阅读说明：本技术 血栓抽吸装置及其使用方法 (Thrombus aspiration device and using method thereof ) 是由 刘涛 杨舒文 于 2019-05-17 设计创作，主要内容包括：血栓抽吸装置,包括导管组件和导丝组件,导管组件包括：外导管、内导管、支撑网、导管手柄。导丝组件包括：外导丝、内导丝、网篮、导丝手柄。血栓抽吸装置的使用方法,将导管组件缓慢穿入血管内,使支撑网抵达血管内血栓处,推动导管推柄启动支撑网。然后将导丝组件自导丝接口缓慢穿入导管内芯中,直至软头部穿透血栓,网篮整体穿过血栓并到达血栓的另一侧,然后推动导丝推柄启动网篮。最后将导丝组件缓慢向导管组件外拉动,网篮带动血栓向支撑网移动,此时,用注射器向外抽吸,使血栓被吸入导管内芯,然后进入注射器。(Thrombus aspiration device, including catheter subassembly and guide wire assembly, the catheter subassembly includes: outer catheter, interior pipe, support net, pipe handle. The guidewire assembly comprises: outer seal wire, interior seal wire, basket, seal wire handle. The thrombus aspiration device is used by slowly penetrating the catheter component into the blood vessel to make the support net reach the thrombus in the blood vessel and pushing the catheter push handle to start the support net. Then the guide wire component slowly penetrates into the catheter inner core from the guide wire interface until the soft head part penetrates the thrombus, the basket integrally penetrates through the thrombus and reaches the other side of the thrombus, and then the guide wire push handle is pushed to start the basket. And finally, slowly pulling the guide wire assembly out of the guide pipe assembly, driving the thrombus to move towards the support net by the net basket, sucking outwards by using an injector at the moment, sucking the thrombus into the inner core of the guide pipe, and then entering the injector.)

1. Thrombus aspiration device, including catheter subassembly (1) and guide wire subassembly (2), its characterized in that: a catheter assembly (1) includes: an outer catheter (1-1), an inner catheter (1-2), a support net (1-3) and a catheter handle (1-4);

the outer catheter (1-1) comprises a catheter (1-1-1) and a catheter push handle (1-1-2), the inner catheter (1-2) comprises a catheter inner core (1-2-1) and a multi-way interface (1-2-2), the multi-way interface (1-2-2) comprises a guide wire interface (1-2-2-1) and a suction port (1-2-2-2), the catheter (1-1-1) and the catheter inner core (1-2-1) are both hollow tubes, and the length of the catheter (1-1-1) is smaller than that of the catheter inner core (1-2-1); the supporting net (1-3) is a cylindrical woven net, one end of the supporting net (1-3) is a straight cylindrical net opening, the other end of the supporting net (1-3) is turned inwards to form a funnel-shaped net opening, a coating film (1-3-1) is arranged from the funnel-shaped net opening to the middle part of the supporting net (1-3),

one end of the catheter (1-1-1) is connected with the catheter push handle (1-1-2), the other end of the catheter is connected with a straight cylindrical net opening of the support net (1-3), one end of the catheter inner core (1-2-1) is connected with the multi-way interface (1-2-2), the other end of the catheter inner core penetrates through the outer catheter (1-1) to be connected with a funnel-shaped net opening of the support net (1-3), the outer catheter (1-1) and the catheter inner core (1-2-1) can slide relatively, when the catheter inner core slides, the support net (1-3) contracts along with the increase of the relative distance between the straight cylindrical net opening and the funnel-shaped net opening, and the relative distance is reduced and expanded;

the catheter handle (1-4) is a cylindrical hollow frame and is fixed at the joint of the multi-way interface (1-2-2) and the catheter inner core (1-2-1); the catheter push handle (1-1-2) is positioned in the catheter handle (1-4);

the guidewire assembly (2) comprises: an outer guide wire (2-1), an inner guide wire (2-2), a basket (2-3) and a guide wire handle (2-4); the inner guide wire (2-2) comprises a guide wire inner core (2-2-1), a guide wire push handle (2-2-2) and a soft head part (2-2-3), the guide wire handle (2-4) is of a hollow structure, a slide way (2-4-1) is arranged on the upper surface of the guide wire handle, the outer guide wire (2-1) is of a hollow structure, the inner guide wire (2-2) is of a solid structure, and the length of the outer guide wire (2-1) is smaller than that of the inner guide wire (2-2);

one end of the outer guide wire (2-1) is connected with the guide wire handle (2-4), the other end of the outer guide wire is connected with the basket (2-3), one end of the guide wire inner core (2-2-1) is connected with the guide wire push handle (2-2-2), the other end of the guide wire inner core is connected with the soft head (2-2-3) and penetrates through the inner part of the outer guide wire (2-1), the soft head (2-2-3) penetrates through the basket (2-3) to integrally extend out of the outer guide wire (2-1), the basket (2-3) is a shuttle-shaped woven net, and a beam port at the other end of the basket (2-3) is fixed on the outer surface of the guide wire inner core (2-2-1) and is positioned at the joint of the soft head (2-2-3) and the guide wire inner core (2-2-;

the guide wire push handle (2-2-2) is positioned in the slide way (2-4-1) and can slide in the slide way (2-4-1) and drive the guide wire inner core (2-2-1) to slide in the outer guide wire (2-1), and when the guide wire push handle slides, the net basket (2-3) contracts along with the increase of the relative distance between the soft head (2-2-3) and the outer guide wire (2-1), and the relative distance is reduced and expanded;

the length of the guide wire component (2) is larger than that of the catheter component (1), the guide wire component (2) penetrates through the catheter component (1), and the net basket (2-3) integrally extends out of the catheter component (1).

2. The use method of the thrombus aspiration device according to claim 1, characterized in that: firstly, a support net (1-3) of a catheter component (1) is adjusted to be in a contraction state by pushing a catheter push handle (1-1-2), and a net basket (2-3) of a guide wire component (2) is adjusted to be in a contraction state by pushing a guide wire push handle (2-2-2);

secondly, slowly penetrating the catheter component (1) into the blood vessel (3) to enable the support net (1-3) to reach the thrombus (3-1) in the blood vessel (3), then holding a catheter handle (1-4) to push a catheter push handle (1-1-2) to reduce the distance between the straight cylindrical net opening and the funnel-shaped net opening, so that the support net (1-3) is expanded, the support net (1-3) is converted into a starting state to form support on the wall of the blood vessel (3), and at the moment, a coating (1-3-1) on the support net (1-3) plays a role in blocking a blood vessel passage;

thirdly, slowly penetrating the guide wire assembly (2) into the catheter inner core (1-2-1) from the guide wire interface (1-2-2-1) until the soft head (2-2-3) reaches the thrombus (3-1), continuously pushing the guide wire assembly (2) to enable the soft head (2-2-3) to penetrate through the thrombus (3-1) and enable the basket (2-3) to integrally penetrate through the thrombus (3-1) and reach the other side of the thrombus (3-1), then holding the guide wire handle (2-4) to push the guide wire push handle (2-2-2) to enable the distance between the soft head (2-2-3) and the end part of the outer guide wire (2-1) to be reduced, so that the basket (2-3) is expanded, and the basket (2-3) is converted into a starting state, the edge of the basket (2-3) is propped against the inner wall of the blood vessel (3);

fourthly, slowly pulling the guide wire component (2) out of the guide tube component (1), wherein the net basket (2-3) drives the thrombus (3-1) to move to the supporting net (1-3), at the moment, connecting an injector at the suction port (1-2-2-2), sucking the thrombus (3-1) outwards by using the injector, sucking the thrombus (1-2-1) into the inner core (1-2-1) of the catheter, and then entering the injector;

and fifthly, pushing the catheter push handle (1-1-2) to increase the distance between the straight cylindrical net opening and the funnel-shaped net opening, shrinking the support net (1-3) and recovering the vascular access, then pushing the guide wire push handle (2-2-2) to increase the distance between the soft head (2-2-3) and the end part of the outer guide wire (2-1) to shrink the basket (2-3), and finally slowly pulling out the catheter assembly (1) and the guide wire assembly (2).

Technical Field

The present invention relates to a thrombus aspiration device and methods of use thereof, which can be used to treat coronary arteries, peripheral arteries, pulmonary arteries, and all venous thrombi.

Background

For patients with acute myocardial infarction, timely and effective treatment is most critical; approximately one third of patients die from the acute phase. The current technology has some limitations, which can cause unstable performance and effect. All current thrombectomy catheters have an end or side hole design that functions like a suction tube to aspirate thrombi. Although these catheters enable clot removal, studies have shown that the use of this method results in 30-50% clot remaining and a significant amount of blood being carried through during aspiration, making aspiration very inefficient. Another prior art technique, mechanical thrombectomy, has proven to be very costly and cumbersome to use. In the treatment of ST-segment elevated myocardial infarction, time constraints are critical, and the attractiveness of mechanical devices as the preferred treatment is gradually lost. In addition, both techniques use an invasive aspiration technique that cuts the blood clot into fragments, but the consequence is that the fragments become dislodged, causing embolisms and myocardial damage at downstream locations.

Disclosure of Invention

In view of the defects of the prior art, the invention provides a thrombus suction device and a use method thereof, which adopt a structure of combining a catheter component and a guide wire component, and push thrombus into a funnel-shaped supporting net at the distal end of the catheter component through an expansion basket at the distal end of the guide wire component, so that thrombus blocks can be sucked integrally, the suction efficiency is increased, and the thrombus can be prevented from being broken and falling into a downstream blood vessel to cause injury.

In order to achieve the purpose, the invention adopts the technical scheme that: a thrombus aspiration device includes a catheter assembly and a guidewire assembly.

The method is characterized in that: the catheter assembly includes: outer catheter, interior pipe, support net, pipe handle.

The outer catheter comprises a catheter and a catheter push handle, the inner catheter comprises a catheter inner core and a multi-way interface, the multi-way interface comprises a guide wire interface and a suction port, the catheter and the catheter inner core are hollow tubes, and the length of the catheter is smaller than that of the catheter inner core. The supporting net is a cylindrical woven net, one end of the supporting net is a straight cylindrical net opening, the other end of the supporting net is turned inwards to form a funnel-shaped net opening, a covering film is arranged from the funnel-shaped net opening to the middle part of the supporting net,

one end of the catheter is connected with the catheter pushing handle, the other end of the catheter is connected with a straight cylindrical net opening of the supporting net, one end of the catheter inner core is connected with the multi-way interface, the other end of the catheter inner core penetrates through the outer catheter to be connected with a funnel-shaped net opening of the supporting net, the outer catheter and the catheter inner core can slide relatively, when the catheter inner core slides, the supporting net contracts along with the fact that the relative distance between the straight cylindrical net opening and the funnel-shaped net opening is enlarged, and the relative distance is reduced.

The catheter handle is a cylindrical hollow frame and is fixed at the joint of the multi-way interface and the catheter inner core. The catheter push handle is positioned in the catheter handle.

The guidewire assembly comprises: outer seal wire, interior seal wire, basket, seal wire handle. The inner guide wire comprises a guide wire inner core, a guide wire push handle and a soft head, the guide wire handle is of a hollow structure, the upper surface of the guide wire handle is provided with a slide, the outer guide wire is of a hollow structure, the inner guide wire is of a solid structure, and the length of the outer guide wire is smaller than that of the inner guide wire.

One end of the outer guide wire is connected with the guide wire handle, the other end of the outer guide wire is connected with the net basket, one end of the guide wire inner core is connected with the guide wire push handle, the other end of the guide wire inner core is connected with the soft head and penetrates through the inner portion of the outer guide wire, the soft head penetrates through the net basket to be integrally extended out of the outer guide wire, the net basket is a shuttle-shaped woven net, and a binding port at the other end of the net basket is fixed on the outer surface of the guide wire inner core and located at the joint.

The guide wire push handle is positioned in the slide way and can slide in the slide way, and drives the guide wire inner core to slide in the outer guide wire, and when the guide wire push handle slides, the net basket contracts along with the increase of the relative distance between the soft head and the outer guide wire, and the relative distance is reduced and expanded.

The length of the guide wire component is larger than that of the catheter component, the guide wire component is internally penetrated in the catheter component, and the net basket integrally extends out of the catheter component.

The use method of the thrombus suction device is characterized in that: the first step, the support net of the catheter component is adjusted to be in a contraction state by pushing the catheter push handle, and the net basket of the guide wire component is adjusted to be in a contraction state by pushing the guide wire push handle.

And secondly, slowly penetrating the catheter assembly into the blood vessel to enable the support net to reach the thrombus in the blood vessel, holding the catheter handle to push the catheter push handle to reduce the distance between the straight-tube-shaped net opening and the funnel-shaped net opening, so that the support net expands, the support net turns into a starting state to form a support on the blood vessel wall, and at the moment, the coating on the support net plays a role in blocking the blood vessel passage.

And thirdly, slowly penetrating the guide wire assembly into the catheter inner core from the guide wire interface until the soft head reaches the thrombus, continuously pushing the guide wire assembly to enable the soft head to penetrate through the thrombus, enabling the basket to integrally penetrate through the thrombus and reach the other side of the thrombus, holding the guide wire handle to push the guide wire push handle to enable the distance between the soft head and the end part of the outer guide wire to be reduced, and accordingly expanding the basket, turning the basket into a starting state, and enabling the edge of the basket to abut against the inner wall of the blood vessel.

And fourthly, slowly pulling the guide wire assembly out of the catheter assembly, driving the thrombus to move towards the support net by the net basket, connecting an injector at the suction port, sucking outwards by the injector, sucking the thrombus into the inner core of the catheter, and then entering the injector.

And fifthly, pushing the catheter push handle to increase the distance between the straight cylindrical net port and the funnel-shaped net port, shrinking the support net and recovering the vascular access, then pushing the guide wire push handle to increase the distance between the soft head and the end part of the outer guide wire so as to shrink the basket, and finally slowly pulling out the catheter assembly and the guide wire assembly.

The invention has the beneficial effects that: compared with the single-channel type suction catheter in the prior art, the support net of the catheter assembly can temporarily block blood flow, so that blood does not obstruct the suction of blood clots, and the suction is more concentrated. Moreover, after the blood flow is blocked, the thrombus or residue is not quickly flushed into the downstream blood vessel, which makes the aspiration more complete and the residue less, thereby reducing more damage to the flow of residue into the downstream blood vessel. The expanded support net can support the inner wall of the blood vessel, so that the suction port is arranged at the position opposite to the center of the blood vessel, and the opening of the catheter is prevented from tightly sucking the blood vessel wall in the suction process. The basket of the guidewire assembly can provide sufficient traction to pull the entire thrombus into and through the catheter, which is very effective for removing tissue or recalcitrant thrombus, which is also unattainable by other devices that rely solely on the vacuum suction principle. In addition, during the operation, the catheter component can also support other instruments besides the guide wire component by means of the supporting net structure, and other guide wire instruments can be introduced to operate by means of the supporting function of the catheter component before or after the suction process.

Drawings

FIG. 1 is a schematic view of the thrombus aspiration device of the present invention;

FIG. 2 is a schematic view of a catheter assembly of the present invention;

FIG. 3 is a schematic view of an outer catheter of the present invention;

FIG. 4 is a schematic view of an inner catheter in accordance with the present invention;

FIG. 5 is a schematic view of a guidewire assembly of the present invention;

FIG. 6 is a schematic view of an inner guidewire of the present invention;

FIG. 7 is a schematic view of a guidewire handle of the present invention;

FIG. 8 is a schematic view of the support net of the present invention in an activated state;

FIG. 9 is a schematic view of the basket in an activated state according to the present invention;

FIG. 10 is a schematic view of the support net and the basket in the combined activated state of the thrombus extraction device;

FIG. 11 is a schematic diagram of the method of the present invention.

Detailed Description

As shown in fig. 1 to 10, the thrombus aspiration device includes a catheter assembly 1 and a guide wire assembly 2.

As shown in fig. 1 to 4, and 9 to 10, the catheter assembly 1 includes: 1-1 part of an outer catheter, 1-2 parts of an inner catheter, 1-3 parts of a supporting net and 1-4 parts of a catheter handle.

The outer catheter 1-1 comprises a catheter 1-1-1 and a catheter push handle 1-1-2, the inner catheter 1-2 comprises a catheter inner core 1-2-1 and a multi-way interface 1-2-2, the multi-way interface 1-2-2 comprises a guide wire interface 1-2-2-1 and a suction port 1-2-2-2, the catheter 1-1-1 and the catheter inner core 1-2-1 are hollow tubes, and the length of the catheter 1-1-1 is smaller than that of the catheter inner core 1-2-1. The supporting net 1-3 is a cylindrical woven net, one end of the supporting net 1-3 is a straight cylindrical net opening, the other end is turned inwards to form a funnel-shaped net opening, a covering film 1-3-1 is arranged from the funnel-shaped net opening to the middle part of the supporting net 1-3,

one end of the conduit 1-1-1 is connected with the conduit push handle 1-1-2, the other end is connected with a straight cylindrical net port of the support net 1-3, one end of the conduit inner core 1-2-1 is connected with the multi-pass port 1-2-2, the other end passes through the outer conduit 1-1 to be connected with a funnel-shaped net port of the support net 1-3, the outer conduit 1-1 and the conduit inner core 1-2-1 can slide relatively, when the outer conduit 1-1 and the conduit inner core 1-2-1 slide, the support net 1-3 contracts along with the increase of the relative distance between the straight cylindrical net port and the funnel-shaped net port, and the relative distance.

The catheter handle 1-4 is a cylindrical hollow frame and is fixed at the joint of the multi-way interface 1-2-2 and the catheter inner core 1-2-1. The catheter push handle 1-1-2 is positioned in the catheter handle 1-4.

As shown in fig. 1, 5 to 8, and 10, the guidewire assembly 2 includes: 2-1 parts of an outer guide wire, 2-2 parts of an inner guide wire, 2-3 parts of a net basket and 2-4 parts of a guide wire handle. The inner guide wire 2-2 comprises a guide wire inner core 2-2-1, a guide wire push handle 2-2-2 and a soft head 2-2-3, the guide wire handle 2-4 is of a hollow structure, the upper surface of the guide wire handle is provided with a slide way 2-4-1, the outer guide wire 2-1 is of a hollow structure, the inner guide wire 2-2 is of a solid structure, and the length of the outer guide wire 2-1 is smaller than that of the inner guide wire 2-2.

One end of the outer guide wire 2-1 is connected with the guide wire handle 2-4, the other end is connected with the net basket 2-3, one end of the guide wire inner core 2-2-1 is connected with the guide wire push handle 2-2-2, the other end is connected with the soft head part 2-2-3 and penetrates through the inner part of the outer guide wire 2-1, the soft head part 2-2-3 penetrates through the net basket 2-3 to integrally extend out of the outer guide wire 2-1, the net basket 2-3 is a shuttle-shaped woven net, and the other end opening of the net basket 2-3 is fixed on the outer surface of the guide wire inner core 2-2-1 and is positioned at the joint of the soft head part 2-2-3 and the guide wire inner core 2-2-1.

The guide wire push handle 2-2-2 is positioned in the slide way 2-4-1 and can slide in the slide way 2-4-1 and drive the guide wire inner core 2-2-1 to slide in the outer guide wire 2-1, and when the guide wire push handle slides, the net basket 2-3 contracts along with the increase of the relative distance between the soft head 2-2-3 and the outer guide wire 2-1, and the relative distance is reduced and expanded.

The length of the guide wire assembly 2 is larger than that of the catheter assembly 1, the guide wire assembly 2 is internally threaded into the catheter assembly 1, and the net basket 2-3 integrally extends out of the catheter assembly 1.

As shown in fig. 1 to 11, the thrombus aspiration device is used by: firstly, the support net 1-3 of the catheter component 1 is adjusted to be in a contraction state by pushing the catheter push handle 1-1-2, and the net basket 2-3 of the guide wire component 2 is adjusted to be in a contraction state by pushing the guide wire push handle 2-2-2.

Secondly, slowly penetrating the catheter component 1 into the blood vessel 3 to enable the support net 1-3 to reach the thrombus 3-1 in the blood vessel 3, then holding the catheter handle 1-4 to push the catheter push handle 1-1-2 to reduce the distance between the straight cylindrical net opening and the funnel-shaped net opening, so that the support net 1-3 expands, the support net 1-3 is converted into a starting state to form support on the wall of the blood vessel 3, and at the moment, the coating 1-3-1 on the support net 1-3 plays a role in blocking the blood vessel passage.

Thirdly, slowly penetrating the guide wire assembly 2 into the catheter inner core 1-2-1 from the guide wire interface 1-2-2-1 until the soft head 2-2-3 reaches the thrombus 3-1, continuously pushing the guide wire assembly 2 to enable the soft head 2-2-3 to penetrate through the thrombus 3-1, enabling the basket 2-3 to integrally penetrate through the thrombus 3-1 and reach the other side of the thrombus 3-1, then holding the guide wire handle 2-4 to push the guide wire push handle 2-2-2 to enable the distance between the soft head 2-2-3 and the end part of the outer guide wire 2-1 to be reduced, enabling the basket 2-3 to expand, enabling the basket 2-3 to be in a starting state, and enabling the edge of the basket 2-3 to abut against the inner wall of the blood vessel 3.

Fourthly, the guide wire component 2 is slowly pulled out of the catheter component 1, the net basket 2-3 drives the thrombus 3-1 to move towards the support net 1-3, at the moment, an injector is connected to the suction port 1-2-2-2, the injector is used for sucking outwards, so that the thrombus 3-1 is sucked into the inner core 1-2-1 of the catheter, and then the thrombus enters the injector.

And fifthly, pushing the catheter push handle 1-1-2 to increase the distance between the straight cylindrical net opening and the funnel-shaped net opening, shrinking the support net 1-3 to restore the vascular access, then pushing the guide wire push handle 2-2-2 to increase the distance between the soft head 2-2-3 and the end part of the outer guide wire 2-1 to shrink the basket 2-3, and finally slowly pulling out the catheter component 1 and the guide wire component 2.