Resection system

Abstract

The invention belongs to the technical field of interventional medical instruments, and relates to a resection system which comprises a handle and a catheter connected to the handle and further comprises a bending adjusting assembly and a wire fixing assembly. The wire fixing assembly is movably connected to the catheter and fixedly connected to the near end of the bending adjusting wire, the bending adjusting assembly is connected to the wire fixing assembly and the catheter, the bending adjusting assembly is used for driving the catheter to rotate in the circumferential direction, and the bending adjusting assembly can control the far end of the catheter to bend through the wire fixing assembly and the bending adjusting wire. The excision system is simple and reliable in structure, capable of accurately and stably adjusting bending from different angles, diversified in function, good in operation effect and good in universality, and the medical requirement for an operator is greatly lowered.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and particularly to an excision system. Background Art

[0002] Peripheral Arterial Disease (PAD), also known as Lower Extremity Atherosclerotic Occlusive Disease (LEAOD), is a common vascular surgery disease in which atherosclerotic changes occur in the inner wall of the lower extremity arterial blood vessels, or atherosclerotic substances in the arterial blood vessels continuously expand and secondary thrombosis forms, causing stenosis and occlusion of the arterial wall, resulting in chronic or acute ischemia in parts such as the extremities, abdominal arteries, carotid arteries, and renal arteries. With the progress of the aging society and the changes in people's eating habits and lifestyles, the incidence of lower extremity atherosclerotic occlusive disease has been increasing year by year, and severe lower extremity ischemia may lead to amputation or death.

[0003] With the development of interventional treatment technology, newly emerged plaque cutting devices have achieved rapid removal or reduction of embolic loads such as thrombus and plaque at the lesion site. However, the existing plaque cutting devices have a single function, mostly only capable of bending the cutter head, and the pushing and bending of the cutter head can only be achieved by the doctor holding the handle and making corresponding operations. For example, for eccentric calcified lesions, during cutting, the doctor needs to hold the handle and rotate the hand to rotate the handle, thereby changing the bending direction of the distal end of the cutting catheter. In this way, on the one hand, it increases the doctor's operation and improves the medical skills requirements for the doctor, and on the other hand, it is difficult to accurately control the direction and position of the cutter head after rotation, increasing the risk of cutting into the inner wall of the blood vessel and being unfavorable for better treatment. Summary of the Invention

[0004] The purpose of the embodiments of the present invention is to solve the technical problems of the existing excision system having a single function, being unable to accurately bend the cutter head, and having relatively high medical skills requirements for the operator.

[0005] To solve the above technical problems, the embodiments of the present invention provide an excision system, including a handle and a catheter connected to the handle. Among them, it further includes a bending adjustment component and a wire fixing component. A bending adjustment wire connected to the distal end of the catheter is arranged inside the catheter. The wire fixing component is movably connected to the catheter and fixedly connected to the proximal end of the bending adjustment wire. The bending adjustment component is connected to the wire fixing component and the catheter. The bending adjustment component is used to drive the catheter to rotate circumferentially, and the bending adjustment component can control the distal end of the catheter to bend through the wire fixing component and the bending adjustment wire.

[0006] In some embodiments of the cutting system of the present invention, the wire fixing assembly is movably sleeved on the catheter and is arranged inside the bending adjustment assembly. The bending adjustment assembly can separately drive the wire fixing assembly to axially move relative to the catheter or separately drive the wire fixing assembly and the catheter to rotate synchronously.

[0007] In some embodiments of the cutting system of the present invention, the wire fixing assembly includes a hollow first wire fixing slider sleeved outside the catheter. The bending adjustment assembly includes a mounting seat arranged on the handle and a bending adjustment knob rotatably connected to the mounting seat. The first wire fixing slider is slidably connected to the mounting seat and is threadedly connected to the bending adjustment knob. When the bending adjustment knob rotates, it can drive the first wire fixing slider to axially move along the catheter.

[0008] In some embodiments of the cutting system of the present invention, the mounting seat includes a rotation limiting structure, and the first wire fixing slider is slidably connected to the rotation limiting structure. The mounting seat includes a fixed seat connected to the handle and a rotation knob rotatably connected to the fixed seat. The rotation limiting structure is arranged at the distal end of the rotation knob, and the rotation knob and the mounting seat are clamped through a damping tooth structure.

[0009] In some embodiments of the cutting system of the present invention, the mounting seat further includes a rod seat arranged at the proximal end of the fixed seat. The rod seat is rotatably connected to the handle. The catheter is fixedly connected to the bending adjustment knob and the rod seat. A buffer elastic member is arranged between the rod seat and the fixed seat, and the buffer elastic member is used to drive the fixed seat to move away from the rod seat.

[0010] In some embodiments of the cutting system of the present invention, it further includes a wire locking device arranged at the proximal end of the handle. A wire passing hole for the wire to pass through is axially opened in the rotating shaft, and the wire locking device is used to lock the wire that enters the wire passing hole from the outside through the wire locking device.

[0011] In some embodiments of the cutting system of the present invention, an installation cylinder is arranged at the distal end of the catheter, and a protective cover covering one side of the cutter is arranged at the distal end of the installation cylinder. When the bending adjustment assembly is used to drive the catheter to rotate to drive the protective cover to rotate circumferentially.

[0012] Compared with the prior art, the cutting system provided by the embodiments of the present invention mainly has the following beneficial effects:

[0013] The resection system is provided with a posture adjustment device sleeved on the handle, wherein the fixed wire assembly is sleeved on the catheter and fixedly connected to the proximal end of the bending wire pre-buried on the catheter at the distal end, and the bending adjustment assembly is arranged on the handle and sleeved with the catheter, so as to control the axial sliding of the fixed wire assembly by operating the bending adjustment assembly. Since the pulling length of the bending adjustment wire is fixed, the traction force of the bending adjustment wire is adjusted. When the axial position of the catheter remains unchanged, it is equivalent to adjusting the bending radius of the catheter by releasing or pulling the bending adjustment wire, so that the catheter is offset in a predetermined direction, thereby adjusting the bending angle of the catheter and / or the cutter sleeved with the catheter. When the bending adjustment assembly is rotatably arranged on the handle, the catheter can also be controlled to rotate with it through the bending adjustment assembly. In this way, on the one hand, it is convenient for doctors to accurately and stably adjust and rotate by operating the resection system; on the other hand, it is convenient for doctors to select a suitable direction for bending according to the specific conditions of the lesion location, etc., which is conducive to flexibly and accurately controlling the bending direction and / or bending angle of the catheter, thereby adjusting the direction of the cutter, so as to better and faster treat eccentric calcified emboli. Therefore, the resection system can be accurately, flexibly and stably adjusted from different angles, has diverse functions, good surgical effects and good versatility, and greatly reduces the medical skill requirements for the surgeon. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] In order to more clearly illustrate the scheme in the present invention, the drawings required for use in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present invention or corresponding prior arts. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0015] in:

[0016] Figure 1 is a schematic diagram of the three-dimensional structure of the resection system in the first embodiment of the present invention; wherein the guide wire locking device is not shown in the figure;

[0017] Figure 2 is a front view of the resection system in the first embodiment of the present invention; wherein the guide wire locking device is not shown in the figure, and a protective cover is added;

[0018] Figure 3 is a three-dimensional exploded view of the cutting system in the first embodiment of the present invention; wherein the cutting knife is not shown in the figure;

[0019] Figure 4 is a three-dimensional exploded view of the posture adjustment device in the cutting system in the first embodiment of the present invention;

[0020] Figure 5 yes Figure 2 Sectional view of the AA section;

[0021] Figure 6It is a schematic longitudinal sectional view of the catheter of the resection system in the first embodiment of the present invention;

[0022] Figure 7 It is a schematic three-dimensional structure view of the cutting assembly installed in the installation cylinder in the first embodiment of the present invention;

[0023] Figure 8 It is a schematic three-dimensional exploded view of the cutter, the sleeve and the barrel claw of the resection system in the first embodiment of the present invention;

[0024] Figure 9 It is a schematic view of a state of the distal end of the resection system in a blood vessel in the first embodiment of the present invention; wherein, in this figure, the cutter has not reached the lesion;

[0025] Figure 10 It is a schematic view of another state of the distal end of the resection system in a blood vessel in the first embodiment of the present invention; wherein, in this figure, the cutter contacts the lesion;

[0026] Figure 11 It is a schematic three-dimensional structure view of the first specific embodiment of the protective cover in the first embodiment of the present invention;

[0027] Figure 12 It is Figure 11 The side view of the protective cover in;

[0028] Figure 13 It is a schematic three-dimensional structure view of the second specific embodiment of the protective cover in the first embodiment of the present invention;

[0029] Figure 14 It is a schematic three-dimensional structure view of the third specific embodiment of the protective cover in the first embodiment of the present invention;

[0030] Figure 15 It is Figure 14 The top view of the protective cover in;

[0031] Figure 16 It is a schematic three-dimensional structure view of the fourth specific embodiment of the protective cover in the first embodiment of the present invention

[0032] Figure 17 It is Figure 16 The front view of the protective cover in;

[0033] Figure 18 It is a schematic three-dimensional structure view of the fifth specific embodiment of the protective cover in the first embodiment of the present invention;

[0034] Figure 19 It is Figure 18 The top view of the protective cover in;

[0035] Figure 20 It is Figure 18 The side view of the protective cover in;

[0036] Figure 21 It is a schematic three-dimensional structure diagram of the cutting system without a protective cover in the second embodiment of the present invention;

[0037] Figure 22 It is a schematic three-dimensional structure diagram of the cutting system when removing a second handle shell and a first cylinder shell in the second embodiment of the present invention;

[0038] Figure 23 It is a schematic three-dimensional exploded view of the cutting system from a perspective in the second embodiment of the present invention;

[0039] Figure 24 It is a schematic plan sectional view of the guide wire locking device and the gear with a shaft of the cutting system in the second embodiment of the present invention in cooperation through a bearing;

[0040] Figure 25 It is a schematic three-dimensional exploded view of the cutting system from another perspective in the second embodiment of the present invention;

[0041] Figure 26 It is a schematic three-dimensional structure diagram of the first cylinder shell with a push switch installed in the second embodiment of the present invention;

[0042] Figure 27 It is a schematic three-dimensional structure diagram of the hollow limit shaft of the push switch in the second embodiment of the present invention;

[0043] Figure 28 It is a schematic three-dimensional structure diagram of the second wire fixing slider of the wire fixing assembly in the second embodiment of the present invention;

[0044] Figure 29 It is a schematic three-dimensional structure diagram of the clamp of the push switch in the second embodiment of the present invention;

[0045] Figure 30 It is a schematic three-dimensional structure diagram of the ratchet plate of the push switch in the second embodiment of the present invention;

[0046] Figure 31 It is a schematic three-dimensional exploded view of the drive device of the cutting system in the second embodiment of the present invention;

[0047] Figure 32 It is a schematic three-dimensional exploded view of the cutting system in the third embodiment of the present invention;

[0048] Figure 33 It is a schematic three-dimensional structure diagram of the sliding key of the wire fixing assembly in the third embodiment of the present invention;

[0049] Figure 34 It is a schematic three-dimensional structure diagram of the second cylinder shell of the adjusting cylinder in the third embodiment of the present invention. Detailed implementation manners

[0050] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the technical field to which this invention belongs; the terms used in this specification are only for the purpose of describing specific embodiments and are not intended to limit the present invention. For example, the directions or positions indicated by terms such as "length", "width", "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. are based on the directions or positions shown in the drawings, and are only for convenience of description and should not be construed as a limitation to the technical solution of the present invention.

[0051] The terms "comprising" and "having" and any variations thereof in the description and claims of the present invention and the above description of the drawings are intended to cover non-exclusive inclusion; the terms "first", "second", etc. in the description and claims of the present invention or the above drawings are used to distinguish different objects and not to describe a specific order. The meaning of "a plurality" is two or more unless otherwise specifically defined.

[0052] In the description, claims and above description of the drawings of the present invention, when an element is referred to as being "fixed to" or "mounted on" or "disposed on" or "connected to" another element, it can be directly or indirectly located on that other element. For example, when an element is referred to as being "connected to" another element, it can be directly or indirectly connected to that other element.

[0053] In addition, the mention of "embodiment" herein means that a particular feature, structure or characteristic described in connection with the embodiment can be included in at least one embodiment of the present invention. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment mutually exclusive with other embodiments. Those skilled in the art will explicitly and implicitly understand that the embodiments described herein can be combined with other embodiments.

[0054] It should be noted that in the field of interventional medical devices, "proximal" and "distal" are conventional terms. Among them, "proximal" refers to the end of the medical device implanted in the body that is closer to the operator, and "distal" refers to the end that is farther from the operator. And based on this principle, the "proximal" and "distal" of any part of the medical device are defined. "Axial" generally refers to the length direction of the medical device when it is being delivered, and "radial" generally refers to the direction perpendicular to its "axial" direction of the medical device, and based on this principle, the "axial" and "radial" of any part of the medical device are defined. "Intermediate section" generally refers to the part of any part of the medical device that is different from the two ends, and does not only refer to the part located in the exact middle position of any part of the medical device.

[0055] An embodiment of the present invention provides an excision system 100, which is mainly used to excise an embolus 300 formed by a lesion in a blood vessel 200, such as a thrombus or plaque tissue, etc., including but not limited to being applicable to scenarios such as peripheral atherectomy.

[0056] Generally, the excision system 100 has diverse functions. Based on the principle of bending by a bending wire 21 in existing products, the precise bending of the distal part of the excision device 3, such as a cutter 322, the head of the catheter 2, a protective cover 33, etc., is directly achieved through the physical structure of the excision system 100, reducing the doctor's operation of pushing the instrument mainly relying on experience and the resulting human influence, which is beneficial to reducing the medical skill requirements for the operator; moreover, it can also achieve a 360° rotation of the catheter 2, which is conducive to adjusting the head of the catheter 2 to an appropriate bending direction and bending angle according to the size, position, and shape of the lesion, etc., so as to excise the embolus 300 better and more thoroughly. At the same time, it solves the problems that the catheter 2 cannot rotate and the bending wire 21 is prone to entanglement when using wire drawing for bending in existing products, and when there is a protective cover 33 provided with a cutter 322 at the head of the catheter 2, the circumferential position of the protective cover 33 relative to the cutter 322 can be adjusted, and a guide wire (not shown in the figure) can pass through the entire excision system 100, facilitating the pushing of the excision device 3 and the catheter 2, etc. to the lesion site.

[0057] As Figures 1 to 3 shown, the excision system 100 includes a handle 1, a catheter 2, an excision device 3, and a driving device 4. The handle 1 has a hollow housing structure, and both the catheter 2 and the driving device 4 are arranged in the handle 1. Exemplarily, the proximal end of the catheter 2 is arranged inside the handle 1, and the distal end is exposed outside the handle 1. A part of the excision device 3 is exposed at the distal end of the catheter 2, and the main body part of the driving device 4 is arranged inside the handle 1.

[0058] In an embodiment of the present invention, as Figure 2 and Figure 7 shown, the excision device 3 includes a mounting cylinder 31 and a cutting assembly 32 driven to rotate by the driving device 4. Among them, the cutting assembly 32 includes a rotating shaft 321 and a cutter 322. The rotating shaft 321 is sleeved with the catheter 2 and is driven to rotate by the driving device 4. The cutter 322 is arranged at the distal end of the rotating shaft 321 to rotate with the rotating shaft 321, and the head of the cutter 322 is exposed at the distal end of the catheter 2 to achieve the excision of the embolus 300 at the lesion site. Specifically, to ensure the stability of the cutter 322 during use, the mounting cylinder 31 is arranged at the distal end of the catheter 2, the cutter 322 is rotatably mounted on the mounting cylinder 31, and the head axially protrudes from the mounting cylinder 31.

[0059] Exemplarily, the rotating shaft 321 is a torque shaft with a spiral structure, and is mainly fixed on the handle 1 by means of mechanical fitting, welding and the like. The cutter 322 is mainly fixed at the distal end of the rotating shaft 321 by means of laser welding, bonding and the like, and both the rotating shaft 321 and the cutter 322 can be made of materials such as stainless steel or nitinol alloy. In addition, the driving device 4 is used to drive the rotating shaft 321 to rotate.

[0060] In the embodiment of the present invention, based on the bending adjustment by the bending wire 21, the catheter 2 is pre-buried with a bendable wire 21 that can be pulled out on the distal side of the handle 1. Exemplarily, to realize the pre-burial of the bending wire 21, as Figure 5 and Figure 6 shown, the catheter 2 includes an outer tube 22, a braided layer 23, an inner tube 24, and a fixing ring 25 for fixing the bending wire 21. Among them, on the proximal side of the fixing ring 25, an axial wire routing channel 26 is formed between the outer tube 22 and the braided layer 23. The distal end of the bending wire 21 is connected to the fixing ring 25, and the proximal end is pulled out of the catheter 2 along the wire routing channel 26. Moreover, the outer tube 22 and the braided layer 23 are integrally formed by processes such as heat melting, so that the bending wire 21 can be sleeved and pressed on the outside of the braided layer 23, facilitating the bending of the head of the catheter 2 under the pulling action of the bending wire 21 when pulling the bending wire 21 outside the outer tube 22.

[0061] It should be noted that the mounting cylinder 31 is fixed on the distal end of the outer tube 22 of the catheter 2 by means of welding, bonding and the like. The outer tube 22 of the catheter 2 is usually made of a soft material because it needs to pass through the blood vessel 200. The mounting cylinder 31 can be made of a hard material such as stainless steel or nitinol alloy. The fixing ring 25 can be made of tantalum alloy or platinum-iridium alloy and the like, so as to have a radiographic function and be able to show the orientation of the distal end of the catheter 2, so that the bending condition of the head end of the catheter 2 can be identified with the assistance of the fixing ring 25.

[0062] In addition, in order to transmit the embolism 300 cut by the cutter 322 to the outside of the body, a discharge cavity communicating with the outside is formed in the handle 1 (not shown in the figure). As Figure 5 and Figure 6 shown, a transmission channel 27 communicating with the discharge cavity is further formed between the inner tube 24 of the catheter 2 and the rotating shaft 321. During the process of the rotating shaft 321 driving the cutter 322 to rotate and cut off embolisms such as plaques 300, the cut thrombus or plaque can enter the transmission channel 27 from the gap between the cutter 322 and the mounting cylinder 31, and is conveyed in the direction of the proximal end of the handle 1 under the drive of the rotating shaft 321 with a spiral structure and in rotation, so as to be discharged out of the body through the discharge cavity.

[0063] In an embodiment of the present invention, the resection system 100 further includes an attitude adjustment structure disposed on the handle 1 for adjusting the attitude of the distal portion of the catheter 2. Exemplarily, it is mainly used to adjust the attitude of the catheter 2 and / or the cutter 322, such as adjusting the bending angle of the catheter 2 and / or the cutter 322, or driving the catheter 2 to rotate. When a protective cover 33 is provided at the distal end of the catheter 2, the orientation of the protective cover 33 can also be adjusted circumferentially.

[0064] Specifically, as Figures 2 to 4 shown, the resection system 100 includes a wire fixing assembly 5 and a bending adjustment assembly 6. Among them, the wire fixing assembly 5 is movably connected to the bending adjustment assembly 6 and fixedly connected to the proximal end of the bending wire 21. The bending adjustment assembly 6 is disposed on the handle 1 and sleeved with the catheter 2, and is mainly used to adjust the traction force of the bending wire 21 by controlling the axial sliding of the wire fixing assembly 5, thereby adjusting the bending angle of the catheter 2.

[0065] It can be understood that under the control of the bending adjustment assembly 6, the wire fixing assembly 5 can move back and forth along the axis of the catheter 2. Since the length of the bending wire 21 is fixed, when the wire fixing assembly 5 moves forward, the proximal end of the bending wire 21 moves forward, which is equivalent to reducing the traction force and releasing the bending wire 21 to reduce the bending angle of the head of the catheter 2; conversely, when moving backward, it is equivalent to increasing the traction force and pulling the bending wire 21 to increase the bending angle of the head of the catheter 2. In this way, the bending angle of the head of the catheter 2 is adjusted by controlling the sliding distance of the wire fixing assembly 5 to achieve the adjustment of the bending angle of the cutter 322. Exemplarily, the resection system 100 of the present invention can achieve a bending function of adjusting the catheter 2 by 0° to 45° based on the current state.

[0066] In addition, the bending adjustment assembly 6 can also be used to control the rotation of the catheter 2, so that the doctor can select a suitable direction for bending according to the size, position and shape of the embolism 300, etc., which is beneficial to flexibly and accurately control the bending direction and / or bending angle of the catheter 2, so as to pass through the bent part of the blood vessel and control the orientation of the cutter 322, facilitating the doctor to better and more quickly handle the eccentric calcified embolism 300.

[0067] Compared with the method of relying on the doctor's hand to make pushing operations such as rotation and turning to drive the entire handle 1 to adjust together, the resection system 100 adjusts and rotates through its own physical structure, with high precision and good stability, which can greatly reduce the doctor's medical skills requirements and human influence, and is beneficial to reducing the surgical risk.

[0068] In an embodiment of the present invention, to prevent the bending wire 21 from being wound when the catheter 2 rotates, when the bending adjustment assembly 6 is rotatably disposed on the handle 1, the wire fixing assembly 5 can rotate synchronously with the catheter 2. It can be understood that when the bending adjustment assembly 6 is rotated, both the catheter 2 and the wire fixing assembly 5 can rotate together with the bending adjustment assembly 6. Therefore, the bending wire 21 fixed to the wire fixing assembly 5 can remain circumferentially relatively stationary with the catheter 2 to avoid winding.

[0069] Exemplarily, since both the bending adjustment assembly 6 and the wire fixing assembly 5 are sleeved with the catheter 2, in order to simplify the overall structure, the attitude adjustment device only needs to restrict the circumferential rotation of the wire fixing assembly 5 through the bending adjustment assembly 6, so that the wire fixing assembly 5 only axially slides relative to the bending adjustment assembly 6, which can ensure that when the bending adjustment assembly 6 rotates, the wire fixing assembly 5 rotates circumferentially together with the bending adjustment assembly 6 to achieve synchronous rotation with the catheter 2 fixedly connected to the bending adjustment assembly 6. Of course, the synchronous rotation of the wire fixing assembly 5 and the catheter 2 can also be achieved by other means.

[0070] In an embodiment of the present invention, as Figure 2 shown, the resection device 3 may further include a protective cover 33, wherein the protective cover 33 is disposed at the distal end of the mounting cylinder 31 and is externally sheathed with a clearance on one side of the cutting blade 322. Specifically, both the protective cover 33 and the cutting head of the cutting blade 322 axially protrude from the mounting cylinder 31, and the protective cover 33 is located on one side of the cutting blade 322, so that one side of the cutting blade 322 is isolated from the wall of the blood vessel 200 through the protective cover 33, and the other side is radially exposed outside the protective cover 33 for removing the embolism 300 in the blood vessel 200. Exemplarily, the protective cover 33 is fixed to the distal end of the mounting cylinder 31 by means of welding, bonding or hot melting, etc. The material of the protector is preferably stainless steel or nitinol.

[0071] Also exemplarily, for an eccentric stenosis lesion in the blood vessel 200, in the clinical use state, as Figure 9 shown, the resection device 3 extends into the lesion position of the blood vessel 200. At this time, the cutting blade 322 approaches the embolism 300 but does not contact the embolism 300. As Figure 10 shown, when the cutting blade 322 is pushed to contact the embolism 300 and is gradually axially passed through the embolism 300, under the control of the driving device 4, the rotating shaft 321 rotates to drive the cutting blade 322 to rotate relative to the catheter 2, the mounting cylinder 31 and the protective cover 33 to remove the eccentric embolism 300 in the blood vessel 200. When the cutting blade 322 performs rotary cutting, since the protective cover 33 is fixed and located between the non-lesion side of the blood vessel 200 and the cutting blade 322 to separate the cutting blade 322, the risk of the wall of the blood vessel 200 on the opposite side of the embolism 300 being scratched or perforated by the cutting blade 322 can be greatly reduced, better adapting to various different conditions and improving the versatility of the resection system 100.

[0072] Specifically, even if the cutter 322 deflects during rotary cutting due to accidental deflection, excessive pushing speed or poor alignment with the blood vessel 200, under the protection of the protective cover 33, the cutter 322 will not directly contact the wall of the blood vessel 200 on the opposite side of the embolus 300, which allows the doctor to safely perform multiple resections of the embolus 300 around the embolus 300, ensuring that most or even all of the embolus 300 can be removed in one operation, thereby reducing the amount of residual embolus 300 after surgery, trying to obtain a larger blood vessel 200 cavity at the lesion site, reducing the requirements for the doctor's medical skills, and ensuring the surgical effect.

[0073] In addition, Figure 2 As shown, in the radial direction, the protective cover 33 and the cutter 322 are provided with a gap, so that, on the one hand, interference with the cutter 322 can be avoided, and the size of the gap between the cutter 322 and the mounting tube 31 can be ensured not to be reduced due to the provision of the protective cover 33. On the other hand, it is conducive to reducing the cost of surgery and shortening the duration of surgery. Specifically, after the cut embolic material 300 falls on the protective cover 33, it will be broken up by the relative rotation between the cutter 322 and the protective cover 33 during rotary cutting at and near the radial gap between the protective cover 33 and the cutter 322, which is conducive to the smoother discharge of the cut embolic material 300 from the body, reducing the risk of distal embolism of the blood vessel 200, and reducing the frequency of using the distal protective umbrella separately, thereby helping to reduce the difficulty and cost of surgery and shorten the duration of surgery.

[0074] It can be understood that the above-mentioned embodiment can at least adjust the circumferential position of the protective cover 33. Specifically, since the protective cover 33 is arranged on the mounting tube 31 connected to the catheter 2, when the above-mentioned bending adjustment component 6 rotates, the protective cover 33 can rotate driven by the bending adjustment component 6 to adjust its circumferential position, that is, the protective cover 33 can realize 360° rotation together with the catheter 2 to circumferentially adjust the direction of the protective cover 33 so that it is located on the opposite side of the lesion in the blood vessel 200 during resection, so as to isolate and protect the wall of the blood vessel 200 on the opposite side of the lesion.

[0075] In other embodiments, the protective cover 33 can be arranged on the catheter 2 or on the cutting device 3. For example, the protective cover 33 is movably connected to the mounting tube 31, and the protective cover 33 can be retracted into the mounting tube 31. Specifically, an axially movable control line (not shown) is passed through the catheter 2, and the proximal end of the protective cover 33 is connected to the control line. In the initial state, the protective cover 33 is retracted inside the mounting tube 31. When the protective cover 33 is required to cover the cutter 322, the control line is pushed to the distal end to make the protective cover 33 extend from the mounting tube 31. Through the above embodiment, the protective cover 33 can be retracted inside the mounting tube 31 when the catheter 2 passes through the curved part of the blood vessel, so as to avoid the protective cover 33 affecting the passability of the distal end of the catheter 2.

[0076] In summary, compared with the prior art, the resection system 100 has at least the following beneficial effects:

[0077] Among them, the wire fixing assembly 5 is movably sleeved on the catheter 2, and the proximal end of the wire bending wire 21 fixedly connected to the distal end is embedded on the catheter 2. The wire bending assembly 6 is arranged on the handle 1 and sleeved with the catheter 2, so as to control the axial sliding of the wire fixing assembly 5 by operating the wire bending assembly 6. Since the pulling length of the wire bending wire 21 remains fixed, the pulling force of the wire bending wire 21 is adjusted accordingly. When the axial position of the catheter 2 remains unchanged, it is equivalent to adjusting the bending radius of the catheter 2 by releasing or pulling the wire bending wire 21, causing the catheter 2 to deviate in a predetermined direction, thereby adjusting the bending angle of the catheter 2, and further adjusting the orientation of the cutter 322. And when the wire bending assembly 6 is rotatably arranged on the handle 1, the catheter 2 can also be controlled to rotate with it by the wire bending assembly 6. In this way, on the one hand, it is convenient for the doctor to directly and precisely and stably perform wire bending and rotation by operating the resection system 100; on the other hand, it is convenient for the doctor to select a suitable direction for wire bending according to the specific situation at the lesion site, etc., which is beneficial to flexibly and precisely control the bending direction and / or bending angle of the catheter 2, so as to better and faster pass through the curved part of the blood vessel, and adjust the orientation of the cutter 322 to handle the eccentric calcified embolus 300. Therefore, the resection system 100 can be precisely, flexibly and stably bent from different angles, with diverse functions, good surgical effects and good versatility, greatly reducing the medical skills requirements for the operator.

[0078] In addition, the resection system 100 can also selectively set a protective cover 33 on the resection device 3. By setting the protective cover 33 at the distal end of the mounting cylinder 31 and arranging the protective cover 33 with a radial gap on one side of the cutter 322 to cover the periphery of one side of the cutter 322, during the operation, the protective cover 33 is located on the opposite side of the embolus 300 to isolate the cutter 322 and the blood vessel wall 200 on the opposite side of the embolus 300, which is convenient for the doctor to safely perform multiple resections on the embolus 300 in various situations. A larger blood vessel lumen 200 can be obtained at the lesion site in one operation, and the cut embolus 300 can also be fragmented under the relative rotation of the protective cover 33 and the rotating cutter 322, so as to be discharged out of the body more smoothly, reducing the risk of distal embolism of the blood vessel 200 and the frequency of using a distal protection umbrella separately. Therefore, the resection system 100 can further reduce the surgical difficulty, improve the surgical effect, reduce the surgical cost, shorten the surgical duration, and has a simple and reliable structure.

[0079] Embodiment 1 of the excision system 100 of the present invention

[0080] In order to enable those skilled in the art to better understand the solution of the present invention, the following will be combined with the attached Figures 1 to 20 , and the technical solution in the first embodiment of the present invention will be described clearly and completely.

[0081] Regarding the structure of the mounting cylinder 31 of the resection device 3, in the first embodiment of the present invention, as Figure 7 and Figure 8 shown, the mounting cylinder 31 includes a sleeve 311 and a cylinder claw 312. Among them, the sleeve 311 is fixedly connected to the distal end of the catheter 2, and the cylinder claw 312 is rotatably connected to a cutter 322. The sleeve 311 and the catheter 2 are fixedly sleeved on the cylinder claw 312 at their connection.

[0082] The outer diameter of the cylinder claw 312 is less than or equal to the inner diameter of the sleeve 311. The distal end of the cylinder claw 312 is axially inserted into the sleeve 311, and the cylinder claw 312 is fixedly connected to the sleeve 311 by welding, bonding, etc.; the part of the cylinder claw 312 extending from the proximal end of the sleeve 311 is inserted into the distal end of the catheter 2 and is fixedly connected to the inner tube 24 of the catheter 2 by UV curing, glue, etc. In addition, the proximal end of the sleeve 311 can be fixedly connected to the distal end of the outer tube 22 of the catheter 2 by welding, bonding, etc.

[0083] In this embodiment, the cylinder claw 312 is inserted at the connection between the sleeve 311 and the catheter 2 from the inside of the catheter 2, and the cylinder claw 312 is fixedly connected to the sleeve 311 and the catheter 2, so that the cylinder claw 312 supports the sleeve 311 and the catheter 2, and also enables the sleeve 311 to be not only directly fixedly connected to the catheter 2, but also fixedly connected to the catheter 2 again through the cylinder claw 312, so as to effectively strengthen the connection strength and reliability between the sleeve 311 and the catheter 2, which is beneficial to improving the surgical safety.

[0084] In some specific embodiments of the first embodiment of the present invention, as Figure 8 shown, in order to rotatably connect the cutter 322 to the mounting cylinder 31, a plurality of clamping claws 3121 are circumferentially spaced at the distal end of the cylinder claw 312, and limiting protrusions 3122 are provided on the inner walls of the plurality of clamping claws 3121. Correspondingly, a limiting groove 3221 is circumferentially opened on the outer wall of the cutter 322. Among them, when the limiting groove 3221 and the limiting protrusion 3122 are in concave-convex fit, the cutter 322 is clamped by the plurality of clamping claws 3121 radially restricted by the sleeve 311 to be rotatably connected to the cylinder claw 312.

[0085] It should be noted that when the limiting protrusion 3122 and the limiting groove 3221 are in concave-convex fit, the length of the part of the cutter 322 exposed from the mounting cylinder 31 can be maintained within a certain range, preventing the cutter 322 from recessing into the sleeve 311 or further protruding from the sleeve 311, which is beneficial to improving the stability of the rotary cutting action of the cutter 322, thereby ensuring the surgical effect and reducing the surgical risk.

[0086] As Figure 3 and Figure 4 shown, the wire fixing assembly 5 includes a hollow first wire fixing slider 51 fixedly provided with a bending wire 21. Exemplarily, as Figure 4As shown, the first wire fixing slider 51 is provided with a first wire threading hole 511 , and the proximal end of the bending wire 21 can be wound around the first wire fixing slider 51 after passing through the first wire threading hole 511 to be fixedly connected to the first wire fixing slider 51 .

[0087] like Figures 2 to 4 As shown, the bending adjustment assembly 6 includes a mounting seat 61 and a bending adjustment knob 62, wherein the mounting seat 61 is arranged on the handle 1, and a rotation limiting structure 6121 is provided at the far end of the mounting seat 61; the bending adjustment knob 62 is rotatably connected to the mounting seat 61, and the interior of the bending adjustment knob 62 is threadedly connected to the first wire fixing slider 51, so that a screw structure is formed through the cooperation of the rotation limiting structure 6121 during rotation, so that the first wire fixing slider 51 moves axially.

[0088] Exemplarily, the bending adjustment knob 62, the first wire fixing slider 51 and the mounting seat 61 are all sleeved on the catheter 2, thereby saving internal space. The bending adjustment knob 62 is rotatably sleeved on the distal end of the mounting seat 61, and the bending adjustment wire 21 passes through the bending adjustment knob 62 and is fixed to the first wire fixing slider 51 in the bending adjustment knob 62. The first wire fixing slider 51 cannot rotate relative to the bending adjustment knob 62 due to the limitation of the rotation limiting structure 6121. Therefore, when the bending adjustment knob 62 is rotated to rotate it relative to the mounting seat 61, the rotation of the bending adjustment knob 62 can be converted into the axial movement of the first fixed slider along the catheter 2, so as to realize the bending of the catheter 2 by adjusting the traction force of the bending adjustment wire 21.

[0089] like Figure 3 and Figure 4 As shown, the rotation limiting structure 6121 is a slide groove for radially limiting the first wire fixing slider 51, wherein the first wire fixing slider 51 is axially slidably inserted into the slide groove in the bending knob 62. For example, the slide groove can be formed by a radial gap enclosed by a limiting plate (not shown) protruding from the far end of the mounting seat 61.

[0090] In the first embodiment of the present invention, in order to realize the rotation of the catheter 2 on the basis of being able to bend, as Figures 2 to 4 As shown, the mounting seat 61 includes a fixed seat 611 and a rotating knob 612, wherein the fixed seat 611 is clamped on the handle 1 and is sleeved with the catheter 2; the rotating knob 612 is rotatably connected to the distal end of the fixed seat 611, is fixedly sleeved on the catheter 2 and is provided with a rotation limiting structure 6121 at the distal end, which is mainly used to drive the bending adjustment knob 62, the first fixed wire slider 51 and the catheter 2 to rotate synchronously when rotating.

[0091] Exemplarily, the catheter 2 is fixedly connected to the bending knob 62 by welding, bonding, etc., and the fixing seat 611 is installed at the distal end of the handle 1, for example, Figures 1 to 3As shown, the handle 1 includes two first handle shells 11 that are radially covered. An installation hole 111 is axially formed at the distal end of the first handle shell 11 inside the handle 1. An installation groove 6111 is formed on the fixing seat 611. Through the concave-convex fit between the installation groove 6111 and the shell ribs forming the installation hole 111, the fixing seat 611 can be snapped onto the handle 1. Among them, the axial depth of the installation groove 6111 is greater than the thickness of the hole wall of the installation hole 111, that is, there is a gap between the installation groove 6111 and the hole wall of the installation hole 111, so that the fixing seat 611 can move axially by a distance of a preset gap.

[0092] In addition, to achieve the damped rotation of the rotation knob 612, a first damping tooth 6122 is provided at the proximal end of the rotation knob 612, and a tooth structure meshing with the first damping tooth 6122 is provided at the distal end of the fixing seat 611.

[0093] It can be understood that when the rotation knob 612 is rotated relative to the fixing seat 611, since the bending adjustment knob 62 is rotatably sleeved on the rotation knob 612 of the mounting seat 61 and is circumferentially rotationally restricted by the above-mentioned rotation limiting structure 6121, the rotation knob 612 can drive the bending adjustment knob 62, the first wire fixing slider 51 and the catheter 2 to rotate simultaneously. While adjusting the circumferential position of the catheter 2 and the protective cover 33, the winding of the bending wire 21 can be avoided. And through the meshing of the damping tooth structure at the connection between the rotation knob 612 and the fixing seat 611, the fixing of the rotation knob 612 at any angle is achieved.

[0094] As Figures 2 to 4 shown, to ensure the installation and rotation stability of the catheter 2, the mounting seat 61 further includes a rod seat 613 and a buffer elastic member 614 located inside the handle 1. Among them, a rotation groove 6131 is provided on the outer wall of the rod seat 613, and a rotation hole 112 is provided inside the first handle shell 11. Through the concave-convex fit between the rotation groove 6131 and the shell ribs forming the rotation hole 112, the rod seat 613 can be rotatably installed inside the handle 1. In addition, the rod seat 613 is fixedly sleeved on the catheter 2 by means of bonding or the like. A buffer elastic member 614 is provided between the rod seat 613 and the fixing seat 611 to radially support the middle section of the catheter 2 through the rod seat 613 and to tension the rotation knob 612 through the buffer elastic member 614.

[0095] Specifically, the buffer elastic member 614 is a compression spring. The catheter 2 is fixedly connected to the rod seat 613 and the bending adjustment knob at the same time. Since the fixing seat 611 is snap-fixed to the handle 1 and has a moving gap axially with the installation hole 111 of the handle 1, the compression spring provided between the fixing seat 611 and the rod seat 613 can press the fixing seat 611 and the rotation knob 612 tightly to achieve the circumferential positioning of the rotation knob 612.

[0096] In addition to this, in the first embodiment of the present invention, as Figures 1 to 3As shown, to make the catheter 2 pushed more smoothly along the guide wire, the resection system 100 further includes a guide wire locking device 7 provided at the proximal end of the handle 1. Among them, a wire passing hole 3211 for the guide wire to pass through is axially formed in the rotating shaft 321, and the guide wire locking device 7 is mainly used to fix the guide wire that enters the wire passing hole 3211 from the outside through the guide wire locking device 7.

[0097] Exemplarily, the guide wire locking device 7 includes a rotary cap 71 and a sealing gasket 72 (see Figure 3 ), and a locking thread 3212 is provided on the outer wall of the rotating shaft 321 (see Figure 1 ). Among them, the sealing gasket 72 is inserted into the stepped hole of the rotating shaft 321 from the proximal end of the rotating shaft 321. The rotary cap 71 is threadedly sleeved on the proximal end of the rotating shaft 321 through the locking thread 3212 and can axially abut against the sealing gasket 72 inside the rotating shaft 321. And the guide wire can sequentially pass through the rotary cap 71 and the sealing gasket 72 from the outside and enter the wire passing hole 3211 of the rotating shaft 321, realizing that the guide wire axially passes through the handle 1 as a whole, facilitating the more smooth pushing of the catheter 2 into the lesion site. When the rotary cap 71 is tightened, the sealing gasket 72 can be axially extruded in the rotary cap 71, so that the aperture of the sealing gasket 72 shrinks to lock the guide wire, so as to fix the guide wire, prevent the guide wire from rotating with the cutter 322 during the operation and damaging the blood vessel 200, and at the same time seal the proximal end of the handle 1.

[0098] Combined with Figure 2 and Figure 3 shown, to realize the rotation of the cutting assembly 32, the driving device 4 includes a motor 41, a battery 43, a Y-valve 46, a gear pair 47 and a mounting shaft 49 provided in the handle 1. Among them, the Y-valve 46 includes a main valve pipe and a waste discharge pipe. Inside the handle 1, the motor 41 is electrically connected to the battery 43 through a wire, and the output shaft of the motor 41 is connected to the driving wheel of the gear pair 47; the proximal end of the rotating shaft 321 of the cutting assembly 32 is inserted into the mounting shaft 49 in the main valve pipe of the Y-valve 46 and is fixedly connected to the mounting shaft 49 by means such as welding. The distal end of the mounting shaft 49 is rotatably mounted in the main valve pipe of the Y-valve 46 through a bearing, and the mounting shaft 49 is fixedly connected to the driven wheel of the gear pair 47. After the switch is turned on and the battery 43 is powered on, the motor 41 can work to drive the rotating shaft 321 to rotate, so as to realize the rotary cutting function of the cutter 322.

[0099] Regarding the specific structure of the protective cover 33, in the first embodiment of the present invention, as Figures 9 to 11 、 Figure 13 、 Figure 14 、 Figure 16 and Figure 18 shown, the protective cover 33 is concavely provided with a protective groove 331 for receiving the cutter 322 on the side close to the cutter 322, and the part of the cutter 322 facing away from the protective cover 33 is exposed outside the protective groove 331.

[0100] Exemplarily, within blood vessel 200, during the operation, the intraoperative protective cover 33 needs to be located on the opposite side of the blood vessel 200 wall where the embolism 300 is located, and the notch of the protection groove 331 faces the embolism 300. A part of the cutter 322 is accommodated within the protection groove 331. The cutter 322 and the blood vessel 200 wall on the opposite side of the embolism 300 are isolated by the protective cover 33, and a part of it radially exposes outside the protection groove 331 towards the embolism 300, so as to excise the embolism 300. Of course, in other embodiments, the protective cover 33 can also be a structure whose outer wall surface (i.e., the side facing away from the cutter 322) is adapted to the blood vessel 200 wall, and the inner wall surface (i.e., the side facing the cutter 322) is of other suitable shapes.

[0101] As Figure 2 , Figure 9 and Figure 10 shown, the proximal end of the protective cover 33 is arranged at the distal end of the mounting cylinder 31, and the axial length L1 of the protective cover 33 is greater than the length L2 of the cutter 322 axially exposed outside the mounting cylinder 31. That is, the distal end of the protective cover 33 axially extends beyond the distal end of the cutter 322. On the one hand, it is beneficial to improve the centering of the torque shaft and the cutter 322. Specifically, on the distal side of the cutter 322, the protective cover 33 can pre-correct the blood vessel 200 at the distal end of the cutter 322, so that the blood vessel 200 at the distal end of the cutter 322 is arranged along the axis of the protective cover 33 in advance, so as to ensure that the cutting assembly 32 is parallel to the blood vessel 200 where the embolism 300 is located as much as possible, which is beneficial to reducing the risk of blood vessel 200 scratching or perforation, and is more convenient for excising the embolism 300 in the diseased blood vessel 200 multiple times during one operation.

[0102] On the other hand, the protective cover 33 can catch the cut embolism 300 on the distal side of the cutter 322, so that the cut embolism 300 is concentrated near the cutter 322, preventing it from escaping distally and reducing the risk of distal embolism.

[0103] Exemplarily, the circumferential direction of the protective cover is arranged in an arc shape, and the circumferential angle of the protective cover is 60 degrees to 180 degrees, so as to adapt to eccentric thrombi or plaques with different embolism degrees.

[0104] The proximal end of the protective cover 33 is fixed on the distal end of the sleeve 311 of the mounting cylinder 31 by means of welding or bonding, etc. The bottom of the protection groove 331 is smoothly transitioned with the inner wall at the distal end of the mounting cylinder 31, and the outer wall of the protective cover 33 is flush with and smoothly transitioned with the outer wall of the mounting cylinder 31, so as to ensure that the cut embolism 300 smoothly enters the transmission channel 27, avoid blockage at the cutter 322, and reduce the risk of thrombus formation at the distal end of the cutter 322.

[0105] As Figure 11 , Figure 13 , Figure 14 , Figure 16 and Figure 18As shown, the cross-section of the protective cover 33 is concave arc-shaped, that is, the protective cover 33 as a whole is a tile-like structure, so as to adapt to the shape of the inner wall of the blood vessel, and the groove wall of the protective groove 331 is a closed structure or a hollow structure, thereby isolating the cutter 322 and the wall of the blood vessel 200 through the cover wall of the protective cover 33.

[0106] In addition, in some specific embodiments, in order to allow the cut embolus 300 to be discharged from the body more smoothly, at least a portion of the edge of the protective cover 33 may have a serrated structure 335, so that the embolus 300 on the wall of the blood vessel 200 can be squeezed by the protective cover 33 to loosen the embolus 300 in advance, which is conducive to the cutter 322 to remove the embolus 300 more quickly.

[0107] The specific structure of the protective cover 33 will be described in detail below through several specific implementations:

[0108] In a first specific embodiment of the protective cover 33, the groove wall of the protective groove 331 of the protective cover 33 is a closed structure, and the groove wall of the protective groove 331 is smoothly arranged. For example, Figure 11 and Figure 12 As shown, the groove wall surface of the protection groove 331 is a smooth concave arc surface. Alternatively, the groove wall of the protection groove 331 is arranged in a concave-convex manner, and in addition, the edge of the protection cover 33 can also be selectively arranged in a serrated structure.

[0109] Exemplarily, when the groove wall of the protection groove 331 is arranged in a concave-convex manner, a protrusion may be convexly arranged on the groove wall of the protection groove 331, and / or a groove may be concavely arranged, so that the inner wall of the protection cover 33 is uneven, but the outer wall is a closed wall.

[0110] Understandably, the uneven inner wall of the protective cover 33 can increase the friction between the cutter 322 and the protective cover 33 on the cut embolic material 300, so that the cut embolic material 300 is broken into finer particles by the relative rotation between the cutter 322 and the protective cover 33 during rotary cutting, which is conducive to the cut embolic material 300 being discharged from the body more smoothly.

[0111] In a second specific embodiment of the protective cover 33, as shown in FIG. Figure 13 As shown, the groove wall of the protection groove 331 of the protection cover 33 is a hollow structure. Specifically, the groove wall of the protection groove 331 is provided with a plurality of crushing holes 332 , and the gaps between the plurality of crushing holes 332 are distributed throughout the groove wall of the protection groove 331 .

[0112] Exemplarily, the crushing hole 332 is a through hole, so that the protective cover 33 is covered with meshes as a whole, forming a hollow mesh cover, so that the cut embolic material 300 can be crushed into finer particles by the cutter 322 and the hollow mesh cover during rotary cutting, which is conducive to the smoother discharge of the cut embolic material 300 from the body. In addition, the shape of the crushing hole 332 includes but is not limited to regular holes such as round holes, and can also be irregular holes.

[0113] In the third specific embodiment of the protective cover 33, as Figure 14 and Figure 15 shown, axially extending serrated through-holes 333 are provided starting from the distal end of the protective cover 33. A plurality of serrated through-holes 333 are provided on the protective cover 33, and the plurality of serrated through-holes 333 are arranged at intervals. The serrated through-holes 333 can also cause the cut embolism 300 to be crushed into finer particles by the cutter 322 and the protective cover 33 during rotary cutting, which is beneficial for the cut embolism 300 to be discharged out of the body more smoothly. In addition, the edge of the protective cover 33 can be provided with a serrated structure 335 to facilitate the cutter 322 to cut off the embolism 300 more quickly.

[0114] In the fourth specific embodiment of the protective cover 33, as Figure 16 and Figure 17 shown, the groove wall of the protective groove 331 has a hollow structure, and the protective cover 33 includes a plurality of insertion strips 334 that are circumferentially spaced and connected at the proximal end. Among them, the hollow gap structure formed between adjacent insertion strips 334 can also cause the cut embolism 300 to be crushed into finer particles by the cutter 322 and the protective cover 33 during rotary cutting, which is beneficial for the cut embolism 300 to be discharged out of the body more smoothly.

[0115] In addition, the distal ends of the plurality of insertion strips 334 can be flush; or, the projections of the plurality of insertion strips 334 on the horizontal axis plane of the protective cover 33 are arranged in a convex arc 3341 shape at the distal end, that is, as it gets closer to the embolism 300 radially, the axial length of the insertion strip 334 extending out of the cutter 322 becomes shorter, so that the distal ends of the plurality of insertion strips 334 are arranged along the convex arc 3341 route to guide the cut embolism 300 to the vicinity of the cutter 322 as soon as possible and reduce the probability of it escaping to the distal end of the cutter 322.

[0116] In the fifth specific embodiment of the protective cover 33, as Figures 18 to 20 shown, the protective cover 33 includes a cover body 335 and a plurality of insertion strips 334. Among them, the cover body 335 faces the cutter 322, and the corresponding groove wall of the cover body 335 has a closed structure or a hollow structure; the plurality of insertion strips 334 are circumferentially spaced and arranged at the distal end of the cover body 335.

[0117] Exemplarily, as Figures 18 to 20 shown, the inner wall of the cover body 335 has a closed structure, and a plurality of convex points 3351 are convexly provided on the inner wall of the cover body 335. The plurality of convex points 3351 are arranged at intervals, and they can be arranged in an array. In addition, the axial length of the cover body 335 is greater than or equal to the length of the cutter 322 exposed from the mounting cylinder 31.

[0118] Understandably, the multiple inserts 334, the hollow gap structure formed between the inserts 334, and the concave-convex structure formed by the multiple bumps 3351 can cause the cut embolism 300 to be crushed into finer particles by the cutter 322 and the protective cover 33 during rotational cutting, facilitating the smoother discharge of the cut embolism 300 out of the body.

[0119] Embodiment 2 of the excision system 100 of the present invention

[0120] As Figures 21 to 31 shown, the main technical features of the second embodiment are generally the same as those of the first embodiment above. The main difference between it and the first embodiment lies in the specific structures of the bending adjustment assembly 6 and the wire fixing assembly 5.

[0121] As Figures 21 to 23 shown, a wire fixing assembly 5 and a bending adjustment assembly 6 are provided on the handle 1, and a bending adjustment wire 21 is provided inside the catheter 2. The distal end of the bending adjustment wire 21 is fixedly connected to the distal end portion of the catheter 2, and the proximal end of the bending adjustment wire 21 is connected to the wire fixing assembly 5. The wire fixing assembly 5 is movably connected to the bending adjustment assembly 6 and fixedly connects the proximal end of the bending adjustment wire 21. The bending adjustment assembly 6 is provided on the handle 1 and sleeved outside the catheter 2, and is mainly used to adjust the traction force of the bending adjustment wire 21 by controlling the axial sliding of the wire fixing assembly 5, thereby adjusting the bending angle of the catheter 2.

[0122] Under the control of the bending adjustment assembly 6, the wire fixing assembly 5 can move back and forth along the axis of the catheter 2. Since the length of the bending adjustment wire 21 remains fixed, when the distal end of the wire fixing assembly 5 moves, the proximal end of the bending adjustment wire 21 moves towards the distal end, which is equivalent to reducing the traction force and releasing the bending adjustment wire 21 to reduce the bending angle of the head of the catheter 2; conversely, when moving towards the proximal end, it is equivalent to increasing the traction force and pulling the bending adjustment wire 21 to increase the bending angle of the head of the catheter 2. In this way, the bending angle of the head of the catheter 2 is adjusted by controlling the sliding distance of the wire fixing assembly 5, so as to pass through the bent part in the blood vessel.

[0123] The bending adjustment assembly 6 includes an adjustment cylinder 63. Among them, the adjustment cylinder 63 is communicatively provided on the handle body and sleeved on the catheter 2. The wire fixing assembly 5 is axially slidably arranged in the adjustment cylinder 63 through a push switch 64.

[0124] The proximal end of the adjustment cylinder 63 is connected to the distal end of the handle 1 and communicates with the inner cavity of the handle 1. The main parts of the wire fixing assembly 5 and the push switch 64 are both arranged in the adjustment cylinder 63; the adjustment cylinder 63, the wire fixing assembly 5 and the push switch 64 are all sleeved on the catheter 2, and the catheter 2 and the adjustment cylinder 63 are fixedly connected by means of bonding, welding, etc. In this way, when the adjustment cylinder 63 rotates, it can drive the catheter 2 to rotate.

[0125] A stress diffusion tube 123 is provided at the distal end of the bending adjustment assembly 6. The stress diffusion tube 123 is sleeved on the catheter 2 and fixedly connected to the distal end of the adjustment cylinder 63 to prevent stress concentration and folding at the connection between the catheter 2 and the adjustment cylinder 63 when the catheter 2 is bent.

[0126] To achieve the adjustment of the bending angle of the catheter 2, the wire fixing assembly 5 includes a hollow second wire fixing slider 52. The second wire fixing slider 52 is sleeved on the catheter 2 and is used to fix the proximal end of the bending wire 21 and pull the bending wire 21 by axial movement.

[0127] See Figures 25 to 28 , the wire fixing assembly 5 further includes a wire fixing pin 53. An axial second wire passing hole 521 and a wire fixing hole 522 communicating with the second wire passing hole 521 and extending radially are formed on the outer wall of the second wire fixing slider 52. Among them, the bending wire 21 led out from the catheter 2 passes through the second wire passing hole 521 and enters the wire fixing hole 522. By inserting the wire fixing pin 53 into the wire fixing hole 522 through which the bending wire 21 passes, the bending wire 21 can be fixed on the second wire fixing slider 52.

[0128] As Figure 21 shown, the push switch 64 includes a push key 641. The push key 641 is axially slidably arranged on the outer wall of the adjustment cylinder 63. Specifically, as shown in combination with Figure 23 , the adjustment cylinder 63 includes two first cylinder shells 631. The two first cylinder shells 631 are covered relative to each other left and right to enclose the adjustment cylinder 63. A first key groove 6311 is recessed on the outer wall of the adjustment cylinder 63. The push key 641 is accommodated in the first key groove 6311 and can axially slide along the first key groove 6311. By sliding the push key 641, the second wire fixing slider 52 is driven to slide.

[0129] Among them, as shown in combination with Figure 25 and Figure 26 , a hollow limiting shaft 642 and a clamping member 643 are further arranged in the adjustment cylinder 63. The hollow limiting shaft 642 is arranged along the axial direction of the adjustment cylinder 63. The second wire fixing slider 52 is slidably sleeved on the hollow limiting shaft 642, so as to guide the axial sliding of the second wire fixing slider 52.

[0130] The clamping member 643 is sleeved on the outer side of the second wire-fixing slider 52. The clamping member 643 is connected to the pressing key 641 and can be slidably connected to the second wire-fixing slider 52 in the radial direction. A rack 6421 is provided on the hollow limiting shaft 642, and the rack 6421 is arranged on the other side of the hollow limiting shaft 642 relative to the pressing key 641. A tooth plate 6432 corresponding to the rack 6421 is provided on the clamping member 643. A return spring 644 is provided between the clamping member 643 and the second wire-fixing slider 52. The return spring 644 is used to drive the clamping member 643 to move towards the side of the pressing key 641. In the natural state, the rack 6421 and the tooth plate 6432 are engaged under the drive of the return spring 644, so that the pressing key 641 and the hollow limiting shaft 642 are axially relatively fixed.

[0131] When the pressing key 641 is pressed, the return spring 644 is compressed, and the rack 6421 and the tooth plate 6432 are separated. At this time, the pressing key 641 can move axially, thereby driving the second wire-fixing slider 52 to move axially, and further driving the distal end of the catheter 2 to bend through the wire bending wire 21.

[0132] An end wire hole 6422 is axially formed in the distal end of the hollow limiting shaft 642. The wire bending wire 21 sequentially enters the fixed wire hole 522 from the end wire hole 6422 and the second wire-passing hole 521 for fixation, combined with Figure 28 . The clamping member 643 includes a fixed-connected clamp 6431, and the tooth plate 6432 is arranged on the clamp 6431.

[0133] Specifically, as shown in Figures 26 to 30 , the clamp 6431 is provided with a positioning groove 64311. The tooth plate 6432 protrudes with a positioning protrusion 64322 on the side facing the hollow limiting shaft 642. The clamp 6431 passes through the radial sliding groove 612 on the second wire-fixing slider 52 and then is buckled with the tooth plate 6432. The clamp 6431 and the tooth plate 6432 are fixed through the positioning groove 64311 and the positioning protrusion 64322. Thus, the clamping member 643 is sleeved on the second wire-fixing slider 52, and the clamping member 643 can move radially relative to the radial sliding groove 612 on the second wire-fixing slider 52.

[0134] Among them, the tooth plate 6432 is provided with a tooth slot 64321, and the rack 6421 on the outer wall of the hollow limiting shaft 642 is clamped in the tooth slot 64321 on the tooth plate 6432. An avoidance hole 523 is also formed on the second wire-fixing slider 52. Among them, the tooth slot 64321 of the clamping member 643 can enter the cavity of the second wire-fixing slider 52 through the avoidance hole 523 to be clamped with the rack 6421 on the hollow limiting shaft 642.

[0135] The push button 641 is fixedly connected to the top of the clamp 6431 by means of adhesion, welding or the like. A return spring 644 is arranged between the second wire-fixing slider 52 and the clamp 6431. An installation post 64312 is arranged on one side of the clamp 6431 facing the second wire-fixing slider 52, and the return spring 644 is assembled on the installation post 64312.

[0136] Through the above implementation manner, in the initial state, the return spring 644 will push up the clamp 6431, so that the tooth gaps 64321 on the tooth plate 6432 are engaged with the rack 6421 on the hollow limiting shaft 642 to axially fix the second wire-fixing slider 52. When the push button 641 is pressed, the tooth plate 6432 will be pushed out to disengage the tooth gap 64321 from the rack 6421, and then the push button 641 is axially pushed to realize the bending adjustment of the catheter 2. For example, when the push button 641 is moved proximally, the second wire-fixing slider 52 can be driven by the clamp 6431 to move proximally to increase the traction force on the bending wire 21, so that the head of the catheter 2 is bent to realize the bending function.

[0137] To realize the positioning after the rotation of the catheter 2, there is a large damping between the adjusting cylinder 63 and the handle 1. Thus, under the action of no external force, the adjusting cylinder 63 can be stationary relative to the handle 1. When the doctor rotates the adjusting cylinder 63, the adjusting cylinder 63 can rotate relative to the handle 1, and simultaneously drives the second wire-fixing slider 52 to rotate through the push switch 64, avoiding the winding of the bending wire 21 and the internal structure of the handle 1 when the adjusting cylinder 63 rotates. When the doctor operates the push switch 64, the push button 641 can drive the wire-fixing assembly 5 to move axially, so as to bend the distal end of the catheter 2.

[0138] Specifically, as shown in Figure 26 Since the catheter 2 is fixedly connected to the adjusting cylinder 63, and the clamp 6431 of the push switch 64 is connected to the second wire-fixing slider 52 and the hollow limiting shaft 642 of the wire-fixing assembly 5, and the hollow limiting shaft 642 is fixedly arranged on the first cylinder shell 631 of the adjusting cylinder 63 and movably sleeved on the catheter 2. Therefore, when the adjusting cylinder 63 is rotated and the push button 641 is not subjected to a pressing force, the entire push switch 64 can rotate together with the adjusting cylinder 63 and the catheter 2. When the axial limit of the second wire-fixing slider 52 is released after the push button 641 is subjected to a pressing force, the push button 641, the clamping member 643, the second wire-fixing slider 52 and the catheter 2 of the push switch 64 can also rotate together with the adjusting cylinder 63. In this way, the synchronous rotation of the second wire-fixing slider 52 and the catheter 2 with the adjusting cylinder 63 can be realized, avoiding the winding of the bending wire 21 and the catheter 2.

[0139] As shown in Figures 21 to 23As shown in the figure, to achieve the damped rotation of the adjusting cylinder 63 relative to the handle 1, the handle 1 includes a second handle shell 12. A damping rib position 121 protrudes from the second handle shell 12. A convex rib 6312 is circumferentially arranged on the proximal end of the first cylinder shell 631 of the adjusting cylinder 63. A damping hole 63121 is axially formed on the convex rib 6312. When the proximal end of the adjusting cylinder 63 is rotationally inserted into the distal end of the handle 1, the convex rib 6312 is inside the handle 1 and on the proximal side of the damping rib position 121, so that the ball 122 inserted into the damping hole 63121 abuts against the damping rib position 121 to achieve the damping effect when the adjusting cylinder 63 rotates.

[0140] Combined with Figure 22 and Figure 31 As shown in the figure, to achieve the rotation of the cutting assembly 32, the driving device 4 includes a motor 41, a wire 42, a battery 43, a driving switch 44, a Y-shaped valve 46, a gear pair 47, a bearing 48, and a mounting shaft 49 arranged inside the handle 1. It also includes a key switch 45 arranged on the outer wall of the handle 1 and connected to the driving switch 44. Among them, the Y-shaped valve 46 includes a main valve pipe and a waste discharge pipe. Inside the handle body, the motor 41 is electrically connected to the battery 43 and the driving switch 44 through the wire 42. The output shaft of the motor 41 is connected to the driving wheel of the gear pair 47. The proximal end of the rotating shaft 321 of the cutting assembly 32 is inserted into the mounting shaft 49 inside the main valve pipe of the Y-shaped valve 46 and fixedly connected to the mounting shaft 49 by welding or other means. The distal end of the mounting shaft 49 is rotatably installed inside the main valve pipe of the Y-shaped valve 46 through a bearing 48. The mounting shaft 49 is fixedly connected to the driven wheel of the gear pair 47 and is installed inside the cylinder base 73 through another bearing 48 at the proximal end. When the battery 43 is powered on, by operating the key switch 45 to start the driving switch 44, the motor 41 can be made to work to drive the rotating shaft 321 to rotate, thereby realizing the rotary cutting function of the cutter 322.

[0141] The Y-shaped valve 46 communicates with the transmission channel 27 of the catheter 2 and obliquely extends out of the handle body along the direction of removing the embolus 300, so as to quickly discharge the cut embolus 300.

[0142] In other embodiments, the rotation speed and torque of the rotating shaft 321 can also be adjusted by different transmission ratios between the driving wheel and the driven wheel in the gear pair 47 to meet the removal requirements of emboli 300 with different hardnesses. For example, in the normal removal state, a high-speed gear can be selected to facilitate quick removal and shorten the operation time; in case of special situations such as eccentric calcified lesions, a low-speed gear can be selected to prevent the cutter 322 from jamming.

[0143] Such as Figures 22 to 24As shown in the figure, the guide wire locking device 7 includes a screw cap 71, a sealing gasket 72, and a barrel base 73. Among them, the barrel base 73 is fixedly installed at the proximal end of the handle body. The proximal end of the mounting shaft 49 of the driving device 4 is rotatably installed in the stepped hole at the distal end of the barrel base 73 through a bearing 48. The sealing gasket 72 is inserted into the barrel base 73 from the proximal end of the barrel base 73. The screw cap 71 is threadedly sleeved on the proximal end of the barrel base 73 and can axially abut against the sealing gasket 72 inside the barrel base 73. The guide wire can sequentially pass through the screw cap 71, the sealing gasket 72, the barrel base 73, and the mounting shaft 49 from the outside and enter the rotating shaft 321, so as to realize the overall axial passing of the guide wire through the handle body, facilitating the more smooth pushing of the catheter 2 into the lesion site. When the screw cap 71 is tightened, the sealing gasket 72 inside the barrel base 73 can be axially extruded, causing the aperture of the sealing gasket 72 to contract and lock the guide wire to fix the guide wire, preventing the guide wire from rotating with the cutter 322 during the operation and damaging the blood vessel 200. At the same time, it also seals the proximal end of the handle body.

[0144] Embodiment 3 of the excision system 100 of the present invention

[0145] As Figures 32 to 34 shown, the main technical features of the third embodiment are generally the same as those of the second embodiment above. The main difference between it and the second embodiment lies in the specific structures of the bending adjustment assembly 6 and the wire fixing assembly 5.

[0146] Among them, the bending adjustment assembly 6 includes an adjustment cylinder 63. Among them, the adjustment cylinder 63 is communicatively arranged on the handle 1 and sleeved on the catheter 2. The wire fixing assembly 5 is axially slidably arranged in the adjustment cylinder 63 to adjust the bending angle of the catheter 2.

[0147] The proximal end of the adjustment cylinder 63 is connected to the distal end of the handle 1 and is communicated with the inner cavity of the handle 1. The main part of the wire fixing assembly 5 is located inside the adjustment cylinder 63. The adjustment cylinder 63 and the wire fixing assembly 5 are respectively sleeved on the catheter 2. In addition, the wire fixing assembly 5 is movably connected to the catheter 2, and the adjustment cylinder 63 and the catheter 2 are fixedly connected by means of bonding, welding, etc.

[0148] As Figures 32 to 34 shown, in order to realize the axial sliding arrangement of the wire fixing assembly 5 in the adjustment cylinder 63, the wire fixing assembly 5 includes a sliding key 54. The sliding key 54 includes a sliding shaft 541, a fixing frame 542, and a sliding key 543. Among them, the sliding shaft 541 is movably sleeved on the catheter 2. The fixing frame 542 is radially arranged on the outer wall of the sliding shaft 541 and is used for fixing the bending adjustment wire 21. The sliding key 543 is connected to the end of the fixing frame 542 away from the sliding shaft 541 and is axially and dampedly slidably arranged on the outer wall of the adjustment cylinder 63.

[0149] As Figure 32 With Figure 33As shown, a second keyway 6321 is concavely provided on the outer wall of the adjusting cylinder 63. The sliding key 543 is accommodated in the second keyway 6321 and can axially slide along the second keyway 6321. To realize the functions of fixing the wire and bending the adjusting wire 21, a third wire threading hole 5421 is axially provided on the fixing bracket 542. Among them, the bending wire 21 passes through the third wire threading hole 5421 and then winds around the fixing bracket 542, so that the bending wire 21 can be fixed on the fixing bracket 542. And because the entire sliding key 54 is axially movably sleeved on the catheter 2, when the sliding key 543 axially slides with damping in the second keyway 6321, the sliding key 543 can drive the connected fixing bracket 542 and the sliding shaft 541 to axially slide relative to the catheter 2 together, thereby adjusting the traction force of the bending wire 21 and realizing the adjustment of the bending angle of the catheter 2.

[0150] As Figure 34 shown, to realize the axially sliding with damping of the sliding key 543, the adjusting cylinder 63 includes two second cylinder shells 632, and the two second cylinder shells 632 are oppositely covered up and down to enclose the adjusting cylinder 63. And a second damping tooth 6322 is provided on the inner wall of the second cylinder shell 632. Correspondingly, an elastic hook 5422 is provided on the fixing bracket 542. Among them, when the sliding key 543 axially slides, the hook 5422 can be engaged with the second damping tooth 6322 at the corresponding position, so as to realize the damping effect of the axially sliding of the sliding key 543.

[0151] The bending adjustment assembly 6 further includes a guiding cylinder 645. The adjusting cylinder 63 is rotatably arranged on the handle 1, and the guiding cylinder 645 is fixedly connected to the catheter 2. When the adjusting cylinder 63 rotates relative to the handle 1, the guiding cylinder 645 rotates synchronously with the adjusting cylinder 63. To realize the guiding function of the guiding cylinder 645 and ensure that the sliding key 54 rotates with the adjusting cylinder 63, the sliding shaft 541 is movably sleeved on the guiding cylinder 645, and the guiding cylinder 645 supports the sliding shaft 541 from the inside of the sliding shaft 541. A guiding rib 6451 is provided on the outer wall of the guiding cylinder 645, and a sliding hole 5411 is provided on the inner wall of the sliding shaft 541. The guiding rib 6451 extends along the axis of the guiding cylinder 645, and the guiding rib 6451 is slidably connected with the sliding hole 5411. Thus, the sliding shaft 541 can axially slide along the guiding cylinder 645 while being relatively stationary circumferentially.

[0152] Through the above structure, when the adjusting cylinder 63 rotates, the sliding key 54 arranged on the adjusting cylinder 63 and the catheter 2 fixedly connected to the adjusting cylinder 63 will rotate with the adjusting cylinder 63 together, so as to avoid the winding of the bending wire 21 while realizing the rotation of the catheter 2.

[0153] In this embodiment, the handle 1 includes two third handle shells 13, and the two third handle shells 13 are oppositely covered up and down to enclose the handle 1. The proximal end of the second cylinder shell 632 of the adjusting cylinder 63 is damping rotatably connected to the distal end of the third handle shell 13 of the handle 1 by friction.

[0154] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. For those skilled in the art, various modifications and variations can be made to the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included within the scope of the claims of the present invention.

Claims

1. An excision system, comprising a handle and a catheter connected to the handle, characterized in that, It further includes a bending adjustment assembly and a wire fixing assembly. A bending wire connected to the distal end of the catheter is arranged inside the catheter. The wire fixing assembly is movably connected to the catheter and fixedly connected to the proximal end of the bending wire. The bending adjustment assembly is connected to the wire fixing assembly and the catheter. The bending adjustment assembly is used to drive the catheter to rotate circumferentially, and the bending adjustment assembly can control the bending of the distal end of the catheter through the wire fixing assembly and the bending wire.

2. The resection system according to claim 1, wherein The wire fixing assembly is movably sleeved on the catheter and arranged inside the bending adjustment assembly. The bending adjustment assembly can separately drive the wire fixing assembly to axially move relative to the catheter or separately drive the wire fixing assembly and the catheter to rotate synchronously.

3. The resection system according to claim 2, wherein The wire fixing assembly includes a hollow first wire fixing slider sleeved outside the catheter. The bending adjustment assembly includes a mounting seat arranged on the handle and a bending adjustment knob rotatably connected to the mounting seat. The first wire fixing slider is slidably connected to the mounting seat and threadedly connected to the bending adjustment knob. When the bending adjustment knob rotates, it can drive the first wire fixing slider to axially move along the catheter.

4. The resection system according to claim 3, wherein, The mounting seat includes a rotation limiting structure. The first wire fixing slider is slidably connected to the rotation limiting structure. The mounting seat includes a fixed seat connected to the handle and a rotation knob rotatably connected to the fixed seat. The rotation limiting structure is arranged at the distal end of the rotation knob. The rotation knob and the mounting seat are clamped through a damping tooth structure.

5. The resection system according to claim 4, wherein The mounting seat further includes a rod seat arranged at the proximal end of the fixed seat. The rod seat is rotatably connected to the handle. The catheter is fixedly connected to the bending adjustment knob and the rod seat. A buffer elastic member is arranged between the rod seat and the fixed seat. The buffer elastic member is used to drive the fixed seat to move away from the rod seat.

6. The resection system according to claim 5, wherein An installation groove is arranged on the outer peripheral surface of the fixed seat. An installation hole that is circumferentially clamped with the installation groove is arranged at the distal end of the handle. The axial depth of the installation groove is greater than the thickness of the hole wall of the installation hole, so that the fixed seat can axially move along the handle but cannot rotate relative to the handle.

7. The resection system according to claim 1, characterized in that, It further includes a cutting assembly connected to the catheter and a driving device arranged on the handle and used to drive the cutting assembly.

8. The resection system according to claim 7, wherein The cutting assembly includes a rotating shaft passing through the catheter and a cutting knife. The cutting knife is arranged at the distal end of the rotating shaft. At least part of the cutting knife is exposed outside the distal end of the catheter. The driving device drives the cutting knife to rotate through the rotating shaft.

9. The resection system according to claim 8, wherein It further includes a wire locking device arranged at the proximal end of the handle. A wire passing hole for a guide wire to pass through is axially arranged on the rotating shaft. The wire locking device is used to lock the guide wire that passes through the wire locking device from the outside and enters the wire passing hole.

10. The resection system according to claim 8, wherein, An installation cylinder is arranged at the distal end of the catheter. A protective cover covering one side of the cutting knife is arranged at the distal end of the installation cylinder. When the bending adjustment assembly is used to drive the catheter to rotate to drive the protective cover to rotate circumferentially.

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