WO2017157081A1

WO2017157081A1 - Covered stent with branches and implantation system thereof

Info

Publication number: WO2017157081A1
Application number: PCT/CN2016/113069
Authority: WO
Inventors: 李雷; 张晓冬; 姜君
Original assignee: 北京奇伦天佑创业投资有限公司
Priority date: 2016-03-15
Filing date: 2016-12-29
Publication date: 2017-09-21
Also published as: CN205612594U

Abstract

Disclosed is a covered stent with branches and an implantation system thereof. The covered stent comprises a covered body portion (201), and covered branch portions (202) connected on the covered body portion (201), with an end of the covered body portion (201) being integrated with a pre-placed stent (301). The covered stent is provided with the pre-placed support (301), thereby enhancing the locating capability of the covered stent and facilitating position adjustment after implantation.

Description

Covered stent with branch and its implantation system

Technical field

The present disclosure relates to the field of vascular stents and, in particular, to a stent graft with a branch and an implant system therefor.

Background technique

With the advent of an aging society, cardiovascular and cerebrovascular diseases are increasing. When the lesion of the aortic arch occurs, it is necessary to isolate the blood flow from the lesion to reduce the pressure on the blood vessel wall of the aortic arch. Among them, the aortic arch is a curved and large branch with multiple branches, wherein the three branches of the aortic arch, the left carotid artery and the left subclavian artery are large variations, the diameters are not the same, the distance between the aortic arch and the aortic arch The angles are also different, wherein the implanted vascular stent is a stent graft, wherein the membrane acts as an artificial blood vessel to direct blood flow into the three branches, and the stent is radially supported and anchored. The role of the membrane. In the prior art, the stent graft is implanted in such a manner that the stent and the stent are simultaneously implanted, that is, the membrane is previously coated on the stent and simultaneously implanted into the blood vessel with the stent. However, this approach has the following problems:

1. The implant system of the implanted stent can be oversized, which is not conducive to transport in the blood vessel;

2. The main body part of the film and the branch part of the film are difficult to locate at the three branch vessels, and the implantation is difficult;

Therefore, improvements in the stent graft and its implantation system capable of solving at least one of the above problems are of positive significance.

Summary of the invention

The purpose of the present disclosure is to provide a stent graft with a branch and an implant implanted with the stent graft system.

In order to achieve the above object, according to an aspect of the present disclosure, a stent graft having a branch body including a film body portion and a film branch portion attached to the film body portion, wherein the end portion of the film body portion is provided The part is combined with a preset bracket.

Optionally, the two ends of the main body of the film are respectively combined with a preset bracket.

Optionally, the preset bracket is an annular structure that is tightly coupled to the main body of the film.

Optionally, the preset bracket extends from the end of the body of the film to the adjacent film branch.

Optionally, the preset bracket is a self-expanding bracket.

Optionally, the stent graft is a three-branch vessel stent graft of the aorta.

In accordance with another aspect of the present disclosure, an implant system for implanting a stent graft provided by the present disclosure is provided, the implant system including a body guidewire, a guide core movably sleeved over the body guidewire, And a guide sheath for releasably receiving the stent graft, the guide sheath being movably sleeved outside the lead core, wherein the implant system has an adjustment mechanism for adjusting the axial position of the stent graft after the sheath sheath releases the stent graft, The adjustment mechanism includes a control wire releasably coupled to the preset bracket.

Optionally, the control wire includes a front end control wire releasably coupled to the front end of the main body portion of the film and a rear end control wire releasably coupled to the rear end of the main body portion of the film.

Optionally, the implant system further includes a sheath for releasably nesting the end of the stent graft to bind the preset stent.

Alternatively, the sheath film is formed into a cylindrical structure that is unilaterally sutured by a release line.

According to the above technical solution, since the end portion of the main body portion of the film has a preset bracket, the position adjustment can be facilitated, and the positioning ability of the stent graft can be enhanced without subsequently implanting the stent in the main body portion of the film.

Other features and advantages of the present disclosure will be described in detail in the detailed description which follows.

DRAWINGS

The drawings are intended to provide a further understanding of the disclosure, and are in the In the drawing:

1 is a schematic view showing the structure of a stent graft implanted in a three-branch vessel of the aortic arch according to an alternative embodiment of the present disclosure;

2 is a schematic structural view of a stent graft provided by an alternative embodiment of the present disclosure;

Fig. 3 is a schematic structural view of a sheath membrane.

detailed description

The specific embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings. It is to be understood that the specific embodiments described herein are not to be construed

In the present disclosure, the positional words used, such as "inside and outside", generally refer to the inside and outside of the contour of the corresponding object, and "far, near" is the relative position of one component relative to another component. In the near and far position, the "front and back" are usually defined based on the direction in which the stent and related components are implanted along the blood vessel, that is, the corresponding member enters the blood vessel forward and withdraws from the blood vessel backward. These orientations are only used to illustrate the disclosure and are not intended to limit the disclosure.

As shown in Figures 1-3, the present disclosure provides a stent graft with a branch and an implant system for implanting the stent graft. As shown in FIG. 2, the film body of the stent graft includes a membrane main body portion 201 and a membrane branching portion 202 connected to the membrane main body portion 201 and communicating with the membrane main body portion 201 to respectively accommodate the branching branch. Vascular structure. In the present embodiment, the tip end portion of the film main body portion 201 is coupled with the preset holder 301. In this way, when the stent graft is implanted in place, the anchoring force of the preset stent 301 can stably position the membrane in the blood vessel, thereby avoiding the influence of blood flow on the stent, and since it is disposed at the end of the main body portion, Will affect the branch. And optional The front end of the main body portion of the film is respectively coupled with a preset bracket 301. Make the positioning of the film more stable. In other possible embodiments, only one segment may be provided with a preset bracket 301.

In addition, in the implant system provided by the present disclosure, since the preset bracket 301 is disposed on the film, the control wire such as the front end control wire and the rear control wire described below can be directly detachably connected to the preset bracket. It is not necessary to perform processing of a joint structure such as a hole in the main body portion of the film, and the connection is made more stable and reliable.

As an embodiment, the preset bracket 301 can be pre-stitched onto the outer wall of the main body of the film, that is, the preset bracket 301 is located on the outer wall of the main body of the film to facilitate the bonding. In other embodiments, the preset bracket may also be built into the inner wall of the main body of the film or incorporated into the main body portion 201 of the film during film formation.

In order to balance the force applied to the film, the preset holder 301 is an annular structure that is tightly coupled to the film body portion 201. Thereby, the end portion of the main body portion of the film is more uniformly supported in the circumferential direction. Further, in consideration of the effect of the force application not interfering with the blood flow of the normal film branch portion, the preset holder 301 is optionally extended from the end portion of the film body portion to the adjacent film branch portion. In this way, the maximum anchoring force can be generated without affecting the blood flow in the branch portion of the membrane.

As an embodiment, the preset bracket 301 is a self-expanding bracket. That is, the preset bracket can also be opened during the release of the film even if the film is anchored in place. As an optional structure, the preset bracket 301 is a wire mesh structure. In terms of material, the preset bracket 301 can be the same as the bracket body of the bracket implanted after the present disclosure, for example, can be woven into a Z-shaped compressible structure using a wire material such as metal iridium, medical stainless steel, and nickel-titanium alloy, for its material and compression. Various variations of the structure are well within the scope of the present disclosure.

[implant system]

First, an implant system and method for a stent of a stent graft will be described below with reference to FIG. 1, wherein FIG. 1 schematically shows an internal portion structure of an implant system provided by the present disclosure. In the implant system provided by the present disclosure, the stent graft includes a membrane main body portion 201 formed into a cylindrical structure and connected thereto The membrane branching portion 202 on the membrane main body portion 201, wherein the number of the membrane branching portions 202 depends on the position of the blood vessel used, for example, in the aortic arch three-branch vessel position of the present disclosure, which includes the first membrane branching portion 2021, The second membrane branching portion 2022 and the third membrane branching portion 2023 are adapted to the innominate artery, the left cervical aorta, and the left subclavian artery, respectively. Wherein, the stent graft implantation method and system provided by the present disclosure can adjust the axial position of the film at the external end. This includes adjusting the axial position of the front end and the rear end of the main body portion 201 and the front end of the film branching portion 202. Specifically, the axial direction position adjustment of the film-coated main body portion 201 in the both end directions can be performed at one end of the outer body, for example, the rear end, and the film branching portion 202 of the film can also be axially guided by the guide wire of the branch blood vessel. The position is adjusted to achieve a precise fit of the membrane to the vessel wall of the three branches. Furthermore, since the stent graft provided by the present disclosure is used, the stent graft can be fixed by the preset stent anchor after implantation, without the need for subsequent implantation of the stent.

Specifically, as shown in FIG. 1 , the implant system provided by the present disclosure includes a body guide wire 203 , a branch guide wire 204 , a lead core 205 , and a guide sheath 206 , wherein the guide core 205 is movably sleeved on the body guide wire 203 . The upper sheath sheath 206 houses the membrane main body portion 201 and the membrane branching portion 202 of the stent graft, and the sheath sheath 206 is movably sleeved outside the guide core 205. Wherein the implant system has an adjustment mechanism for adjusting the axial position of the stent graft after the sheath 206 is released from the membrane, the adjustment mechanism being releasably coupled to the stent graft, in particular releasably coupled to the pre-position at the end Set on the stand. Thereby, the stent graft can be released from the stent graft and can be withdrawn from the blood vessel.

Among them, due to the existence of the preset bracket, it is only necessary to separately implant a separate bracket for the branch portion of the film, without separately implanting a separate bracket for the body portion of the film. In addition, in order to avoid premature opening of the preset bracket and affecting the axial position adjustment of the front and rear ends of the main body of the membrane, optionally, the implant system provided by the present disclosure further comprises a detachable sleeve at the end of the stent graft. The sheath 400 of the preset holder 301 is restrained. In this way, the preset stent can be released when the membrane body portion is pushed out from the sheath sheath and adjusted in position, and then the sheath membrane is released from the end portion. Specifically, as an embodiment, as shown in FIG. 3, the sheath film 400 is formed into a cylindrical structure that is unilaterally sewn by the release wire 500. In this way, you only need to operate the solution at the external end. The release of the off-line can complete the operation of releasing the sheath, so that the preset stent is opened to achieve anchoring of the main body of the membrane, and the sheath can be taken out in a subsequent procedure or left in the body with the stent.

The implantation system and method of the stent graft in the present disclosure are described in detail below.

The body guidewire 203 can be selected such that the superabrasive guidewire can be inserted into the blood vessel from behind to serve as a guide for subsequent components. A guiding head 2051 located in front of the main body portion 201 of the stent graft is fixed on the guiding core 205. The guiding head 2051 has a conical shape or other streamlined structure to guide the guiding core 205 to non-destructively move along the blood vessel wall. The inner core 205 has a hollow structure to be sleeved outside the main body guide wire 203 and axially moved along the main body guide wire 203. The number of the branch guide wires 204 depends on the number of branch blood vessels, and the three branches of the aortic arch of the present disclosure The vessel position, the branch guidewire 204 includes a first branch guidewire 2041, a second branch guidewire 2042, and a third branch guidewire 2043 to correspond to the three branch vessels on the aorta, respectively. The introducer sheath 206 is a hollow structure to accommodate the compressed stent graft, and the introducer sheath 206 can be controlled by extending rearwardly beyond the outer end, such as a handle at the extracorporeal end. The guide sheath 206 is movably sleeved outside the guide core 205 that also extends rearwardly to be controlled to move along the guide core 205 simultaneously with the simultaneous movement of the guide core 205. In addition, the front end of the guiding sheath 206 has no connection relationship with the guiding head 2051. For example, it can be positioned against the guiding head 2051 or at a certain interval from the guiding head 2051, so that when the coating stent needs to be released, The guide sheath 206 is withdrawn back from the stent graft to release the stent graft. At this point, the introducer sheath 206 can be withdrawn to the release stent graft for use as a channel for subsequent stent implantation.

Wherein, in order to achieve precise adjustment and positioning of the axial position of the membrane main body portion 201 of the stent graft after releasing the stent graft, the adjustment mechanism provided by the present disclosure includes a front end control wire 207 and a rear end control wire 208. The control wires are respectively attached to the front end and the rear end of the film main body portion 201 of the film, such as the above-described preset holder 301, by various detachable means known in the art, such as electrolytic stripping and mechanical release. Among them, the method of electrolytic stripping can be performed by applying a current to the outside through the relevant wire to melt and release the joint structure to realize the separation mode of the corresponding portion. In addition to control wire The number and the connection position are not limited as long as the film main body portion 201 can be stably pulled. For example, in the preferred embodiment of the present disclosure, the front end control wire 207 and the rear end control wire 208 are both three, and are arranged at equal intervals along the circumferential direction of the film main body portion 201, so that the film main body portion 201 can be stably pulled. Move forward or backward. It should be noted that, in order to clearly show the rear end control wire 208 and the branch guide wire 204 in FIG. 1, the three rear end control wires 208 are not displayed in a circumferentially equally spaced manner, which constitutes a limitation on the present disclosure. .

In order to achieve pulling the adjustment cover body portion 201 toward the sides at the outer end of the body, as a preferred embodiment, the adjustment structure of the present disclosure includes a steering transmission structure 209 that enables the corresponding control wire to be steered. In an alternative embodiment of the present disclosure, the present disclosure may enable the front end control wire to be steered rearward and rearward through the steering transmission structure 209, that is, the pulling of the front end of the stent graft can be achieved at the outer outer end of the rear, combined with The posterior extension of the posterior control wire 208, the implant system provided by the present disclosure enables the pulling of the ends of the stent graft at the outer end of the rear. Specifically, the steering transmission structure 209 may be provided in front of the film main body portion 201. It should be noted that, in other embodiments, the front end control wire 207 may be connected to the lead core 205 in a manner of adjusting the front end of the stent graft at the rear end. Specifically, the front end control wire 207 may be directly connected to the lead core 205 or connected thereto. The seeker 2051 is indirectly connected to the guide core 205, so that when it is necessary to adjust the front end of the stent graft forward, it is only necessary to push the guide core 205 forward.

In addition, in other embodiments, the manner of pulling the rear end of the stent graft is not limited to the use of the rear control wire 208, and there may be other ways, such as not providing the rear control wire 208 only after pushing the film through the blood flow. The end is in close contact with the vessel wall. Such modifications are intended to fall within the scope of the present disclosure.

In an alternative embodiment of the present disclosure, specifically, the front end control wire 207 is movably passed through the lead core 205, and the steering transmission structure 209 is disposed on the lead core 205, preferably on the seek head 2051. The steering transmission structure 209 can be a steering hole formed on the guiding head 2051. The steering hole can be directly opened on the guiding head 2051, or can be connected to the guiding head 2051 by being disposed. Obtained from the upper guide ring. Thus, the front end control wire 207 can be drawn out from the front end of the film main body portion 201, penetrates into the guide core 205, and extends rearward along the guide core 205. Therefore, when it is necessary to move the main body portion 201 toward the front side, the front end control wire 207 can be pulled forward only by pulling the front end control wire 207 at the outer end of the rear side, and the overall structure is simple and ingenious.

In addition, the rear end control wire 208 may be directly detachably connected to the rear end of the film main body portion 201, and drawn out from the rear end and penetrated into the guide sheath 206 and extended rearward along the guide sheath 206. Thus, when it is necessary to pull the film main body portion 201 rearward, the film main body portion 201 can be moved backward by directly pulling the rear end control wire 208 backward at the outer outer end. Accordingly, the implant systems and methods provided by the present disclosure enable precise adjustment of the axial position of the membrane body portion 201 at one extracorporeal end.

The adjustment of the axial position of the main body portion 201 of the film is described above, and the adjustment of the axial position of the film branching portion 202 will be described below. However, due to the presence of the main body portion 201 of the film, the implantation system only needs to pull the film branching portion 202 forward to fit the blood vessel wall, without pulling the film branching portion 202 rearward. Accordingly, the present disclosure creatively utilizes the branching guidewire 204 to adjust the axial position of the stent branch 202, wherein the branching guidewire 204 penetrates into the rearwardly extending guide sheath 206 to extend rearwardly along the introducer sheath 206. Specifically, in order to realize the adjustment of the film branching portion 202 by the branching guide wire 204, the adjusting mechanism includes a limiting knot 211 disposed on the branching guide wire 204, and the limiting hole 210 is disposed on the coating branching portion 202, wherein The size of the junction 211 is larger than the size of the limiting hole 210, and the limiting hole 210 is located in front of the limiting junction 211. Thus, when the blade branching portion 202 needs to be pulled forward, the branching wire 204 is only pulled forward, and the limiting node 211 is caught on the limiting hole 210 to drive the film branching portion 202 to move forward.

The limiting node 211 can be formed by winding two guiding wires or connecting additional components on the guide wire. Optionally, the limiting node 211 is detachably disposed in the branching guide wire 204, for example, the two guiding wires are circumscribed in a detachable manner (electrolytic removal, mechanical release, etc.). Whether the limit junction 211 needs to be disengaged from the branch guide wire 204 depends on the branch guide wire The last withdrawal mode of 204, if the branch wire 204 is withdrawn from the front, the limit knot 211 is required to be detachable from the branch wire 204, if the branch wire 204 is withdrawn from the rear. In this way, the limit junction 211 and the branch guide wire 204 are not required to be released, and the branch guide wire 204 can be directly withdrawn from the rear.

In addition, the limiting hole 210 may be formed by connecting a limiting ring on the coating branch portion 202, and the limiting ring may be formed of a metal that can be implanted into a human body. Due to its small size, the limit ring can be placed in the patient with the stent graft without causing vascular lesions. In addition, in order not to affect the guiding of the branching guide wire 204, it is preferable to connect the limiting ring and the film branching portion 202 by a connecting line so as to be spaced apart from each other, so that the branching guide wire 204 to the coating film branching portion 202 can be reduced. abrasion. In order to effectively pull the film branching portion 202, the connecting line is plural and is detachably connected to the film branching portion 202 in the circumferential direction, so that the limiting ring is located at the radial center of the film branching portion 202, so that the branching guide wire 204, the film branching portion 202 is pulled more effectively. At this time, the connecting line can be detached from the film branching portion 202. Therefore, after the detachment, the limiting ring can be withdrawn forwardly with the branching wire 204, and no limit is needed at this time. The knot can be released. In this way, after the withdrawal ring is withdrawn, it does not interfere with the circulation of blood in the blood vessels in the later stage. In addition, the limit junction 211 and the limiting hole 210 have other modifications, and various modifications are within the scope of the disclosure without departing from the concept of the disclosure.

In addition, as shown in FIG. 1, since the rear end control wire 208 and the branching guide wire 204 penetrate into the inside of the guiding sheath 206, in order to avoid interference with the implantation of the later stent, the inner wall of the guiding sheath 206 may be disposed to extend along the extending direction of the guiding sheath 206. The guidewire receiving groove allows the corresponding wire to extend only on the inner wall of the introducer sheath 206 without affecting the stent that still passes through the introducer sheath 206 at a later stage.

When the stent of the present disclosure and the stent of the stent branch are accurately positioned, the guiding core 205, the guiding sheath 206, various wires, and the stent delivery device of the implantation system can be withdrawn back from the human blood vessel, thereby completing the present invention. The complete implantation process of the covered stent is disclosed. It should be noted that, in the stent graft implantation method of the present disclosure, the stent implantation may also adopt other stent implantation techniques well known in the art, and the implantation method of the branch vessel disclosed in FIG. 1 may also be used. Carry out the late branch The implantation of the stent, the deformation of the various stent implants, falls within the scope of the present disclosure.

In summary, the present disclosure focuses on an implant system, a method, and a stent graft for a stent graft for a three-branch vessel of aortic arch, which enables accurate positioning of the stent graft, and is simple in structure and convenient to operate. High practicality and promotion value.

The preferred embodiments of the present disclosure have been described in detail above with reference to the accompanying drawings. However, the present disclosure is not limited to the specific details of the above embodiments, and various simple modifications can be made to the technical solutions of the present disclosure within the scope of the technical idea of the present disclosure. These simple variations are all within the scope of the disclosure.

It should be further noted that the specific technical features described in the above specific embodiments may be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the present disclosure is applicable to various possibilities. The combination method will not be described separately.

In addition, any combination of various embodiments of the present disclosure may be made as long as it does not deviate from the idea of the present disclosure, and should also be regarded as the disclosure of the present disclosure.

Claims

A stent graft with a branch, comprising a membrane body portion (201) and a membrane branching portion (202) attached to the membrane body portion (201), wherein the membrane body portion (201) The end of the ) is combined with a preset bracket (301).
The stent graft according to claim 1, wherein the preset holder (301) is coupled to both ends of the membrane main body portion (201).
The stent graft according to claim 1 or 2, wherein the preset stent (301) is an annular structure that is tightly coupled to the membrane main body portion (201).
The stent graft according to claim 1, wherein the preset bracket (301) extends from an end of the membrane main body portion (201) to an adjacent one of the membrane branch portions (202) .
The stent graft according to claim 1, wherein the preset stent (301) is a self-expanding stent.
The stent graft according to claim 1, wherein the stent graft is a three-branch vessel stent graft of the aorta.
An implant system for implanting a stented stent graft according to any of claims 1-6, characterized in that the implant system comprises a body guidewire (203), a movably sleeve a guide core (205) disposed on the body guide wire (203), and a guide sheath (206) releasably receiving the stent graft, the guide sheath (206) being movably sleeved on the guide core (205) wherein the implant system has the cover stent adjusted after the introducer sheath (206) releases the stent graft An adjustment mechanism for the axial position, the adjustment mechanism comprising a control wire releasably coupled to the preset bracket (301).
The implant system according to claim 7, wherein said control wire comprises a front end control wire (207) releasably coupled to a front end of said film body portion (201) and releasably coupled to said A rear end control wire (208) of the rear end of the main body portion (201) of the film.
The implant system of claim 7 wherein said implant system further comprises a sheath for releasably nesting the end of said stent graft to bind said preset stent (301) (400).
The implant system of claim 9, wherein the sheath membrane (400) is formed as a tubular structure that is unilaterally sutured by a release line (500).