Directional rotary cutting catheter and system based on ultrasonic guidance

Abstract

The invention provides a directional rotary cutting catheter and system based on ultrasonic guidance. The catheter comprises a rotary-cut catheter main body, an operating handle and a directional guide device, and the system comprises the directional rotary-cut catheter, a main machine and a main machine joint, the rotary-cut catheter body internally comprises a first channel, a rotary-cut blade, an ultrasonic transmitting and receiving device and a rotating shaft are arranged in the first channel, and real-time ultrasonic imaging can be achieved so as to accurately position plaques. The directional guiding device is composed of an expandable bag-shaped structure or a metal wire and a metal ring, so that the rotary cutting blade can be accurately close to and cut blood vessel plaques. The operating handle comprises a rotating head, a push-pull sliding block and an angle control module, the lateral opening of the rotary cutting catheter body, the axial movement of the rotary cutting tool bit and the inclination angle of the rotary cutting tool bit can be adjusted through manual or artificial intelligence control, and multi-degree-of-freedom adjustment of the rotary cutting tool bit is achieved; the collecting tube is rotationally connected to the far end of the rotary cutting catheter body and used for collecting tissues such as plaques and thrombus which are cut off.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a directional rotary cutting catheter based on ultrasound guidance. Background Art

[0002] Arterial atherosclerosis refers to lipids in the blood entering the arterial wall and depositing in the intima to form atherosclerotic plaques, which cause the arteries to thicken and harden. Unstable plaques can also form blood clots, which are difficult to remove after calcification, and thus have a high incidence and mortality rate. Atherosclerosis is associated with the risk of myocardial infarction, stroke, and vascular death. According to statistics, the number of people with peripheral arterial disease (PAD) worldwide has reached 236 million, and about 10% to 15% of claudication patients will progress to severe limb ischemia in the fifth year after the onset of the disease, and face the risk of amputation.

[0003] At present, balloon dilatation and stent placement are still the most basic and commonly used methods for PAD treatment in clinical practice, but balloon dilatation treatment cannot overcome the elastic retraction of the target blood vessel, nor can it avoid the formation of blood flow-restricting dissections. The literature reports that the 12-month patency rate of ordinary stents can reach 60% to 80%, but the in-stent restenosis (ISR) rate is 14% to 50%. Although the restenosis rate of drug-coated stents is significantly reduced, it still reaches 17%. Therefore, a new intracavitary treatment method, intracavitary volume reduction, has emerged, which effectively solves the problems of balloons and stents. Intracavitary volume reduction refers to the use of special instruments to perform thrombectomy, plaque removal or plaque ablation on highly calcified, multiple scattered lesions or cross-joint lesions in blood vessels. It is a more suitable treatment method than stent placement. The advantages of intracavitary volume reduction are that it reduces the occurrence of arterial dissection caused by balloon angioplasty, can permanently remove plaques, expand the capacity of target blood vessels, and can effectively delay intimal hyperplasia, thereby slowing down the occurrence of arterial occlusion and improving long-term patency. Currently, the commonly used methods of intraluminal volume reduction in clinical practice include percutaneous intraluminal mechanical plaque resection, plaque rotational excision system, percutaneous mechanical thrombectomy, excimer laser ablation angioplasty, etc.

[0004] In order to solve the above problems, ultrasound guidance has become an ideal solution. Ultrasound imaging can display the location of blood vessel walls and plaques in real time, providing clearer soft tissue structure information. However, traditional ultrasound guidance technology has problems such as insufficient positioning accuracy and inability to simultaneously control the direction of the operating instrument, so it still has certain limitations in actual operation.

[0005] At present, although some research and technology attempts to combine the rotary cutting blade with imaging technology to improve surgical accuracy, the existing technology still faces the following problems: First, it is impossible to achieve real-time and precise docking between the blade and the plaque, resulting in inaccurate cutting or cutting failure. Patent application number 202110228695.9 discloses a catheter system integrating ultrasonic imaging and intracavitary plaque rotary cutting. Although real-time imaging is achieved by installing an ultrasonic probe on a rotating axis, the inclination angle of the rotary cutting blade is fixed, and the inclination of the rotary cutting blade is achieved through a pre-made bend, and the inclination angle of the rotary cutting blade cannot be adjusted in real time in combination with ultrasonic imaging. Patent application number 202321402660.3 discloses an adjustable bending instrument for interventional surgery. The image sensor realizes real-time imaging, but its image sensor only serves to observe the external calcification of the plaque. It does not actually work in the process of the rotary cutting head removing the plaque, and the angle of the rotary cutting head cannot be adjusted in real time according to the imaging; second, the imaging technology is not suitable for directional guided plaque rotary cutting, and the complexity of intraoperative operation increases. The patent with application number 202080081742.5 discloses an imaging catheter, an imaging system and its operation method. It uses OCT imaging technology, and the blood near the plaque needs to be transferred to make the field of view clear. Therefore, this scheme requires frequent flushing of the blood vessels, and the steps are relatively cumbersome; in addition, whether it is OCT imaging technology or image sensors, their penetration is not as good as ultrasound imaging, and they cannot gain insight into the internal structure of the plaque to formulate a resection strategy.

[0006] Therefore, it is of great clinical significance to develop a directional rotary cutting catheter and system that can combine ultrasound guidance, precise positioning and directional cutting. The catheter can not only provide high-precision rotary cutting blade positioning, but also achieve precise docking of the blade with the target plaque through directional guidance, thereby improving the safety and effectiveness of plaque removal. Summary of the invention

[0007] The object of the present invention is to provide a directional rotary cutting catheter and system based on ultrasound guidance, which adopts a directional guiding device and an operating handle to achieve multi-degree-of-freedom adjustment of the rotary cutting blade.

[0008] The purpose of the present invention is achieved by the following technical solutions: In a first aspect, the present invention provides a directional rotary cutting catheter based on ultrasound guidance, comprising: A rotary cutting catheter body, wherein the rotary cutting catheter body comprises a first channel; a rotary cutting blade, an ultrasonic transmitting and receiving device and a rotating shaft are arranged in the first channel; A collecting tube, wherein the collecting tube comprises a second channel therein, the collecting tube is rotatably connected to the rotary cutting catheter body, a lateral opening is provided at the proximal end of the collecting tube, and the rotary cutting blade extends from the rotary cutting catheter body and is exposed to the lateral opening; A directional guide device, the directional guide device comprises a connecting portion and an action portion, the action portion is connected to the collection tube or the rotary cutting catheter body; the action portion is moved by controlling the connecting portion so that the rotary cutting catheter body and the collection tube form a certain angle; The operating handle comprises a rotating head, a push-pull slider and an angle control module; the rotating head is connected to the rotary cutting catheter body so as to rotate to adjust the lateral opening direction; the angle control module is connected to the connecting portion to control the angle between the rotary cutting catheter body and the collecting tube; the push-pull slider is connected to the rotating shaft to control the axial movement of the rotary cutting cutter head.

[0009] Preferably, the rotating shaft is a multi-layer and multi-strand spring tube made of stainless steel, the ultrasonic transmitting and receiving device is fixed at the distal end of the rotating shaft, the rotation speed of the rotating shaft is 10~2000 rpm; the ultrasonic center frequency of the ultrasonic transmitting and receiving device is 1~100 MHz; the imaging depth of the ultrasound-guided directional rotary cutting catheter is 1~100 mm.

[0010] Preferably, the first channel is connected to an external first infusion cavity to flush the lumen of the first channel.

[0011] Furthermore, the rotary cutting catheter body also includes a third channel, and a vascular guide wire is arranged inside the third channel.

[0012] Preferably, the rotary cutting catheter body is also provided with at least one developing ring to indicate its relative position in the blood vessel.

[0013] Furthermore, the action part includes a sac-type structure, which is arranged on the side of the collecting tube or the rotary cutting catheter body opposite to the lateral opening; the connecting part is a filling tube, and the sac-type structure is connected to the external second infusion port through the filling tube; the angle control module is connected to the second infusion port to control the expansion of the sac-type structure, so that the rotary cutting catheter body and the collecting tube form a certain angle.

[0014] Furthermore, the action portion includes at least one metal ring, and the connection portion includes at least two metal wires; by tightening or loosening the metal wires, the rotary cutting catheter body and the collection tube form a certain angle.

[0015] Preferably, the directional guiding device is installed on the collecting pipe to control the collecting angle of the collecting pipe.

[0016] Furthermore, the collecting tube includes a metal skeleton and a covering layer, and the covering layer is a polymer material; the collecting tube is a conical tube with a radius gradually decreasing from the proximal end to the distal end.

[0017] Furthermore, the material of the metal skeleton is stainless steel or nickel-titanium alloy, and the polymer material is polyamide or polyether block polyamide.

[0018] Preferably, the directional guiding device also includes a metal spring, and both ends of the metal spring are respectively connected to the collecting tube and the rotary cutting catheter body; when not subject to external force, the traction force of the metal spring causes the axial direction of the collecting tube and the rotary cutting catheter body to form a certain angle θ, and the angle θ is 0°~30°.

[0019] In a second aspect, the present invention provides a directional rotary cutting system based on ultrasound guidance, which includes the above-mentioned directional rotary cutting catheter based on ultrasound guidance and a host; the host adjusts the operating handle according to ultrasound image artificial intelligence.

[0020] Compared with the prior art, the beneficial effects that can be achieved by at least one of the above technical solutions adopted in the embodiments of this specification include at least: First, the present invention realizes multi-degree-of-freedom adjustment of the rotary cutting blade through an operating handle, allowing the operator to accurately control the angle and position of the rotary cutting blade, thereby solving the problem of insufficient precision of the rotary cutting blade in the prior art; the operating handle includes a rotating head, a push-pull slider and an angle control module, which can respectively control the rotation around the axis, axial movement and angle adjustment of the rotary cutting blade, thereby making the plaque removal process more precise, adaptable to vascular plaques of different shapes and sizes, reducing damage to the vascular wall due to improper operation, and thus improving the safety and success rate of the operation.

[0021] Second, the present invention provides real-time and accurate images of the interior of blood vessels through real-time ultrasonic imaging technology, helping the operator to monitor the progress of plaque removal in real time; through ultrasonic feedback, the operator can accurately control the angle between the main body of the rotary cutting catheter and the collecting tube, ensuring that the rotary cutting blade delicately cuts the vascular plaque while ensuring that the removed plaque can accurately enter the collecting tube, thereby accurately removing the intravascular plaque and avoiding the removal of tissue in the blood vessel, reducing the risk of postoperative complications; and ultrasonic imaging has a higher visual depth than imaging technologies such as OCT imaging or image sensor imaging, and can more accurately detect the deep structure of the blood vessel wall, thereby formulating a plaque rotary cutting strategy; and compared with imaging methods such as OCT imaging or image sensor imaging, ultrasonic imaging does not require frequent flushing operations, which simplifies the use steps and reduces the difficulty of catheter operation.

[0022] Third, the present invention can adjust the installation position of the action part in the directional guidance device according to the plaque situation; the action part is installed on the main body of the rotary cutting catheter, and the inclination angle of the rotary cutting blade can be accurately controlled to more thoroughly remove smaller plaques in the blood vessel; the action part is installed on the collection tube, and the collection angle of the collection tube can be accurately controlled; by adjusting the angle of the collection tube, it is ensured that all removed plaques, regardless of their size and position, can be accurately received by the collection tube, effectively avoiding the omission or deviation of plaques, and preventing larger plaques from remaining in the blood and causing certain risks, thereby further improving the accuracy and safety of the operation and reducing the postoperative risks caused by missed plaques.

[0023] Fourth, the collection tube of the present invention adopts a design of a metal skeleton combined with polymer materials to ensure the strength and flexibility of the system to adapt to complex clinical environments; the skeleton of the collection tube is composed of metal materials such as stainless steel or nickel-titanium alloy, which provides good mechanical strength and support. These metal materials can effectively withstand the external forces generated during the rotary cutting process, while ensuring the stability and durability of the collection tube throughout the operation; polymer materials such as polyamide or polyether block polyamide (PEBAX) are covered on the surface of the metal skeleton, which has excellent flexibility and compliance, allowing the collection tube to smoothly pass through the narrow and curved complex vascular structure during the operation.

[0024] Fifth, the outer diameter of the collecting tube of the present invention gradually decreases from the proximal end to the distal end, forming a gradually shrinking lumen, which can not only reduce the pressure and trauma on the surrounding tissues, but also ensure that the collecting tube can enter the blood vessel or cavity more smoothly, especially when passing through narrower or tortuous areas, which can reduce the difficulty of the overall insertion of the directional excision catheter and the discomfort of the patient; by gradually reducing the outer diameter, the collecting tube can more flexibly adapt to lesions of different sizes, and is particularly suitable for smaller and narrower blood vessels.

[0025] Sixth, the directional rotary cutting system of the present invention integrates an artificial intelligence system, which automatically adjusts the operating handle to control the direction of the rotary cutting blade to ensure that the rotary cutting blade is always aimed at the target plaque; the directional rotary cutting system can automatically analyze the characteristics and location of the targeted lesions, thereby achieving more accurate and efficient surgical operations; specifically, artificial intelligence automatically identifies vascular plaques and other diseased tissues through real-time processing of ultrasound images, and accurately locates the target area through image analysis technology. This process greatly reduces the operator's operating burden, improves the accuracy of the operation, and significantly reduces the overall learning cost and use cost of the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0027] Figure 1 A schematic structural diagram of a directional rotary cutting catheter according to a first embodiment of the present application is shown; Figure 2 A partially enlarged structural schematic diagram of a directional rotary cutting catheter according to the first embodiment of the present application is shown; Figure 3 A schematic diagram showing a directional rotary cutting catheter according to the first embodiment of the present application performing plaque removal surgery; Figure 4 A schematic structural diagram of a directional rotary cutting catheter according to a second embodiment of the present application is shown; Figure 5 Shows Figure 4 Schematic diagram of the proximal AA cross section of the mid-directional rotary cutting catheter; Figure 6 This is a schematic structural diagram of a directional rotary cutting catheter according to a third embodiment of the present application; Figure 7 This is a schematic diagram of the metal spring structure of the third embodiment of the present application.

[0028] Description of Reference Numerals 110. Peeling blade; 120. Ultrasonic transmitting and receiving device; 130. Capsule-type structure; 140. Rotating axis; 150. Collecting tube; 160. Third channel; 170. Metal ring; 171. Metal wire; 180. Coaxial shielding wire; 190. Metal spring; 210. Rotating head; 220. Push-pull slider; 230. First infusion port; 240. Second infusion port; 300. Host connector; 400. Host; 500. Blood vessel wall; 510. Plaque. DETAILED DESCRIPTION

[0029] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0030] The following describes the embodiments of the present invention through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the following embodiments and features in the embodiments can be combined with each other without conflict. Based on the embodiments in the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the scope of protection of the present invention.

[0031] It should be noted that various aspects of the embodiments within the scope of the appended claims are described below. It should be apparent that the aspects described herein may be embodied in a wide variety of forms, and any specific structure and / or function described herein is merely illustrative. Based on the present invention, a person skilled in the art should understand that an aspect described herein may be implemented independently of any other aspect, and two or more of these aspects may be combined in various ways. For example, any number and aspect described herein may be used to implement the device and / or practice the method. In addition, other structures and / or functionalities other than one or more of the aspects described herein may be used to implement this device and / or practice this method; it should be understood that in the embodiments of this specification, atherectomy is only an example of one of the application scenarios of the present application, and the present application is generally used to cut plaques, thrombi or calcified tissues of blood vessels, etc., but may also be applied to other application scenarios of vascular or endovascular volume reduction.

[0032] It should also be noted that the illustrations provided in the following embodiments are only schematic illustrations of the basic concept of the present invention. The drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components in actual implementation. In actual implementation, the type, quantity and proportion of each component may be changed arbitrarily, and the component layout may also be more complicated.

[0033] Additionally, in the following description, specific details are provided to facilitate a thorough understanding of the examples. However, it will be understood by those skilled in the art that the examples can be practiced without these specific details.

[0034] At the same time, in this specification, descriptions involving orientations, such as up, down, left, right, front, back, inside, outside, longitudinal, lateral, vertical, horizontal, etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention; the "proximal end" is the end close to the operator, and the "distal end" is the end away from the operator.

[0035] Furthermore, in the description of this specification, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances, and they cannot be understood as limitations on the present invention.

[0036] Embodiment 1: This embodiment provides a directional rotary cutting catheter based on ultrasound guidance, such as Figure 1 and Figure 2The structure diagram and partial enlarged diagram of the directional rotary cutting catheter are shown in FIG. 1 . The rotary cutting catheter body includes a first channel inside the rotary cutting catheter body; a rotary cutting blade 110, an ultrasonic transmitting and receiving device 120 and a rotating shaft 140 are arranged in the first channel, and the position of the plaque 510 can be determined in real time through ultrasonic imaging. The ultrasonic wave has strong penetrability and can detect the internal structure of the blood vessel wall 500, so as to formulate an overall rotary cutting strategy for the plaque 510, including rotary cutting depth, stroke, etc.; a collecting tube 150, and the collecting tube 150 includes a second channel inside. 150 is rotatably connected to the main body of the rotary cutting catheter, and a lateral opening is provided at the proximal end of the collection tube 150, and the rotary cutting blade head 110 extends from the main body of the rotary cutting catheter and is exposed to the lateral opening; a directional guide device, the directional guide device includes a connecting portion and an action portion, the action portion is connected to the collection tube 150 or the main body of the rotary cutting catheter, when the action portion is installed on the main body of the rotary cutting catheter, the directional guide device mainly controls the tilt angle of the rotary cutting blade head 110, and when the action portion is installed on the collection tube 150, the directional guide device mainly controls the tilt angle of the collection tube 150; by controlling The control connection part makes the action part move, so that the main body of the rotary cutting catheter and the collection tube 150 form a certain angle; the operating handle includes a rotating head 210, a push-pull slider 220 and an angle control module; the rotating head 210 is connected to the main body of the rotary cutting catheter so as to rotate to adjust the lateral opening direction. Compared with rotating the entire directional rotary cutting catheter, the rotating head 210 is integrated in the operating handle to make the rotation operation more convenient, and the rotary cutting catheter body can also be conveniently rotated after entering the body; the angle control module is connected to the connection part to control the rotation of the main body of the rotary cutting catheter and the collection tube 150 The push-pull slider 220 is connected to the rotating shaft 140 to control the axial movement of the rotary cutting blade 110; the rotation of the rotating head 210 can be combined with the ultrasonic image detected by the ultrasonic transmitting and receiving device 120 to direct the lateral opening of the rotary cutting catheter body toward the position of the plaque 510, and the directional plaque 510 rotary cutting is performed under the action of the directional guiding device; the directional rotary cutting catheter can also be integrated with artificial intelligence to realize automatic operation. Due to the setting of the operating handle, artificial intelligence can more conveniently control the rotary cutting catheter body and the rotary cutting blade to achieve more precise cutting.

[0037] In a preferred embodiment, the main body of the rotary cutting catheter is composed of a braided tube, the inner layer material of the braided tube is polytetrafluoroethylene (PTFE), the middle layer is a stainless steel wire braided mesh, and the outer layer is polyamide (PA) or polyether block polyamide (PEBAX); further, the rotating shaft 140 is a multi-layer torsion spring tube, which can provide a stable rotational torque, so that the rotary cutting head 110 rotates at a uniform and controllable speed, avoiding the inaccuracy of the rotary cutting process due to unstable torque; the rotary cutting head 110 and the ultrasonic transmitting and receiving device 120 are fixed at the distal end of the rotating shaft 140, and the proximal end is connected to the main host connector 300, which plays a role in transmitting torque; preferably, the rotation speed of the rotating shaft 140 is 20~500 rpm; further, the collection tube 150 is made of metal material, such as stainless steel or nickel-titanium alloy.

[0038] like Figure 3 The figure shows a schematic diagram of the bending of the directional exfoliation catheter of the first embodiment of the present invention; after the ultrasonic transmitting and receiving device 120 detects and locates the position of the vascular plaque 510 in the target blood vessel wall 500; the directional guide device is expanded by filling the second infusion port 240 with liquid, so that the lateral opening of the exfoliation catheter body and the exfoliation cutter head 110 can be brought close to the target blood vessel plaque 510; thereby, precise exfoliation of the plaque 510 is implemented to avoid excessive damage to non-target blood vessels.

[0039] In a preferred embodiment, the ultrasonic transmitting and receiving device 120 is fixed to the distal end of the rotating shaft 140, and the rotation speed of the rotating shaft 140 is 10~2000 rpm; the ultrasonic center frequency of the ultrasonic transmitting and receiving device 120 is 1~100 MHz; the imaging depth of the ultrasound-guided directional rotary cutting catheter is 1~100 mm.

[0040] In a preferred embodiment, the first channel is connected to an external first infusion cavity to flush the lumen of the first channel; the rotary cutting catheter body further includes a third channel 160, and a vascular guide wire is arranged inside the third channel 160; the rotary cutting catheter body is also provided with at least one developing ring to indicate its relative position in the blood vessel; preferably, the third channel 160 is a quick exchange (RX) design, that is, the proximal end of the third channel 160 extends to a designated position on the side of the rotary cutting catheter body, rather than passing through the entire catheter.

[0041] In a preferred embodiment, the action part includes a sac-type structure 130, which is arranged on the side of the collection tube 150 or the rotary cutting catheter body relative to the lateral opening; the connecting part is a filling tube, and the sac-type structure 130 is connected to the external second infusion port 240 through the filling tube; the angle control module is connected to the second infusion port 240 to control the expansion of the sac-type structure 130, so that the rotary cutting catheter body and the collection tube 150 form a certain angle; preferably, the sac-type structure 130 is made of a compliant polymer material, such as silicone; further, the sac-type structure 130 is arranged on the collection tube 150 to control the angle at which it collects the removed plaque 510; the expansion size of the sac-type structure 130 is controlled by controlling the infusion volume of the second infusion port 240, and a manually controlled valve can be set in the second infusion port 240.

[0042] In a preferred embodiment, the collecting tube 150 includes a metal skeleton and a covering layer, the covering layer is a polymer material, the material of the metal skeleton is stainless steel or nickel-titanium alloy, and the polymer material is polyamide or polyether block polyamide; the combination of the metal skeleton and the polymer material enables the collecting tube to have good bending resistance and operability, and can operate stably in complex anatomical structures while minimizing damage to surrounding tissues; the collecting tube 150 is a conical tube with a radius gradually decreasing from the proximal end to the distal end; since the collecting tube 150 is located at the distal end relative to the directional rotary cutting catheter, the diameter of the collecting tube 150 determines the overall passability of the directional rotary cutting catheter, and since the intravascular plaque 510 will block the approach of the directional rotary cutting catheter, the conical design of the collecting tube 150 can better pass through the narrow position of the intravascular plaque 510, allowing the rotary cutting catheter body to approach the plaque 510.

[0043] Embodiment 2: This embodiment provides a directional rotary cutting catheter based on ultrasound guidance. Compared with the first embodiment, the action part of this embodiment includes a metal ring 170, and the connecting part includes two metal wires 171; Figure 4 and Figure 5 It is a schematic diagram of the structure of a directional exfoliation catheter according to the second embodiment of the present invention; by tightening or loosening the metal wire 171, the exfoliation catheter body and the collection tube 150 form a certain angle, so that the exfoliation cutter head 110 is tilted close to the plaque 510; its directional guide device adopts the design of an adjustable bend catheter; the directional guide device comprises a metal ring 170 arranged inside the exfoliation catheter body, and at least two metal wires 171 connecting the metal ring 170 and the operating handle; the metal wire 171 is tightened or loosened by the bending knob of the operating handle, so as to achieve the effect of adjusting the bending direction of the exfoliation catheter body. According to the size and depth of the plaque 510, the angle between the exfoliation catheter body and the collection tube 150 can be accurately controlled by controlling the rotation angle of the bending knob, thereby controlling the exfoliation depth to achieve a better exfoliation effect. Preferably, the directional guide device is made of stainless steel and nickel-titanium alloy. Figure 5 Shown Figure 4 Schematic diagram of the proximal AA cross section of the catheter. The metal wire 171 is movably attached to the inner wall of the rotary cutting catheter body; the first cavity of the rotary cutting catheter body contains a rotating shaft 140; the rotating shaft 140 contains a coaxial shielding wire 180; the distal end of the coaxial shielding wire 180 is connected to the ultrasonic transmitting and receiving device 120, and the proximal end is connected to the host connector 300 for transmitting electrical signals between the two.

[0044] In a preferred embodiment, different from Figure 4 The middle metal ring 170 is arranged inside the main body of the rotary cutting catheter, and the metal ring 170 is set on the outside of the collection tube 150. The collection tube 150 is pulled by the metal wire 171 to control its inclination angle, thereby driving the main body of the rotary cutting catheter to tilt; not only the directional collection of the plaque 510 is realized, but also the directional rotary cutting of the rotary cutting head 110 is realized.

[0045] Embodiment 3: This embodiment provides a directional rotary cutting catheter based on ultrasound guidance. Compared with the first embodiment and the second embodiment, Figure 6 and Figure 7 As shown, the directional guiding device also includes a metal spring 190, and the two ends of the metal spring 190 are respectively connected to the collection tube 150 and the peeling catheter body; when not subject to external force, the traction force of the metal spring 190 causes the collection tube 150 and the peeling catheter body to form a certain angle θ in the axial direction, and the angle θ is 0°~30°. By pre-setting an angle θ, the peeling blade 110 is brought closer to the plaque 510.

[0046] Embodiment 4: The present embodiment provides a directional exfoliation system based on ultrasound guidance, which includes a directional exfoliation catheter, a host 400 and a host connector 300; the host 400 adjusts the operating handle according to the ultrasound image artificial intelligence. Due to the setting of the operating handle in the directional exfoliation catheter, the artificial intelligence can directly realize all directional guidance by controlling the operating handle; the host connector 300 plays the role of transmitting torque and signal transmission; it rotates with the rotating shaft 140, and transmits electrical signals between the ultrasonic transmitting and receiving device 120 and the host 400; the host 400 is used to transmit and receive electrical signals, and converts the received electrical signals into image information through certain signal processing, providing accurate ultrasound images to the operator; the host 400 can also integrate artificial intelligence, automatically analyze target lesion information through artificial intelligence, and can automatically control the rotating head 210, the push-pull slider 220 and the directional guidance device to implement treatment, thereby controlling the offset angle of the directional exfoliation catheter and the angle of the exfoliation blade, greatly reducing the operator's operating steps and improving surgical efficiency.

[0047] This embodiment also provides a method for using an ultrasound-guided directional rotary cutting system, which is based on the ultrasound-guided directional rotary cutting system and is applied to treat plaques 510 or thrombi in a patient's blood vessels. Through this method, the target plaque 510 can be accurately removed by the directional rotary cutting blade 110 under the guidance of real-time ultrasound images, and the removed tissue is sent to a collection device to avoid damage to non-target blood vessels.

[0048] S1. The operating handle is connected to the host 400 through the host connector 300. First, the operator connects the first infusion port 230 and the second infusion port 240 through the filling pump, and ensures that the air in the first channel and the second channel is emptied so that the system can operate normally.

[0049] S2. Under the guidance of X-ray, the operator inserts the vascular guide wire into the patient's blood vessel and guides the rotary cutting catheter body to the target lesion site through the third channel 160. The vascular guide wire helps the catheter to be positioned in the blood vessel, ensuring that the catheter accurately reaches the site where the plaque 510 is located.

[0050] S3, the operator starts the ultrasonic transmitting and receiving device 120, and uses its ultrasonic signal to scan the blood vessel wall 500 and the plaque 510 in real time, generating a real-time ultrasonic image. The host 400 receives and processes the ultrasonic signal, outputs the intravascular image, and clearly displays the location of the plaque 510.

[0051] S4. The operator manually rotates the rotating head 210, or allows the host 400 to control the rotation of the rotating head 210 through artificial intelligence. The rotation of the rotating head 210 aligns the lateral opening of the rotary cutting catheter body and the rotary cutting blade 110 with the position of the target vascular plaque 510. During this process, the ultrasonic transmitting and receiving device 120 provides continuous image feedback to ensure the accuracy of the cutting position.

[0052] S5. Infuse physiological saline into the directional guide device through the second infusion port 240 to expand it. The expanded sac structure 130 pushes the lateral opening of the rotary cutting catheter body to approach the target plaque 510, ensuring that the rotary cutting blade 110 is accurately aligned with the plaque 510.

[0053] S6. The operator pushes the rotary cutting blade 110 axially by pushing and pulling the slider 220 to start cutting the plaque 510. The rotary cutting blade 110 rotates at high speed driven by the rotating shaft 140 to cut the plaque 510, and collects the cut vascular plaque 510 and thrombus and other tissues through the collection tube 150. The cut tissue enters the collection device through the second channel to prevent it from remaining in the blood vessel.

[0054] S7. If the target plaque 510 is large or widely distributed, the operator can adjust the cutting direction and position of the rotary cutting head 110 according to the ultrasonic image guidance. The rotary head 210 and the push-pull slider 220 are manually or artificially controlled to complete multiple cutting operations until the plaque 510 is completely removed.

[0055] S8. After all target plaques 510 are removed, the operator stops the movement of the directional rotary cutting catheter, removes the rotary cutting catheter, and cleans it. After the catheter is withdrawn, the vascular guide wire is also removed, and the patient can be observed and recovered after the operation.

[0056] In this embodiment, the metal ring 170 and the metal wire 171 can also be selected as directional guide devices according to the ultrasonic imaging characteristics of the patient's blood vessels. The tension of the metal wire 171 is adjusted by the bending knob of the operating handle, thereby controlling the bending angle of the rotary cutting catheter body and the collection tube 150 to adapt to plaques 510 of different sizes and depths; through the adjustment of the metal wire 171, the rotary cutting catheter body can bend more flexibly and adapt to complex blood vessel paths, thereby improving the accuracy of plaque 510 removal and the convenience of operation.

[0057] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. A directional rotary cutting catheter based on ultrasound guidance, characterized in that: include: A rotary cutting catheter body, wherein the rotary cutting catheter body comprises a first channel; a rotary cutting blade, an ultrasonic transmitting and receiving device and a rotating shaft are arranged in the first channel; A collecting tube, wherein the collecting tube comprises a second channel therein, the collecting tube is rotatably connected to the rotary cutting catheter body, a lateral opening is provided at the proximal end of the collecting tube, and the rotary cutting blade extends from the rotary cutting catheter body and is exposed to the lateral opening; A directional guide device, the directional guide device comprises a connecting portion and an action portion, the action portion is connected to the collection tube or the rotary cutting catheter body; the action portion is moved by controlling the connecting portion so that the rotary cutting catheter body and the collection tube form a certain angle; The operating handle comprises a rotating head, a push-pull slider and an angle control module; the rotating head is connected to the rotary cutting catheter body so as to rotate to adjust the lateral opening direction; the angle control module is connected to the connecting portion to control the angle between the rotary cutting catheter body and the collecting tube; the push-pull slider is connected to the rotating shaft to control the axial movement of the rotary cutting cutter head.

2. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The rotating shaft is a multi-layer, multi-strand spring tube made of stainless steel. The ultrasonic transmitting and receiving device is fixed at the distal end of the rotating shaft. The rotation speed of the rotating shaft is 10 to 2000 revolutions per second. The ultrasonic center frequency of the ultrasonic transmitting and receiving device is 1 to 100 MHz. The imaging depth of the ultrasound-guided directional rotary cutting catheter is 1 to 100 mm.

3. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The first channel is connected to an external first infusion cavity to flush the lumen of the first channel.

4. The ultrasound-guided directional rotary cutting catheter according to claim 3, characterized in that: The rotary cutting catheter body also includes a third channel, and a vascular guide wire is arranged inside the third channel.

5. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The rotary cutting catheter body is also provided with at least one developing ring to indicate its relative position in the blood vessel.

6. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The action part includes a sac-type structure, which is arranged on a side of the collecting tube or the rotary cutting catheter body opposite to the lateral opening; the connecting part is a liquid filling tube, and the sac-type structure is connected to an external second infusion port through the liquid filling tube; the angle control module is connected to the second infusion port to control the expansion of the sac-type structure, so that the rotary cutting catheter body and the collecting tube form a certain angle.

7. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The action part includes at least one metal ring, and the connection part includes at least two metal wires; by tightening or loosening the metal wires, the rotary cutting catheter body and the collection tube form a certain angle.

8. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The directional guide device is installed on the collecting pipe to control the collecting angle of the collecting pipe.

9. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The collecting tube comprises a metal skeleton and a covering layer, wherein the covering layer is made of a polymer material; the collecting tube is a tapered tube with a radius gradually decreasing from the proximal end to the distal end.

10. The ultrasound-guided directional rotary cutting catheter according to claim 9, characterized in that: The material of the metal skeleton is stainless steel or nickel-titanium alloy, and the polymer material is polyamide or polyether block polyamide.

11. The ultrasound-guided directional rotary cutting catheter according to claim 1, characterized in that: The directional guiding device also includes a metal spring, the two ends of which are respectively connected to the collection tube and the rotary cutting catheter body; when not subject to external force, the traction force of the metal spring causes the axial direction of the collection tube and the rotary cutting catheter body to form a certain angle θ, and the angle θ is 0° to 30°.

12. A directional rotary cutting system based on ultrasound guidance, characterized in that: It comprises an ultrasound-guided directional rotary cutting catheter and a host as described in any one of claims 1 to 11; the host adjusts the operating handle according to ultrasound image artificial intelligence.

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