Ultrasonic imaging enhanced balloon, preparation method thereof and ultrasonic imaging enhanced abdominal aorta blocking device

Abstract

The invention provides an ultrasound imaging enhanced balloon, a preparation method thereof and an ultrasound imaging enhanced abdominal aorta blocking device. The ultrasonic imaging enhanced balloon comprises a balloon body and an ultrasonic imaging enhanced coating, and the outer surface of the balloon body is coated with the ultrasonic imaging enhanced coating; wherein the ultrasonic imaging enhanced coating comprises ultrasonic imaging enhanced particles, a silica gel polymer and a curing agent; the ultrasonic imaging enhanced particles comprise at least one of metal nanoparticles, metal oxide nanoparticles, gas encapsulated microbubbles or liquid encapsulated microbubbles, and the average particle size of the ultrasonic imaging enhanced particles is 40-150 nm. According to the balloon, real-time and clear positioning and state recognition can be achieved, the intraoperative balloon positioning precision is remarkably improved, dependence on the experience of an operator is reduced, and the occurrence rate of complications such as puncture injury and intraoperative bleeding caused by inaccurate positioning is also effectively reduced.

Description

Technical Field

[0001] This invention belongs to the field of interventional surgical balloon medical device technology, and relates to an ultrasound-enhanced balloon, its preparation method, and an ultrasound-enhanced abdominal aortic occlusion device. Background Technology

[0002] In recent years, with the continuous increase in the proportion of repeat pregnancies after cesarean section and older pregnant women, the incidence of placenta accreta has increased significantly. Placenta accreta is a high-risk pregnancy complication, primarily dangerous due to its potential to cause fatal postpartum hemorrhage and a high probability of hysterectomy, and in severe cases, even maternal death. Therefore, it has become a crucial clinical problem that urgently needs to be addressed in the field of obstetrics. With the rapid development of interventional medicine, interventional treatments are increasingly widely used in controlling obstetric hemorrhage. Among them, abdominal aortic balloon occlusion, as an effective intraoperative hemostasis technique, has become a research hotspot and a key focus of clinical practice in cesarean section surgery. This technique, by temporarily blocking blood flow in the abdominal aorta during surgery, can effectively reduce intraoperative blood loss, significantly lower the hysterectomy rate, and reduce perioperative risks, demonstrating significant clinical application value.

[0003] In the procedure of abdominal aortic balloon occlusion, the accuracy of balloon placement directly affects the occlusion effect and patient safety. Ideally, the balloon should be positioned between the renal artery orifice and the abdominal aortic bifurcation, avoiding accidental occlusion of the renal artery while ensuring sufficient blood flow blockage. However, current techniques often use X-ray fluoroscopy to guide balloon placement. Although this method provides clear imaging and reliable positioning, it inevitably exposes the mother, fetus, and surgical staff to ionizing radiation during the procedure, posing potential health risks. Furthermore, X-ray equipment is bulky, expensive, and requires sophisticated hospital facilities, limiting the widespread adoption and application of this technology in primary healthcare institutions and routine surgeries.

[0004] To mitigate the adverse effects of X-rays, intraoperative ultrasound-assisted balloon localization is increasingly being used in clinical practice. While ultrasound technology offers significant advantages such as real-time performance, lack of radiation, convenient equipment, and relatively low cost, making it a promising technology, current balloon materials exhibit poor imaging performance under ultrasound. This makes it difficult to directly and accurately display the balloon's specific location, size, and shape, often relying on indirect signs or the operator's experience for judgment. This not only increases the complexity of the surgical procedure but also raises the risk of serious complications such as accidental occlusion of the renal artery or misplacement of the iliac artery due to inaccurate balloon localization.

[0005] Reference 1 discloses a balloon assembly comprising an inner inflatable balloon fluid-tightly attached to the distal end of a carrier catheter, the inner balloon providing an inner cavity; and an outer inflatable balloon concentrically disposed above the inner balloon, the outer balloon fluid-tightly attached to the distal end of the catheter and providing an outer cavity; wherein the outer balloon encloses the inner balloon, and wherein the expansion diameter of the inner balloon is such that the inner balloon does not cause the outer balloon to unwrap; the inner and outer balloons are independently inflatable; and an echo fluid source configured to be coupled to the first inner cavity, thereby allowing the inner balloon to expand using the echo fluid. The balloon assembly can, through the expansion of the inner balloon, contain sufficient air or other echo fluid for easy visualization under ultrasound imaging. However, the presence of cavities in the inner and outer balloons of this balloon assembly may still result in some degree of positioning inaccuracy.

[0006] Reference 2 discloses an ultrasound catheter therapy device and its usage method. The device includes an ultrasound catheter, an ultrasound transducer, a pressure sensor, a pressure analyzer, and an imaging control assembly. The ultrasound catheter includes a catheter body, a balloon disposed on the catheter body and used to cover the ultrasound transducer, a first tubing, and a second tubing. By installing a pressure sensor on the ultrasound catheter, when the catheter is inserted into the patient's pulmonary artery, the vascular pressures—central venous pressure, right ventricular pressure, and pulmonary artery pressure—are different from those passing through the inferior vena cava to the right ventricle to the pulmonary artery. The pressure sensor transmits the blood pressure data to the pressure analyzer for recording and analysis, thereby determining the effective target point at the patient's detection site. Simultaneously, the imaging control assembly controls the ultrasound transducer to perform ablation treatment on the target point. However, this positioning device relies on pressure changes, limiting its application range.

[0007] Therefore, how to clearly and accurately visualize the position and shape of the balloon under intraoperative ultrasound guidance has become a key technical problem that urgently needs to be solved in this field.

[0008] References:

[0009] Reference 1: GB2533375B

[0010] Reference 2: CN117796880A Summary of the Invention

[0011] The problem the invention aims to solve

[0012] To address the problems of radiation risks, expensive equipment, and inconvenient operation associated with existing abdominal aortic balloon occlusion procedures that rely on X-ray localization, as well as the technical difficulties of unclear balloon imaging and inaccurate localization under intraoperative ultrasound guidance, one of the objectives of this invention is to provide an ultrasound-enhanced balloon that achieves accurate localization and morphological recognition of the balloon under intraoperative ultrasound guidance without relying on X-rays, thereby improving occlusion accuracy and reducing surgical risks. This balloon enables safe, precise, and low-cost blood flow occlusion control, and is particularly suitable for intraoperative hemorrhage intervention in high-risk obstetric surgeries such as placenta accreta.

[0013] In addition, the present invention also provides a method for preparing an ultrasound-enhanced balloon. The coating preparation method used in this method is simple and easy to implement, and the resulting coating has good stability and biocompatibility. It can be applied to a variety of balloon materials and has good versatility and practical application value.

[0014] Furthermore, the present invention also provides an ultrasound-enhanced abdominal aortic occlusion device. This device inflates the balloon provided by the present invention through an injection mechanism, so that it can be clearly visualized under intraoperative ultrasound guidance, which facilitates doctors to identify its location, size and shape in real time and judge the occlusion effect. According to the actual needs of the operation, the inflation degree and occlusion time of the balloon can be adjusted, which can realize real-time monitoring and fine control of the balloon status during the operation to complete the precise blood flow occlusion of the abdominal aorta.

[0015] Solution for solving the problem

[0016] The present invention first provides an ultrasound-enhanced balloon, which includes a balloon body and an ultrasound-enhancing coating, wherein the ultrasound-enhancing coating is coated on the outer surface of the balloon body;

[0017] The ultrasonic imaging enhancement coating includes ultrasonic imaging enhancement particles, silicone polymer, and curing agent.

[0018] The ultrasound imaging enhancement particles include at least one of the following: metal nanoparticles, metal oxide nanoparticles, gas-encapsulated microbubbles, or liquid-encapsulated microbubbles.

[0019] The average particle size of the ultrasonic imaging enhancement particles is 40nm-150nm.

[0020] According to the balloon of the present invention, the ultrasound imaging enhancement particles account for 5% to 30% of the total volume of the ultrasound imaging enhancement coating.

[0021] According to the balloon of the present invention, the average particle size of the ultrasound imaging enhancement particles is 40nm-110nm.

[0022] According to the balloon of the present invention, the silicone polymer comprises polydimethylsiloxane or a modified thereof;

[0023] The curing agent includes methyltriethoxysilane or methyltripropoxysilane.

[0024] According to the balloon of the present invention, the mass ratio of the silicone polymer to the curing agent is 10:1 to 20:1.

[0025] According to the balloon of the present invention, the thickness of the ultrasound imaging enhancement coating is 50 μm-150 μm.

[0026] The present invention also provides a method for preparing an ultrasound-enhanced balloon according to the present invention, which includes the following steps:

[0027] S1: The raw materials for forming ultrasonic imaging enhancement particles, silicone polymer and curing agent are mixed in proportion to obtain a coating;

[0028] S2: After applying the coating to the surface of the balloon body, heat treatment is performed to obtain an ultrasound-enhanced balloon.

[0029] According to the preparation method of the present invention, the heat treatment temperature is 60~100℃ and the time is 60~120min.

[0030] Furthermore, the present invention also provides an ultrasound-enhanced abdominal aortic occlusion device, comprising a balloon and an injection mechanism according to the present invention, wherein the injection mechanism is connected to the balloon body in the balloon.

[0031] According to the device of the present invention, the injection mechanism includes at least one of a syringe, a conduit, and a control valve.

[0032] The effects of the invention

[0033] Through the above technical solution, the present invention has at least the following beneficial effects:

[0034] 1. The ultrasound-enhanced balloon provided by the present invention, by introducing an ultrasound-enhanced coating on the surface of the balloon body, enables the balloon to have good visualization effect under intraoperative ultrasound, realize real-time and clear positioning and status recognition, significantly improve the positioning accuracy of the balloon during surgery, reduce the dependence on the surgeon's experience, and effectively reduce the incidence of complications such as puncture injury and intraoperative bleeding caused by inaccurate positioning.

[0035] 2. The ultrasound-enhanced balloon provided by this invention can achieve real-time positioning and status monitoring of the balloon under pure ultrasound conditions, avoiding the ionizing radiation exposure problem caused by traditional X-ray positioning, ensuring the safety of the mother, fetus and medical staff, while significantly reducing the difficulty of intraoperative operation and equipment dependence, and helping to improve the ability of primary medical institutions to carry out the operation.

[0036] 3. The ultrasound-enhanced balloon provided by this invention possesses excellent material compatibility and clinical applicability. The ultrasound-enhanced coating used in this invention has high film-forming quality and good biocompatibility, and is suitable for various common medical balloon materials and different sizes, exhibiting excellent versatility and feasibility for mass production. This balloon can be directly integrated into existing catheter systems, facilitating rapid product replacement and clinical promotion, and has broad practical value.

[0037] 4. The balloon preparation method used in this invention is simple and easy to implement, and can be applied to a variety of common medical balloon materials and different specifications and sizes, possessing good versatility and practical application value.

[0038] 5. The abdominal aortic occlusion device provided by this invention inflates the balloon through an injection mechanism, allowing it to be clearly visualized under intraoperative ultrasound guidance. This facilitates real-time identification of the balloon's location, size, and shape by the surgeon, enabling assessment of the occlusion effect. The balloon's inflation level and occlusion time can be adjusted according to actual intraoperative needs, allowing for real-time monitoring and precise control of the balloon's status to achieve accurate blood flow occlusion of the abdominal aorta. This device is particularly suitable for high-risk surgical scenarios requiring blood flow control, such as placenta accreta and preoperative assessment for hysterectomy, and has significant clinical implications. Attached Figure Description

[0039] Figure 1 A schematic diagram of the structure of the ultrasound-enhanced abdominal aortic occlusion device provided by the present invention is shown.

[0040] Figure 2 A flowchart illustrating the steps of the abdominal aortic occlusion method based on ultrasound imaging enhancement coating provided in an embodiment of the present invention is shown.

[0041] Figure 3 The ultrasound image of the balloon obtained in Example 1 using TiO2 nanoparticles as ultrasound imaging enhancement particles is shown.

[0042] Figure 4 The image shows an ultrasound image of the balloon obtained in Example 1, which uses TiO2 nanoparticles as ultrasound imaging enhancement particles, in a simulated human body environment.

[0043] Figure 5 The following is an ultrasound image of the balloon obtained by using gas-encapsulated microbubbles as ultrasound imaging enhancement particles in Example 2;

[0044] Figure 6 The ultrasound image of the balloon obtained by using liquid-encapsulated microbubbles as ultrasound imaging enhancement particles in Example 3 is shown.

[0045] Figure 7 An ultrasound image of a conventional balloon in Comparative Example 1 is shown;

[0046] Figure 8 The ultrasound image of the conventional balloon in Comparative Example 1 under a simulated human body environment is shown;

[0047] Figure 9 An ultrasound image of the balloon in Comparative Example 2 is shown;

[0048] Figure 10 An ultrasound image of the balloon in Comparative Example 3 is shown.

[0049] Explanation of reference numerals in the attached figures:

[0050] 1. Balloon body; 2. Ultrasonic imaging enhancement particles; 3. Ultrasonic imaging enhancement coating; 4. Balloon outer membrane; 5. Catheter; 6. Control valve. Detailed Implementation

[0051] The present invention will now be described in detail. The descriptions of the technical features described below are based on representative embodiments and specific examples of the present invention, but the present invention is not limited to these embodiments and specific examples. It should be noted that:

[0052] In this specification, the range of values ​​referred to as "value A to value B" refers to the range including the endpoint values ​​A and B.

[0053] In this specification, the numerical range indicated by "above" or "below" refers to the numerical range that includes the stated number.

[0054] In this specification, the word "may" has two meanings: to perform a certain process and not to perform a certain process.

[0055] In this specification, the terms "optional" or "optional" are used to indicate the use or omission of certain substances, components, procedures, application conditions, etc.

[0056] In this instruction manual, "normal temperature" or "room temperature" refers to an indoor ambient temperature of "23±2℃".

[0057] All unit names used in this manual are international standard unit names, and unless otherwise stated, the "%" indicates weight or mass percentage.

[0058] In this specification, the term "substantially" is used to indicate that the standard deviation from the theoretical model or theoretical data is within a range of 5%, preferably 3%, and more preferably 1%.

[0059] In this specification, the terms “comprising” and / or “including” are used to indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0060] In this specification, references to "some specific / preferred embodiments," "other specific / preferred embodiments," "implementation," etc., refer to specific elements (e.g., features, structures, properties, and / or characteristics) related to that embodiment, which are included in at least one of the embodiments described herein and may or may not be present in other embodiments. Furthermore, it should be understood that these elements may be combined in any suitable manner in various embodiments.

[0061] This invention mainly provides an ultrasound-enhanced balloon, its preparation method, and an ultrasound-enhanced abdominal aortic occlusion device. This invention is based on the following insights:

[0062] It is known that current abdominal aortic balloon occlusion procedures primarily rely on X-ray localization for clear imaging and reliable positioning. However, this method carries radiation risks, hindering its widespread application. While ultrasound-assisted balloon localization eliminates radiation concerns, existing balloon materials exhibit poor imaging performance under ultrasound, making it difficult to directly and accurately display the balloon's specific location, size, and shape. This increases the complexity of the surgical procedure and the risk of complications due to operational errors.

[0063] Through long-term research, the inventors discovered that specific particle materials can generate significant echo signals under the action of ultrasound. By coating the surface of the balloon with this particle material, the imaging clarity of the balloon boundary can be effectively enhanced. Combined with silicone polymers with good biocompatibility, flexibility and film-forming properties, a coating with excellent structural stability and adhesion is formed, which can ensure sufficient ultrasound imaging capabilities without affecting the balloon's expansion performance and intravascular passage.

[0064] Furthermore, the ultrasound-enhanced abdominal aortic occlusion device inflates the ultrasound-enhanced balloon through an injection mechanism, allowing it to be clearly visualized under intraoperative ultrasound guidance. This facilitates real-time identification of its location, size, and shape by the surgeon, enabling them to assess the occlusion effect. The balloon inflation level and occlusion time can be adjusted according to the actual needs during the procedure.

[0065] [First aspect]

[0066] A first aspect of the present invention provides an ultrasound-enhanced balloon, comprising a balloon body and an ultrasound-enhancing coating, wherein the ultrasound-enhancing coating is coated on the outer surface of the balloon body.

[0067] (Balloon body)

[0068] The material of the balloon body of the present invention is not particularly limited, and commonly used medical elastic materials in the art can be used, which have good expandability and biocompatibility.

[0069] There is no particular limitation on the size of the balloon body of the present invention, and balloon bodies of different models, sizes and shapes can be selected according to the needs of actual applications.

[0070] (Ultrasound imaging enhancement coating)

[0071] The ultrasound imaging enhancement coating of the present invention comprises ultrasound imaging enhancement particles, silicone polymer and curing agent. The coating has good biocompatibility and stable ultrasound imaging capability, and is mainly used to improve the imaging capability of balloons under intraoperative ultrasound imaging.

[0072] The ultrasound imaging enhancement particles are particle materials with good acoustic impedance differences, good acoustic scattering, and ultrasonic echo characteristics. Specifically, they include at least one of metal nanoparticles, metal oxide nanoparticles, gas-encapsulated microbubbles, or liquid-encapsulated microbubbles. Preferably, these particles have a substantially spherical shape. Under the action of ultrasound, these particles can generate significant echo signals, thereby enhancing the imaging clarity of the balloon boundary.

[0073] The metal elements in the metal nanoparticles and metal oxide nanoparticles may include at least one of Ti, Ni, Zn, Co, etc.

[0074] The gas in the gas-encapsulated microbubbles can be at least one of the following: air, nitrogen, etc.

[0075] The liquid encapsulated in the microbubble should be human-friendly and should not be miscible or diffuse with the silicone polymer used to ensure the stability of the microbubble structure and the consistency of imaging. For example, the liquid may include silicone oil.

[0076] In some specific implementations, the ultrasonic imaging enhancement particles account for 5% to 30% of the total volume of the ultrasonic imaging enhancement coating, for example, 10%, 15%, 20%, 25%, etc.

[0077] In some preferred embodiments, when the ultrasound imaging enhancement particles are metal nanoparticles or metal oxide nanoparticles, the ultrasound imaging enhancement particles account for 5% to 10% of the total volume of the ultrasound imaging enhancement coating; when the ultrasound imaging enhancement particles are gas-encapsulated microbubbles or liquid-encapsulated microbubbles, the ultrasound imaging enhancement particles account for 20% to 30% of the total volume of the ultrasound imaging enhancement coating.

[0078] In this invention, the average particle size of the ultrasonic imaging enhancement particles can be 40nm-150nm, such as 50nm, 60nm, 70nm, 80nm, 90nm, 100nm, 110nm, 120nm, 130nm, 140nm, etc. It has been found that if the particle size is too small, it may lead to problems with the uniformity of dispersion in the silicone system, resulting in a deterioration in the final image quality.

[0079] The silicone polymer, used as the base material for the coating, exhibits good biocompatibility, flexibility, and film-forming properties, ensuring strong coating adhesion and long-lasting performance without affecting the balloon's elasticity. In some preferred embodiments, the silicone polymer may include polydimethylsiloxane (PDMS) and its modified forms. Furthermore, for modified silicone polymers, liquid silicone rubber (LSR) at room temperature is preferred.

[0080] The curing agent can cross-link with the silicone polymer to form a dense and stable three-dimensional network structure, giving the coating excellent structural stability and adhesion, resulting in a structurally stable imaging enhancement layer. In some specific embodiments, the curing agent can be selected from condensation-type curing agents, typically including methyltriethoxysilane, methyltripropoxysilane, methyltriacetoxysilane, etc.

[0081] In some specific implementations, the mass ratio of the silicone polymer to the curing agent can be 10:1 to 20:1, for example, 12:1, 15:1, 18:1, etc.

[0082] Regarding the thickness of the coating, considering both imaging performance and flexibility, the thickness of the ultrasound imaging enhancement coating can be 50μm-150μm, such as 60μm, 80μm, 100μm, 120μm, 140μm, etc. When the coating thickness is within the above range, it can ensure that the ultrasound imaging capability is fully improved without affecting the balloon's expansion performance and intravascular passage.

[0083] [Second aspect]

[0084] A second aspect of the present invention provides a method for preparing a balloon according to the first aspect, comprising the following steps:

[0085] S1: The raw materials for forming ultrasonic imaging enhancement particles, silicone polymer and curing agent are mixed in proportion to obtain a coating;

[0086] S2: After applying the coating to the surface of the balloon body, heat treatment is performed to obtain an ultrasound-enhanced balloon.

[0087] The materials and dosage specifications of the ultrasound imaging enhancement particles, silicone polymer, curing agent, and balloon body are the same as those described in the first aspect, and will not be repeated here.

[0088] For the raw materials used to form ultrasound imaging enhancement particles, when metal nanoparticles or metal oxide nanoparticles are used as ultrasound imaging enhancement particles, the raw materials can be metal or metal oxide nanoparticle powder, etc.; when gas-encapsulated microbubbles are used as ultrasound imaging enhancement particles, the raw materials can be deionized water, etc., and the deionized water is evaporated during subsequent heating treatment, leaving microbubble cavities, thereby forming a gas-encapsulated structure; when liquid-encapsulated microbubbles are used as ultrasound imaging enhancement particles, the raw materials can be liquid developer, and the specific types are as described in the first aspect.

[0089] There is no particular limitation on the amount of the raw materials used, as long as the volume fraction described in the first aspect is met.

[0090] The present invention does not specifically limit the mixing method. To ensure sufficient and uniform dispersion of the ultrasonic imaging enhancement particles, silicone polymer, and curing agent, and to provide consistent coating quality for subsequent coating and curing, a mixing device can be used. The present invention does not specifically limit the mixing device; for example, it can be a high-speed mixing device commonly used in the art, capable of mixing for 1 to 3 minutes at a rotation speed of 4000 to 6000 r / min.

[0091] The present invention does not specifically limit the coating method; common methods such as spraying can be used for coating.

[0092] In some specific embodiments, the coating method may involve transferring the homogenized ultrasonic imaging enhancement coating to a spraying device and applying it using a precision spray gun driven by compressed air. Preferably, the nozzle diameter of the spray gun can be controlled between 0.2 and 0.5 mm, and the spraying pressure can be controlled between 0.2 and 0.3 MPa to ensure uniform atomization and avoid droplet accumulation that could lead to uneven coating.

[0093] In some more specific embodiments, during the spraying process, the balloon body should remain rotated or move at a constant speed to ensure that the coating evenly covers the outer surface of the balloon. Preferably, an electric turntable combined with a moving spray head can be used for automated coating. The balloon rotation speed can be controlled at 20 rpm, the spraying distance at 5-15 cm, and the spraying speed at 2 cm / s to avoid local over- or under-coating.

[0094] Furthermore, to obtain a multi-layered coating of uniform thickness, the spraying process can employ a strategy of multiple coats and layered drying. After each layer of film is sprayed, it should be allowed to stand for 5-10 minutes to allow the coating to initially form a film and for some solvent to evaporate before applying the next layer. The final total coating thickness should be controlled within the aforementioned range of 50-150 μm, with the number of coats and thickness adjusted according to the balloon model and the target imaging intensity.

[0095] In some preferred embodiments, the spraying environment should be controlled within the range of relative humidity 40-60% and temperature 20-25°C to avoid the influence of moisture or dust in the air on the coating structure and to ensure that the surface of the imaging enhancement layer is smooth, uniform and free of particle deposits or bubble inclusions.

[0096] The heat treatment process is used to drive the cross-linking reaction between the silicone polymer and the curing agent, further improving the mechanical strength, adhesion performance and environmental stability of the coating.

[0097] In some specific implementations, the heat treatment temperature can be 60~100℃, such as 75℃, 80℃, 90℃, etc.; the time can be 60~120min, such as 70min, 80min, 90min, 100min, 110min, etc. The heat treatment temperature can be either staged heating or constant temperature treatment, which can be adjusted as needed. The specific heat treatment time can be appropriately adjusted according to the coating thickness and the performance of the curing agent used to ensure that the crosslinking reaction is fully carried out and the coating structure is uniform and dense. For example, if the coating contains volatile components (such as deionized water used in the gas-encapsulated microbubble scheme) during the heat treatment process, the heating time should be appropriately extended (e.g., staged heating to 80℃, preheating for 10min, and then continuous heating for 110min) to avoid rapid liquid evaporation causing pores or coating cracking.

[0098] The present invention does not particularly limit the equipment used for the heat treatment; it can be a commonly used heating device, such as a hot air circulating oven.

[0099] Furthermore, after heat treatment, the balloon should be slowly cooled to room temperature to avoid stress concentration or peeling of the coating due to sudden cooling. After the surface temperature of the balloon returns to room temperature, its surface can be visually inspected and blew using a lint-free cloth or compressed gas to confirm the continuity of the coating and surface quality, and samples with peeling, sagging, or significant bubbles should be discarded.

[0100] In some specific implementations, the surface coating stability and ultrasound imaging performance of the heat-treated balloon reach their optimal state after being left at room temperature for 24 hours.

[0101] In some preferred embodiments, the preparation method may include the following steps:

[0102] S1. Preparation of ultrasonic imaging enhancement coating. Ultrasonic imaging enhancement particles, silicone polymer, and curing agent are mixed in a predetermined ratio to obtain a composite coating with significant imaging capabilities.

[0103] Further, step S1 includes:

[0104] S11. Based on the expected imaging performance requirements, select appropriate imaging particle types, including metal nanoparticles, metal oxide nanoparticles, gas-encapsulated microbubbles, or liquid-encapsulated microbubbles, and use them together with silicone polymers (preferably PDMS) and curing agents (such as methyltriethoxysilane) as raw materials.

[0105] S12. Weigh the above three raw materials according to the mass ratio, with the preferred volume fraction of metal / metal oxide nanoparticles being 5%, and the preferred volume fraction of gas-encapsulated microbubbles and liquid-encapsulated microbubbles being 30%.

[0106] S13. Use a centrifugal mixer to mix at 5000r / min for 2 minutes to ensure uniform particle dispersion and obtain the ultrasonic imaging enhancement coating required for uniform coating.

[0107] S2. Application and curing to form an imaging enhancement coating. The coating is uniformly applied to the outer surface of the balloon body using a spraying process, and a stable ultrasonic imaging enhancement coating is formed through heat treatment.

[0108] Further, step S2 includes:

[0109] S21. Use a spray gun to spray the surface of the balloon body in multiple layers, control the spraying pressure at 0.2~0.3MPa, and keep the spraying distance between 10~15cm to ensure the uniformity and continuity of the spraying.

[0110] S22. After each layer is sprayed, let it stand for 5 to 10 minutes to allow the solvent to partially evaporate before spraying the next layer. The final coating thickness should be controlled between 50 and 150 μm.

[0111] S23. After spraying, place the balloon in an 80℃ constant temperature oven for 60~120 minutes for heat treatment to allow the coating to cross-link and cure, forming a dense structure with stable ultrasonic imaging performance.

[0112] [Third aspect]

[0113] A third aspect of the present invention provides an ultrasound-enhanced abdominal aortic occlusion device comprising a balloon and an injection mechanism as described in the first aspect, the injection mechanism being connected to a balloon body within the balloon.

[0114] The injection mechanism is mainly used to precisely adjust the volume of injected liquid or gas within the balloon, regulating the balloon's inflation state during surgery to control its volume changes. Specifically, it can adopt the structural form commonly used in existing medical balloons, typically including a syringe, catheter, and control valve assembly, which has advantages such as high inflation control precision and convenient operation.

[0115] This invention does not substantially alter the structure of the injection mechanism; therefore, its structural details can be found in existing clinical products and will not be repeated here.

[0116] The ultrasound-enhanced abdominal aortic occlusion device provided by this invention can achieve precise blood flow occlusion of the abdominal aorta. In some specific embodiments, the occlusion method can refer to... Figure 2 .

[0117] Specifically, in combination Figure 2 Each step is described.

[0118] Steps S1 and S2 have already been described in the preparation method described in the second aspect, and will not be repeated here.

[0119] S3. Implantation and positioning of the balloon. The balloon described in the first aspect is delivered to the target site in the abdominal aorta via a guidewire and catheter, preferably positioned between the renal artery orifice and the bifurcation of the abdominal aorta.

[0120] Further, step S3 includes:

[0121] S31. Under intraoperative ultrasound guidance, the balloon morphology is identified through images and the catheter position is adjusted step by step;

[0122] S32. Ensure the balloon is positioned in the center of the target segment, without strong contact or deviation with the arterial wall, to guarantee the effectiveness and safety of subsequent inflation and occlusion.

[0123] S4. Inflate the balloon and achieve intraoperative imaging. The balloon is controlled to inflate using an injection mechanism, allowing it to be clearly visualized under ultrasound imaging. Doctors can identify the balloon's position, size, and inflation status in real time, thereby assessing the effectiveness of the occlusion.

[0124] Further, step S4 includes:

[0125] S41. Slowly inject physiological saline or contrast fluid using a syringe, and adjust the injection speed and volume according to real-time ultrasound feedback.

[0126] S42. Observe the adhesion between the balloon and the blood vessel wall. If there is insufficient filling or over-inflation, the pressure should be adjusted immediately through the control valve to prevent the balloon from slipping or causing damage to the blood vessel.

[0127] S5. Adjusting the occlusion parameters intraoperatively and achieving precise occlusion. Based on the actual situation during the procedure, the surgeon can adjust the balloon inflation level and duration as needed to achieve precise control and intervention of blood flow.

[0128] Further, step S5 includes:

[0129] S51. During critical stages of the operation (such as placental abruption and uterine suturing), the balloon pressure is adjusted in real time according to changes in blood loss.

[0130] S52. After the blockade is completed, slowly depressurize to ensure that the balloon is withdrawn smoothly without causing damage to the blood vessels;

[0131] S53. Record ultrasound images and filling parameters throughout the entire blocking process to facilitate postoperative follow-up and device evaluation.

[0132] Example

[0133] The embodiments of the present invention will be described in detail below with reference to examples. However, those skilled in the art will understand that the following examples are for illustrative purposes only and should not be considered as limiting the scope of the invention. Unless otherwise specified in the examples, conventional conditions or conditions recommended by the manufacturer are followed. Reagents or instruments whose manufacturers are not specified are all commercially available conventional products.

[0134] Example 1

[0135] In this embodiment, a balloon coated with a TiO2 nanoparticle-reinforced coating was prepared, and its ultrasonic imaging performance and morphological recognition performance were verified through experiments. The specific steps are as follows:

[0136] S1: Weigh 22.53g of polydimethylsiloxane, 2.25g of methyltriethoxysilane and 5.2g of TiO2 nanoparticles (average particle size of about 40nm), place the three together in a mixer and mix for 2min at a speed of 5000 r / min to obtain a uniform emulsion coating.

[0137] S2: Apply multiple layers of spray paint to the outer surface of the medical balloon using a spray gun, with a 5-minute interval between each application to ensure uniform film formation. After spraying, place the balloon in an 80℃ hot air oven for 120 minutes to allow the coating to fully cross-link and cure, forming a dense and stable ultrasound imaging enhancement coating with a final thickness of approximately 100μm.

[0138] S31: Connect the treated balloon to the standard injection mechanism and place it in the water tank.

[0139] S41: Under B-mode ultrasound guidance, the balloon is slowly inflated, and its imaging status is recorded. The balloon's edges are clearly visible, with strong reflection and a well-defined shape. Figure 3 As shown.

[0140] S32: Connect the processed balloon to the standard injection mechanism and place it in a water tank. Use two pieces of raw meat tissue to sandwich the balloon body in the middle to simulate the internal environment of the human body.

[0141] S42: Under B-mode ultrasound guidance, the balloon is slowly inflated, and its imaging status is recorded. The balloon's edges are clearly visible, with strong reflection and a well-defined shape. Figure 4 As shown.

[0142] Example 2

[0143] In this embodiment, an ultrasound imaging enhancement coating balloon coated with gas-encapsulated microbubbles was prepared, and its performance was verified. The specific steps are as follows:

[0144] S1: Weigh 6.3g of polydimethylsiloxane, 0.7g of methyltriethoxysilane, and 3.0g of deionized water. Add them to a mixer and mix at 5000r / min for 2min to obtain a mixed coating precursor containing deionized water.

[0145] S2: The obtained mixture is uniformly sprayed onto the outer surface of the balloon and placed in an 80℃ oven for heat treatment for 120 minutes. During the heat treatment, the moisture gradually evaporates, forming a large number of tiny cavities, which constitute a coating with a gas-encapsulated microbubble structure, with a thickness of about 120μm, wherein the size of the gas-encapsulated microbubble is about 100nm.

[0146] S3: Connect the balloon to the injection catheter system and place it in the water tank.

[0147] S4: Observe the imaging effect under ultrasound imaging conditions. Experimental results show that a large number of microbubbles in the coating cause a significant acoustic scattering effect, enhancing the contrast of the balloon interface, clarifying the edge structure, and demonstrating good real-time imaging performance, such as... Figure 5 As shown.

[0148] Example 3

[0149] In this embodiment, a balloon with a liquid-encapsulated microbubble structure was prepared, and its imaging performance and blocking ability were verified. The specific steps are as follows:

[0150] S1: Select an immiscible and biocompatible developing liquid (silicone oil), weigh 3.0g as reinforcing particles, and add it together with 6.7g of polydimethylsiloxane and 0.7g of methyltriethoxysilane into a mixer. Mix at 5000r / min for 2min to obtain a homogeneous coating.

[0151] S2: A layered atomized spraying method is used to apply the coating to the outer surface of the balloon. After spraying, it is heat-treated at 80℃ for 90 minutes. During the process, the developing liquid is encapsulated by the micro-shell structure to form a stable liquid-encapsulated microbubble reinforcement layer with a final thickness of about 110 μm. The size of the liquid-encapsulated microbubbles is about 100 nm.

[0152] S3: Place the processed balloon into the water tank, inflate the balloon with a syringe, and simultaneously turn on ultrasound for real-time observation.

[0153] S4: The liquid microbubble coating produces high-contrast echoes for sound waves, resulting in uniform signal within the imaging area and clear, continuous contour edges, facilitating real-time monitoring of the balloon's status by the operator. Figure 6 As shown.

[0154] Comparative Example 1

[0155] This comparative example uses a traditional balloon and completes performance verification experiments as well as ultrasound imaging and morphological recognition performance verification experiments in a simulated human body environment. The specific steps are as follows:

[0156] S11: A traditional balloon is placed in a water tank, inflated using a syringe, and simultaneously monitored with real-time ultrasound. Results are as follows: Figure 7 As shown.

[0157] S12: Connect a traditional balloon to a standard injection mechanism and place it in a water tank. Use two pieces of raw meat tissue to sandwich the balloon body in the middle to simulate the internal environment of the human body.

[0158] S22: The balloon is slowly inflated under B-mode ultrasound guidance, and its imaging status is recorded. Blurred edges and indistinct shape of the balloon can be observed, such as... Figure 8 As shown.

[0159] Comparative Example 2

[0160] Same as Example 1, but without TiO2 nanoparticles, the final detection image is as follows. Figure 9 As shown, the results are similar to those of traditional balloons, with blurred edges and unclear shape. This demonstrates that without TiO2 nanoparticles, the imaging effect cannot be enhanced.

[0161] Comparative Example 3

[0162] Same as Example 2, but without using deionized water; the final detection image is as follows. Figure 10 As shown, the results are similar to those of traditional balloon catheters, with blurred edges and unclear shape. This demonstrates that without deionized water, the imaging enhancement effect cannot be achieved because gas-encapsulated microbubbles cannot be formed.

[0163] It should be noted that although the technical solution of the present invention has been described with specific examples, those skilled in the art will understand that the present invention should not be limited thereto.

[0164] The various embodiments of the present invention have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles, practical application, or technical improvements to the embodiments in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

Claims

1. A balloon with enhanced ultrasound imaging, characterized in that, It includes a balloon body and an ultrasound imaging enhancement coating, wherein the ultrasound imaging enhancement coating is applied to the outer surface of the balloon body; The ultrasonic imaging enhancement coating includes ultrasonic imaging enhancement particles, silicone polymer, and curing agent. The ultrasound imaging enhancement particles include at least one of the following: metal nanoparticles, metal oxide nanoparticles, gas-encapsulated microbubbles, or liquid-encapsulated microbubbles. The average particle size of the ultrasonic imaging enhancement particles is 40nm-150nm.

2. The balloon according to claim 1, characterized in that, The ultrasonic imaging enhancement particles account for 5% to 30% of the total volume of the ultrasonic imaging enhancement coating.

3. The balloon according to claim 1 or 2, characterized in that, The average particle size of the ultrasonic imaging enhancement particles is 40nm-110nm.

4. The balloon according to any one of claims 1 to 3, characterized in that, The silicone polymer includes polydimethylsiloxane or its modified form; The curing agent includes methyltriethoxysilane or methyltripropoxysilane.

5. The balloon according to any one of claims 1 to 4, characterized in that, The mass ratio of the silicone polymer to the curing agent is 10:1 to 20:

1.

6. The balloon according to any one of claims 1 to 5, characterized in that, The thickness of the ultrasonic imaging enhancement coating is 50μm-150μm.

7. A method for preparing an ultrasound-enhanced balloon according to any one of claims 1 to 6, characterized in that, Includes the following steps: S1: The raw materials for forming ultrasonic imaging enhancement particles, silicone polymer and curing agent are mixed in proportion to obtain a coating; S2: After applying the coating to the surface of the balloon body, heat treatment is performed to obtain an ultrasound-enhanced balloon.

8. The preparation method according to claim 7, characterized in that, The heat treatment temperature is 60~100℃ and the time is 60~120min.

9. An ultrasound-enhanced abdominal aortic occlusion device, characterized in that, It includes a balloon and an injection mechanism according to any one of claims 1 to 6, wherein the injection mechanism is connected to the balloon body in the balloon.

10. The apparatus according to claim 9, characterized in that, The injection mechanism includes at least one of a syringe, a catheter, and a control valve.

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