WO2022077781A1

WO2022077781A1 - Drug injection stent and drug injection thrombolytic system comprising same

Info

Publication number: WO2022077781A1
Application number: PCT/CN2020/142279
Authority: WO
Inventors: 黄定国
Original assignee: 上海腾复医疗科技有限公司
Priority date: 2020-10-13
Filing date: 2020-12-31
Publication date: 2022-04-21

Abstract

A drug injection stent (1) and a drug injection thrombolytic system comprising same. The drug injection stent (1) comprises a drug delivery pipe (10), stent bodies (11) capable of elastically expanding in the radial direction, and a thrombus filtering net (12); the stent bodies (11) are fixedly provided on the drug delivery pipe (10); each stent body (11) comprises a plurality of elastic pipes (110) that form a stent structure; the elastic pipes (110) are communicated with the drug delivery pipe (10), and a plurality of drug injection holes (111) are formed on the elastic pipes (110); and the thrombus filtering net (12) is fixedly provided on the drug delivery pipe (10) and located on the distal end of the stent body (11).

Description

Drug-injected stent and drug-injected thrombolytic system including the same

cross reference

This application refers to Chinese Patent Application No. 202011089653.3 filed on October 13, 2020, entitled "Drug injection stent and drug injection thrombolysis system including the same", which is fully incorporated into this application by reference

technical field

The present application relates to the technical field of medical devices, in particular to a drug injection stent and a drug injection thrombolysis system comprising the same.

Background technique

Pulmonary embolism (PE) is a common cardiovascular disease, often caused by thrombus shedding from deep vein thrombosis in the lower extremities. The existing treatment methods for pulmonary embolism mainly include: drug anticoagulation therapy, systemic thrombolysis therapy, interventional local infusion thrombolysis therapy and traditional pulmonary embolism surgery. With the development of endovascular interventional therapy, interventional therapy of pulmonary embolism has become an effective and important treatment method. However, the traditional catheter-based thrombolysis method requires the thrombolysis catheter to be placed in the body for a long time, and requires the use of large doses of thrombolytic agents, which has low thrombolytic efficiency and wastes a large amount of thrombolytic agents.

SUMMARY OF THE INVENTION

The purpose of some embodiments of the present application is to provide a drug injection stent and a drug injection thrombolytic system including the same, by releasing the elastically expandable drug injection stent at the thrombus position, so that the drug injection stent is embedded in the thrombus and then injects the thrombolytic agent , so that the thrombolytic agent can act on the thrombus directly and accurately and in a large area, so that the thrombolytic efficiency can be improved and the thrombolytic agent and the treatment time can be saved.

In order to solve the above technical problems, the embodiments of the present application provide a drug injection stent, including: a drug delivery tube, a radially elastically expandable stent body and a thrombus filter; the stent body is fixed on the drug delivery tube Above, the stent body includes a plurality of elastic tubes forming a stent structure, the elastic tubes communicate with the drug delivery tube, and a plurality of drug injection holes are opened on the elastic tube; the thrombus filter is fixed on the on the drug delivery tube and at the distal end of the stent body.

The embodiments of the present application also provide a drug injection thrombolysis system, including: a delivery assembly, an external drug injection assembly, and the aforementioned drug injection stent; the drug delivery assembly includes a sheath tube and a delivery handle, and the sheath tube fixedly connected with the delivery handle; the drug injection bracket is accommodated at the inner end of the sheath; the external drug injection assembly includes a drug injection connector and a syringe, and the drug delivery tube of the drug injection bracket passes through the infusion tube In the medicine assembly, the outer end of the medicine delivery tube is connected to the medicine injection joint, and the medicine injection joint is connected to the syringe.

The drug injection stent and the drug injection thrombolysis system including the drug injection stent provided in the embodiment of the present application, the drug injection stent includes a stent body fixed on the drug delivery tube, the stent body includes a plurality of elastic tubes forming a stent structure, the elastic tube and the drug delivery tube The pipes are connected, and the elastic pipe is provided with a plurality of injection holes. The drug injection thrombolysis system includes a delivery component and an external drug injection component. The delivery component includes a sheath tube for receiving a drug injection stent and a delivery handle connected to the sheath tube. The external drug injection component includes a drug injection connector and a syringe. Inside the delivery assembly and connected to a drug injection connector, the drug injection connector is connected to a syringe. Therefore, in the embodiment of the present application, the drug-injected stent can be loaded into the sheath, the drug-injected stent can be delivered to the thrombus through the delivery handle, and then the sheath can be retracted through the delivery handle, so that the drug-injected stent can self-expand at the thrombus position. After opening, it is embedded in the thrombus, and then the thrombolytic drug is injected into the drug injection stent through a syringe, so that the thrombolytic drug is accurately sprayed on the thrombus through the drug injection stent, so that the thrombolytic drug acts on the thrombus in a large area, and the thrombolytic efficiency is improved at the same time. It is also beneficial to save the dosage of thrombolytic agents and the treatment time.

In addition, the stent body is a stent unit; and at least one end of each elastic tube of the stent body is communicated with the drug delivery tube; or the stent body includes a plurality of stent units, the plurality of stent units are The drug delivery tubes are arranged in parallel or staggered in the axial direction.

In addition, the drug injection holes are evenly distributed on the elastic tube; wherein, the drug injection holes at each opening position are single holes and/or symmetrically distributed double holes.

In addition, the drug delivery tube is provided with a side hole at the position of the stent body.

In addition, a developing portion for indicating the position of the stent body is provided on the drug delivery tube at the position of the stent body.

In addition, the elastic tube extends helically along the axial direction of the drug delivery tube.

In addition, the stent body is woven from an elastic metal tube or an elastic polymer material tube.

In addition, the sheath is threadedly connected to the delivery handle, and the sheath is an elastic retractable sheath; the diameter of the sheath when it is naturally opened is larger than the diameter of the inlet of the delivery handle.

In addition, the system further comprises: a recovery handle; the recovery handle is slidably connected with the delivery handle, the recovery handle is fixedly connected with the drug injection joint, and the drug delivery tube is passed through the recovery handle.

Description of drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that are used in the description of the embodiments or the prior art. It is understood that the accompanying drawings in the following description It is only an embodiment of the present application, and for those of ordinary skill in the art, other drawings can also be obtained according to the provided drawings without any creative effort.

1 is a schematic structural diagram of a drug injection stent according to an embodiment of the application;

FIG. 2 is a partial enlarged structural schematic diagram of a stent body of a drug injection stent provided by an embodiment;

3 is a schematic diagram of a drug injection state of a drug injection stent provided by an embodiment;

4 is a schematic structural diagram of a stent body provided by another embodiment;

5 is a schematic structural diagram of a stent body provided by yet another embodiment;

6 is a schematic three-dimensional structure diagram of a thrombolysis drug injection system provided by an embodiment;

FIG. 7 is a schematic structural diagram of a thrombolytic drug injection system provided by an embodiment.

In the figure: drug injection stent 1, drug delivery tube 10, side hole 100, stent body 11, elastic tube 110, drug injection hole 111, thrombus filter 12, tip 13, developing part 14, sheath tube 20, delivery handle 21 , Recovery handle 3 , injection joint 41 , syringe 42 .

Detailed ways

In order to make the objectives, technical solutions and advantages of the embodiments of the present application more clear, the various embodiments of the present application will be described in detail below with reference to the accompanying drawings. However, those of ordinary skill in the art can understand that, in the various embodiments of the present application, many technical details are provided for readers to better understand the present application. However, even without these technical details and various changes and modifications based on the following embodiments, the technical solutions claimed in the present application can be realized.

The embodiment of the present application provides a drug injection stent, which is suitable for pulmonary artery thrombus removal treatment. However, it is not limited to this. The drug injection stent in this embodiment can also be applied to thrombus removal treatment of blood vessels in other parts of the human body. As shown in Figures 1 to 3, the drug injection stent 1 includes: a drug delivery tube 10, a radially elastically expandable stent body 11 and a thrombus filter 12. The stent body 11 is fixed on the drug delivery tube 10, the stent body 11 includes a plurality of elastic tubes 110 forming a stent structure, the elastic tubes 110 are communicated with the drug delivery tube 10, and a plurality of drug injection holes 111 are opened on the elastic tube 110 to prevent thrombosis The filter screen 12 is fixed on the drug delivery tube 10 and is located at the distal end of the stent body 11 .

The drug injection stent of this embodiment includes a stent body disposed on the drug delivery tube. The stent body is formed by a plurality of elastic tubes to form a stent structure. The elastic tube is provided with a drug injection hole, and the elastic tube communicates with the drug delivery tube. The inner end of the stent body is also provided with a thrombus filter. The drug injection stent of this embodiment can be used in cooperation with the delivery assembly and the external drug injection assembly. Before use, the drug injection stent can be received in the sheath tube of the delivery assembly, and the drug delivery tube can pass through the sheath tube, the delivery handle, and communicate with the syringe through the drug injection assembly. When in use, the drug-injection stent loaded in the sheath can be delivered to the thrombus by operating the delivery handle, and then the sheath can be withdrawn to release the drug-injection stent. Thrombolytic agent, the thrombolytic agent reaches the elastic tube of the drug injection stent through the drug delivery tube, and is injected into the thrombus through the drug injection hole on the elastic tube. Therefore, in this embodiment, the thrombolytic agent can act on the thrombus accurately and in a large area, thereby improving the efficiency of thrombolysis, and at the same time, it is beneficial to save the dosage of the agent and the treatment time, and the thrombus filter can effectively prevent the small thrombus from escaping to the distal end. Blood vessel.

Optionally, in this embodiment, the stent body 11 may be a stent unit, and at least one end of each elastic tube 110 of the stent body 11 is communicated with the drug delivery tube 10 . Specifically, as shown in FIG. 1 , the main body of the stent unit is approximately cylindrical after being expanded, surrounds and extends axially along the drug delivery tube 10 , but is not limited to this, the stent unit can also be other suitable for processing and injection. shape of medicine.

Optionally, in this embodiment, the stent body 11 may be braided by an elastic metal tube or an elastic polymer material tube or the like. However, it is not limited to this, and the bracket body 11 can also be prepared by 3D printing technology. Wherein, both end openings of the elastic tube can be communicated with the drug delivery tube or the elastic tube is only communicated with the drug delivery tube at one end away from the thrombus screen. In this embodiment, as shown in FIG. 3 , the end opening of the elastic tube 110 may directly communicate with the lumen of the drug delivery tube 10 . However, it is not limited to this, and the elastic tube can be communicated with the drug delivery tube in any other suitable manner.

Furthermore, in this embodiment, the elastic tube 110 extends helically along the axial direction of the drug delivery tube 10 , which not only facilitates the formation of a stable stent structure, but also facilitates the rapid and smooth flow of the drug in the elastic tube. However, it is not limited to this. In some examples, the stent body 11 may include: an elastic tube extending along the axial direction of the drug delivery tube 10 and an elastic tube surrounding the drug delivery tube 10, wherein the drug injection hole 111 may be opened in the axially extending tube. On the elastic tube, the part of the elastic tube surrounding the drug delivery tube may not have a drug injection hole. Optionally, in this embodiment, the drug injection holes are evenly distributed on the elastic tube, wherein the drug injection holes at each opening position are single holes and/or symmetrically distributed double holes. For example, as shown in FIG. 3 , drug injection holes 111 are evenly formed at multiple positions on a single elastic tube 110 , and each position is provided with a drug injection hole 111 . However, it is not limited to this. In some examples, each opening position of the elastic tube 110 may be symmetrically opened with two injection holes, or the single-hole and double-hole injection holes may be alternately distributed on the elastic tube. Wherein, when the drug injection hole is a single hole, all the drug injection holes can be opened on the same side of the elastic tube, or different drug injection holes are distributed on different sides of the elastic tube, which are not specifically limited here. When two drug injection holes are symmetrically opened at the same position on the elastic tube 110 , the uniformity of drug injection can be prevented from being affected by the contact between the drug injection holes and the blood vessel wall. This embodiment does not limit the specific structure of the stent body, as long as the thrombolytic agent can act on the thrombus in a large area.

On the basis of the above embodiments, in some examples, the stent body 11 may further include a plurality of stent units, and the plurality of stent units are arranged in parallel along the axial direction of the drug delivery tube 10 , or arranged staggered along the axial direction of the drug delivery tube 10 . . For example, as shown in FIG. 4 , the bracket body 11 may include two bracket units, and the two bracket units are arranged side by side. As shown in FIG. 5 , the stent body 11 may include three stent units, and the three stent units are arranged staggered in the axial direction of the drug delivery tube. By arranging multiple stent units, the flow path of the medicament in the elastic tube can be significantly shortened, thereby helping to improve the flow speed of the medicament in the drug injection stent.

Optionally, in this embodiment, the thrombus filter 12 is disc-shaped, and the thrombus filter 12 can be braided from an elastic metal tube or a thin tube of medical polymer material. The thrombus filter 12 can be adapted to the shape and size of the blood vessel after self-expansion and expansion, and the mesh of the thrombus filter 12 can be a finer diamond-shaped or approximately diamond-shaped mesh, so that it can effectively filter and intercept the escape of the thrombolytic agent during thrombolysis. thrombus. It should be understood that this embodiment does not specifically limit the mesh shape and size of the thrombus filter.

Optionally, in this embodiment, the drug injection stent 1 may further include a pointed tip 13 disposed at the inner end of the drug delivery tube 10 .

Optionally, in this embodiment, the drug delivery tube 10 is further provided with a side hole 100 at the position of the stent body 11 . The side hole 100 is a through hole, communicated with the lumen of the drug delivery tube 10 , and the thrombolytic agent can be injected into the thrombus axis area through the side hole 100 of the drug delivery tube 10 .

Optionally, in this embodiment, as shown in FIG. 1 , a developing portion 14 for indicating the position of the stent body is further provided on the drug delivery tube 10 at the position of the stent body. As an example and not a limitation, the developing portion 14 may be a ring-shaped structure, so as to facilitate the determination of whether the stent body accurately reaches the thrombus position under the X-ray machine.

The drug injection stent of this embodiment can be automatically deployed after being released at the thrombus position and adapt to the shape and size of the blood vessel, and the thrombolytic agent can be precisely injected on the thrombus through the drug injection hole of the stent body and the side hole of the drug delivery tube, etc. Therefore, it directly acts on the thrombus in a large area, and a smaller dose of the agent can be used to effectively dissolve the thrombosis and clear the thrombus in a short period of time, thereby reducing the operation time and avoiding the risk of major bleeding.

The embodiments of the present application also provide a drug injection thrombolysis system, which can be used for interventional thrombolysis treatment of pulmonary artery embolism, so as to dredge the pulmonary artery blood vessels to restore smooth blood flow. The system includes: a delivery assembly, an external drug injection assembly, and the drug injection stent 1 as described in the previous embodiments. The drug delivery assembly includes a sheath tube 20 and a delivery handle 21. The sheath tube 20 is fixedly connected to the delivery handle 21, and the drug injection stent 1 can be It is accommodated in the inner end of the sheath tube 20. The external drug injection assembly includes a drug injection connector 41 and a syringe 42. The drug delivery tube 10 of the drug injection bracket 1 is passed through the delivery assembly, and the outer end of the drug delivery tube 10 is connected to the drug injection connector 41. The injection connector is connected to the syringe 42 .

Optionally, in this embodiment, the sheath tube 20 is threadedly connected to the delivery handle 21, and the sheath tube 20 is an elastically retractable sheath tube 21, and the diameter of the sheath tube when it is naturally opened is larger than the diameter of the inlet of the delivery handle. When loading the drug injection stent 1 , the sheath tube 20 and the delivery handle 21 can be separated. At this time, the diameter of the sheath tube in the natural state is larger, which facilitates the loading of the drug injection stent 1 . After the drug injection stent 1 is installed, the sheath tube 20 is then screwed into the delivery handle 21. Since the diameter of the inlet of the delivery handle 21 is small, the diameter of the sheath tube will gradually increase as the length of the sheath tube screwed into the delivery handle 21 increases. The diameter of the end of the sheath tube 20 in which the drug injection stent 1 is accommodated is also reduced accordingly. As shown in FIG. 5 , the loading position of the drug injection stent 1 in the sheath tube 20 is the black tube section at the inner end of the sheath tube. During use, the sheath tube 20 is driven to slide in the axial direction by the delivery handle 21, and after the drug injection stent 1 reaches the thrombus position, part of the sheath tube segment is unscrewed out of the delivery sheath tube 21. At this time, the diameter of the sheath tube 20 will automatically change. Then, the delivery handle 21 can be pulled back, and the sheath tube 20 can release the drug injection stent 1 in it after the delivery handle 21 is withdrawn. In this embodiment, the diameter of the diameter of the sheath tube is controlled by the delivery handle, which makes the loading and releasing of the drug injection stent 1 more convenient. However, it is not limited to this, and in some instances, the sheath tube 20 can also be formed in one piece with the delivery handle 21 .

Optionally, the system may further include: a recovery handle 3 , the recovery handle 3 is slidably connected to the delivery handle 21 , the recovery handle 3 is fixedly connected to the drug injection joint 41 , and the drug delivery tube 10 is passed through the recovery handle 3 . The drug delivery tube 10 establishes a drug delivery channel through the drug injection connector 41 and the syringe 42 . This embodiment does not specifically limit the structure of the drug injection joint, and any joint structure capable of connecting the drug delivery tube and the syringe belongs to the protection scope of the present application.

With reference to the accompanying drawings, the using method and steps of the thrombolytic drug injection system of the embodiment of the present application are as follows:

In the minimally invasive interventional treatment of pulmonary embolism to remove thrombus, a device intervention channel is established in the femoral vein through a puncture needle, a guide wire, a catheter and a puncture sheath. The central pulmonary artery catheter was introduced through the endovascular intervention technique, and then selective main pulmonary angiography was performed to determine the vascular site of the pulmonary artery thrombus. The replacement angiography catheter is a guide wire (the guide wire is introduced and then withdrawn from the catheter). The sheath tube 20 loaded with the drug injection stent 1 of the present application is transported to the pulmonary artery thrombus along the guide wire. Under the X-ray machine, the imaging performance of the stent body and the imaging part is used to confirm whether the position of the stent body 11 is at the thrombus. The delivery handle 21 is operable to adjust the position of the stent body 11 so that it completely covers the thrombus. After confirming that the position of the drug injection stent is in place, hold the recovery handle 3 and withdraw the delivery handle 21 so that the drug injection stent 1 is released and then expanded and deployed. The thrombolytic drug is injected into the drug injection joint 41 through a syringe. Since the drug injection joint 41 is connected with the drug delivery tube and the drug injection stent 1, the thrombolytic drug reaching the drug injection stent 1 can be injected from the drug injection stent 1. The drug hole and the side hole of the drug delivery tube are accurately sprayed and act on the thrombus. The thrombolytic agent can promote fibrinolysis and dissolve the thrombus. During the thrombolysis process, the clotted thrombus may fall off due to the action of blood flow and thrombolytic agent. , at this time, the thrombus filter can filter and intercept the clotted thrombus so as to prevent the shedding thrombus from escaping. After the thrombolysis is completed, the drug injection stent 1 and the thrombus filter 12 are recovered together into the sheath tube 20 by holding the delivery handle and pulling the recovery handle, and then withdrawn from the body.

The thrombolytic drug injection system of this embodiment can precisely inject the thrombolytic agent on the thrombus, so as to directly act on the thrombus in a large area. Reduce operation time and avoid the risk of major bleeding.

Although this paper only describes the way of using the drug injection stent in cooperation with the syringe, it should be understood that the drug injection stent disclosed in the embodiments of the present application can also be used in cooperation with other suitable drug injection devices.

Those of ordinary skill in the art can understand that the above-mentioned embodiments are specific examples for realizing the present application, and in practical applications, various changes in form and details can be made without departing from the spirit and the spirit of the present application. scope.

Claims

A drug injection stent, comprising: a drug delivery tube, a radially elastically expandable stent body and a thrombus filter;

The stent body is fixed on the drug delivery tube, the stent body includes a plurality of elastic tubes forming a stent structure, the elastic tubes communicate with the drug delivery tube, and a plurality of injection tubes are opened on the elastic tube. medicine hole;

The thrombus filter is fixed on the drug delivery tube and is located at the distal end of the stent body.
The drug injection stent according to claim 1, wherein the stent body is a stent unit; and at least one end of each elastic tube of the stent body communicates with the drug delivery tube; or

The stent body includes a plurality of stent units, and the plurality of stent units are arranged in parallel or staggered along the axial direction of the drug delivery tube.
The drug injection stent according to claim 1, wherein the drug injection holes are evenly distributed on the elastic tube;

Wherein, the injection holes at each opening position are single holes and/or symmetrically distributed double holes.
The drug injection stent according to claim 1, wherein the drug delivery tube is provided with a side hole at the position of the stent body.
The drug injection stent according to claim 1, wherein a developing part for indicating the position of the stent body is provided on the drug delivery tube at a position of the stent body.
The drug injection stent according to claim 1, wherein the elastic tube extends helically along the axial direction of the drug delivery tube.
The drug injection stent according to claim 1, wherein the stent body is woven from an elastic metal tube or an elastic polymer tube.
A drug injection thrombolysis system, comprising: a delivery assembly, an external drug injection assembly, and the drug injection stent according to any one of claims 1 to 7;

The drug delivery assembly includes a sheath tube and a delivery handle, and the sheath tube is fixedly connected to the delivery handle;

The drug injection support is accommodated in the inner end of the sheath;

The external medicine injection assembly includes a medicine injection joint and a syringe, the medicine delivery tube of the medicine injection bracket is penetrated in the medicine delivery assembly, the outer end of the medicine delivery tube is connected to the medicine injection joint, and the medicine injection A connector connects the syringe.
The drug injection thrombolysis system according to claim 8, wherein the sheath is threadedly connected to the delivery handle, and the sheath is an elastic retractable sheath; the diameter of the sheath when it is naturally opened is larger than the diameter of the sheath The diameter of the inlet of the delivery handle.
The drug injection thrombolysis system according to claim 8, wherein the system further comprises: a recovery handle;

The recovery handle is slidably connected to the delivery handle, the recovery handle is fixedly connected to the drug injection joint, and the drug delivery tube is passed through the recovery handle.