CN118121267A

CN118121267A - Thrombolysis sheath tube assembly

Info

Publication number: CN118121267A
Application number: CN202211499950.4A
Authority: CN
Inventors: 刘全祖; 张�雄
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2022-11-28
Filing date: 2022-11-28
Publication date: 2024-06-04
Also published as: WO2024114405A1

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a thrombus taking sheath tube assembly, which comprises a sheath core and a sheath tube, wherein the sheath core is arranged in the sheath tube in a penetrating manner, a collecting net is arranged at the distal end of the sheath tube, and a hiding net section for accommodating the collecting net is arranged at the distal end of the sheath core. According to the thrombus taking sheath tube assembly, peripheral blood vessels are sealed through the collecting net, so that the thrombus is prevented from being washed by blood flow and falling off when the thrombus is extracted, the risk that the thrombus stays outside the sheath tube can be effectively solved, the success rate of operation is improved, and other unnecessary complications are avoided. Meanwhile, the front end of the sheath core is provided with the hiding net section, and the hiding net section is used for accommodating the collecting net in the process of placing the sheath tube into the blood vessel, so that an additional conveying sheath is not required to be placed in the process of placing the sheath tube into the blood vessel, the whole process of thrombus suction can be completed only through the sheath tube and the sheath core, and the operation process is optimized.

Description

Thrombolysis sheath tube assembly

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a thrombus taking sheath tube assembly.

Background

Thrombus is a small mass of blood that forms on the surface of the heart blood system where the intima peels off or repairs, including insoluble fibrin, deposited platelets, accumulated leukocytes, and trapped erythrocytes. When a thrombus is located in the neurovascular system, a stroke may be initiated; pulmonary embolism may be initiated when thrombus is located in the pulmonary vasculature; when an obstruction such as atherosclerosis and its plaque is restricting blood flow, it may also become dangerous, causing abnormal blood flow, causing various vascular diseases.

At present, methods for treating thrombus mainly comprise a medicine antithrombotic treatment method and an artificial mechanical method for physically recovering vascular patency. The mechanical thrombus eliminating device is one set of apparatus for eliminating the obstruction in blood vessel, and adopts dissolving, crushing, sucking, rack or basket to eliminate thrombus, plaque and other obstruction in blood vessel to restore blood circulation function.

For the mode of taking thrombus from the stent, the thrombus is taken by matching the sheath tube with the stent, and when the stent pulls the thrombus into the sheath tube, the thrombus is easy to fall off due to the small inlet of the sheath tube, blood flow scouring and other reasons. Aiming at the problems, the prior art improves the sheath, and the balloon is added at the head end of the sheath to seal, so that the thrombus is prevented from falling off due to scouring of blood flow. There is still a risk of thrombus lodging outside the sheath due to the smaller sheath inlet.

Therefore, a new technical solution is needed to solve the above problems.

Disclosure of Invention

The invention aims to at least solve the problems that the existing thrombus-taking sheath tube is low in suction rate and a suction cavity is easy to block.

The invention provides a thrombus taking sheath tube assembly, which comprises a sheath tube and a sheath core, wherein the sheath tube is penetrated in the sheath tube, a collecting net is arranged at the far end of the sheath tube, and a hiding net section for accommodating the collecting net is arranged at the far end of the sheath tube.

According to the thrombus taking sheath tube assembly, peripheral blood vessels are sealed through the collecting net, so that the thrombus is prevented from being washed by blood flow and falling off when the thrombus is extracted, the risk that the thrombus is remained outside the sheath tube can be effectively solved, the success rate of operation is improved, and other unnecessary complications are avoided. Meanwhile, the front end of the sheath core is provided with the hiding net section, and the hiding net section is used for accommodating the collecting net in the process of placing the sheath tube into the blood vessel, so that an additional conveying sheath is not required to be placed in the process of placing the sheath tube into the blood vessel, the whole process of thrombus suction can be completed only through the sheath tube and the sheath core, and the operation process is optimized. In addition, as the collection net is arranged at the distal end of the sheath tube and the collection net is accommodated by the hidden net section, the design of the outer sheath can be canceled, thereby reducing the number and the volume of tubular parts penetrating into the blood vessel, ensuring the suction area of the suction cavity of the sheath tube and effectively improving the suction efficiency.

In addition, the thrombolytic sheath tube assembly according to the present invention may have the following additional technical features:

In some embodiments of the invention, the mesh-hiding section includes a mesh-hiding cover connected to the sheath core, and a mesh-hiding cavity for accommodating the collecting mesh is formed between the mesh-hiding cover and the sheath core.

In some embodiments of the invention, a guide head is disposed at a distal end of the sheath core, and the mesh enclosure is connected to a proximal end of the guide head.

In some embodiments of the present invention, the hidden screen is cylindrical, the hidden screen is coaxially disposed with the sheath core, a distal end of the hidden screen is fixedly connected to the guide head, and a proximal end of the hidden screen is open.

In some embodiments of the invention, wherein the proximal end of the collection mesh is connected to the sheath, the proximal end of the collection mesh is closed and the distal end is open, the collection mesh comprises a mesh body having shape memory properties.

In some embodiments of the invention, a cover is provided on the mesh body, the cover being integrally connected to the mesh body and closing the mesh openings of the mesh body.

In some embodiments of the invention, wherein the mesh body is a metal mesh woven by braiding wires having a shape memory function, the cover completely covers the mesh body or the cover partially covers the mesh body.

In some embodiments of the invention, wherein the proximal end of the sheath is provided with an end piece, the end piece is provided with a suction opening, and the end of the suction opening is provided with a first connection part for connecting an external negative pressure component.

In some embodiments of the invention, wherein the proximal end of the end piece is provided with an instrument inlet, the suction opening is provided on one side of the end piece.

In some embodiments of the present invention, a fixing member is disposed on the sheath core, the fixing member is fixedly connected with the sheath core and detachably connected with the first connecting portion, and a positioning member for limiting and fixing the fixing member is disposed on the sheath tube.

In some embodiments of the invention, an outer sheath is sleeved outside the sheath, an outer sheath hemostatic valve is disposed between the outer sheath and the sheath, the outer sheath hemostatic valve is disposed at a proximal end of the outer sheath, and a visualization structure is disposed on the sheath, the visualization structure being located at a proximal end of the collection mesh.

In some embodiments of the invention, the development structure comprises a first development site fixedly disposed proximal to the collection mesh and/or a development ring disposed on the sheath and positioned proximal to the collection mesh, and a second development site disposed distal to the collection mesh.

Drawings

FIG. 1 is a schematic view showing the overall structure of a thrombolysis sheath assembly according to an embodiment of the present invention;

FIG. 2 is a schematic view of a sheath according to an embodiment of the present invention;

FIG. 3 is a schematic view of a sheath core according to an embodiment of the present invention;

FIG. 4 is a cross-sectional view taken along line A-A of FIG. 1 in accordance with a first embodiment of the present invention;

FIG. 5 is a cross-sectional view of the portion B-B of FIG. 3 in accordance with one embodiment of the present invention;

FIG. 6 is a schematic diagram of a first embodiment of the invention after the collection mesh is released from the storage segment;

FIG. 7 is a schematic view showing the overall structure of a thrombus removal sheath tube assembly according to the second embodiment of the present invention;

FIG. 8 is a schematic view showing a part of the structure of the collecting net released from the outer sheath according to the second embodiment of the present invention;

FIG. 9 is a schematic view of a sheath-core structure including a hidden network segment according to a second embodiment of the present invention;

FIG. 10 is a schematic view of a sheath tube according to a second embodiment of the present invention;

FIG. 11 is a schematic view of the structure of an outer sheath in a second embodiment of the present invention;

FIG. 12 is a schematic view of a sheath-core structure without a hidden network segment according to a second embodiment of the present invention;

FIG. 13 is a schematic view showing the assembly structure of a sheath and a sheath hemostatic valve according to a third embodiment of the present invention;

FIG. 14 is a schematic view showing a development structure of a collecting net in a third embodiment of the present invention;

FIG. 15 is a schematic view showing the overall structure of a thrombus removal sheath tube assembly according to the third embodiment of the present invention;

FIG. 16 is a schematic view showing the overall structure of a collection net released from a storage section according to the third embodiment of the present invention;

FIG. 17 is a schematic view showing the overall structure of a sheath tube assembly according to a fourth embodiment of the present invention;

FIG. 18 is a cross-sectional view taken at C-C in FIG. 17 in a fourth embodiment of the present invention;

FIG. 19 is a schematic diagram of a fourth embodiment of the present invention after filling the hidden network segment;

FIG. 20 is a schematic diagram of a structure of a hidden network segment with a bell mouth shape according to a fourth embodiment of the present invention;

fig. 21 is a schematic structural view of a mesh body with a cover member according to a fourth embodiment of the present invention.

FIG. 22 is a schematic view showing the overall structure of a thrombus removal sheath tube assembly according to the fifth embodiment of the present invention;

FIG. 23 is a schematic view showing the structure of a sheath tube in a fifth embodiment of the present invention;

FIG. 24 is a schematic view showing the internal structure of a sheath tube according to a fifth embodiment of the present invention;

FIG. 25 is a schematic view showing the structure of an inner tube and a knob according to another embodiment of the present invention;

fig. 26 is a schematic structural diagram of an outer tube fixedly connected to a slide button according to another embodiment of the fifth embodiment of the present invention;

Fig. 27 is a schematic view of a structure of a sheath according to another embodiment of the fifth embodiment of the present invention;

FIG. 28 is a schematic view showing the overall structure of a thrombus removal sheath tube assembly according to a sixth embodiment of the present invention;

FIG. 29 is a schematic view showing the internal structure of a sheath tube according to a sixth embodiment of the present invention;

FIG. 30 is a schematic view showing the structure of a sheath tube with three sets of control wires inserted therein according to the sixth embodiment of the present invention;

FIG. 31 is a schematic view showing the structure of a sheath tube with four sets of control wires inserted therein according to a sixth embodiment of the present invention;

FIG. 32 is a schematic diagram showing a structure of a control wire and a slide button according to another embodiment of the sixth embodiment of the present invention;

Fig. 33 is a schematic view of a collection net in a collection net section according to a sixth embodiment of the present invention.

The reference numerals in the drawings are as follows:

10. a thrombolysis sheath assembly; 100. a sheath core; 110. a guide head; 120. hiding the network segment; 121. hiding the net cover; 122. hiding the net cavity; 123. a proximal reservoir segment; 124. a remote network hiding section; 130. an annular groove body; 140. a guidewire lumen; 150. an operation handle; 160. a fixing member; 161. a first threaded portion; 200. a sheath; 210. a collection net; 211. a net body; 212. a cover; 213. weaving filaments; 214. closing up the end; 215. an open end; 220. an end piece; 221. an instrument inlet; 222. a suction port; 223. a first connection portion; 224. a control lever; 225. a control member; 2251. a knob; 2252. a slide button; 2253. a control block; 226. a catheter holder; 227. a guide part; 2271. a guide block; 2272. a guide groove; 228. controlling the wire; 229. a control chamber; 230. an inner sheath hemostasis valve; 240. a positioning piece; 260. a locking member; 270. a suction chamber; 280. an inner tube; 281. a connecting pipe; 290. an outer tube; 291. a threaded connection; 300. an outer sheath; 310. an outer sheath hemostatic valve; 311. a second threaded portion; 320. developing structure; 321. a first developing point; 322. a developing ring; 323. a second developing point; 330. a jack; 340. a second connecting portion; 350. an extension tube; 351. and a locking connection.

Detailed Description

Exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present application are shown in the drawings, it should be understood that the present application 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 application 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.

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.

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 ease of description, the following description uses the terms "proximal" and "distal", wherein "proximal" refers to the end proximal to the operator and "distal" refers to the end distal to the operator, the phrase "axial direction" should be understood herein to mean the direction in which the interventional element is advanced and pushed out, and the direction perpendicular to the "axial direction" is defined as the "radial direction".

Example 1

An embodiment of the present invention proposes a thrombectomy sheath assembly 10, wherein the structure of the thrombectomy sheath assembly 10 is shown in fig. 1 to 6, please refer to fig. 1 to 3, and the thrombectomy sheath assembly comprises a sheath core 100 and a sheath tube 200, wherein the sheath core 100 is disposed inside the sheath tube 200 in a penetrating manner, a collecting net 210 is disposed at a distal end portion of the sheath tube 200, and the collecting net 210 is used for intercepting thrombus, so as to prevent broken thrombus which is not successfully sucked from entering a downstream branch vessel during a thrombus sucking process, thereby causing secondary embolism. The distal end of the sheath core 100 is provided with a collection mesh segment 120 for receiving the collection mesh 210, the collection mesh 210 is received in the collection mesh segment 120 during placement of the sheath into the blood vessel, and the collection mesh 210 is released from the collection mesh segment 120 after the sheath core 100 has been moved to the target site.

As shown in fig. 4 and 5, the mesh-hiding section 120 includes a mesh-hiding cover 121 connected to the sheath core 100, the mesh-hiding cover 121 is sleeved outside the sheath core 100, and a mesh-hiding cavity 122 for accommodating the collecting mesh 210 is formed between the mesh-hiding cover 121 and the sheath core 100. The front end of the sheath core 100 is provided with a guide head 110, and a mesh cover 121 is connected to the proximal end of the guide head 110. The distal end of the guide head 110 is tapered, and its guiding action during penetration of the sheath core 100 into a blood vessel improves the passability of the sheath core 100.

Specifically, the mesh enclosure 121 is cylindrical, and the mesh enclosure 121 is disposed coaxially with the sheath core 100, and the distal end of the mesh enclosure 121 is fixedly connected to the guide head 110, and the proximal end of the mesh enclosure 121 is open. The mesh cover 121 is integrally formed with the guide head 110 or is fixed after being separately formed.

In other embodiments, the aperture of the proximal opening of the mesh enclosure 121 is larger than the aperture of the distal opening of the mesh enclosure 121, i.e. the mesh enclosure 122 is configured in a conical flare opening shape. With the above arrangement, collection mesh 210 is more easily released from mesh chamber 122, facilitating the surgical procedure.

A guidewire lumen 140 is provided within the sheath core 100, axially through the sheath core 100, the guidewire lumen 140 being for guidewire penetration (guidewire not shown in the figures), the guidewire lumen 140 being coaxially disposed with the sheath core 100. The guidewire is used to establish an access path for the sheath core 100 prior to the sheath core 100 entering the body lumen. The sheath core 100 is advanced over the guidewire into a body lumen, such as a blood vessel, and the collection mesh 210 is advanced to a location within the body lumen having thrombus, plaque, or other pre-established target location.

As shown in fig. 2, the collecting net 210 includes a net body 211 and a cover 212 provided on the net body 211, and the cover 212 is used to close the mesh of the net body 211, and serves to seal blood flow to block thrombus. Specifically, the covering member 212 is a film-coated structure coated or sewn on the net body 211, and the covering member 212 may be made of silica gel, polyethylene (PE), polyurethane, nylon, or other materials.

Wherein, the cover 212 may be a film-coated structure entirely covering the net body 211, or the cover 212 may be a film-coated structure partially covering the net body 211. When the cover 212 is a film-coated structure that completely covers the net body 211, the collection net 210 can better block blood to prevent crushed plugs that have not been successfully sucked from being flushed with blood to downstream branch vessels, thereby causing downstream branch vessel embolism. When the cover 212 is a film-coated structure partially covering the net body 211, the net body 211 portion where no film coating is provided allows blood to circulate, so as to prevent adverse effects caused by long-time non-flowing of blood during the operation.

The mesh body 211 includes a metal mesh having a shape memory function, which is woven and formed by the weaving filaments 213. Specifically, the braided wire 213 is a memory metal wire, such as nickel titanium wire, and the braided wire 213 is shaped by heat treatment after being braided and molded. The proximal end of the collection mesh 210 is connected to the sheath core 100, and the proximal end of the collection mesh 210 is closed and the distal end is open, forming a flare structure.

As shown in fig. 6, when the collection mesh 210 reaches a predetermined position, the sheath 200 is retracted or the sheath core 100 is pushed forward, so that the collection mesh 210 is released from the hidden mesh segment 120, and the collection mesh 210 automatically pops open under the elastic restoring force of the mesh body 211 itself to seal the surrounding blood vessel, thereby preventing the thrombus from being washed by blood flow and falling off when the thrombus is removed. The risk that thrombus stays outside the sheath 200 can be effectively solved, the success rate of the operation is improved, and other unnecessary complications are avoided.

The proximal end of the sheath 200 is provided with an end piece 220, the distal end of the end piece 220 is connected to the sheath 200, the proximal end of the end piece 220 is provided with an instrument inlet 221, and the sheath core 100 is inserted into the sheath 200 from the instrument inlet 221 of the sheath 200 when assembled. One side of the end piece 220 is provided with a suction port 222, and the suction port 222 is used to connect an external negative pressure member, such as a negative pressure pump or a syringe, by which thrombus is drawn out of the body from the inside of the blood vessel through the lumen of the sheath 200. The suction port 222 may also be used as a flushing port, the suction port 222 is provided with a first connection portion 223, the first connection portion 223 is used for being fixedly connected with the negative pressure component, and in the present embodiment, the first connection portion 223 is provided at the end of the suction port 222.

Wherein the hollow interior cavity of the sheath 200 serves as a sheath core penetration lumen, an irrigation lumen, and a suction lumen simultaneously.

The scheme can be used for taking the thrombus in a thrombus sucking mode on one hand, and can be used for taking the thrombus in a mode of matching with a bracket on the other hand. Specifically, when the thrombus aspiration mode is adopted, the sheath assembly in the assembled state is used to enter a human body, after reaching a designated position, the sheath core 100 pushes forward to release the collecting net 210, after the collecting net 210 is released from the net hiding section 120 of the sheath core 100, the collecting net is automatically opened under the action of self elastic restoring force and is abutted against the inner wall of a blood vessel to seal the blood vessel, so that the thrombus is prevented from falling off, and the phenomenon that the thrombus is crushed and is not successfully aspirated when the thrombus is aspirated can be avoided, and secondary embolism of a downstream branch blood vessel is caused. The sheath core 100 is then withdrawn and an external negative pressure member is connected through the suction port 222 of the end piece 220, with which suction of the thrombus is performed. Since the distal end of the sheath 200 is provided with a collection mesh 210, the thrombus can be blocked during aspiration to ensure successful deployment of the procedure.

When the stent thrombolysis mode is adopted, the sheath component in the assembled state enters the human body, after reaching the designated position, the sheath core 100 is pushed forward to release the collecting net 210, and then the sheath core 100 is withdrawn and matched with the stent thrombolysis mode. Since the distal end of the sheath 200 is provided with the collection mesh 210, the risk of thrombus lodging outside the sheath 200 due to the smaller inlet of the sheath 200 can be prevented when the stent pulls thrombus into the sheath 200.

In other embodiments, the cover 212 may not be disposed on the mesh body 211 of the collecting mesh 210, and the mesh body 211 forms a dense woven mesh by densely weaving the woven wires 213, where the mesh maximum aperture of the dense woven mesh is not greater than 1mm. Thus, after the collecting net 210 is unfolded, the thrombus can be intercepted, blood circulation can be ensured, and the safety of the operation can be ensured for patients with special symptoms. Because thrombus can be naturally dissolved or dissolved through medicine acceleration, when the collection net in the form of a dense woven net is adopted for auxiliary suction, even if smaller broken thrombus is dissociated to a downstream branch blood vessel, a preset amount of thrombolytic anticoagulant medicine can be injected after the suction is finished, so that the safety of the operation is ensured.

In addition, an operating handle 150 is provided at the proximal end of the sheath core 100 to facilitate grasping by an operator to facilitate pushing or retracting the sheath assembly.

According to the technical scheme, the collecting net 210 is arranged at the front end of the sheath tube 200, and the broken thrombus falling off in the suction process is intercepted by the collecting net 210, so that the risk that thrombus stays outside the sheath tube 200 can be effectively solved. Meanwhile, the hiding net section 120 is arranged at the front end of the sheath core 100, and in the process of placing the thrombus taking sheath tube 200 into a blood vessel, an additional conveying sheath is not required to be placed, so that the whole process of thrombus suction can be completed only through the sheath tube 200 and the sheath core 100, and the operation process is optimized.

Additionally, since conventional embolectomy sheath assemblies 10 are typically formed by assembling multiple tubular members, the delivery sheath, and sheath core may be sequentially included from the outside to the inside, allowing the smaller the inner diameter of the lumen the more inside the product at the same outer diameter. Therefore, by designing the hidden net section 120, the application can cancel the traditional design of the delivery sheath because the hidden net section 120 is used for accommodating the collection net 210 at the same time of arranging the collection net 210 at the distal end of the sheath 200, thereby reducing the number and the volume of tubular parts penetrating into the blood vessel, ensuring the suction area of the suction cavity of the sheath 200 and effectively improving the suction efficiency.

In the second embodiment, the structure of the thrombectomy sheath tube assembly 10 is shown in fig. 9 to 12, and the details of the structure of the thrombectomy sheath tube assembly 10 are not repeated in the same points as those of the first embodiment, but the difference between the second embodiment and the first embodiment is that, referring to fig. 7, the thrombectomy sheath tube assembly 10 includes a sheath core 100 and a sheath tube 200, and further includes an outer sheath 300, and the sheath tube 200 is disposed in the outer sheath 300 during assembly.

In this embodiment, the thrombus removing sheath 200 further includes an outer sheath 300, and by disposing the outer sheath 300 outside the sheath 200, the collecting mesh 210 does not need to be used with other sheaths when being taken out, thereby increasing the applicability of the thrombus removing sheath 200.

Meanwhile, as shown in fig. 8 and 9, since the distal end of the sheath core 100 is provided with the hidden net section 120, the front end of the sheath 200 is provided with the collecting net 210, and the collecting net 210 is gathered in the hidden net section 120 when being transported. Compared with the traditional thrombus taking sheath tube assembly 10 without the hidden net section 120, since the sheath core 100 is not provided with the hidden net section 120 for accommodating the collecting net 210, the collecting net 210 can be naturally unfolded in the outer sheath 300 under the action of self elastic restoring force in the assembly process of the sheath tube 200 and the outer sheath 300, and the unfolded collecting net 210 can be clung to the inner wall of the outer sheath 300 to cause friction force to be increased, so that the assembly difficulty of the sheath tube 200 and the outer sheath 300 is increased. When the metal mesh outer side of the collecting mesh 210 is provided with the covering member 212 with a larger friction coefficient like silica gel, the covering member 212 can be even shifted or even broken in the process of assembling the sheath 200 and the outer sheath 300, so that the condition that the collecting mesh 210 is not tightly sealed in the blood vessel is caused, and the effect of thrombus interception is affected.

The application adds the hidden net section 120 for accommodating the collecting net 210 on the sheath core 100 by improving the structure of the front end of the sheath core 100, thereby further providing convenience for assembling the thrombus taking sheath tube assembly 10 in the case that the thrombus taking sheath tube assembly 10 comprises the outer sheath 300, not only reducing the assembling difficulty of the sheath tube 200 and the outer sheath 300, but also protecting the collecting net 210 and ensuring the sealing performance of the collecting net 210.

In the present embodiment, as shown in connection with fig. 10, a first connection portion 223 is provided at a port of the proximal end of the sheath 200, and the first connection portion 223 serves as a connection member for connection with an external negative pressure member.

The embolectomy sheath assembly 10 is particularly useful in that when the assembled sheath assembly is advanced into the body and reaches a desired location, the sheath core 100 is pushed forward to release the collection mesh 210 from within the hidden mesh 120, and the outer sheath 300 is withdrawn to release the collection mesh 210. The sheath core 100 is then withdrawn from the sheath tube 200, and the negative pressure member is connected to the sheath tube 200 via the first connection portion 223, and suction is performed by operating the negative pressure member. After the thrombus is removed, the sheath 200 is withdrawn, the collection mesh 210 is retracted into the outer sheath 300, and the sheath 200 is withdrawn from the vessel with the outer sheath 300.

Further, as shown in connection with fig. 11, the proximal end of the outer sheath 300 is provided with an outer sheath hemostasis valve 310, one end of the outer sheath hemostasis valve 310 is fixedly connected to the outer sheath 300, and the other end of the outer sheath hemostasis valve 310 is provided with a jack 330 for penetration of the sheath tube 200. When assembled, the sheath 200 is inserted into the outer sheath 300 from the hub 330.

When it is desired to retain the outer sheath 300 in the vessel for use with other instruments, after the removal of the thrombus is completed, the outer sheath 300 is held relatively stationary and the sheath 200 is withdrawn until the vessel is withdrawn. The sheath 300 is retained in the vessel as a delivery sheath for use with other instruments, avoiding repeated insertion of the sheath 300 during the procedure, and optimizing the procedure.

In other embodiments, as shown in connection with fig. 12, the distal end of the sheath core 100 may also be free of the hidden web segment 120. That is, when the distal end of the sheath core 100 is not provided with the hidden screen 120, the collecting screen 210 is retracted within the outer sheath 300, and after the sheath assembly in the assembled state enters the human body and reaches the designated site, the sheath core 100 is withdrawn, and then the outer sheath 300 is retracted to release the collecting screen 210. After the thrombus is removed, the sheath 200 is withdrawn, the collection mesh 210 is retracted into the outer sheath 300, and the sheath 200 is withdrawn from the lumen of the human body together with the outer sheath 300.

In this embodiment, the hidden section 120 is located outside the distal end of the outer sheath 300 after assembly, or the hidden section 120 is located within the outer sheath 300 after assembly. The particular location design of the Tibetan net section 120 after assembly is selected according to the actual needs of the operation.

As shown in fig. 9 and 10, the first connection portion 223 is disposed at a port of the proximal end of the sheath tube 200, and the first connection portion 223 serves as a connection member for connection with an external negative pressure member on the one hand, and the first connection portion 223 serves as a connection member for fixedly connecting with the sheath core 100 when the sheath assembly penetrates into a blood vessel on the other hand.

The sheath core 100 is provided with a fixing member 160, the fixing member 160 is fixedly connected with the sheath core 100 and detachably connected with the first connecting portion 223, the sheath tube 200 is provided with a positioning member 240 matched with the fixing member 160, and the positioning member 240 is used for playing a role in limiting and fixing when the fixing member 160 is connected with the first connecting portion 223.

Specifically, the first connection portion 223 is an external thread formed at the proximal end of the sheath 200, the distal end of the fixing member 160 is provided with a first thread portion 161, the distal end of the first thread portion 161 defines an inner cavity for accommodating the first connection portion 223, and an internal thread is provided on the inner wall of the inner cavity, so that the fixing member 160 is screwed with the first connection portion 223. The positioning member 240 is a retainer ring structure fixedly connected to the sheath 200, and when the fixing member 160 is connected to the first connecting portion 223 by means of a threaded connection, the fixing member 160 is rotated to screw the fixing member 160 toward the positioning member 240 until the distal end of the fixing member 160 is tightly attached to the proximal end of the positioning member 240, so that the fixing member 160 is abutted to the positioning member 240 to be screwed and fixed.

According to the application, the fixing piece 160 is arranged on the sheath core 100 and is detachably connected with the first connecting part 223 on the sheath tube 200, so that the relative fixation of the sheath core 100 and the sheath tube 200 can be ensured when the sheath assembly enters into a blood vessel, and the displacement of the sheath core 100 and the sheath tube 200 in the conveying process can be prevented.

When the distal end portion of the sheath core 100 is provided with the hidden net section 120, the sheath core 100 and the sheath tube 200 can be prevented from being relatively displaced during the transportation process, and further, the collection net 210 can be prevented from being removed from the hidden net section 120 in advance. When the assembled sheath assembly reaches a predetermined position, the securing member 160 is disengaged from the primary connection 223, whereby the sheath core 100 or sheath 200 is operable to release the collection mesh 210 from the collection mesh 120 and the sheath core 100 can be withdrawn from the sheath 200 for a further thrombus aspiration step.

Further, an inner sheath hemostatic valve 230 is further disposed on the sheath 200 to ensure that the gap between the sheath 200 and the sheath core 100 is sealed well, and when the sheath core 100 is operated to release the collecting net 210, the gap between the sheath 200 and the sheath core 100 can be ensured not to leak blood.

In addition, an operating handle 150 is provided at the proximal ends of the sheath core 100, the sheath tube 200 and the outer sheath 300, respectively, to facilitate grasping by an operator and to facilitate pushing or retracting the sheath assembly.

Thus, the present embodiment can realize the evacuation of the sheath 200 and the sheath core 100 from the blood vessel after the completion of the thrombus aspiration process by the above-described technical scheme, but the outer sheath 300 can be retained in the blood vessel without completely evacuating all the devices from the blood vessel. The outer sheath 300 remaining in the blood vessel can be used as a delivery sheath when being used in combination with other instruments for treatment, and a new delivery sheath does not need to be reinserted into the blood vessel, so that the time is saved, the operation process is optimized, and the operation efficiency and success rate are improved.

In the third embodiment, the structure of the thrombolytic sheath tube assembly 10 is shown in fig. 13 to 16, and the details of the structure of the thrombolytic sheath tube assembly 10 are not repeated in the same as those of the second embodiment, but the difference between the third embodiment and the second embodiment is that, as shown in fig. 13 and 14, a detachable sheath hemostasis valve 310 is provided on the sheath 300, and the sheath hemostasis valve 310 is detachably connected with the proximal end of the sheath 300. The sheath 200 is provided with a visualization structure 320, the visualization structure 320 being located at the proximal end of the collection mesh 210.

The proximal end of the outer sheath 300 is provided with a second connection portion 340, and the outer sheath hemostasis valve 310 is detachably connected to the outer sheath 300 through the second connection portion 340. Specifically, the second connection portion 340 is an external thread disposed at the proximal end of the outer sheath 300, the distal end of the outer sheath hemostasis valve 310 is provided with a second thread portion 311, the distal end of the second thread portion 311 defines an inner cavity for accommodating the second connection portion 340, and an internal thread is disposed on the inner wall of the inner cavity, so that the second thread portion 311 is in threaded connection with the second connection portion 340. The inner side of the second threaded portion 311 is further provided with a sealing ring (not shown in the figure), and the sealing ring abuts against the distal end of the second connecting portion 340 to perform a sealing function, thereby preventing blood leakage.

One end of the outer sheath hemostatic valve 310 is detachable from the outer sheath 300, and the other end of the outer sheath hemostatic valve 310 is provided with a jack 330 for penetration of the sheath 200. When assembled, the sheath 200 is inserted into the outer sheath 300 from the hub 330.

The developing structure 320 may be a material with developing performance, such as a tantalum material or a platinum material. The developing structure 320 includes a first developing point 321 fixedly disposed at a proximal end of the collecting net 210, and/or a developing ring 322 disposed on the sheath tube 200 and disposed at a proximal end of the collecting net 210, and when the developing structure 320 is the developing ring 322, the developing ring 322 may be fixedly disposed on the sheath tube 200 by embedding.

In addition, the developing structure 320 further includes a second developing point 323 disposed on the collection web 210, the second developing point 323 being disposed at a distal end of the collection web 210. The distal end of the collecting net 210 is provided with at least two second developing points 323 which are circumferentially arranged, and by setting the second developing points 323, a user can clearly judge the unfolding and recycling states of the collecting net 210 during operation, so that the attaching state of the collecting net 210 during unfolding and the position of the distal end of the collecting net 210 during recycling are known. In the present embodiment, the plurality of second developing points 323 are uniformly distributed along the distal end circumference of the collecting net 210.

Specifically, as shown in fig. 16 in combination with fig. 15, when the thrombolytic sheath 200 is used, the sheath assembly in the assembled state is advanced along the guide wire into the blood vessel to reach the target lesion site, the sheath 200 and the outer sheath 300 are fixed, and the sheath core 100 is pushed forward to release the collection mesh 210. The sheath core 100 is removed and the sheath 200 and outer sheath 300 are retained within the vessel to accommodate aspiration, balloon or stent embolization.

When the removal of the thrombus is completed, the outer sheath 300 is secured and the sheath 200 is pulled back to collect the mesh 210. When the collecting net 210 is retracted, and the sheath tube 200 is retracted to the first developing point 321, it can be judged that the collecting net 210 is already at the position of the outer sheath hemostatic valve 310, at this time, the outer sheath hemostatic valve 310 is removed and the collecting net 210 is taken out, and the outer sheath 300 remains in the blood vessel to be used as a sheath for other instrument treatment. After the collection mesh 210 is removed, the sheath hemostatic valve 310 is reinstalled on the sheath 300 to avoid leakage of blood from the sheath 300.

If re-thrombectomy is required, the sheath core 100 is inserted into the sheath 200 while the collection mesh 210 is loaded into the hidden section 120 of the sheath core 100, and then the sheath core 100 is re-introduced into the outer sheath 300 along the guidewire, bringing the collection mesh 210 into the target vessel and releasing it. At this time, the operation can be ensured to be smoothly performed by observing the position of the second developing point 323 to determine the state in which the collecting net 210 is unfolded.

Further, the proximal end of the sheath 200 is provided with an inner sheath hemostasis valve 230 to ensure that the gap between the sheath 200 and the sheath core 100 is sealed well, and the gap between the sheath 200 and the sheath core 100 will not leak blood when the sheath core 100 is operated to release the collection mesh 210. In this embodiment, the inner sheath hemostasis valve 230 is removably coupled to the sheath 200.

Specifically, as shown in fig. 14, a first connection portion 223 is provided at a port of the proximal end of the sheath tube 200, and the first connection portion 223 of the inner sheath hemostasis valve serves as a connection member detachably connected to the inner sheath hemostasis valve 230 during the sheath assembly delivery process. When the sheath assembly is delivered to the preset position, the inner sheath hemostatic valve 230 on the sheath 200 is first removed, and then an external negative pressure member is connected to the first connection portion 223, through which thrombus aspiration is performed.

Since the sheath 200 is an aspiration lumen during thrombus aspiration, the detachable inner sheath hemostatic valve 230 can ensure the inner lumen area of the sheath 200, provide a larger aspiration lumen, and enhance the effect of thrombus aspiration.

By the above, the present embodiment realizes the visualization in the operation process through the above technical solution, and when a user operates, the user can clearly determine the state of deployment and recovery of the collection net 210, so as to obtain the adhesion state of the collection net 210 during deployment and the position of the distal end of the collection net 210 during recovery. And, the structural design of the detachable hemostatic valve provides for ease of withdrawal and secondary aspiration of the sheath 200.

In the fourth embodiment, the structure of the thrombectomy sheath tube assembly 10 is shown in fig. 17 to 20, and the differences between the fourth embodiment and the second embodiment are not repeated, and in the fourth embodiment, as shown in fig. 17 and 19, the outer side of the sheath tube 200 is provided with the outer sheath 300, the collecting mesh 210 is disposed at the distal end of the outer sheath 300, and the collecting mesh 210 is fixedly connected to the distal end of the outer sheath 300. The collection web 210 includes a web body 211 having shape memory properties. The sheath 200 is provided with a storage section 120 for receiving the collection mesh 210. The hidden section 120 is disposed between the sheath 200 and the outer sheath 300, with its distal end connected to the distal end of the sheath 200 and its proximal end connected to the outer sheath 300.

Wherein the hidden network segment 120 comprises a proximal hidden network segment 123 and a distal hidden network segment 124 which are connected, the proximal hidden network segment 123 is connected with the outer sheath 300, and the distal hidden network segment 124 is connected with the sheath 200.

Further, one end of the distal hidden section 124 is connected to the distal end of the sheath 200, the other end of the distal hidden section 124 is fixedly connected to the proximal hidden section 123, and the proximal end of the proximal hidden section 123 is connected to the distal end of the sheath 300. The proximal and distal segments 123, 124 are closed and connected and the closed interior forms a receiving cavity (not shown) for receiving the mesh body 211.

The mesh body 211 may be a metal mesh with memory performance, for example, a metal mesh formed by braiding nickel titanium wires, and the mesh body 211 is shaped by heat treatment after being braided and formed by braiding wires 213, and has elastic memory performance. The net body 211 is covered inside the net storage section 120, and the net storage section 120 has a film structure with good expansion and contraction performance. So that an operator can control the unfolded state of the net body 211 by manipulating the shape of the hidden net section 120.

It is understood that the proximal and distal hidden network segments 123 and 124 may be integrally or separately disposed, the proximal hidden network segment 123 may be fixedly connected or movably connected to the network body 211, and the materials of the proximal and distal hidden network segments 123 and 124 may be the same or different.

Specifically, when the proximal and distal hidden segments 123, 124 are integrally formed, the proximal and distal hidden segments 123, 124 are formed of the same material. In this embodiment, the Tibetan net section 120 is a balloon having good expansion and contraction performance, such as a silica gel balloon. At the time of balloon molding, the net body 211 is disposed inside the balloon to form one body. At this time, the net body 211 is movably connected to the hidden net section 120 in a split manner.

When the proximal and distal hidden network segments 123 and 124 are separately disposed, the materials of the proximal and distal hidden network segments 123 and 124 may be the same or different, and specifically, one or more of Polyethylene (PE), polyurethane, and nylon may be used. At this time, after the proximal and distal hidden net sections 123 and 124 are formed, respectively, the net body 211 is disposed inside the proximal hidden net section 123, and then the proximal hidden net section 123 and the distal hidden net section 124 are heat-fused into a whole.

When the proximal hidden network segment 123 and the distal hidden network segment 124 are separately configured, the network body 211 may be fixedly connected to the proximal hidden network segment 123 or movably connected to each other. If the net body 211 and the proximal hidden net section 123 are fixedly connected, the proximal hidden net section 123 is a film coated on the net body 211.

It will be appreciated that in another embodiment of the present application, the collecting net 210 further includes a cover 212 provided on the net body 211, the cover 212 covers the mesh of the net body 211, and the cover 212 is a film structure covering the net body 211. The materials of the Tibetan web segment 120 and the cover 212 may be the same or different. Through set up covering 212 on net body 211 for net body 211 is more even when deformation, net body 211 can not directly with hiding net section 120 when expanding in addition, but through softer covering 212 with hide net section 120 contact, make hide net section 120 can not be damaged because of net body 211 deformation volume is too big or deformation speed is too fast, has improved the holistic security of subassembly.

According to the technical scheme, the size of the filling and hiding net section 120 can be controlled, the released diameter of the net body 211 is controlled, and the filling shape of the hiding net section 120 is adjusted by controlling the relative positions of the sheath tube 200 and the outer sheath 300, so that the purpose that vessels with various diameters can be adapted by using only one-scale collecting net 210 is achieved.

Because the conventional embolectomy sheath assembly 10 is formed by assembling a plurality of tubular members, for example, the inventive embolectomy sheath assembly 10 includes the outer sheath 300, the sheath 200, and the sheath core 100 in that order from the outside to the inside, the smaller the inner diameter of the lumen, the more inside, of the product is at the same outer diameter. Meanwhile, the collecting net 210 with one specification can only correspond to a blood vessel with one diameter, if the blood vessel is too large, the sealing cannot be performed, and if the blood vessel is too small, a gap is easily formed between the covering piece 212 and the blood vessel after the collecting net 210 is released, so that the sealing effect is affected.

In this embodiment, the mesh storage section 120 with good expansion performance is disposed on the outer side of the mesh body 211, and the diameter of the collection mesh 210 is indirectly controlled by controlling the shape and the size of the mesh storage section 120, so that the purpose that the collection mesh 210 with the same specification can adapt to blood vessels with various diameters is achieved. The Tibetan net section 120 of the embodiment specifically adopts a silica gel balloon, and the diameter of the metal net can be effectively compressed due to the larger contraction force of the silica gel balloon, so that the product has a larger inner diameter under the same outer diameter.

Referring to fig. 19 and 20, one end of the mesh hiding section 120 is connected to the outer sheath 300, the other end of the mesh hiding section 120 is connected to the sheath 200, the mesh body 211 is disposed inside the mesh hiding section 120, and the axial length of the mesh body 211 is smaller than the axial length of the whole mesh hiding section 120. The net body 211 has a shape with a proximal end contracted and a distal end expanded, and in this embodiment, the net body 211 has a bell mouth shape. The ratio of the axial length of the net body 211 in the fully expanded state to the axial length of the hidden net section 120 in the filled state is 1:4 to 3:4.

Further, a sheath hemostasis valve 310 is provided at the proximal end of the sheath 300, an extension tube 350 is provided at the proximal end of the sheath hemostasis valve 310, and the distal end of the sheath 200 passes through the extension tube 350 and into the interior of the sheath 300.

In this embodiment, the sheath 200 is provided with a locking member 260, and the proximal end of the extension tube 350 is provided with a locking connection 351, and the locking connection 351 is locked to the locking member 260 so as to keep the sheath 200 and the outer sheath 300 relatively fixed. The locking connection portion 351 is an external thread structure fixedly disposed at the proximal end of the extension tube 350, the locking member 260 is screwed with the locking connection portion 351, and the locking member 260 is rotatably connected to the sheath tube 200. In this embodiment, the locking member 260 is provided with a protrusion, and the sheath 200 is provided with an annular groove (the protrusion and the annular groove are not shown in the figure) for engaging the protrusion, so that the locking member 260 can rotate relative to the sheath 200 without axial movement.

In other embodiments, the locking member 260 and the locking connection 351 may be engaged by a hook, or may be detachably connected.

In this embodiment, during the delivery process of the sheath assembly, the locking member 260 is fixed on the locking connection portion 351 to fix the outer sheath 300 and the sheath 200 relatively, the hidden screen 120 is long when the locking member 260 is fixed on the locking connection portion 351, and the hidden screen 120 and the collecting screen 210 are attached to the outer wall of the sheath 200 under tension when no filling medium is injected into the hidden screen 120.

When the locking member 260 is unlocked from the locking connection 351, the locking connection of the sheath 300 and the sheath 200 is simultaneously released, and at this time, the operator can control the filling state of the hidden network segment 120 by injecting the filling medium into the hidden network segment 120, and the filling medium may be gas or liquid. After the mesh body 211 is deployed, the operator may move the outer sheath 300 or the sheath 200 to change the shape of the hidden mesh segment 120.

In this embodiment, after the outer sheath 300 and the sheath 200 are unlocked, the sheath 200 is retracted relative to the outer sheath 300, so that the distal end of the distal hidden web segment 124 moves proximally relative to the distal end of the outer sheath 300 until the hidden web segment 120 gradually changes from an approximately elliptical shape to an approximately horn shape, and forms a horn mouth shape that is adapted to the web body 211. In this state, the operator can further adjust the relative hardness of the storage net section 120 by injecting or extracting the medium filled in the storage net section 120 to adjust the adherence of the net body 211.

Subsequently, the sheath core 100 is withdrawn from the body vessel, and the interior of the sheath 200 forms a suction lumen 270, as shown in connection with fig. 18. The external negative pressure member is connected to the first connection portion 223 at the proximal end of the sheath 200, and aspiration of the intravascular thrombus is achieved by the external negative pressure member.

Specifically, when the embolectomy sheath assembly 10 of the present embodiment is in use, the embolectomy sheath assembly 10 in the assembled state is first advanced along a guidewire into a blood vessel to a target lesion site. The filling degree of the hidden net section 120 is selected according to the diameter of the blood vessel, so that the net body 211 is expanded under the action of the elastic restoring force of the net body and is tightly attached to the inner wall of the hidden net section 120. The locking structure between the sheath 200 and the outer sheath 300 is then released, allowing the outer sheath 300 to remain relatively fixed, and the sheath 200 is moved back relative to the sheath 200, so that the hidden web segment 120 forms a flare shape that fits the web body 211. Finally, the sheath core 100 is withdrawn, the tail end of the sheath tube 200 is connected with the inner sheath hemostatic valve 230, and the suction plug or the stent plug is matched.

After the suction is completed, the sheath 200 is moved toward the distal end of the outer sheath 300, and simultaneously, the filled medium inside the hidden network segment 120 is pumped away, and then the locking member 260 is fixedly connected with the locking connection 351 again, so that the sheath 200 and the outer sheath 300 are locked relatively. At this time, the hidden screen 120 is reattached to the outer wall of the sheath 200, the sheath 200 and the outer sheath 300 can be withdrawn from the blood vessel, and the hidden screen 120 attached to the sheath 200 is in the form shown in fig. 17.

To sum up, in this embodiment, the mesh segment 120 with expansion and contraction performance is disposed outside the mesh body 211, and the filling state of the mesh segment 120 is controlled, so as to control the diameter released by the mesh body 211, thereby achieving the purpose of adapting the mesh body 211 with one specification to vessels with various diameters. Meanwhile, the mesh body 211 can be compressed by the mesh hiding section 120 in the conveying process, so that the sheath assembly can be conveniently penetrated into a blood vessel after assembly.

An embodiment five of the present invention provides a thrombectomy sheath tube assembly 10, where the structure of the thrombectomy sheath tube assembly 10 is shown in fig. 22 to 27, and the differences between the embodiment five and the embodiment one are not repeated, and the difference between the embodiment five and the embodiment one is that, as shown in fig. 22 and 23, the thrombectomy sheath tube assembly 10 includes a sheath tube 200 and a sheath core 100, the sheath core 100 is disposed inside the sheath tube 200, and a collecting net 210 is disposed at a distal end of the sheath tube 200, and the collecting net 210 is used for intercepting thrombus, so as to prevent the thrombus from being crushed, which is not successfully sucked, from entering into a downstream branch vessel during the thrombus aspiration process, and causing secondary embolism. Wherein, the distal end of the sheath 200 is provided with a collection mesh segment 120 for receiving the collection mesh 210, and the collection mesh 210 is received in the collection mesh segment 120 during the process of placing the sheath 200 into a blood vessel, and the collection mesh 210 is released from the collection mesh segment 120 after the sheath 200 moves to a target position.

As shown in fig. 23 and 24, the proximal end of the sheath 200 is provided with an end piece 220, the sheath 200 includes an inner tube 280 and an outer tube 290, the outer tube 290 is sleeved outside the inner tube 280, and the inner tube 280 and the outer tube 290 are relatively movable in the axial direction. The collection mesh 210 is fixedly attached to the distal end of the inner tube 280 and the collection mesh 120 is disposed inside the distal end of the outer tube 290. The end piece 220 includes a control rod 224, a catheter hub 226 disposed at a proximal end of the control rod 224, and a control member 225 disposed on the control rod 224, the control member 225 for controlling the relative movement of the inner tube 280 and the outer tube 290.

In this embodiment, the control 225 is a knob 2251, the knob 2251 being rotatably coupled to the lever 224. The inner tube 280 and the outer tube 290 are connected to the catheter hub 226 and the knob 2251, respectively. Wherein, knob 2251 has a hollow inner cavity and is rotatably connected to control rod 224, outer tube 290 is fixedly connected to the inner cavity of knob 2251, and inner tube 280 is inserted into catheter hub 226 after passing through outer tube 290.

A threaded connection portion 291 is provided between the inner tube 280 and the outer tube 290, wherein an inner thread is provided on an inner wall of the outer tube 290, an outer thread is provided on an outer wall of the inner tube 280, and the inner tube 280 is in threaded connection with the outer tube 290. A guide part 227 is arranged between the inner tube 280 and the catheter holder 226, wherein a guide block 2271 is arranged on the inner tube 280, a guide groove 2272 is arranged on the inner wall of the catheter holder 226, and the guide block 2271 slides along the guide groove 2272, so that the inner tube 280 can move along the axial direction of the catheter holder 226 but cannot rotate around the circumferential direction of the catheter holder 226.

Since the collecting net 210 is closely attached to the inner wall of the storage net section 120 under the action of its elastic restoring force when the collecting net 210 is accommodated in the storage net section 120 of the outer tube 290, it is necessary to overcome the friction between the collecting net 210 and the storage net section 120 when the collecting net 210 is pushed out of the outer tube 290. By rotating the knob 2251 to release the collection mesh 210, the rotational motion of the knob 2251 is translated into translation of the outer tube 290, thereby saving more effort in release.

In this embodiment, the internal threads on the outer tube 290 and the external threads on the inner tube 280 are self-locking threaded fits. By means of the self-locking connection of the internal thread and the external thread, accurate positioning of the inner pipe 280 and the outer pipe 290 can be achieved, and the proportion of the collecting net 210 extending out of the outer pipe 290 can be controlled conveniently so as to adapt to blood vessels with different inner diameters. And can avoid the false touch of operators, ensure the stability of the state of the collecting net 210 in the sucking process and improve the success rate of the operation.

Wherein, the hidden net section 120 is an annular groove 130 arranged on the inner wall of the distal end of the outer tube 290, and the annular groove 130 provides a receiving space for the collecting net 210 when the collecting net 210 is received in the outer tube 290. The annular groove 130 may be circular or conical. In this embodiment, the annular groove 130 is conical, and the inner diameter of the annular groove 130 gradually increases from the proximal end to the distal end. Through the design, the collection net section 120 can accommodate the collection net 210, and the conical section design can enable the process of releasing and recycling the collection net 210 to be smoother, so that the efficiency and success rate of releasing and recycling the collection net 210 are improved.

In use, the embolectomy sheath assembly 10 of this embodiment is first introduced into a vessel along a guidewire, to a target lesion site, and then the sheath core 100 is withdrawn, and the collection mesh 210 is released. Upon release of the collection mesh 210, the operator rotates the outer tube 290 simultaneously by rotating the knob 2251 and engages the threads to move the inner tube 280 distally along the axis of the outer tube 290. The collection mesh 210 moves gradually out of the storage section 120 as the inner tube 280 moves and expands under the elastic restoring force of itself. The operator may select the length of the collection mesh 210 extending out of the sheath 200 based on the diameter of the patient's blood vessel, thereby controlling the amount of expansion of the collection mesh 210. When the collection mesh 210 is released and placed against the inner wall of the vessel, an external negative pressure member is attached to the end piece 220, through which the thrombus within the vessel is aspirated.

When aspiration is complete, collection mesh 210 is first withdrawn into hidden mesh segment 120 within sheath 200, and sheath 200 is then withdrawn from the vessel. When the collection mesh 210 is recovered, the operator rotates the outer tube 290 in a reverse direction by rotating the knob 2251 in a reverse direction and moves the inner tube 280 proximally along the axial direction of the outer tube 290 by threaded engagement. The collection mesh 210 gradually retracts into the storage section 120 as the inner tube 280 moves and is contained within the storage section 120 under the compression of the outer tube 290.

The end piece 220 further comprises a suction opening 222, the suction opening 222 being arranged at a port at the proximal end of the catheter hub 226, the suction opening 222 comprising a first connection 223, the first connection 223 being intended for connection with an external negative pressure component. When assembled, the sheath core 100 passes from the aspiration port 222 into the catheter hub 226 and into the inner tube 280. At the time of suction, the sheath core 100 is withdrawn from the sheath tube 200, and an external negative pressure member is connected to the first connection portion 223, and a suction step is performed.

The end piece 220 further comprises an inner sheath hemostasis valve 230 to ensure a good sealing of the gap between the sheath 200 and the sheath core 100. In the present embodiment, the inner sheath hemostasis valve 230 is used to close the inner tube 280 and the sheath core 100, so that the gap between the inner tube 280 and the sheath core 100 is ensured not to leak blood when the sheath core 100 is operated.

In other embodiments, as shown in fig. 25, the outer tube 290 may also be fixedly coupled to the control rod 224, with the inner tube 280 passing through the proximal end of the outer tube 290 and threadably coupled to the knob 2251. When knob 2251 is turned, inner tube 280 can be driven to move axially, thereby effecting release or recovery of collection mesh 210. By adopting the mode of fixedly connecting the outer tube 290 and the control rod 224, the stability between the outer tube 290 and the inner wall of the blood vessel can be ensured in the process of releasing or recovering the collecting net 210, thereby avoiding the outer tube 290 from scratching the blood vessel in the operation process.

Wherein, the distal end of inner tube 280 is provided with connecting pipe 281, and connecting pipe 281 inlays the distal end at inner tube 280 to strengthen the intensity of inner tube 280 distal end, so that collection net 210 is more stable in the in-process of propelling movement.

In other embodiments, as shown in fig. 26, the control member 225 may also be a slide button 2252 provided on the lever 224, with the inner tube 280 and the outer tube 290 being connected to the catheter hub 226 and the slide button 2252, respectively. Wherein the inner tube 280 is fixedly connected to the catheter hub 226, the outer tube 290 is fixedly connected to the slide button 2252, the slide button 2252 is slidably connected to the control lever 224, and when the slide button 2252 is moved by the operator, the outer tube 290 slides synchronously with the slide button 2252, thereby releasing or retrieving the collection mesh 210. The inner tube 280 and the outer tube 290 of the sliding connection are more tightly attached, so that better sealing performance can be provided, and the blood leakage prevention performance of the end piece 220 is improved.

According to the technical scheme, the collecting net 210 and the hiding net section 120 are integrally arranged on the sheath tube 200, and broken plugs falling off in the suction process are intercepted by the collecting net 210, so that the risk that thrombus is retained outside the sheath tube 200 can be effectively solved. Meanwhile, due to the design of the hidden net section 120, in the process of placing the thrombus taking sheath tube 200 into a blood vessel, an additional conveying sheath is not needed to be placed, the whole process of thrombus suction can be completed only through the sheath tube 200 and the sheath core 100, and the operation process is optimized.

In other embodiments, as shown in fig. 27, the embolectomy sheath tube assembly 10 can further include an outer sheath 300, the outer sheath 300 being disposed over the outer side of the sheath tube 200. By sleeving the sheath tube 200 with the outer sheath 300, when the thrombus taking sheath tube assembly 10 is used for sucking thrombus or plaque in a main branch vessel, the overall strength of the thrombus taking sheath tube assembly 10 of the outer sheath 300 can be improved by adding the thrombus taking sheath tube assembly 10, the deformation of the sheath tube 200 due to the bent part of the vessel is avoided, the sucking area of the inner cavity of the sheath tube 200 is ensured, and the thrombus sucking efficiency and success rate are ensured. During the actual operation, the operator may choose to insert only the sheath 200, or to insert both the outer sheath 300 and the sheath 200.

Embodiment six of the present invention provides a embolectomy sheath tube assembly 10, wherein the structure of the embolectomy sheath tube assembly 10 is shown in fig. 28 to 33, and the differences between the embodiment six and the embodiment five are not repeated, and the embodiment six and the embodiment five are that, as shown in fig. 28 and 29, the embolectomy sheath tube assembly 10 includes a sheath tube 200 and a sheath core 100, the sheath core 100 is disposed in the sheath tube 200 in a penetrating manner, a collection net 210 and a hidden net section 120 are disposed on the sheath tube 200, the collection net 210 is disposed at the distal end of the sheath tube 200, and the hidden net section 120 includes an annular groove 130 disposed on the inner wall of the distal end of the sheath tube 200. When the sheath 200 is placed in the blood vessel, the collection mesh 210 is received in the hidden mesh 120, and after the sheath 200 is moved to the target site, the collection mesh 210 is released from the hidden mesh 120.

The proximal end of the sheath 200 is provided with an end piece 220, a control wire 228 is arranged in the wall of the sheath 200 in a penetrating way, one end of the control wire 228 is connected with the end piece 220, the other end of the control wire 228 is connected with the collecting net 210, and the control wire 228 is used for controlling the shape of the collecting net 210. In this embodiment, a control lumen 229 is embedded in the wall of the sheath 200, and a control wire 228 is inserted into the control lumen 229. Wherein, a plurality of groups of control wires 228 are arranged in the sheath 200.

In this embodiment, as shown in connection with fig. 30, three sets of control wires 228 are provided within the sheath 200 to provide more uniform and stable force to the collection mesh 210 during recovery and release. It will be appreciated that in other embodiments, four or more sets of control wires 228 may be provided within the sheath 200, as shown in connection with fig. 31.

The end piece 220 includes a control rod 224, a catheter hub 226 disposed at a proximal end of the control rod 224, and a control member 225 disposed on the control rod 224, the control member 225 for adjusting the axial movement of the control wires 228 and thereby the morphology of the collection mesh 210.

Wherein the control 225 includes a knob 2251 rotatably coupled to the lever 224 and a control block 2253 coupled to the knob 2251. The control block 2253 is screwed to the knob 2251, and the control block 2253 is slidably coupled to the control lever 224, and one end of the control wire 228 is fixedly coupled to the control block 2253. Rotating knob 2251 may drive control block 2253 to slide along control rod 224, thereby operating control wire 228.

In other embodiments, as shown in connection with fig. 32, the control member 225 may further include a slide button 2252 slidably coupled to the control lever 224, and the control wire 228 is fixedly coupled to the slide button 2252 to urge the slide button 2252 to move along the control lever 224, thereby operating the control wire 228.

As shown in fig. 29, in the present embodiment, the collecting mesh 210 includes a closed end 214 that closes and an open end 215 that is open, the closed end 214 of the collecting mesh 210 is connected to the distal end of the sheath 200, and the open end 215 of the collecting mesh 210 is connected to the control wire 228. Since the control block 2253 is screwed to the knob 2251, when the knob 2251 is rotated, the control block 2253 moves axially along with the rotation of the knob 2251, thereby driving the control wire 228 to move axially, and thus controlling the shape of the collection net 210.

When the collection net 210 is controlled to be in the unfolded state, as shown in fig. 29, the knob 2251 is rotated to move the control block 2253 toward the distal end of the control rod 224, the distal end portion of the control wire 228 moves toward the distal end along with the movement of the control block 2253, and the collection net 210 gradually protrudes out of the storage net section 120 under the elastic restoring force of itself and returns to the natural expansion state. When the control block 2253 is moved to the distal end of the control rod 224, the control wire 228 exerts no pulling force on the collection mesh 210, at which time the collection mesh 210 returns to its natural expanded state under its elastic restoring force to occlude the vessel lumen.

When the control collection mesh 210 is in the stored state, as shown in fig. 33, the knob 2251 is rotated to move the control block 2253 toward the proximal end of the control rod 224, and the distal end of the control wire 228 moves toward the proximal end of the sheath 200 with the movement of the control block 2253. Since the control wire 228 is connected to the open end 215 of the collection mesh 210, the control wire 228 moves toward the proximal end of the sheath 200 and gradually retracts into the hidden section 120 as the control wire 228 moves toward the proximal end of the sheath 200 by the pulling action of the control wire 228. When the control block 2253 is moved to the proximal end of the control rod 224, the collection mesh 210 will fit within the hidden mesh segment 120 under the pulling action of the control wire 228.

In this embodiment, the axial length of the collection mesh 210 is less than or equal to the radius of the lumen of the sheath 200. Thereby ensuring that the collection mesh 210 can be freely accommodated or unfolded without being blocked in the sheath 200, and improving the efficiency and success rate of the operation.

In other embodiments, the axial length of the collection mesh 210 may be greater than the lumen of the sheath 200, and the stiffness of the control wire 228 may be greater than the stiffness of the collection mesh 210, so that the traction or pushing force of the control wire 228 on the collection mesh 210 is greater than the friction between the collection mesh 210 and the sheath 200 during the process of accommodating or expanding the collection mesh 210, thereby ensuring that the collection mesh 210 can be accommodated or expanded smoothly.

The present application is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present application are intended to be included in the scope of the present application. Therefore, the protection scope of the application is subject to the protection scope of the claims.

Claims

1. The thrombus taking sheath tube assembly comprises a sheath core and a sheath tube, wherein the sheath core is arranged in the sheath tube in a penetrating mode, and the thrombus taking sheath tube assembly is characterized in that a collecting net is arranged at the distal end portion of the sheath tube, and a hiding net section for accommodating the collecting net is arranged on the sheath core.

2. The embolectomy sheath assembly of claim 1, wherein the hidden screen segment comprises a hidden screen coupled to the sheath core, the hidden screen and the sheath core defining therebetween a hidden screen cavity for receiving the collection screen.

3. The embolectomy sheath assembly of claim 2, wherein the distal end of the sheath core is provided with a guide head, and the mesh enclosure is connected to the proximal end of the guide head.

4. The thrombolysis sheath assembly according to claim 3, wherein said mesh enclosure is cylindrical, said mesh enclosure is coaxially disposed with said sheath core, a distal end of said mesh enclosure is fixedly connected to said guide head, and a proximal end of said mesh enclosure is open.

5. The embolectomy sheath assembly of claim 1, wherein the proximal end of the collection mesh is attached to the sheath, the proximal end of the collection mesh is closed and the distal end is open, the collection mesh comprising a mesh body having shape memory properties.

6. The embolectomy sheath assembly of claim 5, wherein a cover is disposed on the mesh body, the cover closing the mesh openings of the mesh body.

7. The embolectomy sheath assembly of claim 6, wherein the mesh body comprises a metal mesh woven by braided filaments having shape memory, the cover completely covering the mesh of the mesh body or the cover partially covering the mesh of the mesh body.

8. The embolectomy sheath assembly of claim 1, wherein the proximal end of the sheath is provided with an end piece having a suction port provided thereon, the suction port having a first connection for connection to an external negative pressure member.

9. The embolectomy sheath assembly of claim 8, wherein the end piece has an instrument inlet disposed thereon and the aspiration port is disposed on one side of the end piece.

10. The embolectomy sheath assembly of claim 8, wherein a securing member is disposed on the sheath core, the securing member is fixedly connected to the sheath core and detachably connected to the first connecting portion, and a positioning member for spacing the securing member is disposed on the sheath.

11. The embolectomy sheath assembly of claim 1, wherein an outer sheath is disposed over the sheath, a sheath hemostatic valve is disposed between the sheath and the sheath, the sheath hemostatic valve is disposed at a proximal end of the sheath, and a visualization structure is disposed on the sheath, the visualization structure being disposed at a proximal end of the collection mesh.

12. The embolectomy sheath assembly of claim 11, wherein the visualization structure comprises a first visualization site fixedly disposed proximal to the collection mesh and/or a visualization ring disposed on the sheath and positioned proximal to the collection mesh, and a second visualization site disposed distal to the collection mesh.