Ultrasonic suction knife body, ultrasonic suction knife, carotid plaque crushing and suction device and application

Abstract

The invention belongs to the technical field of medical instruments, and discloses an ultrasonic suction knife body, an ultrasonic suction knife, a carotid plaque breaking and sucking device and application. In particular to application of an ultrasonic suction knife body or an ultrasonic suction knife or a carotid plaque breaking and sucking device to preparation of a common carotid artery plaque breaking and sucking device or preparation of an internal carotid artery C1 section plaque breaking and sucking device or preparation of an internal carotid artery C1 section blocked plaque breaking and sucking device, and a connecting section of the knife body intersects with an extension line of a knife head section and is in arc transition with the extension line of the knife head section. The invention provides a brand new way for removing carotid plaques.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an ultrasonic aspiration blade, an ultrasonic aspiration knife, a carotid artery plaque fragmentation and aspiration device, and their applications. Background Technology

[0002] Carotid artery stenosis, characterized by plaque buildup in the carotid arteries, has a high prevalence and disability rate. A meta-analysis in the United States showed an overall prevalence of ≥50% carotid artery stenosis of 4.2%. A nationwide cross-sectional study published in *JAMA Network Open* in 2024 found an overall prevalence of carotid artery plaques of approximately 36.7% and a prevalence of carotid artery stenosis (≥50%) of approximately 3.1%. The prevalence increases significantly with age, exceeding 10% in people over 70 years of age. In China, an ultrasound examination revealed that 7% of adults had ≥50% carotid artery stenosis, and the trend towards younger onset is becoming increasingly apparent, with 50% of cases occurring in the 40-64 age group. Studies have shown that approximately 25%-30% of strokes are caused by carotid artery stenosis, and according to the World Health Organization, stroke is the second leading cause of death worldwide, second only to heart disease. Carotid artery occlusion often results from thrombosis or progressive thickening of atherosclerotic plaques on a background of carotid artery stenosis, leading to luminal occlusion, sudden aortic dissection, embolization due to plaque or embolus detachment, or the continuous progression of inflammatory vascular lesions. A review in the *Chinese Journal of Cerebrovascular Diseases* indicates that acute internal carotid artery occlusion accounts for 6%–15% of acute ischemic stroke events; in the Caucasian population of the United States, the incidence of symptomatic chronic carotid artery occlusion is 6 per 100,000. A study published in *Nature* sub-journal in 2025 suggests that symptomatic solitary internal carotid artery occlusion accounts for 3%–11% of large vessel occlusions.

[0003] Currently, the main treatments for carotid artery stenosis include medication and surgery. Medication includes controlling blood pressure, blood sugar, lowering lipids, and using antiplatelet agents. While medication can stabilize carotid plaques and slow the progression of stenosis to some extent, it cannot effectively reverse the stenosis, and some medications have complications such as liver damage, cerebral hemorrhage, and rhabdomyolysis. When the stenosis exceeds 50% and there are signs of insufficient cerebral perfusion, surgery is required to widen the narrowed artery. The two most commonly used surgical methods globally are carotid endarterectomy (CEA) and carotid artery stenting (CAS). Both CEA and CAS have their drawbacks. CEA is highly invasive, carries high surgical risks, leaves surgical scars, and requires complex intraoperative and postoperative management. CAS is an interventional procedure, which, while minimally invasive, is expensive, and requires lifelong antiplatelet medication after stent implantation, carrying risks such as cerebral hemorrhage and gastrointestinal bleeding.

[0004] The Cavitron Ultrasonic Surgical Aspirator (CUSA) consists of a main unit, a handle, and a blade. Its working principle comprises three parts: vibration cutting, flushing, and suction. During operation, an energy converter transforms electrical energy into ultrasonic energy, causing a hollow titanium tube to vibrate longitudinally at high frequency. Upon contact with diseased tissue, thin-walled tissue is broken up. The tissue fragments are flushed with injected saline solution and then suctioned away through the hollow titanium tube under negative pressure. Meanwhile, tougher tissues are less likely to be broken up and are retained, thus achieving the effect of removing the diseased tissue. Currently, the ultrasonic aspirator is widely used in surgical procedures for liver tumors, brain tumors, and other conditions. Summary of the Invention

[0005] The present invention aims to provide new applications for ultrasonic aspiration blades and ultrasonic aspiration knives, and to provide ultrasonic aspiration blades, ultrasonic aspiration knives, carotid plaque fragmentation and aspiration devices optimized for these applications, and their applications.

[0006] To achieve the above objectives, the present invention provides the following basic solution: Basic Scheme 1: The application of the ultrasonic aspiration scalpel blade in the preparation of a device for fragmenting and aspirating plaques in the common carotid artery, or a device for fragmenting and aspirating plaques in the C1 segment of the internal carotid artery, or a device for fragmenting and aspirating occluded plaques in the C1 segment of the internal carotid artery. The connecting section of the blade and the extension line of the blade tip intersect, and the two transition in an arc shape.

[0007] Basic Scheme 2: An ultrasonic aspiration knife body used in the preparation of a device for fragmenting and aspirating plaques in the common carotid artery, a device for fragmenting and aspirating plaques in the C1 segment of the internal carotid artery, or a device for fragmenting and aspirating occluded plaques in the C1 segment of the internal carotid artery, wherein the connecting section of the knife body and the extension line of the knife head section intersect, and the two transition in an arc shape.

[0008] Basic Option 3: An ultrasonic aspiration scalpel, comprising the aforementioned scalpel body.

[0009] Basic Scheme 4: Application of the above-mentioned ultrasonic aspiration knife in the preparation of a device for fragmenting and aspirating plaques in the common carotid artery, a device for fragmenting and aspirating plaques in the C1 segment of the internal carotid artery, or a device for fragmenting and aspirating occluded plaques in the C1 segment of the internal carotid artery.

[0010] The ultrasonic aspiration scalpel consists of a main unit, a handle, and a blade. The main body of the blade is a hollow titanium tube. During surgery, the blade tip enters the body to dissipate and aspirate diseased tissue. For ease of description, the blade is divided into two sections: the section near the tip is the tip section, which contacts the diseased tissue during use; the section near the handle is the connecting section, which connects to the handle.

[0011] Currently, both the blade and the ultrasonic aspiration scalpel are used for surgical procedures involving liver and brain tumors, not for carotid artery plaques. This is primarily because carotid artery plaques are located within the carotid artery, a location requiring high precision in surgery and equipment. Furthermore, the blade of the ultrasonic aspiration scalpel is rigid and could easily damage the blood vessel wall. More importantly, unlike liver or brain tumor cases, in the carotid artery scenario, fragmented plaque tissue can easily travel with the bloodstream, causing embolisms or even entering the brain, leading to more serious complications. Therefore, given the limitations of current technology, those skilled in the art would not consider applying the blade or scalpel to carotid artery plaque treatments.

[0012] The inventors of this application propose a novel application for the ultrasonic aspiration scalpel blade and ultrasonic aspiration knife, using them to prepare a device for fragmenting and aspirating carotid artery plaques. This device can be used to fragment and aspirate carotid artery plaques. With this new application, a completely new approach to the treatment of carotid artery plaques will be available, replacing existing CEA and CAS methods. Compared to CEA, this new approach is less invasive and easier to manage intraoperatively and postoperatively; compared to CAS, this new approach can remove plaques more thoroughly, resulting in a more complete treatment.

[0013] Furthermore, CEA and CAS surgeries require X-ray support for precise surgical execution, meaning both patients and medical staff are exposed to X-rays, undoubtedly increasing radiation exposure for both. However, when using an ultrasonic aspiration scalpel to prepare a device for fragmenting and removing carotid artery plaques, the procedure can be performed under surface ultrasound monitoring. This is because the plaque, the metallic ultrasonic aspiration scalpel blade, and the blood vessel wall all have excellent resolution under ultrasound, thus avoiding the increased radiation risk associated with X-ray exposure for patients and medical staff during surgery.

[0014] Furthermore, the ultrasonic aspiration blade and ultrasonic aspiration scalpel can be used not only to prepare devices for fragmenting and aspirating common carotid artery plaques, but also for preparing devices for fragmenting and aspirating C1 segment plaques of the internal carotid artery, and even devices for fragmenting and aspirating occluded C1 segment plaques of the internal carotid artery. Both types of plaques are extremely difficult to treat clinically, especially occluded C1 segment plaques of the internal carotid artery, which are currently almost impossible to treat medically. In such cases, the carotid artery must be blocked, and the brain is supplied with blood through another carotid artery, which undoubtedly has a significant impact on the patient's health. However, the solution proposed in this application will solve this problem.

[0015] In the above application, the connecting section of the blade and the extended line of the blade tip intersect, and the two transition in an arc shape, meaning that the whole formed by the two is curved, and the curved part transitions in an arc shape. The included angle between the connecting section of the blade and the extended line of the blade tip is preferably in the range of 5°-20°, with 10° being the preferred value. The core reason for the curved design of the blade is to adapt to the specific physiological and anatomical characteristics of the human neck. Existing blades are all straight, and straight or non-adaptive interventional tools cannot follow the natural anatomical path from the surface above the clavicle to the lesion. They are prone to scraping against surrounding important tissues, increasing the risk of injury and making it difficult to accurately reach the target area. For this reason, in the existing technology, medical personnel rarely think of applying ultrasonic aspiration knives to the removal of carotid artery plaques, which also increases the difficulty of this application. This application designs a continuous arc segment with a specific curvature based on the average anatomical course curve of the common carotid artery from the supraclavicular segment to the lesion site in the adult population. This is to achieve both the safety of the puncture operation and the accuracy of lesion localization by adapting to the natural course of the blood vessel and avoiding adjacent key structures.

[0016] Furthermore, the outer diameter of the blade is 2.0-2.2 mm, and the inner diameter is 1.1-1.6 mm. This design of inner and outer diameters allows for good insertion into the carotid artery and is relatively easy to manufacture. An outer diameter of 2.2 mm and an inner diameter of 1.4 mm are considered optimal values.

[0017] Furthermore, the free end face of the blade tip section is corrugated. This corrugation design increases the contact area between the blade tip and the diseased tissue, thereby improving the efficiency of fragmentation and suction. Preferably, the vibration direction of the corrugations is circumferential to the free end face of the blade tip section. This design is more effective, and more importantly, the resulting troughs face radially towards the blade, facilitating the flow of fragmented plaque to both sides of the blade, thus exposing the blade tip for continued fragmentation. The number of corrugations is preferably 1-15, and the amplitude is preferably 0-0.4 mm.

[0018] Furthermore, the free end face of the blade tip is beveled to adapt to the special environment of the carotid artery, facilitating access to plaques of different shapes within this environment. Preferably, the angle between the beveled surface and the central axis of the blade is 30°-60°.

[0019] Furthermore, the blade length is 12-20cm. This length not only accommodates the neck length of a normal adult, but more importantly, avoids excessive vibration caused by excessive length, which could affect surgical operation and outcomes. Preferably, the blade length is 20cm, and the curved transition section can be individually customized based on the distance from the surgical puncture point to the upper edge of the lesion. For example, in one case, both the connecting section and the blade tip are designed to be 10cm.

[0020] This invention also provides the following basic solutions: Basic Solution 5: A carotid artery plaque fragmentation and aspiration device, comprising a protective device and the aforementioned ultrasonic aspiration scalpel. The protective device includes an arterial sheath and a counterflow device. The arterial sheath is fitted over the outside of the blade of the ultrasonic aspiration scalpel, and the free end of the blade extends beyond the arterial sheath. The counterflow device includes a flexible tube communicating with the sidewall of the arterial sheath, and the flexible tube is equipped with a flow rate control device and a filter device.

[0021] Basic Scheme Six: Application of the above-mentioned carotid plaque fragmentation and aspiration device in the preparation of a common carotid artery plaque fragmentation and aspiration device, or a preparation of a C1 segment plaque fragmentation and aspiration device, or a preparation of a C1 segment occluded plaque fragmentation and aspiration device.

[0022] The carotid plaque fragmentation and aspiration device is the application of an ultrasonic aspiration blade and ultrasonic aspiration scalpel. It consists of two main parts: a protective device and an ultrasonic aspiration blade. The protective device includes an arterial sheath and a reversal device. The arterial sheath is fitted over the outside of the ultrasonic aspiration blade. The arterial sheath is a key medical device used in vascular interventional surgery. Its structure has a hemostatic valve at one end and the other end extends into the artery to deliver stents or interventional instruments into the blood vessel. This design fits it over the outside of the ultrasonic aspiration blade to protect the blade and patient tissue, preventing damage to the patient's tissue, especially the blood vessel wall, thus ensuring safe delivery of the blade to the lesion site. The free end of the blade, i.e., the working surface of the blade, extends beyond the arterial sheath, facilitating contact with the plaque for fragmentation and aspiration. Furthermore, the gap between the outer wall of the blade and the inner wall of the arterial sheath connects to the flexible tube of the reversal device. During operation, the other end of the flexible tube connects to the patient's femoral vein using existing puncture techniques, thus forming an external pathway from the carotid artery to the femoral vein.

[0023] In practical applications, this external pathway is particularly important. The blade, vibrating at high frequency, pulverizes the plaque. Due to the existence of this external pathway, a significant pressure difference exists between the high pressure in the arteries and the low pressure in the veins. This pressure difference temporarily alters the direction of blood flow in the arteries. Blood that would normally flow into the brain through the arteries is redirected and flows through a flexible tube into the femoral vein. Crucially, this redirected blood flow carries the pulverized plaque along with the plaque into the flexible tube, where it is filtered by a filter before entering the femoral vein. This prevents the pulverized plaque from entering the brain and causing serious complications such as plaque detachment and stroke.

[0024] The ingenious aspect of this solution lies in the fact that existing ultrasonic aspiration scalpels require flushing with water during the fragmentation process. This flushes away the fragmented lesions at the scalpel tip, exposing it for continued fragmentation, and simultaneously creates a cavitation effect from the scalpel's vibration, releasing energy to further fragment the plaque. This solution, however, utilizes the redirected blood flow instead of water. This flushes away the fragmented plaque, allowing the scalpel to continue its work smoothly, and the vibration creates a cavitation effect without the need for additional flushing. Because no additional flushing is required, the diameter of the arterial sheath can be made smaller than the protective sleeve used in existing ultrasonic aspiration scalpels, allowing a smaller diameter sheath to be inserted into the carotid artery. Furthermore, the flow rate control device in this solution allows for real-time adjustment of blood flow during surgery, based on the specific surgical situation, to ensure the smooth progress of the procedure.

[0025] Furthermore, the distance from the free end of the blade tip extending beyond the arterial sheath is less than or equal to 0.5 cm. Since the blade is made of hard metal, if the extension distance is too large, it is easy to collide with tissues such as the blood vessel wall, thereby causing damage to the tissue; if the extension distance is too small, it is difficult to make sufficient contact with the diseased tissue. Experiments have shown that designing this distance to be less than or equal to 0.5 cm is more appropriate based on the patient and the condition of their plaque.

[0026] Furthermore, the arterial sheath has several side holes on its sidewall near the free end of the blade tip. These side holes facilitate the entry of fragmented plaque into the gap between the inner wall of the arterial sheath and the outer wall of the blade, allowing it to be filtered within the counterflow device. In this device, due to its application in the carotid artery, the dimensions of both the arterial sheath and the blade cannot be too large. Consequently, the gap between the end of the arterial sheath and the end of the blade is relatively small, making it difficult for fragmented plaque to pass through, resulting in low efficiency or even complete blockage. These problems further hinder those skilled in the art from inventing this solution. Therefore, the design of these side holes in this device is crucial, as it increases the pathway for fragmented plaque to flow, improving surgical efficiency and reducing surgical risks. Preferably, the side holes are distributed within a 1cm axial distance from the free end face of the arterial sheath.

[0027] Furthermore, the outer diameter of the arterial sheath is 2.97 mm, and the inner diameter is 2.77 mm. This design of the inner and outer diameters allows for excellent insertion into the carotid artery, and, in conjunction with the blade, achieves the desired surgical effect.

[0028] Furthermore, a spare tube is connected to the side wall of the arterial sheath near the hemostatic valve, and the spare tube is equipped with a valve. The spare tube is used to flush in liquids such as heparin and saline when necessary to assist in surgical procedures. In particular, in the application scenario of this embodiment, the spare tube plays a more critical role. Currently, occlusion of the common carotid artery and the C1 segment of the internal carotid artery is a contraindication for CEA and CAS surgery. That is, when the carotid artery is completely occluded, existing medical methods cannot handle it. With the carotid plaque fragmentation and aspiration device of this embodiment, this contraindication can be overcome, and the occlusion of the common carotid artery and the C1 segment of the internal carotid artery can be reopened. Specifically, saline can be added to the spare tube, and the cavitation physical effect of water under high-frequency vibration can be used to gradually break up the plaque, which is then aspirated by an ultrasonic aspiration knife until the carotid artery is opened. Then, the saline supply to the spare tube is stopped, and the surgery continues through the diverted blood flow. Therefore, the setting of this device makes it possible to open a completely occluded carotid artery, which has extremely high medical value. On the other hand, the spare tube can also be connected to an invasive arterial pressure monitor to continuously and in real time measure arterial blood pressure during the operation.

[0029] Furthermore, the flow control device is a roller-type flow regulator for the infusion set, and a flow stop clamp is provided on the tubing. Firstly, this type of flow regulator is readily available and inexpensive. More importantly, this flow regulator can be continuously adjusted, enabling control of multiple flow rates, which is more conducive to the procedure. The flow stop clamp allows for complete severing of blood flow in the tubing in special circumstances, ensuring surgical safety.

[0030] Furthermore, the filtration device includes an outer cylinder and a filter screen disposed inside the outer cylinder, with both ends of the outer cylinder detachably connected to flexible hoses. This design allows the filter screen and outer cylinder to be reused, while the flexible hoses can still be disposable. Furthermore, a groove is provided on one end face of the outer cylinder, and a locking block is provided on the side of the filter screen, with the locking block located within the groove; a cylinder cap is also threaded onto this end face of the outer cylinder, and the cylinder cap abuts against the locking block, with the flexible hose communicating with one end of the outer cylinder through the cylinder cap. This design allows the filter screen to be disassembled after the cylinder cap and outer cylinder are removed, facilitating cleaning. Attached Figure Description

[0031] Figure 1 This is a schematic diagram illustrating the application of an embodiment of the present invention; Figure 2 This is a schematic diagram of the structure of the protection device according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of the protective device inserted behind the ultrasonic suction knife according to an embodiment of the present invention; Figure 4 This is a schematic diagram of the structure of the ultrasonic suction blade (the free end face of the blade head section is a vertical plane) according to an embodiment of the present invention; Figure 5This is a schematic diagram of the ultrasonic suction blade head section (the free end face of the blade head section is a vertical plane) according to an embodiment of the present invention; Figure 6 This is a schematic diagram of the structure of the ultrasonic suction blade (the free end face of the blade head section is a bevel) according to an embodiment of the present invention; Figure 7 This is a schematic diagram of the ultrasonic suction blade head section (the free end face of the blade head section is a bevel) according to an embodiment of the present invention; Figure 8 This is a schematic diagram of the structure of the filtration device according to an embodiment of the present invention; Figure 9 This is a cross-sectional schematic diagram of the filtering device according to an embodiment of the present invention. Detailed Implementation

[0032] The following detailed description provides further details on specific implementation methods.

[0033] It should be understood that in the description of the specific embodiments, the terms "longitudinal", "lateral", "vertical", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the present invention and 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 present invention.

[0034] The reference numerals in the accompanying drawings include: blade 1, blade head section 11, connecting section 12; arterial sheath 2, spare tube 21, wing 22; counterflow device 3, three-way valve 31, flow rate control device 32, flow stop clamp 33, filter device 34; outer cylinder 341, cylinder cover 342, retaining ring 3421, filter screen 343, and retaining block 3431.

[0035] This embodiment provides the application of the ultrasonic aspiration knife blade and ultrasonic aspiration knife in the preparation of a device for fragmenting and aspirating plaques in the common carotid artery, or in the preparation of a device for fragmenting and aspirating plaques in the C1 segment of the internal carotid artery, or in the preparation of a device for fragmenting and aspirating occluded plaques in the C1 segment of the internal carotid artery.

[0036] The ultrasonic aspiration scalpel used in the above application includes a main unit, a handle, and a blade. Both the main unit and the handle are existing components and are not shown in the accompanying drawings. In this embodiment, both the main unit and the handle are Integra Ultrasonics CUSA Clarity, with the main unit model being C7000 and the handle model being C7036. This embodiment optimizes and improves the existing blade as follows.

[0037] like Figure 4 , Figure 6As shown, the blade 1 includes an integrally formed connecting section 12 and a blade head section 11. The connecting section 12 and the blade head section 11 are integrally formed, but the extension lines of the connecting section 12 and the blade head section 11 intersect, and the two are curved, that is, the whole formed by the two is curved. The included angle between the extension lines of the connecting section 12 and the blade head section 11 is any value between 5 and 15°, preferably 10°.

[0038] In this embodiment, the total length of the blade 1 is 12-20cm, preferably 20cm. The arc-shaped transition can be customized according to the distance from the surgical puncture point to the upper edge of the lesion. In this embodiment, the connecting section 12 and the blade tip section 11 are designed to be of equal length, i.e., the connecting section is 10cm and the blade tip section is 10cm. The material of the blade 1 is the same as that in the prior art, using titanium alloy. The blade 1 is a uniformly shaped tube with an outer diameter of 2.0-2.2mm and an inner diameter of 1.1-1.6mm, preferably 2.2mm and 1.4mm.

[0039] The free end of connecting section 12, like in the prior art, has a threaded design for connection with the handle, such as... Figure 3 , Figure 4 , Figure 6 As shown. The free end face of the cutter head section 11 can be a vertical plane, such as... Figure 4 , Figure 5 As shown, it can also be an inclined plane, such as... Figure 6 , Figure 7 As shown, the inclination angle of the bevel can be adaptively adjusted according to the specific shape and position of the plaque. Preferably, the angle between the bevel and the central axis of the blade 1 is 30°-60°, and in this embodiment, the preferred inclination angle is 45°. The vertical surface and the bevel with different inclination angles are adapted to different plaque shapes and positions. Here, the inventors have also conducted in-depth research. The existing blade end face is a vertical surface, but due to the current application scenarios, they do not intend to change this end face. However, in the application scenario of the carotid artery, due to the special environment and narrow space constraints within the carotid artery, it is difficult for the vertical surface to reach some plaques well, thus making it impossible to fragment and aspirate them effectively and achieve the desired treatment effect. The design of bevels with different inclination angles can overcome this problem.

[0040] In addition, the inventors designed corrugations on the free end face of the cutter head section 11, such as... Figure 5 , Figure 7As shown, in this embodiment, the vibration direction of the corrugations is circumferential to the free end face of the cutter head section 11, that is, the corrugations are connected end to end, forming a ring. The number of corrugations is preferably designed to be 5-15, and in this embodiment, it is preferably 10 (one corrugation is between two adjacent peaks or two adjacent troughs). The amplitude of the corrugations is preferably 0-0.4 mm, and in this embodiment, it is preferably 0.4 mm. This data is a better value after balancing the crushing and suction effect, efficiency, and production difficulty. In another embodiment of this application, the corrugations are designed as asymmetrical corrugations, that is, while keeping the wave pitch constant, the height of the peaks and the depth of the troughs are not equal. Specifically, the height of the peaks is greater than the depth of the troughs. Preferably, the height of the peaks is 0.4 mm, and the depth of the troughs is 0.2 mm. This design is significant for carotid artery plaque removal. During the process of the blade entering the carotid artery and contacting the plaque, the peaks actively approach, contact, and compress the plaque, while plaque tissue between adjacent peaks passively enters the troughs. Because this is passive, the contact between the troughs and plaque is less tight compared to the peaks, and sometimes the troughs are even hollow, meaning the plaque tissue at the troughs doesn't make contact, thus limiting the contact area and inevitably affecting plaque fragmentation efficiency. In the carotid artery scenario, the space for movement is particularly limited after the blade enters the carotid artery, making it difficult to improve this situation by adjusting the blade angle. However, in this embodiment, designing a lower trough depth improves this. When plaque tissue between adjacent peaks passively enters the trough, it can more easily contact and be enveloped by the trough, thus ensuring the contact area and consequently guaranteeing plaque fragmentation efficiency.

[0041] Of course, this embodiment also provides an ultrasonic aspiration blade and an ultrasonic aspiration knife. The ultrasonic aspiration blade and the ultrasonic aspiration knife containing the blade are both protected objects of this invention. Their specific optimized and improved structures are the same as above, and will not be described again here.

[0042] In addition, this embodiment also provides a carotid plaque fragmentation and aspiration device and its application, such as... Figure 2 , Figure 3 As shown, the device includes a protective device and the aforementioned ultrasonic aspiration knife. The protective device includes an arterial sheath 2 and a counterflow device 3. The arterial sheath 2 is sleeved on the outside of the blade 1 of the ultrasonic aspiration knife. The counterflow device 3 includes a flexible tube communicating with the side wall of the arterial sheath 2. The flexible tube is equipped with a flow rate control device 32 and a filter device 34.

[0043] The arterial sheath 2 can be directly adopted from the existing arterial sheath 2, and its structure can remain unchanged. Only appropriate dimensions and other parameters are selected according to the specific application scenario. In this embodiment, in order to improve the application effect of this embodiment, some details of the arterial sheath 2 have been specially selected and designed, as detailed below.

[0044] The outer diameter of the arterial sheath 2 is 2.97 mm, and the inner diameter is 2.77 mm. A hemostatic valve is located at the tail end of the arterial sheath 2. A spare tube 21 is connected to the side wall of the arterial sheath 2 near the hemostatic valve, and a valve is installed on the spare tube 21. The arterial sheath 2 has a certain degree of elasticity and is in a straight position when not fitted onto the outside of the blade 1. Figure 2 As shown, when the arterial sheath 2 is fitted onto the outside of the blade 1, the arterial sheath will bend adaptively with the curvature of the blade, such as... Figure 3 As shown. In addition, when the arterial sheath 2 is sleeved on the outside of the blade 1, the tail end of the connecting section 12 of the blade 1 is engaged with the hemostatic valve, that is, the connecting section 12 passes through the hemostatic valve, and the hemostatic valve can fix the connecting section 12. The blade 1 can also be removed from the hemostatic valve and detached from the hemostatic valve.

[0045] The arterial sheath 2 has several side holes (not shown in the figure) on its front end, near the free end of the blade section 11. These side holes are preferably located within 1 cm of the front end (free end face) of the arterial sheath 2, where 1 cm refers to the longitudinal distance along the arterial sheath 2. The diameter of the side holes is preferably 0.2 mm. The blade 1 of the ultrasonic aspiration scalpel extends within 0.5 cm of the arterial sheath 2, meaning the length of the blade 1 exposed outside the arterial sheath 2 is 0.5 cm, preferably 0.3 cm.

[0046] Existing arterial sheaths 2 typically have a fixation device fitted around their middle section to secure them, facilitating interventional procedures. This existing fixation device includes a sleeve with an inclined wing 22 at its front end. The wing 22 has a fixation hole. In use, both the sleeve and the wing 22 are fitted over the outside of the arterial sheath 2, with the wing 22 positioned close to the front end of the arterial sheath 2, i.e., near the end where the sheath enters the tissue. During surgery, the wing 22 is sutured close to the patient's skin to securely fix the arterial sheath 2. Specifically, sutures are passed sequentially through the fixation hole on the wing 22 and the subcutaneous soft tissue of the patient's skin. However, in this embodiment, as... Figure 2 , 3 As shown, due to differences in usage scenarios and methods, the arterial sheath 2 will move axially during surgery. Therefore, the fixation device is modified by removing the sleeve and retaining the wing 22 with fixation holes. The wing 22 is positioned at the end of the arterial sheath 2 near the spare tube 21. During fixation, sutures are passed sequentially through the fixation holes on the wing 22 and the subcutaneous soft tissue of the patient's skin. However, the wing 22 is kept at a distance from the patient's skin and restrained by sutures, thus allowing the arterial sheath 2 to move axially during surgery.

[0047] In the counterflow device 3 of this embodiment, the flexible tube can be a general infusion tube, which is connected to the middle of the arterial sheath 2. The connection point is located between the front end of the arterial sheath 2 and the spare tube 21. Figure 1 , 2As shown in Figure 3, a three-way valve 31, a flow rate control device 32, a flow stop clamp 33, and a filter device 34 are sequentially installed on the hose.

[0048] The three-way valve 31 has two ends connected to the hose, and the third port is normally closed for backup, such as to add other liquids to the device in special circumstances.

[0049] The flow stop clamp 33 is fitted onto the tubing. In an emergency, the operator holds both sides of the flow stop clamp 33 and presses it inward to deform the tubing, blocking the flow of liquid inside the tubing and preventing further blood flow.

[0050] The flow rate control device 32 is an infusion set roller-type flow regulator, that is, a roller-type flow regulator used on the infusion tubing. Specifically, it includes a channel for accommodating the tubing, with an inclined slide rail connected to the upper side of the channel. A roller is installed inside the slide rail, and the roller abuts against the tubing. Rolling the roller changes the amount of compression deformation on the tubing, thereby changing the cross-sectional area of ​​the liquid flow within the tubing, and thus controlling the liquid flow rate.

[0051] like Figure 8 , Figure 9 As shown, the filter device 34 includes an outer cylinder 341 and a filter screen 343 disposed inside the outer cylinder 341. One end of the outer cylinder 341 is tapered, and a flexible tube is fitted onto the tapered opening, with the two fitting tightly together. The other end of the outer cylinder 341 is cylindrical, and two slots are provided on both sides of the end face. A locking block 3431 is provided on the side of the filter screen 343, and the locking block 3431 is located in the slot, with the two engaging. The end face of the outer cylinder 341 is also threadedly connected to a cylinder cover 342. Specifically, the outer side of the outer cylinder 341 has an external thread, and the inner side of the cylinder cover 342 has an internal thread. A retaining ring 3421 is provided above the internal thread. After the internal thread and the external thread engage, the retaining ring 3421 abuts against the locking block 3431, thereby fixing the filter screen 343. The appearance of the cover 342 is stepped, that is, the outer diameter of the cover 342 decreases in a stepwise manner away from the outer cylinder 341. The hose is sleeved on the outer wall of the cover 342 with the smallest outer diameter, and the two fit tightly together, thereby realizing the connection between the hose and the outer cylinder 341, that is, the connection with the filter device 34.

[0052] In this embodiment, the filter screen 343 is cylindrical. The upper end of the cylinder, i.e., the end with the locking block 3431, is open and the other end is closed. The filter holes of the filter screen 343 are distributed on the side wall of the cylinder. In order to ensure the strength and shape of the filter screen 343, reinforcing columns are provided on both sides of the cylinder.

[0053] In practical applications, the other end of the carotid plaque fragmentation and aspiration device is connected to the patient's femoral vein. The specific connection method uses the existing puncture technique, and the instruments used include puncture needles, guide wires, vein dilators, and vein sheaths, which will not be described in detail here.

[0054] When the carotid plaque fragmentation and aspiration device provided in this embodiment is used in clinical practice to remove carotid plaques from patients, the frequency of the handle is controlled at 20-40KHZ, preferably 36KHZ; the maximum amplitude of the handle is preferably controlled at 210um.

[0055] For those skilled in the art, without departing from the concept of the technical solution of this invention, several modifications and improvements can be made, and these should also be considered within the scope of protection of this invention. These will not affect the effectiveness of the implementation of this patent or the practicality of the patent.

Claims

1. The application of the ultrasonic aspiration scalpel blade in the preparation of a device for fragmenting and aspirating plaques in the common carotid artery, a device for fragmenting and aspirating plaques in the C1 segment of the internal carotid artery, or a device for fragmenting and aspirating occluded plaques in the C1 segment of the internal carotid artery, wherein the connecting section of the blade and the extension line of the blade tip intersect, and the two transition in an arc shape.

2. The application according to claim 1, characterized in that: The angle between the connecting section of the blade and the extended line of the blade tip is 5°-20°, preferably 10°; The outer diameter of the blade is 2.0-2.2mm, and the inner diameter is 1.1-1.6mm, with the preferred outer diameter being 2.2mm and the inner diameter being 1.4mm. The free end face of the blade tip section is either a bevel or a vertical surface. When it is a bevel, the angle between the bevel and the central axis of the blade is preferably 30°-60°. The blade length is 12-20cm, preferably 20cm.

3. The application according to claim 1, characterized in that: The free end face of the blade tip section is corrugated; the vibration direction of the corrugations is preferably circumferential to the free end face of the blade tip section; the number of corrugations is preferably 5-15, and the amplitude is 0-0.4mm.

4. An ultrasonic aspiration blade for preparing a device for fragmenting and aspirating plaques in the common carotid artery, a device for fragmenting and aspirating plaques in the C1 segment of the internal carotid artery, or a device for fragmenting and aspirating occluded plaques in the C1 segment of the internal carotid artery, characterized in that: The connecting section of the blade and the extended section of the blade tip intersect, and the two transition in an arc.

5. The ultrasonic aspiration scalpel blade according to claim 4, characterized in that: The angle between the connecting section of the blade and the extended line of the blade tip is 5°-20°, preferably 10°; The outer diameter of the blade is 2.0-2.2mm, and the inner diameter is 1.1-1.6mm, with the preferred outer diameter being 2.2mm and the inner diameter being 1.4mm. The free end face of the blade tip section is either a bevel or a vertical surface. When it is a bevel, the angle between the bevel and the central axis of the blade is preferably 30°-60°. The blade length is 12-20cm, preferably 20cm.

6. The ultrasonic aspiration scalpel blade according to claim 4, characterized in that: The free end face of the blade tip section is corrugated; the vibration direction of the corrugations is preferably circumferential to the free end face of the blade tip section; the number of corrugations is preferably 5-15, and the amplitude is 0-0.4mm.

7. An ultrasonic aspiration scalpel, characterized in that: Includes the ultrasonic aspiration knife blade as described in any one of claims 4-6.

8. The application of the ultrasonic aspiration knife according to claim 7 in the preparation of a device for fragmenting and aspirating plaques in the common carotid artery, a device for fragmenting and aspirating plaques in the C1 segment of the internal carotid artery, or a device for fragmenting and aspirating occluded plaques in the C1 segment of the internal carotid artery.

9. A carotid artery plaque fragmentation and aspiration device, characterized in that: The device includes a protective device and the ultrasonic aspiration knife as described in claim 7. The protective device includes an arterial sheath and a counterflow device. The arterial sheath is fitted over the outside of the blade of the ultrasonic aspiration knife, and the free end of the blade tip extends beyond the arterial sheath. The counterflow device includes a flexible tube communicating with the sidewall of the arterial sheath, and the flexible tube is equipped with a flow rate control device and a filter device.

10. The carotid plaque fragmentation and aspiration device according to claim 9, characterized in that: The free end of the blade tip extends beyond the arterial sheath by less than or equal to 0.5 cm; the arterial sheath has several side holes on its side wall near the free end of the blade tip, and the side holes are distributed within a 1 cm axial distance from the end face of the free end of the arterial sheath; the outer diameter of the arterial sheath is 2.97 mm and the inner diameter is 2.77 mm; a spare tube is connected to the side wall of the arterial sheath near the hemostatic valve, and the spare tube is equipped with a valve.

11. The carotid plaque fragmentation and aspiration device according to claim 9, characterized in that: The flow control device is a roller-type flow regulator for infusion sets, and the tubing is equipped with a flow stop clamp; the filtration device includes an outer cylinder and a filter screen installed inside the outer cylinder. A groove is provided on one end face of the outer cylinder, and a locking block is provided on the side of the filter screen. The locking block is located in the groove. A cylinder cap is also threadedly connected to this end face of the outer cylinder, and the cylinder cap abuts against the locking block. The tubing is connected to one end of the outer cylinder through the cylinder cap.

12. The use of the carotid plaque fragmentation and aspiration device according to any one of claims 9-11 in the preparation of a device for fragmenting and aspirating common carotid artery plaque, a device for fragmenting and aspirating internal carotid artery C1 segment plaque, or a device for fragmenting and aspirating internal carotid artery C1 segment occluded plaque.

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