound coupling device 1 includes a coupling compartment 20 effective for holding the gel component 10 in place. The coupling compartment 20 includes a wall-like structure 21 having a sidewall 22, a top portion 23, and a bottom portion 24. A top seal 25 is removably integrated to the top portion 23 of the wall-like structure 21, and a bottom seal 26 is removably integrated to the bottom portion 24 of the wall-like structure 21.

[0142] FIG. 1, FIG. 1 A, FIG. IB, FIG. 1C, and / or FIG. ID further shows an adhesive fabric 30 configured for interfacing the ultrasound coupling device 1 with a subject. The adhesive fabric 30 includes a vacant area 32 in which the coupling compartment 20 is situated for operation. The adhesive fabric 30 includes a bottom facing removable adhesive retainer liner 34.

[0143] In the illustrated configuration, the bottom seal 26 is structurally integrated with the bottom facing removable adhesive retainer liner 34 such that removal of the bottom facing removable adhesive retainer liner 34 and the bottom seal 26 can be effectuated in a single action. In use, an ultrasound transducer (not shown) can be operably attached at the top portion 23 of the wall-like structure 21 such that ultrasound energy emitted by the ultrasound transducer is conducted through the gel component 10 toward the subject.

[0144] FIGS. 2A-2D illustrate how one embodiment of the ultrasound coupling device of the present disclosure can be prepared for use by a subject, including showing the single-step process of removing the adhesive retainer and bottom seal prior to use thereof.

[0145] In certain aspects, the present disclosure provides an improved ultrasound coupling device that includes: (i) Foil Type (e.g., FastelFoil HS230; FM3-AL1W-PT05); (ii)PATENT Attorney Docket No.: 6381.023WO1 (AKG) Foil and Sealing Head Dimensions (e g., 43 mm Diameter (~5mm increase); increase in sealing head step contour; and (iii) Sealing Parameters (e.g., Dwell 300ms (decrease); Pressure 70 PSI (same); Temp 400F (decrease)).

[0146] FIG. 3 shows photos of certain aspects and improvements of the new bottom seal foil / dimensions of the ultrasound coupling device of the present disclosure.

[0147] FIG. 4 is a table that illustrates improvements provided by embodiments of the ultrasound coupling device of the present disclosure over existing ultrasound gel patches.

[0148] Additional aspects, embodiments, features, parameters, methods of making, and methods of using the devices and systems of the present disclosure are further described in Examples 1-4, the contents of which are hereby incorporated by reference in their entirety herein. More specifically, Examples 1-4 provide testing data illustrating improvements of the ultrasound coupling device over existing ultrasound gel patches.Additional Features Disclosed in the Field

[0149] Sections 1-3 provided below reiterate disclosures contained in prior patent applications of applicant entitled “Ultrasound Coupling Patch with Gel Capture Feature” and published as WO2018 / 102828A1 and US2020 / 0061393A1, the entire disclosures of which are incorporated by reference herein. The disclosures of Sections 1-3 are being provided for convenience. All references to Figure numbers in Sections 1-3 correspond to the Figures as disclosed and numbered in WO2018 / 102828A1 and US2020 / 0061393A1. Further, any references to aspects or embodiments of the “present disclosure” in Sections 1-3 correspond to those described in WO2018 / 102828A1 and US2020 / 0061393 Al .Section 1:Pre-Formed Seal to Hold a Known Volume of Coupling Agent inFront of an Ultrasound Device

[0150] In a first aspect, the present disclosure provides an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; and (ii) a coupling compartment effective for holding the gel component in place. The coupling compartment includes: a wall-like structure having a sidewall, a top portion, and a bottom portion; a top seal removably integrated to the top portion of the wall-like structure; and a bottom seal removably integrated to the bottom portion of the wall-like structure. The bottomPATENT Attorney Docket No.: 6381.023WO1 (AKG) seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure. The gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0151] In one embodiment of this coupling device of the present disclosure, the top and bottom seals are made from aluminum foil.

[0152] In another embodiment, the preformed bottom seal is integrated with an adhesive retainer liner of the coupling device.

[0153] In another embodiment, the gel material is selected from the group consisting of a gel, a gel-like composition, a hydrogel, a low density cross-linked polymer hydrogel, and the like.

[0154] In another embodiment, the gel material is provided so as to have a thickness of between 0.25 mm and about 10 mm (including any measurement contained between 0.25 mm and 10 mm), and a shape of the performed seal to accommodate the ultrasound transducer.

[0155] In another embodiment, this ultrasound coupling device further includes an adhesive fabric for interfacing the coupling device with a subject, where the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation.

[0156] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) the ultrasound coupling device disclosed herein above; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0157] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. This method involves: (i) providing the ultrasound coupling system disclosed herein above; and (ii) using the system to apply therapeutic ultrasound energy to a subject, where the therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0158] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. This method involves: (i) providing the ultrasound coupling system disclosed herein above; and (ii) using the system to apply ultrasound energy to a surface of a subject, where the ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device. In one embodiment, applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0159] FIGS. 1-8 illustrate various aspects of the above-described embodiment of the ultrasound coupling device of the present disclosure. With respect to FIGS. 1-8, the reference numbers of this embodiment of the ultrasound coupling device are identified in the paragraph below, as follows: As shown in FIGS. 1-8, ultrasound coupling device 10a includes: (i) a gel component 20a comprising a gel material effective to conduct acoustic energy; and (ii) a coupling compartment 30a effective for holding gel component 20a in place. Coupling compartment 20a includes: wall-like structure 32a having sidewall 33a, top portion 34a, and bottom portion 35a; top seal 40a removably integrated to top portion 34a of wall-like structure 32a; and bottom seal 42a removably integrated to bottom portion 35a of wall-like structure 32a. Bottom seal 42a is preformed to hold a desired volume of the gel material between ultrasound transducer 50a and bottom seal 42a when ultrasound transducer 50a is attached at top portion 34a of wall-like structure 32a. Gel component 20a is contained at least within a portion of sidewall 33a of wall-like structure 32a of coupling compartment 30a and at least a portion outside of walllike structure 32a. Ultrasound coupling device 10a can further include adhesive fabric 60a for interfacing coupling device 10a with a subject, where adhesive fabric 60a includes a vacant area in which coupling compartment 30a is situated for operation.

[0160] FIG. 1 illustrates the top of the ultrasound coupling device with a top seal and gelcontainment structure.

[0161] FIG. 2 illustrates the bottom of the ultrasound coupling device with a pre-formed seal on the bottom. Inside of the device is a sealed volume of ultrasound gel.

[0162] FIG. 3 illustrates the top of the ultrasound coupling device with a top seal removed with a known quantity of coupling gel sealed within patch (shown in light blue).

[0163] As shown in FIG. 4, when the ultrasound transducer is clipped into the ultrasound coupling patch, the ultrasound gel within the device moves in a forward direction with no gel escaping from the device and fully coating the ultrasound transducer surface.

[0164] FIG. 5 illustrates the side / bottom view of the ultrasound transducer clipped into ultrasound coupling device. As shown, the gel is captured between the ultrasound transducer and bottom pre-formed seal.

[0165] As shown in FIG. 6, when the bottom pre-formed seal is removed, the ultrasound coupling gel is contained within and extends beyond the bottom surface of the ultrasound coupling patch and the gel-containment structure. This gel fdls any voids of cavities where the ultrasound coupling device is applied to the body.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0166] As shown in FIG. 7, the adhesive retainer liner of the patch is removed and ultrasound gel is shown in blue between the ultrasound transducer and the patch surface.

[0167] FIG. 8 illustrates a side view of the ultrasound coupling device and a known quantity of gel captured in front of ultrasound transducer.Section 2:Expandable Seal to Control and Position a Known Volume of Coupling Agent in Front of the Ultrasound Device

[0168] In a second aspect, and similar to the above described embodiment of the ultrasound coupling device, the present disclosure relates to a configuration in which the seal is made of foil (folded / crinkled) or a flexible material in a flat form factor which is able to expand outward when the transducer is inserted into the chamber displacing the ultrasound gel in the forward direction, as discussed below and illustrated in FIGS. 9-13.

[0169] In this aspect, there is provided an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; and (ii) a coupling compartment effective for holding the gel component in place. The coupling compartment includes: a wall-like structure having a sidewall, a top portion, and a bottom portion; a top seal removably integrated to the top portion of the wall-like structure; and a bottom seal removably integrated to the bottom portion of the wall-like structure. The bottom seal is expandable to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure. The gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

[0170] In one embodiment of this coupling device of the present disclosure, the expandable bottom seal is made from an elastic material which expands outward upon insertion of the ultrasound transducer.

[0171] In another embodiment, the expandable bottom seal is made from an aluminum foil seal which expands outward upon insertion of the ultrasound transducer.

[0172] In another embodiment, the gel material is selected from the group consisting of a gel, a gel-like composition, a hydrogel, a low density cross-linked polymer hydrogel, and the like.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0173] In another embodiment, the gel material is provided so as to have a thickness of between 0.25 mm and about 10 mm (including any measurement contained between 0.25 mm and 10 mm), and a shape of the performed seal to accommodate the ultrasound transducer.

[0174] In another embodiment, this ultrasound coupling device further includes an adhesive fabric for interfacing the coupling device with a subject, where the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation.

[0175] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) the ultrasound coupling device disclosed herein above; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0176] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. This method involves: (i) providing the ultrasound coupling system disclosed herein above; and (ii) using the system to apply therapeutic ultrasound energy to a subject, where the therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0177] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. This method involves: (i) providing the ultrasound coupling system disclosed herein above; and (ii) using the system to apply ultrasound energy to a surface of a subject, where the ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device. In one embodiment, applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.

[0178] FIGS. 9-13 illustrate various aspects of the above-described embodiment of the ultrasound coupling device of the present disclosure. With respect to FIGS. 9-13, the reference numbers of this embodiment of the ultrasound coupling device are identified in the paragraph below, as follows: As shown in FIGS. 9-13, ultrasound coupling device 10b includes: (i) gel component 20b comprising a gel material effective to conduct acoustic energy; and (ii) coupling compartment 30b effective for holding gel component 20b in place. Coupling compartment 30b includes: wall-like structure 32b having sidewall 33b, top portion 34b, and bottom portion 35b; top seal 40b removably integrated to top portion 34b of the wall-like structure 32b; and bottom seal 42b removably integrated to bottom portion 35b of wall-like structure 32b. Bottom seal 42b is expandable to hold a desired volume of the gel material between ultrasound transducer 50b and bottom seal 42b when ultrasound transducer 50b is attached at top portion 34b of wall-likePATENT Attorney Docket No.: 6381.023WO1 (AKG) structure 32b. Gel component 20b is contained at least within a portion of sidewall 33b of walllike structure 32b of coupling compartment 30b and at least a portion outside of wall-like structure 32b. Ultrasound coupling device 10b can further include adhesive fabric 60b for interfacing coupling device 10b with a subject, where adhesive fabric 60b includes a vacant area in which coupling compartment 30b is situated for operation.

[0179] FIG. 9 illustrates the ultrasound coupling device with a flat foil seal on the bottom of the patch which has crinkles in the seal to allow for expansion when pressure is applied to the device. The profde of the seal is flat and does not protrude from the bottom of the ultrasound coupling device.

[0180] FIG. 10 illustrates the top side of the ultrasound coupling device, illustrating the crinkle in the bottom foil seal, along with the ultrasound coupling gel in light blue.

[0181] FIG. 11 illustrates the ultrasound transducer inserted into the ultrasound coupling device causing the gel to displace in the forward direction pushing out the expandable foil seal.

[0182] FIG. 12 illustrates the underside view of the device, showing how the foil expands outward with gel inside protruding beyond the base of the ultrasound coupling device.

[0183] As shown in FIG. 13, when the ultrasound transducer is clipped into the ultrasound coupling patch, the ultrasound gel within the device moves in a forward direction with no gel escaping from the device and fully coating the ultrasound transducer surface.Section 3:Top and Bottom Seals with Contours to Allow for the First Aspect Described Herein of the Ultrasound Coupling Device, with Reduced Volumetric Area for Product Stacking and Shipping

[0184] In a third aspect, since the disclosure described as the first aspect above increases the outward dimension of the ultrasound coupling patch along with introducing additional deadspace into the device, this reduces packing efficiency of putting one ultrasound coupling device on top of another device in a box. To increase packaging efficiency, the top seal of the ultrasound coupling device can be an inversion of the bottom seal. This is effective to displace the same volume from the top and bottom of the ultrasound coupling patch and allows for increased packing efficiency, as discussed below and illustrated in FIGS. 14-17.

[0185] In this aspect, there is provided an ultrasound coupling device that includes: (i) a gel component comprising a gel material effective to conduct acoustic energy; and (ii) a couplingPATENT Attorney Docket No.: 6381.023WO1 (AKG) compartment effective for holding the gel component in place. The coupling compartment includes: a wall-like structure having a sidewall, a top portion, and a bottom portion; a top seal removably integrated to the top portion of the wall-like structure; and a bottom seal removably integrated to the bottom portion of the wall-like structure. The top and bottom seals are formed to hold a known volume of gel in a defined location within the coupling compartment.

[0186] In one embodiment of this coupling device of the present disclosure, the top and bottom seals are made from aluminum foil.

[0187] In another embodiment, the top and / or bottom seal is made from a plastic part of the wall-like structure material.

[0188] In another embodiment, the top and bottom seals reduce non-gel volume within the device to less than 50%.

[0189] In another embodiment, this ultrasound coupling device further includes an adhesive fabric for interfacing the coupling device with a subject, where the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation.

[0190] In another aspect, the present disclosure provides an ultrasound coupling system that includes: (i) the ultrasound coupling device disclosed herein above; and (ii) an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

[0191] In another aspect, the present disclosure provides a method for performing physiotherapy on a subject. This method involves: (i) providing the ultrasound coupling system disclosed herein above; and (ii) using the system to apply therapeutic ultrasound energy to a subject, where the therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

[0192] In another aspect, the present disclosure provides a method for applying ultrasound energy to a subject. This method involves: (i) providing the ultrasound coupling system disclosed herein above; and (ii) using the system to apply ultrasound energy to a surface of a subject, where the ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device. In one embodiment, applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.

[0193] FIGS. 14-17 illustrate various aspects of the above-described embodiment of the ultrasound coupling device of the present disclosure. With respect to FIGS. 14-17, the reference numbers of this embodiment of the ultrasound coupling device are identified in the paragraphPATENT Attorney Docket No.: 6381.023WO1 (AKG) below, as follows: As shown in FIGS. 14-17, ultrasound coupling device 10c includes: (i) gel component 20c comprising a gel material effective to conduct acoustic energy; and (ii) coupling compartment 30c effective for holding gel component 20c in place. Coupling compartment 30c includes: wall-like structure 32c having sidewall 33c, top portion 34c, and bottom portion 35c; top seal 40c removably integrated to top portion 34c of wall-like structure 32c; and bottom seal 42c removably integrated to bottom portion 35c of wall-like structure 32c. Top (40c) and bottom (42c) seals are formed to hold a known volume of gel in a defined location within coupling compartment 30c. Ultrasound coupling device 10c can further include adhesive fabric 60c for interfacing coupling device 10c with a subject, where adhesive fabric 60c includes a vacant area in which coupling compartment 30c is situated for operation.

[0194] FIG. 14 illustrates the ultrasound coupling device with a formed top seal extending into wall-like structure holding coupling gel.

[0195] FIG. 15 illustrates the bottom of the ultrasound coupling device, with formed seal extending outward from bottom of patch.

[0196] As shown in FIG. 16, formed seals of gel containment structure on both top and bottom of ultrasound coupling patch increase density packing of patches on top of one another as shown in the picture above.

[0197] FIG. 17 illustrates another angle of four ultrasound coupling patches with gelcontainment structures to maintain high density packing, and reduce void volume of non-gel within ultrasound coupling device.EXAMPLES

[0198] The following examples are intended to illustrate particular embodiments of the present disclosure, but are by no means intended to limit the scope of the present disclosure.Example 1:Gel Volume Displacement Verification Testing for Single Peel Patch Purpose

[0199] The example provides the data and analysis of the gel volume displacement verification testing for the Single Peel Patch. This test was completed to find the optimized gelPATENT Attorney Docket No.: 6381.023WO1 (AKG) volume for the Single Peel Patch to set the specification range. This testing was also done on the current Gel Capture Patch to set a standard for comparison.

[0200] The goal of the testing is to determine an increased specification range for the amount of gel dispensed into the Single Peel Patch during assemblyApplicable Documents

[0201] Applicable documents associated with this example are found below in Table 1.Table 1:Protocol

[0202] The following protocol was designed to validate the weight range of gel filling for the single peel patch to both optimize performance and prevent gel spilling. Different initial filling weights of the ultrasound gel were tested by applying an applicator as shown on the Quick Start Guide printed on the 6-pack box for the Single Peel Patch.

[0203] The Protocol is set forth below:1. Data range was determined using the current specification for the Gel Capture patch (2.7- 3.1 grams) and expanding to increase the maximum value of the range. Initial filling weights for the Single Peel Patch Testing were (in grams):a. 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.72. Six samples were prepared for each initial filling volume.3. The patch was then prepared for treatment following the Quick Start Guide for the Single Peel Patch.a. Remove top foilb. Attached applicator to gel cupPATENT Attorney Docket No.: 6381.023WO1 (AKG) c. Peel fabric liner off in one motion (Bottom foil peels off with the bandage liner)4. After the bottom foil is removed the amount of gel on the applicator and on the bottom foil was measured and recorded.5. This process was completed for all six samples at all 10 values.6. This protocol was repeated with the following changes for the Gel Capture Patch to use as a comparison:a. Tested the current range called out in the current Work Instructions / Specifications (2.7, 2.8, 2.9, 3.0, 3.1 grams)b. Tested three samples of each weight because the range is already defined c. Follow the Patch application instructions for the Gel Capture Patch i. Remove the bottom foil firstii. Remove the bandage liner afterwardsDefinitionsSample Size

[0204] For the Single Peel Patch samples:• 11 different initial filling weight values were tested:o 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5, 3.6, 3.7 (grams)o Six samples were prepared for each weighto 66 samples in total

[0205] For the Gel Capture Patch samples:• 5 different initial filling weight values were tested (following the specification range called out in the work instructions):o 2.7, 2.8, 2.9, 3.0, 3.1 (grams)o Three samples were prepared for each weighto 15 samples in totalAcceptance Criteria

[0206] The acceptance criteria will create a range of values to define the filling weight specification for the single peel patch. The data for the Gel Capture Patch (GCP) samples will bePATENT Attorney Docket No.: 6381.023WO1 (AKG) used as a control to compare the performance of the Single Peel Patch (SPP). The following features will be observed• Gel on Applicator Weighto The weight of the gel remaining on applicator for the SPP must be equal to or greater than the average weight of the gel remaining on the applicator for the GCP (+ / - 10%)• Gel on Applicatoro The gel remaining on the applicator after the bottom foil is removed must cover the entire face of the transducer• Gel spillageo The gel must not spill out the sides when the applicator is attached to the gel cupResultsGel Capture Patch Testing:

[0207] The testing data from the Gel Capture Patch testing is shown in Table 2 below.Table 2:

[0208] On average, the gel capture patch leaves 1.89 grams of gel on the applicator face after preparation. The target range (+ / - 10%) would be 1.70 grams to 2.08 grams. See Figure 5.Single Peel Patch Testing:

[0209] The average data for each initial data point is presented in Table 3 below:Table 3:PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0210] Once the initial filling weight passed 3.5 grams in the single peel patch, spilling started to occur when the applicator was attached. Using the ideal range of gel on the applicator set by the gel capture patch (1.7 to 2.08 grams) we are able to define a specification range for the single peel patch. See Figure 6. The range of 3.1 to 3.5 grams for the initial filling weight of gel in the single peel patch meets the following acceptance criteria:• Gel on applicator weight + / - 10% of the average weight for a GCPo GCP range: 1.7 to 2.08 gramso SPP range: 1.78 to 2.16 grams• Gel on applicator surface areao Full coverage of the applicator face for initial filling weight of 3 grams and greater• Gel spillageo No spillage when an applicator is attached to the gel for initial filling weight of 3.5 grams and belowConclusion

[0211] The prototype met all predefined acceptance criteria standards and engineering requirements established for current Gel Capture Patches commercially available. The gel on applicator weight range for the Single Peel Patch is slightly higher than the upper range for the GCP. This is still acceptable because it adds more coupling medium for the patient’s treatment and still does not cause any spillage upon application.

[0212] The SPP can move on to the next phase in development which will include Human Factors validation and further engineering verification.Example 2:Engineering Validation Tests for Multiple Generations of the Single Peel Patch PrototypePATENT Attorney Docket No.: 6381.023WO1 (AKG)Purpose

[0213] The example provides all data and results from the engineering validation tests for multiple generations of the single peel patch prototype. This includes creep tests, burst tests, and dye ingress tests to verify patch prototypes meet current patch standards. The engineering requirement specifications tested are listed below:• Withstand 90 second creep test at 7 PSI• Burst at >= 10 PSI• No leakage after 5-hour submersion in waterApplicable Documents

[0214] Applicable documents associated with this example are found below in Table 4.Table 4:No Deviations from Protocol Occurred.DefinitionsPATENT Attorney Docket No.: 6381.023WO1 (AKG) Sample Size

[0215] For prototype generation 1 :• 9 Patches were Creep and Burst Tested• 5 Patches were Dye Ingress Tested

[0216] For prototype generation 2:• 6 Patches were Creep and Burst Tested• 5 Patches were Dye Ingress TestedAcceptance Criteria

[0217] Acceptance criteria is set by previous test protocols and standards set for previous generations of the SAM patch, including both the original SAM patch and the SAM gel capture patch.Creep Test:

[0218] Withstand a 90 second hold at 80% pressure (7 PSI) of the minimum burst strength (9 PSI).Burst Test:

[0219] Withstand a fill rate of 1 psi / second until at least 9 PSI.Dye Ingress Test:

[0220] Withstand 5 hours of submersion without experiencing any leaks. This is shown by using color dyed water and opening the patches to check the light blue ultrasound gel for any discoloration.Results

[0221] The results for both generation prototypes for all three tests are found here.

[0222] The Generation 1 prototype uses the foil FM5-AL5 with the following USW parameters:• Hold Time: 0.800• Weld Time: 0.250• Trigger Pressure: 8PATENT Attorney Docket No.: 6381.023WO1 (AKG) • PSI: 35-40 PSI

[0223] The Generation 2 prototype uses the foil FM3-ALW1-PT05 with the following USW parameters:• Hold Time: 0.950• Weld Time: 0.400• Trigger Pressure: 5• PSI: 35-40 PSICreep Test:Generation 1

[0224] All 9 patches passed the creep test holding a pressure of 7 PSI for 90 seconds.Generation 2

[0225] All 6 patches passed the creep test holding a pressure of 7 PSI for 90 seconds.Burst Test:Generation 1:Table 5:Burst strength of nine SAM Ultrasound Gel Bandages with prototype Generation 1 foil seal.Bandage Burst Pressure (psi)Std Dev 2.42PATENT Attorney Docket No.: 6381.023WO1 (AKG)Generation 2Table 6Burst strength of nine SAM Ultrasound Gel Bandages with prototype Generation 2 foil seal.Bandage Burst Pressure (psi)Std Dev 2.27Dye Ingress Test:Generation 1

[0226] As shown in Figure 7, all 5 patches passed. See picture below to confirm no discoloration of blue transparent ultrasound gel.Generation 2

[0227] As shown in Figure 8, all 5 patches passed. See picture below to confirm no discoloration of blue transparent ultrasound gel.Conclusion

[0228] Both generation prototypes met all standards and engineering requirements established for both current patches commercially available. Since both patches met all acceptance criteria, they PASS these tests and can move on to the next phase in development.Example 3:Human Factors Test Comparing the Predicate Gel Capture Patch To The Next Generation Single Peel Patch Final PrototypePurposePATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0229] This example provides the results from the internal human factors test comparing the predicate gel capture patch to the next generation patch final prototype. The next generation patch, or single peel patch, was designed to streamline the user interface for using and applying the sam patch with the sam device. One difference is the ability to peel the paper backing and foil in one step / motion opposed to the gel capture that involves two steps to remove the foil then the paper. The human factors evaluation was done to obtain feedback on the user experience and compare ease of use between the predicate patch and the next generation patch.Applicable Documents

[0230] The TP-5079 protocol was followed for this test with a few alterations. Subjects were given 3 samples of the predicate patch and 6 samples of the next generation patch. The same form was used from Appendix I but subjects were only asked to complete the applicable questions. Nonapplicable questions were crossed. A copy of the edited version can be found in the Appendix of this document.DefinitionsSample size

[0231] Participants were as follows:• 10 participants

[0232] Samples were as follows:• 3 Gel Capture Patches, Predicate patch• 6 Single Peel Patches, next generation patchPATENT Attorney Docket No.: 6381.023WO1 (AKG) Acceptance Criteria

[0233] Next generation patch should be identified as the same or better than the old patch in majority of categories.Results

[0234] Responses tallied in Table 7 below:Table 7:

[0235] Positive / the same: The new patch is superior in the ease of the bottom seal removal.

[0236] The new patch relatively displaces less gel when the applicator is secured into the gel cup.

[0237] Needs improvement: The new patch tends to collect more gel than the old patch when the backing is removed.

[0238] Discussion: The bottom seal of the new patch was much easier to remove than the old patch. This is consistent with the main goal of the next generation patch. The patches displace similar amounts of gel. This is to be expected since the dimensions of the bottom seal foil pain are the same. The main difference between the two generation patches is the foil material used for the bottom seal. About half of the time, the new patch bottom seal did pull away more gel than the old patch bottom seal.Conclusion

[0239] The new generation patch outperformed the old patch in 2 of 3 categories. While the new patch has more gel stuck to the bottom seal after removing, there could still be enough gel on the applicator for proper function. This third parameter, gel stuck to the bottom seal, canPATENT Attorney Docket No.: 6381.023WO1 (AKG) be validated through additional engineering tests before moving to external human factors testing.Example 4:Validation Tests for Multiple Generations of the Single Peel Patch Purpose

[0240] This example provides all data and results from the engineering validation tests for multiple generations of the single peel patch prototype. This includes creep tests, burst tests, dye ingress tests, and leak tests to verify patch prototypes meet current patch standards. The engineering requirement specifications tested are listed below:• Withstand 90 second creep test at 7 PSI• Burst at >= 10 PSI• No leakage inwards after 5-hour submersion in water• No leakage outwards after sitting with dyed water inside gel cupApplicable DocumentsNo Deviations from Protocol Occurred.DefinitionsPATENT Attorney Docket No.: 6381.023WO1 (AKG)Sample size

[0241] For each test, sample size is as follows:• 6 Patches were Creep and Burst Testedo 3 white fabrico 3 tan fabric• 10 Patches were Dye Ingress Testedo 5 white fabrico 5 tan fabric• 20 patches were Leak testedo 10 white fabrico 10 tan fabricAcceptance Criteria

[0242] Acceptance criteria is set by previous test protocols and standards set for previous generations of the SAM patch, including both the original SAM patch and the SAM gel capture patch.Creep Test:

[0243] Withstand a 90 second hold at 80% pressure (7 PSI) of the minimum burst strength (9 PSI).Burst Test:

[0244] Withstand a fill rate of 1 psi / second until at least 9 PSI.Leak Test:

[0245] Hold 3 ml water for 5+ hours without experiencing any leaks. This is shown by using color dyed water in the gel cup hole.PATENT Attorney Docket No.: 6381.023WO1 (AKG) Dye Ingress Test:

[0246] Withstand 5 hours of submersion without experiencing any leaks. This is shown by using color dyed water and opening the patches to check the light blue ultrasound gel for any discoloration.Results

[0247] The prototype uses the foil FM3-ALW1-PT05 with the following heat sealer parameters:• Temperature: 400°F• Dwell Time: 300 ms• PSI: 70PSICreep Test:

[0248] All 6 patches passed the creep test holding a pressure of 7 PSI for 90 seconds.Burst Test:Table 8: Burst strength of six SAM Ultrasound Gel Bandages with Generation 3 patch prototype on both fabrics.Bandage Burst Pressure (psi) Fabric TypeStd Dev 1.5Leak Test:

[0249] As shown in Figures 9A-9D, all 20 patches passed the leak test. See pictures in Figures 9A-9D to confirm no water leaked out and colored the bandages.PATENT Attorney Docket No.: 6381.023WO1 (AKG) Dye Ingress Test:

[0250] As shown in Figures 10A-10B, all 5 patches passed. This confirms that there was no discoloration of blue transparent ultrasound gel.Conclusion

[0251] The prototype met all predefined acceptance criteria standards and engineering requirements established for current patches commercially available. The prototype can move on to the next phase in development.Example 5:Evaluation of Next-Generation Sustained Acoustic Medicine (SAM) Technology:From Young Adults to GeriatricsAbstract

[0252] Background: Arthritis is a musculoskeletal disease causing joint pain and inflammation. Patients with arthritis have difficulty performing tasks involving physical strength. Sustained Acoustic Medicine (SAM), a medical device approved by the FDA to provide long-duration continuous ultrasound, reduces arthritis-associated pain. This study examined a new single-peel patch (SPP) for usability by young and old, healthy and arthritic subjects.

[0253] Methods: 30 healthy subjects (aged 19-78) used the SAM device with the SPP, assisted by trained professionals, and were given surveys on their experience. Later, subjects took the device home, used it normally three times, and filled out a separate survey. 8 subjects (aged 25-66) with moderate to extreme arthritis used the device with the SPP. They rated ease of use and pain during various setup, usage, and storage steps.

[0254] Results: Most healthy subjects found it easy to attach the applicator (93.3%) and remove the SPP liner (96.4%) with assistance in the office. These percentages changed during the at-home sessions to 94.0% and 88.1%, respectively. In all sessions, all patients were able to successfully apply and remove the device. Arthritis subjects gave each step an average ease of use rating between 4 and 5, with an overall average of 4.6 out of 5. They also experienced no pain during any of the usage steps.

[0255] Conclusions: SAM and the SPP are easy to use for healthy and arthritic subjects, receiving the Arthritis Foundation Ease of Use certification and making SAM an effective treatment option for athletes suffering from arthritis.PATENT Attorney Docket No.: 6381.023WO1 (AKG)BackgroundArthritis• Between 2019-2021, 21.2% of US adults had diagnosed arthritis (Fallon+, CDC MMWR, 2023)• Primarily targets joints, causing inflammation and pain• Active athletes, especially professionals, have increased risk for hip, knee, and ankle osteoarthritis (Bestwick-Stevenson+, AOSSM, 2021)Sustained Acoustic Medicine (SAM)• FDA-approved, cost-effective medical device• Provides long-duration ultrasound directly to joint• Effective at treating sports injuries (Walters+, Open Orthop J, 2023)• Improves overall joint health by:• Increases tissue vascularization, improving blood flow (Scanzuso+, Front Med Technol, 2025)• Diathermic effect warms local tissue4• Newly released single-peel patch comes off in one step• Easier for people with joint issues and the elderlyMethodsHealthy Subjects:• 30 subjects (aged 19-78, avg. 41) used SAM device with patch in office with assistance• Answered survey questions about usage difficulty• All subjects took device home for personal use• Used device 3 times at home alone• Answered survey questions about usage difficultyArthritis Subjects:• 8 subjects total (aged 25-66, avg. 57)• Filled survey and answered questions while using SAM devicePATENT Attorney Docket No.: 6381.023WO1 (AKG) • Ease of Use - 5-point Likert Scale, 5 = “extremely easy to use”• Pain - Wong-Baker Faces Pain Rating Scale, 0 = “no pain”Results & Conclusion

[0256] The single-peel patch is easy to use for both healthy and arthritic people from young to old. As shown in Figure 11, healthy subjects found the patch easy to use and could use the device normally. Subjects fdled out surveys while using the device in the office with assistance or at home, alone, n=28-30.

[0257] SAM, along with the single peel patch, received the Arthritis Foundation’s Ease of Use certification, proving SAM’s ability to help athletes with arthritis. As shown in Figures 12A-12B, SAM was easy to use with no pain for arthritic patients. Through normal usage steps, arthritic patients gave (Figure 12A) a high Ease of Use rating on the Likert scale and (Figure 12B) a low pain rating on the Wong-Baker scale, n=8.Example 6:SAM Gel Form 4A. Gel Form 4 Batch Composition

[0258] The formulation corresponds to a 3,000 g theoretical batch size. The recorded components, target percentages, and measured masses are shown in Table 9, as follows:Table 9:&

[0259] The formulation totals 100.00% w / w, with a 3,000.0 g theoretical batch size.PATENT Attorney Docket No.: 6381.023WO1 (AKG)B. Preparation of FD&C Brilliant Blue 1 Solution

[0260] A 0.1 mg / mL FD&C Brilliant Blue 1 solution was prepared with a 100.010 g theoretical batch size, using the following components as shown in Table 10:Table 10:&

[0261] The container was closed and shaken for approximately 30 seconds to mix.C. Preparation of Sodium Hydroxide Solution

[0262] As shown in Table 11, an 18% w / w sodium hydroxide solution was prepared with a 100.0 g theoretical batch size using:Table 11:

[0263] The sodium hydroxide pellets were added slowly to water while mixing. The dissolution was noted as exothermic and required approximately 20 minutes.D. Recorded Gel Manufacturing Procedure

[0264] The following procedure is recorded in the formulation documentation:1. Materials were weighed and staged prior to mixing.2. Under overhead mixing on a hot plate, water, propylene glycol, polyoxyl 20 cetostearyl ether, maltol isobutyrate, and 2-phenoxy ethanol were combined and mixed for not less than 30 minutes at approximately 55 °C ± 5 °C.PATENT Attorney Docket No.: 6381.023WO1 (AKG) 3. Sodium carboxymethyl cellulose and carbomer were added while maintaining mixing and temperature, followed by mixing for not less than 30 minutes at approximately 55 °C ± 5 °C.4. Heat was removed and the 0.1 mg / mL FD&C Brilliant Blue 1 solution was added, followed by mixing for approximately 5 minutes.5. The gel was subjected to vacuum deaeration for a minimum of 120 minutes.The recorded batch indicates vacuum applied overnight.6. The pH of the gel was measured and adjusted as needed using the 18% sodium hydroxide solution. Approximately 70.0 g of the sodium hydroxide solution was added, adjusting the pH from approximately 2.9 to approximately 6.07.7. Additional water was added q.s. to bring the batch mass to 3,000 g. The recorded q.s. water addition was 217.9 g.8. The gel was transferred to containers and yield recorded.E. Key Recorded Process Parameters and Results

[0265] The formulation record includes the following data:• Vehicle mixing speed: approximately 200 rpm• Polymer mixing speed: approximately 350 rpm• Colorant mixing speed: approximately 150 rpm• T arget pH range : 6.0-7.0• Final recorded pH: approximately 6.07• Vacuum deaeration duration: minimum 120 minutes; recorded as overnight • Theoretical batch size: 3,000.0 g• Recorded net yield: 2,954.4 g• Yield: approximately 98%Miscellaneous

[0266] The terms “a,” “an,” “the” and similar referents used in the context of describing the disclosure (especially in the context of the following claims) are to be construed to cover both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. Recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of anyPATENT Attorney Docket No.: 6381.023WO1 (AKG) and all examples, or exemplary language (e.g., “such as”) provided herein is intended merely to better illuminate the disclosure and does not pose a limitation on the scope of the disclosure otherwise claimed. No language in the specification should be construed as indicating any nonclaimed element essential to the practice of the disclosure.

[0267] Groupings of alternative elements or embodiments of the disclosure disclosed herein are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other members of the group or other elements found herein. It is anticipated that one or more members of a group may be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.

[0268] Certain embodiments of this disclosure are described herein, including the best mode known to the inventors for carrying out the disclosure. Of course, variations on these described embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. The inventor expects skilled artisans to employ such variations as appropriate, and the inventors intend for the disclosure to be practiced otherwise than specifically described herein. Accordingly, this disclosure includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the disclosure unless otherwise indicated herein or otherwise clearly contradicted by context.

[0269] Furthermore, references have been made to patents and printed publications throughout this specification. Citation of a reference herein shall not be construed as an admission that such reference is prior art to the present disclosure. All references cited herein are hereby incorporated by reference in their entirety.

[0270] In closing, it is to be understood that the embodiments of the disclosure disclosed herein are illustrative of the principles of the present disclosure. Other modifications that may be employed are within the scope of the disclosure. Thus, by way of example, but not of limitation, alternative configurations of the present disclosure may be utilized in accordance with the teachings herein. Accordingly, the present disclosure is not limited to that precisely as shown and described.PATENT Attorney Docket No.: 6381.023WO1 (AKG)

[0271] Although the present disclosure has been described for the purpose of illustration, it is understood that such detail is solely for that purpose and variations can be made by those skilled in the art without departing from the spirit and scope of the disclosure which is defined by the following claims.

Claims

PATENT Attorney Docket No.: 6381.023WO1 (AKG) WHAT IS CLAIMED IS:

1. An ultrasound coupling device comprising:a gel component comprising a gel material effective to conduct acoustic energy;a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; andan adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner,wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action,wherein said bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure, andwherein said gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

2. The coupling device according to claim 1, wherein the top and bottom seals are made from aluminum foil.

3. The coupling device according to claim 1, wherein said gel material is selected from the group consisting of a gel, a gel-like composition, a hydrogel, a low density cross-linked polymer hydrogel, and the like, and wherein a particular gel material comprises a water-based acoustic coupling gel with one or more ingredient selected from the group consisting of humectants, viscosity modifiers, preservatives, buffering agents, and optionally pharmaceutical agents, wherein the gel material is effective to enhance, improve, and facilitate cleaning and removal ofPATENT Attorney Docket No.: 6381.023WO1 (AKG) the gel material by enabling removal of a polymer layer of the gel material formulation used with the ultrasound coupling device.

4. The coupling device according to claim 1, wherein said gel material is provided so as to have a thickness of between 0.25 mm and about 20 mm, and a shape of the performed seal to accommodate the ultrasound transducer.

5. The coupling device according to claim 1, wherein the dimensions of the gel component are such to provide increased gel filling volume and other improvements over existing ultrasound coupling devices, including, without limitation, enabling a gel material weight of less than or at least between about 3.0 and 3.5 grams, a bottom seal diameter prior to sealing of less than or at least 43 mm, and / or a bottom seal diameter after sealing of less than or at least 37 mm.

6. An ultrasound coupling system comprising:an ultrasound coupling device according to any one of claims 1-5; and an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

7. A method for performing physiotherapy on a subject, said method comprising:providing an ultrasound coupling system according to claim 6; andapplying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

8. A method for applying ultrasound energy to a subject, said method comprising:providing an ultrasound coupling system according to claim 6; andapplying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

9. The method according to claim 8, wherein applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.PATENT Attorney Docket No.: 6381.023WO1 (AKG) 10. An ultrasound coupling device comprising:a gel component comprising a gel material effective to conduct acoustic energy;a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; andan adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner,wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action,wherein a bottom seal is expandable to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure, andwherein said gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

11. The coupling device according to claim 10, wherein the expandable bottom seal is made from an elastic material which expands outward upon insertion of the ultrasound transducer.

12. The coupling device according to claim 10, wherein the expandable bottom seal is made from an aluminum foil seal which expands outward upon insertion of the ultrasound transducer.

13. The coupling device according to claim 10, wherein said gel material is selected from the group consisting of a gel, a gel-like composition, a hydrogel, a low density cross-linked polymer hydrogel, and the like, and wherein a particular gel material comprises a water-based acoustic coupling gel with one or more ingredient selected from the group consisting of humectants, viscosity modifiers, preservatives, buffering agents, and optionally pharmaceutical agents, wherein the gel material is effective to enhance, improve, and facilitate cleaning and removal ofPATENT Attorney Docket No.: 6381.023WO1 (AKG) the gel material by enabling removal of a polymer layer of the gel material formulation used with the ultrasound coupling device.

14. The coupling device according to claim 11, wherein said gel material is provided so as to have a thickness of between 0.25 mm and about 20 mm, and a shape of the performed seal to accommodate the ultrasound transducer.

15. An ultrasound coupling system comprising:an ultrasound coupling device according to any one of claims 10-14; and an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

16. A method for performing physiotherapy on a subject, said method comprising:providing an ultrasound coupling system according to claim 15; andapplying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

17. A method for applying ultrasound energy to a subject, said method comprising:providing an ultrasound coupling system according to claim 15; andapplying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

18. The method according to claim 17, wherein applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.

19. An ultrasound coupling device comprising:a gel component comprising a gel material effective to conduct acoustic energy;a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; andPATENT Attorney Docket No.: 6381.023WO1 (AKG) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner,wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, andwherein the top and bottom seals are formed to hold a known volume of gel in a defined location within the coupling compartment.

20. The coupling device according to claim 19, wherein the top and bottom seals are made from aluminum foil.

21. The coupling device according to claim 19, wherein the top and / or bottom seal is made from a plastic part of the wall-like structure material.

22. The coupling device according to claim 19, wherein the top and bottom seals reduce nongel volume within the device to less than 50%.

23. An ultrasound coupling system comprising:an ultrasound coupling device according to any one of claims 19-22; and an ultrasound transducer configured for operable attachment to the ultrasound coupling device.

24. A method for performing physiotherapy on a subject, said method comprising:providing an ultrasound coupling system according to claim 23; andapplying therapeutic ultrasound energy to a subject, wherein said therapeutic ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

25. A method for applying ultrasound energy to a subject, said method comprising:providing an ultrasound coupling system according to claim 23; andPATENT Attorney Docket No.: 6381.023WO1 (AKG) applying ultrasound energy to a surface of a subject, wherein said ultrasound energy is generated by the transducer and emitted through the gel component of the coupling device.

26. The method according to claim 25, wherein applying the ultrasound energy to the surface of the subject is effective to alleviate pain in tissue of the subject in and around the surface.

27. A method of making an ultrasound coupling device according to claim 1, comprising: assembling the ultrasound coupling device using a heat seal head that is contoured to create a step feature, wherein the ultrasound coupling device provided by the method comprises the following:a gel component comprising a gel material effective to conduct acoustic energy;a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; andan adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner,wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action,wherein said bottom seal is preformed to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure, andwherein said gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.PATENT Attorney Docket No.: 6381.023WO1 (AKG) 28. A method of making an ultrasound coupling device according to claim 10, comprising:assembling the ultrasound coupling device using a heat seal head that is contoured to create a step feature, wherein the ultrasound coupling device provided by the method comprises the following:a gel component comprising a gel material effective to conduct acoustic energy;a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; andan adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner,wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action,wherein a bottom seal is expandable to hold a desired volume of the gel material between an ultrasound transducer and the bottom seal when said ultrasound transducer is attached at the top portion of the wall-like structure, andwherein said gel component is contained at least within a portion of a sidewall of the wall-like structure of the coupling compartment and at least a portion outside of the wall-like structure.

29. A method of making an ultrasound coupling device according to claim 19, comprising:assembling the ultrasound coupling device using a heat seal head that is contoured to create a step feature, wherein the ultrasound coupling device provided by the method comprises the following:a gel component comprising a gel material effective to conduct acoustic energy;a coupling compartment effective for holding the gel component in place, wherein said coupling compartment comprises a wall-like structure having a sidewall, a top portion, and a bottom portion, a top seal removably integrated to the top portion of the wall-like structure, and a bottom seal removably integrated to the bottom portion of the wall-like structure; andPATENT Attorney Docket No.: 6381.023WO1 (AKG) an adhesive fabric for interfacing the coupling device with a subject, wherein the adhesive fabric includes a vacant area in which the coupling compartment is situated for operation, and wherein the adhesive fabric includes a bottom facing removable adhesive retainer liner,wherein said bottom seal is structurally integrated with the removable adhesive retainer liner so that removal of the removable adhesive retainer liner and the bottom seal can be effectuated in a single action, andwherein the top and bottom seals are formed to hold a known volume of gel in a defined location within the coupling compartment.

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