WO2023185486A1

WO2023185486A1 - Occlusion stent and delivery system

Info

Publication number: WO2023185486A1
Application number: PCT/CN2023/081806
Authority: WO
Inventors: 刘伟; 王雪琴; 朱京; 杨豪; 卢俊; 岳斌
Original assignee: 上海微创医疗器械（集团）有限公司
Priority date: 2022-03-28
Filing date: 2023-03-16
Publication date: 2023-10-05
Also published as: CN114601521A

Abstract

An occlusion stent (100) and a delivery system (200). A main body unit (500) is cylindrical, and has a proximal opening and a distal opening. An occlusion unit (600) has a proximal opening and a distal occlusion head. The proximal opening of the occlusion unit (600) is connected to the distal opening of the main body unit (500). The end opening area of the proximal opening of the main body unit (500) is larger than the end occlusion area of the distal occlusion head of the occlusion unit (600).

Description

Blocking stents and delivery systems

Related applications

This application claims priority to the Chinese patent application filed on March 28, 2022, with application number 202210312038.7 and titled "Blocking Stent and Delivery System", the full text of which is hereby incorporated by reference.

Technical field

This application relates to the technical field of medical devices, and in particular to a blocking stent and delivery system.

Background technique

Coronary arteries do not pass through the capillary network, but directly communicate with the heart chamber (Cornary-cameral fistual) or large blood vessels (systemic circulation or pulmonary circulation) at any stage. Their pathological and physiological changes are the same, and they can be collectively called coronary arteriovenous fistulas. (Cornary arteriovenous fistula,CAVF), referred to as coronary artery fistula (Cornary artery fistula, CAF)

The target blood vessel of coronary artery fistula is relatively large, often accompanied by vessel tortuosity and tumor-like expansion, and the fistula opening is large. The pathological and physiological manifestations include enlargement of the heart chamber, heart failure, angina pectoris, and arrhythmia. In severe cases, myocardial infarction may occur. The tortuous part of the blood vessel may cause thrombus. Increased blood flow in the proximal coronary artery may induce shear stress-induced intimal damage, leading to coronary atherosclerosis.

At present, the clinical treatment methods for coronary fistula mainly include surgical treatment or percutaneous catheter interventional closure. Percutaneous catheter interventional closure usually uses patent ductus arteriosus occluder mushroom-shaped stent, which is mostly made of nickel. It is made of titanium-cobalt alloy wire and has multiple layers of high-density polyester fiber membrane sewn inside. It will remain in the body for a long time after implantation and can easily cause inflammation and complications. In severe cases, nickel poisoning may occur. Therefore, it is necessary to reduce the volume of the stent and reduce the cost. Side effects on the human body have become an urgent problem that needs to be solved in this field.

Contents of the invention

According to various embodiments of the present application, the present application provides a blocking stent, which includes:

A main unit, which is cylindrical and has a proximal opening and a distal opening; and

Blocking unit, the blocking unit has a proximal opening and a distal plug, the proximal opening of the blocking unit is connected to the distal opening of the main unit, and the end of the proximal opening of the main unit The opening area is larger than the end blocking area of the distal plug of the blocking unit.

In one embodiment, the end opening area of the proximal opening of the main body unit is greater than or equal to the end opening area of the distal opening of the main body unit.

In one embodiment, at least a portion of the main body unit is straight-cylindrical.

In one embodiment, the main body unit is straight-cylindrical.

In one embodiment, at least a portion of the main body unit is cone-shaped.

In one embodiment, the main body unit is cone-shaped.

In one embodiment, a portion of the main body unit located at the proximal end is in the shape of a straight cylinder, and the other portion of the main body unit located at the distal end is in the shape of a conical cylinder.

In one embodiment, the end opening area of the proximal opening of the blocking unit is greater than or equal to the end blocking area of the distal plug of the blocking unit.

In one embodiment, at least a portion of the blocking unit is straight-cylindrical.

In one embodiment, the blocking unit is straight-cylindrical.

In one embodiment, at least a portion of the blocking unit is cone-shaped.

In one embodiment, the blocking unit is cone-shaped.

In one embodiment, the outer wall surface of the blocking unit is linear or curved in the direction from the distal end to the proximal end.

In one embodiment, a plurality of grooves are formed at the distal end of the blocking unit, and the plurality of grooves are circumferentially distributed around the distal end of the blocking unit.

In one embodiment, a portion of the section located at the proximal end of the blocking unit is in the shape of a straight cylinder, and the other section of the blocking unit located at the distal end is in the shape of a cone.

In one embodiment, the end opening area of the distal opening of the main body unit is greater than or equal to the end opening area of the proximal opening of the blocking unit.

In one embodiment, the blocking stent includes:

A deformation unit, the deformation unit is connected to the proximal end of the main body unit, the deformation unit has an expanded state and a contracted state, and the deformation unit is configured to be able to communicate with the proximal end opening of the main body unit in the expanded state. , capable of blocking the proximal opening of the main body unit in the contracted state.

In one embodiment, the expanded state of the deformation unit is a spirally distributed filamentous structure.

In one embodiment, the blocking stent includes:

The main body additional unit is cylindrical and has a proximal opening and a distal opening. The proximal opening of the main body additional unit is connected to the distal plug of the blocking unit. The main body additional unit has a proximal opening and a distal opening. The end opening area of the proximal opening is larger than the end blocking area of the distal plug of the blocking unit.

In one embodiment, the distal plug of the blocking unit is formed by at least one of welding, hot melting, coating, tying, knotting, filling, or solidification.

The present application provides a delivery system, which includes the blocking stent.

The details of one or more embodiments of the present application are set forth in the following drawings and description, and other features, objects, and advantages of the present application will be apparent from the description, drawings, and claims.

Description of drawings

Figure 1 is a schematic diagram of the delivery state of the blocking stent provided by some embodiments of the present application;

Figure 2 is a schematic diagram of the delivery state of the blocking stent provided by other embodiments of the present application;

Figure 3 is a schematic structural diagram of a blocking stent provided by the first embodiment of the present application;

Figure 4 is a side view of the blocking stent provided in the first embodiment as shown in Figure 3;

Figure 5 is a schematic structural diagram of a blocking stent provided by the second embodiment of the present application;

Figure 6 is a side view of the blocking stent provided in the second embodiment shown in Figure 5;

Figure 7 is a schematic structural diagram of a blocking stent provided by the third embodiment of the present application;

Figure 8 is a side view of the blocking stent provided in the third embodiment as shown in Figure 7;

Figure 9 is a schematic structural diagram of a blocking stent provided in the fourth embodiment of the present application;

Figure 10 is a schematic structural diagram of a blocking stent provided by the fifth embodiment of the present application;

Figure 11 is a schematic structural diagram of a blocking stent provided by the sixth embodiment of the present application;

Figure 12 is a schematic structural diagram of a blocking stent provided by the seventh embodiment of the present application;

Figure 13 is a schematic structural diagram of a blocking stent provided by the eighth embodiment of the present application;

Figure 14 is a side view of the blocking stent provided in the eighth embodiment as shown in Figure 13;

Figure 15 is a schematic structural diagram of a blocking stent provided in the ninth embodiment of the present application.

Reference number:
100. Blocking stent; 200. Delivery device; 300. Balloon; 400. Traction wire; 500. Main unit; 600.
Blocking unit; 700, deformation unit; 800, main body additional unit;
610. Groove.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those of ordinary skill in the art without creative efforts fall within the scope of protection of this application.

Referring to Figures 1 and 2, the present application provides a delivery system. The delivery system includes a balloon 300 and a traction wire 400. The balloon 300 and the traction wire 400 can be used to deliver the occlusion stent provided by the present application. 100. Referring to Figures 3 to 15, the blocking bracket 100 includes a main unit 500 and a blocking unit 600. The main unit 500 and the blocking unit 600 can be an integral one-piece structure or can be split. interconnected structures and made of the same or different materials. The main unit 500 is cylindrical. The cylindrical shape represents a structural shape with an axial hollow inner cavity, and all radial sections of the cylindrical shape are closed rings. shape, the ring shape can be a regular shape such as a circular ring, a square ring, or Other closed irregular shapes, and the radial cross-sections formed along the axial direction may be the same or different. For example, according to different cross-sectional shapes, the main unit 500 may be cylindrical, square, straight, conical, etc. Compared with the mesh-shaped structure, this cylindrical structure only needs one layer of bracket material (or a circle of bracket material) to form the cylinder of the blocking bracket 100. It can be understood that one layer of bracket material Since the blocking stent 100 is cut and spread out into only one layer, the amount of material used in the blocking stent 100 can be effectively reduced from the perspective of the number of layers used.

At the same time, the main body unit 500 has a proximal opening and a distal opening, the blocking unit 600 has a proximal opening and a distal plug, and the proximal opening of the blocking unit 600 is connected to the distal opening of the main unit 500. The end opening is connected, so the main unit 500 and the blocking unit 600 can be connected to each other. The end opening area of the proximal opening of the main body unit 500 is larger than the end blocking area of the distal plug of the blocking unit 600. , therefore, in the direction from the distal end to the proximal end of the occlusion stent 100, the area of the distal end of the occlusion stent 100 (ie, the distal end of the occlusion unit 600) is larger than the area of the proximal end (the main unit 600). 500) is small, so that the blocking stent 100 as a whole forms a conical or conical-like structure. This structure has the effect of constantly changing opening area in the axial direction from the distal end to the proximal end, so it can be applied to many applications. Blocking arterial fistula lesions of various sizes not only has wide applicability, but also the tapered or cone-like structure of the blocking stent 100 is compared with the mesh structure because the distal end of the blocking stent 100 The smaller end area also reduces the amount of material used in the distal region of the occluding stent 100 .

The distal plug is a seal formed on the distal end of the blocking unit 600. The sealing area and sealing area of the distal plug at the distal end of the blocking unit 600 can be selected according to the needs. The distal plug can be at At least a part of the blocking unit 600 forms a sealing structure. The sealing structure can seal the distal end of the blocking unit 600, thereby achieving the function of sealing the fistula. The sealing structure can be formed in a variety of forms, for example, it can be used to seal the fistula. The openings or hollows of the plugging unit 600 and other areas that need to be plugged are welded, hot-melted, covered, tied, knotted, and filled. The entire plugging unit 600 can also be directly made with an internal solid structure, and then the plugging unit 600 can be sealed. The unit 600 forms the sealing structure, and the sealing structure is used to ensure the blocking effect of the blocking unit 600.

Therefore, the blocking stent 100 can effectively reduce the amount of material on the basis of ensuring the blocking effect by constructing the barrel into a conical or cone-like structure on the basic cylindrical stent structure, that is, using more Less material can be used to achieve the same blocking effect. For implants that need to be implanted and stored in the body for a long time, reducing the amount of material can effectively reduce the probability of inflammation and complications, and reduce the patient's postoperative complications. Discomfort.

Moreover, the blocking stent 100 has a tapered or conical-like structure and has good wall adhesion, does not have high requirements on the size of the lesion, can match tubular arterial fistula cavities of various sizes, and has good fixation effect. After being implanted into the body, the stent 100 can trigger a foreign body reaction and stimulate endothelialization. Through expansion and shaping, the blocking stent 100 can be supported in the arterial fistula cavity and block the coronary artery fistula cavity to avoid cardiac chamber enlargement, heart failure, and Angina pectoris, arrhythmia, myocardial infarction and coronary atherosclerosis and other cardiovascular and vascular diseases.

The tapered or cone-like shape of the blocking stent 100 can be formed into a variety of structural forms. On the basis that the opening area of the distal end of the blocking stent 100 is smaller than the opening area of the proximal end, other sections of the blocking stent 100 can also be used. Various structural forms can be formed according to requirements. For example, the main unit 500 or the blocking unit 600 can adopt different structural forms according to corresponding functional requirements. In one embodiment, the proximal end of the main unit 500 can be The opening area is greater than or equal to the opening area of the distal end of the main unit 500. Therefore, in the structure of the main unit 500, the main unit 500 can also separately form a conical or conical-like structure, and is based on the conical or conical-like structure. The shaped structure provides good adhesion to the wall. Similarly, the opening area of the proximal end of the blocking unit 600 can be greater than or equal to the opening area of the distal end of the blocking unit 600. Therefore, in the structure of the blocking unit 600, the blocking unit 600 can also be It forms a cone-shaped or cone-like structure alone, and provides good wall adhesion based on the cone-shaped or cone-like structure.

When the end opening area of the proximal opening of the main body unit 500 is greater than the end opening area of the distal opening of the main body unit 500, on the basis that the distal end of the main unit 500 is smaller than the proximal end, other parts of the main unit 500 The sections can also be configured in various structural forms according to requirements. For example, in one embodiment, at least a part of the sections of the main body unit 500 is cone-shaped. Alternatively, when the end opening area of the proximal opening of the main body unit 500 is equal to the end opening area of the distal opening of the main body unit 500, on the basis that the distal end and the proximal end of the main body unit 500 are substantially consistent, Other sections of the main body unit 500 can also be configured in various structural forms according to requirements. For example, at least a portion of the main body unit 500 is straight-cylindrical. In one embodiment, the main body unit 500 can be The whole body is straight cylindrical, or the main body unit 500 can be the whole cone shape, or a portion of the main body unit 500 located at the proximal end is straight cylindrical, and the other portion of the main body unit 500 located at the distal end is straight cylindrical. It is in the shape of a cone, and the main body unit 500 is composed of a combination of a straight cylinder and a cone in the axial direction.

Similarly, when the end opening area of the proximal opening of the blocking unit 600 is larger than the end blocking area of the distal plug of the blocking unit 600, the distal end of the blocking unit 600 is smaller than the proximal opening area. Basically, other sections of the plugging unit 600 can also be configured in various structural forms according to requirements. For example, in one embodiment, at least a part of the section of the plugging unit 600 is cone-shaped. Alternatively, when the end opening area of the proximal opening of the blocking unit 600 is equal to the end blocking area of the distal plug of the blocking unit 600, the distal and proximal ends of the blocking unit 600 are approximately On the same basis, other sections of the plugging unit 600 can also be configured in various structural forms according to requirements. For example, at least a part of the section of the plugging unit 600 is straight cylindrical. In one embodiment, , the blocking unit 600 may be in the shape of a straight cylinder as a whole, or the blocking unit 600 may be in the shape of a cone as a whole, or a part of the proximal section of the blocking unit 600 may be in the shape of a straight cylinder. The other section located at the distal end of the unit 600 is in the shape of a cone, and the blocking unit 600 is composed of a straight cylinder and a cone in the axial direction.

In addition, when the blocking unit 600 is in the shape of a cone as a whole, the cone-shaped structure of the blocking unit 600 can also have different structural features on the outer contour. For example, in one embodiment, the blocking unit 600 is in the shape of a cone as a whole. cylindrical, and On the basis of the cone-shaped structure, the outer wall surface of the blocking unit 600 is linear or curved in the direction from the distal end to the proximal end. The linear shape enables the cone-cylindrical shape of the blocking unit 600 to be in the direction from the distal end to the proximal end. The opening area or diameter gradually and uniformly increases in the direction, and the curved shape can cause the cone shape of the blocking unit 600 to have an opening area or diameter that gradually increases in the direction from the distal end to the proximal end, but gradually increases non-uniformly. Or the blocking unit 600 is in the shape of a cone as a whole, and based on the cone-shaped structure, a plurality of grooves 610 are opened at the far end of the blocking unit 600, and the plurality of grooves 610 surround the sealing unit. The distal end of the blocking unit 600 is distributed circumferentially.

Since the main unit 500 and the blocking unit 600 are axially connected, at the position where the main unit 500 and the blocking unit 600 are connected, the end opening area of the distal opening of the main unit 500 can be set to be equal to the desired area. The end opening area of the proximal opening of the blocking unit 600 is such that adjacent proximal openings and distal openings with the same end opening area can directly butt together and form axial communication between the main unit 500 and the blocking unit 600, Alternatively, it may also be configured such that the end opening area of the distal opening of the main body unit 500 is greater than the end opening area of the proximal opening of the blocking unit 600, in which case adjacent proximal openings with different end opening areas The main unit 500 and the sealing unit 600 can be indirectly connected to the main unit 500 and the sealing unit 600 in an axial direction by forming a step structure with the distal opening. The table top of the step between the adjacent proximal opening and the distal opening can be perpendicular to the sealing unit. The axial direction of the blocking bracket 100 may also form a certain angle with the axial direction of the blocking bracket 100, which is not limited here.

In order to clearly illustrate the various structures of the product, various types of blocking brackets 100 are used for explanation. For example, as shown in Figures 3 and 4, the main unit 500 of the blocking bracket 100 can be in the shape of a cone, and can be made of metal or metal. The absorbable pipe is hollowed out, and the pipe diameter is preferably Ф2.0-Ф6.0. The cone length of the main unit 500 can be 3mm-10mm. For example, the cone length of the main unit 500 is 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The blocking unit 600 of the blocking stent 100 can be a solid structure of 1-4MM pipe material. The distal plug of the blocking unit 600 is formed by physical welding or hot melting to block the lesion after implantation. The length of the blocking unit 600 may be 1 mm-5 mm. For example, the length of the blocking unit 600 may be 1 mm, 2 mm, 3 mm, 4 mm or 5 mm. The occluding stent 100 can be compressed, expanded, and fixed and endothelialized after implantation.

Referring to Figures 5 and 6, the main unit 500 of the blocking stent 100 can be in the shape of a cone, and can be hollowed out of metal or absorbable tubing. The diameter of the tubing is preferably Ф2.0-Ф6.0, and the cone of the main unit 500 can be hollowed out. The body length may be 3mm-10mm. For example, the vertebral body length of the main unit 500 is 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The blocking unit 600 of the blocking stent 100 can be processed from 1-4MM pipe into strip or wire shape. This structure is suitable for distal expansion sealing, making the blocking stent 100 more adherent to the wall. The tip position of the wire can be physically welded , banding, knotting or hot melting to form the distal plug of the blocking unit 600, which is used to block the lesion after implantation. The length of the blocking unit 600 can be 1mm-5mm, for example, the blocking unit 600 is available in lengths of 1mm, 2mm, 3mm, 4mm or 5mm. The occluding stent 100 can be compressed, expanded, and fixed and endothelialized after implantation.

Referring to Figures 7 and 8, the main unit 500 of the blocking stent 100 can be in the shape of a cone, and can be hollowed out of metal or absorbable tubing. The diameter of the tubing is preferably Ф2.0-Ф6.0, and the cone of the main unit 500 can be hollowed out. The body length may be 3mm-10mm. For example, the vertebral body length of the main unit 500 is 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The blocking unit 600 of the blocking bracket 100 can be processed by electrospinning processing, and a layer of flow-blocking film can be added. The porosity of the flow-blocking film is <0.001mm, which has a better blocking effect. The thickness of the flow-blocking film is 200±50 μm. , used to seal the lesion after implantation. The length of the blocking unit 600 may be 1 mm-5 mm. For example, the length of the blocking unit 600 may be 1 mm, 2 mm, 3 mm, 4 mm or 5 mm. The occluding stent 100 can be compressed, expanded, and fixed and endothelialized after implantation.

In addition, as shown in FIGS. 9 to 11 , the blocking unit 600 can also have a variety of structural forms, such as a pointed structure, a flat structure, and a structure composed of grooves 610 .

Referring to Figure 12, the front end of the blocking bracket 100 can use a cone-shaped blocking unit 600, and the blocking unit 600 can be made of pipes, wires or electrospun flow-blocking films. Please refer to the previous article, Blocking The proximal end of the stent 100 may adopt a structure that combines a cone shape and a straight cylindrical shape. The distal end of the main unit 500 is a cone shape and the proximal end is a straight cylindrical shape. The main unit 500 of the blocking stent 100 can be made of hollow metal or absorbable tubing. The diameter of the tubing is preferably Ф2.0-Ф6.0. The length of the cone of the main unit 500 can be 3mm-10mm, such as the cone of the main unit 500. Lengths are 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm or 10mm. The length of the blocking unit 600 may be 1 mm-5 mm. For example, the length of the blocking unit 600 may be 1 mm, 2 mm, 3 mm, 4 mm or 5 mm. The occluding stent 100 can be compressed, expanded, and fixed and endothelialized after implantation.

Referring to Figures 13 and 14, the main unit 500 or the blocking unit 600 of the blocking stent 100 can be made of metal or absorbable tubing, and both the main unit 500 and the blocking unit 600 are straight cylindrical, wherein the main unit 500 The length can be 5-10mm. For example, the length of the main unit 500 can be 5mm, 6mm, 7mm, 8mm, 9mm or 10mm, and the diameter can be Ф0.5-Ф2. It is used for positioning the fistula opening and the blocking unit 600. The length may be 1-5 mm, for example, the length of the blocking unit 600 may be 1 mm, 2 mm, 3 mm, 4 mm or 5 mm.

The proximal end of the blocking stent 100 is connected to a deformation unit 700. The length of the deformation unit 700 can be 2-10 mm, and the deformation unit 700 can process the wire through absorbable materials to form a spirally distributed filament structure. The width can be 0.2-1mm and is in the form of a hypotube. After the blocking stent 100 is implanted, the filamentous structure can be pushed into the interior of the main unit 500 through the push tube to block the lesion after implantation.

Referring to Figure 15, the main unit 500, the blocking unit 600 and the main additional unit 800 of the blocking stent 100 can be made of metal or absorbable pipes. The main additional unit 800, the blocking unit 600 and the main unit 500 are axially connected to form " I-shaped, this structure has the structural characteristics of flaring at both ends and a girdle in the middle, and can be applied to lesions with large cavities at both ends and fistulas in the middle. The length of the main unit 500 may be 5-10 mm, for example The length is 5mm, 6mm, 7mm, 8mm, 9mm or 10mm, and the diameter can be Ф0.5-Ф2, which is used for positioning the fistula opening. The length of the blocking unit 600 can be 1-5mm, for example, the blocking unit 600 The length is 1mm, 2mm, 3mm, 4mm or 5mm.

In one embodiment, the occlusion stent 100 further includes a deformation unit 700, which is connected to the proximal end of the main body unit 500. The deformation unit 700 has an expanded state and a contracted state, and the deformation unit 700 has an expanded state and a contracted state. The unit 700 is configured to communicate with the proximal opening of the main body unit 500 in the expanded state and to block the proximal opening of the main body unit 500 in the contracted state. Therefore, when the blocking stent 100 is implanted into the After reaching the target position, the deformation unit 700 can be switched from the expanded state to the contracted state. For example, the deformation unit 700 can be changed in shape to form a ball-like structure that is blocked inside the main unit 500 to block the proximal opening of the main unit 500 .

The deformation unit 700 can adopt any structural form or material. For example, in one embodiment, the unfolded state of the deformation unit 700 is a spirally distributed filamentous structure. The spiral distribution can make the deformation unit 700 in the unfolded state communicate with the main body. The units 500 are connected and roughly cylindrical, and the filament-like structure is easy to deform. It can be easily inserted into the interior of the main unit 500 after being deformed to a contracted state. For example, the deformation unit 700 can adopt a filament-like structure such as hypowire. No limitation is made here.

In one embodiment, the occlusion stent 100 includes a main body additional unit 800. The main body additional unit 800 is cylindrical and has a proximal opening and a distal opening. The proximal opening of the main body additional unit 800 is connected to the distal opening. The distal plug of the blocking unit 600 is connected, and the end opening area of the proximal opening of the main body additional unit 800 is larger than the end blocking area of the distal plug of the blocking unit 600. The main additional unit 800 You can refer to the structural form, material, etc. of the main unit 500, or the main additional unit 800 can be completely consistent with the main unit 500 and symmetrical to each other in the axial direction relative to the blocking unit 600. Therefore, any technical content of the main additional unit 800 can be Refer to the main unit 500, which will not be described again.

At least one of the main unit 500, the blocking unit 600, the deformation unit 700 and the main body additional unit 800 of the blocking stent 100 can be made of metal or non-metal material. For example, the material can be nickel-titanium or polymer. material or polyester. The blocking stent 100 can be made of absorbable material or a composite material of metal and non-metal. If it is made of absorbable material, the absorption time should be less than or equal to 3 years, preferably less than or equal to 1 year. More preferably less than or equal to 6 months. For metals, it can be self-developing, and for non-metallic materials, development marks can be added by inlaying. For example, the main unit 500 can be a metal frame, a bundle of non-metallic filaments, or an electrospun flow-blocking film. Corresponding hollow structures can be constructed on the element 500 according to requirements. After the main structure is implanted at the target position through the delivery device 200, it can be expanded through the balloon 300, and a positioning effect will be formed after expansion.

In at least one of the main unit 500, the blocking unit 600, the deformation unit 700 and the main additional unit 800 of the blocking stent 100, the skeleton wall thickness of the structure is ≥200 microns, preferably ≥50 microns, and the length of the main unit 500 is 3- 10mm, the length of the blocking unit 600 is 1-5mm. The blocking structure may have certain supporting properties, such as the radial extrusion resistance of the blocking stent 100 is ≥150Kpa, preferably ≥50Kpa. The blocking stent 100 can be laser engraving, injection molding, knitting, 3D printing or electrospinning, etc., which is not limited here.

Referring to Figure 1, during the process of implanting the occlusion stent 100 in the delivery system, the occlusion stent 100 can first be pressed and held on the matching balloon 300, transported through the delivery device 200 to reach the lesion location, and inflated through the balloon 300. Expansion, the pressure value can be determined according to the size of the occlusion stent 100, for example, it can usually be 7-14 atm, the occlusion stent 100 is released, and the released occlusion stent 100 passes through the end with a larger proximal opening on the main unit 500 At the same time, the sealing stent 100 seals the fistula cavity through the sealing unit 600, and the balloon 300 is used to expand and release the sealing stent 100 after implantation. Compared with the self-expanding sealing device used Release the two, and the operation is simpler.

Referring to Figure 2, if the proximal end of the occlusion stent 100 has a deformation unit 700, the filamentous structure of the deformation unit 700 can be connected to the traction wire in the delivery tube, and the balloon 300 can be withdrawn from the delivery tube after the pressure is released. The pulling wire is connected to the filamentous structure of the deformation unit 700. Pulling the pulling wire back, the spiral length of the filamentary structure can be determined by the stretching length of the pulling wire. When the spiral length remains 5 mm, the delivery tube can be pushed to the distal direction for 5 mm. ±2 mmm, the filamentous structure is introduced into the interior of the main unit 500 by pushing the pulling wire, forming an occlusion at the proximal end of the occlusion stent 100 .

Among them, the outline of the delivery tube of the delivery device 200 can be less than or equal to 5 mm. It can be seen that the main unit 500 and the blocking unit 600 of the blocking stent 100 have the functions of positioning and blocking respectively. After expansion, the main unit 500 can position and block. Fixed, constructing a patterned hollow structure on the main unit 500 can also reduce the amount of implanted material. The blocking unit 600 can be used to block fistulas. The blocking unit 600 can be carved with filamentous structures or electrospun. The silk structure can also reduce the amount of implanted material.

The technical features of the above-described embodiments can be combined in any way. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, All should be considered to be within the scope of this manual.

The above-described embodiments only express several implementation modes of the present application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the patent application. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all fall within the protection scope of the present application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

A blocking stent, characterized in that the blocking stent includes:

A main unit, which is cylindrical and has a proximal opening and a distal opening; and

Blocking unit, the blocking unit has a proximal opening and a distal plug, the proximal opening of the blocking unit is connected to the distal opening of the main unit, and the end of the proximal opening of the main unit The opening area is larger than the end blocking area of the distal plug of the blocking unit.
The occlusion stent according to claim 1, wherein the end opening area of the proximal opening of the main body unit is greater than or equal to the end opening area of the distal opening of the main body unit.
The occlusion stent according to claim 2, characterized in that at least a portion of the main body unit is straight-cylindrical.
The blocking stent according to claim 3, characterized in that the main body unit is straight-cylindrical.
The occlusion stent according to claim 2, wherein at least a portion of the main body unit is cone-shaped.
The blocking stent according to claim 5, characterized in that the main body unit is cone-shaped.
The occlusion stent according to claim 2, wherein a portion of the main body unit located at the proximal end is straight-cylindrical, and the other portion of the main body unit located at the distal end is cone-shaped.
The blocking stent according to claim 1, wherein the end opening area of the proximal opening of the blocking unit is greater than or equal to the end blocking area of the distal plug of the blocking unit.
The blocking stent according to claim 8, wherein at least a portion of the blocking unit is straight-cylindrical.
The blocking stent according to claim 9, wherein the blocking unit is straight-cylindrical.
The blocking stent according to claim 8, wherein at least a portion of the blocking unit is cone-shaped.
The blocking stent according to claim 11, wherein the blocking unit is cone-shaped.
The blocking stent according to claim 12, wherein the outer wall surface of the blocking unit is linear or curved in the direction from the distal end to the proximal end.
The occlusion stent according to claim 12, wherein a plurality of grooves are formed at the distal end of the occlusion unit, and the plurality of grooves are circumferentially distributed around the distal end of the occlusion unit.
The occlusion stent according to claim 8, characterized in that a part of the section located at the proximal end of the occlusion unit is straight-cylindrical, and the other part of the section located at the distal end of the occlusion unit is cone-shaped. .
The occluding stent according to claim 1, characterized in that the distal opening end of the main body unit The opening area is greater than or equal to the end opening area of the proximal opening of the blocking unit.
The blocking stent according to any one of claims 1-16, characterized in that the blocking stent includes:

A deformation unit, the deformation unit is connected to the proximal end of the main body unit, the deformation unit has an expanded state and a contracted state, and the deformation unit is configured to be able to communicate with the proximal end opening of the main body unit in the expanded state. , capable of blocking the proximal opening of the main body unit in the contracted state.
The occlusion stent according to claim 17, wherein the expanded state of the deformation unit is a spirally distributed filamentary structure.
The blocking stent according to any one of claims 1-16, characterized in that the blocking stent includes:

The main body additional unit is cylindrical and has a proximal opening and a distal opening. The proximal opening of the main body additional unit is connected to the distal plug of the blocking unit. The main body additional unit has a proximal opening and a distal opening. The end opening area of the proximal opening is larger than the end blocking area of the distal plug of the blocking unit.
The blocking stent according to any one of claims 1 to 16, characterized in that the blocking unit is formed by at least one of welding, hot melting, coating, tying, knotting, filling or solidification. The other forms the distal plug of the blocking unit.
A delivery system, characterized in that the delivery system includes the blocking stent according to any one of claims 1-20.