Ultrasound-guided arterial intervention embolism hemostasis device

Abstract

The invention relates to the technical field of medical equipment, in particular to an ultrasound-guided arterial intervention embolism hemostasis device which is adopted in battlefield or field environment and under the condition that conventional X-ray developing equipment cannot reach, the ultrasound-guided arterial intervention embolism hemostasis device comprises an arterial puncture suite and a guide wire, the head end of the guide wire is provided with a nano-silver ion plating layer, and the ultrasound-guided arterial intervention embolism hemostasis device can resist bacteria and enhance developing under ultrasound; the guide wire is arranged at the proximal end of an artery rupture point, the balloon is arranged at the head end of the guide wire, the balloon can be filled with normal saline through a high-pressure injector after the catheter is positioned, and the purposes of mechanically blocking blood flow in the artery and stopping bleeding are achieved. Under the guidance of the artery puncture suite and the guide wire, under the condition that no DSA and other X developing devices exist in the field, the artery puncture intervention technology is adopted, the balloon catheter embolism ruptured artery is arranged, the hemostasis effect is achieved, and the technology is particularly suitable for battlefield application.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to an ultrasound-guided arterial interventional embolization hemostasis device. BACKGROUND

[0002] Due to the wide application of large-scale explosions, fragmentary weapons and personnel-killing landmines in modern wars, the limb and facial injuries of combatants have significantly increased. In such cases, the only way to stop the bleeding of the artery rupture is to use a tourniquet to compress the bleeding or to use an external pressure hemostatic dressing. However, the hemostatic effect of these methods is poor in the process of rescuing the large artery rupture.

[0003] Interventional embolization is a minimally invasive interventional treatment technology, which is an important part of interventional radiology. It is guided by medical imaging equipment (such as DSA) to send specially designed embolic materials into the blood vessels or lumens of the lesion site through the blood vessels or non-blood vessels, so as to block the blood flow, cut off the blood supply of the lesion tissue, or occlude the abnormal channel, so as to achieve the purpose of treating diseases. For sending embolic materials to the designated location, the existing Kangyi Medical Guide Wire includes a guide wire, which is composed of a stainless steel core and a spring coil sheath. The surface of the guide wire is provided with a hydrophilic coating on the side close to the blood vessel, which forms a lubricating film after encountering water, thereby reducing the resistance of the blood vessel and being suitable for passing through narrow or twisted blood vessels. The surface of the guide wire is provided with a hydrophobic coating on the side away from the blood vessel, which reduces the friction between the guide wire and the inner wall of the catheter, and improves the smoothness of the pushing. Under the real-time image monitoring of DSA, the guide wire is sent into the blood vessel through the catheter sheath, and by pushing and rotating the guide wire, it gradually passes through the blood vessel branches (such as the aorta→the carotid artery→the intracranial artery), and reaches the target lesion site (such as an aneurysm, a tumor-feeding artery).

[0004] In actual implementation, although the guide wire can be positioned in real time through the cooperation of the guide wire and the image of DSA, and then the guide wire is pushed to the designated location for arterial hemostasis; however, the DSA machine is large in size, requires a large amount of power supply, and needs to be operated in a radiation protection environment, which is not suitable for field conditions and front-line battlefield applications.

[0005] Therefore, the present application provides an ultrasound-guided arterial interventional embolization hemostasis device to solve the above problems. SUMMARY

[0006] To solve the above problems, the present application provides an ultrasound-guided arterial interventional embolization hemostasis device, which is guided by an arterial puncture kit and a guide wire. Under the condition of no X-ray imaging equipment such as DSA in the field, the arterial puncture interventional technology is used to place a balloon catheter into the ruptured artery for hemostasis. This technology is especially suitable for battlefield applications.

[0007] In order to achieve the above object, the technical scheme of the present application is as follows: An ultrasound-guided arterial interventional embolization hemostasis device comprises an arterial puncture kit and a guide wire, the arterial puncture kit is provided with a controller, one end of the guide wire is fixedly connected with a head end, a balloon catheter is sleeved on the guide wire, the guide wire is in a linear structure, a first coating is arranged on one side of the surface of the guide wire close to the head end, a plurality of second coatings are arranged on one side of the surface of the guide wire away from the head end, the materials of the first coating and the second coating are both made of silver nanoparticles, and a positioning assembly for positioning the head end is arranged on the head end.

[0008] The technical principle of the above scheme is as follows: the position of the guide wire with the coating is detected by the arterial puncture kit through the good ultrasonic reflection characteristics of the silver nanoparticles of the first coating and the second coating, and the positioning of the guide wire and the accurate positioning of the head end are realized in combination with the positioning assembly, after the positioning is completed, the balloon catheter is sleeved on the guide wire and the balloon reaches the specified position along the guide wire path, and the intravascular mechanical compression hemostasis is realized by inflating the balloon.

[0009] The above scheme has the following beneficial effects: compared with the prior art, the present scheme does not need to rely on large image equipment, reduces the demand for operation space, has accessibility in the field and battlefield conditions, and the actual operation is simple, and medical personnel can master the kit after short-term training in practice; the guide wire can be accurately positioned under the action of ultrasound through the cooperation of the silver nanoparticle coating and the positioning assembly; the silver nanoparticles can reduce the formation of bacterial biofilm, effectively inhibit bacterial growth, prevent infection during vascular intervention, and improve safety.

[0010] Further, the positioning assembly comprises a plurality of grooves, the grooves are all opened on the surface of the head end, and corresponding silver ion balls are embedded in the grooves.

[0011] Beneficial effect: by embedding the silver ion balls in the grooves, the ultrasonic waves can be reflected at multiple angles, the signal attenuation is reduced, the reflection intensity is further enhanced, the silver ion balls serve as ultrasonic reflection enhancement points, and the spatial positioning of the head end in the blood vessel is further assisted.

[0012] Further, the spacing between the second coatings is equal.

[0013] Beneficial effect: by arranging the second coatings at equal intervals, the surface of the guide wire forms regularly distributed ultrasonic markers, the signal interval corresponding to the second coating interval is detected by the arterial puncture kit, and thus the depth and movement distance of the guide wire into the blood vessel are calculated.

[0014] Further, the thickness of the second coatings is all set to 1 mu m, and the thickness of the first coating is set to 2 mu m.

[0015] Beneficial effects: through the thickness difference of the first coating layer and the second coating layer, the guide wire can be marked in different zones, the first coating layer near the head end reflects a stronger signal due to its greater thickness, while the second coating layer reflects a weaker signal due to its smaller thickness, but the regular distribution of the second coating layer can serve as an auxiliary marker for depth reference; the differentiated markers can distinguish the head end group markers from the depth auxiliary markers, avoiding signal confusion and further improving accuracy.

[0016] Further, a temperature-sensitive hydrogel is provided on the surface of the first coating layer.

[0017] Beneficial effects: the temperature-sensitive hydrogel is in a solid or semi-solid state at low temperature (such as room temperature or in vitro storage temperature), covering the surface of the first coating layer to prevent the first coating layer from being worn or falling off due to friction and collision during storage, transportation or preoperative preparation; at body temperature, the temperature-sensitive hydrogel undergoes a phase change from solid to gel, and after the phase change, the temperature-sensitive hydrogel becomes loose, reducing the coverage of the first coating layer, and thus the silver ions in the first coating layer are released, enhancing the antibacterial effect; at the same time, the temperature-sensitive hydrogel after the phase change is closer to the physiological environment, which can reduce the friction coefficient of the guide wire surface, and thus reduce the stimulation to the vascular endothelial cells and the risk of inflammation.

[0018] Further, an optical fiber sensor is embedded in the head end, and the optical fiber sensor is signal connected with the controller.

[0019] Beneficial effects: the temperature and blood oxygen parameters of the environment in which the head end is located are monitored in real time through the optical fiber sensor, and the physiological index reference is provided for embolization operation to avoid excessive embolization or tissue ischemia.

[0020] Further, a pressure sensor is embedded in the head end, and the pressure sensor is signal connected with the controller.

[0021] Beneficial effects: the pressure in the blood vessel is monitored in real time through the pressure sensor, and the pressure value can prevent the blood vessel wall from being excessively contacted to cause perforation, as well as the blood flow blockage effect after embolization, and the sudden drop of the pressure value indicates the success of embolization, improving the controllability of operation safety and hemostasis effect.

[0022] Further, the head end is designed as a conical blunt structure.

[0023] Beneficial effects: the conical blunt structure design facilitates the separation of tissues during the advancement of the guide wire to reduce resistance, and at the same time avoids scratching the blood vessel wall during the advancement process, reducing the risk of blood vessel damage.

[0024] Further, a heparin molecule coating layer is grafted on the surface of the second coating layer.

[0025] Beneficial effects: Heparin molecules inhibit thrombin activity, preventing platelet aggregation on the guidewire surface. This prevents blood clots from forming on the guidewire surface and within the blood vessel, prolonging the guidewire's manipulation time within the blood vessel, reducing the need for additional anticoagulants, and lowering the risk of bleeding complications.

[0026] Furthermore, the thickness of both the thermosensitive hydrogel and the heparin molecular coating is less than 1 μm.

[0027] Beneficial effects: By controlling the thickness of the thermosensitive hydrogel and the heparin molecular coating, biocompatibility and anticoagulation effects are ensured, while the functions of the first and second coatings are not affected.

[0028] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0029] Figure 1 This is an overall isometric view of an embodiment of the ultrasound-guided arterial interventional embolization hemostasis device of the present invention; Figure 2 This is a lateral sectional view of the head end of an embodiment of the ultrasound-guided arterial interventional embolization hemostasis device of the present invention; Figure 3 This is an appendix to an embodiment of the ultrasound-guided arterial interventional embolization hemostasis device of the present invention. Figure 2 -Detailed drawing at point A.

[0030] The reference numerals in the accompanying drawings include: 1. guidewire; 2. tip; 3. first coating; 4. second coating; 5. groove; 6. silver ion ball. Detailed Implementation

[0031] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0032] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0033] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0034] The following detailed description illustrates the specific implementation method: Example

[0035] As attached Figure 1 As shown: An ultrasound-guided arterial interventional embolization hemostasis device includes an arterial puncture kit (arterial seldering puncture kit) and a guidewire 1. The arterial puncture kit contains a controller, preferably an STM32H743 model. One end of the guidewire 1 is integrally formed and fixedly connected to a tip 2, which is a tapered blunt rounded structure. An optical fiber sensor and a pressure sensor are embedded in the tip 2, both of which are connected to the controller. A balloon catheter is fitted onto the guidewire 1, which is a linear structure. Due to the urgency of battlefield injuries, patients are highly susceptible to rupture of the femoral artery and facial arterial network, resulting in massive blood loss in a short time, followed by hemorrhagic shock and loss of rescue opportunity. External pressure alone is extremely difficult to use for hemostasis. Clinically, vascular interventional techniques are used for endovascular compression hemostasis, but on the battlefield, precise and rapid treatment is needed to effectively save lives. To achieve more precise positioning of the vascular intervention, as shown in the attached... Figure 1 and attached Figure 2 As shown, the guidewire 1 has a first coating 3 on the side near the tip 2, with a thickness of 2 μm. The guidewire 1 has several second coatings 4 on the side away from the tip 2, with equal spacing and a thickness of 1 μm between each coating. Both the first coating 3 and the second coating 4 are made of electroplated silver nanoparticles. Silver nanoparticles have excellent ultrasonic reflection properties, allowing the arterial puncture kit to detect the coating positions. The tip 2 is equipped with a positioning component for positioning the tip 2, as shown in the attached diagram. Figure 3 As shown, the positioning component includes several grooves 5, all of which are opened on the surface of the head end 2, and each groove 5 contains a corresponding silver ion ball 6.

[0036] The specific implementation process is as follows: When arterial hemostasis is required on the battlefield, interventional embolization is used for hemostasis. First, the tip 2 of guidewire 1 is inserted into the blood vessel. The tapered and blunt structure of tip 2 facilitates tissue separation during guidewire 1 advancement to reduce resistance and avoid scratching the blood vessel wall during advancement. Then, through the 2μm thick first coating 3 on the surface of guidewire 1 near tip 2 and the 1μm thick second coating 4 on the side of guidewire 1 away from tip 2, the difference in thickness between the first coating 3 and the second coating 4 makes the ultrasonic signal reflected by the first coating 3 stronger than that reflected by the second coating 4. The difference in ultrasonic reflected signals between the first coating 3 and the second coating 4 is due to their own acoustic impedance difference. Acoustic impedance is an inherent property of a medium, representing the resistance encountered by sound waves when propagating in the medium. The greater the thickness of the medium, the higher its own acoustic impedance, and the stronger the reflected signal, thus making the guidewire 1 more effective. The ultrasound markings on the side near the tip 2 are more prominent. Simultaneously, the multi-angle reflection of the silver ion ball 6 enhances the ultrasound reflection intensity of the tip 2, enabling precise positioning. The evenly spaced distribution of the second coating 4 creates regular ultrasound markings on the side of the guidewire 1 away from the tip 2. By detecting the signal intervals between the second coatings 4, the depth of the guidewire 1 entering the blood vessel and its movement distance can be calculated. The fiber optic sensor embedded in the tip 2 monitors the temperature and blood oxygen parameters of the environment in real time, providing physiological references for the embolization procedure. After the tip 2 is advanced to the designated position, a balloon catheter is fitted onto the guidewire 1, and the balloon is moved along the guidewire 1 to the designated position. Hemostasis is achieved by inflating the balloon and applying pressure. Hemostasis is completed when the pressure value detected by the pressure sensor drops sharply. The entire interventional embolization process does not rely on large imaging equipment, reducing the operating space and making it more suitable for battlefield use.

[0037] The ultrasound-guided arterial interventional embolization hemostasis device of Example 1 was compared with the traditional Kangyu Medical guide wire 1. The specific experiment is as follows: Experimental Objective: To compare the performance of a novel ultrasound-guided arterial interventional embolization hemostasis device (Example 1) with that of a traditional Kangyu Medical guide wire in a simulated battlefield environment for arterial interventional embolization hemostasis, focusing on evaluating its advantages and disadvantages in terms of device dependence, operation time, positioning accuracy, antibacterial and anticoagulant properties, and overall safety.

[0038] Experimental steps: 1. Experimental preparation: Simulated vascular models and animal experimental models (such as the porcine femoral artery model) are used to simulate battlefield vascular injury scenarios.

[0039] Prepare the device of Example 1 (containing silver nano-coating, thermosensitive hydrogel, heparin coating, optical fiber and pressure sensor) and the traditional Kangyu Medical guide wire (DSA dependent type).

[0040] Using the same group of experienced interventional physicians to perform the procedure avoids the impact of operator differences on the outcome.

[0041] 2. Operating Procedures: Each of the two groups underwent 10 simulated femoral artery embolization hemostasis procedures.

[0042] Record the total operation time from guidewire insertion to balloon inflation for hemostasis.

[0043] Use ultrasonic equipment to monitor the guidewire positioning accuracy (the error distance between the tip and the target position).

[0044] Record whether any adverse events such as vascular injury, thrombosis, or signs of infection occur during the procedure.

[0045] Data from fiber optic and pressure sensors are collected to assess the ability to monitor physiological parameters.

[0046] 3. Data Collection: Record indicators such as operation time, positioning error, thrombosis incidence, coating wear, and sensor data validity.

[0047] Microbial culture was performed on the surface of the guidewire to evaluate its antibacterial properties.

[0048] Experimental data:

[0049] Experimental Conclusion: The experimental results show that the ultrasound-guided arterial interventional embolization hemostasis device described in Example 1 is significantly superior to the traditional Kangyu Medical guide wire in several key performance indicators. The new device achieves shorter operation time, higher positioning accuracy, lower thrombosis and infection risks, and better coating protection and sensor monitoring capabilities without requiring large DSA equipment. Its thermosensitive hydrogel and heparin coating design effectively improves biocompatibility and operational safety, making it particularly suitable for emergency arterial hemostasis operations in resource-constrained environments such as battlefields. Example

[0050] As attached Figure 1As shown, the difference from Example 1 is that, during the preoperative preparation process, the guidewire 1 may be at risk of wear and detachment of the first coating 3 due to friction and collision, which may affect the ultrasound positioning effect. In order to reduce the risk of wear of the first coating 3, the guidewire 1 is provided with a thermosensitive hydrogel on the surface of the first coating 3. At low temperature (room temperature or in vitro storage temperature), the thermosensitive hydrogel is solid or semi-solid, while at body temperature, the thermosensitive hydrogel changes from solid to gel state. When the guidewire 1 is inserted into the blood vessel, the blood in the blood vessel may accumulate on the surface of the guidewire 1 to form a thrombus, making it difficult to advance the guidewire 1. In order to prevent thrombus formation, the surface of the second coating 4 is grafted with a heparin molecular coating. The heparin molecular coating can inhibit thrombin activity and prevent platelet aggregation. The thickness of both the thermosensitive hydrogel and the heparin molecular coating is less than 1 μm, ensuring that the thermosensitive hydrogel and the heparin molecular coating do not affect the function of the first coating 3 and the second coating 4.

[0051] The specific implementation process is as follows: During the preoperative preparation, the thermosensitive hydrogel on the surface of guidewire 1 is solid at low temperatures, covering the surface of guidewire 1 to protect the first coating 3 and prevent wear of the first coating 3 from reducing the accuracy of ultrasound positioning. After guidewire 1 is advanced into the blood vessel, the thermosensitive hydrogel undergoes a phase transition under the action of body temperature, changing from a solid state to a gel state. The surface of the thermosensitive hydrogel after the transformation becomes loose, increasing the porosity and reducing the coverage of the first coating 3, allowing silver ions to be released and enhancing the antibacterial effect. At the same time, the gel-like thermosensitive hydrogel is closer to the physiological environment, which can reduce the friction coefficient of the guidewire 1 surface, thereby reducing the stimulation of cells in the blood vessel during the advancement of guidewire 1 and reducing the risk of inflammation. Meanwhile, heparin molecules inhibit platelet aggregation and prevent thrombosis, avoiding the need for additional anticoagulant drugs, thereby reducing the risk of bleeding complications. Furthermore, heparin molecules prevent platelets from attaching to guidewire 1, reducing the obstruction of ultrasound reflection by the first coating 3 and enhancing the ultrasound effect.

[0052] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. An ultrasound-guided arterial interventional embolization hemostasis device, comprising an arterial puncture kit and a guidewire (1), wherein the arterial puncture kit is equipped with a controller, one end of the guidewire (1) is fixedly connected to a tip (2), and a balloon catheter is sleeved on the guidewire (1), characterized in that: The guide wire (1) is configured as a linear structure. A first coating (3) is provided on the side of the guide wire (1) near the head end (2), and several second coatings (4) are provided on the side of the guide wire (1) away from the head end (2). The materials of the first coating (3) and the second coating (4) are both made of silver nanoparticle electroplating. The head end (2) is provided with a positioning component for positioning the head end (2).

2. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 1, characterized in that: The positioning component includes several grooves (5), all of which are opened on the surface of the head end (2), and each groove (5) contains a corresponding silver ion ball (6).

3. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 1, characterized in that: The spacing between the second coatings (4) is equal.

4. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 3, characterized in that: The thickness of the second coating (4) is set to 1 μm, and the thickness of the first coating (3) is set to 2 μm.

5. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 4, characterized in that: The guidewire (1) is provided with a temperature-sensitive hydrogel located on the surface of the first coating (3).

6. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 1, characterized in that: The head end (2) is embedded with an optical fiber sensor, which is connected to the controller signal.

7. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 1, characterized in that: The head end (2) is embedded with an optical fiber sensor, which is connected to the controller signal.

8. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 7, characterized in that: The head end (2) is set as a tapered blunt round structure.

9. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 8, characterized in that: The second coating (4) has a heparin molecule coating grafted onto its surface.

10. The ultrasound-guided arterial interventional embolization hemostasis device according to claim 9, characterized in that: The thickness of both the thermosensitive hydrogel and the heparin molecular coating is less than 1 μm.

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