WO2021185046A1

WO2021185046A1 - Stent and placement system

Info

Publication number: WO2021185046A1
Application number: PCT/CN2021/077954
Authority: WO
Inventors: 李鹏; 赵彦; 张澍田; 韦建宇; 沈正华; 冯明浩; 李常青; 冷德嵘
Original assignee: 南微医学科技股份有限公司; 首都医科大学附属北京友谊医院
Priority date: 2020-03-20
Filing date: 2021-02-25
Publication date: 2021-09-23
Also published as: CN111249044A

Abstract

A stent (100) and a placement system (10). The stent (100) has a proximal end and a distal end opposite to each other, and in a direction from the distal end to the proximal end, the stent comprises a first large-diameter section (111), a first connection section (112), a middle section (120), a second connection section (131), and a second large-diameter section (132) which are connected in sequence. In the direction from the distal end to the proximal end, the outer diameter of the first connection section (112) is gradually reduced. Therefore, when the stent (100) is radially compressed to install the stent (100) into a placement device (200), along the axis of the first connection section (112), the middle section (120), the first connection section (112), and the first large-diameter section (111) are located at different axial positions, and thus, the thickness of the first connection section (112) after compression is smaller. Therefore, it is beneficial to reducing the radial pressing force between the first connection section and the displacement device (200) during installation, thereby reducing the friction force between the stent (100) and the placement device (200), and allowing stents having larger sizes to be installed without increasing the inner diameter of the placement device (200).

Description

Support and placement system

Cross-references to related applications

This disclosure claims the priority of a Chinese patent application filed with the Chinese Patent Office on March 20, 2020, with the application number CN202010203737.9 and titled "A stent and implantation system", the entire content of which is incorporated into this disclosure by reference middle.

Technical field

The present disclosure relates to the technical field of medical devices, and in particular, to a stent and an implantation system.

Background technique

In the course of the tumor, obstruction caused by direct infiltration or compression of the tumor, for example, in the course of malignant tumors of the digestive tract, esophageal stenosis caused by malignant tumors of the esophagus, tumors of the stomach, descending duodenum, pancreaticobiliary series, and gastric cancer after surgery In the face of stenosis, colonic malignant tumor obstruction and anastomotic stenosis after colon surgery, in the face of stenosis or obstruction and other diseases, the current common method is to implant a stent in the stenosis and obstruction to ensure the patency of the lumen.

Existing stents are classified into TTS (Through The Scope) stents and OTW (Over The Wire) stents according to different implantation methods. The OTW stent, that is, the stent inserter, does not go through the endoscope clamp channel, but only reaches the lesion location through the auxiliary observation of the guide wire and X-rays. Therefore, a stent with a larger outer diameter can be inserted. The stent has strong support and good anti-displacement effect. However, during the implantation process, doctors and patients are exposed to X-rays for a long time, causing damage to the human body; the TTS stent, the stent implanter, is inserted through the endoscope clamp channel and placed through direct observation of the endoscope, so as to better confirm The stent is placed in the position, but the outer diameter of the TTS implanter is small, so its supporting stent has problems such as small outer diameter, poor supporting force, and easy displacement after insertion.

Summary of the invention

The purpose of the present disclosure includes, for example, providing a stent that can be more conveniently installed in an inserter, facilitates the insertion of a larger-sized stent through the endoscopic forceps, and has a function of preventing displacement .

The purpose of the present disclosure also includes providing an implantation system, which includes the above-mentioned stent.

The embodiments of the present disclosure can be implemented as follows:

The embodiment of the present disclosure provides a stent, the stent has a distal end and a proximal end opposite to each other, and in the direction from the distal end to the proximal end, the stent includes a first large-diameter section connected in sequence, The first connecting section, the middle section, the second connecting section and the second large diameter section;

Along the direction from the distal end to the proximal end, the outer diameter of the first connecting section gradually decreases;

The middle section, the second connecting section, and the second large-diameter section form a limiting step, and the limiting step is configured to prevent displacement.

Optionally, there is an included angle α between the outer wall of the first connecting section and the outer wall of the middle section; and an included angle β between the outer wall of the second connecting section and the outer wall of the middle section;

Among them, α-β≥20°

Optionally, 90°<α≤180°.

Optionally, 115°≤α≤155°.

Optionally, 60°≤β≤120°.

Optionally, the first connecting section is tapered.

Optionally, the connection point of the first large-diameter section and the first connecting section has a circular arc transition.

Optionally, the first large-diameter section is cylindrical.

Optionally, there is an included angle β between the outer wall of the second connecting section and the outer wall of the intermediate section, 80°≤β≤100°.

Optionally, the second connecting section is perpendicular to the middle section.

Optionally, the first large-diameter section, the first connecting section, the intermediate section, the second connecting section and the second large-diameter section are all covered with a film.

Optionally, the first large-diameter section, the first connecting section, the intermediate section, the second connecting section, and the second large-diameter section are all symmetrically arranged about a preset axis.

Optionally, the radial dimension of the middle section is R, and 14mm≤R≤24mm.

The embodiment of the present disclosure also provides an insertion system. The implantation system includes an implanter and the above-mentioned bracket; the implanter has an accommodating cavity, and the stent is arranged in the accommodating cavity.

Optionally, the inserter includes an inner tube, an outer tube, and a pushing member, the outer tube is sleeved on the inner tube; the inner tube includes a metal tube part, the metal tube part and the outer tube The accommodating cavity is formed therebetween, the pushing member is arranged between the inner tube and the outer tube, and the pushing member is configured to push the stent located in the accommodating cavity.

Optionally, the material of the inner tube is metal.

Optionally, the inserter further includes a head, a mounting hole and a through hole communicating with each other are provided on the head, the distal end of the metal tube is mounted in the mounting hole, and the through hole It communicates with the inner hole of the inner tube to form a channel configured for the guide wire to pass through, and the radial size of the through hole is smaller than or equal to the radial size of the inner hole.

Optionally, the head has a first wall surface corresponding to the through hole, and the head further includes a second wall located outside the head and connected to the first wall and the second wall. The connecting surface between the two, the connecting surface is a circular arc surface.

Optionally, the second wall surface is a circular arc surface, and the distance from the second wall surface to the axis of the head gradually increases along the direction from the distal end of the head to the proximal end.

Optionally, the material of the head is metal.

Optionally, the head and the metal tube are fixed by laser welding.

Optionally, the proximal end of the head has an abutting surface, and the abutting surface is configured to abut against the distal end of the outer tube.

Optionally, the head further includes a blocking block protruding from the abutting surface, the blocking block and the abutting surface form a positioning space, and the positioning space is configured to accommodate the distal end of the outer tube .

Optionally, a release mark is provided on the inserter.

The beneficial effects of the stent and placement system of the embodiments of the present disclosure include, for example:

Embodiments of the present disclosure provide a stent having opposite distal and proximal ends. Along the direction from the distal end to the proximal end, the stent includes a first large-diameter section, a first connecting section, a middle section, a second connecting section, and a second large-diameter section connected in sequence. Along the direction from the distal end to the proximal end, the outer diameter of the first connecting section gradually decreases. Therefore, when the stent is radially compressed to install the stent into the implanter, along the axis of the first connecting section, the middle section, The first connecting section and the first large-diameter section are located at different axial positions, so the thickness of the first connecting section after compression is smaller, which helps to reduce the radial extrusion force with the inserter during installation , Thereby reducing the friction between the stent and the inserter, so that a larger-sized stent can be installed without increasing the inner diameter of the inserter. At the same time, the middle section, the second connecting section, and the second large-diameter section form a limiting step. After the stent is placed in the lumen of the human body, the human tissue grows toward the middle section to interfere with the limiting step in the axial direction of the lumen, and then Helps prevent the stent from shifting.

The embodiments of the present disclosure also provide an implantation system. The implantation system includes the above-mentioned stent. Therefore, the implantation system can also realize the implantation of a larger-sized stent without increasing the inner diameter of the implanter, especially The placement of a stent that is large in size and can prevent displacement at the same time.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present disclosure more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. It should be understood that the following drawings only show certain embodiments of the present disclosure, and therefore do not It should be regarded as a limitation of the scope. For those of ordinary skill in the art, other related drawings can be obtained based on these drawings without creative work.

FIG. 1 is a schematic diagram of the structure of a stent provided by an embodiment of the disclosure;

FIG. 2 is a schematic diagram of a partial structure of an insertion system provided by an embodiment of the present disclosure;

FIG. 3 is a schematic diagram of a partial structure of a second type of stent provided by an embodiment of the present disclosure;

4 is a partial structural diagram of a third type of bracket provided by an embodiment of the disclosure;

FIG. 5 is a partial structural diagram of the connection between the first large-diameter section and the first connecting section in the stent provided by an embodiment of the present disclosure;

FIG. 6 is a partial structural diagram of a fourth type of bracket provided by an embodiment of the present disclosure;

FIG. 7 is a schematic diagram of the overall structure of the implanter in the implantation system provided by the embodiment of the disclosure;

FIG. 8 is a schematic diagram of a partial structure of the implanter in the implantation system provided by an embodiment of the disclosure; FIG.

FIG. 9 is a schematic structural diagram of the implantation system provided by the embodiments of the disclosure when the implanter is in a released state; FIG.

Fig. 10 is an enlarged view of the partial structure at Ⅹ in Fig. 9.

Icon: 10-insertion system; 100- stent; 110- first cup opening section; 111- first large diameter section; 112- first connecting section; 113- transition section; 120- middle section; 130- second cup Orifice section; 131- second connecting section; 132- second large diameter section; 140- limit step; 200- inserter; 210- inner tube; 211- metal tube part; 220- outer tube; 230- pusher 231-Middle tube; 232-Booster tube; 240-Head; 241-Mounting hole; 242-Through hole; 243-First wall surface; 244-Second wall surface; 245-Connecting surface; 246-Abutting surface; 247-block; 251-first operating handle; 252-second operating handle; 253-lock catch; 254-lock nut; 260-accommodating cavity; 270-guide wire.

Detailed ways

In order to make the objectives, technical solutions, and advantages of the embodiments of the present disclosure clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present disclosure with reference to the accompanying drawings in the embodiments of the present disclosure. Obviously, the described embodiments These are a part of the embodiments of the present disclosure, but not all of the embodiments. The components of the embodiments of the present disclosure generally described and illustrated in the drawings herein may be arranged and designed in various different configurations.

Therefore, the following detailed description of the embodiments of the present disclosure provided in the accompanying drawings is not intended to limit the scope of the claimed present disclosure, but merely represents selected embodiments of the present disclosure. Based on the embodiments in the present disclosure, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present disclosure.

It should be noted that similar reference numerals and letters indicate similar items in the following figures. Therefore, once a certain item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

In the description of the present disclosure, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner" and/or "outer" is based on the orientation or positional relationship shown in the drawings. , Or the position or position relationship usually placed when the product of the invention is used, is only for the convenience of describing the present disclosure and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation and be constructed in a specific orientation And operation, therefore cannot be understood as a limitation of the present disclosure.

In addition, if the terms "first" and/or "second" appear, they are only used for distinguishing description, and cannot be understood as indicating or implying relative importance.

It should be noted that, in the case of no conflict, the features in the embodiments of the present disclosure can be combined with each other.

FIG. 1 is a schematic structural diagram of a stent 100 provided by this embodiment, and FIG. 2 is a partial structural schematic diagram of an implantation system 10 provided by this embodiment. Please refer to FIG. 1 and FIG. 2 in combination. This embodiment provides a stent 100, and correspondingly, an implantation system 10 is provided. It should be noted that in the description of this embodiment, the “stent” refers to a stent that can be inserted into the lumen of the human body through the endoscopic forceps through the inserter 200 under the direct view of the endoscope.

The implantation system 10 includes the aforementioned stent 100, and the implantation system 10 also includes an implanter 200. The inserter 200 has an accommodating cavity 260 configured to accommodate the stent 100. After the stent 100 is put into the inserter 200, the stent 100 is inserted into the lumen of the human body through the endoscopic forceps through the inserter 200. Similarly, since the inserter 200 is in use, the front end of the inserter 200 will extend into the human body, and the rear end of the inserter 200 is provided with a handle for medical personnel to operate. Therefore, correspondingly, insert The part of each component in the device 200 near the front end is called the distal end of the component, and the part near the rear end is called the proximal end of the component.

The stent 100 has opposite distal and proximal ends. In the direction from the distal end to the proximal end, the stent 100 includes a first large-diameter section 111, a first connecting section 112, a middle section 120, a second connecting section 131, and a second large-diameter section 132 that are connected in sequence. Along the direction from the distal end to the proximal end, the outer diameter of the first connecting section 112 gradually decreases. Therefore, when the stent 100 is radially compressed to install the stent 100 into the inserter 200, along the first connecting section 112 Axis, the middle section 120, the first connecting section 112 and the first large-diameter section 111 are located at different axial positions. Therefore, the thickness of the first connecting section 112 after compression is smaller, which helps to reduce the installation time and The radial pressing force of the inserter 200 further reduces the friction between the stent 100 and the inserter 200, so that a larger stent 100 can be installed without increasing the inner diameter of the inserter 200, Therefore, the stent 100 having a larger size than the existing TTS stent can be used as a TTS stent and inserted into the human body through an endoscopic clamp. At the same time, the middle section 120, the second connecting section 131 and the second large-diameter section 132 form a limiting step 140. After the stent 100 is placed in the lumen of the human body, the human tissue (ie, the inner wall tissue of the corresponding lumen) grows toward the middle section 120. Thereby, it conflicts with the limiting step 140 in the extending direction of the lumen, and the function of preventing displacement of the stent 100 can be realized.

It should be noted that in the description of this embodiment, the “proximal end” refers to the end close to the outside of the human body after being placed in the human body, and the “distal end” refers to the end close to the inside of the human body after being placed in the human body, for example, the end is placed in the esophagus of the human body. After the stent, the proximal end of the stent is the end of the stent close to the oral cavity, and the distal end of the stent is the end of the stent close to the stomach.

The stent 100 provided in this embodiment will be further described below:

1 and 2 in combination, in this embodiment, the bracket 100 includes a first cup opening section 110, a middle section 120, and a second cup opening section 130 arranged in sequence, the middle section 120 is cylindrical, and the first cup The radial dimensions of the mouth section 110 and the second cup mouth section 130 are both larger than the middle section 120, thereby forming the stent 100 with a dumbbell shape. Specifically, the first mouth section 110 is located at the distal end of the middle section 120, and the second mouth section 130 is located at the proximal end of the middle section 120, that is, along the first mouth section 110, the middle section 120, and the second mouth section 130. The direction from the distal end to the proximal end of the stent 100 is arranged in sequence. At the same time, the first mouth section 110, the middle section 120 and the second mouth section 130 are integrally formed by weaving metal wires.

The first cup section 110 includes a first large-diameter section 111 and a first connecting section 112. The two ends of the first connecting section 112 are connected to the first large-diameter section 111 and the middle section 120 respectively. The diameter is larger than the outer diameter of the middle section 120, so that the connection transition between different outer diameter sizes is realized through the first connecting section 112. Specifically, along the direction from the distal end to the proximal end of the stent 100 (ie the direction from bottom to top in FIG. 1), the outer diameter of the first connecting section 112 gradually decreases, that is, the proximal and distal ends of the first connecting section 112 The ends are arranged at intervals along the axial direction of the first connecting section 112. It should be noted that in the description of this embodiment, the "outer diameter of the first connecting section 112" refers to the distance from each point on the first connecting section 112 to the axis of the stent 100. The distance between.

Since the outer diameter of the first large-diameter section 111 is greater than the outer diameter of the middle section 120, the proximal outer diameter of the first connecting section 112 is smaller than the distal outer diameter of the first connecting section 112, and the middle section 120 and the first connecting section 112 And the first large-diameter section 111 are arranged in sequence in the axial direction. Therefore, when the stent 100 is compressed in the radial direction and the shape is reduced to fit into the inserter 200, the middle section 120, the first connecting section 112 and the first large-diameter section The sections 111 are arranged in sequence in the axial direction, that is, the middle section 120. There is no overlap between the first connecting section 112 and the first large-diameter section 111 in the axial direction, thereby helping to reduce the radial pressing force between the stent 100 and the implanter 200 during installation. The friction force between 200 makes it possible to install a larger stent 100 without increasing the inner diameter of the inserter 200.

1, in this embodiment, the second cup mouth section 130 includes a second connecting section 131 and a second large-diameter section 132, and two ends of the second connecting section 131 are connected to the second large-diameter section 132 and the middle section respectively. 120 connection, that is, along the direction from the distal end to the proximal end of the stent 100, the first large-diameter section 111, the first connecting section 112, the middle section 120, the second connecting section 131, and the second large-diameter section 132 are sequentially connected.

The middle section 120, the second connecting section 131, and the second large-diameter section 132 form a limit step 140. A limit space corresponding to the limit step 140 is formed between the middle section 120 and the second connecting section 131. When the stent 100 is inserted After being in the lumen of the human body, the human tissue grows into the limiting space, so that the human tissue conflicts with the limiting step 140 in the extension direction of the lumen and prevents the stent 100 from shifting in the extension direction of the lumen Condition. Optionally, the connection between the second connecting section 131 and the second large-diameter section 132 is provided with a smooth arc transition, which can reduce the stimulation and damage to the human body by the limit step 140, and also contribute to the larger-sized stent 100 It is more smoothly loaded into the inserter 200.

Specifically, the second large-diameter section 132 is cylindrical, and the second large-diameter section 132 is arranged coaxially with the middle section 120, so the second large-diameter section 132 and the middle section 120 are projected in the plane as shown in FIG. 1 The contour lines formed are parallel to each other. And the first large-diameter section 111, the first connecting section 112, the middle section 120, the second connecting section 131, and the second large-diameter section 132 are all symmetrically arranged about a preset axis, which is the first large-diameter section 111, The straight line where the axes of the middle section 120 and the second large-diameter section 132 are located.

Please continue to refer to FIG. 1, in this embodiment, the first connecting section 112 is tapered, that is, the outer wall of the first connecting section 112 is a tapered surface. Specifically, there is an included angle between the outer wall of the first connecting section 112 and the outer wall of the middle section 120, that is, the contour line formed by the outer wall of the first connecting section 112 in the plane shown in FIG. The included angle formed by the intersection of the contour lines formed in the plane as shown in FIG. 1, the included angle is α; similarly, there is an included angle between the outer wall of the second connecting section 131 and the outer wall of the middle section 120, namely The angle formed by the intersection of the contour line formed by the outer wall of the second connecting section 131 in the plane shown in FIG. 1 and the contour line formed by the outer wall of the intermediate section 120 in the plane shown in FIG. 1, and the included angle is β; α-β≥20°. Specifically, 90°<α≤180°, by setting α to an obtuse angle, it helps to reduce the radial pressing force between the first connecting section 112 and the implanter 200 during installation, thereby reducing the stent 100 and the insertion The frictional force between the stents 200 makes it easier to fit the large-sized stent 100 into the stent 200 without increasing the inner diameter of the stent 200, and thus can be larger than the existing TTS stent. The stent 100 of the size is used as a TTS stent and is inserted into the human body through the endoscope clamp channel. Further, 115°≤α≤155°. Optionally, the included angle α is 115°, 135°, or 155°. It is understandable that in other embodiments, the specific value of the included angle can also be specifically set according to requirements. Specifically, 60°≤β≤120°. By setting the specific angle values of α and β, it helps to ensure the anti-displacement effect of the stent 100 and the convenience of installing the inserter 200 at the same time. Optionally, the included angle β is 60°, 90° or 120°.

In order to further ensure the anti-displacement effect of the stent 100, an included angle β is formed between the outer wall of the second connecting section 131 and the outer wall of the middle section, 80°≤β≤100°. In this embodiment, the second connecting section 131 is perpendicular to the middle section 120, that is, the contour lines formed by the projection of the second connecting section 131 and the middle section 120 in the plane shown in FIG. 1 are perpendicular to each other. In other words, in this embodiment In the example, β=90°. Therefore, the second connecting section 131 extends along the radial direction of the middle section 120, and the second connecting section 131 is arranged perpendicular to the second large-diameter section 132. Optionally, the included angle β can also be set to 80° or 100°. It should be noted that in this embodiment, the second connecting section 131 is arranged perpendicular to the middle section 120. It is understandable that in other embodiments, it can also be arranged in a way that an acute angle is formed between the second connecting section 131 and the middle section 120. (As shown in Figure 3).

It should be noted that in this embodiment, the first connecting section 112 is tapered. It is understandable that in other embodiments, the shape of the first connecting section 112 can also be specifically set according to requirements, for example, the first connecting section 112 112 is arranged as a curved surface with a gradually increasing outer diameter along the direction from the proximal end to the distal end (as shown in FIG. 4). It should be noted that when the first connecting section 112 is configured as a curved surface, the included angle between the first connecting section 112 and the middle section 120 is the included angle between the tangent of the first connecting section 112 and the middle section 120.

FIG. 5 is a partial structural diagram of the connection between the first large-diameter section 111 and the first connecting section 112 in the stent 100 provided by this embodiment. Please refer to FIG. 5, further, the junction of the first large-diameter section 111 and the first connecting section 112 transitions in a circular arc. Specifically, the first cup mouth section 110 further includes a transition section 113 located between the first large-diameter section 111 and the first connecting section 112, and the shape of the transition section 113 intercepted on the plane as shown in FIG. 4 is an arc. The two ends of the transition section 113 are respectively connected with the first large-diameter section 111 and the first connecting section 112, and the first large-diameter section 111, the transition section 113 and the first connecting section 112 are integrally formed by wire braiding. It can be understood that in other embodiments, the structure of the connection between the first large-diameter section 111 and the first connecting section 112 can also be set according to requirements, for example, the proximal end of the first large-diameter section 111 is directly connected to the first connecting section. The distal end of the 112 is connected to form an angle at the connection between the first large-diameter section 111 and the first connecting section 112.

1 and 5 in combination, in this embodiment, the first large-diameter section 111 is cylindrical, and the first large-diameter section 111 and the middle section 120 are coaxially arranged, so the first large-diameter section 111 and the middle section The contour lines formed by the projection of 120 on the plane as shown in FIG. 1 are parallel to each other. It should be noted that the shape of the first large-diameter section 111 is not limited here. It can be understood that in other embodiments, the shape of the first large-diameter section 111 can also be set according to requirements, for example, the first large-diameter section 111 111 is set in an arc shape with continuously changing outer diameter in the axial direction (as shown in FIG. 6 ), etc., so that the outer diameter of the first large-diameter section 111 is larger than the outer diameter of the middle section 120.

1, in this embodiment, the radial dimension of the middle section 120 is R, 14mm≤R≤24mm, optionally, the radial dimension of the middle section 120 is 14mm, 19mm or 24mm. The radial size of the first large-diameter section 111 is equal to the size of the second large-diameter section 132, and the specific values of the radial sizes of the first large-diameter section 111 and the second large-diameter section 132 are based on the existing intermediate section 120 and The size relationship between the first large-diameter section 111 and the second large-diameter section 132 is set.

In this embodiment, the stent 100 is covered with a film as a whole, that is, the first large-diameter section 111, the first connecting section 112, the middle section 120, the second connecting section 131, and the second large-diameter section 132 of the stent 100 are all covered with a film . Specifically, the specific operation mode of the film is optionally: the metal frame body formed by weaving is immersed in liquid silica gel, and the metal frame body is taken out after the liquid silica gel covers the mesh holes on the metal frame body. After cooling, the film coating is completed, thereby sealing the mesh holes on the metal frame body, and avoiding the growth of human tissue into the inside of the stent 100 through the mesh holes. It is understandable that in other embodiments, only parts of the first large-diameter section 111, the first connecting section 112, the middle section 120, the second connecting section 131, and the second large-diameter section 132 may be coated according to requirements. .

According to a bracket 100 provided in this embodiment, the working principle of the bracket 100 is as follows:

First, the stent 100 is radially compressed to reduce the radial size of the stent 100 so as to facilitate the installation of the stent 100 into the inserter 200. When installing, the proximal end of the stent 100 is first inserted into the receiving cavity 260. In the accommodating cavity 260, a radial force is generated between the stent 100 and the inserter 200, thereby generating friction that prevents the stent 100 from continuing to enter the accommodating cavity 260. After the intermediate section 120 is inserted into the accommodating cavity 260, the stent The frictional force received by 100 is generated by the middle section 120, the second connecting section 131 and the second large-diameter section 132 at the same time. At this time, the frictional force received by the stent 100 is relatively large, because the first connecting section 112 extends from the distal end to the proximal end. The outer diameter is gradually reduced, so the friction force generated at the first connecting section 112 can be effectively reduced, thereby ensuring that the stent 100 is smoothly installed in the inserter 200.

After the stent 100 is inserted into the lumen of the human body under the action of the inserter 200, the limit step 140 formed by the middle section 120, the second connecting section 131, and the second large-diameter section 132 will play an anti-displacement function to avoid the stent. 100 is displaced relative to the lumen, and at the same time, at the proximal end of the stent 100, that is, at the second large-diameter section 132, clamps can be used to assist in realizing the anti-displacement function, and the anti-displacement effect is better.

The stent 100 provided in this embodiment has at least the following advantages:

The embodiment of the present disclosure provides a stent 100. The stent 100 is configured to have a structure in which the outer diameter of the first connecting section 112 gradually decreases from the distal end to the proximal end, thereby reducing the time when the stent 100 is installed in the inserter 200. The frictional resistance is conducive to inserting the stent 100 with a larger size in the inserter 200 without increasing the inner diameter of the inserter 200, so that the stent 100 has a greater supporting force to smoothly transfer the human body’s tube The narrow part of the cavity is opened, and the effect is better. At the same time, a limiting step 140 is provided at the proximal end of the stent 100, and the function of preventing the stent 100 from shifting is realized through the interaction of the limiting step 140 with human tissues, which has a good anti-shift effect, thereby ensuring the treatment effect and reducing the patient's pain. By specifically setting the included angle α formed by the first connecting section 112 and the middle section 120 and the included angle β formed by the second connecting section 131 and the middle section 120, the bracket 100 has a better anti-displacement effect and is easier. The performance of the ground loading inserter 200.

Referring to FIG. 2, this embodiment also provides an implantation system 10, which includes the above-mentioned stent 100, and at the same time, the implantation system 10 also includes an implanter 200, and the implanter 200 has an accommodating cavity 260. The stent 100 is installed in the accommodating cavity 260 so as to enter the human body through the endoscopic forceps with the implanter 200, and then the stent 100 is released by operating the implanter 200 to place the stent 100 in the body lumen.

FIG. 7 is a schematic diagram of the overall structure of the implanter 200 in the implantation system 10 provided by this embodiment, and FIG. 8 is a schematic diagram of a partial structure of the implanter 200 in the implantation system 10 provided by this embodiment. Please refer to FIGS. 2, 7 and 8 in combination. In this embodiment, the inserter 200 includes an inner tube 210, an outer tube 220, and a pushing member 230. The outer tube 220 is sleeved outside the inner tube 210, and the outer tube 220 It is arranged coaxially and spaced apart from the inner tube 210 so as to form a gap between the inner tube 210 and the outer tube 220. The distal end of the inner tube 210 is provided as a metal tube portion 211, and a receiving cavity 260 is formed between the metal tube portion 211 and the outer tube 220, that is, the part of the inner tube 210 configured to form the receiving cavity 260 with the outer tube 220 is made of metal material By providing the metal pipe portion 211, the thickness of the metal pipe portion 211 can be effectively reduced while ensuring sufficient strength, thereby increasing the space size of the accommodating cavity 260, so as not to increase the inner diameter of the outer pipe 220 A larger space is provided for the bracket 100 to fit the bracket 100 with a larger size in the receiving cavity 260.

Optionally, the material of the inner tube 210 is metal, and the metal tube portion 211 is the part corresponding to the accommodating cavity 260 at the distal end of the inner tube 210. Specifically, the inner tube 210 is a stainless steel tube. It is understandable that in other embodiments, the material of the metal pipe 211 can also be specifically set according to requirements, and the thickness of the metal pipe 211 can be reduced under the premise of ensuring the strength, so as to obtain the accommodating cavity 260 with a larger space. .

It should be noted that in this embodiment, the inner tube 210 is entirely made of metal, and the metal tube portion 211 is the part of the inner tube 210 corresponding to the accommodating cavity 260. It is understood that in other embodiments, the inner tube may also be The tube 210 is configured as a structure formed by splicing a metal tube and a plastic tube. For example, only the metal tube portion 211 is provided with a metal material, and the other parts of the inner tube 210 are made of plastic.

The pushing member 230 is arranged at the gap between the inner tube 210 and the outer tube 220 and slidably cooperates with the outer tube 220. When in use, the pushing member 230 pushes the bracket 100 to move the bracket 100 relative to the outer tube 220, thereby The accommodating cavity 260 is opened to realize the release of the stent 100 (as shown in FIG. 9).

Further, in this embodiment, the inner tube 210 includes a metal tube part 211 and a hose part that are connected to each other, and the hose part is located at the proximal end of the inner tube 210. It is understandable that in other embodiments, it can also be used as required. , The inner tube 210 is integrally set into a tubular piece made of metal material. Specifically, the metal tube part 211 and the hose part are fixedly connected by glue.

7 and 9 in combination, further, the inserter 200 includes a first operating handle 251 and a second operating handle 252 disposed at the proximal end, and the first operating handle 251 is located at the distal end of the second operating handle 252. The inner tube 210 and the pushing member 230 are connected to the second operating handle 252, and the outer tube 220 is connected to the first operating handle 251. When in use, by operating the first operating handle 251 and the second operating handle 252 relatively close together, The inner tube 210 is pushed out from the outer tube 220, thereby opening the accommodating cavity 260. The stent 100 moves relative to the outer tube 220 under the action of the pushing member 230. When the accommodating cavity 260 is opened, the outer tube 220 exerts a radial blocking on the stent 100 The force disappears, so that the stent 100 radially expands under the action of its own elasticity, thereby restoring the original radial size and releasing it.

Fig. 10 is an enlarged view of the partial structure at Ⅹ in Fig. 9. Please refer to FIGS. 2, 9 and 10 in combination. Further, the booster includes a middle tube 231 and a booster tube 232. The middle tube 231 is arranged between the inner tube 210 and the outer tube 220, and the middle tube 231 is a hose In order to facilitate the extension of the implanter 200 in the human body, the booster tube 232 is fixedly connected to the second operating handle 252, and the distal end of the booster tube 232 is connected to the proximal end of the middle tube 231, and is pushed by the booster tube 232 The middle tube 231 moves, thereby pushing the stent 100 to move. Optionally, the proximal end of the middle tube 231 is wrapped outside the distal end of the booster tube 232, so as to realize the connection between the middle tube 231 and the booster tube 232. It is understandable that in other embodiments, the connection mode of the middle tube 231 and the booster tube 232 can also be set according to requirements, for example, the connection of the middle tube 231 and the booster tube 232 is realized by gluing.

Further, the inserter 200 further includes a lock nut 254 and a lock catch 253. The proximal end of the first operating handle 251 is provided with a cavity configured to receive the lock catch 253, and the lock nut 254 is screwed to the first operating handle 251. And the booster tube 232 passes through the lock nut 254 and the lock catch 253. When the lock nut 254 is tightened, the lock catch 253 is compressed under the squeeze of the lock nut 254 to lock the booster tube 232 When the lock nut 254 is loosened, the lock catch 253 expands to loosen the booster tube 232. The booster tube 232 can move relative to the outer tube 220 under the action of the pushing force, thereby pushing The stent 100 moves to release.

Please refer to FIGS. 7 and 8 in combination. In this embodiment, the inserter 200 further includes a head 240, and the head 240 is provided with a mounting hole 241 and a through hole 242 communicating with each other. The distal end of the metal tube portion 211 is installed in the mounting hole 241, and the through hole 242 communicates with the inner hole of the inner tube 210 to form a channel configured for the guide wire 270 to pass through. The radial dimension of the through hole 242 is smaller than or equal to the radial dimension of the inner hole. Therefore, after the metal pipe portion 211 is installed in the mounting hole 241, the end surface of the distal end of the metal pipe portion 211 completely abuts on the bottom of the mounting hole 241, Therefore, it is avoided that the sharp angle formed by the inner hole and the end surface of the metal tube portion 211 damages the guide wire 270 during the inward movement of the inserter 200 along the guide wire 270. Optionally, the guide wire 270 adopts a 0.63 mm guide wire 270, so as to make room for the inserter 200 to put a stronger and larger stent 100 in the inserter 200.

Further, the material of the head 240 is metal. By setting the head 240 to a metal material, during the process of inserting the implanter 200 into the human body, the head 240 has a strong ability to be too narrow and a strong visualization ability, thereby enabling more Observing the position of the head 240 clearly is helpful for the accurate release of the stent 100. Optionally, the head 240 and the metal tube 211 are fixed by laser welding, and the head 240 and the metal tube 211 are smoothly connected, so as to avoid cutting the outer skin of the guide wire 270 and effectively reduce the risk of surgery.

Further, the head 240 has a first wall 243 corresponding to the through hole 242, and at the same time, the head 240 also includes a connecting surface 245 and a second wall 244 located outside the head 240. Specifically, the second wall 244 is the head 240 is the distal part of the outer peripheral surface. The first wall surface 243 and the second wall surface 244 are connected by a connecting surface 245, that is, two ends of the connecting surface 245 are connected to the first wall surface 243 and the second wall surface 244, respectively. The connecting surface 245 is a curved surface, thereby achieving a smooth transition between the first wall surface 243 and the second wall surface 244, avoiding damage to the guide wire 270, avoiding damage to the human body during penetration into the human body, and reducing damage caused by the placement of the stent.

Further, the second wall surface 244 is a circular arc surface, that is, in the cross-sectional structure as shown in FIG. 8, the cross-sectional profile of the second wall surface 244 is a circular arc surface. Along the direction from the distal end of the head 240 to the proximal end, the distance between the second wall surface 244 and the axis of the head 240 gradually increases.

Furthermore, the proximal end of the head 240 has an abutting surface 246, and the abutting surface 246 is configured to abut against the distal end of the outer tube 220. Further, the head 240 further includes a blocking block 247 protruding from the abutting surface 246, and the blocking block 247 and the abutting surface 246 form a positioning space to accommodate the distal end of the outer tube 220. Specifically, the blocking block 247 is an annular protrusion formed by the abutting surface 246 protruding from the distal end to the proximal end. The outer tube 220 is sleeved on the annular protrusion, and the end surface of the distal end of the outer tube 220 is in contact with the When the surface 246 conflicts, the axial limit of the outer tube 220 is realized.

Furthermore, a release mark (not shown in the figure) is also provided on the inserter 200, and the release position of the stent 100 is more conveniently determined by the release mark, thereby realizing the accurate release of the stent 100 and reducing the difficulty of operation of the insertion system 10 , And operational risks. Specifically, a release mark is provided on the appearance and the booster tube 232, and the release mark is produced by laser engraving. The mark of the outer tube 220 can be clearly observed under the direct view of the endoscopic screen, so that the stent 100 can be accurately released.

According to an implantation system 10 provided in this embodiment, the working principle of the implantation system 10 is as follows:

In use, the guide wire 270 is first fed into the lesion site through the endoscopic forceps, and then the head 240 of the inserter 200 with the stent 100 is passed through the guide wire 270, and the guide wire 270 enters the inner tube 210 through the head 240 , And finally pass through the second operating handle 252. After the release position of the stent 100 is selected, the entire release process of the stent 100 can be seen under direct vision of the endoscope, and the developed head 240 can also be observed under CT to determine the distal position of the stent 100 to ensure the stent 100 Release with precision. When releasing, first unscrew the lock nut 254 to separate the lock nut 254 from the first operating handle 251. At this time, the lock 253 expands to release the wrapped booster tube 232, the booster tube 232 is unlocked, and then hold with one hand Tighten the first operating handle 251, hold the second operating handle 252 with one hand and push it slowly, so that the stent 100 in the implanter 200 is pushed out through the distal end of the middle tube 231, and the stent 100 is slowly released.

The implantation system 10 provided in this embodiment has at least the following advantages:

The implantation system 10 provided by the embodiment of the present disclosure includes the above-mentioned stent 100, and therefore also has the ability to install a larger-sized stent 100 in the implanter 200 without increasing the inner diameter of the implanter 200, thereby The stent 100 has a greater supporting force to smoothly open the narrow part of the lumen of the human body, the supporting effect is better, and the anti-displacement effect is good. At the same time, the inserter 200 inserted into the system 10 is provided with a metal tube portion 211 in the inner tube 210, so that the thickness of the metal tube portion 211 can be reduced under the premise of ensuring the strength, thereby obtaining a receiving cavity 260 with a larger space, which can be used in The accommodating cavity 260 is loaded with a stent 100 having a larger size, thereby effectively ensuring that the stent 100 has sufficient supporting force.

The above are only specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed in the present disclosure. All should be covered within the protection scope of this disclosure. Therefore, the protection scope of the present disclosure should be subject to the protection scope of the claims.

Claims

A stent having opposite distal ends and proximal ends, characterized in that, along the direction from the distal end to the proximal end, the stent includes a first large-diameter section and a first connection connected in sequence. Section, middle section, second connecting section and second large diameter section;

Along the direction from the distal end to the proximal end, the outer diameter of the first connecting section gradually decreases;

The middle section, the second connecting section, and the second large-diameter section form a limiting step, and the limiting step is configured to prevent displacement.
The stent according to claim 1, wherein there is an included angle α between the outer wall of the first connecting section and the outer wall of the middle section; the outer wall of the second connecting section and the outer wall of the middle section There is an angle β between them;

Among them, α-β≥20°.
The stent according to claim 2, wherein 90°<α≤180°.
The stent according to claim 3, wherein 115°≤α≤155°.
The stent according to claim 2, wherein 60°≤β≤120°.
The stent according to claim 1, wherein the first connecting section is tapered.
The stent according to claim 6, characterized in that the junction of the first large-diameter section and the first connecting section has a circular arc transition.
The stent according to claim 6, wherein the first large-diameter section is cylindrical.
The stent according to claim 1, wherein the outer wall of the second connecting section and the outer wall of the middle section have an included angle β, 80°≤β≤100°.
The bracket according to claim 9, wherein the second connecting section is perpendicular to the middle section.
The stent according to claim 1, wherein the first large-diameter section, the first connecting section, the middle section, the second connecting section, and the second large-diameter section are all covered with a film .
The stent according to claim 1, wherein the first large-diameter section, the first connecting section, the intermediate section, the second connecting section, and the second large-diameter section are all related to the Set the axis to be symmetrical.
The stent according to any one of claims 1-12, wherein the radial dimension of the middle section is R, 14mm≤R≤24mm.
An implantation system, characterized in that the implantation system comprises an implanter and the stent according to any one of claims 1-13; the implanter has a containing cavity, and the stent is arranged in the containing Cavity.
The implantation system according to claim 14, wherein the implanter comprises an inner tube, an outer tube and a pushing member, the outer tube is sleeved on the inner tube; the inner tube includes a metal tube part , The accommodating cavity is formed between the metal tube portion and the outer tube, the pushing member is disposed between the inner tube and the outer tube, and the pushing member is configured to push the accommodating cavity Inside the bracket.
The implantation system according to claim 15, wherein the material of the inner tube is metal.
The implantation system according to claim 15, wherein the implanter further comprises a head, the head is provided with mounting holes and through holes that communicate with each other, and the distal end of the metal tube is mounted In the mounting hole, the through hole communicates with the inner hole of the inner tube to form a channel configured for the guide wire to pass through, and the radial dimension of the through hole is smaller than or equal to the radial dimension of the inner hole. size.
The implantation system according to claim 17, wherein the head has a first wall surface corresponding to the through hole, and the head further includes a second wall located outside the head and connected to The connecting surface between the first wall surface and the second wall surface is a circular arc surface.
The implantation system according to claim 18, wherein the second wall surface is a circular arc surface, along the direction of the distal end of the head toward the proximal end, and the second wall surface reaches the end of the head The distance between the axes gradually increases.
The implantation system according to claim 17, wherein the material of the head is metal.
The implantation system according to claim 20, wherein the head and the metal tube are fixed by laser welding.
The implantation system according to claim 17, wherein the proximal end of the head has an abutting surface, and the abutting surface is configured to abut against the distal end of the outer tube.
The implantation system of claim 22, wherein the head further comprises a blocking block protruding from the abutting surface, the blocking block and the abutting surface form a positioning space, and the positioning The space is configured to accommodate the distal end of the outer tube.
The implantation system according to any one of claims 14-23, wherein a release mark is provided on the implanter.