WO2021088145A1

WO2021088145A1 - Graft suitable for implantation into aneurysmal cavity of aortic dilatation disease

Info

Publication number: WO2021088145A1
Application number: PCT/CN2019/120320
Authority: WO
Inventors: 冯睿; 朱铁桥; 景在平; 冯家烜; 曾照祥; 赵玉玺; 吴明炜; 鲍贤豪; 艾克白尔江艾尼瓦尔; 李涛
Original assignee: 上海孚曼医疗科技有限公司; 北京英佳麦迪克医用材料有限公司
Priority date: 2019-11-08
Filing date: 2019-11-22
Publication date: 2021-05-14

Abstract

Provided is a graft suitable for implantation into an aneurysmal cavity of an aortic dilatation disease, relating to the field of medical instruments. The graft comprises: a framework (1) comprising a main body (11) and a branch stent (12) connected to the periphery of the main body (11); and a covering body (2) which covers the periphery of the framework (1). The covering body (2) is made of a material which expands or contracts according to the change of implantation environment, and the branch stent (12) can expand or contract relative to the main body (11) along with the expansion or contraction of the covering body (2). The graft is filled in the aortic aneurysmal cavity or aortic dissection to embolize the aneurysmal cavity, has a self-expanding performance for sufficient filling of the aneurysmal cavity, and has a soft surface so as to have a protective effect on the aneurysmal cavity and the main body stent.

Description

Graft suitable for implantation into the tumor cavity of aortic dilatation disease

Cross-references to related applications

This application requires a Chinese invention patent application filed on November 08, 2019, with the application number 201911087389.7 and the title of the invention "graft suitable for implantation in the tumor cavity of aortic dilatation disease", and on November 08, 2019 The priority of the Chinese utility model patent application whose application number is 201921920290.6 and the invention title is "graft suitable for implantation into the tumor cavity of aortic dilatation disease", the entire content of the above-mentioned Chinese patent application is incorporated herein by reference.

Technical field

The invention relates to the field of medical devices, in particular to a graft suitable for implanting into the tumor cavity of aortic dilatation disease.

Background technique

Aortic dilatation disease is a disease with dangerous onset, rapid progress, and high mortality. This type of disease is mainly divided into true aortic aneurysm, aortic dissection and pseudo aortic aneurysm. The current treatment for this type of disease is mainly divided into Surgical treatment and catheter interventional treatment. Surgical treatment is mainly artificial blood vessel replacement, and catheter intervention is mainly percutaneous stent grafting (ie endoluminal isolation). Artificial blood vessel replacement is an open operation. Due to its large trauma, long operation time, high mortality and complications, it is not suitable for elderly and weak patients.

Compared with traditional open surgery, the use of covered stents for endovascular exclusion for aortic dilatation disease has the advantages of less surgical trauma, faster postoperative recovery, and shorter hospital stay. However, for some patients with aortic dilatation disease with an overly large tumor cavity, after endovascular exclusion, the tumor cavity cannot be completely thrombosis, in order to achieve the purpose of vascular remodeling. Packing of the tumor cavity can not only promote the complete thrombosis of the tumor cavity, but also treat the formation of endoleak after endocavity isolation.

Embolic agents are usually divided into solid embolic agents and liquid embolic agents. Among them, polyvinyl alcohol (PVA) particles, coils, and atrial septal occluders are commonly used as fixed embolic agents. Existing embolic materials have some shortcomings. For example, the coils are mainly made of stainless steel, platinum and their alloys, and do not have a shape memory function. After they are placed in the tumor cavity, they cannot be filled according to a predetermined shape, especially when filling large tumors. In the cavity, insufficient packing of the tumor cavity will occur. In addition, the existing liquid embolization materials such as ONXY glue can achieve irregular embolization of the tumor cavity, but it is easy to move with the blood, and when the volume of the aortic aneurysm cavity or false cavity is too large, the embolization is not complete, and the operation cost is difficult. Etc. are larger.

Summary of the invention

In view of the above-mentioned problems in the prior art, the present invention provides a graft suitable for implanting into the aneurysm cavity of aortic dilatation disease, so that when it is filled in the aortic aneurysm cavity or aortic dissection, it has expansion and contraction properties. In addition, the aortic aneurysm cavity can be fully packed, and the cure rate of the graft can be improved.

In order to achieve the above objective, the embodiments of the present invention provide a graft suitable for implanting into the tumor cavity of aortic dilatation disease, which includes: a skeleton having a main body and a branch stent connected to the periphery of the main body; and a coating Body, covered on the outer periphery of the skeleton; wherein the covering body is made of a material that expands or contracts according to changes in the implantation environment, and the branch stent can be expanded or contracted with the expansion or contraction of the covering body Expand or contract relative to the main body.

In some embodiments of the present invention, the material of the framework is a material with a certain supporting force, such as Nitinol, or a polymer material, which can generate a certain supporting force from the inside of the graft.

According to the embodiment of the present invention, the covering body can expand or contract according to the change of the implantation environment. For example, when the covering body absorbs water from the implantation environment, it expands, and it expands to reach the embolism cavity or pseudosurgery. The purpose of the cavity. Optionally, the covering body may expand according to the body temperature of the implantation environment, that is, may be made of a thermally expandable material.

In some embodiments of the present invention, at least one layer of the branch bracket is formed on the outer circumference of the main body. For example, the branch stent may be provided with one layer, two layers or multiple layers, and the number of layers of the branch stent can be adjusted according to the length of the main body and the support strength of the branch stent to meet the requirements of different implantation environments.

In some embodiments of the present invention, the branch brackets of each layer are evenly distributed along the circumference of the main body. According to the embodiment of the present invention, evenly distributing the branch stents of each layer along the circumference of the main body can ensure that when the branch stents are implanted in the aneurysm cavity, the force of the entire graft is uniform, and the graft is ensured in the aneurysm cavity. keep it steady.

In some embodiments of the present invention, each layer is provided with 2 to 18 branch brackets. For example, 2, 6, 10, 14, or 18.

According to the embodiment of the present invention, the number of branch stents can be adjusted according to the actual use environment to ensure that the branch stents have a certain supporting effect on the entire graft, and at the same time prevent the branch stents from being too strong, which is not conducive to implantation. And other issues.

In some embodiments of the present invention, the skeleton includes at least three layers of the branch support, and the interval between two adjacent layers is the same.

According to the embodiment of the present invention, when the skeleton is provided with at least three layers of the branch stents, the interval between two adjacent layers is the same to ensure that the skeleton receives the force of the branch stents evenly, and prevents There is a risk that the covering body deforms and compresses the main body.

In some embodiments of the present invention, the interval is 2 mm to 10 mm. For example, 2 mm, 6 mm, 8 mm, or 10 mm. According to the embodiment of the present invention, the interval can be adjusted according to the implantation environment of the graft, so as to meet the optimal setting.

In some embodiments of the present invention, the outer diameter of the skeleton, that is, the diameter of the circumscribed circle of a layer of branch stents is 10 mm to 40 mm. For example, the outer diameter of the skeleton is set to 10 mm, 20 mm, 30 mm, or 40 mm.

According to the embodiments of the present invention, grafts with different skeleton outer diameters can be selected according to the position of the implanted aortic aneurysm cavity, so that the graft can fully fill the aneurysm cavity after being implanted in the aortic aneurysm cavity. The role of the to ensure the therapeutic effect.

In some embodiments of the present invention, when the branch stent is fully deployed relative to the main body (that is, when the branch stent is not under force), the angle between the branch stent and the main body is in the range of 10° To 90°. For example, 10°, 50°, or 90°.

According to the embodiment of the present invention, grafts with different angles in a fully expanded state can be selected according to actual needs. Before the graft is implanted into the tumor cavity, the covering body is compressed by external force to make the branch stent and The included angle between the main body is close to 0°. After the graft is implanted into the tumor cavity, the branch stent is deployed relative to the main body, so that the included angle is kept at less than or equal to the maximum angle when it is fully deployed between. In this way, on the one hand, it is ensured that the graft can fully fill the tumor cavity by expansion after being implanted in the tumor cavity, and on the other hand, it is ensured that the branch stent has a certain supporting effect on the graft.

In some embodiments of the present invention, the branch stent is configured in a cylindrical shape with a diameter of 1 mm to 2 mm.

In some embodiments of the present invention, the skeleton contains a developing material or is provided with a developing mark made of a developing material.

According to the embodiment of the present invention, a developing material or a developing mark is provided in the skeleton. After the graft is implanted into the tumor cavity or dissection, the tumor cavity or dissection can be located in real time through visualization to improve implantation. Accuracy.

In some embodiments of the present invention, a procoagulant drug is provided in the coating body.

According to the embodiment of the present invention, the provision of a procoagulant drug in the coating body can promote the thrombosis of the tumor cavity or dissection and improve the therapeutic effect.

In some embodiments of the present invention, the branch bracket and the main body are integrally formed.

In some embodiments of the present invention, the covering body is a sponge. The sponge adopts a water-absorbing swelling material. After the graft is implanted in the body, the sponge absorbs water and expands to achieve the purpose of embolizing the tumor cavity or false cavity. After the sponge is foamed, the density of the sponge is reduced by reducing the density of the sponge. And compression to achieve high expansion performance.

In some embodiments of the present invention, the material includes: polyvinyl alcohol (PVA), polyvinyl fluoride (PVF), or polyglycolide (PGLA). For example, polyvinyl alcohol (PVA) particles are expandable and compressible. They are made of polyvinyl alcohol foam and formaldehyde through cross-linking, drying, crushing, sieving and other processes. They are non-water-soluble and the commonly used size is 100 ~1000μm, it can swell in contact with aqueous liquid, and the volume swells about 20%. The implementation of the present invention has the following beneficial effects:

(1) A covering body is arranged outside the skeleton, and the covering body expands or contracts according to the change of the implantation environment, for example, expands when encountering an aqueous liquid or expands according to body temperature, so that the graft can better treat the tumor The cavity or interlayer is fully filled to improve the treatment effect. With the developed skeleton in the middle, the tumor cavity or dissection can be better positioned.

(2) The covering body is used to cover the main body and branch brackets of the skeleton, which can effectively avoid the embolic material from squeezing the whole skeleton and the tumor cavity wall, and reduce the risk of tumor cavity rupture.

Description of the drawings

FIG. 1 is a three-dimensional schematic diagram of a graft involved in an exemplary embodiment of the present invention, which uses a dotted line to show the internal skeleton;

Fig. 2 is a schematic top view of the graft shown in Fig. 1, which shows the internal skeleton with dashed lines;

Fig. 3 is a cross-sectional view of the graft shown in Fig. 1 along the line A-A of Fig. 2.

In the picture: 1-skeleton, 2-covering body, 11-main body, 12-branch stent.

Detailed ways

In order to make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the graft suitable for implantation into the tumor cavity of aortic dilatation disease of the present invention will be described in further detail with reference to the accompanying drawings. Obviously, the described The embodiments are only a part of the embodiments of the present invention, but not all of the embodiments. Based on the embodiments of the present invention, all other embodiments implemented by those of ordinary skill in the art without departing from the essence of the present invention fall within the protection scope of the present invention.

Figures 1 to 3 show schematic structures of grafts according to exemplary embodiments of the present invention.

As shown in FIG. 1, the graft according to the exemplary embodiment may include a skeleton 1 and a covering body 2 covering the outer circumference of the skeleton 1, wherein the skeleton 1 may include a main body 11 and a branch stent connected to the outer circumference of the main body 11. 12. The main body 11 and the branch stent 12 may be integrally formed of a nickel-titanium alloy into the skeleton 1. Specifically, the main body 11 of the skeleton 1 is formed into a cylindrical shape, and a multi-layer branch stent 12 is integrally formed on the outer peripheral side of the main body 11. In addition, the main body 11 and the branch bracket 12 have a certain supporting effect on the covering body 2, and the branch bracket 12 can be expanded or contracted relative to the main body 11. When the number of layers of the branch brackets 12 is more than three, the intervals between the adjacent two sides of the branch brackets 12 are the same. For example, in this embodiment, the branch brackets 12 are arranged in 4 layers, each layer is provided with 2-18 branch brackets, for example 8, and the branch brackets on each layer are evenly distributed along the circumference of the main body 11 to ensure The branch brackets 12 of each layer are equally spaced on the circumference. It can be seen from FIG. 2 that the extension lines of all the branch brackets 12 of each layer intersect on the central axis of the main body 11. In addition, the interval between two adjacent layers of the 4-layer branch bracket 12 is the same, and the interval is set between 2-10 mm, for example, 6 mm. In an alternative embodiment, the number of layers of the branch stents may be 1 layer, 2 layers, or 5 layers, 6 layers or more, and each layer of branch stents may be unevenly distributed along the circumference. Of course, in an alternative embodiment, the interval between two adjacent layers may be unequal.

In this embodiment, the outer diameter of the skeleton 1, that is, the diameter of the circle enclosed by the outermost end of the branch bracket 12 is 10 mm to 40 mm, for example, 25 mm. Moreover, the inside of the skeleton 1 contains a visualization material, such as barium sulfate or a visualization strip. When the graft is implanted into the lesion position, the position of the graft can be determined by visualization, thereby realizing real-time positioning. In an alternative embodiment, the skeleton may be made of a rigid sponge or the like with a developing function, or a developing mark may be provided on the skeleton.

In this embodiment, the upper and lower ends of the covering body 2 are provided with arc-curved chamfers at the joints between the upper and lower ends of the covering body 2 to ensure that the covering body 2 will not damage the lesion position during implantation. In addition, the outer diameter of the covering body 2 is larger than the outer diameter of the skeleton 1, so that the skeleton 1 and the lesion position have a certain distance, and at the same time, the covering body 2 has a certain buffering effect. In addition, the covering body 2 is made of sponge, and the sponge covering body covers the outside of the skeleton 1 to form a soft layer. When it contacts the tumor cavity wall, it can reduce the compression of the tumor cavity and reduce the rupture of the tumor cavity. risks of. The sponge coating is made of water-absorbing or thermally expanding materials, such as PVA, PVF or PGLA. When the sponge covering body is implanted in the human body, it absorbs water or absorbs human body heat and expands, so that the covering body 2 fully fills the tumor cavity or interlayer. In addition, optionally, a procoagulant drug, such as a coagulation factor, is dispersed in the sponge coating body to promote thrombosis of the tumor cavity.

In this embodiment, the branch bracket 12 and the central axis of the main body 11 form a certain included angle α, as shown in FIG. 3, and when the branch bracket 12 is fully deployed relative to the main body 11, the included angle α The range of is between 10° and 90°, and grafts with different included angles can be selected according to actual needs. For example, a graft with a maximum of 45° can be selected. Before implantation, the covering body 2 is compressed by external force. At this time, the branch stent 12 shrinks relative to the main body 11 as the covering body 2 shrinks, and the angle α formed by the branch stent 12 and the central axis of the main body 11 decreases. , So that the branch stent 12 is gathered along the axial direction, that is, the angle between the branch and the main body is close to 0°, the implantation volume of the graft is reduced, and the operation is convenient for the surgeon. When the graft is implanted in the body, the graft is released, and the covering body 2 expands by absorbing water. The branch stent 12 expands relative to the main body 11 as the covering body 2 expands. At this time, the branch stent 12 and The included angle α formed by the central axis of the main body 11 increases, and α≤45°. At this time, the branch stent 12 supports the covering body 2 so that the covering body 2 can fully fill the tumor cavity or dissection.

In an exemplary embodiment, the implantation method of the graft involved in the present invention is as follows:

Use a conveyor to place the graft into the tumor cavity or dissection, specifically: first, introduce the introducer sheath through external compression, and pre-install the graft in the introducer sheath, and then deliver the introducer sheath to the aorta through the delivery sheath For tumors or dissection lesions, the implantation position of the graft is determined according to the development of the skeleton 1 during the radiography. After reaching the designated position, the graft is supported by the introducer sheath core, and the delivery sheath is withdrawn to release the graft and transport During the process, the skeleton 1 of the graft plays a supporting role in the tumor cavity to avoid distortion of the graft itself. After the graft is released, the outer covering body 2 gradually expands after absorbing the water or heat in the blood, thereby reducing The tumor cavity is completely filled, which better promotes the thrombosis of the tumor cavity.

The embodiments of the present invention are described in detail and in detail above, and their purpose is to illustrate the present invention, but it should not be understood as a limitation to the protection scope of the present invention. It should be pointed out that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can be made, and these modifications and improvements fall within the protection scope of the present invention. Therefore, the scope of protection of the present invention should be subject to the claims.

Claims

A graft suitable for implanting into the tumor cavity of aortic dilatation disease, which is characterized in that it comprises:

A skeleton, which has a main body and a branch bracket connected to the outer periphery of the main body;

A covering body, covering the outer circumference of the frame;

Wherein, the covering body is made of a material that expands or contracts according to changes in the implantation environment, and the branch stent can be expanded or contracted relative to the main body with the expansion or contraction of the covering body.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to claim 1, wherein at least one layer of the branch stent is formed on the outer circumference of the main body.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to claim 2, wherein the branch stents of each layer are evenly distributed along the circumference of the main body.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to claim 3, wherein each layer is provided with 2 to 18 branch stents.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to claim 2, wherein the skeleton includes at least three layers of the branch stent, and the interval between two adjacent layers is the same.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to claim 5, wherein the interval is 2 mm to 10 mm.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to any one of claims 1 to 6, wherein the outer diameter of the skeleton is 10 mm to 40 mm.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to any one of claims 1 to 6, wherein when the branch stent is fully deployed relative to the main body, the branch stent and The included angle between the main bodies ranges from 10° to 90°.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to any one of claims 1 to 6, wherein the branch stent is arranged in a cylindrical shape with a diameter of 1 mm to 2 mm.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to any one of claims 1 to 6, wherein the skeleton contains a visualization material or a visualization mark is provided on the skeleton.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to any one of claims 1 to 6, wherein the coating body is provided with a procoagulant drug.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to any one of claims 1 to 6, wherein the branch stent and the main body are integrally formed.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to any one of claims 1 to 6, wherein the covering body is a sponge.
The graft suitable for implanting into the tumor cavity of aortic dilatation disease according to claim 1, wherein the material comprises: polyvinyl alcohol PVA, polyvinyl fluoride PVF or polyglycolide PGLA.