A multi-branch stent for distal aneurysm of aortic dissection

Abstract

The present invention proposes a multi-branch stent for aortic dissection distal aneurysm zoning, belonging to the field of medical device technology. It includes a main covered stent, which is composed of a covering and a main stent. The main covered stent is sequentially arranged from one end to the other end as an upper half, a waist transition section and a lower half; the upper and lower parts of the upper half in the vertical direction are respectively a soft zone and a hard zone; the upper and lower parts of the lower half in the vertical direction are respectively a hard zone and a soft zone; the upper and lower parts are respectively provided with two embedded branch stents; the embedded branch stent in the upper half is used to reconstruct the celiac trunk and the superior mesenteric artery, and the embedded branch stent in the lower half is used to reconstruct the bilateral renal arteries. The present invention increases the adaptability of the anchoring areas at both ends of the main covered stent to the blood vessels, prevents the rupture of the inner membrane sheet of the distal rupture, improves the adhesion of the main covered stent to the tube wall, reduces the incidence of type I internal leakage, reduces the incidence of new stent-induced ruptures after surgery, and can reconstruct visceral arteries at the same time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a multi-branch stent for aortic dissection distal aneurysm zoning. Background Art

[0002] Thoracic endovascular aortic repair (TEVAR) has become the recognized first-line treatment for Stanford type B aortic dissection. However, conventional TEVAR does not address the distal rupture, and continued perfusion of blood in the distal false lumen ultimately leads to chronic aneurysmal dilation in up to 20%-40% of patients after surgery, which can progress to aneurysm rupture and even death. Therefore, the formation of distal dissecting aneurysms has become a major factor affecting the long-term efficacy of TEVAR treatment, posing a significant challenge to clinical treatment.

[0003] There are some objective technical obstacles to the use of a fully endovascular approach to treat distal aneurysmal dilatation, such as: (1) the length of the anchoring zone required for endovascular repair is insufficient, and in order to obtain a sufficient anchoring zone, the artificial vascular stent (SG) may cover the visceral branch artery; (2) the true lumen is narrow and the operating space is limited, which affects the full opening of the SG; (3) the visceral artery may originate from the false lumen or be supplied by both the true and false lumens, and the anatomy is more complex, making reconstruction difficult; (4) there are often multiple distal ruptures, and the spatial positions of each other are more complex, making it difficult to completely repair them at one time.

[0004] Currently, there are several technologies for endovascular treatment of distal aortic dissection aneurysms: (1) PETTICOAT (provisional extension to induce complete attachment), which is characterized by extending the distal bare metal stent beyond the proximal SG and further expanding it downward to the distal aorta. However, it may still cause adverse events and medium- and long-term complications, such as migration of the bare metal stent and new rupture of the distal stent. (2) Parallel stent, which belongs to the true lumen intervention technology, has a high incidence of type I endoleak due to the presence of inherent grooves in the stent and the mismatch between the internal parallel stent and the external main stent. Due to the large difference in the diameter of the stents used, the stents may squeeze each other in the narrow true lumen, which can easily cause stent occlusion and affect the long-term patency rate. (3) Fenestrated and branched stents. Fenestrated SGs are usually customized. Compared with standard SGs, they are not only very expensive but also time-consuming to customize. They often require a production cycle of up to 4-8 weeks. Therefore, they are not suitable for emergency patients with rupture or threatened rupture. Branched SGs are mainly used for patients with multiple visceral arteries involved at the same time. The customization time for branched stents is longer. Generally, the production and transportation process takes about 8-12 weeks. Therefore, they are also not feasible for emergency surgery. (4) Hybrid surgery. The endovascular repair process is simple and the long-term effect of the anastomosis is usually high. However, there are still problems such as huge surgical trauma, high technical requirements for renal artery anastomosis, and a high incidence of spinal cord ischemia. (5) Candy-plug. It is difficult to align the distal end of the stent in the true and false cavities. There is a possibility that the distal endothelial sheet may be torn again under the influence of radial force. (6) Knickerbocker, which uses a compliant balloon to expand the middle part of the distal stent, causing the local stent to generate a huge radial force, squeezing outward and causing local tearing of the distal endothelium. However, the deliberately applied radial force may cause the tube wall to rupture and bleed. Summary of the Invention

[0005] The purpose of the present invention is to propose a partitioned multi-branch stent for distal aortic dissection aneurysms, in order to solve the problems in the prior art of easy migration of intraluminal grafts, unsatisfactory anchoring effects, high incidence of type I endoleaks, easy occlusion of stents, low long-term patency rates, large radial forces exerted on the distal endothelial sheet, and easy local tearing of the distal endothelial sheet leading to rupture and bleeding of the tube wall. Partitioned multi-branch stent for treating distal aortic dissection aneurysms. While ensuring that the waist transition section of the main covered stent opens the distal true lumen of the aortic dissection, the adaptability of the anchoring areas at both ends of the main covered stent to the blood vessels is increased, the rupture of the distal ruptured endothelial sheet is prevented, the fit between the main covered stent and the tube wall is improved, the incidence of type I endoleaks is reduced, the incidence of new stent-induced ruptures after surgery is reduced, and the visceral arteries can be reconstructed at the same time.

[0006] The technical solution of the present invention is achieved as follows:

[0007] The present invention provides a multi-branch stent for aortic dissection distal aneurysm zoning, comprising a main covered stent, the main covered stent comprising a covering and a main stent, the main covered stent being sequentially arranged from one end to the other end into an upper half section, a waist transition section, and a lower half section;

[0008] The upper portion of the upper half in the vertical direction is a soft area, and the lower portion is a hard area; the upper portion of the lower half in the vertical direction is a hard area, and the lower portion is a soft area;

[0009] The upper and lower sections are each provided with two embedded branch brackets;

[0010] The upper half of the embedded branch stent is used for reconstructing the celiac trunk and the superior mesenteric artery, and the lower half of the embedded branch stent is used for reconstructing the bilateral renal arteries.

[0011] As a further improvement of the present invention, the upper half embedded branch bracket is arranged at one end of the upper half adjacent to the waist transition section; the lower half embedded branch bracket is arranged at one end of the lower half adjacent to the waist transition section.

[0012] As a further improvement of the present invention, the diameter of the upper section is 22-30 mm and the length is 45-60 mm, the diameter of the waist transition section is 15-20 mm and the length is 30 mm, and the diameter of the lower section is 20-35 mm and the length is 32-48 mm.

[0013] As a further improvement of the present invention, the diameter of the embedded branch bracket in the upper half is 8mm or 7mm, and its length is 10-15mm; the diameter of the embedded branch bracket in the lower half is 7mm or 6mm, and its length is 10-20mm.

[0014] As a further improvement of the present invention, the coating is made of polyester or a composite film material, and the composite film material is composed of an inner layer film material and an outer layer film material, with a thickness ratio of 2-4:3-5. The inner layer film material is made of anticoagulant material, and the outer layer film material is made of anti-inflammatory material.

[0015] As a further improvement of the present invention, the preparation method of the anticoagulant material is as follows:

[0016] S1. Preparation of modified silica: Nano-silica was added to ethanol, a composite silane coupling agent was added, the reaction was heated and stirred, centrifuged, washed, and dried to obtain modified silica;

[0017] S2 Preparation of modified polyester: The polyester fabric was immersed in an alkali solution, heated to react, acid washed and dried, immersed in a KH560 solution, heated in a water bath, and dried to obtain a modified polyester;

[0018] S3. Preparation of an anticoagulant material: o-aminotrifluorotoluene and modified silica are added to ethanol, and modified polyester is added thereto. The mixture is stirred for reaction, filtered, washed, and dried to obtain an anticoagulant material.

[0019] As a further improvement of the present invention, the composite silane coupling agent in step S1 is a mixture of KH550 and dodecyltrimethoxysilane in a mass ratio of 4-5:7, the mass ratio of the nano-silica to the composite silane coupling agent is 10:1-2, the temperature of the heating and stirring reaction is 40-50°C, and the time is 2-4 hours. The alkali solution in step S2 is a 30-40 g / L NaOH or KOH solution, the temperature of the heating reaction is 85-95°C, and the time is 0.5-1.5 hours. The concentration of the KH560 solution is 10-15 g / L, the temperature of the heating water bath reaction is 65-75°C, and the time is 1-3 hours. In step S3, the mass ratio of o-aminotrifluorotoluene, modified silica, and modified polyester is 2-4:4-5:10, and the stirring reaction time is 4-6 hours.

[0020] As a further improvement of the present invention, the preparation method of the anti-inflammatory material is as follows:

[0021] T1. Preparation of modified polyester: The polyester fabric was immersed in an alkali solution, heated for reaction, acid washed and dried, immersed in a mixed solution of KH560 and KH550, heated in a water bath for reaction, and dried to obtain a modified polyester;

[0022] T2. Preparation of Chinese herbal extracts: Phellodendron chinense and Coptis chinensis were crushed, added to water and heated to boiling for extraction, filtered, and dried to obtain a Chinese herbal extract;

[0023] T3. Preparation of anti-inflammatory material: Add modified polyester to water, add Chinese herbal medicine extract, heat and stir to react, filter, wash, and dry to obtain anti-inflammatory material.

[0024] As a further improvement of the present invention, the concentrations of KH560 and KH550 in the mixed solution of KH560 and KH550 in step T1 are 20-30 g / L and 15-25 g / L, respectively, the alkali solution is a 30-40 g / L NaOH or KOH solution, the temperature of the heating reaction is 85-95°C, the time is 0.5-1.5 h, and the temperature of the heated water bath reaction is 65-75°C, and the time is 1-3 h; in step T2, the mass ratio of Phellodendron chinense, Coptis chinensis, and water is 3-5:2-4:40-50, and the time of heating to boiling extraction is 3-5 h; in step T3, the mass ratio of the modified polyester and the traditional Chinese medicine extract is 10:1-2, the temperature of the heating and stirring reaction is 45-55°C, and the time is 0.5-1.5 h.

[0025] As a further improvement of the present invention, the main stent is a tubular stent composed of a hollow diamond woven mesh made of a medical memory alloy of a material that can be absorbed by the human body. The medical memory alloy of the material that can be absorbed by the human body is magnesium and its magnesium alloy material that can be absorbed by the human body or iron and its iron alloy material that can be absorbed by the human body.

[0026] The present invention has the following beneficial effects:

[0027] The present invention has a reasonable structural design, and the thickness of each branch is adapted to the diameter of the visceral artery. It can effectively treat distal aortic dissection aneurysms and reconstruction of the celiac trunk, superior mesenteric artery and bilateral renal arteries, and can balance the internal use of the main stent lumen space. The branches have high space utilization efficiency for the main stent, and hard areas and soft areas are respectively provided in different segments. The hard area ensures that the distal true lumen of the aortic dissection stenosis can be fully opened, creating conditions for subsequent superselection of visceral branch arteries. The soft area can reduce the radial force exerted by the stent on the endothelial sheet, prevent the rupture of the endothelial sheet, increase the fit between the main covered stent and the tube wall, reduce the incidence of type I endoleak, and reduce the incidence of new stent-induced ruptures after surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0029] Figure 1 This is a front view schematic diagram of a multi-branch stent for zoning distal aortic dissection aneurysm;

[0030] Figure 2 This is a side view schematic diagram of a multi-branch stent for zoning distal aortic dissection aneurysm;

[0031] Figure 3 This is a diagram of the internal structure of the upper half of the main covered stent;

[0032] Figure 4 This is the internal structure diagram of the lower half of the main covered stent;

[0033] Figure 5 This is the internal structure diagram of the upper half of the main covered stent (from another perspective);

[0034] Explanation of the numbers: 1-upper section of the main covered stent, 2-lumbar transition section of the main covered stent, 3-lower section of the main covered stent, 4-soft area of ​​the upper section of the main covered stent, 5-soft area of ​​the lower section of the main covered stent, 6-hard area of ​​the upper section of the main covered stent, 7-hard area of ​​the lower section of the main covered stent, 8-branch stent one embedded in the upper section of the main covered stent, 9-branch stent two embedded in the upper section of the main covered stent, 10-branch stent one embedded in the lower section of the main covered stent, 11-branch stent two embedded in the lower section of the main covered stent, 12-metal marker of branch stent one embedded in the upper section of the main covered stent, 13-metal marker of branch stent two embedded in the upper section of the main covered stent, 14-metal marker of branch stent one embedded in the lower section of the main covered stent, 15-metal marker of branch stent two embedded in the lower section of the main covered stent. DETAILED DESCRIPTION

[0035] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0036] In order to help those skilled in the art better understand the technical solutions in this application, the technical solutions in the embodiments of this application will be clearly and completely described below. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without making any creative efforts shall fall within the scope of protection of this application.

[0037] It should be noted that when an element is referred to as being “fixed on” or “set on” another element, it can be directly on the other element or indirectly set on the other element; when an element is referred to as being “connected to” another element, it can be directly connected to the other element or indirectly connected to the other element.

[0038] It should be understood that the terms "length", "width", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate 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 understood as a limitation on the present application.

[0039] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, "multiple" and "several" mean two or more, unless otherwise clearly and specifically defined.

[0040] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions under which this application can be implemented. Therefore, they have no substantive technical significance. Any structural modification, change in proportional relationship or adjustment of size should still fall within the scope of the technical content disclosed in this application without affecting the efficacy and purpose that can be achieved by this application.

[0041] like Figure 1 , 2, the present embodiment is suitable for a multi-branch stent for zoning distal aneurysms of aortic dissection, including a main body stent, wherein the main body stent is sequentially arranged as an upper half 1, a waist transition section 2 and a lower half 3 from one end to the other, the diameter of the waist transition section 2 is smaller than the diameters of the upper half 1 and the lower half 3, and knots are provided on the surfaces of the upper half 1 and the lower half 3, the upper half 1 is divided into an upper soft area 4 and a lower hard area 6 according to the thickness and rigidity of the metal wire, the lower half 3 is divided into an upper hard area 7 and a lower soft area 5 according to the thickness and rigidity of the metal wire, the thickness and rigidity of the metal wire of the waist transition section 2 are the same as those of the hard area 6 and the hard area 7, and are larger than the soft area 4 and the soft area 5, the waist transition section 2 is connected with the upper half 1 and The adjacent areas of the lower section 3 are all smoothly transitioned. Two windows are opened in the smooth transition area between the upper section 1 and the lumbar transition section 2, and two embedded branch stents 8 and 9 are provided, respectively extending from the windows to the upper section 1. Embedded branch stents 10 and 11 extending to the lower section 3 are provided on both sides of the smooth transition area between the lower section 3 and the lumbar transition section 2. The embedded branch stents 8 and 9 are used to reconstruct the celiac trunk and the superior mesenteric artery, and the embedded branch stents 10 and 11 are used to reconstruct the bilateral renal arteries.

[0042] like Figure 3As shown in Figures 4 and 5, the orientation of the embedded branch stents 8 and 9 is parallel to the axis of the upper section 1, the embedded branch stents 10 and 11 are spiral relative to the axis of the lower section 3, the openings of the embedded branch stents 8 and 9 inside the upper section 1 are perpendicular to the axis of the upper section 1, the openings of the embedded branch stents 10 and 11 inside the lower section 3 are perpendicular to the axis of the lower section 3, the embedded branch stents 8 and 9 are respectively provided with metal markers 12 and 13 at the internal opening ends of the main stent, and the embedded branch stents 10 and 11 are respectively provided with metal markers 14 and 15 at the internal opening ends of the main stent. The common femoral artery is selected as the vascular access for surgical incision or percutaneous puncture. Angiography is used for visualization during stent implantation. The positioning and release of the stent body are performed under fluoroscopic control and adjusted according to the surgical plan when necessary.

[0043] The diameter of the upper section is 24 mm and the length is 60 mm. The diameter of the waist transition section is 18 mm and the length is 30 mm. The diameter of the lower section is 22 mm and the length is 48 mm.

[0044] As a further improvement of the present invention, the diameter of the embedded branch bracket in the upper half is 8 mm or 7 mm, and its length is 15 mm; the diameter of the embedded branch bracket in the lower half is 7 mm or 6 mm, and its length is 20 mm.

[0045] After the stent body is fully deployed, cannulation of the internal branches can begin. The upper two internal branch stents are cannulated through surgical exposure of the axillary or brachial artery. The choice of side is determined by the individual patient's aortic arch configuration and the availability of the medical center. The lower two internal branch stents are cannulated through surgical exposure of the femoral artery. Typically, cannulation of the bilateral renal arteries is performed via the brachial artery, and cannulation of the celiac trunk and superior mesenteric artery is performed via the femoral artery to avoid damage to the already cannulated branches during reconstruction. A bridging stent graft is selected as needed for the internal branches. Metallic markers are located within the internal opening of the main stent as indicators. Once the bridging stent graft is confirmed to be inserted into the corresponding visceral branch vessel through the internal branch and to have sufficient overlap with the internal branch, it can be deployed. After all visceral vessels with the internal branch stent grafts have been provided with bridging stent grafts and connected to the internal branches, a final angiogram is performed to comprehensively assess the position of the stent body and bridging stent.

[0046] In the above structure, as a more preferred embodiment, the main stents 1, 2, 3 in the embodiment of the present invention are tubular stents composed of hollow diamond-shaped woven mesh made of medical memory alloy.

[0047] In the above structure, as a more preferred embodiment, the main stents 1, 2, and 3 in the embodiment of the present invention are made of a material that can be absorbed by the human body, and the covering is made of a material that cannot be absorbed by the human body. Specifically, the main stents 1, 2, and 3 in the embodiment of the present invention are made of magnesium and its magnesium alloy materials that can be absorbed by the human body, or iron and its iron alloy materials that can be absorbed by the human body. The covering in the embodiment of the present invention is made of polyester or a composite film material, and the main stents 1, 2, and 3 are connected to the covering by suturing.

[0048] The composite membrane material is formed by gluing or hot-pressing an inner layer membrane material and an outer layer membrane material, with a thickness ratio of 3:4. The inner layer membrane material is made of anticoagulant material, and the outer layer membrane material is made of anti-inflammatory material.

[0049] Preparation Example 1 Preparation of anticoagulant material

[0050] Here’s how:

[0051] S1. Preparation of modified silica: 10 g of nanosilica (average particle size 100 nm, purchased from Hubei Huifu Nanomaterials Co., Ltd.) was added to 200 mL of ethanol, along with 1 g of a composite silane coupling agent. The mixture was heated to 40°C and stirred for 2 h. The mixture was centrifuged, washed, and dried to obtain the modified silica.

[0052] The composite silane coupling agent is a mixture of KH550 and dodecyltrimethoxysilane in a mass ratio of 4:7;

[0053] S2. Preparation of modified polyester: 10 g of polyester fabric was immersed in 100 mL of a 30 g / L NaOH solution, heated to 85°C, reacted for 0.5 h, acid-washed to neutrality, dried, and then immersed in 100 mL of a 10 g / L KH560 solution, heated to 65°C, reacted in a water bath for 1 h, and dried to produce the modified polyester.

[0054] S3. Preparation of anticoagulant material: 2 g of o-aminotrifluorotoluene and 4 g of modified silica were added to 200 mL of ethanol, and 10 g of modified polyester was added. The mixture was stirred for 4 h, filtered, washed, and dried to obtain an anticoagulant material.

[0055] Preparation Example 2 Preparation of anticoagulant material

[0056] Here’s how:

[0057] S1. Preparation of modified silica: 10 g of nanosilica (average particle size 100 nm, purchased from Hubei Huifu Nanomaterials Co., Ltd.) was added to 200 mL of ethanol, along with 2 g of a composite silane coupling agent. The mixture was heated to 50°C and stirred for 4 h. The mixture was centrifuged, washed, and dried to obtain modified silica.

[0058] The composite silane coupling agent is a mixture of KH550 and dodecyltrimethoxysilane in a mass ratio of 5:7;

[0059] Preparation of modified polyester: 10 g of polyester fabric was immersed in 100 mL of a 40 g / L KOH solution, heated to 95°C, reacted for 1.5 h, acid-washed to neutrality, dried, and then immersed in 100 mL of a 15 g / L KH560 solution, heated to 75°C, reacted in a water bath for 3 h, and dried to produce the modified polyester.

[0060] S3. Preparation of anticoagulant material: 4 g of o-aminotrifluorotoluene and 5 g of modified silica were added to 200 mL of ethanol, and 10 g of modified polyester was added. The mixture was stirred for 6 h, filtered, washed, and dried to obtain an anticoagulant material.

[0061] Preparation Example 3 Preparation of anticoagulant material

[0062] Here’s how:

[0063] S1. Preparation of modified silica: 10 g of nanosilica (average particle size 100 nm, purchased from Hubei Huifu Nanomaterials Co., Ltd.) was added to 200 mL of ethanol, along with 1.5 g of a composite silane coupling agent. The mixture was heated to 45°C and stirred for 3 h. The mixture was centrifuged, washed, and dried to obtain modified silica.

[0064] The composite silane coupling agent is a mixture of KH550 and dodecyltrimethoxysilane, with a mass ratio of 4.5:7;

[0065] S2. Preparation of modified polyester: 10 g of polyester fabric was immersed in 100 mL of a 35 g / L NaOH solution, heated to 90°C, reacted for 1 h, acid-washed to neutrality, dried, and then immersed in 100 mL of a 12 g / L KH560 solution, heated to 70°C, reacted in a water bath for 2 h, and dried to produce the modified polyester.

[0066] S3. Preparation of anticoagulant material: 3 g of o-aminotrifluorotoluene and 4.5 g of modified silica were added to 200 mL of ethanol, and 10 g of modified polyester was added. The mixture was stirred for 5 h, filtered, washed, and dried to obtain an anticoagulant material.

[0067] Preparation Example 4

[0068] Compared with Preparation Example 3, the difference is that the composite silane coupling agent is a single KH550.

[0069] Preparation Example 5

[0070] Compared with Preparation Example 3, the difference is that the composite silane coupling agent is a single dodecyltrimethoxysilane.

[0071] Comparative Preparation Example 1

[0072] Compared with Preparation Example 3, the difference is that step S1 is not performed.

[0073] The details are as follows:

[0074] Preparation of modified polyester: 10 g of polyester fabric was immersed in 100 mL of a 35 g / L NaOH solution, heated to 90°C, reacted for 1 h, acid-washed to neutrality, dried, and then immersed in 100 mL of a 12 g / L KH560 solution, heated to 70°C, reacted in a water bath for 2 h, and dried to produce the modified polyester.

[0075] S2. Preparation of anticoagulant material: 3 g of o-aminotrifluorotoluene and 4.5 g of silica were added to 200 mL of ethanol, and 10 g of modified polyester was added. The mixture was stirred for 5 h, filtered, washed, and dried to obtain an anticoagulant material.

[0076] Comparative Preparation Example 2

[0077] Compared with Preparation Example 3, the difference is that o-aminotrifluorotoluene is not added in step S3.

[0078] The details are as follows:

[0079] S3. Preparation of anticoagulant material: 7.5 g of modified silica was added to 200 mL of ethanol, and 10 g of modified polyester was added. The mixture was stirred for 5 h, filtered, washed, and dried to obtain an anticoagulant material.

[0080] Comparative Preparation Example 3

[0081] Compared with Preparation Example 3, the difference is that no modified silica is added in step S3.

[0082] The details are as follows:

[0083] S3. Preparation of anticoagulant material: 7.5 g of o-aminotrifluorotoluene was added to 200 mL of ethanol, and 10 g of modified polyester was added. The mixture was stirred for 5 h, filtered, washed, and dried to obtain an anticoagulant material.

[0084] Test Example 1

[0085] The anticoagulant materials prepared in Examples 1-5 and Comparative Examples 1-3 were tested for water contact angle and oil repellency, with the oil repellency rating being based on the standard AATCC 118-2018, "Oil Repellency and Hydrocarbon Resistance Test." The results are shown in Table 1.

[0086] Table 1

[0087]

[0088] It can be seen from the above table that the anticoagulant materials prepared in Preparation Examples 1-3 of the present invention have good hydrophobic and oleophobic properties.

[0089] Preparation Example 6 Preparation of anti-inflammatory materials

[0090] Here’s how:

[0091] T1. Preparation of modified polyester: 10 g of polyester fabric was immersed in 100 mL of a 30 g / L NaOH solution, heated to 85°C, reacted for 0.5 h, acid-washed to neutrality, dried, and then immersed in a mixed solution of KH560 and KH550 (concentrations of KH560 and KH550, respectively, at 20 g / L and 15 g / L). The modified polyester was heated to 65°C, reacted in a water bath for 1 h, and dried to produce the fabric.

[0092] T2. Preparation of Chinese herbal extract: 3g of Phellodendron chinense and 2g of Coptis chinensis were crushed, added to 40mL of water, heated to boiling, extracted for 3h, filtered, and dried to obtain a Chinese herbal extract;

[0093] T3. Preparation of anti-inflammatory material: Add 10 g of modified polyester to 100 mL of water, add 1 g of traditional Chinese medicine extract, heat to 45°C, stir and react for 0.5 h, filter, wash, and dry to obtain the anti-inflammatory material.

[0094] Preparation Example 7 Preparation of anti-inflammatory materials

[0095] Here’s how:

[0096] T1. Preparation of modified polyester: 10 g of polyester fabric was immersed in 100 mL of a 40 g / L KOH solution, heated to 95°C, reacted for 1.5 hours, acid-washed to neutrality, dried, and then immersed in a mixed solution of KH560 and KH550 (concentrations of 30 g / L and 25 g / L, respectively). The modified polyester was heated to 75°C, reacted in a water bath for 3 hours, and dried to produce the fabric.

[0097] T2. Preparation of Chinese herbal extract: 5g of Phellodendron chinense and 4g of Coptis chinensis were crushed, added to 50mL of water, heated to boiling, extracted for 5h, filtered, and dried to obtain a Chinese herbal extract;

[0098] T3. Preparation of anti-inflammatory material: Add 10 g of modified polyester to 100 mL of water, add 2 g of traditional Chinese medicine extract, heat to 55°C, stir and react for 1.5 hours, filter, wash, and dry to obtain the anti-inflammatory material.

[0099] Preparation Example 8 Preparation of anti-inflammatory materials

[0100] Here’s how:

[0101] T1. Preparation of modified polyester: 10 g of polyester fabric was immersed in 100 mL of a 35 g / L NaOH solution, heated to 90°C, reacted for 1 hour, acid-washed to neutrality, dried, and then immersed in a mixed solution of KH560 and KH550 (concentrations of 25 g / L and 20 g / L, respectively). The modified polyester was heated to 70°C, reacted in a water bath for 2 hours, and dried to produce the fabric.

[0102] T2. Preparation of Chinese herbal extract: 4g of Phellodendron chinense and 3g of Coptis chinensis were crushed, added to 45mL of water, heated to boiling, extracted for 4h, filtered, and dried to obtain a Chinese herbal extract;

[0103] T3. Preparation of anti-inflammatory material: Add 10 g of modified polyester to 100 mL of water, add 1.5 g of traditional Chinese medicine extract, heat to 50°C, stir and react for 1 hour, filter, wash, and dry to obtain the anti-inflammatory material.

[0104] Comparative Preparation Example 4

[0105] Compared with Preparation Example 8, the difference is that the mixed solution of KH560 and KH550 is replaced by a single KH560 solution with a concentration of 35 g / L.

[0106] Comparative Preparation Example 5

[0107] Compared with Preparation Example 8, the difference is that the mixed solution of KH560 and KH550 is replaced by a single KH550 solution with a concentration of 35 g / L.

[0108] Comparative Preparation Example 6

[0109] Compared with Preparation Example 8, the difference is that steps S2 and S3 are not performed.

[0110] The details are as follows:

[0111] Preparation of anti-inflammatory material: 10 g of polyester fabric was immersed in 100 mL of 35 g / L NaOH solution, heated to 90°C, reacted for 1 hour, acid-washed to neutrality, dried, immersed in a mixed solution of KH560 and KH550, with the concentrations of KH560 and KH550 being 25 g / L and 20 g / L, respectively, heated to 70°C, reacted in a water bath for 2 hours, and dried to obtain the anti-inflammatory material.

[0112] Test Example 2

[0113] Female Kunming KM mice, standard grade, weighing 22-25 g, were randomly divided into a control group, Preparation Examples 6-8, and Comparative Preparation Examples 4-6. Each mouse had 20 μL of xylene applied to the inner and outer sides of the left auricle to induce inflammation, while the right ear was left unapplied as a control. The inflamed left ear was then wrapped with the prepared anti-inflammatory material, while the control group was wrapped with ordinary polyester. After 3 consecutive days of treatment, the mice were sacrificed by cervical dislocation. Ear pieces were removed from the same part of the left and right ears using a 7 mm diameter punch and weighed on an analytical balance. The difference in mass between the left and right ear pieces was used to represent the degree of swelling. The degree of ear swelling and the rate of swelling inhibition were calculated for each group. The results are shown in Table 2.

[0114] Swelling inhibition rate (%) = (average swelling degree of the control group - average swelling degree of the drug-treated group) / average swelling degree of the control group × 100%.

[0115] Table 2

[0116]

[0117] As can be seen from the above table, the anti-inflammatory materials prepared in Preparation Examples 6-8 of the present invention have a good inhibitory effect on mouse ear swelling and a good anti-inflammatory effect.

[0118] The description of the disclosed embodiments is provided to enable one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be readily apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention is not limited to the embodiments shown herein but is to be construed in the widest manner consistent with the principles and novel features disclosed herein.

[0119] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A multi-branch stent for aortic dissection distal aneurysm, characterized in that: It comprises a main body stent graft, the main body stent graft comprises a membrane and a main stent, and the main body stent graft is sequentially provided with an upper half section, a waist transition section and a lower half section from one end to the other end; The upper part of the upper half section in the vertical direction is a soft area, and the lower part is a hard area; the upper part of the lower half section in the vertical direction is a hard area, and the lower part is a soft area; The upper section and the lower section are respectively provided with two embedded branch brackets; The upper half of the embedded branch stent is used to reconstruct the celiac trunk and the superior mesenteric artery, and the lower half of the embedded branch stent is used to reconstruct the bilateral renal arteries; The coating is a composite film material, which is composed of an inner layer film material and an outer layer film material, with a thickness ratio of 2-4:3-5. The inner layer film material is made of an anticoagulant material, and the outer layer film material is made of an anti-inflammatory material. The preparation method of the anticoagulant material is as follows: S1. Preparation of modified silica: adding nano-silica to ethanol, adding a composite silane coupling agent, heating and stirring the reaction, centrifuging, washing, and drying to obtain modified silica; S2. Preparation of modified polyester: The polyester fabric was immersed in an alkali solution, heated for reaction, acid washed and dried, immersed in a KH560 solution, heated in a water bath for reaction, and dried to obtain a modified polyester; S3. Preparation of anticoagulant material: adding o-aminotrifluorotoluene and modified silica to ethanol, adding modified polyester, stirring to react, filtering, washing, and drying to obtain an anticoagulant material; The preparation method of the anti-inflammatory material is as follows: T1. Preparation of modified polyester: The polyester fabric is immersed in an alkali solution, heated for reaction, acid washed and dried, immersed in a mixed solution of KH560 and KH550, heated in a water bath for reaction, and dried to obtain modified polyester; T2. Preparation of Chinese herbal medicine extract: Phellodendron chinense and Coptis chinensis are crushed, added to water and heated to boiling for extraction, filtered, and dried to obtain a Chinese herbal medicine extract; T3. Preparation of anti-inflammatory materials: Add modified polyester into water, add Chinese herbal medicine extract, heat and stir to react, filter, wash and dry to obtain anti-inflammatory materials.

2. The multi-branch stent for distal aortic dissection aneurysm according to claim 1, characterized in that: The upper section embedded branch bracket is arranged at one end of the upper section adjacent to the waist transition section; the lower section embedded branch bracket is arranged at one end of the lower section adjacent to the waist transition section.

3. The multi-branch stent for distal aortic dissection aneurysm according to claim 1, characterized in that: The diameter of the upper section is 22-30mm and the length is 45-60mm. The diameter of the waist transition section is 15-20mm and the length is 30mm. The diameter of the lower section is 20-35mm and the length is 32-48mm.

4. The multi-branch stent for distal aortic dissection aneurysm according to claim 1, characterized in that: The diameter of the embedded branch bracket in the upper half is 8mm or 7mm, and its length is 10-15mm. The diameter of the embedded branch bracket in the lower half is 7mm or 6mm, and its length is 10-20mm.

5. The multi-branch stent for distal aortic dissection aneurysm according to claim 1, characterized in that: The composite silane coupling agent in step S1 is a mixture of KH550 and dodecyltrimethoxysilane in a mass ratio of 4-5:7, the mass ratio of the nano-silica to the composite silane coupling agent is 10:1-2, the temperature of the heating and stirring reaction is 40-50°C, and the time is 2-4h, the alkali solution in step S2 is 30-40g / L NaOH or KOH solution, the temperature of the heating reaction is 85-95°C, and the time is 0.5-1.5h, the concentration of the KH560 solution is 10-15g / L, the temperature of the heating water bath reaction is 65-75°C, and the time is 1-3h, and the mass ratio of o-aminotrifluorotoluene, modified silica, and modified polyester in step S3 is 2-4:4-5:10, and the time of the stirring reaction is 4-6h.

6. The multi-branch stent for distal aortic dissection aneurysm according to claim 1, characterized in that: The concentrations of KH560 and KH550 in the mixed solution of KH560 and KH550 in step T1 are 20-30 g / L and 15-25 g / L respectively, the alkali solution is 30-40 g / L NaOH or KOH solution, the temperature of the heating reaction is 85-95°C, the time is 0.5-1.5 h, the temperature of the heating water bath reaction is 65-75°C, and the time is 1-3 h; the mass ratio of Phellodendron chinense, Coptis chinensis, and water in step T2 is 3-5:2-4:40-50, and the time of heating to boiling extraction is 3-5 h; the mass ratio of the modified polyester and the Chinese medicine extract in step T3 is 10:1-2, the temperature of the heating and stirring reaction is 45-55°C, and the time is 0.5-1.5 h.

7. The multi-branch stent for distal aortic dissection aneurysm according to claim 1, characterized in that: The main stent is a tubular stent composed of a hollow diamond woven mesh made of a medical memory alloy of a material that can be absorbed by the human body. The medical memory alloy of the material that can be absorbed by the human body is magnesium and its magnesium alloy material that can be absorbed by the human body or iron and its iron alloy material that can be absorbed by the human body.

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