Medical rotary cutting tool bit assembly, rotary cutting catheter and visual blood vessel volume reduction system

Abstract

According to the medical rotary cutting tool bit assembly, the rotary cutting catheter and the visual blood vessel volume reduction system, the rotary cutting tool bit assembly is provided with a front rotary cutting tool bit and a rear rotary cutting tool bit to conduct rotary cutting operation on blocked blood vessel plaques or thrombus and the like, and the effects of opening blocked blood vessels and enlarging the diameter of a lumen are achieved; a larger blood vessel lumen diameter can be obtained under the condition that surgical instruments do not need to be replaced or repeated rotary cutting is not needed, and the surgical operation steps and time are reduced; meanwhile, by means of an imaging assembly, especially an ultrasonic transmitting and receiving device, instrument positioning in the blood vessel is carried out, a real-time and accurate ultrasonic image view is provided, and the lesion condition can be accurately evaluated; under the scene that a blood vessel guide wire or other surgical instruments cannot effectively penetrate through the occluded lesion, a lesion area can be smoothly reached, and the occluded blood vessel can be opened, so that the operation is safer and more effective.

Description

Technical Field

[0001] The present invention relates to the field of interventional medical technology, and in particular to a medical rotary cutting blade assembly, a rotary cutting catheter and a visualized blood vessel volume reduction system. Background Art

[0002] Atherosclerosis has become the most common disease among the middle-aged and elderly in my country, with an incidence rate of up to 79.9% in people over 60 years old in my country. Atherosclerosis obliterans is a local manifestation of systemic atherosclerosis in the limbs, mainly manifested by the appearance of atherosclerotic plaques in the intima of the artery, degeneration or calcification of the middle layer of tissue, and secondary thrombosis in the lumen, which damages the arterial wall and eventually narrows the lumen or even completely occludes it, causing acute or chronic ischemic symptoms in the affected limb, and in severe cases can cause necrosis of the extremities. Data show that the 5-year mortality rate of patients with lower limb arteriosclerosis obliterans is 10% to 15%, the 5-year mortality rate of patients with "intermittent claudication" is 30%, and the 5-year mortality rate of severe patients with "rest pain" and ulcer gangrene is as high as 70%, and the 1-year amputation rate of severe patients is as high as 30%.

[0003] For arteriosclerotic occlusive disease, in addition to drug treatment, the commonly used treatment method in clinical practice is interventional surgery, including balloon dilatation and stent placement. However, 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%~80%, but the in-stent restenosis (ISR) rate is 14%~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 the existing interventional treatment methods for atherosclerosis, when encountering occlusive lesions, intraluminal opening is often required first. That is, a vascular guidewire is used to pass through the occlusive lesion, and after a treatment track is established in the proximal and distal true lumen (true lumen) of the lesion, the instrument is passed through the lesion area to perform the next step of lesion treatment. However, in actual surgical operations, when encountering tough lesion areas (such as severely calcified atherosclerotic plaques or thrombi), the vascular guidewire or surgical instrument is often unable to effectively pass through the occlusive lesion, ultimately leading to treatment failure. In addition, during the current occluded blood vessel opening surgery, there is a lack of real-time and accurate intravascular positioning means, and often only experience or angiography can be relied on to locate and guide the delivery of the instrument, thereby increasing the risk of the instrument entering the vascular false lumen, dissection or vascular damage. In addition, the existing instruments often have only one rotary cutting head, and multiple operations are required during the operation to expand the diameter of the vascular lumen. Not only is the operation complicated and the operation time long, it is also easier to stimulate the blood vessels, increasing the risk of vascular damage. Therefore, how to design a device for opening occluded blood vessels that can accurately perform real-time intravascular imaging to assess the condition of the lesion and guide the positioning of the device, and reliably and efficiently open occluded blood vessels and expand the diameter of the vascular lumen, is an urgent problem to be solved. Summary of the invention

[0005] The purpose of the present application is to solve at least one of the problems existing in the above-mentioned difficult technologies, and aims to provide a medical rotary cutting blade assembly, a rotary cutting catheter and a visualized vascular volume reduction system to solve the problems in the prior art that the treatment track established by the guide wire cannot effectively pass through the occluded lesions, and that repeated rotary cutting easily causes the risk of vascular damage.

[0006] To this end, the present invention provides a medical rotary cutting tool head assembly in a first aspect, comprising a first hollow rotating shaft; Also includes: A first rotary cutting cutter head, wherein the first rotary cutting cutter head is fixedly connected to the distal end head of the first hollow rotating shaft, and the first rotary cutting cutter head has a first rotary cutting diameter; a second rotary cutting cutter head, the second rotary cutting cutter head is arranged at a proximal end of the first rotary cutting cutter head along a proximal direction of the first hollow rotating shaft, the second rotary cutting cutter head has a second rotary cutting diameter, and the second rotary cutting diameter is larger than the first rotary cutting diameter; An imaging component, wherein the proximal end of the imaging component is fixed to the distal end of the first hollow rotating shaft or between the first rotary cutting cutter head and the second rotary cutting cutter head or to the proximal end of the second rotary cutting cutter head.

[0007] Preferably, the first rotary cutting cutter head comprises at least one opening to connect the blood vessel with the inner cavity of the first hollow rotating shaft and / or the second rotary cutting cutter head further comprises at least one opening to connect the blood vessel with the inner cavity of the first hollow rotating shaft.

[0008] Preferably, the imaging component is at least one of a miniature camera, an ultrasonic imaging device, an electromagnetic imaging device, and a laser imaging device.

[0009] Preferably, the imaging component forms a first angle with the axial direction of the catheter body, and the first angle is 5°~45°.

[0010] Preferably, the axial angle between the imaging component and the catheter body can be adjusted arbitrarily within the range of 5° to 45° by an angle adjustment component.

[0011] Preferably, the second rotary cutting cutter head is fixedly connected to the side surface of the first hollow rotating shaft.

[0012] Furthermore, a plurality of metal rings are disposed outside the first hollow rotating shaft, and a certain gap is formed between each metal ring.

[0013] Furthermore, the medical rotary cutting blade assembly also includes a second hollow rotating shaft, which is coaxially sleeved on the outside of the first hollow rotating shaft, and the second rotary cutting blade is fixedly connected to the second hollow rotating shaft, and the first rotary cutting blade and the second rotary cutting blade can independently slide and rotate axially.

[0014] Furthermore, a plurality of metal rings are disposed outside the second hollow rotating shaft, and a certain gap is formed between each metal ring.

[0015] In a second aspect, the present invention provides a medical rotary cutting catheter, comprising: Introducer sheath; The medical rotary cutting blade assembly described in any one of the first to seventh embodiments; the medical rotary cutting blade assembly is slidably and rotatably disposed in the guide sheath, a first channel A is defined between the first hollow rotating shaft and the guide sheath, and the distal end of the first channel A is communicated with a human body pipeline; An operating handle, the operating handle includes a guide sheath interface and a driving part; the guide sheath interface is fixedly connected to the proximal end of the guide sheath; the driving part is used to drive the medical rotary cutting blade assembly to slide and rotate along the axial direction of the guide sheath.

[0016] Preferably, the operating handle further comprises a suction port, and the suction port is connected to the proximal air path of the first channel A.

[0017] Furthermore, the driving part at least includes a rotational power source, a sleeve assembly, a rolling bearing and a driving slider, wherein the sleeve assembly includes an inner core driving member and an outer sleeve, and the inner core driving member and the outer sleeve are movably matched in at least one manner of a keyway, a spline, a spiral groove, and a magnetic coupling; the rotational power source is transmission-connected to the inner core driving member, the proximal end of the hollow rotating shaft is fixedly connected to the distal end of the outer sleeve, the inner ring of the rolling bearing is rotationally matched with the outer sleeve, the bearing seat of the rolling bearing is fixedly connected to the driving slider, and the driving slider can move axially along the operating handle under the drive of an external force.

[0018] Preferably, the driving part also includes an outer sleeve, the inner core driving member is passed through the outer sleeve and fixedly connected to the outer sleeve, the outer sleeve is outer-engaged in the outer sleeve, and the outer sleeve and the outer sleeve are movably matched in at least one manner of keyway, spline, spiral groove, and magnetic coupling.

[0019] The present invention provides a medical rotary cutting catheter in a third aspect, comprising: Introducer sheath; The medical rotary cutting blade assembly described in the eighth embodiment or the ninth embodiment; the medical rotary cutting blade assembly is slidably and rotatably disposed in the guide sheath, a first channel B is defined between the second hollow rotating shaft and the guide sheath, and a distal end of the first channel B is connected to a human body pipeline; An operating handle, the operating handle includes a guide sheath interface and a drive unit; the guide sheath interface is fixedly connected to the proximal end of the guide sheath; the drive unit includes a first drive unit and a second drive unit, the first drive unit is used to drive the first rotary cutting cutter head to slide axially and rotate along the second hollow rotating shaft; the second drive unit is used to drive the second rotary cutting cutter head to slide axially and rotate along the guide sheath.

[0020] Preferably, the operating handle further comprises a suction port, and the suction port is connected to the proximal air path of the first channel B.

[0021] Preferably, the rotation speed of the second peeling blade is lower than or equal to that of the first peeling blade.

[0022] Preferably, the operating handle also includes an infusion port, which is connected to the proximal liquid path of the first hollow rotating shaft, and the distal end of the hollow rotating shaft and / or the first rotary cutting cutter head and / or the second rotary cutting cutter head are connected to the human body pipeline through a liquid outlet.

[0023] In a fourth aspect, the present invention provides a visual vascular volume reduction system, comprising: Proximal surgical control platform, and the medical rotary cutting catheter according to any one of the above embodiments, Wherein, the surgical proximal control platform includes a surgical imaging system, and the surgical imaging system is electrically connected to the imaging component to transmit the working status of the medical rotary cutting catheter in real time.

[0024] Compared with the prior art, the at least one technical solution adopted in the embodiments of this specification can achieve the following beneficial effects: The present invention realizes a guidewire-free lumen design, which can not only reduce the outer diameter of the catheter and bring better passability; but also is more suitable for the scenario of opening occluded blood vessels, and can perform occluded blood vessel opening in the scenario where the vascular guidewire or other surgical instruments cannot effectively pass through the occluded lesions.

[0025] The medical rotary cutting blade assembly of the present invention uses an imaging component, such as an ultrasonic transmitting and receiving component, to locate the instrument in the blood vessel, and the imaging component forms a first angle with the axial direction of the catheter body. The first angle is preferably 5°~45°, which can provide real-time and accurate image field of view, accurately evaluate the lesion condition, and guide the relative position of the catheter, the blood vessel and the lesion, effectively reducing the damage to the blood vessel during the opening process, making the operation safer and more effective.

[0026] Third, the medical interventional rotary cutting blade assembly of the present invention is designed with two rotary cutting blades, one in front and one in the back, to perform rotary cutting operations on vascular plaques or thrombi, respectively, to open blocked blood vessels and expand the lumen diameter, respectively. A larger vascular lumen diameter can be obtained without replacing surgical instruments or repeated rotary cutting, thereby reducing the number of surgical steps and duration.

[0027] Fourth, the medical rotary cutting blade assembly of the present invention can be adapted to the commonly used guide sheath that is already on the market. With the help of the guide sheath, a suction channel is formed between the catheter body and the catheter sheath. While opening the occluded blood vessels, the cut plaques, thrombi, etc. are suctioned in time to prevent the cut tissue from falling into the distal end of the blood vessel again.

[0028] Fifth, the outer part of the hollow rotating shaft of the present invention is further wrapped with a layer of metal wire, and a certain gap is formed between each circle of metal wire. When the metal wire rotates with the rotating shaft in the guide sheath, an Archimedean effect is generated to form a negative pressure, which can further enhance the suction effect.

[0029] Sixth, the interventional rotary cutting blade assembly of the present invention also includes a second hollow rotating shaft in a preferred embodiment, and the second hollow rotating shaft is coaxially sleeved on the outside of the first hollow rotating shaft, and the second rotary cutting blade is fixedly connected to the second hollow rotating shaft, and the first rotary cutting blade and the second rotary cutting blade can slide axially independently. This arrangement can apply different rotation speeds and sliding strokes to the two rotary cutting blades respectively, so as to better achieve the effect of opening occluded blood vessels and expanding the diameter of blood vessels.

[0030] Seventh, in the medical rotary cutting catheter of the present invention, the rotary power source, sleeve assembly, rolling bearing and driving slider in the operating handle cooperate with each other to achieve decoupling between the rotary motion driven by the rotary power source and the axial motion driven by the driving slider, so that the axial motion and rotary motion of the rotary cutting cutter head assembly inside the rotary cutting catheter are independent of each other, thereby implementing precise rotary cutting control. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative work. Figure 1 This is a schematic structural diagram of a first embodiment of a medical interventional rotary cutting blade assembly of the present invention; Figure 2 This is a schematic structural diagram of a second embodiment of a medical interventional rotary cutting blade assembly of the present invention; Figure 3 This is a schematic structural diagram of a third embodiment of a medical interventional rotary cutting blade assembly of the present invention; Figure 4 It is a schematic structural diagram of a preferred embodiment of a medical rotary cutting catheter of the present invention; Figure 5 It is a schematic diagram of the structure of the driving part in a preferred embodiment of the medical rotary cutting catheter of the present invention; Figure 6 It is a schematic diagram of the structural principle of the visualized vascular volume reduction system of the present invention;

[0032] 1. Medical rotary cutting blade assembly; 11. First hollow rotating shaft; 12. First rotary cutting blade; 13. Second rotary cutting blade; 14. Imaging assembly; 111. First ring; 112. First gap; 15. Second hollow rotating shaft; 151. Second ring; 152. Second gap; 2. Rotary cutting catheter; 21. Guide sheath; 22. First channel A; 23. Operating handle; 231. Guide sheath interface; 232. Suction port; 233. Drive unit; 234. Infusion port; 2331. Rotary power source; 2332. Sleeve assembly; 2333. Rolling bearing; 2334. Drive slider; 2332a. Inner core drive member; 2332b. Outer sleeve; 2335. Outer sleeve; 24. First channel B; 233a. First drive unit; 233b. Second drive unit; 3. Visualized vascular volume reduction system; 31. Proximal surgical control platform. DETAILED DESCRIPTION

[0033] The embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0034] 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.

[0035] 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 can 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, it should be understood by those skilled in the art that an aspect described herein can be implemented independently of any other aspect, and two or more of these aspects can be combined in various ways. For example, any number and aspect described herein can 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 can be used to implement this device and / or practice this method.

[0036] 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.

[0037] 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.

[0038] 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, and do not indicate or imply 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.

[0039] 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.

[0040] Furthermore, in the description of the claims and specification, it should be noted that the "proximal end" and "distal end" are relative to the position of the surgical operator. During the operation, the end close to the operator is called the "proximal end", and the end far from the operator is called the "distal end".

[0041] Figure 1 The figure shows a schematic structural diagram of the first embodiment of the medical rotary cutting blade assembly of the present invention, wherein the medical rotary cutting blade assembly 1 comprises a first hollow rotating shaft 11, a first rotary cutting blade 12 and a second rotary cutting blade 13, wherein the rotation speed of the first hollow rotating shaft 11 can reach 20 to 100 revolutions per second, and preferably, the first hollow rotating shaft 11 is a multi-layer multi-strand spring tube made of materials such as stainless steel or nickel-titanium alloy, which can provide excellent flexibility and kink resistance, efficient torque transmission capability, high strength, fatigue resistance and biosafety, but it should be understood that the material and structure are only preferred embodiments and cannot be understood as limiting the scope of protection of the claims; wherein the first rotary cutting blade 12 is fixedly connected to the distal end of the hollow rotating shaft 11, and the first rotary cutting blade 12 has a first Peeling diameter; the second peeling cutter head 13 is arranged at the proximal end of the first peeling cutter head 12 along the proximal direction of the first hollow rotating shaft 11. It should be understood that "along the proximal direction of the first hollow rotating shaft" only represents the relative position, that is: the second peeling cutter head 13 is located at the proximal end of the first peeling cutter head 12 in the extension direction of the first hollow rotating shaft 11. This does not mean that the second peeling cutter head 13 must be arranged on the first hollow rotating shaft 11 at the same time as the first peeling cutter head 12. The first peeling cutter head 12 and the second peeling cutter head 13 can be arranged on the first hollow rotating shaft 11 at the same time, or can be arranged on different rotating shafts respectively, as long as the second peeling cutter head 13 is arranged at the proximal end of the first peeling cutter head 12 along the direction of the first hollow rotating shaft 11. When the first rotary cutter head 12 and the second rotary cutter head 13 are disposed on the first hollow rotating shaft 11 at the same time, the two can be disposed separately, that is, the first rotary cutter head 12 is located at the far end of the first hollow rotating shaft 11, and the second rotary cutter head is fixedly connected to the side of the first hollow rotating shaft; or Figure 1As shown, the first rotary cutting blade 12 and the second rotary cutting blade 13 are integrally formed on the same rotary cutting piece. Furthermore, the second rotary cutting blade 13 has a second rotary cutting diameter, and the second rotary cutting diameter is larger than the first rotary cutting diameter. The medical interventional rotary cutting blade assembly 1 of the present invention performs rotary cutting operations on vascular plaques or thrombi respectively by designing two rotary cutting blades one in front and one in the back. The first rotary cutting blade 12 with a smaller distal rotary cutting diameter plays the role of grinding vascular plaques and opening occluded blood vessels. The second rotary cutting blade 13 with a larger proximal rotary cutting diameter further expands the lumen diameter through a secondary rotary cutting operation. Therefore, the present invention can achieve a better blood vessel dredging effect at one time, and a larger blood vessel lumen diameter can be obtained without changing surgical instruments or repeated rotary cutting, thereby reducing the surgical operation steps and duration. Preferably, the first rotary cutting blade 12 and / or the second rotary cutting blade 13 include at least one opening to connect the blood vessel with the inner cavity of the hollow rotating shaft, and the opening can be used as an infusion hole for saline, contrast agent, etc.

[0042] Furthermore, the medical rotary cutting blade assembly 1 described in this embodiment further includes an imaging assembly 14, and the imaging assembly 14 is fixedly connected to the distal end of the first hollow rotating shaft 11 or between the first rotary cutting blade 12 and the second rotary cutting blade 13 or to the proximal end of the second rotary cutting blade 13, and its installation position is not specifically limited, but is preferably as follows: Figure 1 The device is shown to be arranged between the first rotary cutting blade head 12 and the second rotary cutting blade head 13. The imaging component 14 is preferably at least one of a miniature camera, an ultrasonic imaging device, an electromagnetic imaging device, and a laser imaging device, and is more preferably an ultrasonic imaging device. The ultrasonic imaging device can locate the device in the blood vessel through an ultrasonic transmitting and receiving device, provide a real-time and accurate ultrasonic image field of view, accurately evaluate the lesion condition, and guide the relative position of the catheter, the blood vessel and the lesion, effectively reduce the damage to the blood vessel during the opening process, and improve safety. And it is precisely because of the precise real-time guidance provided by the imaging component 14 that the medical rotary cutting blade head assembly 1 does not need to use a guide wire in the working state, and also cancels the guide wire cavity, which brings the advantages of small outer diameter of the catheter and strong passability. In the scenario where the guide wire or other surgical instruments cannot effectively pass through the occluded lesion, it can also smoothly reach the lesion area and perform occluded blood vessel opening, making the operation safer and more effective. Preferably, the imaging direction of the imaging component 14 forms a first angle with the axial direction of the first hollow rotating shaft 11, and the first angle is preferably 5° to 45°, and more preferably, the axial angle between the imaging component 14 and the first hollow rotating shaft 11 can be arbitrarily adjusted and locked within the range of 5° to 45° by an angle adjustment component. By setting the first angle, the imaging position can be focused on the target lesion site, forming a clearer imaging field of view.

[0043] Figure 2The figure shows the structure schematic diagram of the second embodiment of the medical rotary cutting blade assembly of the present invention. Compared with the first embodiment, the main improvement of this embodiment is that a plurality of first rings 111 are additionally provided outside the first hollow rotating shaft 11, and a first gap 112 is formed between each adjacent first ring 111. The first ring 111 is preferably made of metal, but this material is only used as a preferred solution. Any material that can form a ring structure outside the rotating shaft is covered within the protection scope of the present invention. In this embodiment, a layer of first rings 111 is wrapped around the outside of the first hollow rotating shaft 11, and a first gap 112 is formed between adjacent first rings 111. When the first ring 111 rotates with the first hollow rotating shaft 11 in the guide sheath, an Archimedean effect is generated to form a negative pressure, which can further enhance the suction effect.

[0044] Figure 3Shown is a structural schematic diagram of the third embodiment of the medical rotary cutting blade assembly of the present invention. Compared with the first and second embodiments, the medical rotary cutting blade assembly 1 of this embodiment also includes a second hollow rotating shaft 15. The second hollow rotating shaft 15 is preferably a multi-layer multi-strand spring tube made of stainless steel or nickel-titanium alloy and other materials. The material can provide excellent flexibility and kink resistance, provide efficient torque transmission capability, high strength, fatigue resistance and biosafety, but it should be understood that the material and structure are only preferred embodiments and cannot be understood as limiting the scope of protection of the claims. The second hollow rotating shaft 15 is coaxially sleeved on the outside of the first hollow rotating shaft 11, and the second rotary cutting blade 13 is fixedly connected to the second hollow rotating shaft 15. Compared with the first and second embodiments in which the first rotary cutting blade 12 and the second rotary cutting blade 13 are simultaneously arranged on the first hollow rotating shaft 11, in this embodiment, since the first rotary cutting blade 12 and the second rotary cutting blade 13 are respectively fixed to the first hollow rotating shaft 11 and the second hollow rotating shaft 15, the first rotary cutting blade 12 and the second rotary cutting blade 13 can independently slide axially and rotate, respectively. The specific driving structure will be described in detail below. In this embodiment, by setting the first hollow rotating shaft 11 and the second hollow rotating shaft 15 that are coaxially sleeved and independently controlled, the first rotary cutting blade 12 and the second rotary cutting blade 13 can independently slide axially and rotate, respectively, thereby applying different rotation speeds and sliding strokes to the two rotary cutting blades, so as to better achieve the effect of opening the occluded blood vessels and expanding the blood vessel diameter. In this embodiment, the rotation speed of the second hollow rotating shaft 15 can reach 20-100 rpm, but its rotation speed should preferably be less than or equal to the rotation speed of the first hollow rotating shaft 11, so that the rotary cutting speed of the second rotary cutting blade 13 is less than or equal to the first rotary cutting blade 12, thereby providing the second rotary cutting blade with a larger torque, reducing heat generation and reducing the damage of the second rotary cutting blade to the blood vessel wall. More preferably, in this embodiment, a plurality of second rings 151 are also provided outside the second hollow rotating shaft 15, and a second gap 152 is formed between each adjacent second ring 151. The second ring 151 is preferably made of metal, but this material is only used as a preferred solution, and any material that can form a ring structure outside the rotating shaft is covered within the scope of protection of the present invention. In this embodiment, a layer of second rings 151 is also wrapped around the outside of the second hollow rotating shaft 15, and a second gap 152 is formed between adjacent second rings 151. When the second ring 151 rotates with the second hollow rotating shaft 15 in the guide sheath, an Archimedean effect will be generated to form a negative pressure, which can further enhance the suction effect.

[0045] Figure 4The figure is a schematic structural diagram of a preferred embodiment of a medical rotary cutting catheter provided by the second aspect of the present invention, wherein the medical rotary cutting catheter 2 comprises a guide sheath 21, and the medical rotary cutting blade assembly 1 described in the first or second embodiment of the first aspect; the medical rotary cutting blade assembly 1 is slidably and rotatably arranged in the guide sheath 21, and the gap between the first hollow rotating shaft 11 and the guide sheath 21 defines a first channel A22, and the distal end of the first channel A22 is connected to the human body pipeline; further, the medical rotary cutting catheter 2 also comprises an operating handle 23, and the operating handle 23 comprises a guide sheath interface 231, a suction port 232 and a driving part 233; the guide sheath interface 231 is fixedly connected to the proximal end of the guide sheath 21, and the suction port 232 is connected to the proximal air path of the first channel A22 Then, a suction channel is formed through a negative pressure device (not shown), a suction port 232, and a first channel A22, so that the plaque tissue removed by the two rotary cutting blades can be discharged from the body in time through the suction channel to prevent the plaque tissue from re-entering the blood circulation with the blood flow and forming new emboli in other blood vessels; preferably, the operating handle 23 of this embodiment also includes an infusion port 234, a second channel is defined inside the first hollow rotating shaft 11, at least one of the first rotary cutting blade 12, the second rotary cutting blade 13, and the first hollow rotating shaft 11 is provided with at least one liquid outlet, and the infusion port 234 and the second channel are in fluid communication with the liquid outlet, and the operator can inject physiological saline through the infusion port to flush the distal end of the catheter body, or inject contrast agent to perform angiography to assist in observing the patency of the blood vessels. The driving unit 233 is used to drive the medical rotary cutting blade assembly 1 to slide and rotate along the axial direction of the guide sheath 21.

[0046] Preferably, Figure 5As shown, the driving part 233 at least includes a rotating power source 2331, a sleeve assembly 2332, a rolling bearing 2333 and a driving slider 2334, wherein the sleeve assembly 2332 includes an inner core driving member 2332a and an outer sleeve 2332b, the distal end of the outer sleeve 2332b is fixedly connected to the proximal end of the first hollow rotating shaft 11, and the inner core driving member 2332a and the outer sleeve 2332b are movably matched in any one of a keyway, a spline, a spiral groove, and a magnetic coupling, so that the inner core driving member 2332a can be driven by the inner core driving member 2332a. 332a and the outer sleeve 2332b can only slide axially along the axial direction, and the two cannot complete relative rotation; the rotating power source 2331 is connected to the inner core driving member 2332a in a transmission manner to drive the inner core driving member 2332a to perform rotational motion. It should be understood that the transmission connection in this embodiment includes both a direct drive mode in which the rotating power source and the inner core driving member 2332a are directly connected, and an indirect drive mode performed through some intermediate transmission structures, such as gears and other reduction structures. Since the distal end of the outer sleeve 2332b is fixedly connected to the proximal end of the first hollow rotating shaft 11, and the inner core driving member 2332a and the outer sleeve 2332b cannot complete relative rotation, the rotation of the inner core driving member 2332a will drive the outer sleeve 2332b to rotate together, and finally drive the first hollow rotating shaft 11 to drive the two peeling blades to complete the peeling operation. In addition, the rolling bearing 2333 is sleeved on the outer wall of the outer sleeve 2332b, the inner ring of the rolling bearing 2333 is rotatably matched with the outer sleeve 2332b, and the bearing seat of the rolling bearing 2333 is fixedly connected with the driving slider 2334. Since the rolling bearing 2333 supports rotational motion but does not support relative sliding, the driving slider 2334 can move axially along the operating handle under the action of external force, thereby driving the outer sleeve 2332b and the first hollow rotating shaft 11 fixedly connected thereto to move forward and backward axially. The medical rotary cutting catheter 2 of this embodiment realizes the decoupling between the rotary motion driven by the rotary power source 2331 and the axial motion driven by the driving slider 2334 through the mutual cooperation between the rotary power source 2331 of the operating handle 23, the sleeve assembly 2332, the rolling bearing 2333 and the driving slider 2334, so that the axial motion and the rotary motion of the rotary cutting blade assembly inside the rotary cutting catheter are independent of each other, further enhancing the positioning accuracy.

[0047] Preferably, the driving part 233 may further include an outer sleeve 2335, the inner core driving member 2332a is inserted into the outer sleeve 2335 and fixedly connected to the outer sleeve 2335, the outer sleeve 2335 is externally connected to the outer sleeve 2332b, and the outer sleeve 2335 and the outer sleeve 2332b are movably matched in any of the following ways: keyway, spline, spiral groove, and magnetic coupling. It is precisely because the outer sleeve 2335 is arranged around the outer sleeve 2332b that the two can only slide axially along the axial direction, and cannot complete relative rotation between the two, which can further enhance the decoupling between the rotational motion and the axial motion.

[0048] In addition, in another preferred embodiment of the medical rotary cutting catheter of the present invention, this embodiment is applicable to the medical rotary cutting blade head assembly described in the third embodiment of the first aspect above; the medical rotary cutting blade head assembly includes a first hollow rotating shaft and a second hollow rotating shaft, the second hollow rotating shaft is coaxially sleeved on the outside of the first hollow rotating shaft, the first rotary cutting blade is fixedly connected to the distal end of the first hollow rotating shaft, the second rotary cutting blade is fixedly connected to the second hollow rotating shaft, a first channel B is defined between the second hollow rotating shaft and the guide sheath, and the distal end of the first channel B is connected to the human body pipeline; further, the medical rotary cutting catheter also includes an operating handle, the operating handle includes a guide sheath interface, a suction port and a driving part; the guide sheath interface is fixedly connected to the proximal end of the guide sheath, The suction port is connected to the proximal gas path of the first channel B, and a suction channel is formed through a negative pressure device (not shown), the suction port, and the first channel B, so that the plaque tissue peeled off by the two rotary cutting blades can be discharged from the body through the suction channel in time, so as to prevent the plaque tissue from re-entering the blood circulation with the blood flow and forming new emboli in other blood vessels; preferably, the operating handle of this embodiment also includes an infusion port, the first hollow rotating shaft defines a second channel, and at least one of the first rotary cutting blade, the second rotary cutting blade, and the first hollow rotating shaft is provided with at least one liquid outlet, and the infusion port, the second channel and the liquid outlet are fluidically connected, and the operator can inject physiological saline through the infusion port to flush the distal end of the catheter body, or inject contrast agent to perform angiography to assist in observing the patency of the blood vessels. The driving unit includes a first driving unit and a second driving unit, the first driving unit is used to drive the first rotary cutting blade head to slide and rotate along the axial direction of the second hollow rotating shaft; the second driving unit is used to drive the second rotary cutting blade head to slide and rotate along the axial direction of the guide sheath. In this embodiment, the first rotary cutting blade and the second rotary cutting blade can independently slide and rotate axially. This setting can apply different rotation speeds and sliding strokes to the two rotary cutting blades to better achieve the effect of opening occluded blood vessels and expanding the diameter of blood vessels.

[0049] Preferably, in this embodiment, the rotation speed of the second rotary cutting blade is lower than or equal to that of the first rotary cutting blade. This arrangement can provide a greater torque to the second rotary cutting blade, and a lower rotation speed can also reduce heat generation and reduce damage to the blood vessel wall caused by the second rotary cutting blade.

[0050] The present invention provides a third aspect of a visual vascular volume reduction system, such as Figure 6 As shown, the visualized vascular volume reduction system 3 includes: a surgical proximal control platform 31, and the medical rotary cutting catheter 2 described in any one of the embodiments of the second aspect, wherein the surgical proximal control platform 31 includes a surgical imaging system, and the surgical imaging system is electrically connected to the imaging component to transmit the working status of the medical rotary cutting catheter in real time. The surgical imaging system described in this embodiment needs to be compatible with the imaging component. Since the surgical imaging system is an existing imaging system commonly used in the field, it will not be described in detail below.

[0051] 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 medical rotary cutting blade assembly, comprising a first hollow rotating shaft; It is characterized in that Also includes: A first rotary cutting cutter head, wherein the first rotary cutting cutter head is fixedly connected to the distal end head of the first hollow rotating shaft, and the first rotary cutting cutter head has a first rotary cutting diameter; a second rotary cutting cutter head, the second rotary cutting cutter head is arranged at a proximal end of the first rotary cutting cutter head along a proximal direction of the first hollow rotating shaft, the second rotary cutting cutter head has a second rotary cutting diameter, and the second rotary cutting diameter is larger than the first rotary cutting diameter; An imaging component, wherein the proximal end of the imaging component is fixed to the distal end of the first hollow rotating shaft or between the first rotary cutting cutter head and the second rotary cutting cutter head or to the proximal end of the second rotary cutting cutter head.

2. The medical rotary cutting blade assembly according to claim 1, characterized in that: The first rotary cutting cutter head comprises at least one opening, which connects the blood vessel with the inner cavity of the first hollow rotating shaft and / or the second rotary cutting cutter head further comprises at least one opening, which connects the blood vessel with the inner cavity of the first hollow rotating shaft.

3. The medical rotary cutting blade assembly according to claim 1, characterized in that: The imaging component is at least one of a miniature camera, an ultrasonic imaging device, an electromagnetic imaging device, and a laser imaging device.

4. The medical rotary cutting blade assembly according to claim 2, characterized in that: The imaging component forms a first angle with the axial direction of the catheter body, and the first angle is 5°~45°.

5. The medical rotary cutting blade assembly according to claim 1, characterized in that: The axial angle between the imaging component and the catheter body can be adjusted arbitrarily within the range of 5° to 45° through an angle adjustment component.

6. The medical rotary cutting blade assembly according to any one of claims 1 to 5, characterized in that: The second rotary cutting tool head is fixedly connected to the side surface of the first hollow rotating shaft.

7. The medical rotary cutting blade assembly according to any one of claims 1 to 5, characterized in that: A plurality of metal rings are also arranged outside the first hollow rotating shaft, and a certain gap is formed between each metal ring.

8. The medical rotary cutting blade assembly according to any one of claims 1 to 5, characterized in that: The medical rotary cutting blade assembly also includes a second hollow rotating shaft, which is coaxially sleeved on the outside of the first hollow rotating shaft, and the second rotary cutting blade is fixedly connected to the second hollow rotating shaft. The first rotary cutting blade and the second rotary cutting blade can independently slide and rotate axially.

9. The medical rotary cutting blade assembly according to claim 8, characterized in that: A plurality of metal rings are also arranged outside the second hollow rotating shaft, and a certain gap is formed between each metal ring.

10. A medical rotary cutting catheter, characterized in that: include: Introducer sheath; The medical rotary cutting blade assembly according to any one of claims 1 to 7; The medical rotary cutting blade assembly is slidably and rotatably disposed in the guide sheath, a first channel A is defined between the first hollow rotating shaft and the guide sheath, and a distal end of the first channel A is communicated with a human body pipeline; An operating handle, the operating handle includes a guide sheath interface and a driving part; the guide sheath interface is fixedly connected to the proximal end of the guide sheath; the driving part is used to drive the medical rotary cutting blade assembly to slide and rotate along the axial direction of the guide sheath.

11. The medical rotary cutting catheter according to claim 10, characterized in that: The operating handle also includes a suction port, which is connected to the proximal air path of the first channel A.

12. The medical rotary cutting catheter according to claim 10, characterized in that: The driving part at least includes a rotational power source, a sleeve assembly, a rolling bearing and a driving slider, wherein the sleeve assembly includes an inner core driving member and an outer sleeve, and the inner core driving member and the outer sleeve are movably matched in at least one manner of keyway, spline, spiral groove, and magnetic coupling; the rotational power source is transmission-connected to the inner core driving member, the proximal end of the hollow rotating shaft is fixedly connected to the distal end of the outer sleeve, the inner ring of the rolling bearing is rotationally matched with the outer sleeve, the bearing seat of the rolling bearing is fixedly connected to the driving slider, and the driving slider can move axially along the operating handle under the drive of external force.

13. The medical rotary cutting catheter according to claim 12, characterized in that: The driving part also includes an outer sleeve, the inner core driving member is inserted through the outer sleeve and fixedly connected to the outer sleeve, the outer sleeve is outer-engaged in the outer sleeve, and the outer sleeve and the outer sleeve are movably matched in at least one manner of keyway, spline, spiral groove, and magnetic coupling.

14. A medical rotary cutting catheter, characterized in that: include: Introducer sheath; The medical rotary cutting blade assembly according to claim 8 or 9; The medical rotary cutting blade assembly is slidably and rotatably disposed in the guide sheath, a first channel B is defined between the second hollow rotating shaft and the guide sheath, and a distal end of the first channel B is communicated with a human body pipeline; An operating handle, the operating handle includes a guide sheath interface and a drive unit; the guide sheath interface is fixedly connected to the proximal end of the guide sheath; the drive unit includes a first drive unit and a second drive unit, the first drive unit is used to drive the first rotary cutting cutter head to slide axially and rotate along the second hollow rotating shaft; the second drive unit is used to drive the second rotary cutting cutter head to slide axially and rotate along the guide sheath.

15. The medical rotary cutting catheter according to claim 13, characterized in that: The operating handle also includes a suction port, which is connected to the proximal air path of the first channel B.

16. The medical rotary cutting catheter according to claim 13, characterized in that: The second rotary cutting blade has a rotation speed lower than or equal to that of the first rotary cutting blade.

17. The medical rotary cutting catheter according to any one of claims 10 to 15, characterized in that: The operating handle also includes an infusion port, which is connected to the proximal fluid path of the first hollow rotating shaft, and the distal end of the hollow rotating shaft and / or the first rotary cutting blade and / or the second rotary cutting blade are connected to the human body pipeline through a liquid outlet.

18. A visual vascular volume reduction system, characterized in that: include: Proximal surgical control platform, and the medical rotary cutting catheter according to any one of claims 10 to 16, Wherein, the surgical proximal control platform includes a surgical imaging system, and the surgical imaging system is electrically connected to the imaging component to transmit the working status of the medical rotary cutting catheter in real time.

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