CN115670764B - Tubular implant delivery member, delivery system and stent system - Google Patents

Abstract

The present application provides a delivery part, a delivery system and a stent system of a tubular implant. The delivery element includes a styling wire, at least one expansion body and a core wire disposed within the expansion body. The two ends of the core wire are fixedly connected with the two ends of the expansion body, the natural state of the core wire is a pre-shaped state, and the molding wire is arranged outside the expansion body and connected to its end. The transport element is configured to have at least two states. The first state is the bound state of the expansion body, and the second state is the release state of the expansion body; the core wire in the predetermined state has two-stage shapes, the first-stage shape shortens the ends of the core wire to adapt to the changes at both ends of the expansion body, and the second-level shape makes the core wire With the molding line is constructed into a pre-bent type. The present application eliminates the risk of particulate matter shedding caused by friction between the expansion body and the core wire, and makes the expansion body conflict with the inner wall of the tubular implant through a predetermined bending shape, thereby improving poor apposition.

Description

Delivery element, delivery system and stent system for tubular implants

technical field

The present application relates to the technical field of medical devices, in particular, to a delivery component, a delivery system and a stent system of a tubular implant.

Background technique

Vascular implants can be implanted into blood vessels through vascular interventional surgery, and are used for the treatment of various vascular diseases, such as blood flow steering technology for the treatment of hemangiomas, and vascular reconstruction technology for the treatment of stenosis or occlusion of the vascular lumen. Tubular implants (such as stents) are usually delivered to diseased blood vessel sites through a delivery system, and then the tubular implants are released to achieve therapeutic purposes.

The existing delivery system carries out the delivery and release of the stent through the cooperation of the delivery guide wire and the catheter. During the delivery process, there are problems such as poor passability, poor blood vessel compliance, and poor rotation coaxiality, which makes it difficult for the operator to perform the interventional operation. Precisely control the implantation position and shape of the tubular implant.

In order to solve the problems existing in the delivery system, in the prior art, a compressible expansion body with a hollow structure is added to the distal end of the delivery guide wire. The compressible expansion body can improve the passability, compliance and coaxiality of the delivery system. However, the delivery system that adds a compressible expansion body at the distal end of the guide wire still has the characteristics of expansion and contraction of the compressible expansion body. Insufficient conduction problem.

In some existing technologies, a delivery guide wire is inserted inside the compressible expandable body to improve the problem of insufficient push force transmission of the compressible expandable body. The problem of synchronous change is that one end of the compressible expansion body is fixed with the delivery guide wire, and the other end of the compressible expansion body is relatively sliding with the guide wire. However, the relative friction between the wire of the compressible expansion body and the delivery guide wire will It brings the risk of falling particles on the surface of the metal wire. The falling particles in the blood can easily stimulate the coagulation mechanism to form a thrombus. As the falling particles flow in the blood, they enter the small arteries of the surrounding brain tissue, easily causing acute ischemic stroke, and subsequent Epidemic subarachnoid hemorrhage is very likely to bring health risks or hidden dangers to patients.

Further, after the self-expandable vascular implant is released in the blood vessel, the self-expansion of the vascular implant is used to achieve attachment to the inner wall of the blood vessel. However, due to the influence of the structure and size of the blood vessel, the vascular implant may not be able to fit effectively with the inner wall of the blood vessel. If the vascular implant does not fit well with the inner wall of the blood vessel, it may lead to vascular dissection or thrombus formation under long-term blood flow erosion, which will bring health risks.

Contents of the invention

The purpose of the embodiments of the present application is to provide a delivery component, a delivery system and a stent system of a tubular implant, which can at least solve the problems pointed out in the background art.

In a first aspect, a delivery part of a tubular implant is provided, and the delivery part includes an expansion body, a core wire and a molding wire. The number of the expansion body is at least one, the core wire is arranged inside the expansion body, the two ends of the core wire are fixedly connected with the two ends of the expansion body, the natural state of the core wire is a predetermined state, the molding wire is arranged outside the expansion body, and The end connections of the expansion body.

Therein, the conveying element is configured to have at least two states. The first state is the bound state of the expansion body, the expansion body is in the state of radial compression, the core wire is in the state of axial elongation, and the molding wire is in the state of axial elongation. The second state is the release state of the expansion body, the expansion body is in the state of radial expansion, the core wire is in the state of axial limit contraction, and the molding line is in the predetermined state or the natural state. The core wire in the pre-shaped state has two-stage molding. The first-stage molding shortens the two ends of the core wire to adapt to the shortening of the two ends after the expansion body expands. The second-stage molding makes the core wire and the molding wire after the first-stage molding are constructed together Into pre-bending type.

In a practicable solution, the pre-curved shape is designed to have at least one pole close to the inner wall of the tubular implant, and the expansion body is arranged at the position of the pole.

In a practicable solution, the included angle of the predetermined bending shape near the pole is between 90° and 180°.

In a practicable solution, the included angle of the predetermined bending shape near the pole is between 120° and 160°.

In an implementable solution, the distance between the two ends of the core wire in a natural state is A; the distance between the two ends of the expansion body in a natural state is B, and A=0.5B˜1B is satisfied.

In a practical solution, the expansion body is a sphere, an ellipsoid whose long axis extends axially, or a columnar body extending axially.

In a practicable solution, the conveying part includes more than two expansion bodies, the pre-curved shape has at least two poles close to the inner wall of the tubular implant, and one expansion body is provided at each pole.

In a practicable solution, the delivery part is obtained by binding a tubular network structure extending in the axial direction in a segmental manner, and an expansion body is formed between adjacent bound parts.

Wherein, a continuous pre-shaped wire is arranged inside the tube network structure; the pre-shaped wire is pre-shaped corresponding to the position of the expansion body to form a first-level shape of the core wire.

In a practicable solution, the pre-shaped silk thread is subjected to secondary pre-setting to form a pre-curved shape; the position corresponding to the binding part is the molding line.

In a practicable solution, the primary presetting includes shaping the core wire into a state where the distance between two ends is A; the secondary presetting includes shaping the preshaped wire into a state with at least one bend.

In a practicable solution, the one-time presetting includes shaping the core wire into any one of helical shape and wave shape or a combination of at least two of them; the predetermined bending shape includes a curved line shape including crests and troughs.

In a practicable solution, the pipe network structure includes any one or a combination of at least two of a cylindrical pipe network structure and an ellipsoidal pipe network structure.

In a practicable solution, the way of restraint includes setting a sleeve outside the pipe network structure, or setting a fixing member inside the pipe network structure.

In a practicable solution, the binding method includes fixing the binding part of the pipe network structure to the molding line.

In one possible embodiment, the delivery element comprises an expansion body, the pre-curved shape has at least one extreme point close to the inner wall of the tubular implant, and the expansion body is arranged at the extreme point.

In an implementable solution, the expansion body is an ellipsoid whose major axis extends axially or a columnar body extending axially; the molding line connected to the proximal end of the expansion body and the core wire at the proximal end of the expansion body The included angle of the extension direction is 30-60°; the included angle of the molding line connected with the distal end of the expansion body and the extension direction of the distal end of the expansion body is 30-60°.

In a practicable solution, the proximal end of the conveying part is further provided with a retractable auxiliary part, and the retractable auxiliary part includes a fixing part and an opening and closing part arranged at the distal end of the fixing part.

In a practicable solution, the opening and closing part includes a splint with one end fixed to the fixing part and the other end capable of opening and closing.

In a practical solution, the opening and closing part includes a braided mesh tube with one end fixed to the fixing part and the other end forming a bell mouth.

In a second aspect, a delivery system for a tubular implant is provided. The delivery system includes the delivery component in the above solution and a push guide wire fixedly connected to the proximal end of the delivery component.

In a third aspect, a stent system is provided. The stent system includes the aforementioned tubular implant delivery system and a delivered stent, and the delivered stent is sheathed outside the expansion body.

In a fourth aspect, a stent system is also provided, and the stent system includes the aforementioned tubular implant delivery system and the stent to be delivered. The stent to be delivered is sheathed on the outside of the expansion body.

When the delivery component is in the first state, the distance from the distal end of the delivery component to the distal end of the stent being delivered does not exceed the first threshold; when the delivery component is in the second state, the distal end of the delivery component extends beyond the distal end of the stent to be delivered The distance of the transport component does not exceed the second threshold; during the process of the transport component changing from the first state to the second state, the distance from the distal end of the transport component to the distal end of the stent being transported does not exceed the third threshold; and the first threshold, Both the second threshold and the third threshold are less than or equal to 5mm.

In an implementable solution, the first threshold, the second threshold and the third threshold are all ≤0.

In an implementable solution, the distance between the two ends of the core wire in a natural state is A, and the distance between the two ends of the expansion body in a natural state is B, satisfying A=0.5B-0.8B.

Compared with the prior art, the beneficial effects of the present application are:

(1) In the delivery part of the present application, the two ends of the expansion body are fixedly connected to the two ends of the core wire, which eliminates the sliding friction at the joint, avoids the falling off of surface particles, and improves the safety of the operation. Moreover, the core wire in the first-stage modeling structure can adapt to the change of the length of both ends of the expansion body before and after expansion, and satisfy the mutual transformation of the expansion body between the bound state and the released state. Moreover, since the core wire is arranged inside the expansion body, the conductivity of the pushing force from the proximal end to the distal end of the pushing system is enhanced.

(2) In the preferred technical solution, after the molding wire and the core wire in the secondary molding are released following the expansion body, the molding wire and the core wire construct a predetermined bending shape, and the predetermined bending shape formed by the molding wire and the core wire can make The outer wall of the expansion body is more likely to conflict with the inner wall of the tubular implant, so as to achieve a better massage and smoothing effect on the inner wall of the tubular implant, so that the tubular implant can better fit the inner wall of the blood vessel. Possibly eliminates malapposition problems.

(3) In the stent system provided by this application, since the core wire inside the expansion body can shrink axially, the axial elongation and contraction distance of the delivery component containing the expansion body in the restrained and expanded state can be well controlled. Controlling, during the entire process before the stent being delivered starts to be released until the release is completed, the distance from the distal end of the delivery component protruding from the distal end of the stent to be delivered is very small, which reduces the probability of the distal end of the delivery component causing damage to the distal blood vessel. In a preferred technical solution, during the entire process before the stent being delivered begins to be released until the release is completed, the distal end of the delivery component does not protrude from the distal end of the stent to be delivered, which basically eliminates the impact of the distal end of the delivery component on the distal blood vessel. The problem of damage.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the accompanying drawings used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, so It should be regarded as a limitation on the scope, and those skilled in the art can also obtain other related drawings based on these drawings without creative work.

Fig. 1a is a working schematic diagram of a delivery member with a single expansion body and a predetermined bending shape according to Embodiment 1 of the present application;

Figure 1b is a schematic diagram of the internal structure of the tubular implant in Figure 1 after sectioning;

Fig. 2a is a working schematic diagram of a delivery member with multiple expansion bodies and a predetermined bending shape according to Embodiment 1 of the present application;

Figure 2b is a schematic diagram of the internal structure of the tubular implant in Figure 2 after sectioning;

Fig. 3a is a working schematic diagram of a delivery member with a plurality of expansion bodies naturally forming a predetermined bending shape according to Embodiment 1 of the present application;

Figure 3b is a schematic diagram of the internal structure of the tubular implant in Figure 3 after sectioning;

Fig. 4 is a schematic structural diagram of a delivery component located in a catheter according to Embodiment 1 of the present application;

FIG. 5 is a schematic structural view of the delivery component and the tubular implant in a tortuous blood vessel according to Embodiment 1 of the present application;

Fig. 6a is a schematic structural view of a spherical expansion body according to Embodiment 1 of the present application;

Fig. 6b is a schematic structural view of an ellipsoidal or spindle-shaped expansion body according to Embodiment 1 of the present application;

Fig. 6c is a schematic structural view of an expansion body in the form of a column according to Embodiment 1 of the present application;

Fig. 7a is a schematic structural diagram of a conveying part with a retractable auxiliary part in the form of a splint according to Embodiment 1 of the present application;

Fig. 7b is a schematic structural diagram of a conveying component with a retractable auxiliary component in the form of a bell-mouth braided mesh tube according to Embodiment 1 of the present application;

Fig. 8a is a schematic structural view of a pre-curved shape formed by a core wire and a molding wire according to Embodiment 2 of the present application;

Fig. 8b is a schematic structural diagram of an expansion body arranged at a pole position according to Embodiment 2 of the present application;

Fig. 9a is a schematic structural view of two predetermined bending shapes formed by a core wire and a molding wire according to Embodiment 3 of the present application;

Fig. 9b is a schematic structural diagram of two expansion bodies arranged at two different pole positions according to Embodiment 3 of the present application;

Fig. 10a is a schematic diagram of a helical structure with equal diameters formed by the core wire and the molding wire according to Embodiment 3 of the present application;

Fig. 10b is a schematic diagram of a variable-diameter helical structure formed by the core wire and the molding wire according to Embodiment 3 of the present application;

Fig. 11 is a schematic diagram of a pipe network structure according to Embodiment 4 of the present application;

Fig. 12 is a schematic structural diagram of an expanded body obtained by restraining a pipe network structure according to Embodiment 4 of the present application;

Fig. 13a is the first way of restraining the pipe network structure according to Embodiment 4 of the present application;

Fig. 13b is a second way of restraining the pipe network structure according to Embodiment 4 of the present application;

Fig. 13c is a third way of restraining the pipe network structure according to Embodiment 4 of the present application;

Fig. 14 is a schematic diagram of conveying components after secondary presetting of the presetting silk thread according to Embodiment 4 of the present application;

Fig. 15 is a working schematic diagram of a delivery part of a tubular implant according to Embodiment 5 of the present application;

Fig. 16a is a schematic diagram of a pole position of a predetermined bending type according to Embodiment 5 of the present application;

Fig. 16b is a second schematic diagram of pole positions of a predetermined bending type according to Embodiment 5 of the present application;

Fig. 17a, Fig. 17b and Fig. 17c are schematic diagrams of the conveying member in different conveying states according to Embodiment 8 of the present application.

In the figure: 10, conveying part; 11, expansion body; 12, core wire; 13, molding line; 20, pipe network structure; 21, casing; 22, fixing piece; 30, predetermined silk thread; Auxiliary parts; 41, fixed part; 42, opening and closing part; 421, splint; 422, braided mesh tube; 100, tubular implant; 101, conveyed stent; 200, pushing guide wire; 300, catheter; 400, blood vessel; M, pole; N, pole; H, pole.

Detailed ways

In order to make the purposes, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments It is a part of the embodiments of this application, not all of them. The components of the embodiments of the application generally described and illustrated in the figures herein may be arranged and designed in a variety of different configurations.

Accordingly, the following detailed description of the embodiments of the application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of the application. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without creative efforts fall within the protection scope of this application.

In the description of the present application, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner" and "outer" are only for the convenience of describing the present invention and simplifying the description, rather than indicating Or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be construed as limiting the invention. In addition, the terms "first", "second", "third", etc. are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installation", "connection", "connection" and so on should be understood in a broad sense, for example, it can be a fixed connection or a flexible connection. Detachable connection, or integral connection; it can be mechanical connection or electrical connection; it can be direct connection or indirect connection through an intermediary. Those of ordinary skill in the art can understand the specific meanings of the above terms in the present invention according to specific situations.

In the description of the present application, it should be noted that, in the case of no conflict, the embodiments in the present application and the features in the embodiments can be combined with each other.

It should be noted that in the description of this application, "distal", "proximal", "axial" and "radial" are used, "proximal" refers to the end close to the operator of the medical device, and "distal " refers to the end away from the operator of the medical device, "axial" refers to the direction extending from the proximal end to the distal end, and "radial" refers to the direction perpendicular to the "axial".

The present application proposes the following several embodiments.

Example 1:

This embodiment provides a delivery part for a tubular implant. It should be noted that the tubular implant includes various tubular stents for vascular implantation treatment. If it is classified according to the material, it can generally include metal tubular stents and non-metallic tubular stents. Tubular bare stents and tubular covered stents can be included if surface coverage is used. In addition, according to different manufacturing methods, the tubular implant may also include a tubular stent braided with metal wires and a tubular stent integrally carved on a metal tubular structure. Tubular implants are typically used to treat hemangiomas, stenosis or occlusion of blood vessel lumens, and other vascular conditions.

As shown in FIGS. 1 a to 4 , the delivery member 10 includes an expansion body 11 , a core wire 12 and a styling wire 13 .

There is at least one expansion body 11 , the core wire 12 is arranged inside the expansion body 11 , and the two ends of the core wire 12 are fixedly connected with the two ends of the expansion body 11 . The molding line 13 is arranged outside the expansion body 11 and connected with the end of the expansion body 11 . The core wire 12 is in a pre-shaped state in a natural state, where the natural state refers to a state in which the core wire 12 is not subjected to any external force and is not connected to any structure or component.

Wherein, the conveying member 10 is configured to have at least two states. The first state is the expansion body bound state, the expansion body 11 is in the radially compressed state, the core wire 12 is in the axially elongated state, and the molding wire 13 is in the axially elongated state. The second state is the release state of the expansion body, in which the expansion body 11 is in a radially expanded state, the core wire 12 is in a state of axial limit contraction, and the molding wire 13 is in a predetermined state or a natural state. The core wire 12 in the predetermined state has two-stage shapes, the first-stage shape makes the two ends of the core wire 12 shorten to adapt to the change of the shortening of the two ends after the expansion body 11 expands, and the second-level shape makes the core wire 12 after the first-level shape and the shape The wires 13 are configured together into a predetermined bend.

In the above technical solution, the two ends of the expansion body 11 are fixedly connected to the two ends of the core wire 12, which eliminates the sliding friction at the connection, avoids the generation of surface particles as much as possible, and improves the safety of the operation. Moreover, the core wire 12 in the primary shape structure can adapt to the change of the length of both ends of the expansion body 11 before and after expansion, and satisfy the axial changes of the expansion body 11 caused by mutual transformation between the constrained and released states.

As shown in Figure 4, when the expansion body 11 is in the bound state in the catheter 300, the core wire 12 is also in an elongated state. At this time, the expansion body 11 and the core wire 12 jointly transmit the delivery force forward, thereby improving the expansion of the expansion body. 11 Delivery capacity within catheter 300 .

It should be noted that, when the tubular implant moves along the catheter 300 to the distal end of the catheter 300 , the delivery component 10 gives the tubular implant an active delivery force (or referred to as pushing force) to move to the distal end. When the tubular implant is released, the release method is to limit the position of the delivery part 10, and the catheter 300 is withdrawn, so that the delivery part 10 supports the tubular implant and is released into the blood vessel. At this time, the delivery part 10 is due to The catheter 300 is retracted to impart a passive delivery force (or called a holding force) to the tubular implant.

As shown in Figures 1a to 3b, due to the retraction of the catheter 300, when the expansion body 11 is released outside the catheter 300, the core wire 12 shrinks axially with the expansion of the expansion body 11. At this time, the distance between the core wire 12 and the expansion body 11 There is a certain interaction force between them, so as to limit the expansion and contraction of the expansion body 11, so it can basically eliminate the collapse and stacking of the expansion body 11 after release.

As shown in Fig. 1a, Fig. 1b, Fig. 2a and Fig. 2b, the molding line 13 in the secondary molding is in a predetermined state, and the molding line 13 and the core wire 12 together form a predetermined bending shape with memory characteristics. In the second state where the expansion body 11 is released, affected by the tendency to restore the predetermined bending shape of the memory characteristic, the overall line shape of the styling wire 13 and the core wire 12 recovers to have a predetermined bending shape. At this time, the predetermined bending shape can make the outer wall of the expansion body 11 conflict with the inner wall of the tubular implant 100, which helps the expansion body 11 to massage the tubular implant 100 in the expanded state and smooth the inner wall of the tubular implant 100, In order to make the tubular implant 100 fit better to the inner wall of the blood vessel. In one embodiment, when the tubular implant 100 is fully released into the blood vessel from the catheter 300, the delivery member 10 can be rotated slightly to allow the expansion body 11 to massage the inner wall of the tubular implant 100 to further allow the tubular implant to The object 100 fits better with the inner wall of the blood vessel.

In addition, as shown in Fig. 3a and Fig. 3b, the molding wire 13 in the secondary molding is a structure in a natural state. The outer diameter of the tubular implant 100 is smaller than the inner diameter of the tubular implant 100, and the molding wire 13 and the core wire 12 can naturally form a curved shape instead of a predetermined curved shape with memory characteristics. The outer wall of the expansion body 11 at the naturally formed bend can also conflict with the inner wall of the tubular implant 100, which helps the expansion body 11 massage (or smoothen) the inner wall of the tubular implant 100 in the expanded state, so that The tubular implant 100 conforms better to the inner wall of the blood vessel. Similarly, when the tubular implant 100 is fully released into the blood vessel from the catheter 300, the delivery member 10 can be rotated slightly to make the expansion body 11 massage the inner wall of the tubular implant 100, so as to further make the tubular implant 100 better. closely adhere to the inner wall of the blood vessel.

In the foregoing, the molding line 13 and the core wire 12 in Figure 1a and Figure 1b form a predetermined bending shape with memory characteristics, and the angle and position of the bending shape are relatively easy to control, so as shown in Figure 1a and Figure 1b When there is only a single expansion body 11, the outer wall of the single expansion body 11 can also be made to interfere with the inner wall of the tubular implant 100 through the bending effect of the memory characteristic. As shown in Figure 2a and Figure 2b, when there are multiple expansion bodies 11, the outer wall of each expansion body 11 can be made to conflict with the inner wall of the tubular implant 100 to form a form of multi-point contact, which is more conducive to multiple expansions. The body 11 forms a massaging effect on the tubular implant 100, so that the tubular implant 100 fits better with the inner wall of the blood vessel.

Compared with the predetermined bending type, the naturally formed bending type is more adaptable to the pipelines of different blood vessels, but the bending controllability of the predetermined bending type is better, and it can better ensure the connection between the outer wall of the expansion body 11 and the tubular implant 100. The inner walls collide.

As shown in Figure 3a and Figure 3b, the predetermined bending shape formed by the molding wire 13 and the core wire 12 does not have memory characteristics, because the angle and position of the bending shape cannot be controlled, so it is preferably in the structure of multiple expansion bodies 11 used in . After the expansion body 11 is released, even if there are individual expansion bodies 11 that are not in contact with the inner wall of the tubular implant 100, the combined structure of the plurality of expansion bodies 11, the molding wire 13 and the core wire 12 contributes to the natural formation of multiple predetermined Curved type, so that as much as possible the expansion body 11 is in conflict with the inner wall of the tubular implant 100, to play a better massage effect on the inner wall of the tubular implant 100, so that the inner wall of the tubular implant 100 and the blood vessel Better fit.

Further, as shown in FIG. 5, if the released tubular implant 100 is in a tortuous blood vessel 400 position, the pre-curved shape makes the expansion body 11 conflict with the inner wall of the tubular implant 100, and the pre-curved structure is more To adapt to the meandering extension of the tortuous blood vessel 400 , better massage (smooth) the inner wall of the tubular implant 100 .

Further, the distance between the two ends of the core wire 12 in a natural state is A, and the distance between the two ends of the expansion body 11 in a natural state is B, and A and B preferably satisfy A=0.5B˜1B. It should be noted that the natural state means a state without external force.

After the expansion body 11 is released, it shortens in the axial direction and expands in the radial direction, and the core wire 12 also needs to restore the shortened state at this time, so the core wire 12 will give the force of the two ends of the expansion body 11 in the axial direction to approach each other at this time, if A<0.5B, the core wire 12 may cause the two ends of the expansion body 11 to be too close together, causing the expansion body 11 to be easily folded, and the contact area between the outer wall of the expansion body 11 and the inner wall of the tubular implant 100 becomes smaller, reducing the expansion The force exerted by the body 11 on the inner wall of the tubular implant 100.

It should be noted that the core wire 12 can be made of a memory metal material into a predetermined shape, such as a wave shape, a spiral shape, or the like. The metal material includes memory metal, and the memory metal may include one or more of cobalt-chromium alloy, platinum-tungsten alloy and nickel-titanium alloy.

Further, as shown in FIG. 6a , FIG. 6b and FIG. 6c , the expansion body 11 may be a sphere, an ellipsoid whose major axis extends axially, or a cylindrical body extending axially. The distance from the outer wall of the spherical expansion body 11 to the center is basically equal. The axial length of the expansion body 11 in the form of an ellipsoid is greater than the radial length, and the ellipsoid can also be called a spindle. The dimensions from the center to the edge of any radial cross-section of the expanded body 11 of the columnar body are substantially equal.

It should be noted that the expansion body 11 can be braided by metal wire, or obtained by engraving a metal pipe. Exemplary, the engraving may be laser engraving, and an exemplary nickel-titanium alloy tube may be selected for the metal tube.

Several problems can be encountered when introducing tubular implant 100 into a blood vessel. For example, when the release position of the tubular implant 100 is wrong or the release position needs to be adjusted, it is inconvenient to retrieve the tubular implant 100 .

Therefore, based on the above-mentioned problems, as shown in Figure 7a and Figure 7b, the proximal end of the delivery part 10 can also be provided with a retractable auxiliary part 40, and the retractable auxiliary part 40 includes a fixed part 41 and an opening and closing device arranged at the far end of the fixed part 41. Section 42.

The fixing part 41 is fixedly connected to the proximal end of the most proximal expansion body 11 , or the fixing part 41 is fixedly connected to the molding line 13 connected to the proximal end of the most proximal expansion body 11 . The opening and closing portion 42 is towards the far end, and the opening and closing portion 42 has a space for folding in. The opening and closing portion 42 includes at least two states: the first state is the closed state of the opening and closing portion 42, and the opening and closing portion 42 is folded to shrink the space for gathering; the second The state is the open state of the opening and closing part 42, and the opening and closing part 42 expands to increase the storage space.

As shown in FIG. 7 a , the opening and closing part 42 includes a splint 421 with one end fixed to the fixing part 41 and the other end capable of opening and closing. The closed splint 421 has an accommodating cavity inside for accommodating the whole or the proximal part of the tubular implant 100 . When the tubular implant 100 is not completely released from the catheter 300, that is, the predetermined length of the proximal end of the tubular implant 100 is still located in the catheter 300, the splint 421 after opening can guide the tubular implant 100 to enter between the splints 421, and then With the closure of the splint 421, all or the proximal part of the tubular implant 100 is finally retracted into the containing cavity, and the tubular implant 100 is retracted into the catheter 300 by further retraction, and then released again at the correct lesion position. Can. The closed shape of the splint 421 can be a regular prism extending in the axial direction, such as a regular triangular prism, a regular quadrangular prism, a regular pentagonal prism, and a regular hexagonal prism, forming a line contact state with the inner wall of the catheter 300, thereby reducing the friction during pushing.

As shown in FIG. 7 b , the opening and closing part 42 includes a braided mesh tube 422 with one end fixed to the fixing part 41 and the other end forming a bell mouth. The bell-shaped braided mesh tube 422 guides the tubular implant 100 . When the braided mesh tube 422 is retracted into the catheter 300 , the tubular implant 100 is retracted into the catheter 300 along with the braided mesh tube 422 .

It should be noted that the fixing part 41 is a tubular structure, such as a circular tube structure, and has a through hole extending in the axial direction inside, which can be sleeved and fixed on the proximal end of the delivery component 10, or sleeved with the delivery component. 10 proximally connected to push the distal end of the guide wire 200 and fix it. In other examples, the fixing portion 401 may also be a non-tubular structure, such as a solid cylinder, a solid prism, and the like.

Example 2:

This embodiment provides a delivery part for a tubular implant. Compared with Embodiment 1, the differences between this embodiment and Embodiment 1 are:

As shown in FIGS. 8a and 8b, in the second state of the expanded body 11 released, the predetermined bend shape that the core wire 12 is configured with the molding wire 13 is designed to have at least one pole M close to the inner wall of the tubular implant 100. , and the expansion body 11 is set at the position of the pole M.

The pole M may refer to a point in the pre-curved structure that is closer or closest to the inner wall of the tubular implant 100 . As shown in FIG. 7, the pole M is the bottommost point of the bending position of the predetermined bending shape.

The expansion body 11 arranged at the extreme point M is more likely to interfere with the inner wall of the tubular implant 100, so as to control the position where the expansion body 11 interferes with the tubular implant 100, thereby better controlling the inner wall of the tubular implant 100. smoothen.

As shown in Figures 8a and 8b, the angle of the predetermined bending shape near the pole M is preferably between 90° and 180°, so that the angle of the predetermined bending shape is in an obtuse state, which is more conducive to the expansion body 11 at the pole and the tubular shape. The inner walls of the implant 100 are in contact, and the predetermined curvature in the obtuse angle state makes stacking of the conveying parts 10 less easy.

As shown in Figures 8a and 8b, β represents the included angle of the predetermined bending shape. If 0<β<90° or 270°<β<360°, it means that the included angle of the bend is less than 90°, only the orientation is different, and the included angle of the bend at the pole M is smaller, and the catheter 300 is withdrawn to release the tubular implant In the process of feeding 100, the expansion body 11 may be folded or stacked. In severe cases, the entire delivery part 10 may be folded and blocked the tubular implant 100, affecting the smooth release of the tubular implant 100. If 180°<β<270° or 90°<β<180°, it means that the included angle of the predetermined bend near the pole is between 90° and 180°, and only the orientation of the bend is different.

Further, the included angle of the pre-curved shape near the pole M is preferably between 120° and 160°, so that the pre-curved shape can be kept facing forward, and at the same time, the expansion body 11 can give the inner wall of the tubular implant 100 a relatively narrow angle. Good radial force to smooth the inner wall of the tubular implant 100.

If the included angle of the predetermined curved shape close to the pole M is greater than 160° and less than or equal to 180°, the curved shape of the curved shape is not obvious, because the angle of the curved shape is small, most of them can only rely on the state of the tortuous blood vessel to realize the expansion body 11 and The contact of the inner wall of the tubular implant 100 makes it difficult to control the contact between the expansion body 11 and the inner wall of the tubular implant 100 , resulting in an unsatisfactory smoothing effect of the expansion body 11 on the inner wall of the tubular implant 100 .

If the included angle of the predetermined bend near the extreme point M is greater than 90° and less than 120°, although the predetermined bend angle is an obtuse angle, the angle of the obtuse angle is small, and it may cause expansion in some too tortuous blood vessel positions The body 11 touches the inner wall of the tubular implant 100, and a plurality of expansion bodies 11 are stacked due to the limitation of the bending angle.

It should be noted that, for the predetermined curved shape with memory characteristics formed by the molding line 13 and the core wire 12 in the secondary molding, the angle limitation of the predetermined curved shape at the pole M in this embodiment 2 should be understood as conveying Part 10 is in its natural form without any external force.

Example 3:

This embodiment provides a delivery part for a tubular implant. Compared with Embodiment 1, the differences between this embodiment and Embodiment 1 are:

As shown in Figures 9a and 9b, the delivery member 10 includes more than two expansion bodies 11, and the core wire 12 is configured together with the molding wire 13 into a predetermined curved shape with at least two poles N close to the inner wall of the tubular implant 100. , and each pole N is provided with an expansion body 11, so that multiple expansion bodies 11 form a form of multi-point contact with the inner wall of the tubular implant 100, which is more conducive to the multiple expansion bodies 11 giving the tubular implant 100 more The better action force of the inner wall of each position, make every place of tubular implant 100 can fit better with the inner wall of blood vessel as far as possible.

The structural form of multiple poles N is preferably used in a structure in which the molding wire 13 and the core wire 12 form a predetermined bending shape with memory characteristics. For example, the overall shape formed by the molding line 13 and the core wire 12 presents a wavy memory shape as a whole, and the poles N are wavy crests and troughs.

As shown in Fig. 10a and Fig. 10b, the overall shape formed by the molding wire 13 and the core wire 12 presents a helical memory shape similar to a spring as a whole. If it is a helical shape with equal diameter as shown in Fig. 10a, the pole N can be any position of the helical structure. As shown in Fig. 10b, if the diameters at different turns of the helical shape are different, it is preferable to set the pole N at the largest diameter of the helical shape.

It should be noted that, for the structural form of the multiple expansion bodies 11 , each expansion body 11 can be manufactured separately, and then the multiple expansion bodies 11 can be connected in series by using the molding line 13 .

The angle of the predetermined bending shape at each pole N is preferably the solution in Embodiment 2.

Example 4:

This embodiment provides a delivery part for a tubular implant. Compared with Embodiment 1, the differences between this embodiment and Embodiment 1 are:

As shown in FIG. 12 , the delivery component 10 is obtained by binding the pipe network structure 20 shown in FIG. 11 in a segmental manner, and an expansion body 11 is formed between adjacent bound parts. As shown in FIG. 14 , a continuous pre-shaped wire 30 is arranged inside the tube network structure 20 , and the pre-shaped wire 30 is pre-shaped corresponding to the position of the expansion body 11 to form a primary shape of the core wire 12 .

The structure of a continuous pre-shaped wire 30 is more stable, and the structural form of one or more expansion bodies 11 can be obtained by restraining the tubular network structure 20 in a segmental manner, which can also increase the stability of the structure.

The tube network structure 20 can be formed by braiding metal wires, and the metal wires can be made of memory metal materials, including but not limited to one or more of memory metal materials such as cobalt-chromium alloy, platinum-tungsten alloy, nickel-titanium alloy, and the like. The tube network structure 20 can also be obtained by laser engraving a tube structure.

The pipe network structure 20 includes any one or a combination of at least two of a cylindrical pipe network structure and an ellipsoidal pipe network structure. Figure 10 shows a cylindrical tube network structure.

As shown in FIG. 14 , a second presetting can be performed on the presetting wire 30 to form a presetting bending shape. Wherein, the position corresponding to the binding part is the molding line 13 .

Further, one-time presetting includes shaping the core wire 12 into a state where the distance between the two ends is A, and the distance A can be equal to the length of the two ends of the expansion body 11 in the natural expansion state, or slightly smaller than the length of the two ends of the expansion body 11 in the natural expansion state.

The secondary presetting includes setting the presetting wire 30 into a state of having at least one bend, for example, three predetermined bends as shown in FIG. 14 .

One-time shaping includes shaping the core wire 12 into any one of spiral shape and wave shape or a combination of at least two. The core wire 12 shown in Figure 14 is wavy. The core wire 12 can also be a combination of helical and wave shapes. In addition, in different expansion bodies 11, core wires 12 of different shapes can be preformed, for example, The core wire 12 in one expansion body 11 is the linear elastic body in Embodiment 1, the core wire 12 in the second expansion body 11 is a spring-like memory shape, and the core wire 12 in the third expansion body 11 is Wavy memory shape.

The pre-curved shape of the pre-shaped wire 30 includes a spring-like shape as shown in FIGS. 10 a and 10 b , and a curved shape including crests and troughs as shown in FIG. 14 .

In one embodiment, the pre-curved shape of the pre-shaped wire 30 is preferably a curved line shape including crests and troughs as shown in FIG. 14 . Embodiment 4 can be combined with the features in Embodiment 2 and Embodiment 3. For example, the pole M described in Embodiment 2 and the feature that the included angle of the predetermined bend at the pole M is an obtuse angle can be combined with Embodiment 4. As shown in Figure 14, a pole N is set at the crest and trough position of the curved line, and the curved angle at the pole N is an obtuse angle, and the expansion body 11 is arranged at the pole N so that the expansion body 11 interferes with the tubular on the inner wall of the implant 100. The obtuse angle of the curved shape ensures that the delivery part 10 keeps facing forward, and at the same time, it can give the inner wall of the tubular implant 100 a better massage and smoothing effect, and at the same time, it can also reduce the folding and stacking of the expansion body 11 of the delivery part 10 probability of occurrence of the situation.

In one conveying part 10, one or more pipe network structures 20 can be used, and when multiple pipe network structures 20 are used, they can be mixed in cylindrical shape and ellipsoid shape, and the corresponding pre-shaped wires 30 pass through two Pipe network structure 20.

There are many ways to segmentally bind the tube network structure 20, see Figures 13a, 13b and 13c.

As shown in Figure 13a, the way of binding includes setting a sleeve 21 outside the pipe network structure 20, and a heat shrinkable tube can be used to bind the pipe network structure 20 and make the binding position tight. Fixed on the pre-shaped wire 30.

Or as shown in Figure 13b, the binding method includes setting a fixing member 22 inside the pipe network structure 20. The fixing member 22 can be a metal tube, which is sleeved and fixed on the pre-shaped wire 30, and the outer wall of the metal tube It is connected with the inner wall of the pipe network structure 20 by heat fusion or welding to form a bondage to the pipe network structure 20 .

Alternatively, as shown in FIG. 13 c , the restraint method also includes hot-melting, welding, etc. the inner wall of the pipe network structure 20 and the molding line 13 directly to achieve restraint. The diameter of the styling wire 13 is preferably larger than the diameter of the core wire 12 to increase the stability of the connection at the binding position.

Further, the pipe network structure 20 may also be restrained segmentally by using two or a combination of the above three restraint methods.

Example 5:

This embodiment provides a delivery part for a tubular implant. Compared with Embodiment 1, the differences between this embodiment and Embodiment 1 are:

As shown in Fig. 15, Fig. 16a and Fig. 16b, the conveying part 10 comprises an expansion body 11, and the pre-curved shape configured with the core wire 12 together with the molding wire 13 has at least one pole H close to the inner wall of the tubular implant 100, And the expansion body 11 is arranged at the pole H. The predetermined curved shape in this solution is a curved shape with memory characteristics, and when it is not subjected to external force, it returns to the state of the predetermined curved shape, so that the pole H is as close as possible to the inner wall of the tubular implant 100, and the The expansion body 11 abuts against the inner wall of the tubular implant 100 so that the expansion body 11 applies force to the tubular implant 100 .

It should be noted that the extreme point H is not necessarily a real point, as shown in Figure 16a, it may be the intersection point of the opposite extension lines at both ends of the predetermined curved shape. As shown in FIG. 16 b , it may also be a point selected in the middle of the bend that is relatively close to the inner wall of the tubular implant 100 .

The expansion body 11 is preferably an ellipsoid whose long axis extends axially or a columnar body extending axially to increase the contact area with the inner wall of the tubular implant 100, provide a relatively large area of smoothing effect, and further improve the tubular implant. Attachment of the object 100 to the blood vessel. As shown in FIG. 15 , the expansion body 11 is substantially similar to a cylindrical body extending in the axial direction.

At the same time, as shown in Figure 15, the included angle λ1 between the molding line 13 connected to the proximal end of the expansion body 11 and the core wire 12 at the proximal end of the expansion body 11 is 30-60°, The angle λ2 between the connected molding line 13 and the core wire 12 at the distal end of the expansion body 11 extending toward the distal end is 30-60°, so that the expansion body 11 has as many areas as possible in contact with the inner wall of the tubular implant 100. Conflict, improve the smoothing effect.

Embodiment 6:

This embodiment provides a delivery system for a tubular implant. As shown in FIGS. 1 a to 4 , the delivery system includes a delivery component 10 and a pushing guide wire 200 fixedly connected to the proximal end of the delivery component 10 . By pushing the push guide wire 200, the delivery member 10 can be pushed to advance along the catheter 300, and by rotating the push guide wire 200, the delivery member 10 can be driven to rotate.

It should be noted that the conveying part 10 can be any conveying part in Embodiment 1 to Embodiment 5, or any conveying part can be obtained by combining the technical features in Embodiment 1 to Embodiment 5 without conflict. .

Embodiment 7:

This embodiment provides a stent system. The stent system includes the delivery system of the tubular implant in Embodiment 6 and the stent to be delivered, and the stent to be delivered is sheathed on the outside of the expansion body 11 . The structure of the delivered stent can be referred to the tubular implant 100 in FIG. 1 a to FIG.

Embodiment 8:

This embodiment provides a stent system. As shown in FIGS. 17 a to 17 c , the stent system includes the delivery system of the tubular implant in Embodiment 6 and the delivered stent 101 , and the delivered stent 101 is sheathed on the outside of the expansion body 11 .

Wherein, when the delivery member 10 is in the first state, the distance by which the distal end of the delivery member 10 protrudes from the distal end of the stent to be delivered 101 does not exceed the first threshold. When the delivery component 10 is in the second state, the distance by which the distal end of the delivery component 10 protrudes from the distal end of the stent to be delivered 101 does not exceed the second threshold. During the process of the transport component 10 changing from the first state to the second state, the distance by which the distal end of the transport component 10 protrudes from the distal end of the stent to be transported 101 does not exceed the third threshold.

As shown in FIG. 17 a , the first state refers to a state where both the stent 101 to be delivered and the delivery member 10 are completely located in the catheter 300 .

As shown in FIG. 17 c , the second state guides the catheter 300 to withdraw proximally, and the delivered stent 101 is exposed from the catheter 300 and is completely released in the blood vessel. At this time, the corresponding delivery component 10 may be released from the catheter 300 entirely, or part of the distal end may be released from the catheter 300 .

As shown in FIG. 17 b , changing from the first state to the second state guides the catheter 300 to retract proximally, and the distal end of the delivered stent 101 is released from the catheter 300 , and a part of the proximal end is still located in the catheter 300 . At this time, a part of the distal end of the corresponding delivery component 10 may be released from the catheter 300 , or the distal end may not be released from the catheter 300 yet.

Wherein, none of the first threshold, the second threshold and the third threshold may be larger than 5mm, for example, it may be 5mm, 4mm and so on. That is to say, during the whole process of the delivered stent 101 being located in the catheter 300 until it is completely released into the blood vessel, the distal end of the delivery member 10 protrudes very little from the distal end of the delivered stent 101 , thus solving the problem of releasing the delivered stent 101 . During the process of using the stent 101, the distal end of the delivery component 10 may cause damage to the distal blood vessel.

Further, the first threshold, the second threshold and the third threshold may all be ≤0. That is to say, during the entire process of the stent 101 being delivered from being located in the catheter 300 until it is completely released into the blood vessel, the distal end of the delivery member 10 will not protrude from the distal end of the stent 101 being delivered, thereby eliminating the possibility of the stent being delivered during release. During the process of delivering the stent 101 , the distal end of the delivery component 10 may cause damage to the distal blood vessel.

Further, the distance between the two ends of the core wire 12 in the natural state is A, the distance between the two ends of the expansion body 11 in the natural state is B, and A=0.5B～0.8B is satisfied, then after the expansion body 11 is released from the catheter 300, due to After the core wire 12 shrinks, it can give the two ends of the expansion body 11 a force close to each other, so as to maintain the expansion state of the expansion body 11, so that the expansion body 11 is not easy to deform when it is squeezed by the blood vessel, so as to give the delivered stent 101 a relatively stable effect force.

The above are only preferred embodiments of the present application, and are not intended to limit the present application. For those skilled in the art, there may be various modifications and changes in the present application. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principles of this application shall be included within the protection scope of this application.

Claims (24)

1. A delivery part of a tubular implant, characterized in that, the delivery part comprises: At least one expansion body and a core wire arranged inside the expansion body; the two ends of the core wire are fixedly connected to the two ends of the expansion body, and the natural state of the core wire is a predetermined state; a molding line arranged outside the expansion body and connected to the end of the expansion body; The conveying element is configured to have at least two states: The first state is the bound state of the expansion body, the expansion body is in a radially compressed state, the core wire is in an axially elongated state, and the molding wire is in an axially elongated state; The second state is the release state of the expansion body, the expansion body is in a radially expanded state, the core wire is in an axial extreme contraction state, and the molding wire is in a predetermined state or a natural state; The core wire in the pre-shaped state has two-stage shapes, the first-stage shape shortens both ends of the core wire to adapt to the shortening of the two ends after the expansion body expands, and the second-stage shape makes the first-stage shape shorten the two ends of the core wire. The core wire is configured into a pre-bending shape together with the styling wire. 2. The delivery part according to claim 1, wherein in the second state, the predetermined curved shape is designed to have at least one pole close to the inner wall of the tubular implant, and the expansion body is arranged at the position of the pole. 3. The conveying member according to claim 2, characterized in that the included angle of the predetermined bend near the pole is between 90° and 180°. 4. The conveying member according to claim 2, characterized in that the included angle of the predetermined bend near the pole is between 120° and 160°. 5 . The conveying component according to claim 1 , wherein the distance between the two ends of the core wire in a natural state is A; the distance between the two ends of the expansion body in a natural state is B, which satisfies A=0.5B˜1B. 6 . The delivery part according to claim 1 , wherein the expansion body is a sphere, an ellipsoid whose major axis extends axially, or a columnar body extending axially. 7 . 7. The delivery component according to claim 1, characterized in that, the delivery component comprises more than two expansion bodies, and the predetermined curved shape has at least two poles close to the inner wall of the tubular implant, and each An expansion body is provided at each pole. 8. The conveying component according to claim 1, characterized in that, the conveying component is obtained by binding a tubular network structure extending in the axial direction, and the expansion is formed between adjacent bound parts. body; a continuous pre-shaped silk thread is arranged inside the pipe network structure; The pre-shaped wire is pre-shaped corresponding to the position of the expansion body part to form a primary shape of the core wire. 9. The conveying part according to claim 8, characterized in that, the pre-shaped wire is subjected to secondary pre-setting to form a pre-curved shape; the position corresponding to the binding part is the molding line. 10. The conveying part according to claim 9, characterized in that, the one-time presetting includes shaping the core wire into a state where the distance between two ends is A; The secondary presetting includes shaping the presetting wire to have at least one bend. 11. The conveying part according to claim 9, characterized in that, the one-time presetting includes shaping the core wire into any one of spiral shape and wave shape, or a combination of at least two of them; The predetermined curved pattern includes a curved line pattern including crests and troughs. 12. The conveying component according to claim 8, wherein the pipe network structure comprises any one or at least two of cylindrical pipe network structures and ellipsoidal pipe network structures. combination. 13 . The delivery component according to claim 8 , characterized in that, the way of restraint includes setting a sleeve outside the pipe network structure, or setting a fixing piece inside the pipe network structure. 14 . 14. The conveying component according to claim 9, characterized in that, the way of binding comprises fixing the binding part of the pipe network structure on the molding line. 15. The delivery member according to claim 1, wherein said delivery member comprises an expander, said pre-curved shape has at least one pole close to the inner wall of said tubular implant, and said expander is positioned at the pole. 16. The delivery part according to claim 15, characterized in that, the expansion body is an ellipsoid whose long axis extends axially or a columnar body extending axially; the expansion body connected to the proximal end The angle between the molding line and the core wire at the proximal end of the expansion body extending toward the proximal end is 30-60°; The included angle of the core wire extending toward the distal end is 30-60°. 17. The delivery part according to claim 1, characterized in that, the proximal end of the delivery part is also provided with a retractable auxiliary part, and the retractable auxiliary part comprises a fixing part and a set at the far end of the fixing part opening and closing department. 18. The conveying member according to claim 17, wherein the opening and closing part includes a splint with one end fixed to the fixing part and the other end capable of being opened and closed. 19. The conveying component according to claim 17, wherein the opening and closing part comprises a braided mesh tube with one end fixed to the fixing part and the other end forming a bell mouth. 20. A delivery system for a tubular implant, characterized in that the delivery system comprises: The conveying member according to any one of claims 1-19; A pushing guide wire fixedly connected to the proximal end of the delivery component. 21. A stent system, characterized in that the stent system comprises: The delivery system for the tubular implant of claim 20; The delivered stent is sheathed on the outside of the expansion body. 22. A stent system, characterized in that the stent system comprises: The delivery system for the tubular implant of claim 20; A delivered stent, the delivered stent is sheathed on the outside of the expansion body; When the delivery member is in the first state, the distance by which the distal end of the delivery member protrudes from the distal end of the delivered stent does not exceed a first threshold; When the delivery member is in the second state, the distance by which the distal end of the delivery member extends beyond the distal end of the delivered stent does not exceed a second threshold; During the transition of the transport component from the first state to the second state, the distance by which the distal end of the transport component protrudes from the distal end of the stent to be transported does not exceed a third threshold; And the first threshold, the second threshold and the third threshold are all less than or equal to 5 mm. 23. The stent system according to claim 22, wherein the first threshold, the second threshold and the third threshold are all ≤0. 24. The stent system according to claim 22, wherein the distance between the two ends of the core wire in a natural state is A, and the distance between the two ends of the expansion body in a natural state is B, satisfying A=0.5B～0.8B .

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