CN115998377A

CN115998377A - Excision device

Info

Publication number: CN115998377A
Application number: CN202211676487.6A
Authority: CN
Inventors: 黎稳
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2022-12-26
Filing date: 2022-12-26
Publication date: 2023-04-25

Abstract

The invention discloses a cutting device, which comprises a cutting assembly and an anchoring assembly, wherein a central cavity is axially arranged in the cutting assembly; the anchoring assembly comprises a catheter and a balloon arranged on the distal end side of the catheter, the catheter penetrates through the central cavity and can penetrate through the distal end of the cutting assembly, the balloon at least covers part of the pipe section of the catheter, and the balloon is used for anchoring the cutting assembly in an expanded state. The distal end of the cutting component of the cutting device is provided with the saccule, and the saccule can be attached to the inner wall of a blood vessel when in an expanded state after being filled, so that thrombus tissue cut off in the blood vessel can be prevented from escaping to the distal end, an embolic protection device is prevented from being independently arranged before an operation, the complexity of the operation is reduced, the operation time is shortened, and the success rate of the operation is improved.

Description

Excision device

Technical Field

The invention relates to the field of medical instruments, in particular to a cutting device.

Background

This section provides merely background information related to the present disclosure and is not necessarily prior art.

With the increasing degree of aging of the population of China and the change of dietary structure, the incidence of vascular lesions is rapidly increased. The main cause of peripheral arterial disease is atherosclerosis, which is often manifested by ischemic changes of limbs, celiac arteries, carotid arteries, renal arteries and the like, and the treatment method mainly comprises basic treatment mainly comprising drug treatment, open surgical treatment typified by classical surgical bypass and recently developed intravascular intervention. Although surgical bypass has a relatively superior long-term patency rate, thereby preserving the traditional role of vascular remodeling, endovascular interventional techniques have been increasingly accepted by clinicians and patients with the advantages of their minimally invasive, safe, effective, and repeatable capabilities, and there has been a trend in the number of applications beyond bypass.

With the accumulation of evidence-based medical evidence and advancement of guidelines and consensus, endovascular interventions on lower extremity arteries have gradually become the preferred or preferred treatment regimen. Wherein the external Zhou Bankuai atherectomy is mainly aimed at the stenosis or occlusion of femoral, popliteal and below knee arteries, the external Zhou Bankuai atherectomy can fully prepare the lumen of vascular lesions, determine the proper size for the subsequent instruments, provide the lumen required for the correct post-expansion of the drug balloon, thus the endoluminal treatment has become the preferred scheme for CLI vascular reconstruction, and vascular bypass is an alternative.

In general, embolic protection devices are used during atherectomy to reduce the incidence of atherectomy-induced embolization in order to prevent the escape of resected emboli, such as thrombus or plaque. The prior art generally adds an additional separate embolic protection device at the distal end of the thrombotic plaque, which, while reducing the occurrence of embolic events, increases the complexity of the procedure and increases the procedure time and consumable costs.

Disclosure of Invention

Based on this, the invention proposes a cutting device which at least solves the technical problem of the escape of thrombus plaque excised from a blood vessel.

To achieve the purpose, the invention adopts the following technical scheme:

The invention provides a cutting device, which comprises a cutting assembly and an anchoring assembly, wherein a central cavity is axially arranged in the cutting assembly; the anchoring assembly comprises a catheter and a balloon arranged on the distal end side of the catheter, the catheter penetrates through the central cavity and can penetrate through the distal end of the cutting assembly, the balloon at least covers part of the pipe section of the catheter, and the balloon is used for anchoring the cutting assembly in an expanded state.

In the cutting device provided by the invention, the balloon is arranged at the distal end of the cutting assembly, and can be attached to the inner wall of a blood vessel when the balloon is in an inflated state after filling, so that thrombus tissue cut in the blood vessel can be prevented from escaping distally, an embolic protection device is prevented from being independently arranged before operation, the complexity of operation is reduced, the operation time is shortened, and the success rate of the operation is improved.

In some embodiments of the ablation device of the invention, the ablation device further comprises a suction assembly connected to the catheter, the suction assembly comprising a suction lumen within the catheter and disposed axially, and a suction port disposed on an outer side of the catheter and in communication with the suction lumen, the suction port being located on a proximal side of the balloon, a suction seat being disposed proximal of the suction lumen for connection to a suction device.

In some embodiments of the ablation device of the invention, a suction developing member is provided on the catheter, the suction developing member being located at or proximal to the suction port.

In some embodiments of the ablation device of the invention, a guidewire lumen for threading a guidewire is provided within the catheter, the proximal end of the guidewire lumen being provided with a guidewire seat; the distal end of the catheter is provided with a conical guide head, the balloon is positioned at the proximal end side of the guide head, and the hardness of the guide head is smaller than that of the catheter.

In some embodiments of the ablation device of the invention, the outer wall of the balloon has a plurality of protrusions, the balloon can be attached to the inner wall of the blood vessel by the protrusions, or the balloon has a spherical structure after inflation, and the outer side of the balloon can be attached to the inner wall of the blood vessel in a line contact manner when the balloon is inflated.

In some embodiments of the ablation device of the invention, the ablation device further comprises at least one internal visualization member disposed on the catheter and within the balloon; when a plurality of the internal developing members are provided on the guide pipe, the plurality of the internal developing members are disposed at intervals along the axial direction of the guide pipe.

In some embodiments of the ablation device of the invention, an inflation lumen is axially disposed within the catheter, a distal end of the catheter is provided with an inflation port in communication with the inflation lumen, and a lumen of the balloon is in communication with the inflation port; the proximal end of the inflation lumen is configured to connect to an inflation device to control the inflation state of the balloon.

In some embodiments of the present invention, the cutting device further comprises an outer tube and a handle connected to the proximal end of the outer tube, the cutting assembly comprises a torque shaft and a cutting member disposed at the distal end of the torque shaft, the central cavity is disposed along the axial direction of the torque shaft, the outer tube is sleeved on the torque shaft, and a transmission cavity is formed between the outer tube and the torque shaft; and a conveying spiral part is arranged on the outer side of a part of the shaft section of the torque shaft and is used for conveying thrombus tissues cut by the cutting part into the conveying cavity and conveying the thrombus tissues to the proximal end.

In some embodiments of the ablation device of the invention, a thrombus ejection in communication with the proximal end of the outer tube and a base disposed at the proximal end of the handle for connection to an external device are disposed within the handle.

In some embodiments of the ablation device of the invention, a bearing assembly is disposed within the handle and cooperates with the proximal end of the torque shaft and a drive mechanism for driving rotation of the torque shaft and rotation of the cutting member to cut thrombotic tissue.

Drawings

FIG. 1 is a schematic view showing the overall structure of a cutting device according to a first embodiment of the present invention;

FIG. 2 is a schematic view showing a partial structure of a distal end of a cutting device according to a first embodiment of the present invention;

FIG. 3 is an enlarged view of a portion of the cutting device of FIG. 1 at the proximal end A

FIG. 4 is a B-B directional cross-sectional view of the cutting device of FIG. 1;

FIG. 5 is a schematic view showing the structure of a cutting assembly without passing through a thrombus plaque according to the first embodiment of the present invention;

FIG. 6 is a schematic view showing the structure of a cutting assembly penetrating a thrombus plaque and the balloon in an inflated state according to the first embodiment of the present invention;

FIG. 7 is a balloon according to a first embodiment of the present invention, wherein the balloon in its inflated state is spherical;

FIG. 8 is a balloon according to a first embodiment of the present invention, wherein the balloon in its inflated state has protrusions;

FIG. 9 is a schematic view of a cutting device with a suction assembly according to a second embodiment of the present invention;

fig. 10 is a schematic structural diagram of a suction assembly in a second embodiment of the present invention;

FIG. 11 is an enlarged view of a portion of the cutting device of FIG. 9 at the proximal end C;

FIG. 12 is a D-D directional cross-sectional view of the cutting device of FIG. 9;

FIG. 13 is a schematic view showing the structure of a cutting assembly of the excision device with suction assembly according to the second embodiment of the invention when the cutting assembly does not pass through a thrombus plaque;

FIG. 14 is a schematic view showing the structure of a cutting assembly of the excision device with aspiration assembly of the second embodiment of the invention as it passes through a thrombus plaque and the balloon is inflated;

FIG. 15 is a schematic view showing the overall structure of a cutting device according to a third embodiment of the present invention;

FIG. 16 is a schematic view showing a partial structure of a distal end of a cutting device according to a third embodiment of the present invention;

FIG. 17 is an enlarged view of a portion of the cutting device of FIG. 15 at the proximal end E;

FIG. 18 is a F-F directional cross-sectional view of the cutting device of FIG. 15;

FIG. 19 is a schematic view showing the structure of a cutting assembly according to the third embodiment of the present invention when the cutting assembly does not pass through a thrombus patch;

FIG. 20 is a schematic view showing the structure of a cutting assembly according to the third embodiment of the present invention in an expanded state through a thrombus plaque and a protective mesh;

FIG. 21 is a schematic view showing the overall structure of a cutting device according to a fourth embodiment of the present invention;

FIG. 22 is a schematic view showing a partial structure of a distal end of a cutting device according to a fourth embodiment of the present invention;

FIG. 23 is an enlarged view of a portion of the cutting device of FIG. 21 at the proximal end G;

FIG. 24 is a H-H directional cross-sectional view of the cutting device of FIG. 21;

FIG. 25 is a schematic view showing the structure of a cutting assembly according to the fourth embodiment of the present invention when the cutting assembly does not pass through a thrombus patch;

FIG. 26 is a schematic view showing a structure in which a cutting member passes through a thrombus plaque and a protective mesh is in an expanded state according to a fourth embodiment of the present invention;

fig. 27 is a schematic structural view of a fourth embodiment of the present invention, in which a cover film is provided on a protective net;

FIG. 28 is a schematic view of the outer tube and handle of the cutting device of the present invention;

FIG. 29 is a schematic view showing the internal structure of the excision device of the invention;

FIG. 30 is an assembly view of a bearing assembly of the cutting device of the present invention;

FIG. 31 is a schematic view showing a transmission mechanism of a cutting device according to a fifth embodiment of the present invention;

FIG. 32 is a first gear ratio driven embodiment of the present invention for a cutting device;

FIG. 33 is a fifth embodiment of the present invention wherein the cutting device is driven at a second gear ratio;

FIG. 34 is an enlarged view of a portion of the portion K of FIG. 33;

FIG. 35 is a schematic illustration of an embodiment of a fifth embodiment of the present invention wherein the cutting device adjusts the direction of rotation of the torque shaft;

FIG. 36 is a schematic view showing the structure of a first card key and a second card key in a fifth embodiment of the present invention;

Fig. 37 is a schematic view showing the structure of a lock key in the fifth embodiment of the present invention.

The reference numerals are as follows:

100. a cutting device; 110. a cutting assembly; 111. a torque shaft; 112. a cutting member; 113. a central cavity; 114. a conveying screw; 120. a conduit; 121. a guide head; 122. filling the cavity; 124. a guidewire lumen; 125. filling port; 130. a balloon; 131. a convex portion; 132. an internal developing member; 140. a suction assembly; 141. a suction chamber; 142. a suction port; 143. sucking the developing member; 150. an outer tube; 151. a transfer chamber; 160. a thrombus ejection member; 200. an anchor assembly; 210. pushing the tube; 220. an inner tube; 221. a first lumen; 230. a protective net; 231. a mesh; 240. an end developing member; 250. coating a film; 300. a handle; 310. a base; 320. a bearing assembly; 321. a bearing; 322. a bearing seat; 342. filling the seat; 343. a suction base; 344. a guide wire seat; 351. a connector; 352. filling the joint; 353. a suction fitting; 354. a guide wire joint; 410. a push handle; 420. a slide block; 500. thrombotic tissue; 600. a transmission mechanism; 610. a speed regulating assembly; 611. a driving shaft; 612. a first transmission gear; 613. a second transmission gear; 620. a direction-adjusting component; 621. a connecting rod; 6211. a fixed key; 622. a connecting gear; 624. connecting a bearing; 623. a steering gear assembly; 6231. a first steering gear; 6232. a second steering gear; 6233. a flange plate; 6234. a first steering shaft; 6235. a second steering shaft; 6236. a second lever; 630. a drive gear; 700. a driving mechanism; 710. a driving motor; 720. a carrying platform; 721. a first position; 722. a second position; 730. a support assembly; 731. a first fixing plate; 732. a second fixing plate; 733. an elastic member; 734. a slide rail; 735. a guide rod; 736. a first lever; 737. a chute; 740. a first housing; 750. a clamping assembly; 751. a first card key; 752. a second clamping key; 760. a stop assembly; 761. a guide hole; 762. a fixing groove; 763. a limit seat; 764. a limiting hole; 765. a first limiting block; 766. a second limiting block; 767. a second lever; 770. a locking key.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

In the field of interventional medical devices, the end of a medical device implanted in a human or animal body or a delivery system for delivering the medical device, which is closer to an operator, is generally referred to as a "proximal end", the end farther from the operator is referred to as a "distal end", and the "proximal end" and the "distal end" of any component of the medical device or the delivery system are defined according to this principle. "axial" generally refers to the longitudinal direction of a medical device when delivered, and "radial" generally refers to the direction of the medical device perpendicular to its "axial" direction, and defines the "axial" and "radial" directions of any component of the medical device in accordance with this principle.

Example 1

An embodiment of the present invention proposes a cutting device 100, as shown in fig. 1 to 8, the cutting device 100 is used for cutting emboli such as thrombus or plaque tissue in a blood vessel, the cutting device 100 comprises a handle 300, and a cutting assembly 110 and an anchor assembly 200 connected to the handle 300, the anchor assembly 200 comprises a catheter 120 and a balloon 130, the cutting assembly 110 comprises a torque shaft 111 and a cutting member 112 disposed at a distal end of the torque shaft 111, and in this embodiment, the cutting member 112 is a helical cutter head. The torque shaft 111 is internally provided with a central cavity 113 along the axial direction, the catheter 120 is penetrated in the central cavity 113 of the torque shaft 111, the distal end of the catheter 120 penetrates out of the distal end of the torque shaft 111, the distal end of the catheter 120 is provided with a guide head 121, the balloon 130 is connected with the guide head 121, wherein the guide head 121 is in conical arrangement, and the hardness of the guide head 121 is smaller than that of the catheter 120, so that guiding and buffering effects are achieved when the catheter 120 penetrates through a blood vessel.

As shown in fig. 1 and 4, the excision device 100 further comprises an outer tube 150 connected to the handle 300, the outer tube 150 is sleeved on the outer side of the torque shaft 111, a transmission cavity 151 is formed between the outer tube 150 and the torque shaft 111, and a conveying screw 114 is disposed on a part of the shaft section of the torque shaft 111, and in this embodiment, the conveying screw 114 includes a coil spring spirally wound and fixed on the torque shaft 111. The delivery screw 114 rotates with the torque shaft 111 and, during rotation, delivers thrombus or plaque severed by the cutting member 112 from the delivery lumen 151 along the outer tube 150 toward the proximal end of the handle 300.

As shown in fig. 28 to 30, a bearing assembly 320 and a driving gear 630 are disposed in the handle 300, the driving gear 630 is matched with the proximal end of the torque shaft 111, and the driving gear 630 is driven by a power source to rotate the torque shaft 111 and can drive the cutting member 112 to rotate so as to cut thrombus or plaque. The bearing assembly 320 includes a bearing 321 for coupling the driving gear 630, the bearing 321 being fixed to the bearing housing 322, the driving gear 630 and the torque shaft 111 being supported by the bearing 321. In this embodiment, a bearing 321 is disposed at both ends of the driving gear 630.

The excision device 100 further comprises a thrombus-draining member 160 provided on the handle 300, the thrombus-draining member 160 being hollow and communicating with the outer tube 150, a thrombus-draining port 161 being provided on the thrombus-draining member 160, the thrombus-draining port 161 communicating with the outer space of the handle 300, the thrombus-draining member 160 collecting thrombus or plaque conveyed by the conveying screw-section 114 and draining it out of the handle 300 through the thrombus-draining port 161.

As shown in fig. 2 to 4, a filling cavity 122 is axially arranged in the catheter 120, a filling port 125 communicated with the filling cavity 122 is arranged at the distal end of the catheter 120, and the proximal end of the filling cavity 122 is used for connecting filling equipment; the balloon 130 is disposed at the distal end of the catheter 120 and at least partially encloses the catheter 120, and the lumen of the balloon 130 is communicated to the filling lumen 122 through the filling port 125, and the filling device controls the filling state of the balloon 130. After the proximal end of the inflation lumen 122 of the catheter 120 is connected to an external inflation device, inflation medium may be injected into the inflation lumen 122 of the catheter 120 and eventually delivered into the lumen of the balloon 130 to inflate the balloon 130, with the outer side of the balloon 130 capable of conforming to the inner wall of the vessel when in the inflated state.

Therefore, the balloon 130 of the excision device 100 is arranged at the distal end of the catheter 120, and the outer side surface of the balloon 130 in the inflated state can be attached to the inner wall of the blood vessel, so that the blood vessel is closed, and when the excision device 100 is used for excision of thrombus or plaque in the blood vessel, broken thrombus or plaque tissues generated in the excision process can be prevented from escaping to the distal end of the blood vessel, secondary embolism of the blood vessel caused by escaping thrombus can be avoided, the success rate of operation is improved, and complications are reduced.

Because of the surgical risk in clinical application, in order to reduce vascular perforation, a doctor usually performs one-time vascular plaque excision conservatively when performing plaque excision, so that residual plaque is not excised after the operation, and the size of the excised lumen is not ideal. And because the cutting member 112 is difficult to maintain good neutrality with the blood vessel, the risk of cutting the blood vessel remains high, and when the cutting device 100 is in the process of cutting a thrombotic plaque, perforation of the blood vessel is easily caused if the centering with the blood vessel is not good.

In this embodiment, the balloon 130 is disposed coaxially with the catheter 120. When the torque shaft 111 rotates, the cutter 112 is driven to rotate to cut thrombus or plaque in the blood vessel. If the cutting member 112 is accidentally deflected during rotation, it is easy to cause the cutting member 112 to cut the side wall of the blood vessel; if the cutting assembly 100 is pushed too fast during the excision, the inner wall of the blood vessel on the opposite side is easily cut when the thrombus at the curved blood vessel is excised.

In the present application, the central cavity 113 of the torque shaft 111 is used for threading the catheter 120, and the catheter 120 can be threaded out of the distal end of the torque shaft 111, and the distal end of the catheter 120 is provided with an inflatable balloon 130. Since the balloon 130 circumferentially encloses the catheter 120, and the catheter 120 and the balloon 130 are coaxially disposed. Therefore, the catheter 120 and the torque shaft 111 have better centering under the anchoring action of the balloon 120, in other words, the balloon 130 is closely attached to the inner wall of the blood vessel after being inflated, and the catheter 120 and the balloon 130 are coaxially arranged, so that after the balloon 130 is inflated and anchored in the blood vessel, the catheter 120 can be centered in the blood vessel under the anchoring action of the balloon 130, and when the torque shaft 111 is pushed along the catheter 120, the cutting member 112 can be prevented from accidentally shifting to cut the blood vessel wall. Thus, the blood vessel in the body can be better protected, and the cutting piece 112 and the blood vessel are axially kept parallel when in clinical use, so that the risks of scratching the blood vessel and perforating the blood vessel can be reduced.

In addition, with the above design, the cutting assembly 100 may also be provided with a larger diameter cutting member 112 to achieve a larger lumen after resection. The torque shaft 111, with the catheter 120 and balloon 130 anchored centrally, can avoid inadvertent deflection of the cutting member 112 at its distal end, thus providing greater safety of the cutting member 112 in the removal of thrombi or plaque. Compared with the prior art, the torque shaft 111 has good centering, so that the cutting piece 112 with a larger shaft diameter can be adopted, the safety of operation is ensured, the outer edge of the cutting piece 112 is closer to the inner wall of a blood vessel, and thus thrombus in the blood vessel or plaque attached to the inner wall of the blood vessel can be resected to the greatest extent.

Through the above analysis, first, the structural form of the excision device 100 of the present application determines that most of the thrombotic tissue of the blood vessel can be excised, so that the thrombus or plaque at the lesion position of the blood vessel can be removed more thoroughly by one-time incision, the thrombus or plaque remained on the inner wall of the blood vessel after the operation is reduced, and the safety is higher. Second, the balloon 130 disposed at the distal end of the ablation device 100 serves to occlude the vessel, thereby fundamentally preventing the cut-off morcellated plug from escaping distally, and further preventing the risk of embolization caused by the escaped morcellated plug and fine plaque tissue remaining in the body during the ablation process.

Specifically, as shown in fig. 2 and 3, a connector 351 is disposed at the proximal end of the catheter 120, and the connector 351 is used for connecting with an external device, either a filling device or an extraction device or a vacuum device. Inflation medium may be injected into balloon 130 to inflate balloon 130 or the cavity of balloon 130 may be evacuated to place balloon 130 in a contracted state.

The ablation device 100 further includes an inner visualization element 132, the inner visualization element 132 being disposed on the catheter 120, and the balloon 130 encasing the inner visualization element 132, wherein the inner visualization element 132 may be a visualization ring or a visualization site. In this embodiment, the inner developing member 132 is a developing ring and may be affixed to the conduit 120 by swaging or adhesive bonding. The balloon 130 completely encloses the inner visualization element 132, and the specific location of the balloon 130 in the external device and the morphology of the distal end of the catheter 120 can be detected by the inner visualization element 132.

In this embodiment, three internal visualization elements 140 are axially spaced at the distal end of the catheter 120. The proximal and distal ends of the balloon 130 are provided with an internal visualization element 132, respectively, for indicating the location of the proximal and distal ends of the balloon 130. And the middle part of the balloon 130 is further provided with an internal developing member 132, so that the direction of the distal end of the catheter 120 is shown by three internal developing members 132 arranged at intervals, the doctor is assisted to recognize the direction of the distal end of the catheter 120 and the degree of bending of the blood vessel, if the internal developing members 132 positioned at the middle part are obviously deviated, the area where the balloon 130 positioned at the distal end of the catheter 120 is anchored is a bent blood vessel part, and the doctor should adjust the operation in time to prevent the cutting member 112 of the excision device 100 from cutting the blood vessel wall when passing through the bent blood vessel part.

As shown in fig. 5 and 6, the excision device 100 of the invention is applied as follows.

With reference to fig. 5, when the ablation device 100 is advanced into a blood vessel and then gradually approaches the thrombus tissue 500 in the blood vessel, and when the ablation device 100 approaches the thrombus tissue 500 at a certain distance, the control catheter 120 is extended from the distal end of the torque shaft 111, and the balloon 130 at the distal end of the catheter 120 is in an evacuated state, so that the lesion site of the blood vessel is more easily accessed, and the thrombus tissue 500 in the blood vessel can be penetrated. And the distal guide head 121 of the balloon 130 is tapered to facilitate passage of the catheter 120 through the thrombotic tissue 500. At this point, the catheter 120 is advanced to pass the balloon 130 through the thrombotic tissue 500.

Referring to fig. 6, after the balloon 130 is pushed through the thrombus tissue 500 by the catheter 120, an inflation medium is injected into the balloon 130 by the inflation device, so that the balloon 130 is inflated, and the balloon 130 in the inflated state can be attached to the inner wall surface of the blood vessel. Since the balloon 130 is attached to the inner wall of the blood vessel, the cutting member 112 of the cutting assembly 100 is well aligned with the blood vessel, thereby reducing the risk of scratching the blood vessel and perforating the blood vessel. At this time, the cutting assembly 110 is pushed forward, and the cutting member 112 is rotated by the torque shaft 111, so that the cutting member 112 resects thrombus tissue in the advancing process.

In other embodiments, as shown in fig. 7, the balloon 130 at the distal end of the catheter 120 of the ablation device 100 is inflated to a spherical configuration, and the outer side of the balloon 130 in the spherical configuration can be attached to the inner wall of the blood vessel in a line contact manner when anchored. The balloon 130 with the spherical structure is more suitable for anchoring with a blood vessel at a curved section in a human body, can better fit with the blood vessel wall at the curved blood vessel, increases the pressure between the balloon 130 and the inner wall of the blood vessel, increases the anchoring force for the curved blood vessel, and has higher safety when the excision device 100 performs excision work on thrombus or plaque at the curved blood vessel.

In other embodiments, as shown in fig. 8, a plurality of protrusions 131 are provided on the outer wall of the balloon 130, and the balloon 130 can be attached to the inner wall of the blood vessel by the protrusions 131; because the effective length range of the saccule 130 is provided with the convex parts 131, the filled saccule 130 can still be in good contact with the blood vessel in the bending state of the blood vessel in the human body, and can be better attached to the wall of the blood vessel; in addition, the balloon 130 having the convex portion 131 has a stronger anchoring property, and displacement of the balloon 130 due to insufficient anchoring force under the pushing force of the catheter 120 can be prevented during pushing of the outer tube 150.

In addition, it should be noted that the excision device 100 provided by the present invention is used for capturing the excised thrombus tissue 500 in the blood vessel, and the catheter 120, the balloon 130 and the guide head 121 are all biocompatible. In this embodiment, the material of the catheter 120 or the guide head 121 may be Pebax. The material of the inner developing member 132 is tantalum alloy or platinum iridium alloy, and the material of the balloon 130 may be any one of PEBAX, nylon, TPU, and silica gel.

Example two

The second embodiment of the present invention proposes a excision device 100, which is the same as the first embodiment, and is not repeated, and the second embodiment is different from the first embodiment in that, as shown in fig. 9 to 14, the excision device 100 further includes a suction assembly 140, the suction assembly 140 includes a suction cavity 141 and a suction port 142, the suction cavity 141 is disposed along an axial direction of the catheter 120, the suction port 142 is disposed on an outer side surface of the catheter 120, the suction port 142 is communicated with the suction cavity 141, and the suction port 142 is disposed at a proximal end of the balloon 130, and when the suction cavity 141 is connected with an external suction device, a negative pressure is formed in the suction cavity 141 under the action of the suction device, so as to draw the crushed thrombus remaining in the blood vessel out of the blood vessel, thereby preventing the crushed thrombus remaining in the blood vessel from causing downstream branch vessel embolism.

By the above, the aspiration port 142 for aspirating fine thrombus or plaque is arranged on the catheter 120, if the cutting assembly 110 cannot expel all the cut thrombus out of the blood vessel, the aspiration action of the aspiration port 142 can timely aspirate the cut thrombus out of the blood vessel, so that the possibility that the cut thrombus tissue 500 escapes to other positions in the blood vessel is reduced to the maximum extent, and the aspiration port is of great significance in timely expelling the cut thrombus tissue 500 in the blood vessel or the thrombus plaque 500 is smaller. Second, after the cut thrombotic tissue 500 is discharged in time, the cutting member 112 can also be checked for the excision effect of the thrombotic tissue, preventing the thrombus or plaque from being thoroughly excised during the operation.

Wherein, as shown in fig. 10, the suction assembly 140 further includes a suction developing member 143 provided at a proximal end of the suction port 142, the suction developing member 143 being for displaying a position of the suction port 142, thereby assisting a doctor's observation and operation.

As shown in fig. 11 and 12, a guidewire lumen 124 is also provided in the catheter 120, the guidewire lumen 124 being used to pass a guidewire. In clinical use, the guidewire is threaded into the guidewire lumen 124, and a path is established through the guidewire for the outer tube 150 of the ablation device 100 to extend into the blood vessel.

In other embodiments, a guidewire may also be threaded from the central lumen 113 of the torque shaft 111 to establish a path for the outer tube 150 of the ablation device 100 to extend into the blood vessel. When the outer tube 150 is threaded into the vessel at the desired location along the path established by the guidewire, the guidewire is withdrawn and the catheter 120 is then inserted into the central lumen 113 and out of the torque shaft 111.

Referring to fig. 13 and 14, the application of the ablation device 100 with the suction port 142 of the present embodiment is illustrated, wherein the ablation device 100 is deployed into a lesion of a blood vessel, the catheter 120 is positioned adjacent to the thrombotic tissue 500 but does not pass through the thrombotic tissue 500, and after the balloon 130 is deployed from the distal end of the outer tube 150 of the ablation device 100, the guide head 121 at the distal end of the balloon 130 is positioned adjacent to the thrombotic tissue 500 in the blood vessel, and the catheter 120 is more easily positioned adjacent to and through the thrombotic tissue 500 to extend into the distal end of the thrombotic tissue 500. Subsequently, the catheter 120 is pushed through the balloon 130 through the thrombotic tissue 500.

After the balloon 130 at the distal end of the catheter 120 passes through the thrombotic tissue 500 and the suction port 142 is located at the distal side of the thrombotic tissue 500 by the suction developing member 143, the balloon 130 is inflated with inflation medium by the inflation device so that the balloon 130 is in an inflated state so as to be able to conform to the inner wall of the blood vessel. At this time, the cutting assembly 110 is pushed to cut the thrombus tissue 500 in the blood vessel and simultaneously aspirate the thrombus through the aspiration port 142, the aspiration assembly 140 aspirates the crushed thrombus while the cutting assembly 110 cuts the thrombus tissue 500, prevents the thrombus plaque from being removed from the blood vessel from escaping, reduces the risk of thrombus at the distal end of the blood vessel, and also reduces the complexity of the operation, thereby shortening the operation time.

With the excision device 100 provided in this embodiment, the escape of the thrombus plaque excised from the blood vessel by the cutting member 110 can be prevented by the balloon 130, and the thrombus plaque which is not excised by the cutting member 110 and delivered to the inside of the handle 300 can be captured by the suction member 140, and the crushed thrombus can be discharged out of the blood vessel by the suction lumen 141 through the negative pressure, so that the risk of the distal embolism of the blood vessel can be reduced, the complexity of the operation can be reduced, and the operation time can be shortened.

In the clinical use state of the excision device 100 provided by the invention, the cutting assembly 110 is axially parallel to the blood vessel, so that the risks of scratching the blood vessel and perforating the blood vessel are reduced, and meanwhile, the plaque in the lesion blood vessel can be excised for multiple times, so that a larger lumen is obtained.

As shown in fig. 11, the handle 300 is connected to the proximal end of the outer tube 150, and in this embodiment, the connector 351 is a base 310 disposed at the proximal end of the handle 300, and the handle 300 is connected to an external device through the base 310. The base 310 includes a filling seat 342 in communication with the proximal end of the filling lumen 122, a filling connector 352 is provided at the proximal end of the filling seat 342, the base 310 further includes a suction seat 343 in communication with the proximal end of the suction lumen 141, a suction connector 353 is provided at the proximal end of the suction seat 343, the base 310 further includes a guide wire seat 344 in communication with the proximal end of the guide wire lumen 124, a guide wire connector 354 may be provided at the proximal end of the guide wire seat 344, and the filling connector 352, the suction connector 353 and the guide wire connector 354 are all used for connecting to an external device.

The guidewire may be advanced into the distal end of the guidewire lumen 124 of the catheter 120 through the guidewire hub 344 and the guidewire connector 354; media may be injected into inflation lumen 122 of catheter 120 through inflation connector 352 of inflation seat 342 to inflate the lumen of balloon 130 in communication with inflation lumen 122, and balloon 130 may be evacuated through inflation connector 352 of inflation seat 342; the thrombotic tissue introduced into the suction lumen 141 of the catheter 120 can be discharged outside the body through the suction connector 353 of the suction base 343.

In addition, it should be noted that the present invention provides an ablation device 100 for capturing ablated thrombotic tissue 500 in a blood vessel. The suction developing member 143 is made of tantalum alloy or platinum iridium alloy; any of the guide wire connector 354, the filling connector 352, the suction connector 353, and the base 310 may be made of a material PC, ABS, PP.

Example III

The third embodiment of the present invention proposes a cutting device 100, and the third embodiment is the same as the first embodiment and is not repeated, and the third embodiment is different from the first embodiment in that, as shown in fig. 15 to 20, the cutting device 100 includes a cutting assembly 110 and an anchor assembly 200, the anchor assembly 200 includes a push tube 210, an inner tube 220 and a protection net 230, the cutting assembly 110 includes a torque shaft 111 and a cutting member 114 disposed at a distal end of the torque shaft 111, and the torque shaft 111 is provided with a central cavity 113. The push tube 210 is disposed through the central cavity 113 and out the distal end of the torque shaft 111, and the inner tube 220 is disposed through the cavity of the push tube 210. The protection net 220 is formed by braiding a braided wire having shape memory property, the protection net 230 is connected to the inner tube 220, and the push tube 210 and the inner tube 220 can be relatively slid in the axial direction to control the release or recovery of the protection net 230.

In this embodiment, the proximal end of the protection net 230 is connected to the distal end of the push tube 210, the distal end of the protection net 230 is connected to the distal end of the inner tube 220, and the protection net 230 is controlled to be in a contracted state or an expanded state by the axial relative movement of the inner tube 220 and the push tube 210, and the expanded protection net 230 can be attached to the inner wall of a blood vessel.

When the inner tube 220 moves axially toward the distal end of the push tube 210, the protection net 230 is gradually elongated under the pulling action of the inner tube 220 and finally fits the inner tube 220, and at this time, the push tube 210 can be moved, so that the anchor assembly 200 is integrally accommodated in the central cavity 113 of the torque shaft 111. When the inner tube 220 moves axially toward the proximal end of the push tube 210, the pulling action of the inner tube 220 on the protective mesh 230 is gradually reduced, and the protective mesh 230 expands under its own elastic restoring force and finally conforms to the inner wall of the blood vessel.

Wherein at least a portion of the inner tube 220 extends out of the lumen of the push tube 210, the protective mesh 230 is in a straightened state when fully covering the inner tube 220, and the inner tube 220 moves proximally relative to the push tube 210 to cause the protective mesh 230 to assume an expanded state. Because the protective mesh 230 is disposed at the distal end of the ablation device 100, the protective mesh 230 can be delivered in a contracted state, and the protective mesh 230 can be attached to the inner wall of a blood vessel in an expanded state, thereby capturing the severed thrombus or plaque and preventing the severed thrombus or plaque from escaping distally.

Since the protection net 230 in the present embodiment is formed by braiding wires, the protection net 230 has mesh openings 231, as shown in fig. 20. Even if the protective mesh 230 swells and adheres to the blood vessel during the operation, blood flow can still flow through the mesh 231 of the protective mesh 230, but cut thrombus or plaque is caught due to the blockage of the protective mesh 230. Therefore, the excision device 100 of the present embodiment can also ensure timely replenishment of blood to the tissue in the body located at the distal end of the thrombotic tissue 500 while excision of thrombus or plaque is performed, improving the safety of the operation.

As shown in fig. 18, a first lumen 221 is further provided within the inner tube 220, the first lumen 221 being for threading a guidewire through which a path can be established for the outer tube 150 of the ablation device 100 to extend into a blood vessel. In other embodiments, the lumen for threading the guidewire may also be provided in the push tube 210 or in the torque shaft 111.

As shown in fig. 16, 19 and 20, an end developing member 240 is further provided in the protective net 230, and the end developing member 240 is provided on the protective net 230, wherein at least one end developing member 240 is provided at both the proximal end and the distal end of the protective net 230, for example, two end developing members 240 are provided at the proximal end of the protective net 230, and two end developing members 240 are provided at the distal end of the protective net 230.

The end developing members 240 are respectively arranged at the proximal end and the distal end of the protection net 230, so that the distance between the proximal end and the distal end of the protection net 230 can be judged in the moving process of the inner tube 220, and the unfolding state of the protection net 230 can be further judged, and the protection net 230 can be unfolded before the cutting assembly 110 is used for cutting the thrombus tissue 500.

In the present embodiment, the end developing member 240 is a developing point fixedly provided on the protective net 230.

In practice, as shown in fig. 19 and 20, the ablation device 100 is extended into the lesion of the blood vessel, and the protective mesh 230 of the ablation device 100 has not yet penetrated the thrombus tissue 500, at this time, the inner tube 220 is moved to the distal end of the push tube 210 so that the protective mesh 230 is in a contracted state and is attached to the inner tube 220. Because protective mesh 230 is positioned at the distal end of ablation device 100, the lesion site is more easily accessed within the vessel when protective mesh 230 is in the contracted state; after the protective mesh 230 passes through the thrombotic tissue 500, the inner tube 220 is moved proximally relative to the push tube 210 such that the protective mesh 230 is expanded under its own elastic restoring force and conforms to the vessel wall. The expanded protective mesh 230 is capable of conforming to the interior wall of the vessel while pushing the cutting assembly 110 along the push tube 210 to control the cutting member 112 to ablate thrombotic tissue.

By the above technical solution of the present embodiment, since the protection net 230 can be expanded and attached to the inner wall surface of the blood vessel, the cutting assembly 110 located at the proximal end of the protection net 230 is well aligned with the blood vessel, so that not only can the thrombus plaque or thrombus tissue be cut off, but also the risk of injury to the blood vessel can be reduced. Further, since the protection net 230 is formed by knitting a shape memory fabric, the protection net 230 has a mesh 231 allowing blood to circulate, thereby facilitating the maintenance of blood circulation during surgery.

In other embodiments, one end of the protection net 230 may be fixed to the inner tube 220 by welding, and the other end of the protection net 230 may be fixed to the push tube 210 by bonding or welding.

When the end developing parts 240 are disposed on the protection net 230, the end developing parts 240 may be made of tantalum alloy or platinum iridium alloy, preferably, the number of the end developing parts 240 disposed on the protection net 230 is four, and the end developing parts are respectively disposed at the proximal end and the distal end of the protection net 230, so that the position and the specific state of the protection net 230 can be observed through external equipment.

The materials of the push tube 210, the inner tube 220 and the protection net 230 should have biocompatibility, for example, the material of the push tube 210 or the inner tube 220 may be PEBAX or nylon, and the material of the protection net 230 may be stainless steel or nickel-titanium alloy.

Example IV

The fourth embodiment of the present invention provides a cutting device 100, and the fourth embodiment and the third embodiment are the same and are not repeated, and the fourth embodiment and the third embodiment are different in that, as shown in fig. 21 to 27, a protection net 230 may be further disposed at a distal end of the inner tube 220, and the inner tube 220 is slidably connected with the push tube 210 along an axial direction, so that the protection net 230 is accommodated in the push tube 210 or the protection net 230 extends out of the push tube 210. When the protective net 230 is extended out of the push tube 210, it is unfolded by its own elastic restoring force, thereby fitting the inner wall of the blood vessel.

The protective mesh 230 is in a straightened state when received within the lumen of the push tube 210, and the push tube 210 moves proximally relative to the inner tube 220 such that the protective mesh 230 extends out of the lumen of the push tube 210 and assumes an expanded state. In this embodiment, the straightened protecting net 230 is disposed in the push tube 210, so as to avoid damage to the protecting net 230 due to misoperation, until the straightened protecting net 230 is passed through the distal end of the thrombus tissue 500 in the blood vessel, the push tube 210 is axially moved proximally relative to the inner tube 220, the contracted protecting net 230 extends out of the push tube 210, the protecting net 230 returns to the expanded state, and the protecting net 230 in the expanded state can be attached to the inner wall of the blood vessel.

As shown in fig. 23, a push handle 410 and a slider 420 provided on the push handle 410 may be further provided at the proximal end of the handle 300, and the push tube 210 and the inner tube 220 may be respectively inserted through the push handle 410. Wherein the push tube 210 is fixed on the push handle 410, the inner tube 220 extends out of the push tube 210 and is fixedly connected with the sliding block 420, and the sliding block 420 is arranged in the push handle 410 and can axially move in the push handle 410. At the distal end of the cutting device 100, the sliding block 420 is operated to axially move in the push handle 410, so as to drive the inner tube 220 to axially move relative to the push tube 210, thereby enabling the protection net 230 disposed at the distal ends of the push tube 210 and the inner tube 220 to contract or expand. In this embodiment, the pushing handle 410 is disposed at the proximal end of the handle 300, so that the operation of a doctor is facilitated, and the operation efficiency and the operation success rate are improved.

In other embodiments, push handle 410 is attached to the proximal end of handle 300, slider 420 is fixedly attached to push tube 210, inner tube 220 is fixedly disposed within push handle 410, and push tube 210 moves with the movement of slider 420 when slider 420 is moved. When the driving slider 420 moves toward the proximal end of the push handle 410, the push tube 210 moves toward the proximal end with respect to the inner tube 220, and the protection net 230 disposed at the distal end of the inner tube 220 is gradually released from the push tube 210, and is unfolded under the elastic restoring force of itself, and finally sticks to the wall.

In other embodiments, the ablation device 100 may also be provided without a push handle 410, and the physician may push and pull the inner tube 220 directly during surgery to retract or expand the protective mesh 230.

In other embodiments, as shown in fig. 27, a covering film 250 may be further disposed on the protection net 230, and when the covering film 250 is disposed on the protection net 230, the mesh 231 on the protection net 230 can be covered by the covering film 250, so that a broken bolt having a size smaller than the mesh 231 passes through the mesh 231, thereby creating a risk of the branched blood vessel being occluded. Wherein the cover film 250 completely covers the protection net 230, or the cover film 250 partially covers the protection net 230. When the cover 250 partially covers the protective mesh 230, the cover 250 may be disposed at the proximal or distal end of the protective mesh 230.

In connection with fig. 24, it should be noted that the inner tube 220 used in the excision device of the present invention may be provided with either a hollow inner tube 220 or a solid inner tube 220, and the purpose of the inner tube 220 is to connect one end of the protection net 230 to the distal end of the inner tube 220, and to realize the contracted state and the expanded state of the protection net 230 by the axial relative movement of the inner tube 220 and the push tube 210. Therefore, according to practical application requirements, the inner tube 220 with the first inner cavity 221 can be adopted, and the guide wire penetrates into the blood vessel through the first inner cavity 221; instead of the inner tube 220, a thin shaft-shaped guide wire may be connected to one end of the protective net 230 at its distal end and inserted into the push tube 210, and moved relative to the axial direction of the push tube 210 to achieve the contracted state and the expanded state of the protective net 230.

Example five

The fifth embodiment of the present invention proposes a cutting device 100, and the fifth embodiment is the same as the first embodiment and is not repeated, and the fifth embodiment is different from the first embodiment in that, as shown in fig. 31 to 37, the cutting device 100 includes a driving mechanism 700, a transmission mechanism 600, and a torque shaft 111 connected to the transmission mechanism 600, and an outer tube 150 is sleeved outside the torque shaft 111. The driving mechanism 700 is connected to the transmission mechanism 600 and provides power to the transmission mechanism 600, and controls the rotational speed and rotational direction of the torque shaft 111 through the transmission mechanism 600.

Wherein, the outer tube 150 is sleeved outside the torque shaft 111, and the cutting member 120 arranged at the distal end of the torque shaft 111 cuts the thrombus in the blood vessel, and the cut thrombus is accommodated in the outer tube 150 and is discharged out of the body along with the conveying screw 114 by the rotation of the torque shaft 111. However, when a blockage occurs between the torque shaft 111 and the outer tube 150, it is difficult to discharge the thrombus in the outer tube 150, and if the thrombus is not discharged in time, the transfer lumen 151 in the outer tube 150 is easily blocked, thereby causing the resecting device 100 to fail, affecting the normal progress of the operation. The cutting device 100 provided by the invention can dredge the blockage between the torque shaft 111 and the outer tube 150 in time by changing the rotation speed and the rotation direction of the torque shaft 111, and can discharge thrombus in time.

As shown in fig. 31 and 32, the transmission mechanism 600 includes a speed adjusting component 610, a direction adjusting component 620 and a driving gear 630, wherein the speed adjusting component 610 is in transmission fit with the direction adjusting component 620 and can form transmission ratios with different values, so that the transmission mechanism 600 can transmit power with different transmission ratios, when the driving gear 630 is arranged on the torque shaft 111 of the excision device 100, the transmission mechanism 600 transmits power to the driving gear 630 with different transmission ratios through the speed adjusting component 610 and the direction adjusting component 620, so that the torque shaft 111 matched with the driving gear 630 is driven to rotate at different rotation speeds, so that the driving mechanism 700 of the excision device 100 transmits power to the transmission mechanism 600, different torques can be output to the torque shaft 111 through the transmission mechanism 600, the torque shaft 111 is enabled to rotate at different speeds, and therefore, the cutting member 120 arranged at the far end of the torque shaft 111 cuts thrombus or plaque with different rotation speeds.

The speed regulating assembly 610 comprises a driving shaft 611, the driving shaft 611 is used for being connected with an output shaft of the driving mechanism 700, a first transmission gear 612 and a second transmission gear 613 are arranged on different axial sections of the driving shaft 611, the first transmission gear 612 and the second transmission gear 613 can be arranged to have different tooth numbers and different tooth diameters, the first transmission gear 612 and the second transmission gear 613 are respectively meshed with the direction regulating assembly 620 to form transmission ratios with different values, for example, the first transmission gear 612 is meshed with the direction regulating assembly 620 to form a first transmission ratio, the second transmission gear 613 is meshed with the direction regulating assembly 620 to form a second transmission ratio, and the first transmission gear 612 and the second transmission gear 613 are arranged on the driving shaft 611 at intervals, so that the matched switching between the first transmission gear 612 and the second transmission gear 613 and the direction regulating assembly 620 can be realized by moving the driving shaft 611.

The steering assembly 620 in the transmission mechanism comprises a connecting rod 621, wherein a connecting gear 622 and a connecting bearing 624 are arranged on the connecting rod 621, and the connecting gear 622 is rotatably connected to the connecting rod 621 through the connecting bearing 624. The connection gear 622 is simultaneously engaged with the first transfer gear 612 and the driving gear 630 connected to the torque shaft 111, or the connection gear 622 is simultaneously engaged with the second transfer gear 613 and the driving gear 630 connected to the torque shaft 111 to drive the rotation of the torque shaft 111 and the cutter 120.

The driving shaft 611 and the connecting rod 621 are arranged in parallel, and the relative movement between the driving shaft 611 and the connecting rod 621 can realize the matched switching between the first transmission gear 612 and the second transmission gear 613 on the driving shaft 611 and the connecting gear 622 on the connecting rod 621.

In the present embodiment, the second transmission gear 613 provided on the driving shaft 611 is a primary gear, the first transmission gear 612 provided on the driving shaft 611, the connecting gear 622 rotatably connected to the connecting rod 621, and the driving gear 630 engaged with the torque shaft 111 are secondary gears, and the primary gear is smaller in size than the secondary gears. For example, the first transfer gear 612 and the connecting gear 622 and the drive gear 630 form a gear ratio of 1:1:1, the transmission ratio formed between the second transmission gear 613 and the connection gear 622 and the drive gear 630 is 1.5:1:1 or 2:1:1.

Since the thrombus or plaque is continuously discharged along the delivery lumen 151 of the outer tube 150 toward the handle 300 by the delivery screw 114 during the process of cutting out the thrombus or plaque, the thrombus or plaque is easily caught in the outer tube 150 if the thrombus or plaque is hard or numerous during the discharge process of the thrombus or plaque. Once a thrombus or plaque becomes lodged within the outer tube 150, the proper excision of the thrombus or plaque by the cutter 112 is affected.

Therefore, in this embodiment, when the thrombus or plaque is caught inside the outer tube 150 and the cutting member 112 is normally cut, the torque of the torque shaft 111 can be adjusted by controlling the transmission mechanism 600, so that the conveying screw 114 can convey the thrombus or plaque with a larger torque, so that the thrombus or plaque caught inside the outer tube 150 can be conveyed into the handle 300, and the rotational cutting speed of the cutting member 112 can be adjusted, so that the cutting member 112 can adapt to the thrombus or plaque with a larger hardness by changing the rotational cutting speed. When it is desired to cut thrombus or plaque at a lower cutting speed, a secondary gear may be optionally used for driving, i.e., a gear ratio of 1 is formed between the first transfer gear 612 and the connecting gear 622 and the driving gear 630: 1:1, a step of; when it is desired to cut the thrombus tissue at a high cutting speed, the primary gear and the secondary gear may be selected to be driven in cooperation, i.e., the gear ratio formed between the second transmission gear 613 and the connection gear 622 and the driving gear 630 is 1.5:1:1 or 2:1:1. in this embodiment, a spur gear is used for transmission.

In other embodiments, a plurality of gears of different gear ratios may also be provided on the drive shaft 611 to form a plurality of different gear ratios to drive the torque shaft 111 for rotation. Gears with other structures can be arranged for transmission, such as helical cylindrical gears, bevel gears or herringbone gears and other transmission gears capable of achieving stable power transmission.

As shown in fig. 31, a steering gear assembly 623 is disposed on the connecting rod 621 in the steering assembly 620, wherein the steering gear assembly 623 may be disposed at an axial end position of the connecting rod 621, and may also be disposed on a partial axial section of the connecting rod 621. This embodiment employs an embodiment in which the shaft end of the connecting rod 621 is provided with a steering gear assembly 623.

Specifically, a flange plate 6233 is fixedly disposed at the shaft end of the connecting rod 621, a first steering shaft 6234 and a second steering shaft 6235 are rotatably connected to the flange plate 6233, the first steering gear 6231 and the second steering gear 6232 are engaged with each other, and the first steering gear 6231 and the second steering gear 6232 are rotatably connected to the flange plate 6233 through the first steering shaft 6234 and the second steering shaft 6235, respectively. The first steering gear 6231 and the second steering gear 6232 meshed with each other are integrally meshed with each other to be transmitted with the first transmission gear 612 provided on the driving shaft 611 and the driving gear 630 engaged with the torque shaft 111, or meshed with the second transmission gear 613 provided on the driving shaft 611 and the driving gear 630 engaged with the torque shaft 111.

By transmitting the meshing transmission between the first transmission gear 612, the steering gear assembly, and the drive gear 630, the drive gear 630 can be rotated in the opposite direction, and the torque shaft 111 connected to the drive gear 630 can be rotated in the opposite direction.

The cutting device 100 of the present invention can achieve rotation of the torque shaft 111 at different speeds and can change the rotational direction of the torque shaft 111. When thrombus or plaque is stuck in the outer tube 150, if the outer tube 150 cannot be dredged in time by the speed regulating assembly 610, the connecting rod 621 can be controlled to control the connecting gear 622 to be disengaged from the first transmission gear 612 or the second transmission gear 613, and the direction regulating assembly 620 is adopted as an intermediate transmission component, so that the rotation direction of the torque shaft 111 is changed, and the blocked portion of the outer tube 150 is dredged.

The steering assembly 620 of the present application can be used with the pumping assembly 140 when changing the rotational direction of the torque shaft 111. Since thrombus or plaque within the outer tube 150 may be pushed out of the distal end of the outer tube 150 when the torque shaft 111 is reversely rotated, thrombus or plaque discharged when the outer tube 150 is dredged by the suction assembly 140 is discharged out of the blood vessel through the suction port 142.

In this embodiment, when the direction adjustment assembly 620 is used to change the mounting direction of the torque shaft 111, the direction adjustment assembly 620 is driven by the first transmission gear 612, and when the direction adjustment assembly is driven by the first transmission gear 612, the transmission mechanism 600 can obtain a larger torque, so that the blockage in the cutting assembly 110 can be dredged conveniently.

As shown in fig. 32 to 35, the driving mechanism 700 includes a first housing 740, a carrying table 720 is provided in the first housing 740, a first position 721 and a second position 722 for carrying the driving motor 710 are provided on the carrying table 720, wherein fig. 32 shows the driving motor 710 fixed at the first position 721 of the carrying table 720, and a supporting assembly 730 connected to the driving motor 710 is provided in order to enable the driving motor 710 to be stably fixed at the first position 721.

The support assembly 730 includes a first fixing plate 731 and a second fixing plate 732 disposed opposite to each other, and an elastic member 733 disposed between the first fixing plate 731 and the second fixing plate 732, the first fixing plate 731 is connected to the driving motor 710, the second fixing plate 732 is connected to an inner wall of the first housing 740, the first fixing plate 731 fixes the driving motor 710 to the first position 721 of the bearing table 720 under the elastic force of the elastic member 733, and the second fixing plate 732 is pressed against the inner wall of the first housing 740, so that the driving motor 710 can be stably fixed to the first position 721 of the bearing table 720, and an output shaft of the driving motor 710 is connected to the driving shaft 611 of the speed adjusting assembly 610, thereby stably outputting power to drive the transmission mechanism 600. In the present embodiment, the elastic member 733 is a spring.

As shown in fig. 32 and 33, a sliding rail 734 is disposed between the first fixing plate 731 and the inner wall of the first housing 740, the sliding rail 734 is fixed on the inner wall of the first housing 740, and the first fixing plate 731 is slidably connected to the sliding rail 734. The support assembly 730 further includes a first lever 736, the first lever 736 extending out of a first housing 740. The handle 300 is provided with a clamping assembly 750, and the clamping assembly 750 includes a first clamping key 751 and a second clamping key 752. The first and

second clamping keys

751 and 752 are disposed on the first housing 740 and used for fixing the first control rod 736, and the first control rod 736 is clamped and fixed with the first and

second clamping keys

751 and 752, as shown in fig. 36.

The first housing 740 is provided with a chute 737, the first control lever 736 is disposed in the chute 737, and the first and

second locking keys

751 and 752 are disposed at two ends of the chute 737, respectively. The first lever 736 moves along the chute 737 to move the drive motor 710 between the first position 721 and the second position 722. Fig. 33 illustrates the drive motor 710 secured to the second position 722 of the pedestal 720.

An output shaft of the driving motor 710 is connected with a driving shaft 611 in the speed regulating assembly 610, a first transmission gear 612 arranged on the driving shaft 611 is meshed with a connecting gear 622 arranged on a connecting rod 621, the connecting gear 622 is meshed with a driving gear 630, and a transmission ratio formed between the first transmission gear 612 and the connecting gear 622 and between the first transmission gear 612 and the driving gear 630 is 1:1:1, the drive mechanism can stably output power to the transmission mechanism, and finally the drive torque shaft 111 stably rotates. When it is desired to increase the rotational speed of the torque shaft 111, the support assembly 730 and the drive motor 710 coupled to the first lever 736 may be moved in the second direction of the bearing table 720 by operating the first lever 736 to move within the chute 737, and the drive motor 710 may be fixed at the second position 722.

As shown in fig. 32 and 33, the stop assembly 760 further includes a limiting seat disposed in the first housing 740, a second control rod 767 connected to the connecting rod 621 is disposed in the limiting seat 763, the second control rod 767 is disposed in the limiting hole 764 in a penetrating manner, and a first limiting block 765 on the connecting rod 621 abuts against an end surface of one side of the limiting seat 763 to limit the second control rod 767 from moving axially in a distal direction. Referring to fig. 37, the first housing 740 is slidably connected with a locking key 770, the locking key 770 is fixedly inserted into an insertion hole (not shown) on the second operating rod 767, when the second operating rod 767 is fixed by the locking key 770 on the first housing 740, the second operating rod 767 is limited to move axially, and after the second operating rod 767 is limited to move axially, the connecting rod 621 connected with the second operating rod 767 and the connecting gear 622 can be in stable meshed transmission with the first transmission gear 612 and the driving gear 630. Engagement of steering gear assembly 623 on connecting rod 621 with timing assembly 610 and drive gear 630 can be accomplished by operating second lever 767 when it is desired to change the direction of rotation of torque shaft 111.

As shown in fig. 34, the cutting device 100 further includes a stop assembly 760, where the stop assembly 760 includes a guide hole 753 disposed in the first housing 740, one end of the connecting rod 621 is disposed in the guide hole 761 and can move axially along the guide hole 761, and the connecting rod 621 can change the relative position between the connecting rod 621 and the driving shaft 611 by moving axially in the guide hole 761, so that the connecting gear 622 or the steering gear assembly 623 on the connecting rod 621 and the speed adjusting assembly 610 perform a cooperative transmission.

The cutting device 100 of the invention can change the overall rotary cutting direction of the torque shaft 111, and can timely adjust the rotary cutting direction of the torque shaft 111 when the torque shaft 111 and the outer tube 150 are blocked or when the rotary cutting effect is poor due to other factors, so as to dredge the blocked position of the outer tube 150, thereby avoiding the problems of distal embolism caused by plaque or thrombus not being timely discharged out of a blood vessel due to the blocking of the rotary cutting outer tube 150 and endangering the life safety of patients, and therefore, the cutting device 100 of the invention can improve the efficiency of the operation.

In addition, the invention realizes the adjustment of the rotary cutting speed of the torque shaft 111, can adapt to thrombus tissues with different hardness, adjusts the meshing relationship between the speed regulating component 610 and the direction regulating component 620 by operating the first control rod 736, outputs power to the driving gear 630 and the torque shaft 111 with higher transmission ratio, and finally increases the rotation speed of the torque shaft 111, so that the thrombus tissues are fully crushed and then discharged out of the outer tube 150.

Referring to fig. 33, the first lever 736 is separated from the first locking key 751 by operating the first lever 736, and moves along the chute 737 toward the second locking key 752 to be finally fixed in the second locking key 752, and at the same time, the support assembly 730 and the driving motor 710 connected to the first lever 736 are moved toward the second position 722 of the carrying platform 720 under the driving of the first lever 736, so that the driving motor 710 is finally fixed in the second position 722, and the movement of the driving motor 710 is further limited by the limit of the first lever 736 in the second locking key 752 and the pressing force provided by the support assembly 730 to the driving motor 710.

When the driving motor 710 is fixed at the second position 722 of the carrying platform 720, the second transmission gear 613 on the driving shaft 611 is meshed with the connecting gear 622 on the connecting rod 621, and since the outer diameter of the second transmission gear 613 is larger than that of the first transmission gear 612, in order to enable the second transmission gear 613 to be meshed with the connecting gear 622 correctly for transmission, the second position 722 and the first position 721 are connected through an inclined plane. The second fixing plate 732 slides on the sliding rail 734 under the action of the first control rod 736 to move the driving motor 710 to the second position 722 along the inclined plane. At this time, the elastic member 733 between the first fixing plate 731 and the second fixing plate 732 is in a compressed state, and a larger elastic force generated by the elastic member 733 acts on the driving motor 710 to fix the driving motor 710 at the second position 722, and when the driving motor 710 moves to the second position 722 of the carrying platform 720, the second locking key 752 for fixing the first control lever 736 is provided on the first housing 740, so as to prevent the first control lever 736 from moving.

In this embodiment, the elastic member 733 is a spring, the second fixing plate 732 is provided with a guide rod 735, and the guide rod 735 is sleeved in the elastic member 733 and passes through the first fixing plate 731 to guide the first fixing plate 731 and the second fixing plate 732. Meanwhile, the first fixing plate 731 and the second fixing plate 732 are prevented from being dislocated when the driving motor 710 is pushed, and the strength of the whole structure is improved.

After the driving motor 710 is fixed at the second position 722, the second transmission gear 613 on the driving shaft 611 and the connecting gear 622 on the connecting rod 621 are meshed for transmission, and the transmission ratio that can be formed by the second transmission gear 613 and the connecting gear 622 is 1.5:1 or 2:1, therefore, power can be transmitted to the drive gear 630 at a higher transmission ratio, so that the drive gear 630 and the torque shaft 111 have a higher rotational speed, and the rotational speed of the torque shaft 111 in the outer tube 150 is increased, whereby the thrombus tissue accommodated in the outer tube 150 can be broken up and discharged out of the outer tube 150 in time.

In other embodiments, the second transmission gear 613 and the connecting gear 622 may have other transmission ratios, so long as the rotation speed and the torque of the torque shaft 111 can be guaranteed to be adjusted, so as to adapt to thrombus or plaque with different hardness, and the outer tube 150 can be effectively dredged.

As shown in fig. 34, a fixed key 6211 may be provided on the connection rod 621, the stopping assembly 760 further includes a fixed slot 762 provided in the guide hole 761, the fixed slot 762 is configured to be engaged with the fixed key 6211, and the rotation of the connection rod 621 can be prevented by sliding engagement between the fixed key 6211 and the fixed slot 762, and this arrangement can make the connection rod 621 more stably supported, wherein the connection gear 622 is rotatably connected with the connection rod 621 through the connection bearing 624, and the first steering gear 6231 and the second steering gear 6232 engaged with each other are rotatably engaged with the connection rod 621 through the flange plate 6233.

Referring to fig. 31 and 35, by operating the second lever 767, the second lever 767 is moved axially proximally along the limiting hole 764 until the second stopper 766 on the second lever 767 abuts against the end surface on one side of the limiting seat 763, and at the same time, the connecting rod 621 connected to the second lever 767 is moved axially proximally, and the first steering gear 6231 and the second steering gear 6232, which are engaged with each other, of the steering gear assembly 623 on the connecting rod 621 are engaged with the first transmission gear 612 on the driving shaft 611 and also engaged with the driving gear 630, so that the torque shaft 111 connected to the driving gear 630 is rotated in different directions by the cooperation between the first transmission gear 612, the first steering gear 6231, the second steering gear 6232 and the driving gear 630. At this time, the driving motor 710 is located at the first position 721 of the carrying platform 720, and the second lever 767 cooperates with the locking key 770 on the first housing 740 to limit the axial movement of the second lever 767.

In summary, the cutting device 100 of the present embodiment can adjust the rotational cutting speed of the torque shaft 111, adapt to thrombus tissue with different hardness, and adjust the torque of the torque shaft 111, so as to dredge the blockage of the outer tube 150. In addition, the overall rotary cutting direction of the torque shaft 111 can be changed, when the torque shaft 111 and the outer tube 150 are blocked or the rotary cutting effect is poor due to other factors, the rotary cutting direction of the torque shaft 111 can be timely adjusted, the blocked position of the outer tube 150 is dredged, and the problem that plaque or thrombus is caused by blockage of the rotary cut outer tube 150 and is not timely discharged out of a blood vessel to cause distal embolism is avoided. Simultaneously, the distal end of the blood vessel is plugged by the anchor assembly 200, so that thrombus or plaque is prevented from escaping to the distal end of the blood vessel, and the suction assembly 140 is adopted to be matched when the outer tube 150 is dredged, so that the thrombus or plaque is timely sucked and discharged out of the blood vessel through the suction cavity 141, and the thrombus or plaque is prevented from embolizing a downstream branch blood vessel.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. A cutting device comprising a cutting assembly and an anchor assembly, wherein a central cavity is axially arranged in the cutting assembly; the anchoring assembly comprises a catheter and a balloon arranged on the distal end side of the catheter, the catheter penetrates through the central cavity and can penetrate through the distal end of the cutting assembly, the balloon at least covers part of the pipe section of the catheter, and the balloon is used for anchoring the cutting assembly in an expanded state.

2. The ablation device of claim 1, further comprising a suction assembly coupled to the catheter, the suction assembly including a suction lumen disposed axially within the catheter and in communication with the suction lumen, and a suction port disposed on an outer side of the catheter and in communication with the suction lumen, the suction port being on a proximal side of the balloon, a proximal end of the suction lumen being provided with a suction mount for connection to a suction device.

3. The ablation device of claim 2, wherein a suction developing member is provided on the catheter, the suction developing member being located at the suction port or on a proximal side of the suction port.

4. The ablation device of claim 1, wherein a guidewire lumen for threading a guidewire is provided within the catheter, a guidewire seat being provided at a proximal end of the guidewire lumen; the distal end of the catheter is provided with a conical guide head, the balloon is positioned at the proximal end side of the guide head, and the hardness of the guide head is smaller than that of the catheter.

5. The ablation device of claim 1, wherein the outer wall of the balloon has a plurality of protrusions, the balloon can be attached to the inner wall of the blood vessel by the protrusions, or the balloon has a spherical structure after being inflated, and the outer side of the balloon can be attached to the inner wall of the blood vessel in a line contact manner when the balloon is inflated.

6. The ablation device of claim 1, further comprising at least one internal visualization member disposed on the catheter and within the balloon; when a plurality of the internal developing members are provided on the guide pipe, the plurality of the internal developing members are disposed at intervals along the axial direction of the guide pipe.

7. The ablation device of claim 1, wherein a filling lumen is axially disposed within the catheter, a distal end of the catheter is provided with a filling port in communication with the filling lumen, and a lumen of the balloon is in communication with the filling port; the proximal end of the inflation lumen is configured to connect to an inflation device to control the inflation state of the balloon.

8. The cutting device of claim 1, further comprising an outer tube and a handle connected to a proximal end of the outer tube, wherein the cutting assembly comprises a torque shaft and a cutting element disposed at a distal end of the torque shaft, wherein the central cavity is disposed axially along the torque shaft, wherein the outer tube is sleeved on the torque shaft, and wherein a transmission cavity is formed between the outer tube and the torque shaft; and a conveying spiral part is arranged on the outer side of a part of the shaft section of the torque shaft and is used for conveying thrombus tissues cut by the cutting part into the conveying cavity and conveying the thrombus tissues to the proximal end.

9. The ablation device of claim 8, wherein a thrombus ejection member in communication with the proximal end of the outer tube and a base disposed at the proximal end of the handle for connection to an external device are disposed within the handle.

10. The ablation device of claim 8, wherein a bearing assembly is disposed within the handle and cooperates with the proximal end of the torque shaft and a drive mechanism for driving the torque shaft in rotation and rotating the cutting member to cut thrombotic tissue.