Minimally invasive covered stent of sewing-free limiting metal stent and preparation method of minimally invasive covered stent

Abstract

The invention belongs to the technical field of biomedical textile preparation, and relates to a minimally invasive covered stent of a sewing-free limiting metal stent and a preparation method of the minimally invasive covered stent. The covered stent comprises a tubular fabric covered stent body, a metal stent and a suture line, the tubular fabric film body is divided into n areas (n is greater than or equal to 2) along the axial direction and comprises a basic area and an annular area; the metal support is located between the outer-layer fabric in the main body area, the head and the tail are connected at the opening and sewn by sewing threads, and the limiting area limits circumferential sliding of the metal support. The preparation method comprises the steps of preparing the tubular fabric body, performing heat treatment to obtain the tubular covering film body or a tubular covering film body semi-finished product, inserting and connecting the metal stent, sewing the opening and the like. The production process is optimized, the structural stability is improved, the fabric and stent structures are adapted, the complication risk is reduced, and the treatment effect is guaranteed.

Description

Technical Field

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

[0002] Covered stents, due to their minimally invasive nature, are widely used in medical fields such as cardiovascular intervention. They replace traditional surgical procedures with endovascular isolation, significantly reducing the risk of trauma and complications. A typical vascular covered stent is composed of a fabric cover and a metal stent, bonded together with sutures. The metal stent provides radial support to maintain vascular patency, while the fabric cover reduces restenosis and thrombosis by preventing tissue proliferation.

[0003] However, the existing technology has significant bottlenecks in production process and structural design.

[0004] Currently, the production of vascular covered stents primarily relies on manual stitching of the metal stent to the fabric covering, stitch by stitch. This requires following the complex shape of the stent, resulting in a cumbersome process and difficulty in automation, leading to low production efficiency. More critically, existing techniques typically perform sutures directly around the shape of the metal stent. To ensure a secure bond, the suture thread is often pulled very tightly, placing it in a highly tense state. With this suturing method, after the stent is implanted in the human body, the metal stent and the fabric covering undergo relative displacement due to the daily pulsation of the blood vessels and the constant impact of blood flow. The tight suture thread, lacking a buffering space, is highly susceptible to breakage. Furthermore, the continued pulling will cause the suture eye to continuously expand. Once the suture thread breaks and the eye expands, blood can seep into the interlayer between the metal stent and the fabric covering, significantly increasing the risk of complications such as type IV endoleak, seriously impacting the patient's treatment outcome and post-procedure recovery. Summary of the Invention

[0005] The purpose of the present invention is to solve the problems existing in the prior art and to provide a minimally invasive covered stent with a suture-free limited metal stent and a preparation method thereof.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows:

[0007] A minimally invasive stent graft with a suture-free limited metal stent, comprising a tubular fabric graft body, a metal stent, and sutures;

[0008] The tubular fabric covering 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;

[0009] The basal domain is a double-layered junctional organization;

[0010] The annular belt area is divided into a main area and a limiting area, or is divided into a main area, a limiting area and a fixed area; the annular belt area is composed of an inner fabric and an outer fabric, and an opening is provided on one side of the fold of the outer fabric;

[0011] The main body area is a double-layered, knotless tissue with the opening located in the main body area;

[0012] The inner fabric layer and the outer fabric layer are connected together at the limiting area, and the limiting area is located on the side of the opening along the circumference of the tubular fabric covering body;

[0013] The fixing area is a double-layer binding structure, and the fixing area is located at the upper end and / or lower end of the opening along the axial direction of the tubular fabric covering body;

[0014] The metal stent is located between the inner fabric and the outer fabric of the main body area, and the head and tail of the metal stent are connected at the opening, and the opening is sutured by sutures;

[0015] The metal stent is a Z-shaped or M-shaped metal stent, and at least a portion of each limiting area is located within the sharp corner of the metal stent, which is used to limit the sliding distance of the metal stent along the circumference of the tubular fabric coating body to 5%-15% of the outer diameter of the tubular fabric coating body.

[0016] As the preferred technical solution:

[0017] As described above, in a minimally invasive covered stent with a suture-free limiting metal stent, the distance between each limiting area and the tip of the sharp corner of the metal stent where it is located along the axial direction of the tubular fabric covered body is d1, and the maximum distance between the tip of the sharp corner of the metal stent and the edge of the annular region where it is located along the axial direction of the tubular fabric covered body is d2 (there are two edges of the annular region where the tip of the sharp corner of the metal stent is located, so the distance between the tip of the sharp corner of the metal stent and the edge of the annular region where it is located along the axial direction of the tubular fabric covered body is 2, and d2 refers to the maximum value of the two), and d1 is 60%-90% of d2.

[0018] As described above, in a minimally invasive covered stent with a suture-free limiting metal stent, the height of the metal stent is 70%-100% of the axial length of the annular zone in which it is located along the tubular fabric covered body, allowing the metal stent to have a sliding space of 0-5mm along the axial direction of the tubular fabric covered body; the diameter of the metal stent is 0.2-0.6mm, the degree of the tip angle is 30°-60°, and the number of tip angles is 10-20.

[0019] In the minimally invasive stent graft with a suture-free limited metal stent as described above, the length of the base domain along the axial direction of the tubular fabric graft body is 10-25 mm; the length of the annular domain along the axial direction of the tubular fabric graft body is 10-30 mm.

[0020] In the minimally invasive stent graft with a suture-free limited metal stent as described above, the ends of the metal stent are connected at the opening by riveting metal blocks.

[0021] The minimally invasive covered stent with a suture-free limited metal stent as described above has a limiting area of ​​double-layered connecting tissue; when the limiting area is double-layered connecting tissue, the minimally invasive covered stent with a suture-free limited metal stent is recorded as minimally invasive covered stent with a suture-free limited metal stent A.

[0022] As described above, the minimally invasive covered stent with a suture-free limited metal stent has a limiting area of ​​double-layer suture fabric. When the limiting area is double-layer suture fabric, the minimally invasive covered stent with a suture-free limited metal stent is recorded as minimally invasive covered stent with a suture-free limited metal stent B.

[0023] The present invention also provides a method for preparing the minimally invasive stent graft A of the suture-free limited metal stent as described above, comprising the following steps:

[0024] Step one: preparing a tubular fabric body;

[0025] Step 2: The tubular fabric body is sheathed on the core rod and subjected to heat treatment to obtain a tubular fabric covered body. At this time, the annular zone of the tubular fabric covered body is divided into a main body area and a limiting area, or divided into a main body area, a limiting area and a fixed area.

[0026] Step 3: Straighten the metal bracket and insert it into the main body area from the opening;

[0027] Step 4: After connecting the ends of the metal stent at the opening, suture the opening with sutures to obtain the minimally invasive covered stent A with a suture-free limited metal stent.

[0028] The tubular fabric covering body is a tubular fabric covering body that has been subjected to heat treatment, so the tubular fabric covering body has a basic domain and an annular zone corresponding to the basic domain and annular zone of the tubular fabric covering body;

[0029] The tubular fabric body is made by textile integrated molding technology. The surface and inner layer basic tissues can be selected from three primary tissues and complex tissues. The pattern patterns of the basic domain and the ring belt domain of the tubular fabric body are obtained by combining the surface and inner layer basic tissues.

[0030] The basic domain of the tubular fabric body 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 shuttle B introduces the second and third layers of weft yarns in sequence. A total of four weft insertions are performed in one cycle. The above cycle can be repeated according to the required length during weaving.

[0031] The annular zone of the tubular fabric body 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. A total of 8 weft insertions are performed in one cycle. The above cycle can be repeated according to the required length during weaving.

[0032] The present invention also provides a method for preparing the minimally invasive stent graft B of the suture-free limited metal stent as described above, comprising the following steps:

[0033] Step 1: preparing a tubular fabric body;

[0034] Step 2: The tubular fabric body is placed on a mandrel and heat treated to obtain a semi-finished tubular fabric covered body. The structure and size of the semi-finished tubular fabric covered body are basically the same as those of the tubular fabric covered body, except that the area corresponding to the limiting area of ​​the tubular fabric covered body is a double-layered non-jointed tissue, which is recorded as the area to be sutured;

[0035] Step 3: Straighten the metal bracket and insert it into the main body area from the opening;

[0036] Step 4: After connecting the ends of the metal stent at the opening, suture the opening with sutures;

[0037] Step 5: Use sutures to sew the area to be sutured of the semi-finished tubular fabric covered body to obtain the minimally invasive covered stent B with a suture-free limited metal stent.

[0038] As the preferred technical solution:

[0039] As described in any of the above methods, the tubular fabric body is composed of medical yarn with a fineness of 12-80D. Considering that in the present invention, the wall thickness increases due to the increase in the number of layers, in order to minimize the wall thickness, single and multifilament yarns of different specifications can be selected for the inner and outer layers; the warp density of the tubular fabric body is 1600-3600 yarns / 10cm, and the weft density is 1600-3600 yarns / 10cm; the outer diameter of the tubular fabric body is 10-35mm, and the wall thickness is 0.09-0.26mm.

[0040] Beneficial effects:

[0041] (1) The present invention is based on textile integrated molding technology. A base domain and annular domain are designed on the tubular fabric covering body. The metal bracket is placed in the annular domain and the fabric at the opening is sewed to achieve fabric-to-fabric suturing, omitting the process of fixing the metal bracket needle by needle, simplifying the suturing process, and greatly improving the production efficiency.

[0042] (2) The metal stent of the present invention is adapted to the limiting area, main area and other structures of the tubular fabric covering body. Part of the limiting area is located within the sharp corner of the metal stent, limiting the circumferential sliding distance of the metal stent to 5%-15% of the outer diameter of the tubular fabric covering body, reducing the relative displacement between the stent and the covering, avoiding the problem of the tight suture line in the prior art being broken by the pulsation of blood vessels and the impact of blood flow, and the enlargement of the needle hole, reducing the risk of blood seeping into the interlayer between the metal stent and the fabric covering, reducing the occurrence of complications such as type IV endoleak, and ensuring the treatment effect and the patient's recovery. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 is a schematic diagram of the tubular fabric body in Example 1;

[0044] Figure 2 Schematic diagram of forming an opening on one side of the folded width of the outer fabric layer in the annular region of the tubular fabric body in Example 1;

[0045] Figure 3 This is a schematic diagram of suturing the opening after inserting the metal stent in Example 1;

[0046] Figure 4 Schematic diagram of a ring region of the minimally invasive covered stent of the suture-free limited metal stent in Example 1 (right view);

[0047] Figure 5 Schematic diagram of the minimally invasive stent graft with suture-free limited metal stent in Example 1;

[0048] Figure 6 This is the pattern card pattern of the tubular fabric body in Example 1;

[0049] Figure 7 is a schematic diagram of the tubular fabric body in Example 2;

[0050] Figure 8 Schematic diagram of forming an opening on one side of the folded width of the outer fabric layer in the annular region of the tubular fabric body in Example 2;

[0051] Figure 9 Schematic diagram of a ring region of the minimally invasive covered stent of the suture-free limited metal stent in Example 2 (right view);

[0052] Figure 10 Schematic diagram of the minimally invasive stent graft with suture-free limited metal stent in Example 2;

[0053] Figure 11 Schematic diagram of the zoned drawing-in process for completing the warp drawing-in process using the zoned drawing-in method when weaving the tubular fabric body in Example 2; the filled areas in the figure represent the areas requiring yarn drawing in the first and second heald frame zones;

[0054] Figure 12This is the pattern pattern of the tubular fabric body in Example 2;

[0055] Figure 13 is a schematic diagram of the tubular fabric body in Example 3;

[0056] Figure 14 Schematic diagram of forming an opening on one side of the folded width of the outer fabric layer in the annular region of the tubular fabric body in Example 3;

[0057] Figure 15 Schematic diagram of a ring region of the minimally invasive covered stent of the suture-free limited metal stent in Example 3 (right view);

[0058] Figure 16 Schematic diagram of the minimally invasive stent graft with suture-free limited metal stent in Example 3;

[0059] Figure 17 Schematic diagram of the zoned drawing-in process for completing the warp drawing-in process using the zoned drawing-in method when weaving the tubular fabric body in Example 3; the filled areas in the figure represent the areas requiring yarn drawing in the first and second heald frame zones;

[0060] Figure 18 This is the pattern pattern of the tubular fabric body in Example 3;

[0061] Figure 19 is a schematic diagram of the tubular fabric body in Example 4;

[0062] Figure 20 Schematic diagram of forming an opening on one side of the folded width of the outer fabric layer in the annular region of the tubular fabric body in Example 4;

[0063] Figure 21 Schematic diagram of a ring region of the minimally invasive covered stent of the suture-free limited metal stent in Example 4 (right view);

[0064] Figure 22 Schematic diagram of the minimally invasive stent graft with suture-free limited metal stent in Example 4;

[0065] Figure 23 Schematic diagram of the zoned drawing-in process for completing the warp drawing-in process using the zoned drawing-in method when weaving the tubular fabric body in Example 4; the filled areas in the figure represent the areas requiring yarn drawing in the first and second heald frame zones;

[0066] Figure 24 This is the pattern pattern of the tubular fabric body in Example 4;

[0067] Figure 25 The figure shows a schematic diagram of connecting the ends of a metal bracket by riveting metal blocks. The arrow in the figure indicates the direction in which one end of the metal bracket is inserted into the metal block.

[0068] Among them, 1-basic domain pattern plate, 2-main area pattern plate, 3-limiting area pattern plate, 4-fixed area pattern plate, 11-basic domain, 12-ring domain, 13-metal bracket, 14-metal block, 61-pattern plate I, 62-pattern plate II, 63-pattern plate Figure III , 64-pattern plate Figure IV , 65-patterned plate Figure V , 66-pattern plate Figure VI , 67-pattern plate Figure VII , 111-first heald frame partition, 112-second heald frame partition, 121-main body area, 122-fixed area, 123-limiting area. DETAILED DESCRIPTION

[0069] 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.

[0070] Example 1

[0071] A minimally invasive covered stent with a suture-free limited metal stent, such as Figure 4 and Figure 5 As shown, it consists of a tubular fabric covered body, a metal stent 13 and sutures;

[0072] The tubular fabric covering body is divided into 7 areas along the axial direction, and the two adjacent areas are respectively marked as the basic area 11 and the annular area 12; the annular area 12 is divided into a main body area 121, a limiting area 123 and a fixing area 122; the annular area 12 is composed of an inner fabric and an outer fabric, and the outer fabric fold is provided with an opening on one side; the main body area 121 is a double-layer non-jointed structure, and the opening is located in the main body area 121; the basic area 11 and the fixing area 122 are both double-layer jointed structures, and the fixing area 122 is located at the upper end of the opening along the axial direction of the tubular fabric covering body; the inner fabric and the outer fabric are connected together at the limiting area 123, and the limiting area 123 is located on the side of the opening along the circumference of the tubular fabric covering body; the length of the basic area along the axial direction of the tubular fabric covering body is 10 mm, and the length of the annular area along the axial direction of the tubular fabric covering body is 11 mm;

[0073] The metal bracket 13 is located between the inner fabric and the outer fabric of the main area 121. The head and tail of the metal bracket 13 are connected at the opening by riveting a metal block 14, and the opening is sutured by sutures; the metal bracket 13 is a Z-shaped metal bracket, the material is nickel-titanium alloy, the diameter is 0.4mm, the height is 11mm, the degree of the tip angle of the metal bracket 13 is 35°, and the number of tip angles of the metal bracket 13 is 14; each limiting area 123 is located in the sharp corner of the metal bracket 13, and the distance between each limiting area 123 and the tip of the sharp corner of the metal bracket 13 where it is located along the axial direction of the tubular fabric coating body is 7mm, and the maximum distance between the tip of the sharp corner of the metal bracket 13 and the edge of the annular zone 12 where it is located along the axial direction of the tubular fabric coating body is 11mm.

[0074] The method for preparing the above-mentioned minimally invasive covered stent with suture-free limited metal stent comprises the following specific steps:

[0075] (1) Preparation of materials;

[0076] PET (polyethylene terephthalate) multifilament: fineness is 40D;

[0077] PET monofilament: fineness is 20D;

[0078] Metal brackets;

[0079] (2) preparing a tubular fabric body;

[0080] The warp density and weft density of the tubular fabric body are both 2400 threads / 10cm; the outer diameter of the tubular fabric body is 15mm, and the wall thickness is 0.22mm;

[0081] (3) The tubular fabric body is placed on a core rod and heat treated to obtain a semi-finished tubular fabric covering body. The structure and size of the semi-finished tubular fabric covering body are basically the same as those of the tubular fabric covering body, with the only difference being that the area corresponding to the limiting area of ​​the tubular fabric covering body is a double-layer non-jointed tissue, which is recorded as the area to be sutured; wherein the heat treatment temperature is 160° C., and the heat treatment time is 15 minutes;

[0082] (4) After straightening the metal stent, insert it into the main body area from the opening;

[0083] (5) Figure 3 and Figure 25 As shown, after the metal stent 13 is connected at the opening, the opening is sutured with sutures;

[0084] (6) Suturing the area to be sutured of the semi-finished tubular fabric covered body with suture thread, thereby obtaining a minimally invasive covered stent with a suture-free limited metal stent.

[0085] The semi-finished tubular fabric covered body is a tubular fabric body that has been heat-treated. Therefore, the tubular fabric body has a base domain, a main body region, and a fixed region corresponding to the base domain, the main body region, and the fixed region of the semi-finished tubular fabric covered body. The steps for preparing the tubular fabric body are as follows:

[0086] (2.1) Using twill as the surface base weave and plain weave as the inner base weave, the base domain, main area and fixed area weave are obtained after combination, and the pattern plate pattern is designed; Figure 6 As shown, the pattern plate diagram is composed of pattern plate diagram I 61, pattern plate diagram II 62, and pattern plate diagram III 63; pattern plate diagram I 61 is composed of a basic domain pattern plate Figure 1 Composition; Pattern plate II 62 consists of a main area pattern plate Figure 2 Composition; Pattern plate Figure Ⅲ63 consists of a main area pattern plate Figure 2 and one Fixed area pattern plate Figure 4 Composition, main area pattern plate Figure 2 Pattern plate in fixed area Figure 4 on the left side;

[0087] (2.2) Design the dimensions and specifications to determine the required weaving length and width for the base area, main area, and fixed area;

[0088] (2.3) PET multifilament yarns and PET monofilament yarns are used to complete the warp threading and reed threading process using a zone threading method; wherein the warp and weft yarns in the inner layer of the base domain and the inner layer of the hoop domain are both PET multifilament yarns, and the warp and weft yarns in the outer layer of the base domain and the outer layer of the hoop domain are both PET monofilament yarns;

[0089] (2.4) forming a tubular fabric body on a loom (e.g. Figure 1 As shown), during the weaving process, an opening is formed on one side of the folded width of the outer fabric of the tubular fabric body ring belt domain by changing the order of the pattern plates on the pattern plate diagram (as shown). Figure 2 shown).

[0090] The minimally invasive stent graft with a suture-free metal stent in this embodiment only requires manual suturing of the opening to achieve the desired effect, completely eliminating the need for manual suturing of the metal stent. Furthermore, because the "annular band" structure is manufactured using a textile-integrated molding process, it is integrated with the tubular fabric body after removal from the machine, preventing slippage and ensuring that the metal stent is not easily displaced axially along the tubular fabric. After the metal stent is implanted, the inner and outer layers of the annular band are manually sutured to form a limiting zone, thereby achieving circumferential positioning of the metal stent.

[0091] Example 2

[0092] A minimally invasive covered stent with a suture-free limited metal stent, such as Figure 9 and Figure 10As shown, it consists of a tubular fabric covered body, a metal stent 13 and sutures;

[0093] The tubular fabric covering body is divided into 7 areas along the axial direction, and the two adjacent areas are respectively marked as the basic area 11 and the annular area 12; the annular area 12 is divided into a main body area 121, a limiting area 123 and a fixing area 122; the annular area 12 is composed of an inner fabric and an outer fabric; the main body area 121 is a double-layer non-jointed structure, and the opening is located in the main body area 121; the basic area 11, the fixing area 122 and the limiting area 123 are all double-layer jointed structures, and the fixing area 122 is located at the upper and lower ends of the opening along the axial direction of the tubular fabric covering body; the inner fabric and the outer fabric are connected together at the limiting area 123, and the limiting area 123 is located on the side of the opening along the circumferential direction of the tubular fabric covering body; the length of the basic area 11 along the axial direction of the tubular fabric covering body is 10 mm, and the length of the annular area 12 along the axial direction of the tubular fabric covering body is 20 mm;

[0094] The metal bracket 13 is located between the inner fabric and the outer fabric of the main area 121. The head and tail of the metal bracket 13 are connected at the opening by riveting a metal block 14, and the opening is sutured by sutures; the metal bracket 13 is an M-shaped metal bracket, the material is nickel-titanium alloy, the diameter is 0.3mm, the height of the metal bracket 13 is 16mm, the degree of the tip angle of the metal bracket 13 is 35°, and the number of tip angles of the metal bracket 13 is 16; each limiting area 123 is located in the sharp corner of the metal bracket 13, and the distance between each limiting area 123 and the tip of the sharp corner of the metal bracket 13 where it is located along the axial direction of the tubular fabric coating body is 14mm, and the maximum distance between the tip of the sharp corner of the metal bracket 13 and the edge of the annular zone 12 where it is located along the axial direction of the tubular fabric coating body is 18mm.

[0095] The preparation method of the above-mentioned minimally invasive covered stent with suture-free limited metal stent comprises the following steps:

[0096] (1) Preparation of materials;

[0097] PET multifilament: fineness is 40D;

[0098] UHMWPE (ultra-high molecular weight polyethylene) monofilament: fineness is 20D;

[0099] Metal brackets;

[0100] (2) preparing a tubular fabric body;

[0101] The warp density and weft density of the tubular fabric body are both 2400 threads / 10cm; the outer diameter of the tubular fabric body is 15mm, and the wall thickness is 0.22mm;

[0102] (3) putting the tubular fabric body on the core rod and performing heat treatment to obtain the tubular fabric coating body; wherein the heat treatment temperature is 120° C. and the heat treatment time is 15 minutes;

[0103] (4) After straightening the metal stent, insert it into the main body area from the opening;

[0104] (5) Figure 9 As shown, after the ends of the metal stent 13 are connected at the opening, the opening is sutured with sutures to obtain a minimally invasive stent graft with a suture-free limited metal stent.

[0105] The tubular fabric covering body is a tubular fabric body that has been heat-treated. Therefore, the tubular fabric body has a basic domain, a main body area, a limiting area, and a fixing area corresponding to the basic domain, the main body area, the limiting area, and the fixing area of ​​the tubular fabric covering body. The steps for preparing the tubular fabric body are as follows:

[0106] (2.1) Using twill as the surface base weave and plain weave as the inner base weave, the base domain, main area, fixed area and limiting area are obtained after combination, and the pattern plate pattern is designed; Figure 12 As shown, the pattern plate diagram is composed of pattern plate diagram I 61, pattern plate diagram III 63, and pattern plate diagram IV 64; pattern plate diagram I 61 is composed of a basic domain pattern plate Figure 1 The number of pattern plate diagram Ⅲ63 is two, each pattern plate diagram Ⅲ63 consists of a main area pattern plate Figure 2 and one Fixed area pattern plate Figure 4 Composition, fixed area pattern plate Figure 4 Located in the main area of ​​the pattern plate Figure 2 Right side: Pattern plate IV 64 consists of five main area patterns Figure 2 and Four Limiting area pattern plate Figure 3 Composition, two adjacent main area pattern plates Figure 2 A limited area pattern plate is embedded between Figure 3 ;

[0107] (2.2) Design the size specifications and determine the required weaving length and width of the base area, main area, fixed area, and limit area;

[0108] (2.3) Using PET multifilament and UHMWPE monofilament, the warp yarn drawing-in and reeding process are completed by the partition drawing-in method. 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 base 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 base domain and the outer layer of the annular belt domain are both UHMWPE monofilaments;

[0109] (2.4) forming a tubular fabric body on a loom (e.g. Figure 7As shown), during the weaving process, an opening is formed on one side of the folded width of the outer fabric of the tubular fabric body ring belt domain by changing the order of the pattern plates on the pattern plate diagram (as shown). Figure 8 shown).

[0110] Taking into account that a small limiting space may easily cause the tip of the metal bracket to repeatedly rub against the fabric and cause damage, this embodiment controls the height of the metal bracket to 80% of the axial length of the annular zone where it is located along the tubular fabric coating body, allowing the metal bracket to have a small displacement sliding space in the axial direction of the tubular fabric coating body.

[0111] Example 3

[0112] A covered stent for minimally invasive interventional treatment with a suture-free limited metal stent, such as Figure 15 and Figure 16 As shown, it consists of a tubular fabric covered body, a metal stent 13 and sutures;

[0113] The tubular fabric covering body is divided into 7 areas along the axial direction, and the two adjacent areas are respectively marked as the basic area 11 and the annular area 12; the annular area 12 is divided into a main area 121 and a limiting area 123; the annular area 12 is composed of an inner fabric and an outer fabric; the main area 121 is a double-layer non-jointed structure, and the opening is located in the main area 121; the basic area 11 and the limiting area 123 are both double-layer jointed structures; the number of limiting areas 123 in each annular area 12 is 2, and the inner fabric and the outer fabric are connected together at the limiting area 123. The two limiting areas 123 are respectively located at the lower left and upper right of the opening along the circumference of the tubular fabric covering body; the axial length of the basic area 11 along the tubular fabric covering body is 15 mm, and the axial length of the annular area 12 along the tubular fabric covering body is 11 mm;

[0114] The metal bracket 13 is located between the inner fabric and the outer fabric of the main area 121. The head and tail of the metal bracket 13 are connected at the opening by riveting with a metal block 14, and the opening is sutured by sutures; the metal bracket 13 is a Z-shaped metal bracket, the material is nickel-titanium alloy, the diameter is 0.3mm, the height of the metal bracket 13 is 11mm, the degree of the tip angle of the metal bracket 13 is 35°, and the number of tip angles of the metal bracket 13 is 14; each limiting area 123 is located in the sharp corner of the metal bracket 13, and the distance between each limiting area 123 and the tip of the sharp corner of the metal bracket 13 where it is located along the axial direction of the tubular fabric coating body is 9mm, and the maximum distance between the tip of the sharp corner of the metal bracket 13 and the edge of the annular zone 12 where it is located along the axial direction of the tubular fabric coating body is 11mm.

[0115] The preparation method of the above-mentioned covered stent for minimally invasive interventional treatment with a suture-free limited metal stent comprises the following steps:

[0116] (1) Preparation of materials;

[0117] PET multifilament: fineness is 40D;

[0118] UHMWPE monofilament: fineness is 20D;

[0119] Metal brackets;

[0120] (2) preparing a tubular fabric body;

[0121] The warp density of the tubular fabric body is 2400 threads / 10cm, and the weft density is 2000 threads / 10cm; the outer diameter of the tubular fabric body is 20mm, and the wall thickness is 0.20mm;

[0122] (3) putting the tubular fabric body on the core rod and performing heat treatment to obtain the tubular fabric coating body; wherein the heat treatment temperature is 120° C. and the heat treatment time is 15 minutes;

[0123] (4) After straightening the metal stent, insert it into the main body area from the opening;

[0124] (5) Figure 15 As shown, after the ends of the metal stent 13 are connected at the opening, the opening is sutured with sutures to obtain a minimally invasive stent graft with a suture-free limited metal stent.

[0125] The tubular fabric covered body is a tubular fabric body that has been heat-treated. Therefore, the tubular fabric body has a basic domain, a main body area, and a limiting area corresponding to the basic domain, the main body area, and the limiting area of ​​the tubular fabric covered body. The steps for preparing the tubular fabric body are as follows:

[0126] (2.1) Using twill as the surface base structure and plain weave as the inner base structure, the basic domain, main area and limiting area are obtained after combination, and the pattern plate pattern is designed; Figure 18 As shown, the pattern plate is composed of pattern plate I 61, pattern plate II 62, and pattern plate V 65; pattern plate I 61 is composed of a basic domain pattern plate Figure 1 The number of pattern plate diagram Ⅴ65 is two, each pattern plate diagram Ⅴ65 consists of a main area pattern plate Figure 2 and one Limiting area pattern plate Figure 3 Composition, limit area pattern plate Figure 3 Located in the main area of ​​the pattern plate Figure 2 Right side; pattern plate II 62 consists of a main area pattern plate Figure 2 composition;

[0127] (2.2) Design the dimensions and specifications to determine the required weaving length and width for the base area, main area, and limiting area;

[0128] (2.3) Using PET multifilament and UHMWPE monofilament, the warp yarn drawing-in and reeding process are completed by the partition drawing-in method. Figure 17 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;

[0129] (2.4) forming a tubular fabric body on a loom (e.g. Figure 13 As shown), during the weaving process, an opening is formed on one side of the folded width of the outer fabric of the tubular fabric body ring belt domain by changing the order of the pattern plates on the pattern plate diagram (as shown). Figure 14 shown).

[0130] Example 4

[0131] A covered stent for minimally invasive interventional treatment with a suture-free limited metal stent, such as Figure 21 and Figure 22 As shown, it consists of a tubular fabric covered body, a metal stent 13 and sutures;

[0132] The tubular fabric covering body is divided into 7 areas along the axial direction, and the two adjacent areas are respectively marked as the basic area 11 and the annular area 12; the annular area 12 is divided into a main area 121 and a limiting area 123; the annular area 12 is composed of an inner fabric and an outer fabric, and an opening is formed on one side of the fold of the outer fabric by changing the order of the pattern plates on the pattern plate diagram during the weaving process; the main area 121 is a double-layer non-junction structure, and the opening is located in the main area 121; the basic area 11 and the limiting area 123 are both double-layer junction structures; the inner fabric and the outer fabric are connected together at the limiting area 123, and the limiting area 123 is located on the side of the opening along the circumference of the tubular fabric covering body; the axial length of the basic area 11 along the tubular fabric covering body is 15 mm; the axial length of the annular area 12 along the tubular fabric covering body is 11 mm;

[0133] The metal bracket 13 is located between the inner fabric and the outer fabric of the main area 121. The head and tail of the metal bracket 13 are connected at the opening by riveting a metal block 14, and the opening is sutured by sutures; the metal bracket 13 is a Z-shaped metal bracket, the material is nickel-titanium alloy, the diameter is 0.4mm, the height of the metal bracket 13 is 11mm, the degree of the tip angle of the metal bracket 13 is 35°, and the number of tip angles of the metal bracket 13 is 12; each limiting area 123 is located in the sharp corner of the metal bracket 13, and the distance between each limiting area and the tip of the sharp corner of the metal bracket 13 where it is located along the axial direction of the tubular fabric coating body is 9mm, and the maximum distance between the tip of the sharp corner of the metal bracket 13 and the edge of the annular zone 12 where it is located along the axial direction of the tubular fabric coating body is 11mm.

[0134] The preparation method of the above-mentioned covered stent for minimally invasive interventional treatment with a suture-free limited metal stent comprises the following steps:

[0135] (1) Preparation of materials;

[0136] PET multifilament, fineness is 40D;

[0137] PET monofilament: fineness is 20D;

[0138] Metal brackets;

[0139] (2) preparing a tubular fabric body;

[0140] The warp density of the tubular fabric body is 2400 threads / 10cm, and the weft density is 2000 threads / 10cm; the outer diameter of the tubular fabric body is 20mm, and the wall thickness is 0.20mm;

[0141] (3) putting the tubular fabric body on the core rod and performing heat treatment to obtain the tubular fabric coating body; wherein the heat treatment temperature is 160° C. and the heat treatment time is 15 minutes;

[0142] (4) After straightening the metal stent, insert it into the main body area from the opening;

[0143] (5) Figure 21 As shown, after the ends of the metal stent 13 are connected at the opening, the opening is sutured with sutures to obtain a minimally invasive stent graft with a suture-free limited metal stent.

[0144] The tubular fabric covered body is a tubular fabric body that has been heat-treated. Therefore, the tubular fabric body has a basic domain, a main body area, and a limiting area corresponding to the basic domain, the main body area, and the limiting area of ​​the tubular fabric covered body. The steps for preparing the tubular fabric body are as follows:

[0145] (2.1) Using twill as the surface base structure and plain weave as the inner base structure, the basic domain, main area and limiting area are obtained after combination, and the pattern plate pattern is designed; Figure 24 As shown, the pattern plate is composed of pattern plate I 61, pattern plate II 62, pattern plate VI 66 and pattern plate VII 67; the number of pattern plate I 61 is 2, and each pattern plate I 61 is composed of a basic domain pattern plate Figure 1 Composition; Pattern plate II 62 consists of a main area pattern plate Figure 2 Composition; Pattern plate Figure VI66 consists of four limit area pattern plates Figure 3 and Four Main body area pattern plate Figure 2 Composition, each limit area pattern plate Figure 3 , Main body area pattern plate Figure 2 Alternating from left to right, adjacent pattern plates have different types, and the leftmost pattern plate is the main area pattern plate Figure 2; Pattern plate Figure VII 67 consists of four limit area pattern plates Figure 3 and Four Main body area pattern plate Figure 2 Composition, each limit area pattern plate Figure 3 , Main area pattern plate Figure 2 Alternating from left to right, adjacent pattern plates have different types, and the leftmost pattern plate is the limit area pattern plate Figure 3 ;

[0146] (2.2) Design the dimensions and specifications to determine the required weaving length and width for the base area, main area, and limiting area;

[0147] (2.3) Using PET multifilament and PET monofilament, the warp yarn drawing-in and reeding process are completed by the partition drawing-in method. The partition drawing-in is as follows: Figure 23 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 PET monofilaments;

[0148] (2.4) forming a tubular fabric body on a loom (e.g. Figure 19 As shown), during the weaving process, an opening is formed on one side of the folded width of the outer fabric of the tubular fabric body ring belt domain by changing the order of the pattern plates on the pattern plate diagram (as shown). Figure 20 shown).

Claims

1. A minimally invasive stent graft with a suture-free limited metal stent, characterized in that: It includes a tubular fabric-covered body, a metal stent, and sutures; The tubular fabric covering 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; The annular belt area is divided into a main area and a limiting area, or is divided into a main area, a limiting area and a fixed area; the annular belt area is composed of an inner fabric and an outer fabric, and an opening is provided on one side of the fold of the outer fabric; The main body area is a double-layered, knotless tissue with the opening located in the main body area; The inner fabric layer and the outer fabric layer are connected together at the limiting area, and the limiting area is located on the side of the opening along the circumference of the tubular fabric covering body; The fixing area is a double-layer binding structure, and the fixing area is located at the upper end and / or lower end of the opening along the axial direction of the tubular fabric covering body; The metal stent is located between the inner fabric and the outer fabric of the main body area, and the head and tail of the metal stent are connected at the opening, and the opening is sutured by sutures; The metal bracket is a Z-shaped or M-shaped metal bracket, and at least a portion of each limiting area is located within the sharp corner of the metal bracket.

2. The minimally invasive stent graft with a suture-free limited metal stent according to claim 1, characterized in that: The distance between each limiting area and the tip of the sharp corner of the metal bracket where it is located along the axial direction of the tubular fabric covering body is d1, and the maximum distance between the tip of the sharp corner of the metal bracket and the edge of the annular zone where it is located along the axial direction of the tubular fabric covering body is d2. d1 is 60%-90% of d2.

3. The minimally invasive stent graft with a suture-free limited metal stent according to claim 1, characterized in that: The height of the metal stent is 70%-100% of the axial length of the annular zone where it is located along the tubular fabric covering body; the diameter of the metal stent is 0.2-0.6mm, the degree of the tip angle is 30°-60°, and the number of the tip angles is 10-20.

4. The minimally invasive stent graft with a suture-free limited metal stent according to claim 1, characterized in that: The length of the basic domain along the axial direction of the tubular fabric covering body is 10-25 mm; the length of the annular zone along the axial direction of the tubular fabric covering body is 10-30 mm.

5. The minimally invasive stent graft with a suture-free limited metal stent according to claim 1, characterized in that: The head and tail of the metal bracket are connected at the opening by riveting metal blocks.

6. The minimally invasive stent graft with a suture-free limited metal stent according to any one of claims 1 to 5, characterized in that: The limiting area is a double-layer connection structure.

7. The minimally invasive stent graft with a suture-free limited metal stent according to any one of claims 1 to 5, characterized in that: The restraining area is double-layered stitched fabric.

8. A method for preparing a minimally invasive stent graft with a suture-free limited metal stent according to claim 6, characterized in that: The following steps are involved: Step one: preparing a 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: Straighten the metal bracket and insert it into the main body area from the opening; Step 4: After connecting the ends of the metal stent at the opening, suture the opening with sutures to obtain a minimally invasive covered stent with a suture-free limited metal stent.

9. A method for preparing a minimally invasive stent graft with a suture-free limited metal stent according to claim 7, characterized in that: The following steps are involved: Step one: preparing a tubular fabric body; Step 2: The tubular fabric body is placed on a mandrel and heat treated to obtain a semi-finished tubular fabric covered body. The structure and size of the semi-finished tubular fabric covered body are basically the same as those of the tubular fabric covered body, except that the area corresponding to the limiting area of ​​the tubular fabric covered body is a double-layered non-jointed tissue, which is recorded as the area to be sutured; Step 3: Straighten the metal bracket and insert it into the main body area from the opening; Step 4: After connecting the ends of the metal stent at the opening, suture the opening with sutures; Step 5: Use sutures to sew the area to be sutured of the semi-finished tubular fabric covered body to obtain a minimally invasive covered stent with a suture-free limited metal stent.

10. The method according to claim 8 or 9, characterized in that The tubular fabric body is composed of medical yarn with a fineness of 12-80D; the warp density of the tubular fabric body is 1600-3600 yarns / 10cm, and the weft density is 1600-3600 yarns / 10cm; the outer diameter of the tubular fabric body is 10-35mm, and the tube wall thickness is 0.09-0.26mm.

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