CN113598881B - Intravascular foreign body removal device and assembly - Google Patents

Abstract

The present disclosure provides intravascular foreign object removal devices and assemblies. The intravascular foreign body removal device includes: the bracket body is of a reticular tube structure; the fluff component is arranged on the bracket body and comprises at least two fiber units, and each fiber unit is fixedly connected with the bracket body. The intravascular foreign matter removing device and the intravascular foreign matter removing assembly can utilize the villus assembly to capture foreign matters, effectively prevent escape and residue of the foreign matters, and further obtain a better foreign matter removing 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 intravascular foreign body removal devices and assemblies.

Background

In China, acute cerebral apoplexy is the first leading cause of death and disability. It is counted that about 200 ten thousand people develop new strokes annually in the country, wherein ischemic strokes account for about 85% of all patients.

Once acute ischemic cerebral apoplexy occurs, how to rapidly clear thrombus blocking blood vessels is the key to whether treatment is successful or not, and two conventional treatment methods exist, firstly, thrombus is eliminated through thrombolytic drugs; second, the thrombus is removed by a mechanical thrombus removal device. Arterial and venous thrombolysis is a conventional method for treating acute ischemic stroke, but the method has high requirements on treatment time window, strict requirements on that patients arrive at a hospital to receive relevant treatment within 6 hours from the onset of the disease, has various limitations on medicaments, and has low vascular recanalization rate for the acute ischemic stroke caused by the most serious large vascular occlusion.

Arterial mechanical thrombolysis devices have gained widespread attention because of the following advantages: rapid recanalization, lower bleeding rate and prolonged time window in apoplexy, and has satisfactory clinical effect especially on acute ischemic vascular recanalization of apoplexy caused by large vessel occlusion. Existing intracranial thrombus removing devices generally adopt a net-shaped structure, but the thrombus removing devices have a plurality of problems to be solved, such as low capture rate of small emboli, and the re-embolism of a distal blood vessel is easy to cause. Similar problems exist with other mechanical embolectomy devices, i.e., aspiration catheters.

Therefore, a new technical solution for removing the foreign matters in the blood vessel is needed.

Disclosure of Invention

The present disclosure proposes 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 reticular tube structure;

the fluff component is arranged on the bracket body and comprises at least two fiber units, and each fiber unit is fixedly connected with the bracket body.

In some alternative embodiments, at least a portion of the fiber units in the fluff assembly extend in a direction away from the axis of the stent body.

In some alternative embodiments, the fluff assembly has a conical, cylindrical, funnel-like or spherical shape when deployed.

In some alternative embodiments, the fluff component is disposed at a distal end of the stent body; or alternatively

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

In some alternative embodiments, the fibre unit has a wave-like curvature in the direction of extension.

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 to the stent body, and the distal end of the fiber unit has a rounded profile.

In some alternative embodiments, the fiber units are made of metal or polymer;

in some alternative embodiments, the fiber units are developable.

In some alternative embodiments, the fluff assembly has an outer diameter when deployed that is greater than an inner diameter of the target vessel.

In some alternative embodiments, the stent body includes at least one expansion, the expansion having an intermediate portion with an outer diameter greater than the outer diameter of the ends of the expansion.

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

In some alternative embodiments, each of the wavy filaments is of equal 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 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 the stent body and the fluff 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 dissolvable gathering member.

In intravascular foreign matter remove device and subassembly that this disclosed embodiment provided, through set up the fine hair subassembly on the support body, can utilize the fine hair subassembly to catch the foreign matter, effectively prevent the escape and the residual of foreign matter to obtain better foreign matter removal effect. In addition, the fluff assembly is also capable of cleaning the vessel wall.

In the intravascular foreign matter removal device and the intravascular foreign matter removal assembly provided by the embodiment of the disclosure, when the intravascular foreign matter removal device is withdrawn, the withdrawing force acts on the bracket body instead of the fluff assembly, so that the retraction force can be avoided to shrink the fluff assembly, the fluff assembly is ensured to have a larger capturing area, and the foreign matter capturing effect is improved.

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

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present disclosure, the following will briefly introduce the drawings that are needed to be used in the description of the embodiments of the present disclosure; the accompanying drawings, which are included to provide a further understanding of the disclosure, illustrate and explain the present disclosure, and together with the description serve to explain the present disclosure.

Fig. 1 to 11 are first to eleventh diagrams of an intravascular foreign body removal device according to an embodiment of the disclosure;

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

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

Reference numerals illustrate: 100. an intravascular foreign body removal device; 110. a fluff assembly; 111. a fiber unit; 120. a bracket body; 121. an expansion section; 122. a constriction; 123. a wavy yarn; 124. radial gathering points; 300. a human blood vessel; 400. a guide wire; 500. a catheter.

Detailed Description

The present disclosure is described in further detail below with reference to the drawings and examples. It is to be understood that the specific embodiments described herein are merely illustrative of the invention and are not limiting of the invention. It should be noted that, for convenience of description, only the portions related to the present 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," and the like indicate orientations or positional relationships, which are merely for convenience in describing the present disclosure and simplifying the description, and do not indicate or imply that the devices or elements being referred to must have a particular orientation, be configured and operated in a particular orientation, 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 should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium. The specific meaning of the terms in this disclosure will be understood by those of ordinary skill in the art as the case may be.

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

The disclosed embodiments provide an intravascular foreign object removal device 100. Fig. 1 to 11 are first to eleventh diagrams of an intravascular foreign body removal device 100 according to an embodiment of the disclosure.

As shown in fig. 1, the intravascular foreign body removal device 100 in this embodiment includes a stent body 120 and a fluff assembly 110. The stent body 120 is a net-shaped tube structure, which may be formed by braiding or engraving. The fluff assembly 110 is disposed on the holder body 120. Both the holder body 120 and the pile assembly 110 are deformable so as to be folded when delivered to a human body and unfolded when reaching a foreign body site.

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

Fig. 2 is an enlarged view of the fluff assembly 110 of fig. 1. As shown in fig. 2, the fluff assembly 110 comprises at least two fiber units 111. Each fiber unit 111 may be a continuous filament-like member and may have a certain elasticity. Each fiber unit 111 is fixedly connected to the holder body 120. The connection between the fiber unit 111 and the stent body 120 may be adhesive, welded, or integrally formed.

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 be developable for developing registration during transport. In other embodiments, the fiber unit 111 may not have developability, but rather rely on other development components (e.g., a development component provided on the stent body 120) to determine the position of the intravascular foreign object removal device 100.

As shown in fig. 2, at least a portion of the fiber units 111 in the fluff assembly 110 extend away from the axis of the stent 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 rightward and upward from the fixing point on the left side so as to gradually be distant from the axis of the stent body 120. Similarly, the fiber units 111 below the axis of the stent body 120 in fig. 2 extend from the left fixed point to the right downward, gradually away from the axis of the stent body 120. In the above manner, the fiber unit 111 can form an effective projection area on the cross section of the blood vessel, which is advantageous in improving the capturing effect of the foreign matter.

Fig. 3 is a variation of the fluff assembly 110 of fig. 2. The fluff component 110 in fig. 3 differs from the fluff component 110 in fig. 2 in that the fiber units 111 of the fluff component 110 in fig. 3 have a wavy curved structure in the extending direction.

Fig. 4 is an enlarged view of the fiber unit 111 in fig. 3. As shown in fig. 4, the degree of relief of the proximal end of the fiber unit 111 is smaller than the degree of relief of the distal end of the fiber unit 111. Generally, the end near the operator may be referred to as the proximal end and the end opposite thereto may be referred to as the distal end. In fig. 4, the left end of the fiber unit 111 is the proximal end, and the right end of the fiber unit 111 is the distal end. The degree of undulation of the fiber units 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. In this way, the fluff component 110 can form a uniform and fine capturing volume, and the capturing effect on the foreign matters can be improved.

In fig. 4, the proximal end of the fiber unit 111 is adapted 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 body removal device 100 enters the blood vessel.

The pile assembly 110 in this embodiment may have a variety of profiles. As shown in fig. 2 and 3, the fluff assembly 110 includes a tapered surface in its deployed profile. As shown in fig. 5, the fluff assembly 110 includes two opposing tapered surfaces in its deployed configuration. As shown in fig. 6, the fluff assembly 110 comprises a spherical surface in its outer shape when deployed. As shown in fig. 7, the fluff component 110 comprises a cylindrical surface in its outer shape when deployed. In addition, the pile assembly 110 may have other profiles, which are not limited by the present disclosure.

Fig. 8 shows a modification of the intravascular foreign body removal device 100 of fig. 1. In fig. 1, an intravascular foreign body removal device 100 includes a fluff assembly 110 at a distal end of a stent body 120. In fig. 8, however, the endovascular foreign body removal device 100 includes a plurality of fluff assemblies 110 at the distal end of the stent body 120 and at a plurality of locations between the distal and proximal ends of the stent body 120, respectively.

Fig. 9 shows a modification of the intravascular foreign body removal device 100 of fig. 1. In fig. 1, the stent body 120 has a cylindrical shape. In fig. 9, the stent body 120 has a bead-shaped outer 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 woven or engraved in a variety of ways.

Fig. 10 shows a modification of the intravascular foreign body removal device 100 of fig. 9. In fig. 9, the stent body 120 is obtained by braiding, engraving, or the like. Whereas in fig. 10, the stent body 120 includes a plurality of wavy filaments 123. The material of the wavy wire 123 is, for example, a memory metal alloy wire or a polymer material. The plurality of wavy filaments 123 collectively form a filament bundle. At least two radial gathering points 124 are arranged on the wire bundle, 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 filament bundle.

In some embodiments, the radial collection points 124 may be annular members that are developable to enable the visualization positioning of the intravascular foreign body removal device 100.

In fig. 10, the rightmost end of the filament bundle is open, forming a fluff assembly 110 between the rightmost radial gathering point 124 and the rightmost end of the filament bundle. As can be seen, the bracket body 120 and the fluff assembly 110 in fig. 10 are integrally formed.

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

Fig. 12 is a schematic view of foreign matter removal using the intravascular foreign matter removal device 100 of an embodiment of the disclosure. As shown in fig. 12, the endovascular foreign body removal device 100 is delivered into a human blood vessel 300 in use, after which the endovascular foreign body removal device 100 is withdrawn. When withdrawn, the stent body 120 can bring the body of the foreign matter out of the blood vessel, and the fluff assembly 110 can catch and bring out smaller foreign matter, thereby obtaining a good foreign matter removal effect.

In the intravascular foreign object removal device 100 provided in the embodiments of the present disclosure, by disposing the fluff assembly 110 on the stent body 120, foreign objects can be captured by using the fluff assembly 110, and escape and residue of the foreign objects can be effectively prevented, thereby obtaining a better foreign object removal effect. In addition, the fluff assembly 110 is also capable of cleaning the vessel wall.

In the intravascular foreign object removal device 100 provided in the embodiments of the present disclosure, when the intravascular foreign object removal device 100 is withdrawn, the withdrawing force acts on the stent body 120 instead of the fluff component 110, so that the retraction force can be avoided to shrink the fluff component 110, the fluff component 110 is ensured to have a larger capturing area, and the foreign object capturing effect is improved.

In addition, in the intravascular foreign body removal device 100 provided by the embodiment of the present disclosure, a gap for blood circulation exists between the fiber units 111 of the fluff assembly 110, and foreign bodies can be removed without blocking the blood flow, thereby reducing the risk of surgery.

The disclosed embodiments also provide an intravascular foreign body removal assembly. Fig. 13 is a schematic view of an intravascular foreign body removal assembly according to an embodiment of the disclosure.

As shown in fig. 13, the foreign matter removal assembly in the present embodiment includes a guide wire 400, a catheter 500, and the intravascular foreign matter removal device 100 described previously. The distal end of the guide wire 400 is fixedly connected to the endovascular foreign body removal device 100. The guide wire 400 and the endovascular foreign body removal device 100 are positioned within the catheter 500, with the stent body 120 and the fluff assembly 110 of the endovascular foreign body 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 adjacent to a foreign object, and the endovascular 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 disengaged from the catheter 500 and deployed. Thereafter, the foreign matter removal device 100 may be withdrawn by pulling the guide wire 400, and foreign matter in the blood vessel is carried away by the foreign matter removal device 100.

In some embodiments, the proximal end of the fluff assembly 110 may be fixedly connected to the stent body 120, and the distal end of the fluff assembly 110 may be provided with a dissolvable gathering member (not shown in fig. 13). The distal end of the fluff assembly 110 can be gathered by a dissolvable gathering member to reduce resistance during delivery. After delivery in place, the dissolvable gathering component is dissolvable in the blood, allowing for smooth release of the fluff assembly 110.

Specific details and technical effects of the foreign matter removal assembly in the embodiments can be found in the foregoing description of the foreign matter removal device, and the detailed description thereof will be omitted.

The foreign matter removal device and the assembly according to the present embodiment can be applied to any type of blood vessel in the human body such as aorta, iliac arteries, femoral arteries, subclavian veins, aortic arch arteries, coronary arteries, carotid arteries, etc., and the present disclosure is not limited thereto. The foreign body removing apparatus and the assembly according to the present embodiment can be used to remove various types of intravascular foreign bodies such as thrombus, which is not limited in the present disclosure.

The foregoing description is only of the preferred embodiments of the present disclosure and description of the principles of the technology being employed. It will be appreciated by those skilled in the art that the scope of the invention referred to in this disclosure is not limited to the specific combination of features described above, but encompasses other embodiments in which features described above or their equivalents may be combined in any way without departing from the spirit of the invention. Such as those described above, are mutually substituted with the technical features having similar functions disclosed in the present disclosure (but not limited thereto).

Claims (12)

1. An intravascular foreign body removal device comprising:

the outer shape of the support body is bead-string-shaped, the support body comprises an expansion part and a contraction part which are sequentially arranged, the outer diameter of the middle part of the expansion part is larger than the outer diameters of two ends of the expansion part, the support body comprises a plurality of wavy silk threads, the wavy silk threads jointly 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;

the fluff component is arranged at the far end of the bracket body, the near end of the fluff component is fixedly connected with the bracket body, and the fluff component comprises at least two fiber units, and each fiber unit is fixedly connected with the bracket body.

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

3. The endovascular foreign body removal device of claim 2, wherein the villus assembly is tapered or cylindrical in shape when deployed.

4. The endovascular foreign body removal device of claim 1, wherein the fibrous element has a wavy curved structure in an extension direction.

5. The endovascular foreign body removal device of claim 4, wherein the proximal end of the fibrous unit is less undulating than the distal end of the fibrous unit.

6. The endovascular foreign body removal device of claim 1, wherein the proximal end of the fibrous unit is fixedly connected to the stent body and the distal end of the fibrous unit has a rounded profile.

7. The endovascular foreign body removal device defined in any one of claims 1-6, wherein the fibrous element is a metallic material or a polymeric material.

8. The endovascular foreign body removal device defined in claim 7, wherein the fibrous element is developable.

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

10. The endovascular foreign body removal device defined in any one of claims 1-6, wherein each of the undulating wires is equal in length in a straightened state.

11. An endovascular foreign body removal assembly comprising a guidewire, a catheter, and an endovascular foreign body removal device as defined in any one of claims 1-10:

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 the stent body and the fluff assembly of the intravascular foreign body removal device are in a compressed state.

12. An endovascular foreign body removal assembly as recited in claim 11, wherein the distal end of the pile assembly is provided with a soluble gathering member.