Integrated artificial blood vessel with sinus

Abstract

The invention discloses an integrated artificial blood vessel with a sinus, which belongs to the technical field of medical instruments and comprises a tube part, a sinus tube junction and a sinus part which are integrally woven and formed, the tube part and the sinus part have the same longitudinal axis, and the sinus part has a compact structure consisting of upper and lower fabric weaves which are connected with each other. The upper-layer weave points and the lower-layer weave points are interwoven, the binding points are located at the overlapping positions of the upper-layer weave points and the lower-layer weave points, the fabric coverage rate of the compact structure is 80%-95%, the upper-layer fabric weave and the lower-layer fabric weave are both formed by circularly weaving a plurality of fabric weaves with the yarn density not lower than 80 pieces per centimeter, and the upper-layer fabric weave and the lower-layer fabric weave comprise twill weaves. The integrated artificial blood vessel with the sinus is good in sinus shape, compact in structure and good in stability, the sinus is provided with a compact tissue structure, the elastic performance of the sinus is guaranteed, meanwhile, high structural support is achieved, long-term radial excessive expansion can be prevented, the service life of the artificial blood vessel and the service life of the autologous valve are prolonged, and the artificial blood vessel with the sinus is suitable for large-scale popularization and application. And the possibility of postoperative secondary intervention is reduced.

Description

Technical Field

[0001] The invention relates to an integrated artificial blood vessel with a sinus, belonging to the technical field of medical devices. Background Art

[0002] The aortic root includes the aortic valve, aortic valve ring, aortic sinus and sinus-tubular junction. The aortic sinus is composed of three bag-like bulges, the upper end of the sinus is the sinus-tubular junction, and the lower end is the aortic valve ring. The radial size of the sinus is significantly larger than the upper and lower ends, and its ampulla shape allows the aortic valve to open freely at 90 degrees.

[0003] The sinotubular junction and the aortic sinus are very important for the normal function of the aortic valve. The sinotubular junction causes blood to vortex in the aortic sinus. During systole, the aortic valve opens, and the vortex generated prevents the aortic valve from colliding with the aortic wall and causing damage to the aortic valve. At the end of systole, the vortex in the sinus closes the aortic valve. In addition, during diastole, the aortic sinus wall expands outward, sharing the pressure of blood on the aortic valve.

[0004] For lesions involving the aortic root, such as aortic dissection, hereditary diseases, aortic inflammatory lesions, degenerative changes, trauma, etc., aortic root replacement is required. Common surgical methods include Bentall surgery with valved conduits, but this surgery replaces the patient with a mechanical valve, which has a certain impact on the patient's quality of life and anticoagulation. If the patient's aortic valve is normal, the patient's native valve can be retained through Tirone David I type aortic valve preservation surgery, that is, the aortic root is replaced with an artificial blood vessel and the native aortic valve is placed in it. However, there are two problems with the use of artificial blood vessels without sinuses: first, the opening and closing of the native valve cannot be in the best state, that is, when the valve is opened, it will collide with the wall of the artificial blood vessel, causing damage to both; second, the blood pressure generated during diastole is only borne by the native valve, which will reduce the service life of the valve.

[0005] Therefore, developing artificial blood vessel products with sinus parts has become a key research direction for technicians in this field. At present, the design of the sinus part is mostly based on the morphology, and no attention is paid to the difference between the elasticity and support of the sinus part and the aortic blood vessels. The aortic sinus has the function of buffering blood flow pressure, so the reconstructed sinus part should have good elasticity and lasting support. However, in the current research and development process, the tissue structure of the sinus part has not been taken into consideration, and it is impossible to provide guarantees for the long-term use of the sinus part. There have been clinical reports of long-term excessive expansion of the sinus part of artificial blood vessels. Summary of the invention

[0006] The purpose of the present invention is to overcome the deficiencies in the prior art and provide an integrated artificial blood vessel with a sinus having a good sinus morphology, a dense structure, and good stability, for replacing the diseased aortic root. The integrated artificial blood vessel with a sinus is composed of a continuously woven tube, a sinus, and a sinus-tube junction, wherein the sinus has a dense tissue structure, so that it has strong structural support while ensuring elastic properties, can prevent long-term radial over-expansion, increase the service life of the artificial blood vessel and the native valve, and reduce the possibility of secondary intervention after surgery.

[0007] To achieve the above object, the present invention is implemented by adopting the following technical solutions:

[0008] In the first aspect, the present invention provides an integrated artificial blood vessel with a sinus, comprising an integrally woven tube portion, a sinus-tube junction and a sinus portion, wherein the tube portion and the sinus portion have the same longitudinal axis, the sinus portion has a dense structure composed of upper and lower layers of fabric tissues connected to each other, and the connection point is located at the overlapping point of the upper and lower tissue points, the fabric coverage rate of the dense structure is 80%-95%, the upper and lower fabric tissues are both woven circularly by multiple fabric tissues with a yarn density of not less than 80 yarns / cm, and the upper and lower fabric tissues contain twill tissues.

[0009] Furthermore, the warp and weft yarn arrangement ratios of the upper and lower fabric tissues are selected from one or two of 1:1, 2:1, and 3:1.

[0010] Furthermore, the junction points of the upper and lower fabric tissues are formed by weaving the upper and lower warp and weft yarns, wherein the weaving structure includes the lower warp yarns floating up and weaving the upper weft yarns, and the upper warp yarns sinking down and weaving the lower weft yarns.

[0011] Furthermore, the upper and lower fabric structures also include plain weave or basket weave.

[0012] Furthermore, the fabric structure includes three yarn cycles, four yarn cycles and six yarn cycles, wherein: the structure of three yarn cycles includes a right twill structure with two ups and one down in the upper layer and a right twill structure with one up and two down in the lower layer; the structure of four yarn cycles includes a 2 / 2 square plain structure on the upper layer and a left twill structure with two ups and two down in the lower layer; the structure of six yarn cycles includes a right twill structure with three ups and three down in both the upper and lower layers.

[0013] Furthermore, the sinus portion has longitudinally extending folds or corrugations, so as to form a radially extensible structure.

[0014] Furthermore, below the sinus portion there is a valve ring made of the same material as that used for the sinus portion, and the valve ring has no texture structure.

[0015] Furthermore, the tube has annular folds or corrugations, so that it can move or extend in the axial direction.

[0016] Furthermore, the tube part is divided into a tube body above the sinus part and a tube body below the sinus part, wherein the tube body below the sinus part is selected and applicable according to actual conditions.

[0017] Furthermore, the fabric material includes polyester, polytetrafluoroethylene and silk.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] 1. The present invention provides an integrated artificial blood vessel with a sinus having a good sinus morphology, a dense structure, and good stability, which is used to replace the diseased aortic root. The integrated artificial blood vessel with a sinus consists of a continuously woven tube, a sinus, and a junction of the sinus and tube. The sinus obtained by the integrated molding and weaving has a good morphology, which is conducive to simulating the hemodynamics of the aortic root after being implanted in the body. The sinus has a dense tissue structure, which ensures elastic performance while having strong structural support, and can prevent long-term radial excessive expansion.

[0020] 2. The twill tissue in the present invention has good elasticity, which can give the sinus part better elastic properties, so that it can simulate the state of the autologous sinus part during use; the double-layer tissue firmly combines the upper and lower layers through a specific connection method, providing excellent structural support for the sinus part, which can reduce the risk of radial excessive expansion of the sinus part due to poor support in the long term, increase the service life of artificial blood vessels and autologous valves, and reduce the possibility of secondary intervention after surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings constituting a part of the present invention are used to provide a further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings:

[0022] Figure 1 A schematic diagram of the structure of an integrated artificial blood vessel with sinus provided in the first embodiment of the present invention;

[0023] Figure 2 A schematic diagram of a latitudinal cross-section of the sinus portion of an integrated artificial blood vessel with sinus provided in the first embodiment of the present invention;

[0024] Figure 3 A schematic diagram of a meridian cross-section of the sinus portion of an integrated artificial blood vessel with sinus provided in Example 1 of the present invention;

[0025] Figure 4 A schematic diagram of a latitudinal cross-section of the sinus portion of an integrated artificial blood vessel with sinus provided in the second embodiment of the present invention;

[0026] Figure 5 A schematic diagram of a meridian cross section of the sinus portion of an integrated artificial blood vessel with sinus provided in the second embodiment of the present invention;

[0027] Figure 6 A schematic diagram of a latitudinal cross-section of the sinus portion of an integrated artificial blood vessel with sinus provided in Example 3 of the present invention;

[0028] Figure 7 A schematic diagram of a meridian cross-section of the sinus portion of an integrated artificial blood vessel with sinus provided in Example 3 of the present invention;

[0029] Among them: 1. Tubular part; 2. Sinus part; 3. Sinus-tubular junction. DETAILED DESCRIPTION

[0030] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present invention can be combined with each other without conflict.

[0031] The following detailed description is an exemplary description, which is intended to provide further detailed description of the present invention. Unless otherwise specified, all technical terms used in the present invention have the same meaning as those generally understood by those skilled in the art to which the present invention belongs. The terms used in the present invention are only for describing specific embodiments, and are not intended to limit the exemplary embodiments according to the present invention.

[0032] Embodiment 1:

[0033] like Figure 1 As shown, the one-piece artificial blood vessel with sinus provided by the present invention comprises, from top to bottom, a tube portion 1, a sinus-tube junction 3 and a sinus portion 2. The tube portion 1 and the sinus portion 2 have the same longitudinal axis. The tube portion 1 has annular folds or corrugations, so that it can move or extend in the axial direction. The tube portion 1 can be divided into a tube body above the sinus portion and a tube body below the sinus portion, wherein the tube body below the sinus portion can be selected according to actual conditions. The sinus portion 2 has longitudinally extending folds or corrugations, so that it forms a radially extensible structure. There is an optional valve ring below the sinus portion 2, and the valve ring is made of the same material as other parts. The materials of the tube portion 1 and the sinus portion 2 are selected from polyester, polytetrafluoroethylene, and silk, but the valve ring has no texture structure.

[0034] The sinus portion 2 has a dense structure consisting of an upper layer and a lower layer connected to each other, and the fabric coverage of the dense structure is 80%-95%, the fabric tissues of the upper and lower layers are selected from one or two of plain weave, twill, and basket weave, and at least one of the fabric tissues used in the upper and lower layers is twill weave. The yarn density of the upper and lower layers should not be less than 80 yarns / cm, and the warp and weft yarn arrangement ratio is selected from one or two of 1:1, 2:1, and 3:1.

[0035] The diameter of the sinus 2 is changed by changing the number of yarns, including the following steps:

[0036] (1) Fix the braiding yarn on the braiding machine and braid the tube part 1 first to the sinus-tube junction 3;

[0037] (2) by gradually increasing the yarn operation, the diameter of the fabric is gradually increased along the axial direction to the widest diameter of the sinus portion 2;

[0038] (3) Then, the yarn is reduced so that the diameter of the fabric is gradually reduced along the axial direction to be the same as the diameter of the tube 1, thereby obtaining an integrated artificial blood vessel with sinus.

[0039] See also Figure 2-3 In each fabric weave cycle, the upper warp yarns are numbered one, two, and three, the upper weft yarns are numbered I, II, and III, the lower warp yarns are numbered A, B, and C, and the lower weft yarns are numbered a, b, and c. The upper weft of the sinus 2 is a right twill weave with two up and one down, and the lower weft is a right twill weave with one up and two down. The yarn density of the upper and lower layers is 80 yarns / cm, and the warp and weft arrangement ratio of the upper and lower layers is 1:1. The connection point connecting the upper and lower layers is formed by the floating of the lower warp yarn and the weaving of the upper weft yarn. This structural design can obtain a sinus 2 with a dense structure. The sinus 2 obtained by one-piece molding and weaving has a good shape, which is conducive to simulating the hemodynamics of the aortic root after being placed in the body. It has strong structural support while ensuring elastic properties, which can prevent long-term radial over-expansion, improve the service life of artificial blood vessels and native valves, and reduce the possibility of secondary intervention after surgery.

[0040] In this embodiment, the inner diameter of the tube portion 1 of the artificial blood vessel and the junction 3 of the sinus tube is 30 mm, the height of the sinus portion 2 is 30 mm, the maximum inner diameter is 36 mm, and the change in the overall diameter of the sinus portion is achieved by first increasing the yarn to gradually increase the fabric diameter along the axial direction to the maximum, and then gradually reducing the yarn to gradually reduce the fabric diameter along the axial direction.

[0041] Embodiment 2:

[0042] See also Figure 4-5In each weaving cycle, the upper warp yarns are numbered as one, two, three, and four, the upper weft yarns are numbered as Ⅰ, Ⅱ, Ⅲ, and Ⅳ, the lower warp yarns are numbered as A, B, C, and D, and the lower weft yarns are numbered as a, b, c, and d. The difference from the first embodiment is that in the present embodiment, the upper weave of the sinus portion 2 is a 2 / 2 square weave, and the lower layer is a left twill weave of two up and two down. The yarn density of the upper and lower layers is 80 yarns / cm, the warp yarn arrangement ratio of the upper and lower layers is 1:1, and the weft yarn arrangement ratio is 2:1. The junction point connecting the upper and lower layers is formed by the floating of the lower warp yarns and the weaving of the upper weft yarns. This structural design can also obtain a sinus portion 2 with a dense structure, and because the upper weave of the sinus portion 2 is a square weave and the lower layer is a left twill weave. Compared with the structure of the first embodiment, the lower twill weave of the present embodiment can provide a better effect of preventing excessive expansion of the sinus while ensuring a certain elastic performance, and the square weave of the upper layer can provide a better effect of preventing excessive expansion of the sinus.

[0043] Embodiment three:

[0044] See also Figure 6-7 In each weave cycle, the upper warp yarns are numbered 1, 2, 3, 4, 5, 6, the upper weft yarns are numbered Ⅰ, Ⅱ, Ⅲ, Ⅳ, Ⅴ, Ⅵ, the lower warp yarns are numbered A, B, C, D, E, F, and the lower weft yarns are numbered a, b, c, d, e, f. The difference from the first embodiment is that the upper and lower tissues of the sinus part 2 in this embodiment are both right twill tissues with three ups and three downs, the yarn density of the upper and lower layers is 80 yarns / cm, the warp and weft arrangement ratio of the upper and lower layers is 1:1, and the junction point connecting the upper and lower layers is formed by the sinking of the upper warp yarns and the weft yarns of the lower layer. Compared with the structure of the first embodiment, the twill tissue in this embodiment has a larger dimension, so it can provide a relatively large expansion dimension.

[0045] The one-piece artificial blood vessel with sinus provided by the present invention has the following characteristics: the sinus portion obtained by one-piece molding and weaving has a good shape, which is conducive to simulating the hemodynamics of the aortic root after being implanted in the body. In addition, the dense tissue structure of the sinus portion can provide good mechanical elasticity and structural stability during use, prevent the long-term radial over-expansion of the sinus portion wall, and reduce the risk of secondary surgery.

[0046] It is known from common technical knowledge that the present invention can be implemented by other embodiments that do not deviate from its spirit or essential features. Therefore, the above disclosed embodiments are only illustrative in all respects and are not exclusive. All changes within the scope of the present invention or within the scope equivalent to the present invention are included in the present invention.

[0047] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, ordinary technicians in the relevant field should understand that the specific implementation methods of the present invention can still be modified or replaced by equivalents. Any modification or equivalent replacement that does not depart from the spirit and scope of the present invention should be covered within the scope of protection of the claims of the present invention.

Claims

1. An integrated artificial blood vessel with sinus, characterized in that: It includes an integrally woven tube portion, a sinus-tube junction and a sinus portion, and the tube portion and the sinus portion have the same longitudinal axis. The sinus portion has a dense structure composed of upper and lower fabric tissues that are connected to each other, and the connection point is located at the overlapping point of the upper and lower tissue points. The fabric coverage rate of the dense structure is 80%-95%. The upper and lower fabric tissues are both woven circularly by multiple fabric tissues with a yarn density of not less than 80 yarns / cm, and the upper and lower fabric tissues contain twill tissues.

2. The one-piece artificial blood vessel with sinus according to claim 1 is characterized in that: The warp and weft yarn arrangement ratios of the upper and lower fabric structures are selected from one or two of 1:1, 2:1, and 3:

1.

3. The integrated artificial blood vessel with sinus according to claim 1 is characterized in that: The junction points of the upper and lower fabric tissues are formed by weaving the upper and lower warp and weft yarns, wherein the weaving structure includes the lower warp yarns floating up and weaving the upper weft yarns, and the upper warp yarns sinking down and weaving the lower weft yarns.

4. The integrated artificial blood vessel with sinus according to claim 1 is characterized in that: The upper and lower fabric structures also include plain weave or basket weave.

5. The integrated artificial blood vessel with sinus according to claim 1 is characterized in that: The fabric structure includes three yarn cycles, four yarn cycles and six yarn cycles, wherein: the structure of three yarn cycles includes a right twill structure of two up and one down in the upper layer and a right twill structure of one up and two down in the lower layer; the structure of four yarn cycles includes a 2 / 2 square plain structure in the upper layer and a left twill structure of two up and two down in the lower layer; the structure of six yarn cycles includes a right twill structure of three up and three down in both the upper and lower layers.

6. The integrated artificial blood vessel with sinus according to claim 1 is characterized in that: The sinus portion has longitudinally extending corrugations or ripples, forming a radially extensible structure.

7. The integrated artificial blood vessel with sinus according to claim 1 is characterized in that: A valve ring made of the same material as that used for the sinus is provided below the sinus, and the valve ring has no texture structure.

8. The integrated sinus artificial blood vessel according to claim 1 is characterized in that: The tube has annular corrugations or ripples to enable it to move or extend in the axial direction.

9. The integrated sinus artificial blood vessel according to claim 1, characterized in that: The tube part is divided into a tube body above the sinus part and a tube body below the sinus part, wherein the tube body below the sinus part is selected and applicable according to actual conditions.

10. The integrated artificial blood vessel with sinus according to claim 1, characterized in that: The fabric materials include polyester, polytetrafluoroethylene and silk.

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