Medical coupling agent bubble removal extrusion head, storage bottle and ultrasonic detection equipment

Abstract

This invention belongs to the field of medical ultrasound instrument technology, specifically a medical coupling agent bubble removal extruder, storage bottle, and ultrasound detection device. The extruder, through the synergistic design of the shell and the double-layer defoaming membrane assembly, achieves efficient gas-liquid separation during the extrusion process of the medical coupling agent, eliminating interference from coupling agent bubbles on ultrasound detection at the source. The defoaming membrane, based on polymer heat-shrinkable film, features a micropillar array, which, together with a micro-nano gap network and back venting holes, forms a directional air sliding channel. Full-area superhydrophobic modification maintains the coupling agent in a Cassirer state, achieving air permeability but liquid impermeability, effectively solving the leakage problem of traditional structures. The micron-level coupling agent flow channel formed by the two defoaming membranes arranged opposite each other is adapted to the flow characteristics of high-viscosity coupling agents. Utilizing viscous resistance difference, it achieves precise bubble capture and discharge without an additional power source; pure physical defoaming ensures biocompatibility, efficiently removing micron-level bubbles from the coupling agent and avoiding ultrasound imaging artifacts.

Description

Technical Field

[0001] This invention belongs to the field of medical ultrasound instrument technology, specifically a medical coupling agent bubble removal extruder, storage bottle, and ultrasonic testing device. Background Technology

[0002] Medical ultrasound coupling agent is an indispensable medium in ultrasound diagnosis and testing. Its core function is to fill the gap between the ultrasound probe and the human skin, expel air, and achieve acoustic impedance matching between the probe and the human soft tissue.

[0003] In clinical applications, medical coupling agents are prone to micro-air bubbles during transportation vibration and filling processes. Furthermore, the "water hammer effect" during extrusion generates new bubbles, becoming a major cause of foaming in coupling agents. Currently, most solutions to the foaming problem in coupling agents focus on the production end, such as centrifugal degassing and vacuum settling. However, effective real-time, online degassing methods are still lacking in the extrusion stage at the end-use stage.

[0004] Existing coupling agent extrusion heads used for defoaming in terminals mostly employ a filter screen structure, attempting to intercept bubbles through the filter. However, this approach has several drawbacks in practical use: First, there is an inherent contradiction between flow resistance and filtration accuracy. Medical coupling agents are high-viscosity non-Newtonian fluids. If the filter screen pore size is too small, extrusion resistance will increase dramatically, making operation difficult. If the filter screen pore size is too large, it cannot effectively intercept micron-sized bubbles, significantly reducing the defoaming effect. Second, ordinary porous filters are prone to wetting failure. Under extrusion pressure, the coupling agent will overcome surface tension and enter the filter screen pores, changing from the Cussky state to the Wenzel state, causing the coupling agent to leak from the venting hole. This results in wasted consumables and contamination of the operating environment. Third, traditional extrusion heads lack a dedicated gas-liquid separation structure design, often relying on simple single-layer filter screens. This fails to establish a stable gas-liquid separation interface during viscous fluid flow and cannot utilize the fluid's own pressure difference to achieve directional and efficient bubble discharge. Furthermore, the filter screen is easily clogged by the coupling agent, leading to a continuous decline in defoaming efficiency over long-term use.

[0005] In summary, given the technical problems of existing medical coupling agent extrusion heads in the terminal defoaming stage, such as poor real-time defoaming effect, easy leakage and blockage, and insufficient structural stability, there is an urgent need to develop a bubble removal extrusion head based on a novel functional membrane structure adapted to the characteristics of high-viscosity coupling agents, which can achieve efficient gas-liquid separation during the extrusion process. This would solve the problem of coupling agent bubbles interfering with ultrasound imaging and meet the stringent requirements of ultrasound medical imaging for imaging clarity, ease of operation, and hygiene. Summary of the Invention

[0006] To address the technical problem of unclear ultrasound medical imaging caused by a large number of air bubbles in the coupling agent due to low defoaming efficiency during coupling agent extrusion, this invention provides a medical coupling agent bubble removal extrusion head. Based on this extrusion head, this invention also provides a storage bottle using this extrusion head and an ultrasonic testing device. To achieve the above objectives, this invention provides the following technical solution:

[0007] A medical coupling agent bubble removal extruder, comprising:

[0008] The housing has a through-hole for installing the membrane module.

[0009] The double-layer defoaming membrane assembly includes two defoaming membranes with the same structure. The defoaming membrane is a polymer heat shrink film with a micropillar array formed on one side surface.

[0010] Two defoaming membranes are installed in the membrane module installation channel with the top surfaces of the micropillars abutting each other. The gaps between adjacent micropillars are connected to form a couplant flow channel for the couplant to flow.

[0011] Each micropillar and the surface of the debubbling membrane on which it is located are formed with a micro-nano gap network for absorbing bubbles and guiding gas flow. The micro-nano gap network is modified with superhydrophobicity. Multiple exhaust holes connected to the micro-nano gap network are opened on the other surface of the debubbling membrane. The micro-nano gap network and the exhaust holes are connected to form an air sliding channel to achieve gas-liquid separation of the coupling agent and the bubbles during extrusion.

[0012] As a further improvement to the above scheme, the inlet area of ​​the coupling agent channel is smaller than its outlet area.

[0013] As a further improvement to the above scheme: two defoaming films are arranged in parallel to each other.

[0014] As a further improvement to the above scheme: two parallel U-shaped grooves are symmetrically opened in the membrane module installation channel, and the groove opening direction coincides with the length direction of the membrane module installation channel. Two rectangular defoaming membranes are inserted into the corresponding U-shaped grooves.

[0015] As a further improvement to the above scheme: a clamping cavity is formed between the inner wall of the membrane module installation channel and the side surface of the two defoaming membranes facing away from the micropillar array. Each clamping cavity is provided with a support block, which abuts against and supports the corresponding defoaming membrane on the side surface facing away from the micropillar array to prevent the defoaming membrane from deforming due to the pressure of the coupling agent.

[0016] As a further improvement to the above scheme: the support block is X-shaped, and the center of the support block is perpendicular to the center of the defoaming membrane it supports, and the perpendicular line is perpendicular to the surface of the defoaming membrane.

[0017] As a further improvement to the above scheme: along the direction of couplant flow, the shell is divided into a connecting section and an installation section connected in sequence. The connecting section is used to connect the outlet of the couplant delivery pipeline or storage device, and the outlet of the connecting section is directly connected to the inlet of the couplant flow channel. The membrane module installation channel is opened in the installation section.

[0018] As a further improvement to the above scheme: the connecting section is a threaded cap that is threaded to the coupling agent delivery pipeline or storage device; the installation section is a cuboid block, and the membrane module installation channel that runs through it is cuboid in shape; the threaded cap and the cuboid block are integrally formed, and the joint between the two forms a two-stage stepped hole that transitions from a round hole to a rectangular hole.

[0019] A medical coupling agent storage bottle includes a bottle body and a medical coupling agent bubble removal extruder;

[0020] The bottle has a liquid storage cavity for storing medical coupling agent. A connecting part is provided at the bottle mouth end of the bottle. The extruder head is detachably or fixedly connected to the connecting part. The inlet of the coupling agent flow channel of the extruder head is connected to the liquid storage cavity of the bottle. The outlet of the coupling agent flow channel of the extruder head is set to face the outside of the bottle, so that the coupling agent in the bottle is extruded outward after being defoamed by the extruder head.

[0021] An ultrasonic testing device includes an ultrasonic probe and a medical coupling agent storage bottle;

[0022] The ultrasound probe is used for detection, and the medical coupling agent storage bottle is used to provide the coupling agent required for the detection.

[0023] Compared with the prior art, the beneficial effects of the present invention are:

[0024] 1. This invention, through micro-nano structure design and superhydrophobic surface control, efficiently separates air bubbles from the coupling agent at the extrusion source, effectively solving the problem of blurred ultrasound imaging caused by air bubbles. When the coupling agent is extruded and flows through the micron-level channels formed by the double-layer debubbling membrane, it comes into full contact with the micropillars equipped with a micro-nano gap mesh. The superhydrophobic modified micro-nano gap mesh utilizes surface tension difference to efficiently adsorb micron-level air bubbles in the coupling agent, preventing them from flowing out with the coupling agent. The adsorbed air bubbles are directed along the air sliding channels formed by the micro-nano gap mesh and discharged through the vent holes on the other side of the debubbling membrane, achieving efficient gas-liquid separation. After extrusion, the coupling agent, with no air bubble residue, perfectly fills the gap between the ultrasound probe and the human skin, eliminating strong ultrasonic wave reflections caused by air acoustic impedance mismatch, fundamentally avoiding imaging artifacts and dark areas, and significantly improving the signal-to-noise ratio and clarity of ultrasound medical images.

[0025] 2. When the coupling agent enters the flow channel through the narrow inlet, the slightly faster flow rate ensures that the coupling agent quickly fills the flow channel. Conversely, when it flows out through the wide outlet, the flow rate naturally slows down, effectively increasing the residence time of the coupling agent within the micron-level flow channel. This allows sufficient time for the microbubbles entrained in the coupling agent to contact the sidewalls of the micropillars, thereby capturing them and expelling them through the air sliding channel, significantly improving the thoroughness of defoaming. Simultaneously, this "narrow inlet, wide outlet" flow channel design effectively avoids turbulence and swirling flow disturbances caused by excessively high flow rates, fundamentally preventing the generation of new bubbles during extrusion due to fluid disturbances, ensuring the continuity of the defoaming effect. Furthermore, the wide outlet allows for more uniform extrusion of the defoamed coupling agent, preventing excessive localized pressure from causing instantaneous impacts on the defoaming membrane, reducing deformation and damage caused by localized stress concentration, extending the service life of the defoaming membrane, and allowing the extruded coupling agent to quickly adhere to the human testing site, meeting the convenience requirements of clinical operation.

[0026] 3. Parallel arrangement ensures uniform micron-level gaps between the two defoaming membranes, resulting in a more stable flow velocity and pressure distribution of the couplant within the flow channel. This eliminates localized velocity differences or pressure dead zones, preventing situations where uneven gaps cause excessively rapid couplant flow and bubble capture in some areas, or excessive flow resistance and extrusion difficulties in others. This guarantees consistent defoaming efficiency throughout the flow channel. Simultaneously, parallel arrangement ensures precise alignment of the micropillar tips of the two defoaming membranes, guaranteeing good connectivity between the micropillars and smoother defoaming paths in the air sliding channel. This prevents problems such as poor defoaming and bubble accumulation caused by micropillar misalignment. Furthermore, the extrusion force exerted by the couplant on the parallel-arranged membranes is evenly distributed, reducing warping and damage caused by localized stress concentration. This effectively protects the micro / nano structure of the defoaming membrane, maintains the integrity of the superhydrophobic modification layer, and ensures the long-term performance of the extruder.

[0027] 4. The rectangular cross-section membrane module installation channel is adapted to the shape of the sheet-like defoaming membrane, which can limit the defoaming membrane from the circumference, preventing the membrane from rotating or shifting during installation and use, and ensuring the assembly accuracy of functional components. The symmetrical parallel U-shaped grooves provide dedicated insertion positions for two defoaming membranes, enabling rapid insertion and removal of the defoaming membranes, greatly improving assembly efficiency. At the same time, the parallel design of the U-shaped grooves can force the two defoaming membranes to remain parallel, structurally avoiding the membrane tilting problem caused by manual assembly, and ensuring the uniformity of the micron-level flow channel gap. In addition, the U-shaped grooves provide rigid support for the edges of the defoaming membrane, effectively reducing the warping deformation of the edges during extrusion and protecting the micro-nano structure of the membrane. Moreover, the simple structural design of the rectangular channel and U-shaped groove, without complex irregular structures, facilitates mass production using processes such as injection molding and 3D printing, and the processing accuracy is easy to control, which can effectively reduce manufacturing costs and meet the industrialization needs of medical consumables.

[0028] 5. Medical coupling agent is a high-viscosity fluid. When manually squeezed, it will generate a large positive pressure on the defoaming membrane. Without a support structure, the defoaming membrane is prone to denting and bending, which will increase the gap in the micron-sized coupling agent flow channel. This will cause the coupling agent to flow directly out from the large gap in the middle without passing through the micro-pillar structure, directly causing gas-liquid separation failure. The support block provides support from the back of the defoaming membrane away from the micro-pillar array, which can provide rigid reaction force to the membrane, effectively counteract the extrusion pressure of the coupling agent, prevent membrane deformation, and ensure that the gap of the coupling agent flow channel always remains at the design value, so that the gas-liquid separation effect is stable in the long term. Meanwhile, the clamping cavity provides dedicated space for the support block, preventing it from occupying space in the coupling agent flow channel or air sliding channel. The clamping cavity remains open to the external atmosphere, preventing pressure resistance on the back of the membrane. This ensures that air bubbles can escape from the vent, and also prevents reverse deformation of the membrane due to pressure. Furthermore, the support block's abutting support disperses the compressive force on the defoaming membrane, reducing localized stress concentration and extending its lifespan, making the extruder suitable for repeated clinical applications. Designing the support block in an X-shape, ensuring its center is perpendicular to the center of the defoaming membrane, achieves uniform support across the entire membrane while maintaining unobstructed airflow for better support. The four radially distributed support arms of the X-shaped support block provide full coverage support for the central area and surrounding perimeter of the defoaming membrane, eliminating blind spots and effectively preventing any dents or bends in the membrane. The X-shaped perforated structure does not obstruct the venting holes on the membrane, ensuring that air bubbles can smoothly escape from the venting holes into the cavity, preventing blockage of the air sliding channels and balancing support and defoaming performance. Furthermore, the design of the support block's center being perpendicular to the center of the defoaming membrane allows the support force to be evenly distributed from the center outwards, precisely counteracting the central pressure generated by the coupling agent. This prevents membrane deformation due to excessive local support force and warping caused by uneven stress, ensuring the defoaming membrane remains flat at all times.

[0029] 6. The shell is functionally divided into a connection section and an installation section along the couplant flow direction. This design makes the shell structure more rational and its function more specialized, ensuring the stability of couplant delivery and improving the assembly precision of the membrane module. The connection section is specifically designed to connect to the outlet of the couplant delivery pipeline or storage device. Its structure can be specifically optimized to meet the requirements of sealing and docking, ensuring no leakage or air intake during couplant delivery. The installation section has a dedicated membrane module installation channel for fixing the double-layer defoaming membrane module. Its structure can be specifically optimized to meet the requirements of positioning and support, ensuring the assembly precision and operational stability of the membrane module. This functional division allows the design of the two core parts to better meet their usage needs, avoiding the design defects caused by a single structure trying to perform multiple functions. At the same time, the outlet of the connection section is directly connected to the inlet of the couplant flow channel, reducing flow channel bends and splicing gaps during couplant delivery. This allows the couplant to enter the defoaming flow channel smoothly and continuously, avoiding turbulence and swirling caused by flow channel bends, preventing the generation of new bubbles during extrusion, and ensuring the pre-defoaming effect. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of the overall structure of the extruder head.

[0031] Figure 2 This is a schematic diagram of the structure of the liquid outlet of the extruder.

[0032] Figure 3 This is a schematic diagram of the structure of the extruder inlet.

[0033] Figure 4 A schematic diagram of the structure when assembling a defoaming membrane inside the shell.

[0034] Figure 5 This is a schematic diagram of the internal structure of the shell.

[0035] Figure 6 This is a schematic diagram of the defoaming membrane.

[0036] Figure 7 This is a schematic diagram of the internal cross-sectional structure of the micropillar.

[0037] Figure 8 This is a bar chart showing the number of microcolumns remaining after removing bubbles at different intervals.

[0038] Figure 9 This is a correlation diagram showing the relationship between different spacings of micropillars and the size of removable bubbles.

[0039] Figure 10 This is a comparison chart of the test results.

[0040] In the figure: 10, shell; 11, connecting section; 12, mounting section; 121, membrane module mounting channel; 122, U-shaped groove; 123, support block; 20, double-layer defoaming membrane module; 21, defoaming membrane; 211, micro-pillar; 212, annular groove; 2121, vent. 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 embodiments of the present invention, and not all embodiments. 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] like Figures 1-7 As shown, the core of the extrusion head of this invention is a defoaming membrane 21 with a micropillar array and micro-nano gap network structure, fabricated using femtosecond laser micro-nano fabrication technology. Combined with the precise assembly design of the housing 10, this achieves passive and efficient gas-liquid separation during the coupling agent extrusion process. Furthermore, by integrating this extrusion head with a coupling agent storage bottle and an ultrasonic testing device, it solves the imaging artifact problem caused by coupling agent bubbles in ultrasonic diagnosis, thereby improving diagnostic efficiency. In the following embodiments, dimensions, materials, and process parameters not explicitly marked are all based on meeting the biocompatibility standards of medical devices and the core function of gas-liquid separation.

[0043] The overall structure of the medical coupling agent bubble removal extruder provided in this embodiment includes a housing 10 and a double-layer defoaming membrane assembly 20 embedded in the housing 10. The housing 10 provides precise installation positioning and structural support for the double-layer defoaming membrane assembly 20, which is the core functional component for gas-liquid separation. The two work together to achieve bubble-free extrusion of the coupling agent.

[0044] I. Shell

[0045] like Figures 1-6 As shown, the shell 10 is an integrally molded structure, divided into a connecting section 11 and an mounting section 12 along the flow direction of the coupling agent. The two sections are internally connected and coaxially arranged. The shell 10 is made of medical-grade polypropylene, but can also be replaced with polycarbonate, ABS plastic, medical stainless steel, or light-cured resin (3D printed) according to actual needs. All inner wall surfaces of the shell 10 are treated with polytetrafluoroethylene for anti-sticking to prevent high-viscosity coupling agent from adhering and causing flow channel blockage.

[0046] 1. Connecting section

[0047] The connecting section 11 is a cylindrical or conical structure, and its inner wall can be machined with standard medical threads for connection with the outlet thread of the coupling agent delivery pipeline or storage device. Alternatively, it can be designed with a smooth inner wall without threads and inserted into the bottle neck or the outlet of the coupling agent delivery pipeline by interference fit. Both structures can achieve quick assembly and disassembly of the extrusion head. The internal flow channel of the connecting section is a circular or conical hole, and its diameter matches the outlet diameter of the external pipeline / storage device, serving as an extension of the inlet of the coupling agent flow channel.

[0048] 2. Installation section

[0049] The mounting section 12 is a cuboid block structure with an axially extending membrane module mounting channel 121 inside. This channel is a rectangular cuboid that matches the double-layer defoaming membrane module 20 and serves as the core mounting carrier for the double-layer defoaming membrane module 20. Two parallel U-shaped grooves 122 are symmetrically formed on the inner wall of the membrane module mounting channel 121. The openings of the two U-shaped grooves 122 face the outlet of the membrane module mounting channel 121, and the groove depth is adapted to the thickness of the defoaming membrane 21. These grooves are used to insert a defoaming membrane 21, which can be firmly fixed by adhesive bonding or directly embedded into the U-shaped grooves 122 with an interference fit. During normal use, the defoaming membrane 21 is constrained by the interference fit of the U-shaped grooves 122 and will not shift, thus maintaining the parallel arrangement of the membrane and the relative assembly accuracy of the micro-columns, preventing gas-liquid separation failure due to membrane misalignment.

[0050] 3. Transition Structure

[0051] like Figures 3-5 As shown, the joint between the connecting section 11 and the mounting section 12 is machined into a two-stage stepped hole. The stepped hole transitions directly from the round hole of the connecting section 11 to the rectangular hole of the mounting section 12, thereby reducing the inlet area of ​​the coupling agent flow channel.

[0052] 4. Cavity formation

[0053] The inner wall of the membrane module installation channel 121 and the surface of the two defoaming membranes 21 facing away from the micropillar array form two independent cavities. The size of the cavities is adapted to the shape of the support block 123 to accommodate the support block 123. The cavities are kept in communication with the external atmosphere to avoid the air pressure resistance generated in the cavities when the coupling agent is squeezed, which would cause the membrane to deform.

[0054] II. Double-layer defoaming film assembly 20

[0055] like Figures 2-4As shown, the double-layer defoaming membrane assembly 20 includes two defoaming membranes 21 with identical structures. The two defoaming membranes 21 are inserted into the U-shaped groove 122 of the membrane assembly mounting channel 121 with the top surfaces of the micropillars 211 facing each other. They are parallel to each other and have a uniform spacing. They are core functional components. Their fabrication is based on femtosecond laser micro-nano processing technology, combined with superhydrophobic modification process, and core forming of key structures such as micropillar array, micro-nano gap network, annular groove 212 and vent 2121.

[0056] 1. Substrate selection

[0057] The defoaming membrane 21 is made of polystyrene heat-shrinkable film (polymer heat-shrinkable film), but can also be replaced with polyolefin, polyethylene, polyvinyl chloride, or polyethylene terephthalate-1,4-cyclohexanediol (PETG) film. All replacement substrates have a heat shrinkage rate ≥40%, ensuring the high aspect ratio of the micropillars 211 after femtosecond laser processing. The defoaming membrane 21 has a thickness of 300 μm and an effective processing size of 19 mm in length and 8 mm in width, adapting to the rectangular membrane module mounting channel 121.

[0058] 2. Femtosecond laser processing of micropillar arrays

[0059] A femtosecond laser micro-nano fabrication system was used to perform layer-by-layer scanning ablation on a polymer heat-shrinkable film, forming a micropillar array integrally on one side surface of the film. Simultaneously, a micro-nano gap network, annular grooves 212 at the bottom of the micropillars, and venting holes 2121 within the grooves were fabricated. All of these structures were formed in a single femtosecond laser process, requiring no subsequent secondary processing. The fabrication process is as follows:

[0060] Pretreatment: Place the polymer heat shrink film in an ultrasonic cleaner and ultrasonically clean it with deionized water for 10 minutes to remove surface particulate impurities and organic residues. After rinsing with anhydrous ethanol, dry it at a low temperature of 45°C for 15 minutes to obtain a pollution-free processed surface.

[0061] Laser positioning: The pre-treated polymer heat shrink film is placed on the three-dimensional moving stage of the femtosecond laser processing platform, and the X / Y / Z axes are adjusted to make the laser focus precisely aligned with the film surface to ensure processing accuracy.

[0062] Global Pre-scanning and Self-Growth of Structures: First, a global scanning path is set in the galvanometer control software, and a femtosecond laser (with fewer scans) is used to perform a global pre-scan on the entire film surface. This step aims to induce the formation of a uniform micro-nano gap network on the overall surface of the film. Second, the processing path parameters for the annular array and the exhaust array are set. The femtosecond laser is started to scan and process according to the preset annular array path. During this process, the local ablation effect of the femtosecond laser removes the material on the scanning path, naturally forming tiny annular grooves 212. At the same time, the local heat accumulation effect generated when the femtosecond laser interacts with the polymer causes the film at the center of the annulus to undergo drastic shrinkage deformation due to heat, thereby "self-growing" micropillar structures 211 (ultimately forming an inverted bowl shape and a volcano shape). Thanks to the pre-scanning and the laser etching effect in this step, the top surface, sides, and peripheral annular grooves 212 of the micropillars, as well as the flat areas of the film that have not undergone deep processing, are all completely covered by the micro-nano gap network. Finally, a femtosecond laser is used to precisely position the micropillar within the annular groove 212 around it and ablate it to create a suitable number of vent holes 2121 to ensure the connectivity of the bubble discharge channel during gas-liquid separation.

[0063] 3. Microcolumns

[0064] The micropillar 211 has a cylindrical structure with a diameter of 0.5 mm and a height of about 500 μm. The center-to-center spacing of adjacent micropillars 211 in the micropillar array is 0.75 mm to ensure the flow space of the coupling agent.

[0065] Micro-nano gap networks are mesh-like gap structures at the micro-nano scale, with gaps ranging from micrometers to nanometers, forming continuous mesh-like flow channels that are suitable for the adsorption and flow of micrometer-sized bubbles.

[0066] The annular groove 212 has a groove width of 0.1~0.2mm and a groove depth of 20~30μm. It is coaxially arranged with the micro-pillar 211 to provide installation and flow guidance space for the exhaust port 2121.

[0067] The vent 2121 is a circular through hole with a diameter of 10~40μm. 4~8 vents 2121 are evenly opened in a single annular groove 212 and are distributed in an array around the annular groove 212 to ensure that bubbles are discharged quickly and reduce flow resistance.

[0068] Furthermore, the arrangement of the micropillar array can be flexibly adapted to different defoaming requirements, specifically including two forms: one is a staggered arrangement, where the rows of micropillars 211 are staggered and irregularly aligned, which can increase the contact area between the coupling agent and the micro-nano gap network and improve the comprehensiveness of bubble capture; the other is a standard rectangular array arrangement, where the micropillars 211 are regularly aligned along the row and column directions, which is convenient for femtosecond laser mass processing and adapts to standardized mass production requirements. When assembling two defoaming membranes 21, different arrangements of defoaming membranes 21 can be used in combination according to the clinical requirements of coupling agent viscosity and extrusion speed (such as one staggered arrangement and the other rectangular array arrangement), or defoaming membranes 21 of the same arrangement type can be used in pairs. Preferably, two defoaming membranes 21, both of which are staggered, are arranged symmetrically. In this case, the micropillars 211 of the two membranes can form complementary flow guiding spaces, which can fully cover the flow area of ​​the coupling agent channel, avoid blind spots caused by bubble leakage due to the gaps in the arrangement, and further improve the thoroughness and stability of gas-liquid separation.

[0069] 4. Superhydrophobic modification treatment

[0070] After laser processing, the defoaming membrane 21 is ultrasonically cleaned and dried again. Then, all surfaces of the micro-nano gap network are treated with superhydrophobic modification. The modification process adopts vapor deposition of chlorosilane reagents combined with superhydrophobic reagent spraying. Specifically, the defoaming membrane 21 is placed in a vacuum chamber, perfluorooctyltrichlorosilane reagent is dropped in, the pressure in the chamber is reduced to -50 kPa and left to stand for 7 hours to complete the vapor deposition. After taking it out, a commercial superhydrophobic nano coating agent is sprayed on the surface of the micro-nano gap network, the inner wall of the annular groove 212 and the wall of the vent hole 2121. It is then dried at a low temperature of 45℃ for 15 minutes. The water contact angle of the modified surface is ≥150°, forming a stable superhydrophobic barrier to ensure the efficient adsorption of bubbles by the micro-nano gap network, while preventing high-viscosity coupling agent from entering the gap network and air slip channels.

[0071] 5. Membrane assembly and flow channel formation

[0072] After the two superhydrophobic modified defoaming membranes 21 are inserted into the U-shaped grooves 122, the following two arrangements can be used to adapt to different coupling agent flow and gas-liquid separation requirements:

[0073] (1) Direct contact arrangement of the top surfaces of the micropillars: The top surfaces of the micropillars 211 of the two defoaming membranes 21 are in contact with each other, and the total gap between the membranes is determined by the height of the micropillars 211. For example, when the height of the micropillars 211 is 500 μm, the total gap between the membranes is 1000 μm (that is, the sum of the heights of the micropillars 211 of the two defoaming membranes 21). This gap is connected with the gap between adjacent micropillars 211, and together they form the coupling agent flow channel, which can provide sufficient flow space and adapt to the rapid extrusion of high viscosity coupling agents.

[0074] (2) Microcolumn top face gap arrangement: A preset micron-level gap is maintained between the top faces of the microcolumns 211 of the two defoaming membranes 21. This gap, together with the height of the microcolumns 211, constitutes the total gap between the membranes. For example, when the height of the microcolumns is 100 μm, the top face gap can be preset to 10 μm, so that the total gap between the membranes is maintained at 210 μm (i.e., 2 × 100 μm + 10 μm), or the micron-level gap between the membranes can be directly set to 10 μm to prolong the contact time between the bubbles and the micro-nano gap network and improve the gas-liquid separation efficiency. This gap is connected with the gap between adjacent microcolumns 211 and together constitutes the coupling agent flow channel.

[0075] The inlet of the couplant channel is located at the transition between the connecting section 11 and the mounting section 12, while the outlet is the end opening of the mounting section 12. The area of ​​the inlet is smaller than that of the outlet, causing the flow velocity of the couplant within the channel to gradually decrease, increasing the contact time between the bubbles and the micro-nano gap mesh, and improving the gas-liquid separation efficiency. The outlet of the couplant channel is completely flush with the outlet of the mounting section 12 of the housing 10, without any protrusions, depressions, or steps. This allows the defoamed couplant to be directly squeezed from the flush outlet to the detection area or contact surface, preventing the couplant from forming turbulence or swirling flow at the outlet, or from excessive contact with air and secondary entrainment of bubbles, thus ensuring the continuity of the defoaming effect.

[0076] III. Support Block

[0077] like Figure 5 As shown, each clamping cavity is provided with an X-shaped support block 123. The support block 123 is made of medical rigid PC plastic, and its shape is adapted to the clamping cavity, and its thickness matches the width of the clamping cavity.

[0078] 1. Structural features

[0079] The cross-section of the support block 123 is a standard X shape and can be made hollow. It has holes on its surface and its four support arms are distributed radially. This ensures uniform support for the debubbling membrane 21 and does not block the vent holes 2121 on the back of the debubbling membrane 21, thus avoiding affecting the discharge of bubbles.

[0080] 2. Positioning Requirements

[0081] The center of the support block 123 is perpendicular to the center of the defoaming membrane 21 it supports. This perpendicular line is perpendicular to the surface of the defoaming membrane 21, so that the supporting force of the support block 123 is evenly applied to the central area and the surrounding area of ​​the defoaming membrane 21. This effectively prevents the defoaming membrane 21 from deforming or bending under the pressure of the coupling agent, ensuring that the micron-level gap between the membranes is always uniform and avoiding gas-liquid separation failure due to uneven gaps.

[0082] 3. Assembly method

[0083] The support block 123 is fitted into the clamping cavity with an interference fit. One end face of the support block is in close contact with the surface of the defoaming membrane 21 that is away from the micropillar array, and the other end face is in close contact with the inner wall of the membrane assembly mounting channel 121, without loosening or displacement, thus ensuring the stability of the support. Alternatively, it can be integrally formed with the shell 10 using 3D printing.

[0084] IV. Air Sliding Channel Composition

[0085] like Figure 7 As shown, the micro-nano gap network and the exhaust port 2121 in the annular groove 212 are sequentially connected to form an air sliding channel. This channel is isolated from the couplant flow channel, allowing only air bubbles to pass through and preventing the couplant from entering. When the couplant flows in the couplant flow channel, the entrained air bubbles are rapidly adsorbed after making full contact with the superhydrophobic micro-nano gap network. The adsorbed air bubbles are directed along the mesh channel of the micro-nano gap network until they flow into the annular groove 212 at the bottom of the micro-pillar, and then discharged into the clamping cavity through the exhaust port 2121 in the groove. Finally, they are discharged from the extruder through the connection between the clamping cavity and the external atmosphere, achieving efficient and directional gas-liquid separation of the couplant and air bubbles.

[0086] V. Medical coupling agent storage bottle

[0087] This section integrates the medical coupling agent bubble removal extruder head with the coupling agent storage bottle, realizing the integration of coupling agent storage and extrusion defoaming, and solving the problem of air bubbles being mixed in during the extrusion process of traditional coupling agent bottles.

[0088] 1. Bottle body

[0089] Made of medical-grade polyethylene by blow molding, the bottle has a reservoir cavity for storing medical coupling agent. The bottle body is a soft, extrudable structure, meeting the clinical need for manual extrusion of the coupling agent. The bottle mouth end is a rigid structure with a connecting part. The outer wall of this connecting part is machined with medical external threads that match the extruder head connecting section 11, enabling a detachable connection between the extruder head and the bottle body.

[0090] 2. Assembly of the extruder head and the bottle body

[0091] The medical coupling agent bubble removal extruder head is threadedly screwed onto the bottle mouth of the bottle via a threaded cap for a detachable connection. Alternatively, it can be fixed using adhesive or snap-fit ​​methods depending on the specific requirements. After assembly, the coupling agent inlet of the extruder head is directly connected to the liquid storage cavity of the bottle, while the coupling agent outlet faces outwards. This ensures that when the bottle is manually squeezed, the coupling agent in the liquid storage cavity passes sequentially through the connecting section 11 and the coupling agent channel, undergoes gas-liquid separation, and is extruded from the outlet. The extruded coupling agent is free of visible air bubbles, meeting the requirements for ultrasonic testing.

[0092] 3. Ancillary Designs

[0093] A dust cap can be added to the bottle opening, which is fastened to the outside of the extruder mounting section 12 to prevent the liquid outlet of the extruder from being contaminated by dust and impurities, thus ensuring the cleanliness of the medical coupling agent. The dust cap is connected to the bottle by a hanging rope to prevent loss.

[0094] VI. Ultrasonic Testing Equipment

[0095] The ultrasound testing equipment includes independent ultrasound probes and a medical coupling agent storage bottle with a defoaming extrusion head. The ultrasound probe is a standard medical ultrasound probe with a handheld handle and a surface that contacts the skin, suitable for various ultrasound diagnostic needs such as B-mode and color Doppler ultrasound, and is the core component of the ultrasound testing system. The medical coupling agent storage bottle is an independent coupling agent supply unit that extrudes defoamed, bubble-free medical coupling agent, adapting to routine clinical ultrasound testing procedures.

[0096] In use, first, hold the storage bottle and squeeze the bubble-free coupling agent directly onto the area to be tested on the human body. Then, use the ultrasound probe to spread the coupling agent evenly on the test site, ensuring that the coupling agent fully fills the gap between the probe's detection surface and the human skin to achieve acoustic impedance matching. After that, start the ultrasound probe to complete the test. This device does not change routine clinical operating habits, eliminating air bubbles in the coupling agent at the source, effectively avoiding ultrasound imaging artifacts caused by air bubbles, improving the clarity of the detection spectrum, and the storage bottle can be used with various sizes of medical ultrasound probes, making it widely compatible. At the same time, squeezing the coupling agent directly onto the test site reduces contact contamination and meets medical hygiene requirements.

[0097] VII. Working Principle of the Extruder

[0098] The medical coupling agent bubble removal extruder of this invention achieves passive gas-liquid separation through the bubble adsorption effect of a superhydrophobic micro-nano gap network and a directional air sliding channel. Combined with the integration of a storage bottle and ultrasonic testing equipment, it realizes the integrated storage, defoaming, and supply of coupling agent, solving the problem of blurred ultrasonic imaging caused by bubbles at the extrusion source. The overall working principle is as follows:

[0099] The soft bottle of the manual extrusion coupling agent storage bottle is squeezed. Under pressure, the coupling agent in the storage cavity enters the connecting section 11 of the extrusion head through the bottle mouth connection part. After passing through the two-stage stepped hole transition, it smoothly enters the coupling agent flow channel.

[0100] The couplant flows slowly within the couplant channel. Since the inlet area is smaller than the outlet area, the flow rate decreases from fast to slow, allowing the micron-sized bubbles entrained in the couplant to come into full contact with the superhydrophobic micro-nano gap network on the surface of the defoaming membrane 21. The bubbles are quickly adsorbed by the micro-nano gap network, while the high-viscosity couplant cannot enter the micro-nano gap network due to the superhydrophobic barrier effect and is blocked in the couplant channel from continuing to flow towards the outlet.

[0101] The adsorbed bubbles are directed along the mesh channels of the micro-nano gap network to the annular groove 212 at the bottom of the micro-column 211, and then discharged into the clamping cavity through the exhaust hole 2121 in the groove. Finally, they are discharged from the extrusion head from the connection between the clamping cavity and the external atmosphere, thus completing the gas-liquid separation.

[0102] The bubble-free coupling agent is squeezed out from the outlet flush with the end of the housing. After application, it can fully fill the gap between the detection surface of the ultrasonic probe and the human skin, eliminate strong ultrasonic wave reflection caused by air acoustic impedance mismatch, avoid ultrasonic imaging artifacts and dark areas from the source, ensure normal ultrasonic wave propagation, and obtain a clear ultrasonic imaging spectrum.

[0103] 8. Defoaming performance test of micro-column gaps

[0104] To investigate the quantitative impact of the microcolumn spacing, a core structural parameter, on defoaming efficiency, this invention designed a controlled variable test. Using the total number of coupling agent bubbles without a defoaming device as a baseline, four microcolumn spacings (0.75mm, 1.00mm, 1.25mm, and 1.50mm) were selected as test variables. Verification was conducted from two core dimensions: the number of bubbles remaining after bubble removal and the threshold size of effectively removable bubbles. This quantified the differences in defoaming efficiency under different spacings and clarified the bubble size adaptation range corresponding to each spacing parameter, forming a complete correlation data system between microcolumn spacing and defoaming efficiency. The following... Figure 8 and Figure 9 The test results were visualized from both the perspectives of quantity statistics and size definition.

[0105] Figure 8 A bar chart is presented showing the number of remaining bubbles after treatment with different microcolumn spacings. The vertical axis represents the total number of bubbles, and the horizontal axis represents the microcolumn spacing (unit: mm). Four key test values ​​were selected: 0.75 mm, 1.00 mm, 1.25 mm, and 1.50 mm. A red horizontal line marks the original total number of bubbles (approximately 120) without using the extruder of this invention, serving as a baseline. The statistical data clearly shows that the number of remaining bubbles after extrusion treatment at each microcolumn spacing is significantly lower than the original total number of bubbles, exhibiting a quantitative trend of gradually increasing remaining bubble count with increasing microcolumn spacing. The lowest number of remaining bubbles and the best bubble removal effect are observed at a microcolumn spacing of 0.75 mm, while the highest number of remaining bubbles are observed at 1.50 mm. This clearly reflects the direct impact of the microcolumn spacing parameter on bubble removal efficiency.

[0106] Figure 9This diagram shows the correlation between different micropillar spacings and the size of removable bubbles. The vertical axis represents the size of removable bubbles (in μm), and the horizontal axis represents the micropillar spacing (in mm). An "×" indicates that bubbles of the corresponding size cannot be removed under that parameter combination, while a "√" indicates effective removal. The blue-filled area represents the size range of removable bubbles for each micropillar spacing. The diagram uses the "no device" group as a blank control, clearly showing that no bubbles of any size can be removed without the extruder head of this invention. However, when using the extruder head of this invention, the micropillar spacing is negatively correlated with the upper limit of the removable bubble size. With a micropillar spacing of 0.75 mm, the upper limit of the removable bubble size reaches over 350 μm. As the spacing increases to 1.50 mm, the upper limit of the removable bubble size gradually decreases, clearly defining the bubble removal size thresholds corresponding to different micropillar spacings, providing a clear visual basis for selecting process parameters for micropillar arrays.

[0107] IX. Comparative Experiment

[0108] like Figure 10 As shown, the defoaming effect of the medical coupling agent extrusion head of the present invention is intuitively demonstrated through two sets of comparative experiments:

[0109] Upper experimental group (without using the extrusion head of this invention): The coupling agent was directly extruded from the medical coupling agent storage bottle onto the surface of the transparent substrate. After local magnification, multiple unevenly distributed bubbles could be clearly observed. Figure 10 (Marked in red) The bubbles vary in size and are randomly scattered. Some bubbles are clearly spherical protrusions, which directly reflects the problem of coupling agent being easily trapped and residual bubbles under traditional extrusion methods.

[0110] The lower experimental group (using the extrusion head of the present invention): After the coupling agent is extruded through the bubble removal extrusion head of the present invention, the coupling agent coating formed on the same substrate surface has almost no visible bubbles. The magnified area is clean and uniform with no obvious bubble residue, which is in stark contrast to the upper experimental group.

[0111] 1. The fabrication process of the extruder head for the experimental group is as follows:

[0112] (1) Pretreatment of polymer heat shrink film

[0113] First, a polymer heat-shrink film with a thickness of 300μm, a length of 19mm, and a width of 8mm is selected. It is placed in an ultrasonic cleaner and ultrasonically cleaned with deionized water for 10 minutes to thoroughly remove surface particulate impurities and organic residues. After cleaning, it is rinsed thoroughly with anhydrous ethanol and dried in a drying oven at 45℃ for 15 minutes to obtain a contaminated processed surface.

[0114] (2) Femtosecond laser patterning

[0115] The cleaned polymer heat-shrinkable film was placed on a femtosecond laser micro / nano processing platform. Path parameters for the staggered cylindrical array and lattice were set in the galvanometer control software, followed by scanning processing. The laser first irradiated the film with low-energy pulses, precisely machining a high aspect ratio cylindrical array on its surface. The laser ablation created tiny annular grooves 212 around the cylinders, and then a suitable number of venting holes 2121 were machined within these grooves to expel air bubbles. This process ensures significant wettability selectivity in subsequent chemical modification of the region.

[0116] (3) Cleaning and hydrophobic treatment after laser processing

[0117] After processing, the sample was again cleaned in an ultrasonic cleaner for 10 minutes to remove particles and residual contaminants generated during laser processing. The cleaned sample was then rinsed with anhydrous ethanol and dried in a drying oven at 45°C for 15 minutes. The cleaned sample was then placed in a vacuum chamber, a few drops of chlorosilane reagent were added, and the vacuum chamber pressure was reduced to -50 kPa. The sample was left to stand for 6-8 hours. A superhydrophobic agent was then sprayed onto the surface, and the sample was dried in a drying oven at 45°C for 15 minutes. Due to the roughened structure created by femtosecond laser processing, hydrophobic molecules deposited in these micro / nano-structured regions, forming a stable hydrophobic coating.

[0118] (4) 3D printing functional bracket and system integration

[0119] Finally, a matching shell is printed using 3D printing technology, which ensures that the two polymer heat-shrink films are precisely bonded together in a way that the micropillars 211 face each other, and guides the coupling agent to the outlet.

[0120] 2. Comparative Analysis

[0121] Figure 10 The core function of the extruder head of this invention is directly verified: through the synergistic effect of the double-layer defoaming membrane component and the micro-nano gap mesh, air bubbles are efficiently separated and discharged during the extrusion of the coupling agent, eliminating residual air bubbles in the coupling agent from the source, providing bubble-free clean coupling agent for ultrasound detection, effectively avoiding ultrasound imaging artifacts and black areas caused by air bubbles, and improving the clarity of medical images and diagnostic accuracy.

[0122] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A medical coupling agent bubble removal extruder, characterized in that, include: The housing (10) has a membrane module installation channel (121) through which the membrane module is installed. The double-layer defoaming membrane assembly (20) includes two defoaming membranes (21) with identical structures, one of which is uniformly covered with a micropillar array. Two defoaming membranes (21) are installed in the membrane module installation channel (121) with the top surfaces of the micropillars (211) abutting each other. The gaps between adjacent micropillars (211) are connected to form a couplant flow channel for the couplant to flow. Each micropillar (211) and the surface of the debubbling membrane (21) on which it is located are formed with a micro-nano gap network for absorbing bubbles and guiding gas flow. The micro-nano gap network is treated with superhydrophobic modification. Multiple exhaust holes (2121) connected to the micro-nano gap network are opened on the other surface of the debubbling membrane (21). The micro-nano gap network and the exhaust holes (2121) are connected to form an air sliding channel to achieve gas-liquid separation of the coupling agent and the bubbles during extrusion.

2. The medical coupling agent bubble removal extruder according to claim 1, characterized in that, The inlet area of ​​the coupling agent flow channel is smaller than its outlet area.

3. The medical coupling agent bubble removal extruder according to claim 1, characterized in that, Two defoaming films (21) are arranged in parallel to each other.

4. The medical coupling agent bubble removal extruder according to claim 1, characterized in that, Two parallel U-shaped grooves (122) are symmetrically opened in the membrane module installation channel (121). The groove opening direction of the U-shaped groove (122) coincides with the length direction of the membrane module installation channel (121). Two rectangular defoaming membranes (21) are inserted into the corresponding U-shaped grooves (122).

5. The medical coupling agent bubble removal extruder according to claim 1, characterized in that, A cavity is formed between the inner wall of the membrane module installation channel (121) and the side surface of the two defoaming membranes (21) facing away from the micropillar array. A support block (123) is provided in each cavity. The support block (123) abuts against and supports the side surface of the corresponding defoaming membrane (21) facing away from the micropillar array to prevent the defoaming membrane (21) from being deformed by the coupling agent.

6. The medical coupling agent bubble removal extruder according to claim 5, characterized in that, The support block (123) is X-shaped, and the center of the support block (123) is perpendicular to the center of the defoaming membrane (21) it supports, and the perpendicular line is perpendicular to the surface of the defoaming membrane (21).

7. The medical coupling agent bubble removal extruder according to claim 1, characterized in that, Along the direction of the coupling agent flow, the housing (10) is divided into a connecting section (11) and an installation section (12) connected in sequence. The connecting section (11) is used to connect the outlet of the coupling agent delivery pipeline or storage device, and the outlet of the connecting section (11) is directly connected to the inlet of the coupling agent flow channel. The membrane module installation channel (121) is opened in the installation section (12).

8. The medical coupling agent bubble removal extruder according to claim 7, characterized in that, The connecting section (11) is a threaded cap that is threaded to the coupling agent delivery pipe or storage device; the installation section (12) is a cuboid block, and the membrane module installation channel (121) that runs through it is cuboid in shape; the threaded cap and the cuboid block are integrally formed, and the joint between the two forms a two-stage stepped hole that transitions from a round hole to a rectangular hole.

9. A medical coupling agent storage bottle, characterized in that, Includes a bottle body and a medical coupling agent bubble removal extruder according to any one of claims 1-8; The bottle has a liquid storage cavity for storing medical coupling agent. A connecting part is provided at the bottle mouth end of the bottle. The extruder head is detachably or fixedly connected to the connecting part. The inlet of the coupling agent flow channel of the extruder head is connected to the liquid storage cavity of the bottle. The outlet of the coupling agent flow channel of the extruder head is set to face the outside of the bottle, so that the coupling agent in the bottle is extruded outward after being defoamed by the extruder head.

10. An ultrasonic testing device, characterized in that, Includes an ultrasound probe and a medical coupling agent storage bottle as described in claim 9; The ultrasound probe is used for detection, and the medical coupling agent storage bottle is used to provide the coupling agent required for the detection.

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