Covered stent for minimally invasive intervention of suture-free metal stent and manufacturing method of covered stent

Abstract

The invention belongs to the technical field of biomedical textile preparation, and discloses a covered stent for minimally invasive intervention of a suturing-free metal stent and a preparation method of the covered stent for minimally invasive intervention of the suturing-free metal stent, and the preparation method of the covered stent for minimally invasive intervention of the suturing-free metal stent comprises the following steps: firstly, preparing a tubular fabric body with a basic domain and an annular band domain; the method comprises the following steps: firstly, preparing a tubular fabric body, sleeving the tubular fabric body on a core rod for heat treatment to obtain a tubular fabric film-covered body, respectively placing a metal stent into each annular belt region, connecting the heads and tails of the metal stents at openings by using metal blocks, and sewing the openings to obtain the film-covered stent for minimally invasive intervention of the sewing-free metal stents. Wherein 0-2 fixed areas are arranged on the annular band area. According to the invention, after the metal stent is placed in the annular zone, only the fabric at the opening of the side edge of the annular zone needs to be stitched, and the stitching process is simplified, so that the manufacturing efficiency is improved, meanwhile, direct contact and repeated friction between the metal stent and the vascular wall at the aneurysm are avoided, and the risk of complications such as stent-derived dissecting aneurysm is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of biomedical textile preparation, and in particular relates to a suture-free metal stent covered stent for minimally invasive intervention and a preparation method thereof. Background Art

[0002] Vascular stents have become a common medical device for treating vascular diseases, especially covered stents, which have more and more indications and a wider range of applications.

[0003] A stent graft is an artificial blood vessel composed of sutures, a metal stent, and a fabric covering. The metal stent is used to provide sufficient radial support to the stent graft, thereby preventing the stent graft from slipping and maintaining the tubular shape of the fabric covering. However, currently, the stent graft used in clinical practice is widely fixed with a metal stent by sutures. Studies have found that there are three problems with the stent graft: (1) During production, the suturing process of the metal stent and the fabric covering is completely manual, which is time-consuming and labor-intensive, greatly reducing production efficiency; (2) During use, the relative slippage between the metal stent and the suture or its own deformation causes the suture needle hole to become larger or break, which can easily cause type IV endoleak in long-term use; (3) The metal stent sutured on the outer surface of the stent graft is in direct contact with the vascular wall at the aneurysm site. After long-term implantation, the metal stent may damage the vascular endothelium, increasing the risk of complications such as stent-induced dissecting aneurysms.

[0004] For example, patent CN107119371B discloses a locally reinforced tubular fabric coating for in-situ fenestration and its preparation method. The tubular fabric coating involved is a combination effect of a full window area and a basic area. The full window area is composed of a non-reinforced structural domain and a locally reinforced structural domain surrounding the non-reinforced structural domain. The fabric tissue of the basic domain is at least one of the three primary tissues, the fabric tissue of the locally reinforced structural domain is any one of a square plain tissue, a double plain tissue or a tear-proof tissue, and the fabric tissue of the non-reinforced structural domain is a plain weave or a twill weave. This technical solution can effectively prevent the tearing of the fenestration hole while enhancing the operability of the in-situ fenestration surgery by designing a locally reinforced fenestration area. This patent uses the tissue selected from the local reinforcement area to have high durability to achieve a reinforcement effect on a single layer of fabric. This method cannot solve the problems of low production efficiency caused by manual suturing, excessive size and breakage of the suture needle eye caused by slippage or deformation of the metal stent, and damage to the vascular endothelium caused by long-term repeated direct action of the metal stent and the blood vessel wall.

[0005] To address the above-mentioned issues, patent CN118383905A discloses a stent graft for minimally invasive interventional therapy that can simplify the suturing of metal stents, and a method for manufacturing the same. This goal of simplifying the suturing of metal stents is achieved by designing pocket areas on the fabric coating. The tubular fabric body consists of a non-pocket area and a pocket area. The pocket area is where the pocket is located, and its function is to fix the metal stent. The pocket area consists of a pocket body area and a pocket edge area. After the tip of the metal stent is placed in the pocket area, the pocket is sewn to the fabric. Although this changes the traditional method of sewing the metal stent to the fabric, since the pocket area opens in different directions, either upward or downward, and there are many pocket areas that need to be set, there is still much room for improvement in manufacturing efficiency.

[0006] Therefore, it is necessary to design and develop a new covered stent, which can not only solve the problems of metal stents easily slipping or deforming, resulting in suture needle holes being too large and breaking, and long-term repeated direct interaction between the metal stent and the blood vessel wall, resulting in damage to the vascular endothelium, but more importantly, improve production efficiency. Summary of the Invention

[0007] The purpose of the present invention is to solve the problems existing in the prior art and to provide a minimally invasive interventional covered stent that does not require a sutured metal stent and a method for manufacturing the same.

[0008] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0009] A method for preparing a suture-free metal stent graft for minimally invasive intervention comprises the following steps:

[0010] Step 1: preparing a tubular fabric body;

[0011] The tubular fabric body is divided into n regions along the axial direction, n ≥ 2, and two adjacent regions are respectively recorded as the base region and the annular region;

[0012] The basal domain is a double-layered junctional organization;

[0013] There is no fixed area on the annular belt area, and the whole area is a non-fixed area. The non-fixed area is a double-layer knotless structure consisting of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by changing the order of the pattern cards on the pattern pattern.

[0014] Alternatively, the annular belt region is provided with a fixed area, which is a double-layer binding structure, and the rest of the region is a non-fixed area, which is a double-layer non-binding structure, and is composed of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by reversing the order of the pattern cards on the pattern card pattern, and the fixed area is located at the upper end or the lower end of the opening along the axial direction of the tubular fabric body.

[0015] Alternatively, the annular belt is provided with two fixed areas, the fixed areas being a double-layer binding structure, and the remaining areas being non-fixed areas, the non-fixed areas being a double-layer unbound structure, and being composed of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by reversing the order of the pattern cards on the pattern pattern, and the two fixed areas are located at the upper and lower ends of the opening along the axial direction of the tubular fabric body.

[0016] When preparing the annular region, a binding tissue is provided at the opening on one side of the fold to introduce a fixing area of ​​appropriate size, thereby replacing part of the suture site and reducing the number of suture needles when suturing the opening subsequently; the height of a single fixing area shall not exceed 1 / 3 of the height of a single annular region;

[0017] Step 2: The tubular fabric body is placed on a core rod and heat treated to obtain a tubular fabric-coated body. The heat treatment temperature and time depend on the material properties and equipment type. For example, when both the inner and outer layers of the fabric are made of polyester (PET) yarn, or when polyester (PET) is used as the inner yarn and ultra-high molecular weight polyethylene (UHMWPE) is used as the outer yarn, the heat treatment temperature is 60-180°C and the heat treatment time is 10-20 minutes. Step 3: A metal stent is placed in each annular zone.

[0018] Step 4: After connecting the ends of the metal stent at the opening, the metal stent is completely fixed, and the fabric at the side opening of the annulus is sutured with suture thread to suture the opening, thereby obtaining a minimally invasive interventional covered stent that does not require suture of the metal stent.

[0019] As the preferred technical solution:

[0020] In the method for preparing a minimally invasive interventional covered stent with a suture-free metal stent, the axial length of the base domain along the tubular fabric body is 5-20 mm, and the axial length of the annular domain along the tubular fabric body is 0.5-25 mm.

[0021] In the method for preparing a suture-free metal stent-grafted stent for minimally invasive intervention as described above, the tubular fabric body is prepared by textile integrated molding technology.

[0022] The method for preparing a suture-free metal stent graft for minimally invasive intervention, wherein the base region is interwoven with four layers of warp yarns and four layers of weft yarns introduced in sequence, the four layers of weft yarns being numbered sequentially from top to bottom, and two shuttles are used for weft insertion, denoted as shuttle A and shuttle B, respectively. The weft insertion pattern is as follows: shuttle A sequentially introduces the first and fourth layers of weft yarns, and then shuttle B sequentially introduces the second and third layers of weft yarns, with a total of four weft insertions in one cycle. The above cycle can be repeated according to the desired length during weaving.

[0023] The annular belt domain is interwoven with four layers of warp yarns and four layers of weft yarns introduced in sequence. The four layers of weft yarns are numbered sequentially from top to bottom. Two shuttles are used for weft insertion, which are denoted as shuttle C and shuttle D respectively. The weft insertion rule is: after shuttle C introduces the first layer of weft yarn and the fourth layer of weft yarn in sequence, shuttle D introduces the second layer of weft yarn and the third layer of weft yarn in sequence. After shuttle C introduces the fourth layer of weft yarn and the first layer of weft yarn in sequence, shuttle D introduces the second layer of weft yarn and the third layer of weft yarn in sequence. There are a total of 8 weft insertions in one cycle. When weaving, repeat the above cycle according to the required length.

[0024] In the method for preparing a minimally invasive interventional stent graft without sutured metal stent, the steps for preparing the tubular fabric body are as follows:

[0025] Step 1: Preparation before weaving;

[0026] 1) Select the surface and back layer basic organization, combine them to obtain the organization of the basic domain, fixed area and non-fixed area, and design the pattern plate;

[0027] 2) Design the size specifications and determine the required weaving length and width of the base area and the ring belt area (fixed area and non-fixed area);

[0028] 3) Use the zone drawing-in method or other drawing-in methods to complete the warp drawing-in and reeding process;

[0029] Step 2: integrally forming a woven tubular fabric body on a loom;

[0030] The surface and inner basic tissues of the basic domain and the annular domain (fixed area and non-fixed area) can be selected from tertiary tissues and complex tissues.

[0031] As described above, a method for preparing a coated stent for minimally invasive intervention with a suture-free metal stent is described, wherein the tubular fabric body is composed of medical yarn with a specification of 12-80D. Currently, the most commonly used coated fabric materials are polyester (PET) and ultra-high molecular weight polyethylene (UHMWPE). Considering that in the present invention, the wall thickness increases due to the increase in the number of layers, in order to reduce the wall thickness as much as possible, monofilament or multifilament yarns of different specifications can be selected for the inner and outer layers. For example, since the inner fabric layer will directly contact the blood, in order to better isolate the blood, the inner layer warp and weft yarns are usually selected as multifilaments, while the outer fabric layer needs to have good metal stent covering and support properties, in order to better reduce the wall thickness, the outer layer warp and weft yarns are usually selected as monofilaments; the warp density and weft density of the tubular fabric body are both 1600-3600 yarns / 10cm; the length of the tubular fabric body is 60-300mm, the outer diameter is 10-35mm, and the wall thickness is 0.09-0.26mm.

[0032] According to the method for preparing a minimally invasive interventional covered stent with a suture-free metal stent as described above, the material of each metal stent must at least ensure that it is suitable for in vivo use and will not cause acute infection, immune system rejection reaction, thrombosis, particle shedding or other adverse reactions. Currently, the commonly used materials for metal stents are nickel-titanium alloy, medical stainless steel and other alloys; the diameter of the metal stent is 0.2-0.6mm, and the type is Z-type, M-type or straight, wherein the diameter of the straight metal stent is not greater than the axial length of the annular region where it is located along the tubular fabric body; the height of the Z-type or M-type metal stent is not greater than the axial length of the annular region where it is located along the tubular fabric body, the degree of the tip angle is 30°-60°, the number of tip angles is 7-14, and the outer diameter of the metal stent matches the circumference of the tubular fabric covered body.

[0033] As described above, in the method for preparing a minimally invasive interventional covered stent with a suture-free metal stent, when a Z-shaped or M-shaped metal stent (which has elastic rebound force) is placed in the annular region, it is first straightened and then inserted from the opening of the outer fabric.

[0034] In the method for preparing a suture-free metal stent graft for minimally invasive intervention, the ends of the metal stent are connected at the opening by riveting metal blocks.

[0035] The present invention also provides a stent graft for minimally invasive intervention without suture of a metal stent, which is prepared by the method for preparing a stent graft for minimally invasive intervention without suture of a metal stent as described in any one of the above items.

[0036] Beneficial effects:

[0037] (1) The existing technology directly sews the metal bracket to the tubular fabric covering body. Since the surface of the metal bracket is smooth, it is necessary to sew one stitch at a time along the shape of the metal bracket to fix the metal bracket. The present invention is based on the textile integrated molding technology. Different tissue structure designs are used on the tubular fabric covering body to obtain the basic domain and the annular domain. The metal bracket is then placed in the annular domain and the fabric at the side opening of the annular domain is sewed. This transforms the traditional method of sewing the metal bracket and the fabric into sewing the fabric and the fabric, thereby simplifying the sewing process and greatly improving the production efficiency.

[0038] (2) In the prior art, the metal stent is sutured to the tubular fabric covering body, and the suture eye may be too large during the suturing process. At the same time, in subsequent use, the relative slippage between the metal stent and the suture thread and the self-deformation may also easily cause the suture eye of the suture thread to become larger and break, thereby causing type IV endoleak. However, in the present invention, since the "annular domain" structure is prepared by textile integrated molding technology and is integrated with the tubular fabric body, it is only necessary to place the metal stent therein, and there is no need to use suture thread to sew the metal stent to the tubular fabric covering body, thereby avoiding the slippage or deformation of the metal stent causing the suture eye of the suture thread to become larger and break.

[0039] (3) In the prior art, in order to ensure that the stent graft is fixed and stable in the blood vessel, the diameter of the stent graft usually needs to be slightly larger than the diameter of the aorta. This design is called the stent magnification ratio. However, an inappropriate stent magnification ratio will cause the stent to exert excessive radial support force on the blood vessel wall, thereby damaging the blood vessel wall. At the same time, because the metal stent itself has a certain elastic recoil force, when the stent graft is placed in a curved blood vessel such as the aortic arch, this elastic recoil force may cause the metal stent to continuously compress and rub the blood vessel wall, thereby causing endothelial damage or stent-induced dissecting aneurysms. Therefore, the present invention places the metal stent in the annular region, which is equivalent to covering the outer layer of the metal stent with a layer of fabric, which not only reduces the direct contact friction between the metal stent and the blood vessel, but also buffers the tip stress of the metal stent, prevents surface wear of the tubular fabric body or the tubular fabric coating body, and also reduces the risk of complications such as stent-induced dissecting aneurysms. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 Schematic diagram of the tubular fabric covering body in Example 1 of the present invention;

[0041] Figure 2 This is a right side view of an annular zone of the tubular fabric covering body in Example 1 of the present invention;

[0042] Figure 3 This is a schematic diagram of specific suture locations in the annulus region of the minimally invasive interventional stent graft of the suture-free metal stent in Example 1 of the present invention;

[0043] Figure 4 Schematic diagram of a minimally invasive stent graft for suture-free metal stent in Example 1 of the present invention;

[0044] Figure 5 This is a schematic diagram of a patterned card of a fabric covering for minimally invasive intervention of a suture-free metal stent in Example 1 of the present invention;

[0045] Figure 6 Schematic diagram of the tubular fabric covering body in Example 2 of the present invention;

[0046] Figure 7 This is a right side view of an annular zone of the tubular fabric covering body in Example 2 of the present invention;

[0047] Figure 8 This is a schematic diagram of specific suture locations in the annulus region of a minimally invasive stent graft for suture-free metal stents in Example 2 of the present invention;

[0048] Figure 9 Schematic diagram of a minimally invasive interventional stent graft with a suture-free metal stent in Example 2 of the present invention;

[0049] Figure 10 This is a schematic diagram of a patterned card of a fabric covering for minimally invasive intervention of a suture-free metal stent in Example 2 of the present invention;

[0050] Figure 11 Schematic diagram of the zoned drawing-in process for completing the warp drawing-in and reeding process using the zoned drawing-in method when weaving the tubular fabric body in Examples 2 and 3 of the present invention; the areas filled with oblique lines in the figure represent the areas requiring yarn drawing in the first and second heald frame zones;

[0051] Figure 12 Schematic diagram of the tubular fabric covering body in Example 3 of the present invention;

[0052] Figure 13 This is a right side view of an annular zone of the tubular fabric covering body in Example 3 of the present invention;

[0053] Figure 14 This is a schematic diagram of specific suture locations in the annulus region of the minimally invasive interventional stent graft of the suture-free metal stent in Example 3 of the present invention;

[0054] Figure 15 Schematic diagram of a minimally invasive interventional stent graft with a suture-free metal stent in Example 3 of the present invention;

[0055] Figure 16 This is a schematic diagram of a patterned card of a fabric covering for minimally invasive intervention of a suture-free metal stent in Example 3 of the present invention;

[0056] Figure 17 This is a schematic diagram of connecting the ends of a metal bracket by riveting a metal block in the present invention, wherein the arrow represents the direction in which one end of the metal bracket is inserted into the metal block;

[0057] Among them, 1-basic domain pattern, 2-non-fixed area pattern, 3-fixed area pattern, 11-basic domain, 12-ring domain, 121-fixed area, 122-non-fixed area, 13-metal bracket, 14-metal block, 51-pattern I, 52-pattern II, 101-pattern A, 102-pattern B, 103-pattern C, 111-first heald frame partition, 112-second heald frame partition, 161-pattern a, 162-pattern b, 163-pattern c. DETAILED DESCRIPTION

[0058] Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiments are only used to illustrate the present invention and are not used in limiting the scope of the present invention.In addition, should be understood that after reading the content taught by the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall equally within the scope limited by the appended claims of the application.

[0059] Example 1

[0060] A method for preparing a suture-free metal stent graft for minimally invasive intervention, comprising the following steps:

[0061] (1) Preparation of raw materials;

[0062] PET multifilament: specification is 40D;

[0063] PET monofilament: specification is 20D;

[0064] Metal stent: Made of nickel-titanium alloy, 0.4mm in diameter, straight type;

[0065] (2) preparing a tubular fabric body;

[0066] The tubular fabric body is divided into 7 regions along the axial direction, and two adjacent regions are marked as the base region and the annular region respectively;

[0067] The basic domain is a double-layer binding structure; the length of the basic domain along the axial direction of the tubular fabric body is 10 mm;

[0068] The annular band has no fixed area and is entirely non-fixed. The non-fixed area is a double-layer, knotless weave consisting of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by reversing the order of the pattern cards on the pattern pattern. The annular band has an axial length of 0.6 mm along the tubular fabric body.

[0069] The warp density of the tubular fabric body is 2400 threads / 10 cm, the weft density is 2400 threads / 10 cm, the length of the tubular fabric body is 41.8 mm, the outer diameter is 15 mm, and the wall thickness is 0.22 mm;

[0070] (2.1) Preparation before weaving the tubular fabric body;

[0071] (a) Using twill as the surface base weave and plain weave as the inner base weave, the base domain and non-fixed area weave are obtained after combination, and the pattern pattern is designed; Figure 5 As shown, the pattern plate diagram is composed of pattern plate diagram I 51 and pattern plate diagram II 52. Pattern plate diagram I 51 is composed of a basic domain pattern plate Figure 1 Composition, pattern plate II 52 consists of a non-fixed area pattern plate Figure 2 composition;

[0072] (b) Design dimensions and specifications to determine the required weaving length and width for the base and non-fixed areas;

[0073] (c) using PET multifilament and PET monofilament to complete the warp threading and reeding process by the flying threading method; wherein the warp and weft yarns of the inner layer of the base domain and the inner layer of the endless belt domain are both PET multifilaments, and the warp and weft yarns of the outer layer of the base domain and the outer layer of the endless belt domain are both PET monofilaments;

[0074] (2.2) integrally forming a woven tubular fabric body on a loom; wherein:

[0075] The basic domain is interwoven with four layers of warp yarns and four layers of weft yarns introduced in sequence. The four weft yarns are numbered sequentially from top to bottom. Two shuttles are used for weft insertion, denoted as shuttle A and shuttle B. The weft insertion pattern is as follows: shuttle A introduces the first and fourth layers of weft yarns in sequence, and then shuttle B introduces the second and third layers of weft yarns in sequence. One cycle has a total of four weft insertions, and the above cycle is repeated until the desired length is reached.

[0076] The loop is interwoven with four layers of warp yarns and four layers of weft yarns introduced in sequence. The four layers of weft yarns are numbered sequentially from top to bottom. Two shuttles are used for weft insertion, denoted as shuttle C and shuttle D. The weft insertion pattern is as follows: shuttle C introduces the first and fourth layers of weft yarns in sequence, and then shuttle D introduces the second and third layers of weft yarns in sequence. After shuttle C introduces the fourth and first layers of weft yarns in sequence, shuttle D introduces the second and third layers of weft yarns in sequence. A total of eight weft insertions are performed in one cycle, and the above cycle is repeated until the desired length is reached.

[0077] (3) The tubular fabric body is placed on the core rod and heat treated to obtain a tubular fabric coating body (such as Figure 1 、 Figure 2 As shown, it is composed of a basic domain 11 and a ring domain 12, and the ring domain 12 is a non-fixed area 122 as a whole); wherein the heat treatment temperature is 160° C. and the heat treatment time is 15 min;

[0078] (4) Place a metal stent in each annulus;

[0079] (5) Figure 3As shown, the metal block 14 is riveted at the opening to connect the end of the metal bracket 13 (as shown in FIG. Figure 17 After that, the opening is sutured with suture thread, and the minimally invasive stent graft for suture-free metal stent is obtained (as shown in FIG. Figure 4 shown).

[0080] The final minimally invasive interventional covered stent with a suture-free metal stent only needs to manually suture the opening of the annular domain to achieve the effect of a suture-free metal stent. Moreover, since the "annular domain" structure is prepared by textile integrated molding technology, when the metal stent is placed in the annular domain, it is equivalent to covering the outer layer of the metal stent with a layer of fabric, thereby avoiding repeated direct interaction between the metal stent and the blood vessel wall. It can be seen that the present invention can not only solve the problems of excessive size and breakage of the suture needle eye caused by slippage or deformation of the metal stent, and damage to the vascular endothelium caused by long-term repeated direct interaction between the metal stent and the blood vessel wall, but more importantly, the present invention can completely omit the process of manually suturing the metal stent, thereby improving production efficiency.

[0081] Example 2

[0082] A method for preparing a suture-free metal stent graft for minimally invasive intervention, comprising the following steps:

[0083] (1) Preparation of raw materials;

[0084] PET multifilament: specification is 40D;

[0085] UHMWPE monofilament: specification is 20D;

[0086] Metal stent: Made of nickel-titanium alloy, 0.4mm in diameter, M-type;

[0087] (2) preparing a tubular fabric body;

[0088] The tubular fabric body is divided into 7 regions along the axial direction, and two adjacent regions are marked as the base region and the annular region respectively;

[0089] The basic domain is a double-layer binding structure, and the length of the basic domain along the axial direction of the tubular fabric body is 15 mm;

[0090] The annular belt is equipped with two fixed areas, each with a double-layer binding structure. The remaining area is a non-fixed area, with a double-layer, unbound structure. The non-fixed area consists of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by reversing the order of the pattern cards on the pattern pattern. The two fixed areas are located at the upper and lower ends of the opening along the axial direction of the tubular fabric body. The annular belt has an axial length of 11 mm along the tubular fabric body.

[0091] The warp density of the tubular fabric body is 2400 threads / 10 cm, the weft density is 2000 threads / 10 cm, the length of the tubular fabric body is 93 mm, the outer diameter is 20 mm, and the wall thickness is 0.24 mm;

[0092] (2.1) Preparation before weaving the tubular fabric body;

[0093] (a) Using twill as the surface base structure and plain weave as the inner base structure, the basic domain, fixed area and non-fixed area are obtained after combination, and the pattern pattern is designed; Figure 10 As shown, the pattern plate is composed of pattern plate A 101, pattern plate B 102 and pattern plate C 103; pattern plate A 101 is composed of a basic domain pattern plate Figure 1 Composition; Pattern plate B 102 consists of a non-fixed area pattern plate Figure 2 and one Fixed area pattern plate Figure 3 Composition, according to the non-fixed area pattern plate Figure 2 On the left, fixed area pattern plate Figure 3 The pattern on the right is arranged regularly; the pattern plate C 103 consists of a non-fixed area pattern plate Figure 2 Composition, by the fixed area pattern plate of pattern plate B 102 Figure 3 Replaced with non-fixed area pattern plate Figure 2 get;

[0094] (b) Design dimensions and specifications to determine the required weaving length and width for the base area, fixed area, and non-fixed area;

[0095] (c) Using PET multifilament and UHMWPE monofilament, the warp yarn drawing-in and reeding process is completed by the partition drawing-in method, and the partition drawing-in is as follows: Figure 11 As shown, it is composed of a first heald frame partition 111 and a second heald frame partition 112; wherein, the warp and weft yarns of the inner layer of the basic domain and the inner layer of the annular belt domain are both PET multifilaments, and the warp and weft yarns of the outer layer of the basic domain and the outer layer of the annular belt domain are both UHMWPE monofilaments;

[0096] (2.2) forming a tubular fabric body on a loom; wherein the weaving process of the base region and the annular region is performed with reference to step (2.2) of Example 1, and is adaptively adjusted according to the structure of the tubular fabric body to be woven in this embodiment;

[0097] (3) The tubular fabric body is placed on the core rod and heat treated to obtain a tubular fabric coating body (such as Figure 6 、 Figure 7 As shown, it is composed of a basic domain 11 and a ring domain 12, and the ring domain 12 is provided with two fixed areas 121, and the other areas are non-fixed areas 122); wherein the heat treatment temperature is 120°C and the heat treatment time is 15 minutes;

[0098] (4) First, straighten the metal stent to the maximum extent, and then place a metal stent with elastic rebound force into each annulus area; the height of the metal stent is 9 mm, the degree of the tip angle is 35°, and the number of tip angles is 7;

[0099] (5) Figure 8 As shown, the metal block 14 is riveted at the opening to connect the end of the metal bracket 13 (as shown in FIG. Figure 17 After that, the opening is sutured with suture thread, and the minimally invasive stent graft for suture-free metal stent is obtained (as shown in FIG. Figure 9 shown).

[0100] Example 3

[0101] A method for preparing a suture-free metal stent graft for minimally invasive intervention, comprising the following steps:

[0102] (1) Preparation of raw materials;

[0103] PET multifilament: specification is 40D;

[0104] UHMWPE monofilament: specification is 20D;

[0105] Metal stent: Made of nickel-titanium alloy, 0.4mm in diameter, Z-shaped;

[0106] (2) preparing a tubular fabric body;

[0107] The woven tubular fabric body is divided into 7 regions along the axial direction, and two adjacent regions are marked as the base region and the annular region respectively;

[0108] The basic domain is a double-layer binding structure; the length of the basic domain along the axial direction of the tubular fabric body is 20 mm;

[0109] The annular belt is provided with a fixed area with a double-layer binding structure. The rest of the area is a non-fixed area with a double-layer, non-binding structure. The non-fixed area is composed of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by reversing the order of the pattern cards on the pattern pattern. The fixed area is located at the upper or lower end of the opening along the axial direction of the tubular fabric body. The length of the annular belt along the axial direction of the tubular fabric body is 8mm.

[0110] The warp density of the tubular fabric body is 2400 threads / 10 cm, the weft density is 2000 threads / 10 cm, the length of the tubular fabric body is 104 mm, the outer diameter is 15 mm, and the wall thickness is 0.24 mm;

[0111] (2.1) Preparation before weaving the tubular fabric body;

[0112] (a) Using twill as the surface base structure and plain weave as the inner base structure, the basic domain, fixed area and non-fixed area are obtained after combination, and the pattern pattern is designed; Figure 16 As shown, the pattern plate is composed of pattern plate a 161, pattern plate b 162 and pattern plate c 163. Pattern plate a 161 is composed of a basic domain pattern plate. Figure 1 The pattern plate b 162 consists of a non-fixed area pattern plate Figure 2 The pattern plate c 163 consists of a non-fixed area pattern plate Figure 2 and one Fixed area pattern plate Figure 3 Composition, according to the non-fixed area pattern plate Figure 2 On the left, fixed area pattern plate Figure 3 In the regular arrangement on the right, by placing the non-fixed area pattern plate of pattern plate b 162 Figure 2 Part of the area is replaced by a fixed area pattern plate Figure 3 get;

[0113] (b) Design dimensions and specifications to determine the required weaving length and width for the base area, fixed area, and non-fixed area;

[0114] (c) Using PET multifilament and UHMWPE monofilament, the warp yarn drawing-in and reeding process is completed by the partition drawing-in method, and the partition drawing-in is as follows: Figure 11 As shown, it is composed of a first heald frame partition 111 and a second heald frame partition 112; wherein, the warp and weft yarns of the inner layer of the basic domain and the inner layer of the annular belt domain are both PET multifilaments, and the warp and weft yarns of the outer layer of the basic domain and the outer layer of the annular belt domain are both UHMWPE monofilaments;

[0115] (2.2) forming a tubular fabric body on a loom; wherein the weaving process of the base region and the annular region is performed with reference to step (2.2) of Example 1, and is adaptively adjusted according to the structure of the tubular fabric body to be woven in this embodiment;

[0116] (3) The tubular fabric body is placed on the core rod and heat treated to obtain a tubular fabric coating body (such as Figure 12 、 Figure 13 As shown, it is composed of a basic domain 11 and an annular domain 12, wherein the annular domain 12 is provided with a fixed area 121, and the other areas are non-fixed areas 122); wherein the heat treatment temperature is 120°C and the heat treatment time is 15 minutes;

[0117] (4) First, straighten the metal stent to the maximum extent, and then place a metal stent with elastic rebound force into each annulus area; the height of the metal stent is 6 mm, the degree of the tip angle is 35°, and the number of tip angles is 7;

[0118] (5) Figure 14As shown, the metal block 14 is riveted at the opening to connect the end of the metal bracket 13 (as shown in FIG. Figure 17 After that, the opening is sutured with suture thread, and the minimally invasive stent graft for suture-free metal stent is obtained (as shown in FIG. Figure 15 shown).

Claims

1. A method for preparing a minimally invasive interventional stent graft without suture of a metal stent, characterized in that: The following steps are involved: Step one: preparing a tubular fabric body; The tubular fabric body is divided into n regions along the axial direction, n ≥ 2, and two adjacent regions are respectively recorded as the base region and the annular region; The basal domain is a double-layered junctional organization; There is no fixed area on the annular belt area, and the whole area is a non-fixed area. The non-fixed area is a double-layer knotless structure consisting of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by changing the order of the pattern cards on the pattern pattern. Alternatively, the annular belt region is provided with a fixed area, which is a double-layer binding structure, and the rest of the region is a non-fixed area, which is a double-layer non-binding structure, and is composed of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by reversing the order of the pattern cards on the pattern card pattern, and the fixed area is located at the upper end or the lower end of the opening along the axial direction of the tubular fabric body. Alternatively, the annular belt is provided with two fixed areas, the fixed areas being a double-layer binding structure, and the remaining areas being non-fixed areas, the non-fixed areas being a double-layer unbound structure, and being composed of an inner fabric and an outer fabric. During the weaving process, an opening is formed on one side of the fold of the outer fabric by reversing the order of the pattern cards on the pattern pattern, and the two fixed areas are located at the upper and lower ends of the opening along the axial direction of the tubular fabric body. Step 2: Put the tubular fabric body on the core rod and perform heat treatment to obtain the tubular fabric coated body; Step 3: Place a metal stent into each annulus area; Step 4: After connecting the ends of the metal stent at the opening, suture the opening to obtain a minimally invasive stent graft that does not require suture of the metal stent.

2. The method for preparing a minimally invasive interventional stent graft with a suture-free metal stent according to claim 1, characterized in that: The length of the basic domain along the axial direction of the tubular fabric body is 5-20 mm, and the length of the annular zone along the axial direction of the tubular fabric body is 0.5-25 mm.

3. The method for preparing a suture-free metal stent graft for minimally invasive intervention according to claim 1, characterized in that: The tubular fabric body is prepared by textile integrated molding technology.

4. The method for preparing a suture-free metal stent graft for minimally invasive intervention according to claim 3, characterized in that: The basic domain is interwoven with four layers of warp yarns and four layers of weft yarns introduced in sequence. The four layers of weft yarns are numbered sequentially from top to bottom. Two shuttles are used for weft insertion, denoted as shuttle A and shuttle B. The weft insertion pattern is as follows: shuttle A introduces the first and fourth layers of weft yarns in sequence, and then shuttle B introduces the second and third layers of weft yarns in sequence. A total of four weft insertions are performed in one cycle. When weaving, the above cycle can be repeated according to the required length. The annular belt domain is interwoven with four layers of warp yarns and four layers of weft yarns introduced in sequence. The four layers of weft yarns are numbered sequentially from top to bottom. Two shuttles are used for weft insertion, which are denoted as shuttle C and shuttle D respectively. The weft insertion rule is: after shuttle C introduces the first layer of weft yarn and the fourth layer of weft yarn in sequence, shuttle D introduces the second layer of weft yarn and the third layer of weft yarn in sequence. After shuttle C introduces the fourth layer of weft yarn and the first layer of weft yarn in sequence, shuttle D introduces the second layer of weft yarn and the third layer of weft yarn in sequence. There are a total of 8 weft insertions in one cycle. When weaving, repeat the above cycle according to the required length.

5. The method for preparing a suture-free metal stent graft for minimally invasive intervention according to claim 3, characterized in that: The steps for preparing the tubular fabric body are as follows: Step 1: Preparation before weaving; 1) Select the surface and back layer basic organization, combine them to obtain the organization of the basic domain, fixed area and non-fixed area, and design the pattern plate; 2) Design the size specifications and determine the required weaving length and width of the base area and the ring belt area; 3) Use the zone drawing-in method or other drawing-in methods to complete the warp drawing-in and reeding process; Step 2: integrally forming a woven tubular fabric body on a loom.

6. The method for preparing a suture-free metal stent graft for minimally invasive intervention according to claim 3, characterized in that: The tubular fabric body is composed of medical yarn with a specification of 12-80D; the warp density and weft density of the tubular fabric body are both 1600-3600 yarns / 10cm; the length of the tubular fabric body is 60-300mm, the outer diameter is 10-35mm, and the wall thickness is 0.09-0.26mm.

7. The method for preparing a suture-free metal stent graft for minimally invasive intervention according to claim 1, characterized in that: The diameter of the metal stent is 0.2-0.6 mm, and the type is Z-type, M-type or straight, among which the diameter of the straight metal stent is not greater than the axial length of the annular zone where it is located along the axial direction of the tubular fabric body; the height of the Z-type or M-type metal stent is not greater than the axial length of the annular zone where it is located along the axial direction of the tubular fabric body, the degree of the tip angle is 30°-60°, and the number of tip angles is 7-14.

8. The method for preparing a suture-free metal stent graft for minimally invasive intervention according to claim 7, characterized in that: When placing a Z-shaped or M-shaped metal stent into the annulus, it is first straightened and then inserted through the opening of the outer fabric.

9. The method for preparing a suture-free metal stent graft for minimally invasive intervention according to claim 1, characterized in that: The ends of the metal brackets are connected at the opening by riveting metal blocks.

10. A minimally invasive interventional stent graft without suture of a metal stent, characterized in that: The stent graft is prepared by the method for preparing a suture-free metal stent for minimally invasive intervention according to any one of claims 1 to 9.

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