CN114098914A

CN114098914A - Medical device and medical system

Info

Publication number: CN114098914A
Application number: CN202010880478.3A
Authority: CN
Inventors: 周振标; 吴星宇; 龙汉
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2020-08-27
Filing date: 2020-08-27
Publication date: 2022-03-01

Abstract

The present invention relates to a medical device and a medical system. The medical device comprises an outer pipe assembly, an inner pipe assembly inserted in the outer pipe assembly, and a cutting assembly connected between the outer pipe assembly and the inner pipe assembly, wherein the cutting diameter of the cutting assembly can be adjusted when the outer pipe assembly and the inner pipe assembly slide relatively. In this embodiment, plaques with different thicknesses in the blood vessel are removed by adjusting the cutting diameter of the cutting assembly and the cutting range of the cutting assembly. Meanwhile, in the process of the plaque removal operation, the positions of the far end and the near end of the cutting assembly in the radial direction do not need to be adjusted repeatedly, the operation difficulty is reduced, and the risk that the blood vessel is easily damaged due to the fact that the positions of the far end and the near end of the cutting assembly in the radial direction are adjusted is reduced. Embodiments of the present application also provide a medical system including a transporter and the medical device, the medical device being deliverable to a target location via the transporter.

Description

Medical device and medical system

Technical Field

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

Background

In current atherectomy procedures, a medical device having a rotating tip is often loaded into a catheter, guided over a guidewire in the catheter into a blood vessel, and the plaque is removed from the blood vessel by rotating the tip. Since the size of such a rotating tip is often fixed, it is necessary to adjust the position of the rotating tip to cut out plaque of varying radial thickness within the vessel. However, in the conventional technique, it is difficult to adjust the position of the rotating tip in the blood vessel, and the blood vessel is easily damaged during the adjustment, increasing the risk of the operation.

Disclosure of Invention

Based on this, there is a need for a medical device that can adjust the cutting diameter of the cutting assembly.

The medical device comprises an outer pipe assembly, an inner pipe assembly inserted in the outer pipe assembly, and a cutting assembly connected between the outer pipe assembly and the inner pipe assembly, wherein the cutting diameter of the cutting assembly can be adjusted when the outer pipe assembly and the inner pipe assembly slide relatively. The plaque with different thicknesses in the blood vessel is removed by adjusting the cutting diameter of the cutting assembly and the cutting range of the cutting assembly. Meanwhile, in the process of the plaque removal operation, the positions of the far end and the near end of the cutting assembly in the radial direction do not need to be adjusted repeatedly, the operation difficulty is reduced, and the risk that the blood vessel is easily damaged due to the fact that the positions of the far end and the near end of the cutting assembly in the radial direction are adjusted is reduced.

Embodiments of the present application also provide a medical system including a transporter and the medical device, the medical device being deliverable to a target location via the transporter.

Drawings

Fig. 1 is a schematic structural diagram of a medical device according to a first embodiment of the present application.

Fig. 2 is a schematic structural diagram of a medical device according to a second embodiment of the present application.

Fig. 3 is a schematic cross-sectional structure of fig. 2.

FIG. 4 is a schematic representation of a cross-section of a cutting element of a medical device provided in accordance with a second embodiment of the present application.

FIG. 5 is a schematic representation of a cross-section of another cutting element in a medical device provided in accordance with a second embodiment of the present application.

Fig. 6 is a schematic structural view of a rotating member in a medical device according to a second embodiment of the present application.

Fig. 7 is a partial schematic view of fig. 6.

Fig. 8 is an elevation view of a medical device provided in accordance with a second embodiment of the present application in a collapsed state.

Fig. 9 is a front view of a medical device provided in accordance with a second embodiment of the present application in a transitional state.

FIG. 10 is a front view of a medical device provided in accordance with a second embodiment of the present application in a deployed state.

FIG. 11 is a schematic illustration of a second embodiment of the application for plaque removal using a medical device.

FIG. 12 is a top view of a medical device according to a second embodiment of the present application.

FIG. 13 is a top view of a second embodiment of the present application for rotating an inner tube assembly in a medical device at a first speed.

FIG. 14 is a top view of a second embodiment of the present application for a medical device in which an inner tube assembly rotates at a second speed (the second speed being greater than the first speed).

FIG. 15 is an elevation view of a medical device according to a second embodiment of the present application in a straightened condition.

Fig. 16 is a schematic cross-sectional view of a medical device according to a third embodiment of the present application.

Fig. 17 is a schematic structural diagram of a medical device according to a fourth embodiment of the present application.

Fig. 18 is a front view of fig. 17.

Fig. 19 is an enlarged view of a fixing block of a medical device according to a fourth embodiment of the present disclosure.

Fig. 20 is an enlarged view of another fixing block of the present application.

Fig. 21 is a schematic structural diagram of a medical device according to a fifth embodiment of the present application.

Fig. 22 is a schematic structural diagram of a medical device according to a sixth embodiment of the present application.

Fig. 23 is a schematic cross-sectional structure of fig. 22.

Fig. 24 is a schematic structural view of a medical device according to a seventh embodiment of the present application.

Fig. 25 is a schematic cross-sectional structure of fig. 24.

Fig. 26 is a schematic structural diagram of a medical system according to an eighth embodiment of the present application.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

In the field of interventional medical devices, the "distal end" is defined as the end that is distal from the operator during the procedure, and the "proximal end" is defined as the end that is proximal to the operator during the procedure. "axial" refers to a direction parallel to the line joining the centers of the distal and proximal ends of the medical device, and "radial" refers to a direction perpendicular to the axial direction.

First embodiment

Referring to FIG. 1, a medical device 100 may remove plaque from a blood vessel. In the process of introducing the medical device 100 into the blood vessel, the medical device 100 is contained in the transporter, and the blood vessel is prevented from being damaged by the medical device 100. And the transporter may transport the medical device 100 to a target location. In the present embodiment, the medical device 100 includes an outer tube assembly 1, an inner tube assembly 2, and a cutting assembly 3. The cutting assembly 3 is connected between the outer tube assembly 1 and the inner tube assembly 2. When the outer tube assembly 1 and the inner tube assembly 2 slide relative to each other, the outer tube assembly 1 and/or the inner tube assembly 2 compress or stretch the cutting assembly 3, and the cutting diameter D of the cutting assembly 3 is changed. Wherein the cutting diameter D refers to the radial distance between the two end points of the cutting assembly 3 which are furthest in the radial direction. In the present embodiment, plaques with different thicknesses in the blood vessel are removed by adjusting the cutting diameter D of the cutting unit 3 and the cutting range of the cutting unit 3. Meanwhile, in the process of the plaque removal operation, the positions of the far end and the near end of the cutting assembly 3 in the radial direction do not need to be adjusted repeatedly, the operation difficulty is reduced, and the risk that the blood vessel is easily damaged due to the fact that the positions of the far end and the near end of the cutting assembly 3 in the radial direction are adjusted is reduced.

Second embodiment

Referring to fig. 2 and 3, the present embodiment is different from the first embodiment in that the outer tube assembly 10 includes an outer tube 11 and a sleeve member 12 connected to a distal end 11a of the outer tube. The portion of the outer tube 11 near the sleeve member 12 is the outer tube distal end 11 a. The hub 12 is connected to a cutting assembly 30. The inner tube assembly 20 is inserted through the outer tube 11 and a portion of the inner tube assembly 20 is inserted through the sleeve member 12. The cutting diameter D of the cutting assembly 30 may be adjusted as the inner tube assembly 20 and/or the sleeve member 12 is axially slid relative to the outer tube member 11. The outer tube assembly 10 has a proximal end 10a and a distal end 10 b. The side of the outer tubular member 11 remote from the outer sleeve member 12 is a proximal end 10a, and the side of the sleeve member 12 remote from the outer tubular member 11 is a distal end 10 b.

The sleeve member 12 is rotatably connected to the outer tubular member 11, and the sleeve member 12 is rotatable around the central axis of the outer tubular member 11. In this embodiment, the sleeve member 12 is partially fitted over the outer wall of the outer tube member 11. In a further embodiment the sleeve member 12 is partly inserted in the inner wall of the outer tube member 11. In the present embodiment, the boss member 12 is held stationary in the axial direction with respect to the outer pipe member 11. In another embodiment, the sleeve member 12 is axially slidable in the axial direction relative to the outer tubular member 11.

In this embodiment, the outer tube 11 is externally connected to a suction system (not shown) such that the outer tube assembly 10 has a suction force. The suction force is used to draw the plaque in a direction from the distal end 10b towards the proximal end 10 a.

In the present embodiment, the cutting assembly 30 is close to the distal end 10b of the outer tube assembly 10, and the plaque cut by the cutting assembly 30 is also close to the distal end 10b, and the plaque is sucked into the outer tube assembly 10 after being subjected to suction force, so as to improve the efficiency of the medical device 1000 in collecting plaque and prevent the plaque from easily separating from the medical device 1000 to block the blood vessel.

Cutting assembly 30 includes a plurality of cutting members 31 spaced circumferentially about inner tube assembly 20. The cutting member 31 is resiliently deformable to facilitate passage through a tortuous, tortuous blood vessel. The cutting member 31 is not limited to being a blade or a wire. The material of the cutter 31 is not limited to being composed of one or more of metal, alloy, and plastic. Part or each cutting member 31, the cutting members 31 being connected between the outer tube assembly 10 and the inner tube assembly 20. In particular, part or each cutting element 31 is connected between the hub 12 and the inner tube assembly 20. And a gap is arranged between two adjacent cutting pieces 31, so that the interference between two adjacent cutting pieces 31 is avoided. In the process of cutting the plaque, when the plaque in a part of the blood vessel is positioned in the gap between two adjacent cutting pieces 31, the plaque can be easily cut by rotating the cutting pieces 31; meanwhile, the plurality of cutting members 31 can block the cut plaque from flowing in the direction of blood flow during the rotation, and prevent the cut plaque from coming off the medical device 1000.

Each cutting member 31 has a first end portion 31a, a second end portion 31b opposite the first end portion 31a, and a body portion 31c connecting the first and

second end portions

31a and 31 b. The first end 31a is connected to the outer tube assembly 10. Specifically, the first end portion 31a is connected to the bushing member 12. The second end 31b is connected to the inner tube assembly 20. As the axial distance between the first end 31a and the second end 31b varies, the cutting diameter D of the cutting assembly 30 varies accordingly.

Medical device 1000 also includes retrieval assembly 40. The recovery assembly 40 is disposed on the inner tube assembly 20 or the outer tube assembly 10. Retrieval assembly 40 is used to collect target objects, including plaque, thrombus, and the like. Plaque generated after cutting by cutting assembly 30 is retrieved by retrieval assembly 40 and delivered outside the blood vessel to avoid plaque escaping medical device 1000 and clogging the blood vessel.

In this embodiment, the projection of the cutting assembly 30 in the radial direction falls to the recovery assembly 40. The cutting assembly 30 is connected between the inner tube assembly 20 and the outer tube assembly 10. After cutting assembly 30 cuts the plaque, the plaque is located in the radial range between cutting assembly 30 and retrieval assembly 40, which facilitates retrieval by retrieval assembly 40 and delivery by retrieval assembly 40 outside the blood vessel, avoiding plaque from escaping medical device 1000 and blocking the blood vessel. In the present embodiment, the recovery assembly 40 is disposed on the outer wall of the inner tube assembly 20. In another embodiment, retraction assembly 40 is disposed on outer tube assembly 10. When medical device 1000 is in a collapsed state, i.e., when cutting assembly 30 is housed within outer tube assembly 10, a radial projection of cutting assembly 30 drops onto retraction assembly 40.

The inner tubing assembly 20 is rotatable about the central axis of the medical device 1000. The recovery assembly 40 extends spirally on the outer wall of the inner tube assembly 20. In the present embodiment, the recovery assembly 40 is disposed on the outer wall of the inner tube assembly 20. In another embodiment, the outer wall of the inner tube assembly 20 is recessed to form the retrieval assembly 40. In yet another embodiment, the recovery assembly 40 is wound around the inner wall of the outer tube assembly 10 or is formed by recessing the inner wall of the outer tube assembly 10.

In the present embodiment, a portion of the recovery assembly 40 is located between the first end 31a and the second end 31 b. During the cutting process, the plaque partially removed by the cutting assembly 30 will flow in the direction of blood flow to the retraction assembly 40. Recovery subassembly 40 can produce the driving force along with the in-process that inner tube subassembly 20 rotated, can be with retrieving the plaque near subassembly 40 input outer pipe member 11 in, prevent that the plaque from breaking away from medical device 1000, avoid the plaque after the cutting to block up the blood vessel, improve the efficiency of collecting the plaque. In the present embodiment, the recovery member 40 is a coil having elasticity, and the coil is spirally wound around the outer wall of the inner tube member 20 and extends in the axial direction of the inner tube member 20. During one revolution of inner tube assembly 20, retraction assembly 40 rotates one revolution and simultaneously advances plaque one lead distance in the direction from distal end 10b to proximal end 11. The material of the coil is not limited to being composed of one or more of a metal, an alloy, or a nonmetal. In another embodiment, the retrieval assembly 40 is formed of a wire that is not resilient. The material of the wire is not limited to being composed of one or more of a metal, an alloy, or a nonmetal. In this embodiment, a portion of the retraction assembly 40 is located within the outer tube 11. In another embodiment, the retrieval assembly 40 located outside the outer tube 11 is only partially opposite the cutter 31.

In the present embodiment, the outer tube assembly 10 further includes a stopper 13. The limiting portion 13 is sleeved on the outer wall of the outer tube 11, and the limiting portion 13 is disposed on a side of the shaft sleeve 12 away from the distal end 10 b. The limiting portion 13 is annular, the wall thickness of the limiting portion 13 is larger than that of the shaft sleeve 12, and the limiting portion 13 blocks the shaft sleeve 12 from axially moving along the proximal end 10a of the outer pipe 11. The end surface of the stopper portion 13 facing the sleeve member 12 is covered with a lubricating material, which reduces the frictional force between the sleeve member 12 and the stopper portion 13. In another embodiment, the sleeve member 12 is partially inserted into the inner wall of the outer member 11, and the position-limiting portion 13 is fixed to the inner wall of the outer member 11. The limiting part 13 is arranged on the side of the shaft sleeve 12 away from the distal end 10b, and the wall thickness of the limiting part 13 is larger than that of the shaft sleeve 12.

In the present embodiment, the shape of the cross section of the cutter 31 is not limited to a shape of an arc, a circle, a polygon, or the like. Referring to fig. 4, each cutting member 31 has a triangular cross-section. Each cutting member 31 has a cross-section including a first side 30a, a second side 30b and a third side 30c connected to each other. The second side 30b and the third side 30c intersect to form a first cutting angle a. The first cutting angle a is directed towards the vessel to facilitate cutting of the plaque, and the first cutting angle a may also be used to open an occlusion.

Referring to fig. 5, each cutting member 31 has a cross section including a cutting body 34 and a protrusion 35 connected to the cutting body 34. The cutting body 34 is integrally formed with the protruding piece 35. The cutting body 34 and the protruding piece 35 are used to cut the plaque. The protruding piece 35 protrudes radially, outwardly with respect to the cutting body 34. The protrusion 35 serves to open the occlusion.

Referring to fig. 6 and 7, the inner tube assembly 20 includes an outer layer 21a and an inner layer 21 b. The outer layer 21a covers the outer wall of the inner layer 21 b. The end faces of the outer layer 21a and the inner layer 21b are flush (the end of the outer layer 21a is hidden from view to show the inner layer 21 b). When the inner tube assembly 20 is rotated, the outer layer 21a and the inner layer 21b are simultaneously rotated. Wherein the outer layer 21a and the inner layer 21b are each formed by one or more wound wires, such that the inner tube assembly 20 is relatively flexible, such that the overall flexibility of the medical device 1000 is relatively good, such that it may be conveniently passed through a tortuous vascular pathway to an occlusion site. The windings are not limited to steel wires. The winding direction of the wire windings in the outer layer 21a is opposite to the winding direction of the wire windings in the inner layer 21 b. In another embodiment, the winding direction of the wire windings in the outer layer 21a is the same as the winding direction of the wire windings in the inner layer 21 b. In yet another embodiment, the inner tube assembly 20 is wound in one layer from a plurality of wires wound in the same winding direction or in opposite winding directions. In yet another embodiment, the inner tube assembly 20 is formed by separately winding a plurality of windings, wherein each winding forms a layer and the winding direction is opposite between adjacent windings.

In the present embodiment, the second end 31b is connected to the inner tube assembly 20. Specifically, the second end 31b is connected to an outer wall of the outer layer 21a (not shown). In one embodiment, the second end 31b is connected to the end surfaces of the outer layer 21a and the inner layer 21 b; in another embodiment, the second end 31b is connected between the outer layer 21a and the inner layer 21 b. In yet another embodiment, the outer layer 21a is formed from a plurality of windings and the second end 31b is connected between windings in the outer layer 21 a.

A specific procedure for using the medical device 1000 is described below. Referring to fig. 8, the medical device 1000 is in a collapsed state. The cutting diameter D of the cutting assembly 30 is less than or equal to the diameter of the sleeve member 12. In this state, the medical device 1000 can be transported from within the transporter to the target area. The inner tube assembly 20 is located inside the outer tube 11. In this state, the cutting assembly 30 can cut off plaque protruding into the outer tube assembly 10. It is understood that the cutting diameter D of the cutting assembly 30 refers to the radial distance between the two extreme points of the cutting assembly 30 that are farthest in the radial direction. In another embodiment, retraction assembly 40 is disposed on outer tube assembly 10. When medical device 1000 is in a collapsed state, a radial projection of cutting assembly 30 drops onto retrieval assembly 40. Plaque excised by cutting assembly 30 is contained within outer tube assembly 10 and is retrieved by retrieval assembly 40 and delivered out of the blood vessel.

Referring to fig. 9, the medical device 1000 is in a transitional state. Wherein, the transition state can be converted from a furled state. Specifically, when cutting assembly 30 is in the collapsed state, and inner tube assembly 20 continues to slide axially, the direction of axial sliding is from proximal end 10a to distal end 10 b. The cutting assembly 30 is also axially slid in the same direction, and the cutting assembly 30 is not completely exposed outside the outer tube member 11 to assume a transitional state. During this period, the cutting assembly 30 is gradually exposed out of the outer tube member 11, the cutting assembly 30 is gradually expanded in a radial direction of the outer tube member 11, and the cutting diameter D of the overall cutting assembly 30 is gradually increased. In the transitional state, the cutting diameter D of the cutting assembly 30 is greater than or equal to the diameter of the outer pipe element 11. The cutting range of the cutting assembly 30 is larger than or equal to the axial extension range of the outer pipe element 11; and the cutting assembly 30 can be used to open an occlusion in a vessel without the need for an additional open drill bit on the inner tube assembly 20, making the medical device 1000 more compact.

Referring to fig. 10 and 11 together, the medical device 1000 is in a deployed state. Wherein the deployment state is convertible from the transition state. Specifically, when cutting assembly 30 is in the transition state, inner tube assembly 20 continues to slide axially in a direction from proximal end 10a to distal end 10 b. Part of the inner tube assembly 20 slides out of the outer tube 11 and the cutting assembly 30 is completely exposed out of the outer tube 11 to assume the deployed state. The cutting diameter D of the cutting assembly 30 is greater than the diameter of the outer tubular member 11. At this time, the cutting assembly 30 can stably cut the plaque of the blood vessel outside the axial extension of the outer tubular member 11. The cutting assembly 30 is housed in a blood vessel 2000, the inner wall of the blood vessel 2000 being covered with a plaque 3000. The inner tube assembly 20 rotates and causes the cutting member 31 to rotate. The cutting member 31 cuts into the plaque 2000 and cuts the plaque 2000 off.

As the axial distance between the first and

second ends

31a, 31b varies, the cutting diameter D of the cutting assembly 30 varies accordingly. In one aspect, medical device 1000 is in a deployed state, if inner tube assembly 20 continues to slide axially, the direction of axial sliding is from proximal end 10a to distal end 10 b. The inner tube assembly 20 causes the second end 31b to slide axially in the same direction. While the positions of the first end portion 31a and the sleeve member 12 relative to the outer tubular member 11 remain unchanged, the axial distance between the second end portion 31b and the first end portion 31a gradually decreases. The second end portion 31b and the first end portion 31a are pressed against the main body portion 31c, so that the main body portion 31c is bent and deformed and radially expanded, thereby increasing the cutting diameter of the cutting assembly 30. At this time, the cutting diameter of the cutting member 30 in the medical device 1000 is larger than the cutting diameter D in the deployed state.

On the other hand, if the inner tube assembly 20 is axially slid in a direction from the proximal end 10a to the distal end 10b, the inner tube assembly 20 carries the second end 31b to axially slide in the same direction. While the positions of the first end portion 31a and the sleeve member 12 relative to the outer tubular member 11 remain unchanged, the axial distance between the second end portion 31b and the first end portion 31a gradually increases. The pressing force of the second end portion 31b and the first end portion 31a to the main body portion 31c is gradually reduced, so that the main body portion 31c is reduced in bending deformation and radially contracted, thereby reducing the cutting diameter of the cutting assembly 30. At this time, the cutting diameter of the cutting unit 30 in the medical device 1000 is smaller than the cutting diameter D in the deployed state.

Referring to fig. 12-14, in fig. 12, the inner tube assembly 20 remains stationary. In fig. 13, the inner tube assembly 20 is rotated at a first speed. In fig. 14, the inner tube assembly 20 is rotated at a second speed, wherein the second speed is greater than the first speed. In this embodiment, the inner tube assembly 20 rotates the cutting member 31, and the cutting member 31 rotates the sleeve 12. The inner tube assembly 20 applies a rotational moment to the second end portion 31b of the cutting member 31, and the sleeve member 12 blocks the rotation of the first end portion 31a of the cutting member 31, so that the second end portion 31b, the body portion 31c and the first end portion 31a are deformed, the cutting member 31 is outwardly inclined as a whole, the cutting diameter of the cutting assembly 30 is increased, and the gap between the adjacent body portions 31c is increased. And the faster the inner tube assembly 20 rotates, the greater the degree of deformation and inclination of the body portion 31 c.

Referring to fig. 15, the medical device 1000 is in a straightened state. Wherein the straightened state can be converted from the unfolded state. Specifically, when cutting assembly 30 is in the deployed state, inner tube assembly 20 continues to slide axially, in a direction from proximal end 10a to distal end 10 b. The cutting assembly 30 is contracted toward the radial direction of the outer pipe member 11 by the pulling force of the inner pipe assembly 20. When inner tube assembly 20 cannot continue to slide axially in a direction proximal to distal end 10b, cutting assembly 30 is straightened to assume a straightened condition. At this time, the cutting assembly 30 is in a circular truncated cone shape, and the end of the cutting assembly 30 where the smaller bottom surface is located is farther away from the proximal end 10a than the end where the larger bottom surface is located, so as to facilitate the opening of the occlusion, and the cutting diameter of the cutting assembly 30 is smaller, so that damage to the blood vessel can be avoided in the process of opening the occlusion, and the safety of opening the occlusion using the medical device 1000 can be improved.

In the present embodiment, during the process of switching the cutting assembly 30 from the folded state to the unfolded state, the cutting assembly 30 is gradually expanded, and the cutting diameter D of the cutting assembly 30 is gradually increased. The cutting range of the cutting assembly 30 can be adjusted by adjusting the cutting diameter D of the cutting assembly 30, so as to cut plaques with different thicknesses in the blood vessel. Meanwhile, the position of the cutting assembly 30 does not need to be adjusted repeatedly, the operation difficulty is reduced, and the risk that the blood vessel is easily damaged due to the adjustment of the position of the cutting assembly 30 is reduced. And the axial sliding of the inner tube assembly 20 can control the cutting assembly 30 to switch from the furled state to the transitional state and then switch from the transitional state to the unfolded state, the straightened state and the furled state, so that the cutting assembly 30 has various forms and different cutting diameters D, the medical device 1000 can adapt to different vascular scenes, and the application range of the medical device 1000 is improved. Meanwhile, the cutting assembly 30 can open the occlusion of the blood vessel, and the situation that the cutting assembly 30 cannot contact with the plaque and the plaque cannot be cut due to the obstruction of the occlusion of the blood vessel is avoided.

Third embodiment

Referring to fig. 16, the present embodiment is different from the above embodiments in that the sleeve member 112 can slide along the outer tube 111 relative to the inner tube assembly 200. In one aspect, the sleeve member 112 slides axially relative to the outer member 111 in a direction from the proximal end 100a to the distal end 100 b. The shaft sleeve 112 drives the first end 310a to axially slide in the same direction relative to the outer pipe 111. While the positions of the inner tube assembly 200 and the second end 310b relative to the outer tube 111 remain unchanged, the distance between the first end 310a and the second end 310b gradually decreases. The second end portion 310b and the first end portion 310a are pressed against the body portion 310c, so that the body portion 310c is bent and deformed and radially expanded, thereby increasing the cutting diameter of the cutting assembly 300.

On the other hand, when the sleeve member 112 is axially slid relative to the outer member 111, the axial sliding direction is from the distal end 100b to the proximal end 100 a. The sleeve member 112 carries the first end portion 310a to axially slide in the same direction. The distance between the first end 310a and the second end 310b gradually increases. The second end portion 310b and the first end portion 310a are gradually pressed toward the main body portion 310c with a smaller force, so that the main body portion 310c is bent and deformed to a reduced degree and radially contracted, thereby reducing the cutting diameter of the cutting assembly 300. Specifically, the medical device 3000 further includes a drive tube 15 and a stop 130. The driving pipe 15 is sleeved on the outer wall of the outer pipe member 111. The distal ends 100b of the outer tube member 111, the cutting assembly 300, the sleeve member 112, and the inner tube member 200 are exposed at the distal end of the driving tube 15. The transmission tube 15 is connected with the limiting portion 130, and the limiting portion 130 abuts against the far end of the transmission tube 15. The driving tube 15 axially slides relative to the outer tube 111 under the action of external force, and drives the limiting portion 130 and the shaft sleeve 112 to axially slide relative to the outer tube 111.

In another embodiment, sleeve member 112 is axially slidable relative to outer member 111 simultaneously with inner tube assembly 200. When the external force causes the sleeve member 112 to slide axially, the axial sliding direction is from the proximal end 100a to the distal end 100 b. The axle sleeve 112 brings the first end portion 310a close to the second end portion 310 b; the external force causes the inner tube assembly 200 to axially slide in a direction from the distal end 100b to the proximal end 100a, the inner tube assembly 200 drives the second end portion 310b to approach the first end portion 310a, so that the distance between the first end portion 310a and the second end portion 310b is reduced, the second end portion 310b and the first end portion 310a are pressed against the main body portion 310c, so that the main body portion 310c is bent, deformed and radially expanded, and the cutting diameter of the cutting assembly 300 is increased.

Fourth embodiment

Referring to fig. 17 and 18, the present embodiment is different from the above embodiments in that the inner tube assembly 520 further includes a rotating member 521 and a fixing member 522 sleeved on the rotating member 521. The fixed member 522 is connected to the rotating member 521. The fixing member 522 and the rotating member 521 are not limited to be welded, and may be screwed. The fixing member 522 is used to fix the cutting assembly 530 to the rotating member 521. Specifically, the second end 531b of the cutting element 531 is fixedly connected to the outer wall of the fixed element 522, so that the second end 531b and the cutting element 530 are fixed to the rotating element; and at the same time, the strength of the second end 531b is improved, and the second end 531b is prevented from being easily damaged in the process of cutting the plaque.

In the embodiment, the fixing element 522 is a ring structure, and the fixing element 522 is sleeved on the outer wall of the rotating element 521. The fixed member 522 has a diameter larger than that of the rotating member 521. The second end 531b is fixed to the outer wall of the fixed member 522, and is connected to the rotating member 521 through the fixed member 522, so that the cutting diameter of the cutting assembly 530 is greater than the diameter of the rotating member 521, thereby increasing the cutting range of the cutting assembly 530. In another embodiment, the second end 531b is fixed between the fixed member 522 and the rotating member 521.

In this embodiment, the cross-sectional area of cutting member 531 near distal end 510b of outer tube 511 is greater than the cross-sectional area of cutting member 531 distal end 510 b. In yet another embodiment, the cross-sectional area of cutting element 531 decreases in a direction from proximal end 510a to distal end 510 b.

Referring to fig. 19, the fixing member 522 includes a plurality of receiving portions 522a disposed at intervals. The partial cutting assembly 530 is received in the receiving portion and connected to the receiving portion 522 a. The receiving portion 522a receives the cutting member 531 of the partial cut assembly 530 and is coupled to the second end portion 531 b. The number of the receiving portions 522a is the same as the number of the cutting members 531, and the second end 531b of each cutting member 531 corresponds to one receiving portion 522 a. The second end portion 531b is accommodated in the accommodating portion 522a and fixed in the accommodating portion 522 a. In the present embodiment, the accommodating portion 522a is a groove, the second end 531b is first fastened to the accommodating portion 522a, and then the second end 531b is welded to the inner wall of the accommodating portion 522 a. By fixing the second end 531b in the accommodating portion 522a of the fixing member 522, the connection strength between the second end 531b and the fixing member 522 is improved, and the second end 531b is prevented from being disconnected from the fixing member 522 during the cutting process. In another embodiment, the receiving portion 522a is a through hole penetrating the fixing member 522. The second end 531b penetrates the housing 522a and is fixed to the outer wall of the rotor 521, and the portion of the second end 531b housed in the housing 522a is fixedly connected to the inner wall of the housing 522 a.

Referring to fig. 20, the opening direction of the receiving portion 522a is inclined, so that the second end portion 531b abuts against the inner wall of the receiving portion 522a, and then the second end portion 531b is also inclined outwards along the opening direction of the receiving portion 522a, so that the cutting element 530 is integrally inclined, and the cutting diameter of the cutting element 530 is increased. At the same time, the cutting assemblies 530 are inclined outward, increasing the gap between two adjacent cutting assemblies 530, so that plaque is more easily introduced into the gap, so that the cutting assemblies 530 cut the plaque.

Fifth embodiment

Referring to fig. 21, the present embodiment is different from the above embodiments in that the medical device 6000 further includes a stabilizing member 6100. Stabilizing member 6100 is connected to the outer wall of shaft sleeve 612. The securing member 6100 is secured to the shaft sleeve 612 by welding, but may be threaded. Stabilizing member 6100 secures first end 631a to hub 612 to stabilize first end 631a to hub 612, thereby increasing the strength of the connection between first end 631a and hub 612 and preventing the disconnection of first end 631a from hub 612.

The medical device 6000 further includes a plurality of fasteners 6101. The fastening member 6101 penetrates the steady member 6100, the first end portion 631a and the sleeve member 612, and the first end portion 631a and the main body portion 531c are rotatable around the center line of the fastening member 6101. When the cutting assembly 530 cuts the plaque, the first end portion 631a and the main body portion 531c can rotate relative to the fastener 6101 to buffer the impact force of the plaque on the first end portion 631a and the main body portion 631c, so as to prevent the cutting assembly 630 from being easily damaged.

Sixth embodiment

Referring to fig. 22 and 23, the present embodiment differs from the previous embodiments in that the recycling assembly 760 includes a first recycling member 761 and a second recycling member 762 spaced apart along the axial direction of the inner tube assembly 720. The first recovery member 761 is opposite the cutting assembly 730. The cutting assembly 730 falls onto the first recovery component 761 in a radial projection. The cutting assembly 730 surrounds the first recovery member 761. Second retriever 762 is outside the radial projection of cutting assembly 730. In another embodiment, the first and

second retrievers

761, 762 are spaced apart axially along the outer tube assembly 710.

During the cutting process, the first and

second recovery members

761, 762 generate pushing force during the rotation of the rotating member 722, the second recovery member 762 can push the plaque or thrombus in the blood vessel to the cutting assembly 730, the cutting assembly 730 can cut the received plaque or thrombus, and the first recovery member 761 can push the cut plaque or thrombus to be accommodated in the outer tube 710, so that the medical device 7000 can collect the plaque or thrombus outside the cutting assembly 730, and the plaque collecting range of the medical device 7000 can be increased.

Reclamation assembly 760 also includes a third reclamation member 763, third reclamation member 763 being disposed within outer tube assembly 700. The third recovery member 763 receives the plaque delivered by the first recovery member 761 and moves the plaque out of the blood vessel.

It is understood that, in the present embodiment, the first recovery member 761 and the second recovery member 762 are spirally wound on the outer wall of the rotating member 722, and the pitch of the first recovery member 761 is the same as that of the second recovery member 762. In another embodiment, the pitch of the second retriever 762 is less than the pitch of the first retriever 761, increasing the contact area of the second retriever 762 with plaque debris or thrombus, increasing the effectiveness of the second retriever 762 in collecting plaque debris or thrombus.

Seventh embodiment

Referring to fig. 24 and 25, the present embodiment is different from the above embodiments in that the medical device 8000 further includes an opening member 850. The access assembly 850 is connected to the distal end 821a of the inner tube assembly 820. The opening member 850 includes a connecting member 851 and an opening member 852 connected to a bottom wall 851a of the connecting member 851. The distal end 821a of the inner tube assembly 820 extends into the attachment member 851 and is coupled to the bottom wall 851a of the attachment member 851. The connecting member 851 is integrally formed with the opening member 852. Specifically, the connecting member 851 is connected to the second end portion 831 b. The opening member 852 is connected to the distal end 821a of the rotating member 821. Further, the connector 851 is provided with a receiving portion 853, and the bottom wall of the receiving portion 853 is the bottom wall 851a of the connector 851 and also the proximal end surface of the opening 852. The receiving portion 853 is used for receiving a material to be cut, which includes a plaque.

The distal end 821a of the inner tube assembly 820 extends into the receiving portion 853, and the distal end 821a of the inner tube assembly 820 is connected to the bottom wall 851a of the receiving portion 853. It will be appreciated that the distal end of the rotating member 821 is the distal end 821a of the inner tube assembly 820. The rotating member 821 is inserted into the receiving portion 853, and the distal end of the rotating member 821 is connected to the bottom wall 851a of the receiving portion 853, so that the opening member 852 and the connecting member 851 rotate as the rotating member 821 rotates. Upon rotation of the opening member 852, an occlusion in the vessel may be opened. When the access assembly 850 has accessed an occlusion, and a portion of thrombus or plaque may still be present in the vessel, the cutting assembly 830 may cut the plaque or thrombus that the access assembly 850 cannot cut by axially sliding the rotating member 821 to adjust the cutting assembly 830 to the deployed state. In this embodiment, the cut diameter of opening assembly 850 is less than or equal to the diameter of outer tube 810. In another embodiment, the cut diameter of opening assembly 850 is greater than or equal to the diameter of outer tubular member 810.

In this embodiment, the recycling assembly 860 includes a first recycling component 861 and a second recycling component 862 spaced apart from the first recycling component distal end 861 a. The first retriever 861 is opposite to the cutting assembly 830. The cutting assembly 830 falls onto the first retriever 861 in a radial projection. The cutting assembly 730 surrounds the first retriever 861. The second receiver 862 is located in the receiving portion 853 of the connector 851. And the second reclaimer 862 is reclaimed in the opposite direction to the first reclaimer 861. The direction of retrieval of the second retriever 862 refers to the direction in which the second retriever 862 delivers plaque or thrombus; the direction of recovery from the first recovery member 861 means a direction in which the first recovery member 861 delivers plaque or thrombus. In this embodiment, the second retriever 862 is opposite to the first retriever 861 in the direction of the screw of the rotating member 821. The first retriever 861 spirals left in the direction of the helix of the rotating member 821, and the first retriever 861 generates a pushing force to deliver plaque or thrombus during rotation in a direction from the distal end 810b to the proximal end 810 a. The second extractor 862 is right-handed in the direction of the thread of the rotating part 821. The second retriever 862 generates an urging force during rotation to deliver plaque or thrombus in a direction from the proximal end 810a toward the distal end 810 b. The pushing force formed by the rotation of the second retriever 862 inputs plaque or thrombus near the second retriever 862 into the housing 853, so that the plaque is prevented from being separated from the medical device 8000, the blockage of the cut blood vessel by the plaque is avoided, and the plaque collection efficiency is improved. The first retriever 861 pushes plaque debris or thrombus cut by the cutting assembly 830 toward the inside of the outer tube 810. In another embodiment, the outer wall of connector 851 has a wire wrap secured thereto such that the wire wrap on the outer wall of connector 851 can cut plaque when opening assembly 850 is rotated.

In this embodiment, a third retriever 863 is located within outer tube 810. The third recovery member 863 is connected to the first recovery member 861, and a spiral direction of the third recovery member 863 is the same as that of the first recovery member 861. The thrust generated by the first and

third recollectors

861, 863 during the rotational overshoot is directed to deliver plaque near the first recollector 861 into the inner tube assembly 820 from the distal end 810b toward the proximal end 810 a.

Eighth embodiment

Referring to fig. 26, the present embodiment further provides a medical system 10, where the medical system 10 includes a transporter 10a and a medical device 10b provided in any of the above embodiments (where the reference numerals of the medical device 10b in any of the above embodiments are 100, 1000, 3000, 5000, 7000, 8000 respectively), and the medical device can be transported to a target location through the transporter 10 a.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express a few embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A medical device, comprising an outer tube assembly, an inner tube assembly inserted into the outer tube assembly, and a cutting assembly connected between the outer tube assembly and the inner tube assembly, wherein the cutting diameter of the cutting assembly is adjustable when the outer tube assembly and the inner tube assembly slide relative to each other.

2. The medical device of claim 1, wherein the outer tube assembly includes an outer tube and a hub coupled to a distal end of the outer tube, wherein the hub is coupled to the cutting assembly, wherein the inner tube assembly is inserted through the outer tube, and wherein a cutting diameter of the cutting assembly is adjustable as the inner tube assembly and/or the hub slides axially relative to the outer tube.

3. The medical device of claim 1, wherein the cutting assembly includes a plurality of cutting members circumferentially spaced about the inner tube assembly, the cutting members being coupled between the outer tube assembly and the inner tube assembly.

4. The medical device of claim 3, wherein each of said cutting members has a first end connected to said outer tube assembly and a second end opposite said first end connected to said inner tube assembly, wherein as the axial distance between said first and second ends varies, the cutting diameter of said cutting assembly varies accordingly.

5. The medical device of claim 1, further comprising an access assembly coupled to the distal end of the inner tubing assembly.

6. The medical device of claim 5, wherein the access assembly includes a connector and an access member coupled to a distal end of the connector, the connector coupled to a distal end of the inner tubing assembly.

7. The medical device of claim 6, wherein the connector has a receiving portion into which the inner tube assembly extends and a distal end of the inner tube assembly is connected to a bottom wall of the receiving portion.

8. The medical device of claim 1, wherein the inner tubing assembly includes a rotatable member and a fixed member that fits over the rotatable member, the fixed member securing the cutting assembly to the rotatable member.

9. The medical device of claim 8, wherein the fastener includes a receiving portion, and wherein a portion of the cutting assembly is received in and coupled to the receiving portion.

10. A medical system comprising a delivery device and a medical device as claimed in any one of claims 1 to 9, the medical device being deliverable to a target site via the delivery device.