CN211749821U

CN211749821U - Graft suitable for implantation in the lumen of an aortic distensible disease tumor

Info

Publication number: CN211749821U
Application number: CN201921920290.6U
Authority: CN
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: Beijing Yingjia Medical Material Co ltd; Shanghai Fuman Medical Technology Co ltd
Current assignee: Beijing Yingjia Medical Material Co ltd; Shanghai Fuman Medical Technology Co ltd
Priority date: 2019-11-08
Filing date: 2019-11-08
Publication date: 2020-10-27
Anticipated expiration: 2029-11-08

Abstract

The utility model relates to the field of medical equipment, it provides a be suitable for implantation aorta expansile disease tumor chamber's graft, and it includes: a frame having a main body and a branch bracket connected to an outer periphery of the main body; and the cladding body is cladded at the periphery of the framework. Wherein the cover is made of a material that expands or contracts according to a change in an implantation environment, and the branch stent is capable of being expanded or contracted with respect to the main body as the cover expands or contracts. The graft is filled in an aortic aneurysm cavity or an aortic dissection for embolizing the aneurysm cavity, has self-expansion performance, and is fully filled in the aneurysm cavity; and the surface is soft, and the tumor cavity and the main body bracket are protected.

Description

Graft suitable for implantation in the lumen of an aortic distensible disease tumor

Technical Field

The utility model relates to the field of medical equipment, concretely relates to be suitable for implant graft of aorta expansivity disease tumor chamber.

Background

The aortic dilatation disease is a disease with fierce morbidity, fast progression and high mortality, the diseases are mainly divided into true aortic aneurysm, aortic dissection and false aortic aneurysm, and the treatment aiming at the diseases is mainly divided into surgical treatment and catheter intervention treatment at present. The surgical operation treatment is mainly artificial blood vessel replacement, and the catheter intervention treatment is mainly percutaneous covered stent implantation (namely endoluminal isolation). The artificial blood vessel replacement is an open operation, and is not suitable for the old and the weak patients due to large trauma, long operation time, high mortality and complications.

Compared with the traditional open surgery, the covered stent for carrying out the intracavity isolation surgery to treat the aortic dilatation disease has the advantages of small surgical wound, quick postoperative recovery, short hospitalization time and the like. However, for some patients with aortic dilatation diseases with too large tumor cavity, after the intraluminal isolation surgery treatment, the tumor cavity can not be completely embolized by whole blood, so as to achieve the purpose of blood vessel remodeling. By filling the tumor cavity, not only can the complete whole blood embolization of the tumor cavity be promoted, but also the formation of the inner leakage after the isolation operation in the cavity can be treated.

Embolic agents are generally classified into solid embolic agents and liquid embolic agents, wherein polyvinyl alcohol (PVA) particles, spring coils, atrial septal occluders, and the like are commonly used for immobilizing the embolic agents. The existing embolism material has some defects, for example, the material of the spring ring is mainly stainless steel, platinum and alloy thereof, which has no shape memory function, when the spring ring is placed in a tumor cavity, the spring ring can not be filled according to a preset shape, and especially when a larger tumor cavity is filled, the tumor cavity is insufficiently filled. In addition, the existing liquid embolization materials such as ONXY glue can realize irregular embolization of a tumor cavity, but the embolization materials are easy to move along with blood, and when the volume of an aortic aneurysm cavity or a false cavity is too large, embolization is incomplete, and operation cost, difficulty and the like are high.

SUMMERY OF THE UTILITY MODEL

In view of the problems existing in the prior art, the utility model provides a be suitable for implanting the graft in aortic dilatation disease tumor chamber, when making it fill in aortic aneurysm chamber or aortic dissection, have the expansion and contraction performance and can fully pack the aortic aneurysm chamber, improve the cure rate of graft.

To achieve the above objects, embodiments of the present invention provide a graft suitable for implantation into the lumen of an aortic expansile disease tumor, comprising: a frame having a main body and a branch bracket connected to an outer periphery of the main body; the cladding body is cladded at the periphery of the framework; wherein the cover is made of a material that expands or contracts according to a change in an implantation environment, and the branch stent is capable of being expanded or contracted with respect to the main body as the cover expands or contracts.

In some embodiments of the present invention, the material of the framework is a material with a certain supporting force, such as nitinol, and may also be a polymer material, which can generate a certain supporting force from the inside of the graft.

According to an embodiment of the present invention, the coating body can expand or contract according to the change of the implantation environment, for example, when the coating body absorbs water from the implantation environment, the expansion occurs, and the purpose of the aneurysm cavity or the dummy cavity is achieved by the expansion. Alternatively, the cover may expand in response to the body temperature of the implantation environment, i.e. may be made of a thermally expansive material.

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

In some embodiments of the invention, the branched struts of each layer are evenly distributed along the circumference of the main body. According to the utility model discloses an embodiment follows the branch's of every layer support evenly distributed of the circumference of main part can guarantee that branch's support is when implanting the aneurysm chamber, and the atress of whole graft is even, guarantees that the graft remains stable in the aneurysm intracavity.

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

According to the utility model discloses an embodiment, the number of branch's support can be adjusted according to actual service environment to guarantee that branch's support has certain supporting role to whole graft, prevent simultaneously again that branch's support power is too big, be unfavorable for implanting the scheduling problem.

In some embodiments of the present invention, the frame comprises at least three layers of the branch stent, and the interval between two adjacent layers is the same.

According to the utility model discloses an embodiment works as be provided with at least three-layer on the skeleton during branch's support, adjacent interval between two-layer is the same, guarantees the skeleton is received branch's atress is even, prevents cladding body warp the oppression the risk of main part.

In some embodiments of the invention, the spacing is 2 mm to 10 mm. For example 2 mm, 6 mm, 8 mm or 10 mm. According to an embodiment of the invention, the interval can be adjusted according to the difference of the implantation environment of the graft to satisfy the optimal setting.

In some embodiments of the present invention, the outer diameter of the framework, i.e., the circumcircle diameter of one layer of the branched stent, 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 utility model discloses an embodiment can select the graft of different skeleton external diameters according to the position in the aortic aneurysm chamber of implanting, so as to satisfy the messenger the graft can realize fully filling the effect in tumour chamber after implanting the aortic aneurysm chamber, guarantees treatment.

In some embodiments of the present invention, when the branch stent is fully deployed relative to the main body (i.e., when the branch stent is not under force), the included angle between the branch stent and the main body ranges from 10 ° to 90 °. For example 10 °, 50 ° or 90 °.

According to the utility model discloses an embodiment can select the graft of the contained angle of different angles under the complete expansion state according to actual need before the tumor chamber is implanted to the graft, through the external force compression the cladding body makes branch's support with contained angle between the main part is close 0, works as after the tumor chamber is implanted to the graft, branch's support for the main part expandes, makes the contained angle keep being less than or equal to between its the biggest angle when expandeing completely. In this way, on the one hand, it is ensured that the graft can be sufficiently filled with the tumor cavity by expansion after implantation 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 support is configured to be cylindrical and has a diameter of 1 mm to 2 mm.

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

According to the utility model discloses an embodiment set up development material or development mark in the skeleton, will after the graft is implanted tumor chamber or intermediate layer, can fix a position tumor chamber or intermediate layer in real time through developing, improve and implant the precision.

In some embodiments of the invention, a pro-coagulant is disposed within the coating.

According to the utility model discloses an embodiment set up the procoagulant medicine in the cladding body, can promote tumour chamber or intermediate layer thrombus to change, improve treatment.

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

In some embodiments of the invention, the coating is a sponge. The sponge is made of water-absorbing expansion materials, when the implant is implanted into a body, the sponge absorbs water and expands to achieve the purpose of embolizing a tumor cavity or a false cavity, and after the sponge is foamed, the sponge achieves high expansion performance by reducing the density and compression of the sponge.

In some embodiments of the invention, the material comprises: polyvinyl alcohol (PVA), polyvinyl fluoride (PVF), or Polyglycolide (PGLA). For example, polyvinyl alcohol (PVA) particles have expansibility and compressibility, are made of polyvinyl alcohol foam and formaldehyde through processes of crosslinking, drying, crushing, sieving and the like, are water-insoluble, are usually 100-1000 μm in size, and can expand with water-soluble liquid and expand by about 20% in volume. Adopt the utility model discloses an embodiment has following beneficial effect:

(1) the skeleton is externally provided with a coating body which expands or contracts according to the change of the implantation environment, for example, the coating body expands with water liquid or expands according to the body temperature, so that the graft can fully fill the tumor cavity or the interlayer, and the treatment effect is improved. The tumor cavity or the interlayer is better positioned through the skeleton developed by the middle belt.

(2) The main body and the branch support of the framework are coated by the coating body, so that the extrusion of the embolism material on the wall of the whole framework and the tumor cavity can be effectively avoided, and the risk of tumor cavity rupture is reduced.

Drawings

Fig. 1 is a perspective view of an implant according to an exemplary embodiment of the present invention, showing the internal framework in phantom;

FIG. 2 is a schematic top view of the implant shown in FIG. 1, with the internal framework shown in phantom;

figure 3 is a cross-sectional view of the implant shown in figure 1 taken along line a-a of figure 2.

In the figure: 1-framework, 2-cladding body, 11-main body and 12-branch bracket.

Detailed Description

To make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the graft suitable for implanting into the aneurysm cavity of an aortic expandable disease according to the present invention will be described in further detail with reference to the accompanying drawings, and it is apparent that the described embodiments are only some embodiments of the present invention, but not all embodiments. Based on the embodiments of the present invention, all other embodiments that can be implemented by a person of ordinary skill in the art without departing from the spirit of the present invention belong to the protection scope of the present invention.

Fig. 1 to 3 show a schematic structure of a graft according to an exemplary embodiment of the present invention.

As shown in fig. 1, the graft according to the exemplary embodiment may include a frame 1 and a cover 2 covering an outer circumference of the frame 1, wherein the frame 1 may include a main body 11 and a branch stent 12 connected to an outer circumference of the main body 11. The main body 11 and the branch stent 12 may be integrally formed as the skeleton 1 of nitinol, and specifically, the main body 11 of the skeleton 1 is formed in a cylindrical shape, and a plurality of layers of branch stents 12 are integrally formed at an outer circumferential side of the main body 11. The main body 11 and the branch bracket 12 have a certain supporting function for the cover 2, and the branch bracket 12 can be expanded or contracted with respect to the main body 11. When the number of layers of the branch stent 12 is more than three, the intervals between the adjacent two side branch stents 12 are the same. For example, in the present embodiment, the branch stents 12 are arranged in 4 layers, each layer is provided with 2 to 18 branch stents, for example, 8 branch stents, and the branch stents on each layer are uniformly distributed along the circumference of the main body 11, so as to ensure that the interval of the branch stents 12 on each layer is equal on the circumference, and as can be seen from fig. 2, the extension lines of all the branch stents 12 on each layer intersect on the central axis of the main body 11. In addition, the interval between two adjacent layers of the 4 layers of branch supports 12 is the same, and the interval is set between 2 and 10 mm, for example, 6 mm. In an alternative embodiment, the number of the branch stent layers may be 1 layer or 2 layers, or may be 5 layers or more than 6 layers, and each layer of the branch stent may be non-uniformly distributed along the circumference. Of course, in alternative embodiments, the spacing between adjacent layers may not be equal.

In the present embodiment, the outer diameter of the frame 1, i.e., the diameter of the circle surrounded by the outermost end points of the branch stent 12, is 10 mm to 40 mm, for example, 25 mm. Moreover, the framework 1 contains developing materials, such as barium sulfate or developing strips, so that when the implant is implanted into a lesion position, the position of the implant can be determined through development, and real-time positioning is realized. In alternative embodiments, the skeleton may be made of a hard sponge or the like with a developing function, or a developing mark may be provided on the skeleton.

In the embodiment, the connecting parts of the upper end and the lower end of the coating body 2 and the side surface are provided with arc curved surface chamfers, so that the coating body 2 cannot damage the pathological change position during implantation. In addition, the outer diameter of the coating body 2 is larger than that of the framework 1, so that the framework 1 has a certain distance with a pathological change position, and meanwhile, the coating body 2 has a certain buffering effect. And, the cladding body 2 adopts the sponge to make, and the sponge cladding body cladding forms the soft layer in the outside of skeleton 1, when contacting with tumor chamber wall, can reduce the extrusion to tumor chamber, reduces the risk that tumor chamber bursts. The sponge coating body adopts water-absorbing expansion or thermal expansion materials, such as PVA, PVF or PGLA and the like. When the sponge coating body is implanted into a human body, the sponge coating body absorbs water or absorbs heat of the human body to expand, so that the coating body 2 is fully filled in a tumor cavity or an interlayer. In addition, optionally, a procoagulant drug, such as a clotting factor, is dispersed within the sponge coating to promote lumenal thrombolysis.

In the present embodiment, the branch stent 12 forms a certain included angle α with the central axis of the main body 11, as shown in fig. 3, and when the branch stent 12 is fully deployed relative to the main body 11, the included angle α ranges from 10 ° to 90 °, and grafts with different included angles can be selected according to actual needs, for example, grafts with α up to 45 ° can be selected. Before implanting, through external force compression cladding body 2, at this moment, branch support 12 is along with cladding body 2's shrink and shrink for main part 11, and the contained angle alpha that branch support 12 and main part 11's central axis formed reduces for branch support 12 gathers together along the axial, even divide the contained angle of branch and main part to be close 0, reduces the implantation volume of graft, makes things convenient for the operation of art person. When the graft is implanted into the body, the graft is released, the coating body 2 expands through absorbing moisture, the branch stent 12 expands relative to the main body 11 along with the expansion of the coating body 2, and at the moment, the included angle alpha formed by the branch stent 12 and the central axis of the main body 11 is increased, and the alpha is less than or equal to 45 degrees. At this time, the branched stent 12 supports the cover 2 so that the cover 2 can sufficiently fill the tumor cavity or the interlayer.

In an exemplary embodiment, the present invention relates to a method for implanting a graft as follows:

the graft is placed in a tumor cavity or an interlayer by adopting a conveyor, and the method comprises the following steps: firstly, a guide sheath is introduced through external compression, a graft is pre-arranged in the guide sheath, then the guide sheath is conveyed to a lesion part of an aortic aneurysm or an interlayer through a conveying sheath, the implantation position of the graft is determined according to development of a framework 1 during radiography, after the graft reaches a designated part, the graft is propped by a sheath core of the guide sheath, meanwhile, the conveying sheath is withdrawn to release the graft, in the conveying process, the framework 1 of the graft plays a supporting role in a tumor cavity, the graft is prevented from being distorted and deformed, and after the graft is released, an outer coating body 2 gradually expands after absorbing moisture or heat in blood, so that the tumor cavity is completely filled, and thrombus in the tumor cavity is better promoted.

The embodiments of the present invention have been described above in detail and with the aim of illustrating the invention, but should not be construed as limiting the scope of the invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several changes and modifications can be made, and these changes and modifications are all within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the claims.

Claims

1. A graft adapted for implantation in the lumen of an aortic distensible disease tumor, comprising:

a frame having a main body and a branch bracket connected to an outer periphery of the main body;

the cladding body is cladded at the periphery of the framework;

wherein the cover is made of a material that expands or contracts according to a change in an implantation environment, and the branch stent is capable of being expanded or contracted with respect to the main body as the cover expands or contracts;

wherein the material comprises polyvinyl alcohol (PVA), polyvinyl fluoride (PVF) or poly (glycolide-co-lactide) PGLA.

2. The graft adapted to be implanted in the lumen of an aortic stent graft as in claim 1, wherein at least one layer of the branch stent is formed on the outer periphery of the main body.

3. The graft adapted to be implanted in the aneurysmal lumen of aortic distensible disease as set forth in claim 2, wherein the branched stents of each layer are uniformly distributed along the circumference of the main body.

4. The graft adapted to be implanted into the aneurysmal lumen of aortic distensible disease as set forth in claim 3, wherein 2 to 18 branch stents are provided per layer.

5. The graft adapted to be implanted into the lumen of an aortic stent graft as recited in claim 2, wherein the scaffold comprises at least three layers of the branched stent, and the spacing between two adjacent layers is the same.

6. The graft adapted to be implanted into the aneurysmal lumen of an aortic expansile disease as in claim 5, wherein the spacing is between 2 mm and 10 mm.

7. The graft adapted to be implanted into the tumor lumen of an aortic expansile disease according to any of claims 1 to 6, wherein the outer diameter of the scaffold is 10 mm to 40 mm.

8. The graft adapted to be implanted into the aneurysmal aortic dilation disease lumen of any one of claims 1 to 6, wherein the angle between the branch stent and the main body ranges from 10 ° to 90 ° when the branch stent is fully deployed relative to the main body.

9. The graft adapted to be implanted into the aneurysmal lumen of aortic distensible disease according to any one of claims 1 to 6, wherein the branch stent is configured to be cylindrical and has a diameter of 1 mm to 2 mm.

10. The graft suitable for implantation into the tumor lumen of an aortic expansile disease according to any of claims 1 to 6, wherein the scaffold comprises a visualization material or is provided with visualization markers on the scaffold.

11. The graft adapted to be implanted into the tumor lumen of an aortic expansile disease according to any of claims 1 to 6, wherein the coating has an procoagulant drug disposed therein.

12. The graft adapted to be implanted into the aneurysmal lumen of aortic distensible disease as in any one of claims 1 to 6, wherein the branch stent and the main body are integrally formed.

13. The graft adapted to be implanted into the tumor lumen of an aortic expansile disease according to any one of claims 1 to 6, wherein the cover is a sponge.