Dry coupling device and method of manufacturing the same

Abstract

The application relates to the field of medical devices, and discloses a dry coupling device and a preparation method thereof, wherein the dry coupling device comprises a dry coupling support provided with a hollow part and a coupling pad arranged in the hollow part; the dry coupling support is provided with a buckle connecting part and is connected with an ultrasonic probe through the buckle connecting part; the coupling pad comprises a supporting layer and a plurality of separable coupling layers arranged above the supporting layer; and the coupling layer comprises a diaphragm and a hydrogel layer. The dry coupling device can greatly improve the efficiency of ultrasonic detection and reduce the detection cost, and the preparation method can realize efficient and high-quality integrated molding by accurately controlling molding process parameters.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a dry coupling device and its preparation method. Background Technology

[0002] With the development of medical imaging technology, ultrasound examinations are widely used in clinical diagnosis. In routine ultrasound examinations, in order to achieve effective transmission of sound waves between the probe and the human skin, a coupling agent is usually applied to the surface of the probe's acoustic lens to eliminate air gaps and ensure stable transmission of ultrasound signals.

[0003] However, relying on manual application of coupling agent has many technical drawbacks, seriously affecting equipment efficiency and infection control safety. First, the coupling agent is highly viscous and easily remains on the probe housing and acoustic lens surface after use, especially in complex areas such as the probe's edge grooves, making complete removal difficult and potentially affecting subsequent disinfection. Second, during repeated cleaning and disinfection, manual wiping can cause physical wear to the acoustic lens, leading to scratches or aging of the lens surface over time, affecting ultrasound image quality and shortening probe lifespan. Furthermore, the need to perform cleaning, disinfection, and reapplication of coupling agent after each examination significantly prolongs the interval between patient examinations, reducing diagnostic and treatment efficiency and failing to meet the demands of high-frequency, rapid-turnaround clinical care.

[0004] Although disposable dry coupling devices exist in existing technologies that effectively circumvent the aforementioned problems, their high production costs lead to increased subsequent ultrasonic testing expenses. Multilayer separable coupling pad structures, in particular, suffer from complex fabrication processes and difficulty in precisely controlling interlayer bonding strength. Insufficient bonding strength results in accidental detachment during use, while excessive bonding strength makes separation difficult, impacting user experience and cost-effectiveness. Furthermore, traditional multilayer structure fabrication methods typically employ a stacking approach, with distinct physical interfaces between layers, easily leading to delamination or incomplete peeling during use. Existing multilayer coupling pad fabrication methods often use a bricklaying-style layer-by-layer molding process, fabricating one coupling layer before moving to the next, stacking them to form a multilayer structure. This method suffers from low production efficiency, uneven interlayer bonding strength, and poor product quality consistency. Additionally, improper selection of diaphragm materials in traditional fabrication methods can easily lead to moisture loss, affecting the coupling pad's performance. Moreover, when the diaphragm thickness is small, deformation easily occurs in the hydrogel solution, affecting the precise control of interlayer distances.

[0005] Therefore, a new dry coupling device is urgently needed to solve the problems of complex fabrication processes and difficulty in controlling interlayer bonding forces in traditional multilayer structures. Summary of the Invention

[0006] Therefore, it is necessary to provide a dry coupling device and its preparation method to address the above-mentioned technical problems, so as to solve the problems of complex preparation process and difficulty in controlling interlayer bonding force in traditional multilayer structures.

[0007] A dry coupling device for snapping onto an ultrasonic probe, the dry coupling device comprising a dry coupling bracket having a hollow portion, and an integrated multilayer coupling pad disposed in the hollow portion, the coupling pad being adhered to the hollow portion of the dry coupling bracket;

[0008] The dry coupling bracket is provided with a snap-fit ​​connection part, which is used to snap the ultrasonic probe together with the snap-fit ​​connection part.

[0009] The coupling pad includes a support layer and a plurality of separable coupling layers disposed on the support layer; the coupling layer includes a diaphragm and a hydrogel layer;

[0010] The diaphragm is a hydrophilic polyurethane diaphragm with a thickness of 10μm to 30μm, and the coupling pad is an integrally molded structure with no physical interface between the layers and connected by molecular-level bonding forces.

[0011] Optionally, the coupling layer may have 10 to 20 layers, and the support layer may include a natural fiber web and / or a polymer fiber web.

[0012] Optionally, the diaphragm comprises a hydrophilic polyurethane diaphragm with a thickness of 10 μm to 30 μm, and the hydrogel layer has a thickness of 0.2 mm to 0.5 mm.

[0013] The method for preparing the dry coupling device as described in any of the above claims is characterized by comprising:

[0014] The support layer is bonded to the dry coupling bracket;

[0015] The dry coupling bracket and the diaphragm stage loaded with multi-layer diaphragms are assembled into the injection mold, such that the multi-layer diaphragms are parallel to the support layer and perpendicular to the horizontal plane; the diaphragm stage includes an expansion cavity and a first fixing plate and a second fixing plate disposed on both sides of the expansion cavity, the multi-layer diaphragms are disposed between the first fixing plate and the second fixing plate and are outside the expansion cavity; the expansion cavity is filled with an expansion material; the first fixing plate, the support layer, the second fixing plate, the side wall of the expansion cavity, and the bottom surface of the injection mold together form an injection cavity;

[0016] A hydrogel solution is added to the infusion cavity to fill the spaces between the membrane layers.

[0017] An expansion solution is added into the expansion cavity. After the expansion material absorbs and expands, it applies an outward expansion force to the first fixing plate and the second fixing plate, thereby causing the diaphragm to be straightened.

[0018] The injection chamber is degassed.

[0019] The infusion cavity is subjected to photocuring treatment to form a hydrogel layer on both sides of the diaphragm; the support layer, the multilayer diaphragm, and the hydrogel layer together form a coupling pad;

[0020] The dry coupling bracket with the coupling pad attached is removed from the injection mold and trimmed to obtain the dry coupling device.

[0021] Optionally, the expansion material is a superabsorbent resin, and the expansion cavity of the superabsorbent resin drives the stage to stretch, so that the diaphragms are evenly distributed.

[0022] Optionally, the hydrogel solution comprises, by mass parts:

[0023] Deionized water, 200 parts;

[0024] Acrylamide, 10-30 parts;

[0025] Acrylates, 10-30 parts;

[0026] Preservative, 0.1~0.5 parts;

[0027] Crosslinking agent, 0.01~0.2 parts;

[0028] Free radical initiator, 0.01~0.1 parts;

[0029] Photoinitiator, 0.01~0.1 parts.

[0030] Optionally, the degassing operation on the infusion chamber includes:

[0031] The injection mold is placed in an ultrasonic cleaner for ultrasonic treatment, so that air bubbles between any two adjacent diaphragm layers float to the surface.

[0032] Optionally, the infusion cavity is subjected to photocuring treatment to form a hydrogel layer on both sides of the diaphragm, including:

[0033] The hydrogel solution is irradiated from multiple directions using a UV lamp of a specified wavelength to solidify the hydrogel solution and obtain the hydrogel layer. The specified wavelength includes 395 nm.

[0034] Beneficial effects:

[0035] (1) The dry coupling device provided by this invention achieves detachable and quick assembly with the ultrasonic probe through a snap-fit ​​connection, facilitating installation and replacement; the multi-layer separable coupling layer has a protective elastic buffer function, which can ensure stability during detection at different angles. At the same time, acoustic contact can be guaranteed without coupling agent, solving the problems of difficult cleaning and easy wear of the probe in ultrasonic examination; after each use, the layers can be peeled off and replaced one by one, increasing the number of uses of the dry coupling device and reducing the cost of use; the support layer ensures the stable positioning of the coupling pad in the bracket, ensuring the consistency of acoustic performance. This invention can greatly improve the efficiency of ultrasonic testing while reducing the testing cost.

[0036] (2) This invention pre-fixes the multilayer diaphragm through a molding auxiliary structure, and combines one-time hydrogel infusion and simultaneous UV curing to achieve efficient molding and stable interlayer bonding of the multilayer coupling pad; hydrophilic polyurethane is selected as the diaphragm, which effectively reduces the loss of hydrogel moisture and has good biocompatibility and convenient separation characteristics; and the expansion cavity filled with superabsorbent resin drives the stage to stretch, so that the diaphragm remains flat and forms a uniform spacing, and then the curing process is carried out to ensure the product's precision and reliable acoustic performance. Attached Figure Description

[0037] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0038] Figure 1 This is a schematic diagram of an embodiment of the present invention, including an exploded structure of a dry coupling device and an ultrasonic probe.

[0039] Figure 2 This is a top view of a casting mold equipped with a dry coupling support and a diaphragm stage according to an embodiment of the present invention.

[0040] Figure 3 This is a process flow diagram of the preparation of the dry coupling device in one embodiment of the present invention. Detailed Implementation

[0041] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0042] In one embodiment, such as Figure 1As shown, a dry coupling device is provided for snapping onto an ultrasonic probe 01. The dry coupling device includes a dry coupling bracket 02 with a hollow portion and a coupling pad 03 disposed in the hollow portion.

[0043] The dry coupling bracket 02 is provided with a snap-fit ​​connection part 021, which is snapped into the ultrasonic probe 01.

[0044] The coupling pad 03 includes a support layer 033 and a plurality of separable coupling layers 032 disposed on the support layer 033; the coupling layer 032 includes a diaphragm 0321 and a hydrogel layer 0322.

[0045] Understandably, the dry coupling device provided in this embodiment is used to snap onto the ultrasonic probe 01 to achieve ultrasonic wave transmission without liquid coupling agent. The ultrasonic probe 01 can be a probe for medical diagnosis or industrial testing, and is particularly suitable for palm ultrasound probes, including but not limited to linear array probes, convex array probes, and phased array probes.

[0046] The dry coupling device includes a dry coupling bracket 02 with a hollow section and a coupling pad 03 disposed within the hollow section. The dry coupling bracket 02 may be a ring structure, with a shape adapted to the ultrasonic probe 01. The hollow section in the middle of the dry coupling bracket 02 ensures that the ultrasonic beam passes through without obstruction.

[0047] The dry coupling bracket 02 is provided with a snap-fit ​​connection part 021, which is used to snap onto the ultrasonic probe 01. The snap-fit ​​connection part 021 includes at least one pair of latches ( Figure 1 (There are two pairs in the middle). Each latch is a movable, press-type protrusion that forms a latch with the corresponding groove on the ultrasonic probe 01. By pressing the latch, it engages with the groove on the ultrasonic probe 01, thus fixing the dry coupling device.

[0048] The coupling pad 03 is disposed in the hollow portion of the dry coupling support 02, and includes a support layer 033 and multiple separable coupling layers 032 disposed on the support layer 033. The support layer 033 provides substrate support and ensures a tight fit between the coupling pad 03 and the probe's acoustic window. Multiple separable coupling layers 032 are disposed on the support layer 033. Each coupling layer 032 includes a diaphragm 0321 and a hydrogel layer 0322. The coupling layer 032 ensures the stability of ultrasonic wave transmission. During ultrasonic testing, the probe excites ultrasonic waves, which are transmitted to the object under test through the coupling, and the echo returns to the probe along the original path.

[0049] In one application example, the dry coupling device is removed from the packaging box and attached to the ultrasound probe 01 using a buckle. Then, the coupling pad 03 is placed against the patient's skin for real-time image examination. After the image examination is completed, the used coupling layer 032 is removed to expose the next new coupling layer 032, and the next patient is examined. After all patients have been examined, the buckle is opened, the dry coupling device is removed from the probe, and placed back into the packaging box for storage.

[0050] The dry coupling device provided in this embodiment achieves detachable and quick assembly with the ultrasonic probe 01 via the snap-fit ​​connection part 021, facilitating installation and replacement. The multi-layered separable coupling layer 032 has a protective elastic buffer function, ensuring stability during detection at different angles. Simultaneously, it ensures acoustic contact without coupling agent, solving the problems of difficult cleaning and easy probe wear in ultrasonic examinations. Each layer can be peeled off and replaced after each use, increasing the number of uses of the dry coupling device and reducing operating costs. The support layer 033 ensures the stable positioning of the coupling pad 03 in the bracket, guaranteeing consistent acoustic performance. This embodiment can significantly improve the efficiency of ultrasonic testing while reducing testing costs.

[0051] Optionally, the coupling pad 03 is bonded to the hollow part of the dry coupling bracket 02.

[0052] Understandably, the coupling pad 03 can be fixed to the dry coupling bracket 02 by adhesive bonding. Specifically, the support layer 033 is first bonded to the annular frame of the dry coupling bracket 02, and then multiple coupling layers 032 are cast onto the support layer 033 using a casting mold 04 to form a coupling pad 03 integrated with the dry coupling bracket 02. Bonding the coupling pad 03 to the hollow portion of the dry coupling bracket 02 ensures its stable fixation, preventing displacement or detachment during use, and improving the stability and reliability of ultrasonic testing. Adhesive bonding simplifies the assembly structure, avoids the complexity and potential damage associated with mechanical fixing, and improves the overall durability of the dry coupling device. Furthermore, the coupling pad 03 and the dry coupling bracket 02 form an integrated unit, facilitating overall replacement and maintenance, and maintaining hygiene.

[0053] Optionally, the number of coupling layers 032 may include 10 to 20.

[0054] Understandably, the number of coupling layers 032 can be 10 to 20, which significantly increases the number of times it can be reused and greatly extends the overall service life of the dry coupling device. This avoids frequent replacements due to too few layers, while too many layers would affect operational flexibility.

[0055] This embodiment, by setting a reasonable range of coupling layers, can effectively save on consumable costs, reduce the generation of medical waste, and improve the economic efficiency and environmental friendliness of dry coupling devices in clinical use.

[0056] Optionally, the diaphragm 0321 comprises a hydrophilic polyurethane diaphragm, and the thickness of the diaphragm 0321 includes 10 μm to 30 μm.

[0057] Understandably, the diaphragm 0321 in the coupling layer 032 can be a hydrophilic polyurethane diaphragm with a thickness of 10μm to 30μm. On the one hand, the surface of the hydrophilic polyurethane diaphragm has hydrophilic groups such as hydroxyl groups, which can form hydrogen bonds with the hydrogel layer 0322. It is not easy to fall off during the use of the coupling pad 03. When removing it, the hydrophilic polyurethane diaphragm is torn open under the action of external force (such as by using tweezers). That is, the hydrophilic polyurethane diaphragm and the hydrogel layer 0322 are tightly bound by intermolecular forces, ensuring that the coupling pad 03 will not fall off during the use of ultrasonic testing. When it is necessary to remove the used coupling layer 032, the edge of the hydrophilic polyurethane diaphragm or the hydrogel layer 0322 can be precisely grasped with the tip of tweezers and pulled outward at a steady speed to completely tear off the hydrophilic polyurethane diaphragm or the hydrogel layer 0322 without damaging the unused coupling structure below. On the other hand, the acoustic impedance of the hydrophilic polyurethane diaphragm is 1.62 MNayl, which is basically the same as that of the hydrogel (1.60 MNayl), so there will be no interfacial attenuation, and the acoustic impedance of the coupling pad 03 is stable and uniform after molding. In addition, the hydrophilic polyurethane diaphragm also has a moisturizing effect, effectively delaying the drying out of the coupling pad 03.

[0058] Optionally, the thickness of the hydrogel layer 0322 includes 0.2 mm to 0.5 mm.

[0059] Understandably, controlling the thickness of the 0322 hydrogel layer within the range of 0.2mm to 0.5mm ensures sufficient acoustic coupling performance, effectively transmits ultrasound waves, reduces interface reflection, and improves imaging clarity. Simultaneously, it balances flexibility and structural stability, allowing for good adhesion to the skin surface and adapting to the needs of exploring different curved areas. An excessively thin 0322 hydrogel layer can lead to insufficient coupling, while an excessively thick layer affects the stability of the multilayer structure.

[0060] Optionally, the support layer 033 comprises a natural fiber web and / or a polymer fiber web.

[0061] Understandably, the support layer 033 comprises a natural fiber web and / or a polymer fiber web. Natural fiber webs include, but are not limited to, cotton yarn webs. Polymer fiber webs include, but are not limited to, nylon webs, polyester webs, polyethylene webs, and polypropylene webs.

[0062] In this embodiment, the support layer 033 is made of natural fiber mesh and / or polymer fiber mesh, which has good mechanical strength and flexibility, effectively supporting the multi-layer hydrogel structure and preventing deformation or damage during use. The fiber mesh structure facilitates uniform stress distribution, improving the overall durability and fit of the coupling pad 03, and ensuring stable acoustic performance. Natural fibers enhance biodegradability, while polymer fibers improve moisture resistance and dimensional stability, allowing for flexible material selection based on requirements.

[0063] like Figure 3 As shown, in another embodiment, a method for fabricating a dry coupling device is provided, comprising:

[0064] The support layer 033 is bonded to the dry coupling bracket 02;

[0065] The dry coupling bracket 02 and the diaphragm stage loaded with multi-layer diaphragms 0321 are assembled into the injection mold 04, so that the multi-layer diaphragms 0321 are parallel to the support layer 033 and perpendicular to the horizontal plane; the diaphragm stage includes an expansion cavity 051 and a first fixing plate 052 and a second fixing plate 053 disposed on both sides of the expansion cavity 051, the multi-layer diaphragms 0321 are disposed between the first fixing plate 052 and the second fixing plate 053 and are outside the expansion cavity 051; the expansion cavity 051 is filled with an expansion material 0512; the first fixing plate 052, the support layer 033, the second fixing plate 053, the side wall 0511 of the expansion cavity 051 and the bottom surface of the injection mold 04 together form an injection cavity;

[0066] Add hydrogel solution into the infusion cavity to fill the spaces between the membrane layers;

[0067] An expansion solution is added into the expansion chamber 051. After the expansion material 0512 absorbs and expands, it applies an outward expansion force to the first fixed plate 052 and the second fixed plate 053, thereby causing the diaphragm 0321 to be straightened.

[0068] Perform a degassing operation on the injection chamber;

[0069] The hydrogel solution is photocured to form hydrogel layers 0322 on both sides of the diaphragm 0321; the support layer 033, the multilayer diaphragm 0321 and the hydrogel layers 0322 together form the coupling pad 03;

[0070] The dry coupling bracket 02 with the coupling pad 03 attached is removed from the injection mold 04 and, after appropriate trimming, a dry coupling device is obtained.

[0071] Understandably, when preparing the dry coupling device, the pre-made support layer 033 (natural fiber mesh or polymer fiber mesh, about 0.1–0.3 mm thick) can be uniformly applied to the hollow base of the dry coupling stent 02 with medical-grade adhesive, the air bubbles can be removed by pressing, and it can be cured at room temperature.

[0072] The diaphragm stage includes an expansion cavity 051 and a first fixing plate 052 and a second fixing plate 053 disposed on both sides of the expansion cavity 051. The first fixing plate 052 and the second fixing plate 053 of the diaphragm stage are made of glass. A multilayer diaphragm 0321 can be bonded to the first fixing plate 052 and the second fixing plate 053 by adhesive bonding. In some examples, multiple slits can be provided on the first fixing plate 052 and the second fixing plate 053, with one end of the diaphragm 0321 clamped through the slits of the first fixing plate 052 and the other end clamped through the slits of the second fixing plate 053. The diaphragm 0321 can be a hydrophilic polyurethane diaphragm, with a thickness ranging from 10 μm to 30 μm and a spacing between the diaphragms 0321 controlled between 0.5 mm and 1 mm.

[0073] like Figure 2 As shown, Figure 2 This is a top view of the injection mold 04. The dry coupling bracket 02 and the diaphragm stage containing the multi-layer diaphragms 0321 are assembled into the injection mold 04, with the multi-layer diaphragms 0321 parallel to the support layer 033 and perpendicular to the horizontal plane, to facilitate the expulsion of air bubbles between adjacent diaphragm layers 0321. The first fixing plate 052, the support layer 033, the second fixing plate 053, the sidewall 0511 of the expansion cavity 051, and the bottom surface of the injection mold 04 together form an injection cavity. After loading, an expansion material 0512, such as SAP resin (superabsorbent polymer), can be added to the expansion cavity 051.

[0074] Next, a pre-prepared hydrogel solution is added to the infusion cavity. The composition of the hydrogel solution can be adjusted according to actual needs. An expansion solution, such as deionized water, is added to the expansion cavity 051. After the expansion material 0512 absorbs and expands, it generates a radial expansion force, pushing the first fixing plate 052 and the second fixing plate 053 outward to ensure uniform tension of the diaphragm 0321. In some examples, the straightening process is carried out simultaneously with the infusion to avoid wrinkles in the diaphragm 0321 that would cause uneven thickness of the hydrogel layer 0322. Here, because the diaphragm 0321 is relatively thin, it is easily deformed in the hydrogel solution. Therefore, it is necessary to use the expansion cavity 051 to drive the fixing plates to stretch and flatten it, forming diaphragms with uniform spacing.

[0075] Next, the injection cavity is degassed. The entire injection mold 04 can be placed in an ultrasonic cleaner for ultrasonic treatment to make the air bubbles float to the surface. Then, the hydrogel solution is photocured. All the hydrogel solution in the injection cavity solidifies, and the hydrogel solution between adjacent diaphragms 0321 solidifies into a hydrogel layer 0322.

[0076] After curing, remove the dry coupling bracket 02 with the coupling pad 03 bonded to it from the pouring mold 04, separate the dry coupling bracket 02 with the coupling pad 03 bonded to it from the diaphragm stage, and trim off any excess burrs to obtain the finished dry coupling device. When not in use, the dry coupling device should be stored in a sterile packaging box to prevent contamination and to avoid water loss from the coupling pad 03.

[0077] This embodiment achieves precise positioning and automatic straightening of the multi-layer diaphragm 0321 through the cooperation of the injection mold 04 and the diaphragm stage, ensuring that each layer of diaphragm 0321 is parallel and wrinkle-free, significantly improving the structural uniformity and acoustic consistency of the coupling pad 03. After the expansion chamber 051 expands, it applies uniform tension to the diaphragm 0321, effectively avoiding misalignment or loosening caused by manual assembly, improving production yield and repeatability. Hydrogel injection, de-bubbling, and photocuring are completed within the injection chamber, ensuring uniform thickness and few bubbles in the hydrogel layer 0322, enhancing the bonding strength with the diaphragm 0321 and the support layer 033. This embodiment achieves integrated, high-precision, and mass production of the coupling pad 03, ensuring stable product quality and greatly improving the production efficiency of the dry coupling device.

[0078] Optionally, the infusion chamber is degassed, including:

[0079] The injection mold 04 is placed in an ultrasonic cleaner for ultrasonic treatment, so that the air bubbles between any two adjacent diaphragms 0321 float to the surface.

[0080] Understandably, during the fabrication of the dry coupling device, an ultrasonic cleaner can be used to treat the injection mold 04 to remove air bubbles between the diaphragms 0321, thereby improving the uniformity of the hydrogel layer 0322. Ultrasonic vibration promotes the detachment of air bubbles from the surface of the diaphragms 0321 and their rise to the liquid surface, significantly improving the density of the hydrogel filling and the quality of interlayer bonding.

[0081] This embodiment can effectively remove tiny air bubbles between any two adjacent diaphragm layers 0321, reduce scattering and attenuation at the acoustic interface, and improve the ultrasonic transmission performance of the coupling pad 03.

[0082] Optionally, the hydrogel solution is photocured to form a hydrogel layer 0322 on both sides of the diaphragm 0321, including:

[0083] The hydrogel solution is irradiated from multiple directions using ultraviolet lamps of a specified wavelength to solidify the hydrogel solution and obtain hydrogel layer 0322. The specified wavelengths include 395nm.

[0084] Understandably, a 395nm ultraviolet lamp can be used to irradiate the hydrogel solution from multiple directions (including from the support mesh direction, the upper and lower parts of the injection mold 04) to solidify the hydrogel solution and obtain hydrogel layer 0322. The irradiation time can be 1 minute (per direction).

[0085] This embodiment achieves a uniform and rapid photocuring reaction by irradiating the hydrogel solution from multiple directions, ensuring that the hydrogel layer 0322 is fully cross-linked in each region and improving the structural consistency of the hydrogel layer 0322.

[0086] Optionally, the hydrogel solution includes, by mass parts:

[0087] Deionized water, 200 parts;

[0088] Acrylamide, 10-30 parts;

[0089] Acrylates, 10-30 parts;

[0090] Preservative, 0.1~0.5 parts;

[0091] Crosslinking agent, 0.01~0.2 parts;

[0092] Free radical initiator, 0.01~0.1 parts;

[0093] Photoinitiator, 0.01~0.1 parts.

[0094] Understandably, the above proportions can be used to prepare the hydrogel solution. Deionized water serves as the reaction medium, dissolving other components and providing a uniform reaction environment. After solidification, some water is locked within the hydrogel network, giving the hydrogel layer flexibility and high water content, which is beneficial for sound wave conduction. Acrylamide, as one of the main monomers, provides mechanical strength and toughness. Its amide groups can form strong hydrogen bonds, making the final hydrogel network structure stable and exhibiting good compression and tear resistance. Acrylates, as another main monomer, provide hydrophilicity and electronegativity. Acrylates (such as sodium acrylate) ionize in water, imparting a negative charge to the polymer chains; the electrostatic repulsion causes the gel network to swell, enhancing water absorption.

[0095] Preservatives are used to inhibit microbial growth and prevent the hydrogel layer from deteriorating. Crosslinking agents are used to link linear molecules into a stable spatial network structure, transforming the hydrogel from a viscous flow state to an elastic solid state. Free radical initiators are used to initiate the chain polymerization reaction of acrylamide monomers and acrylate monomers, forming long polymer chains. Photoinitiators rapidly generate free radicals under ultraviolet light irradiation, promoting the polymerization and crosslinking reactions of acrylamide monomers and acrylate monomers.

[0096] Example 1

[0097] Preparation of hydrogel solution: Add 200g of deionized water to a 500mL glass beaker, then add 30g of acrylamide (Cas No. 79-06-1, analytical grade); 20g of sodium acrylate (Cas No. 7446-81-3, analytical grade); 0.5g of sodium benzoate (preservative) (Cas No. 532-32-1, analytical grade); 0.018g of N,N'-methylenebisacrylamide (crosslinking agent) (Cas No. 110-26-9, analytical grade); 0.06g of potassium persulfate (free radical initiator) (Cas No. 7727-21-1, analytical grade); and 0.06g of photoinitiator 2959 (Cas No. 106797-53-9, analytical grade). Stir well and set aside.

[0098] The hydrogel solution of Example 1 was processed according to the preparation method of the dry coupling device provided in the previous embodiment to prepare the first dry coupling device. The photocuring conditions were as follows: a 395nm ultraviolet curing lamp irradiated the support mesh from the top and bottom for 1 minute.

[0099] Example 2

[0100] The composition of the hydrogel solution is basically the same as that in Example 1, except for the following conditions:

[0101] 10 parts acrylate;

[0102] 0.2 parts crosslinking agent;

[0103] 0.1 parts free radical initiator;

[0104] 0.1 parts photoinitiator.

[0105] The hydrogel solution of Example 2 was processed according to the preparation method of the dry coupling device provided in the previous embodiment to prepare the second dry coupling device. The photocuring conditions were as follows: irradiation with a 395nm ultraviolet curing lamp from the support mesh direction, top and bottom for 0.5 min.

[0106] Example 3

[0107] The composition of the hydrogel solution is basically the same as that in Example 1, except for the following conditions:

[0108] 10 parts acrylamide;

[0109] 30 parts acrylate;

[0110] 0.1 parts preservative;

[0111] 0.01 parts crosslinking agent;

[0112] 0.01 parts free radical initiator;

[0113] 0.01 parts of photoinitiator.

[0114] The hydrogel solution of Example 3 was processed according to the preparation method of the dry coupling device provided in the previous embodiment to prepare the third dry coupling device. The photocuring conditions were as follows: irradiation with a 395nm ultraviolet curing lamp from the support mesh direction, top and bottom for 5 minutes.

[0115] Comparative Example 1

[0116] The composition of the hydrogel solution is basically the same as that in Example 1, except for the following conditions:

[0117] 0 parts photoinitiator.

[0118] The preparation method is basically the same as that in Example 1, except for the curing method. Here, the hydrogel solution is heat-cured at 80°C for 1 hour. The first comparative dry coupling device is finally obtained.

[0119] Comparative Example 2

[0120] The composition of the hydrogel solution is basically the same as that in Example 1, except for the following conditions:

[0121] 0 parts photoinitiator;

[0122] 0.05 parts tetramethylethylenediamine (TEMED-catalyst).

[0123] The preparation method is basically the same as that of Comparative Example 1, except for the curing time, which is 15 min. The second comparative example dry coupling device was finally obtained.

[0124] The molding effect of Examples 1-3 and Comparative Examples 1 and 2 was evaluated, and the results are as follows:

[0125] First dry coupling device Second dry coupling device Third dry coupling device First comparative dry coupling device Second proportional dry coupling device Molding effect The spacing of the multi-layer coupling pad structure is consistent. The spacing of the multi-layer coupling pad structure is consistent. The spacing of the multi-layer coupling pad structure is consistent. The spacing between the multi-layer coupling pads is inconsistent, and the polyurethane spacers are not parallel. The spacing between the multi-layer coupling pads is inconsistent, and the polyurethane spacers are not parallel. quality excellent good good Difference Difference

[0126] As can be seen from Examples 1 to 3, a good molding effect can be obtained when the ratio of acrylamide to sodium acrylate is 30:20 in Example 1.

[0127] From Examples 1-3 and Comparative Examples 1-2, it can be seen that the UV initiation method is more efficient, has a shorter curing time, and the molding effect is better than that of the thermal initiation method. Even if a catalyst is added to Comparative Example 2 to provide more free radicals to promote the reaction, it still cannot achieve the same effect as photoinitiation. It cannot make the hydrogel solution quickly cure during the tightening of the polyurethane interlayer to form a multilayer coupling pad structure with consistent spacing.

[0128] The above-described embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be included within the protection scope of the present invention.

Claims

1. A method for producing a dry coupling device, characterized by, The dry coupling device is used for clamping on an ultrasonic probe, and comprises a dry coupling support provided with a hollow portion and an integrated multi-layer coupling pad arranged in the hollow portion and bonded in the hollow portion of the dry coupling support; The dry coupling support is provided with a buckle connection portion, and the dry coupling support is clamped on the ultrasonic probe through the buckle connection portion; The coupling pad comprises a support layer and a plurality of separable coupling layers arranged on the support layer; the coupling layer comprises a diaphragm and a hydrogel layer; The diaphragm is a hydrophilic polyurethane diaphragm with a thickness of 10-30 microns, and the coupling pad is an integrated molding structure without a physical interface between layers and is connected through molecular level bonding force; The preparation method comprises: bonding the support layer on the dry coupling support; Assembling the dry coupling support and the diaphragm loading platform loaded with the multi-layer diaphragm into a perfusion mold, so that the multi-layer diaphragm is parallel to the support layer and perpendicular to the horizontal plane; the diaphragm loading platform comprises an expansion cavity and first and second fixed plates arranged on both sides of the expansion cavity, the multi-layer diaphragm is arranged between the first and second fixed plates and outside the expansion cavity, the expansion cavity is filled with expansion material, and the first fixed plate, the support layer, the second fixed plate and the sidewall of the expansion cavity jointly form a perfusion cavity with the bottom surface of the perfusion mold; adding a hydrogel solution to the perfusion cavity so that the hydrogel solution is filled between the layers of diaphragm; adding an expansion solution into the expansion cavity, and the expansion material expands to exert an outward expansion force on the first and second fixed plates to drive the diaphragm to be straightened; de-bubbling the perfusion cavity; photocuring the perfusion cavity to form a hydrogel layer on both sides of the diaphragm; the support layer, the multi-layer diaphragm and the hydrogel layer jointly form a coupling pad; taking the dry coupling support with the coupling pad bonded thereon out of the perfusion mold, and trimming to obtain the dry coupling device.

2. The method of claim 1, wherein the dry coupling device is prepared by the steps of: The number of coupling layers is 10-20, and the support layer comprises a natural fiber net and / or a polymer fiber net.

3. The method of claim 1, wherein the dry coupling device is prepared by the steps of: The diaphragm is a hydrophilic polyurethane diaphragm with a thickness of 10-30 microns, and the thickness of the hydrogel layer is 0.2-0.5 mm.

4. The method of claim 1, wherein the dry coupling device is prepared by the steps of: It comprises: The expansion material is super absorbent resin, and the loading platform is stretched by the expansion cavity of the super absorbent resin to make the diaphragm evenly distributed.

5. The method of claim 1, wherein the dry coupling device is prepared by the steps of: It comprises: The hydrogel solution comprises, by mass fraction: deionized water, 200 parts; acrylamide, 10-30 parts; acrylate, 10-30 parts; preservative, 0.1-0.5 parts; crosslinking agent, 0.01-0.2 parts; free radical initiator, 0.01-0.1 parts; photoinitiator, 0.01-0.1 parts.

6. The method for preparing the dry coupling device as described in claim 1, characterized in that, The de-bubbling operation of the perfusion cavity comprises: placing the perfusion mold into an ultrasonic cleaning machine for ultrasonic treatment to make the bubbles between any two adjacent diaphragms float up.

7. The method for preparing the dry coupling device as described in claim 1, characterized in that, The perfusion cavity is subjected to light curing treatment to form a hydrogel layer on both sides of the hydrogel solution of the diaphragm, comprising: The hydrogel solution is irradiated from multiple directions by using a specified wavelength of violet light, including 395 nm, to solidify the hydrogel solution and obtain the hydrogel layer.

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