CN113598881A

CN113598881A - Intravascular foreign body removal device and assembly

Info

Publication number: CN113598881A
Application number: CN202111042807.8A
Authority: CN
Inventors: 高洪亮; 梁栋; 吕怡然
Original assignee: Aike Medical Devices Beijing Co ltd
Current assignee: Aike Medical Devices Beijing Co ltd
Priority date: 2021-09-07
Filing date: 2021-09-07
Publication date: 2021-11-05
Anticipated expiration: 2041-09-07
Also published as: CN113598881B

Abstract

The present disclosure provides intravascular foreign body removal devices and assemblies. The intravascular foreign matter removal device includes: the bracket body is of a net pipe structure; the fluff assembly is arranged on the support body and comprises at least two fiber units, and each fiber unit is fixedly connected with the support body. This endovascular foreign matter remove device and subassembly can utilize the fine hair subassembly to catch the foreign matter, effectively prevents the escape and the residue of foreign matter to obtain better foreign matter and remove the effect.

Description

Intravascular foreign body removal device and assembly

Technical Field

The present disclosure relates to the field of medical devices, and in particular to an intravascular foreign body removal device and assembly.

Background

In China, acute stroke is the third leading cause of death and the first cause of disability. Statistically, about 200 million new stroke occur annually in the country, with ischemic stroke accounting for about 85% of all patients.

Once acute cerebral arterial thrombosis occurs, how to quickly remove thrombus blocking blood vessels is the key of successful treatment, and two conventional treatment methods are adopted, namely firstly, the thrombus is eliminated through thrombolytic drugs; second, the thrombus is removed by a mechanical thrombectomy device. The artery and vein thrombolysis is a conventional method for treating acute ischemic stroke, but the method has high requirement on the treatment time window, strictly requires that patients arrive at hospitals within 6 hours from illness to receive related treatment, has a plurality of limitations on medicaments, and has low recanalization rate of the acute ischemic stroke blood vessel caused by the most serious large blood vessel occlusion.

Mechanical arterial thrombectomy devices have gained widespread attention because of the following advantages: the rapid recanalization, the lower bleeding rate and the prolongation of the time window of the stroke intervention, and particularly has satisfactory clinical effect on the acute ischemic stroke vascular recanalization caused by the occlusion of large blood vessels. The existing intracranial thrombus extraction devices usually adopt a net structure, but the thrombus extraction devices have a plurality of problems to be solved, such as low capture rate of small embolus and easy reocclusion of a far-end blood vessel. Similar problems exist with another type of mechanical embolectomy device, the aspiration catheter.

Therefore, there is a need to provide a new solution for removing the intravascular foreign object.

Disclosure of Invention

The present disclosure presents intravascular foreign body removal devices and assemblies.

In a first aspect, the present disclosure provides an intravascular foreign object removal device comprising:

the bracket body is of a net pipe structure;

the support comprises a support body, a fluff assembly and a fixing device, wherein the fluff assembly is arranged on the support body and comprises at least two fiber units, and each fiber unit is fixedly connected with the support body.

In some alternative embodiments, at least some of the fiber units in the pile assembly extend away from the axis of the carrier body.

In some alternative embodiments, the pile assemblies have a conical, cylindrical, funnel-like, or spherical shape when deployed.

In some alternative embodiments, the pile assembly is disposed at the distal end of the stent body; or

The fluff assembly is disposed between the proximal and distal ends of the stent body.

In some alternative embodiments, the fiber unit has a wavy curved structure in the extending direction.

In some alternative embodiments, the proximal end of the fiber unit undulates less than the distal end of the fiber unit.

In some alternative embodiments, the proximal end of the fiber unit is fixedly connected with the stent body, and the distal end of the fiber unit has a rounded profile.

In some optional embodiments, the fiber unit is made of a metal material or a polymer material;

in some alternative embodiments, the fiber unit is developable.

In some alternative embodiments, the outer diameter of the villus assembly when deployed is greater than the inner diameter of the target vessel.

In some alternative embodiments, the stent body includes at least one expansion portion, and an outer diameter of a middle portion of the expansion portion is larger than outer diameters of both ends of the expansion portion.

In some optional embodiments, the stent body comprises a plurality of wavy wires, the wavy wires together form a wire bundle, at least two radial furling points are arranged on the wire bundle, and the expansion part is formed between two adjacent radial furling points.

In some alternative embodiments, each of the undulating wires is equal in length in the straightened state.

In a second aspect, the present disclosure provides an intravascular foreign object removal assembly, comprising a guidewire, a catheter, and an intravascular foreign object removal device as described in any embodiment of the first aspect of the present disclosure:

the distal end of the guide wire is fixedly connected with the intravascular foreign body removal device;

the guide wire and the intravascular foreign body removal device are positioned in the catheter, and a stent body and a villus assembly of the intravascular foreign body removal device are in a compressed state.

In some alternative embodiments, the proximal end of the fluff assembly is fixedly connected to the stent body, and the distal end of the fluff assembly is provided with a soluble gathering member.

In the intravascular foreign matter removal device and the assembly provided by the embodiment of the disclosure, the fluff assembly is arranged on the bracket body, so that foreign matters can be captured by the fluff assembly, the foreign matters are effectively prevented from escaping and remaining, and a better foreign matter removal effect is obtained. In addition, the villus assembly can also clean the vessel wall.

In the intravascular foreign matter removal device and the assembly provided by the embodiment of the disclosure, when the intravascular foreign matter removal device is withdrawn, the withdrawal force acts on the stent body instead of the fluff assembly, so that the fluff assembly can be prevented from contracting due to the withdrawal force, the fluff assembly is ensured to have a larger capture area, and the foreign matter capture effect is improved.

In addition, in the intravascular foreign matter removal device and assembly provided by the embodiment of the disclosure, gaps for blood to flow through exist among the fiber units of the fluff assembly, so that foreign matters can be taken out without blocking blood flow, and the risk of operation is reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings used in the description of the embodiments of the present disclosure will be briefly introduced below; the accompanying drawings, which are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this disclosure, illustrate embodiments of the disclosure and together with the description serve to explain the disclosure and not to limit the disclosure.

Fig. 1-11 are first through eleventh schematic views of an intravascular foreign object removal device according to an embodiment of the present disclosure;

fig. 12 is a schematic view of foreign matter removal using the intravascular foreign matter removal device of the embodiment of the present disclosure;

fig. 13 is a schematic view of an intravascular foreign object removal assembly according to an embodiment of the present disclosure.

Description of reference numerals: 100. an intravascular foreign body removal device; 110. a pile component; 111. a fiber unit; 120. a stent body; 121. an expansion part; 122. a constriction; 123. a wavy filament; 124. a radial furling point; 300. a human blood vessel; 400. a guide wire; 500. a conduit.

Detailed Description

The present disclosure is described in further detail below with reference to the accompanying drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the relevant invention and not restrictive of the invention. It should be noted that, for convenience of description, only the portions related to the related invention are shown in the drawings.

In the description of the present disclosure, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate orientations or positional relationships and are only used for convenience in describing the present disclosure and simplifying the description, but do not indicate or imply that the referred device or element must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present disclosure. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.

In the description of the present disclosure, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and the like are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present disclosure can be understood by those of ordinary skill in the art as appropriate.

In the description of the present disclosure, it should be noted that the embodiments and features of the embodiments in the present disclosure may be combined with each other without conflict.

The disclosed embodiment provides an intravascular foreign object removal device 100. Fig. 1-11 are first through eleventh schematic views of an intravascular foreign material removal device 100 according to an embodiment of the present disclosure.

As shown in fig. 1, the intravascular foreign substance removal device 100 in the present embodiment includes a stent body 120 and a fur assembly 110. The stent body 120 has a mesh tube structure, which may be formed by weaving or engraving. The pile assembly 110 is disposed on the holder body 120. Both the stent body 120 and the pile assembly 110 are deformable to be collapsed for delivery to the body and to be expanded upon reaching a foreign body site.

In this embodiment, the outer diameter of the villus assembly 110 when deployed is larger than the inner diameter of the target vessel to ensure that the villus assembly 110 can capture foreign matter within the target vessel. In some embodiments, the outer diameter of the villus assembly 110 when deployed can be 1-2 times the inner diameter of the target vessel.

Fig. 2 is an enlarged view of the pile assembly 110 of fig. 1. As shown in fig. 2, the pile assembly 110 includes at least two fiber units 111. Each fiber unit 111 may be a continuous filament-like member and may have some elasticity. Each fiber unit 111 is fixedly connected to the holder body 120. The connection between the fiber unit 111 and the holder body 120 may be made by bonding, welding, or integration.

In this embodiment, the fiber unit 111 may be made of a metal material, a polymer material, or the like. The fiber unit 111 may also have developability to allow for development positioning during transport. In other embodiments, the fiber unit 111 may not have developability, but rely on other development components (e.g., a development component disposed on the stent body 120) to determine the position of the intravascular foreign material removal device 100.

As shown in fig. 2, at least some of the fiber units 111 in the pile assemblies 110 extend in a direction away from the axis of the carrier body 120 (shown in phantom in fig. 2). For example, the fiber unit 111 above the axis of the stent body 120 in fig. 2 extends from the fixing point on the left side to the upper right, gradually moving away from the axis of the stent body 120. Similarly, the fiber unit 111 below the axis of the stent body 120 in fig. 2 extends rightward and downward from the fixing point on the left side so as to gradually get away from the axis of the stent body 120. Through the mode, the fiber unit 111 can form an effective projection area on the cross section of the blood vessel, and the foreign matter capturing effect is favorably improved.

Fig. 3 is a variation of the wool assembly 110 of fig. 2. The difference between the pile assembly 110 of fig. 3 and the pile assembly 110 of fig. 2 is that the fibre units 111 of the pile assembly 110 of fig. 3 have a wave-like curved structure in the direction of extension.

Fig. 4 is an enlarged view of the fiber unit 111 in fig. 3. As shown in fig. 4, the proximal end of the fiber unit 111 has a smaller degree of undulation than the distal end of the fiber unit 111. Generally, the end near the operator may be referred to as the proximal end, and the opposite end may be referred to as the distal end. In fig. 4, the left end of the fiber unit 111 is a proximal end, and the right end of the fiber unit 111 is a distal end. The degree of undulation of the fiber unit 111 gradually increases in the left-to-right direction. When the shape of the fiber unit 111 is regarded as a waveform, the amplitude of the waveform gradually increases in the left-to-right direction. Through the mode, the fluff component 110 can form a uniform and fine capture volume, and the foreign matter capture effect is improved.

In fig. 4, the proximal end of the fiber unit 111 is used for fixed connection with the stent body 120. The distal end of the fiber unit 111 has a rounded shape to prevent damage to the blood vessel when the intravascular foreign substance removal device 100 is introduced into the blood vessel.

The pile assemblies 110 in this embodiment can have a variety of profiles. As shown in FIGS. 2 and 3, the profile of the pile elements 110 when deployed includes a conical surface. As shown in FIG. 5, the profile of the pile elements 110 when deployed includes two opposing tapered surfaces. As shown in FIG. 6, the profile of the pile assembly 110 when deployed comprises a spherical surface. As shown in FIG. 7, the appearance of the fluff assembly 110 when deployed includes a cylindrical surface. In addition, the pile assemblies 110 may have other configurations as well, which are not intended to be limiting of the present disclosure.

Fig. 8 shows a modification of the intravascular foreign material removal device 100 of fig. 1. In fig. 1, the endovascular foreign object removal device 100 includes a fluff assembly 110 located at a distal end of a stent body 120. In fig. 8, the intravascular foreign material removal device 100 includes a plurality of nap elements 110 at a distal end of a stent body 120 and at a plurality of positions between the distal end and a proximal end of the stent body 120, respectively.

Fig. 9 shows a modification of the intravascular foreign material removal device 100 of fig. 1. In fig. 1, the holder body 120 has a cylindrical shape. In fig. 9, the stent body 120 has a bead-string shape, and includes an expansion portion 121 and a contraction portion 122 arranged in this order. Wherein, the outer diameter of the middle portion of the expansion part 121 is larger than the outer diameters of both ends of the expansion part 121. The stent body 120 may be obtained by various methods such as weaving or carving.

Fig. 10 shows a modification of the intravascular foreign material removal device 100 of fig. 9. In fig. 9, the stent body 120 is obtained by weaving, carving, or the like. Whereas in fig. 10, the stent body 120 includes a plurality of undulating wires 123. The material of the wavy filament 123 is, for example, a memory metal alloy wire or a polymer material. The plurality of wavy filaments 123 collectively form a filament bundle. The wire bundle is provided with at least two radial gathering points 124, and an expansion part 121 is formed between two adjacent radial gathering points 124. The radial gathering point 124 may be a welding point or an annular member sleeved outside the wire harness.

In some embodiments, the radial furl point 124 may be a ring-shaped member with visualization properties to enable visualization positioning of the intravascular foreign material removal device 100.

In fig. 10, the rightmost end of the bundle is open, thereby forming a pile assembly 110 between the rightmost radial gathering point 124 and the rightmost end of the bundle. It can be seen that the holder body 120 and the pile assembly 110 in fig. 10 are integrally formed.

Fig. 11 shows the configuration of the intravascular foreign material removal device 100 in fig. 10 in a stretched (compressed) state. As shown in fig. 11, the length of each wavy filament 123 in the straightened state is the same. In this way, the intravascular foreign object removal device 100 can be folded smoothly, and the outer diameter of the folded intravascular foreign object removal device can be reduced.

Fig. 12 is a schematic view of foreign matter removal using the intravascular foreign matter removal device 100 according to the embodiment of the present disclosure. As shown in fig. 12, the intravascular foreign material removal device 100 is delivered into a human blood vessel 300 during use, and then the intravascular foreign material removal device 100 is withdrawn. When withdrawn, the stent body 120 can carry the main body of the foreign object out of the blood vessel, while the lint assembly 110 can catch and carry out a small foreign object, thereby achieving a good foreign object removal effect.

In the intravascular foreign matter removal device 100 provided by the embodiment of the present disclosure, the floss component 110 is disposed on the stent body 120, so that the floss component 110 can be used to capture foreign matter, and escape and residue of the foreign matter can be effectively prevented, thereby obtaining a better foreign matter removal effect. In addition, the villus assembly 110 is also capable of clearing the vessel wall.

In the intravascular foreign object removal device 100 provided by the embodiment of the disclosure, when the intravascular foreign object removal device 100 is withdrawn, the withdrawal force acts on the stent body 120 instead of the fluff assembly 110, so that the fluff assembly 110 can be prevented from being contracted by the withdrawal force, the fluff assembly 110 is ensured to have a larger capture area, and the foreign object capture effect is improved.

In addition, in the intravascular foreign material removal device 100 provided by the embodiment of the disclosure, gaps for blood to flow through exist among the fiber units 111 of the fluff assembly 110, so that foreign materials can be taken out without blocking blood flow, and the risk of operation is reduced.

Embodiments of the present disclosure also provide an intravascular foreign object removal assembly. Fig. 13 is a schematic view of an intravascular foreign object removal assembly according to an embodiment of the present disclosure.

As shown in fig. 13, the foreign substance removal assembly in the present embodiment includes a guide wire 400, a catheter 500, and the intravascular foreign substance removal device 100 described above. The distal end of the guide wire 400 is fixedly connected to the endovascular foreign object removal device 100. The guide wire 400 and the endovascular foreign object removal device 100 are located within the catheter 500 with the stent body 120 and the villus assembly 110 of the endovascular foreign object removal device 100 in a compressed state.

In use, the catheter 500 may be delivered into a human blood vessel with its distal opening positioned near a foreign object, and the intravascular foreign object removal device 100 is moved distally within the catheter 500 by pushing the guidewire 400 until the foreign object removal device 100 is detached and deployed from within the catheter 500. Thereafter, the foreign substance removal device 100 may be withdrawn by pulling the guide wire 400, and the foreign substance in the blood vessel is carried away by the foreign substance removal device 100.

In some embodiments, the proximal end of the fluff assembly 110 can be fixedly attached to the stent body 120, and the distal end of the fluff assembly 110 can be provided with a dissolvable gathering member (not shown in fig. 13). The distal ends of the fluff assembly 110 can be gathered by a dissolvable gathering member, thereby reducing resistance during delivery. After delivery to the site, the dissolvable gathering member can be dissolved in the blood, allowing for smooth release of the fluff assembly 110.

For the details and technical effects of the foreign object removing assembly in the embodiments, reference is made to the foregoing description of the foreign object removing device, and the description is omitted here.

The foreign matter removing device and the assembly in the embodiment can be applied to any type of blood vessels in a human body, such as aorta, iliac artery, femoral artery, subclavian vein, arch artery, coronary artery and carotid artery, and the disclosure does not limit the foreign matter removing device and the assembly. The foreign matter removing device and the assembly in the embodiment can be used for removing various intravascular foreign matters such as thrombus, and the disclosure is not limited thereto.

The foregoing description is only exemplary of the preferred embodiments of the disclosure and is illustrative of the principles of the technology employed. It will be appreciated by those skilled in the art that the scope of the invention in the present disclosure is not limited to the specific combination of the above-mentioned features, but also encompasses other embodiments in which any combination of the above-mentioned features or their equivalents is possible without departing from the inventive concept as defined above. For example, the above features and (but not limited to) the features disclosed in this disclosure having similar functions are replaced with each other to form the technical solution.

Claims

1. An intravascular foreign material removal device comprising:

the bracket body is of a net pipe structure;

2. The endovascular foreign body removal device defined in claim 1, wherein at least some of the fibrous units in the villus assembly extend in a direction away from the axis of the stent body.

3. The endovascular foreign body removal device defined in claim 2, wherein the profile of the villus assembly when deployed comprises a conical, spherical or cylindrical surface.

4. The endovascular foreign body removal device defined in claim 1, wherein the vitta assembly is disposed at a distal end of the stent body; or

5. The intravascular foreign material removal device according to claim 1, wherein the fiber unit has a wavy curved structure in the extending direction;

preferably, the proximal end of the fibre unit undulates to a lesser extent than the distal end of the fibre unit.

6. The intravascular foreign material removal device of claim 1, wherein a proximal end of the fiber unit is fixedly connected with the stent body, and a distal end of the fiber unit has a rounded profile.

7. The intravascular foreign material removal device according to any one of claims 1 to 6, wherein the fiber unit is made of a metal material or a polymer material;

preferably, the fiber unit has developability.

8. The endovascular foreign body removal device defined in any one of claims 1-6, wherein the villus assembly has an outer diameter when deployed that is greater than an inner diameter of a target vessel.

9. The endovascular foreign body removal device defined in any one of claims 1-6, wherein the stent body comprises at least one expanded portion, an outer diameter of a middle portion of the expanded portion being greater than outer diameters of both ends of the expanded portion;

preferably, the stent body comprises a plurality of wavy silk threads, the wavy silk threads together form a silk thread bundle, at least two radial furling points are arranged on the silk thread bundle, and the expansion part is formed between every two adjacent radial furling points;

preferably, each of said undulating wires is of equal length in the straightened condition.

10. An intravascular foreign material removal assembly comprising a guidewire, a catheter and the intravascular foreign material removal device of any one of claims 1-9:

the guide wire and the intravascular foreign body removal device are positioned in the catheter, and a stent body and a villus assembly of the intravascular foreign body removal device are in a compressed state;

preferably, the proximal end of the fluff assembly is fixedly connected with the stent body, and the distal end of the fluff assembly is provided with a soluble furling component.