CN115804629A

CN115804629A - Intravascular thrombolysis device with far-end collecting basket

Info

Publication number: CN115804629A
Application number: CN202211676595.3A
Authority: CN
Inventors: 王盛章; 赵可佳; 蔡云寒; 孙克玉
Original assignee: Yiwu Research Institute Of Fudan University; Fudan University
Current assignee: Yiwu Research Institute Of Fudan University; Fudan University
Priority date: 2022-12-26
Filing date: 2022-12-26
Publication date: 2023-03-17

Abstract

The invention discloses an intravascular thrombolysis device with a distal collection basket, which relates to the technical field of thrombus treatment and comprises an external wire, a central wire and a distal collection basket; the outer wire, the central wire and the far-end collecting basket are formed by weaving a plurality of wires, and the outer wire, the central wire and the far-end collecting basket are made of nickel-titanium metal wires and have outward self-expanding radial force; the central wire and the outer wire are both hollow and have a structure with micropores in the circumferential direction; the invention cuts thrombus mechanically by the self-expanding stent wire with adjustable radial force, and the small dose thrombolytic agent infused by the micropores of the self-expanding stent wire is helpful to soften thrombus and decompose thrombus; the fragmented thrombus particles are sucked from the micropores by generating negative pressure through the micropores of the stent wire. The far-end collecting basket collects escaped emboli, and complications such as far-end embolism and the like are avoided. The invention realizes the combined action of mechanical cutting and medicine to quickly remove thrombus by a single device, reduces the operation time, has less use amount of the thrombolytic agent and is beneficial to reducing the bleeding risk.

Description

Intravascular thrombolysis device with far-end collecting basket

Technical Field

The invention relates to the technical field of thrombus treatment, in particular to an intravascular thrombolysis device with a distal collection basket.

Background

Venous Thromboembolism (VTE) refers to a condition in which blood is abnormally coagulated in a vein, and the blood vessel is completely or incompletely occluded, which is a venous reflux disease. VTEs include Deep Vein Thrombosis (DVT) and pulmonary arterial thromboembolism (PTE), which are two clinical manifestations of VTEs at different sites and at different stages. DVT is a venous reflux disorder caused by abnormal coagulation of blood in deep veins, and may occur in various parts of the body, often in the deep veins of the limbs. PTE refers to the shedding of thrombi from the venous system or right heart, the blockage of pulmonary arteries or their branches resulting in pulmonary circulation and respiratory venous thromboembolism.

Catheter Direct Thrombolysis (CDT) has been used as an effective therapy for some cases of VTE because it has a rapid thrombolysis effect, which can rapidly relieve symptoms. However, it has a higher risk of bleeding than anticoagulant therapy. Mechanical embolectomy involves open surgery or percutaneous insertion of a catheter-based device to aspirate or macerate the thrombus to remove it. The invasiveness of surgical embolectomy limits its use in VTE patients with compromised limbs. Mechanical embolectomy using intravascular devices such as rotating wires, saline sprays, or ultrasound to disperse or aspirate thrombi is often used in conjunction with chemical thrombolysis because they do not work well alone. And although they can effectively remove thrombus using a rotating wire, a saline jet, etc., they may pose a great risk of injury to the vessel wall. Those methods that rely primarily on vacuum extraction often do not completely remove the thrombus.

Therefore, in view of the above-mentioned disadvantages, it is desirable to provide a thrombolytic device having a low risk of bleeding, a low damage to blood vessels, and a rapid thrombus removal.

Disclosure of Invention

In view of the above-mentioned defects of the prior art, the present invention solves the technical problems that the existing thrombolysis device has poor effect when used alone, and may cause damage to the blood vessel wall, and usually cannot completely remove the thrombus.

To achieve the above objects, the present invention provides an intravascular thrombolytic device with a distal collection basket that is capable of being used alone to effectively remove thrombus.

An intravascular thrombolysis device with a distal collection basket, comprising an outer wire, a central wire and a distal collection basket; wherein the outer wire, the central wire and the distal collection basket are all woven by multiple wires; the outer wires, central wire and distal collection basket have a self-expanding radial force; the central wire and the outer wire are both of hollow structures and are provided with micropores in the circumferential direction.

In a preferred embodiment of the present invention, the outer filaments are woven from multiple filaments, and then the ends are welded together or bundled using round tubes.

In a preferred embodiment of the invention, the distal collection basket is woven from multiple filaments and then welded or bundled at one end using a round tube.

In a preferred embodiment of the invention, the multifilament is a nitinol wire.

In a preferred embodiment of the invention, the radial force of the nitinol wire is increased by pulling the distal collection basket.

In a preferred embodiment of the invention, the central wire is in a natural state when the outer wires are in a compressed state; after the outer filaments self-expand, the outer filaments continue to expand outward by pulling back on the central filament.

In preferred embodiments of the invention, the outer wire is rotated about the central wire to cut thrombus, or the outer wire and the central wire are not rotated relative to each other.

In a preferred embodiment of the present invention, the distal collection basket is separated into two parts from the central and outer filaments, or the distal collection basket is bundled together with the central and outer filaments by welding or using a round tube as a whole.

In a preferred embodiment of the invention, the size of the micropores on the central and outer filaments is variable and the spacing between micropores is non-uniform.

In a preferred embodiment of the present invention, the distribution of micropores is a central dense distribution with both ends distributed.

In another preferred embodiment of the present invention, when using the intravascular thrombolytic device with a distal collecting basket, after the entire device is placed at the site of the thrombus, the distal collecting basket self-expands first, after which the outer wire self-expands to cut the thrombus, and the outer wire is further expanded to cut the thrombus by pulling back the central wire. Pharmacological agents are injected into the thrombus through the central and outer filaments to soften and dissolve the thrombus. Finally, undissolved residual thrombus is captured by the outer wire and the fragmented thrombus particles are aspirated from the micropores using negative pressure.

Technical effects

The intravascular thrombolysis device with the distal collection basket provided by the invention has the following technical effects:

1. the thrombus is mechanically cut by the self-expanding stent wire with adjustable radial force, which is beneficial to the medicine to act on the thrombus in a larger area;

2. the small dose thrombolytic agent infused by the self-expanding stent wire is helpful to soften and decompose thrombus; meanwhile, a small amount of thrombolytic agent reduces the bleeding risk;

3. the intravascular thrombolysis device with the far-end collection basket can act independently, so that thrombus can be quickly removed under the combined action of mechanical cutting and medicines, and the operation time is shortened;

4. escaping emboli are collected through the dense net collecting basket, and complications such as far-end emboli are avoided;

5. through the variable sizes of the micropores on the central wire and the outer wire and the uneven distribution of the micropore intervals, the metering adjustment of the thrombolytic agent and the suction of the fragmented thrombus particles through negative pressure can be realized simultaneously.

Drawings

FIG. 1 is a schematic diagram of a thrombolytic device;

fig. 2 is a three-dimensional view of the thrombolytic device in a fully self-expanded state.

FIG. 3 is a schematic view of a micropore

Detailed Description

The technical contents of the preferred embodiments of the present invention will be more clearly and easily understood by referring to the drawings attached to the specification. The present invention may be embodied in many different forms of embodiments and the scope of the invention is not limited to the embodiments set forth herein.

In the drawings, structurally identical elements are represented by like reference numerals, and structurally or functionally similar elements are represented by like reference numerals throughout the several views. The size and thickness of each component shown in the drawings are arbitrarily illustrated, and the present invention is not limited to the size and thickness of each component. The thickness of the components may be exaggerated where appropriate in the figures to improve clarity.

An intravascular thrombolysis device with a distal collection basket of the present embodiment, as shown in fig. 1, includes a thrombus capture assembly, a distal collection basket 1, an outer wire 2, and a central wire 3. Wherein, the outer silk 2 and the central silk 3 are provided with micropores 4. The distal collection basket 1, the outer filaments 2, and the central filament 3 are all woven from multiple filaments, the woven stent is processed from shape memory alloy, has a certain self-expansion capability after heat setting, can be crimped into a microcatheter, and recovers the structure in fig. 2 after release.

The external wires 2 are woven by multiple wires, and then the head end and the tail end of the external wires are respectively welded together or bundled together by using round tubes. The distal collection basket may also be woven from multiple filaments, and then welded or bundled using a round tube at one end.

The distal collection basket 1 may be separated into two parts from the central and

outer filaments

3, 2 or may be welded together or bundled as a unit using round tubes.

As shown in fig. 1 and 2, the outer wire 2 and the central wire 3 are both hollow and have micropores 4 distributed circumferentially for injecting a pharmacological agent to macerate and soften and dissolve thrombi. Wherein the circumferentially distributed micro-holes 4 may be unevenly distributed in the outer and central filaments. The micropores are distributed more densely in the center, spread at both ends and less in the center.

When the device is used, the whole device is placed at the thrombus position, the distal collection basket 1 firstly self-expands, then the outer wire 2 self-expands to cut the thrombus, and the outer wire 2 is driven to further expand to cut the thrombus by pulling back the central wire 3. Pharmacological agents are injected into the thrombus through the micropores 4 of the central wire 3 and the outer wires 2 to macerate and soften the thrombus and dissolve the thrombus. Finally, the undissolved residual thrombus is captured by the distal collection basket 1 and the fragmented thrombus particles are aspirated under negative pressure from the micropores 4 on the outer wire 2 and the central wire 3.

In a preferred embodiment of the invention, the shape memory alloy is nitinol.

When the external wires are in a compressed state, the central wire is in a natural state; after the outer filaments are self-expanding, the outer filaments may continue to expand outward by pulling back on the central filament.

In another embodiment of the present invention, the outer wire may be rotated about the central wire to cut the thrombus.

In another embodiment of the present invention, the outer wire may not rotate relative to the central wire.

The foregoing detailed description of the preferred embodiments of the invention has been presented. It should be understood that numerous modifications and variations could be devised by those skilled in the art in light of the present teachings without departing from the inventive concepts. Therefore, the technical solutions available to those skilled in the art through logic analysis, reasoning and limited experiments based on the prior art according to the concept of the present invention should be within the scope of protection defined by the claims.

Claims

1. An intravascular thrombolysis device with a distal collection basket, comprising an outer wire, a central wire and a distal collection basket; wherein the outer wire, the central wire and the distal collection basket are all woven by multiple wires; the outer wires, the central wire and the distal collection basket have a self-expanding radial force; the central wire and the external wire are both of hollow structures, and micropores are distributed in the circumferential direction.

2. The thrombolytic device of claim 1, wherein the outer filaments are woven from a plurality of filaments and then welded together at their ends or bundled using a circular tube.

3. The thrombolytic device of claim 1, wherein the distal collection basket is woven from multiple filaments and then welded at one end or bundled using a circular tube.

4. The thrombolytic device of claim 1, wherein the multifilament is a nitinol wire.

5. The thrombolytic device of claim 1, wherein the radial force of the nitinol wire is increased by pulling the distal collection basket.

6. The thrombolytic device of claim 1, wherein the central wire is in a natural state when the outer wire is in a compressed state; after the outer filaments self-expand, the outer filaments continue to expand outward by pulling back on the central filament.

7. The thrombolytic device of claim 1, wherein the outer wire rotates about the central wire to cut the thrombus or the outer wire and the central wire do not rotate relative to each other.

8. The thrombolytic device of claim 1, wherein the distal collection basket is separated into two parts from the central and outer filaments, or the distal collection basket is bundled as a whole with the central and outer filaments by welding or using a circular tube.

9. The thrombolytic device of claim 1, wherein the pores of the central and outer filaments are variable in size and non-uniform in pore spacing.

10. The thrombolytic device of claim 9, wherein the distribution of micropores is centrally dense with both ends interspersed.