Vessel opening device

Abstract

The application provides a blood vessel opening device. The device comprises a balloon and a thrombus-removing stent. The thrombus-removing stent is an expandable and contractible stent structure, and the peripheral wall of the thrombus-removing stent has a plurality of mesh holes. The balloon is coaxially arranged in the thrombus-removing stent. The balloon can drive the thrombus-removing stent to expand. The balloon can be radially contracted in the internal space of the thrombus-removing stent relative to the thrombus-removing stent. The thrombus-removing stent can be axially extended and retracted relative to the balloon. In the embodiment of the application, the balloon is coaxially arranged in the thrombus-removing stent. The hard blockage can be expanded through balloon expansion. At the same time, the thrombus-removing stent wrapped outside the balloon can be smoothly embedded in the hard blockage. Then, the blockage can be taken out of the body by retracting the balloon and the thrombus-removing stent. Therefore, the hard blockage in the blood vessel can be effectively removed, and the treatment effect is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a blood vessel opening device. BACKGROUND

[0002] Vascular disease has become the first major cause of death in China, and thrombus and calcified stenosis have become the main factors of vascular disease. In particular, the old thrombus and calcified plaque in the blood vessel belong to the hard blockage in the blood vessel, which cannot be effectively removed by the current interventional thrombectomy technology, and usually needs to be removed by surgical treatment, which is extremely traumatic, has many complications and is difficult to operate.

[0003] At present, there are also balloon expansion and stent implantation for the hard blockage in the blood vessel. Balloon expansion has the advantages of small trauma, short postoperative recovery time, fewer postoperative complications, good surgical effect and is more acceptable to patients. However, there are still many problems in balloon expansion treatment, such as restenosis after expansion, which can only temporarily expand the stenosis, but cannot fundamentally remove the blockage in the blood vessel, resulting in high recurrence rate. Stent expansion is to implant a stent permanently in the body, which may still have the possibility of in-stent restenosis after implantation. Once restenosis occurs, the treatment is extremely difficult and high-risk. At the same time, the existing minimally invasive interventional stent thrombectomy device cannot effectively remove the hard blockage. SUMMARY

[0004] The purpose of the embodiment of the present application is to provide a blood vessel opening device, which can expand the hard blockage by balloon expansion, and at the same time make the thrombectomy stent wrapped outside the balloon smoothly embedded in the hard blockage, and then take out the blockage out of the body by retracting the balloon and the thrombectomy stent, so as to effectively remove the hard blockage in the blood vessel and improve the treatment effect.

[0005] To solve the above technical problems, the embodiment of the present application provides a blood vessel opening device, which comprises a balloon and a thrombectomy stent.

[0006] The thrombectomy stent is a expandable and contractible stent structure, and the peripheral wall of the thrombectomy stent has a plurality of mesh holes; the balloon is coaxially arranged in the thrombectomy stent, the balloon can drive the thrombectomy stent to expand, the balloon can be radially contracted in the internal space of the thrombectomy stent relative to the thrombectomy stent, and the thrombectomy stent can be axially extended and retracted relative to the balloon.

[0007] In addition, the device further comprises a stent control assembly.

[0008] The stent control assembly is connected with the thrombectomy stent and is used for adjusting the axial length of the thrombectomy stent.

[0009] In addition, the balloon distal end is connected with the thrombus extraction stent distal end, the thrombus extraction stent proximal end can axially slide relative to the balloon, the stent control assembly distal end is connected with the thrombus extraction stent proximal end and is used for controlling the axial sliding of the thrombus extraction stent to adjust the axial length of the thrombus extraction stent.

[0010] In addition, the stent control assembly comprises a connecting piece and a stent control handle.

[0011] The connecting piece distal end is connected with the thrombus extraction stent proximal end, the connecting piece proximal end is connected with the stent control handle, and the stent control handle is used for controlling the axial movement of the thrombus extraction stent along the balloon through the connecting piece.

[0012] In addition, the thrombus extraction stent is an integral stent structure formed by a laser cutting process.

[0013] In addition, the thrombus extraction stent is a mesh stent structure formed by weaving wires.

[0014] In addition, the thrombus extraction stent comprises a distal end dense mesh weaving segment and a proximal end sparse mesh weaving segment which are smoothly connected.

[0015] Or the mesh holes of the thrombus extraction stent are uniformly distributed.

[0016] In addition, the weaving wires of the thrombus extraction stent comprise developing wires.

[0017] In addition, the device further comprises a distal end filter screen which is arranged at the distal end of the thrombus extraction stent.

[0018] In addition, the device further comprises a balloon control assembly which is used for controlling the expansion and contraction of the balloon.

[0019] The balloon control assembly comprises a balloon catheter and a balloon handle.

[0020] The stent control handle has a tubular structure, the balloon catheter is arranged in the tubular structure of the stent control handle, and both ends of the balloon catheter respectively extend out of the tubular structure and are connected with the balloon and the balloon handle.

[0021] From the above technical solution, the present application has at least the following advantages and positive effects:

[0022] In the vascular recanalization device of this invention, a balloon is coaxially disposed within a thrombectomy stent, so that the thrombectomy stent is wrapped around the outside of the balloon. The radial dimension of the thrombectomy stent can be adjusted by controlling the axial extension and contraction of the stent. During use, both the thrombectomy stent and the balloon can be in a contracted state to facilitate delivery to the lesion site of the blood vessel. During thrombectomy, the axial length of the thrombectomy stent can be shortened to achieve a larger diameter. The hard blockage in the narrowed blood vessel is expanded by balloon dilation. At the same time, the blockage is brought into the thrombectomy stent by retracting the balloon. Then, the axial extension of the thrombectomy stent can be controlled to clamp the hard blockage embedded in its mesh. Finally, the blockage is peeled off and removed from the body by retracting the balloon and the thrombectomy stent, thereby improving the treatment effect of vascular stenosis caused by hard blockage. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. It is understood that the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the blood vessel opening device provided in Embodiment 1 of the present invention;

[0025] Figure 2 This is an enlarged structural schematic diagram of the balloon and thrombectomy stent of the blood vessel opening device provided in Embodiment 1 of the present invention;

[0026] Figure 3 This is a schematic diagram of the blood vessel opening device provided in Embodiment 2 of the present invention;

[0027] Figure 4 This is an enlarged structural schematic diagram of the balloon and thrombectomy stent portions of the blood vessel opening device provided in Embodiment 2 of the present invention;

[0028] Figure 5 for Figure 4 A schematic diagram of the thrombectomy stent in the vascular recanalization device shown in the figure;

[0029] Figure 6 This is a schematic diagram of the blood vessel opening device provided in Embodiment 3 of the present invention;

[0030] Figure 7 This is an enlarged structural diagram of the balloon and thrombectomy stent of the blood vessel opening device provided in Embodiment 3 of the present invention. Detailed Implementation

[0031] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the various embodiments of the present application will be described in detail below with reference to the drawings. However, those skilled in the art can understand that, in the various embodiments of the present application, many technical details are presented in order to make the readers better understand the present application. However, the technical solutions claimed by the present application can be implemented even without these technical details and various changes and modifications based on the following various embodiments.

[0032] In the description of the present application, the orientation or positional relationship indicated by various indicating orientation or positional relationship terms such as "center", "upper", "lower", "inner", "outer" and the like is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of description, and does not indicate or imply that the indicated device or element must have a particular orientation, be constructed or operated in a particular orientation, and therefore cannot be understood as a limitation of the present application.

[0033] It should be noted that, unless otherwise explicitly specified, the terms "connected", "connected" and the like should be understood broadly, for example, can be fixedly connected, can be detachably connected, or integrally connected; can be directly connected, or indirectly connected through an intermediate medium; can be internal communication of two elements.

[0034] Unless otherwise specified, the proximal end and the distal end mentioned in the present application have the same meaning in the orientation, that is, in the use state, the distal end is the end away from the operator, and the proximal end is the end close to the operator, and the operator controls the blood vessel opening device at the proximal end.

[0035] Embodiment one

[0036] Please refer to Figures 1-2 As shown in the drawings, the present application provides a blood vessel opening device, which can be used for removing intravascular blockage, and is especially suitable for removing hard blockage such as old thrombus and calcified plaque in blood vessels. As shown in the drawings, Figures 1-2 As shown in the drawings, the blood vessel opening device of the present embodiment mainly comprises a balloon 12 and a thrombectomy stent 11.

[0037] The thrombus extraction stent 11 is an expandable and contractible stent structure, and the thrombus extraction stent 11 has a plurality of mesh holes in the peripheral wall. The thrombus extraction stent 11 is used for cutting and capturing the thrombus. The balloon 12 is coaxially arranged in the thrombus extraction stent 11, the balloon 12 can drive the thrombus extraction stent 11 to expand, and the balloon 12 can be radially contracted in the internal space of the thrombus extraction stent 11 relative to the thrombus extraction stent 11, and the thrombus extraction stent 11 can be axially extended and contracted relative to the balloon 12. The balloon 12 and the thrombus extraction stent 11 are arranged in a telescopic manner, the thrombus extraction stent 11 is wrapped outside the balloon 12, can be expanded with the expansion of the balloon 12, and can effectively crush the hard blockage by expanding and expanding the balloon 12 to expand the blockage in the blood vessel. At the same time, the thrombus extraction stent 11 is wrapped outside the balloon 12, can be expanded with the expansion of the thrombus extraction stent 11 and smoothly embedded in the blockage. The balloon 12 and the thrombus extraction stent 11 can be transported as a whole to the lesion and withdrawn from the body.

[0038] By adjusting the axial length of the thrombus extraction stent 11, i.e. the axial extension or shortening, the radial size of the thrombus extraction stent 11 in the natural expansion state can be controlled, the thrombus extraction stent 11 can be transported and the thrombus can be captured, and at the same time the mesh shape and size of the thrombus extraction stent 11 can be adjusted, so that the thrombus extraction stent 11 clamps and embeds the blockage in the mesh hole, and then the blockage is more completely stripped and taken out.

[0039] In the initial state, the balloon 12 and the thrombus extraction stent 11 of the blood vessel opening device are in the contracted state, the thrombus extraction stent 11 is wrapped outside the balloon 12, at this time the balloon 12 and the thrombus extraction stent 11 can be transported in the blood vessel, when the balloon 12 and the thrombus extraction stent 11 reach the lesion position, the axial shortening of the thrombus extraction stent 11 can be controlled, so that the thrombus extraction stent 11 has a larger radial expansion size in the natural state, then the balloon 12 is expanded by filling liquid, and the balloon 12 drives the thrombus extraction stent 11 to cut the blockage, then the balloon 12 is controlled to contract, so that the blockage enters the space between the balloon 12 and the thrombus extraction stent 11 through the mesh hole, and part of the blockage is located in the mesh hole of the thrombus extraction stent 11, then the axial extension of the thrombus extraction stent 11 can be controlled to clamp the hard blockage in the mesh hole of the thrombus extraction stent 11, then the thrombus extraction stent 11 and the balloon 12 are withdrawn as a whole into the catheter (not shown in the figure) matched with the blood vessel opening device, so that the hard blockage in the narrow blood vessel is completely stripped and taken out of the body. The balloon 12 can adopt a balloon with compliance, semi-compliance and non-compliance, which is not limited here, as long as it has the performance of expanding the hard blockage. The expansion performance of the thrombus extraction stent 11 can be made of a material with shape memory ability.

[0040] Please refer to Figure 2As shown, the thrombus extraction stent 11 can be an integral stent structure made by a laser cutting process. The thrombus extraction stent 11 can be made by integrally laser cutting a nickel-titanium tube and heat setting. The mesh shape of the thrombus extraction stent 11 can be rhombic, quadrangular, or other polygonal. The plurality of meshes of the thrombus extraction stent 11 can be uniform in size, which is conducive to uniformly embedding and grabbing the blockage; or the plurality of meshes of the thrombus extraction stent 11 can also be different in size, and the area of the large mesh can be several times that of the small mesh. The material, mesh shape, size, and shape of the thrombus extraction stent 11 are not limited in this embodiment.

[0041] Optionally, the blood vessel recanalization device can further comprise a stent control assembly. The stent control assembly is connected to the thrombus extraction stent 11 and is used to adjust the axial length of the thrombus extraction stent 11. The stent control assembly can be connected to the proximal end, the distal end, or both the proximal end and the distal end of the thrombus extraction stent 11, and any end of the thrombus extraction stent 11 connected to the stent control assembly can slide axially relative to the balloon 12, so that the axial length of the thrombus extraction stent 11 can be adjusted from the proximal end, the distal end, or both ends of the thrombus extraction stent 11. By adjusting the axial length of the thrombus extraction stent 11, the maximum size of the natural expansion of the thrombus extraction stent 11 can be controlled, and the mesh size and shape of the thrombus extraction stent 11 can be adjusted, so that the thrombus extraction stent 11 clamps and embeds the hard blockage in its mesh, and then more thoroughly strips and extracts the blockage.

[0042] Taking adjustment of the axial length of the thrombus extraction stent 11 from the proximal end as an example, the distal end of the balloon 12 is connected to the distal end of the thrombus extraction stent 11, the proximal end of the thrombus extraction stent 11 can slide axially relative to the balloon 12, and the distal end of the stent control assembly is connected to the proximal end of the thrombus extraction stent 11 and is used to control the axial sliding of the thrombus extraction stent to adjust the axial length of the thrombus extraction stent 11.

[0043] Specifically, the stent control assembly can include a connecting member 21 and a stent control handle 22. The distal end of the connecting member 21 is connected to the proximal end of the thrombus extraction stent 11, and the proximal end of the connecting member 21 is connected to the stent control handle 22. The stent control handle 22 is used to control the axial movement of the thrombus extraction stent 11 along the balloon 12 through the connecting member 21. The connecting member 21 can be a connecting wire connected between the proximal end of the thrombus extraction stent 11 and the thrombus control handle 22. The proximal end of the thrombus extraction stent 11 can be connected to a connecting ring, which is sleeved on the balloon catheter 31 (see below) and can slide relative to the balloon catheter 31. The distal end of the connecting wire is connected to the proximal end of the connecting ring. The connecting method of the connecting wire and the thrombus extraction stent is not limited in the embodiment. The connecting member 21 can also be a connecting tube connected between the thrombus extraction stent 11 and the stent control handle 22, which is not limited herein. It can be understood that the stent control assembly can adopt other various alternative forms, as long as it can control the axial elongation or shortening of the thrombus extraction stent 11 from either end or both ends. The implementation of the stent control assembly is not limited in the embodiment.

[0044] The thrombus extraction device can also include a balloon control assembly for controlling the expansion and contraction of the balloon 12. The balloon control assembly can include a balloon catheter 31 and a balloon handle 32. The stent control handle 22 has a tubular structure, the balloon catheter 31 is sleeved in the tubular structure of the stent control handle 22, and the two ends of the balloon catheter 31 extend out of the tubular structure and are connected to the balloon 12 and the balloon handle 32. The balloon handle 32 can be connected to a syringe or the like, and liquid is injected into the balloon 12 through the balloon catheter 31 to expand the balloon 12, or the liquid is extracted from the balloon 12 to contract the balloon 12. The vessel opening device can be used with a catheter or the like to withdraw the thrombus extraction stent 11 and the balloon into the catheter (not shown) and out of the body. It should be noted that the axial length of the thrombus extraction stent 11 can be adjusted by controlling the axial sliding of the stent control handle 22 and the connecting member 21 relative to the balloon catheter 31. Alternatively, the stent control handle 22 and the balloon catheter 31 can be fixed, and the axial length of the thrombus extraction stent 11 can be adjusted by controlling the axial sliding of the connecting member 22 relative to the balloon catheter 31 through the stent control handle 22, which is not limited herein.

[0045] Optionally, the vessel opening device can also include a distal filter (not shown) arranged at the distal end of the thrombus extraction stent 11, so as to filter the thrombus and prevent the broken thrombus from escaping. The distal filter can be woven by braided wire, but is not limited thereto. The distal filter can be in the shape of a disc or other various shapes suitable for intercepting thrombus, which is not limited herein.

[0046] Embodiment two

[0047] The structure of the blood vessel clearing device of the second embodiment is substantially the same as that of the first embodiment, and the main difference is that the thrombus-removing stent 11 of the first embodiment is an integral stent structure made by laser cutting process, while the thrombus-removing stent 11 of the second embodiment is a stent structure woven by braided wires.

[0048] As shown in Figures 3-5 The thrombus-removing stent 11 can be integrally woven by a plurality of braided wires. The braided wires can be alloy wires with shape memory ability, such as nickel-titanium alloy wires. However, the thrombus-removing stent 11 can also be woven by alloy wires with shape memory ability and polymer wires. The plurality of braided wires can be interlaced in a positive and negative spiral structure. The peripheral wall of the thrombus-removing stent has mesh holes for cutting and grabbing thrombus. The mesh holes of the thrombus-removing stent 11 can be uniformly distributed. The mesh hole structure of the peripheral wall of the thrombus-removing stent can be rhombic or other polygonal.

[0049] In this embodiment, the blood vessel opening device can also include a distal filter 13 arranged at the distal end of the thrombus-removing stent 11. The distal filter 13 and the thrombus-removing stent 11 can be integrally woven by braided wires.

[0050] It is worth mentioning that the braided wires of the thrombus-removing stent 11 can include one or more developing wires. The developing wires can facilitate the observation of the position of the thrombus-removing stent 11 in the blood vessel.

[0051] The third embodiment

[0052] As shown in Figures 6-7 The structure of the blood vessel clearing device of the third embodiment is substantially the same as that of the second embodiment, and the main difference is that the mesh holes of the thrombus-removing stent 11 of the second embodiment are uniformly distributed, while the mesh holes of the thrombus-removing stent of the third embodiment adopt a structure of being dense at the distal end and sparse at the proximal end.

[0053] In this embodiment, the thrombus-removing stent 11 includes a distal end dense mesh woven segment 111 and a proximal end sparse mesh woven segment 112 which are smoothly connected. The proximal end sparse mesh woven segment is beneficial to stripping and capturing large thrombus, and the distal end dense mesh woven segment is beneficial to preventing thrombus fragments from escaping.

[0054] In combination with Figures 1-7 The method for using the blood vessel opening device of this embodiment is as follows:

[0055] In the thrombectomy interventional operation treatment, an interventional channel is established in the femoral artery (vein) blood vessel through a puncture needle, a guide wire, a catheter and a small puncture sheath. The guide wire is introduced into the catheter through the blood vessel lumen interventional channel technology to the blood vessel occlusion site, and then selective angiography is performed to determine the blood vessel site of the thrombus. The blood vessel angiography catheter is replaced by the guide wire (the guide wire is introduced into the catheter and then withdrawn). A catheter (i.e. a pre-deployed catheter) is introduced into the blood vessel through the guide wire to approach the thrombus site. A blood vessel opening device is taken out, the blood vessel opening device is emptied by water injection, then the guide wire is passed through the guide wire hole at the head end of the blood vessel opening device, and the blood vessel opening device is introduced along the guide wire to the thrombus site. The balloon is inflated by the inflation device, and the thrombus extraction stent is embedded in the embolic material under the extrusion of the balloon for 1 minute. The balloon is retracted, and the thrombus extraction stent has been embedded in the embolic material. The mesh is retracted by controlling the stent control handle, the hard embolic material is clamped through the retracted mesh, and then the balloon and the thrombus extraction stent are retracted into the pre-deployed catheter, and the embolic material is removed out of the body.

[0056] Based on the above technical solution, the present application has at least the following advantages and positive effects:

[0057] The blood vessel opening device of the embodiment of the present application coaxially arranges the balloon in the thrombus extraction stent, so that the thrombus extraction stent is wrapped outside the balloon, and the axial extension and retraction of the thrombus extraction stent can be controlled by the stent control assembly to adjust the radial size of the thrombus extraction stent. In use, the thrombus extraction stent and the balloon can be in a retracted state to be introduced into the lesion site of the blood vessel. In thrombus extraction, the axial length of the thrombus extraction stent can be shortened to achieve a larger diameter, the hard embolic material in the narrow blood vessel can be expanded by balloon expansion, the embolic material can be introduced into the thrombus extraction stent by retraction of the balloon, then the axial length of the thrombus extraction stent can be controlled to clamp the hard embolic material embedded in the mesh of the thrombus extraction stent, and finally the embolic material can be stripped and taken out of the body by retracting the balloon and the thrombus extraction stent, thereby improving the treatment effect of the blood vessel stenosis caused by the hard embolic material.

[0058] Those skilled in the art can understand that the above embodiments are specific embodiments for implementing the present application, and various changes can be made in form and details in actual application without departing from the spirit and scope of the present application.

Claims

1. A blood vessel opening device, characterized in that, The device comprises: a balloon and a thrombus-removing stent; the thrombus-removing stent is an expandable and contractible stent structure, and the thrombus-removing stent has a plurality of mesh holes; the balloon is coaxially arranged in the thrombus-removing stent, the balloon can drive the thrombus-removing stent to expand, the balloon can contract radially in the internal space of the thrombus-removing stent relative to the thrombus-removing stent, and the thrombus-removing stent can axially extend and contract relative to the balloon; the device further comprises a stent control assembly; the stent control assembly is connected with the thrombus-removing stent and is used for adjusting the axial length of the thrombus-removing stent; the distal end of the balloon is connected with the distal end of the thrombus-removing stent, the proximal end of the thrombus-removing stent can axially slide relative to the balloon; the distal end of the stent control assembly is connected with the proximal end of the thrombus-removing stent and is used for controlling the axial sliding of the thrombus-removing stent to adjust the axial length of the thrombus-removing stent; the stent control assembly comprises a connecting piece and a stent control handle; the distal end of the connecting piece is connected with the proximal end of the thrombus-removing stent, the proximal end of the connecting piece is connected with the stent control handle; the stent control handle is used for controlling the axial movement of the thrombus-removing stent along the balloon through the connecting piece; the device further comprises a distal end filter screen arranged at the distal end of the thrombus-removing stent; the head end of the blood vessel recanalization device has a guide wire hole.

2. The vascular access device of claim 1, wherein, The thrombus-removing stent is an integral stent structure made by a laser cutting process.

3. The vascular access device of claim 1, wherein, The thrombus-removing stent is a mesh stent structure woven by a woven wire.

4. The vascular access device of claim 3, wherein, The thrombus-removing stent comprises a distal end dense mesh woven segment and a proximal end sparse mesh woven segment which are smoothly connected. Or the mesh holes of the thrombus-removing stent are uniformly distributed.

5. The vascular access device of claim 3, wherein the at least one flexible member is configured to be at least partially compressed by the at least one compression member. The woven wire of the thrombus-removing stent comprises a developing wire.

6. The vascular access device of claim 1, wherein, The device further comprises a balloon control assembly used for controlling the expansion and contraction of the balloon; the balloon control assembly comprises a balloon catheter and a balloon handle; the stent control handle has a tubular structure, the balloon catheter is arranged in the tubular structure of the stent control handle, and both ends of the balloon catheter respectively extend out of the tubular structure and are connected with the balloon and the balloon handle.

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