An integrated fenestrated vascular graft

Abstract

The application discloses a medical instrument technical field, and relates to an integrated type artificial blood vessel with a sinus, which comprises a tube part, a sinus-tube joint and a sinus part which are integrally woven and shaped, and the tube part and the sinus part have a same longitudinal axis, the sinus part has a dense structure which is composed of upper and lower layer fabric tissues which are connected with each other, and the connecting points are located at the overlapping positions of the upper and lower layer tissue points, the fabric coverage of the dense structure is 80%-95%, the upper and lower layer fabric tissues are both woven by a plurality of fabric tissues with a yarn density of not less than 80 root / cm, and the upper and lower layer fabric tissues both contain twill tissues. The application provides an integrated type artificial blood vessel with a sinus, which has a good sinus part form, a dense structure and good stability, the sinus part has a dense tissue structure, so that the elastic performance is ensured, the structure support is strong, the long-term radial overexpansion can be prevented, the service life of the artificial blood vessel and the autologous valve is prolonged, and the possibility of postoperative secondary intervention is reduced.

Description

TECHNICAL FIELD

[0001] The present application relates to a one-piece artificial blood vessel with sinus, belonging to the technical field of medical devices. BACKGROUND

[0002] The aortic root includes the aortic valve, the aortic annulus, the aortic sinus and the sinus-stenosis junction. The aortic sinus is composed of three pouch-like bulges. The upper end of the sinus is the sinus-stenosis junction, and the lower end is the aortic annulus. The radial dimension of the sinus is significantly larger than the upper and lower ends, and the ampulla shape allows the aortic valve to open freely at 90°.

[0003] The sinus-stenosis junction and the aortic sinus are very important for the normal function of the aortic valve. The sinus-stenosis junction causes a vortex in the aortic sinus, which, during systole, prevents the aortic valve from being damaged by the impact of the aortic valve on the aortic wall when the aortic valve opens. At the end of systole, the vortex in the sinus causes the aortic valve to close. In addition, during diastole, the aortic sinus wall expands outward, sharing the pressure of the blood on the aortic valve.

[0004] For diseases involving the aortic root, such as aortic dissection, genetic diseases, aortic inflammatory diseases, degenerative changes, trauma, etc., replacement of the aortic root is required. The common surgical approach includes Bentall surgery with a valved conduit, but this surgery replaces the patient's mechanical valve, which affects the patient's quality of life and anticoagulation. If the patient's aortic valve is normal, the Tirone David I type aortic valve preservation surgery can be used to preserve the patient's autologous valve, i.e., an artificial blood vessel is used to replace the aortic root, and the autologous aortic valve is placed in it. However, the use of artificial blood vessels without a sinus will cause two problems: first, the opening and closing of the autologous valve cannot be in the best state, i.e., the valve will collide with the artificial blood vessel wall when it opens, causing damage to both; second, the blood pressure generated during diastole is only borne by the autologous valve, which reduces the service life of the valve.

[0005] Therefore, the development of artificial blood vessels with sinus has become the focus of research for those skilled in the art. Most of the current designs of the sinus are based on the shape, and do not focus on the elasticity, support and differences of the main blood vessels. The aortic sinus has the function of buffering blood flow pressure, so the reconstructed sinus should have good elasticity and durable support. However, the tissue structure of the sinus has not been considered in the current research and development process, which cannot provide long-term protection for the sinus. There have been cases of long-term overexpansion of artificial blood vessel sinuses in clinical practice. SUMMARY

[0006] The purpose of the present application is to overcome the deficiencies in the prior art, provide an integrated type of aortic root replacement with a good sinus morphology, a compact structure and good stability. The integrated type of aortic root replacement is composed of a continuously knitted tube, a sinus and a sinus-tube junction, wherein the sinus has a compact structure, which can ensure elastic performance while having strong structural support, prevent long-term radial overexpansion, improve the service life of the artificial blood vessel and the autograft, and reduce the possibility of postoperative secondary intervention.

[0007] To achieve the above-mentioned purpose, the present application is realized by using the following technical scheme:

[0008] In a first aspect, the present application provides an integrated type of aortic root replacement, which comprises an integrally knitted tube, a sinus-tube junction and a sinus, and the tube and the sinus have the same longitudinal axis, the sinus has a compact structure composed of upper and lower fabric organizations connected to each other, and the connection points are located at the overlapping positions of the upper and lower organization points, the fabric coverage rate of the compact structure is 80%-95%, the upper and lower fabric organizations are both knitted from a plurality of fabric organizations with a yarn density of not less than 80 root / cm, and the upper and lower fabric organizations contain twill organizations.

[0009] Further, the warp and weft arrangement of the upper and lower fabric organizations is selected from one or two of 1:1, 2:1 and 3:1.

[0010] Further, the connection points of the upper and lower fabric organizations are knitted from the upper and lower warp and weft, wherein the knitted structure includes the upper weft knitting with the lower warp floating and the lower weft knitting with the upper warp sinking.

[0011] Further, the upper and lower fabric organizations further contain plain or basket weave organizations.

[0012] Further, the fabric organizations include three-yarn cycles, four-yarn cycles and six-yarn cycles, wherein: the structure of the three-yarn cycle includes the right twill organization of two upper and one lower in the upper layer and the right twill organization of one upper and two lower in the lower layer, the structure of the four-yarn cycle includes the 2 / 2 basket weave organization in the upper layer and the left twill organization of two upper and two lower in the lower layer, and the structure of the six-yarn cycle includes the right twill organization of three upper and three lower in the upper and lower layers.

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

[0014] Further, the lower part of the sinus has a valve ring consistent with the material of the sinus, and the valve ring has no line structure.

[0015] Further, the tube has annular folds or corrugations, so as to be axially movable or extendable.

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

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

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

[0019] I. The present application provides an integrated aortic root graft with good sinus morphology, dense structure and good stability, which is used for replacing the diseased aortic root. The integrated aortic root graft is composed of a continuously knitted tube part, a sinus part and a sinus-tube junction. The sinus part obtained by one-piece molding knitting has good morphology, which is beneficial to simulate the hemodynamics of the aortic root after being implanted in the body. The sinus part has a dense tissue structure, which can ensure the elastic performance while providing strong structural support to prevent long-term radial overexpansion.

[0020] II. The twill weave in the present application has good elasticity, which can provide the sinus part with good elastic performance, so that it can simulate the state of the autologous sinus during use. The double-layer weave is firmly combined with the upper and lower layers by a specific linking method, which provides excellent structural support for the sinus part, reduces the risk of long-term radial overexpansion of the sinus part due to poor support, improves the service life of the artificial blood vessel and the autologous valve, and reduces the possibility of postoperative secondary intervention. BRIEF DESCRIPTION OF DRAWINGS

[0021] The drawings accompanying the specification of the present application form a part thereof, serve to provide further understanding of the present application, and together with the description, explain the present application. The present application is shown by way of illustration in the drawings as follows:

[0022] Figure 1 FIG. 1 is a structural schematic diagram of an integrated aortic root graft according to an embodiment of the present application;

[0023] Figure 2 FIG. 2 is a weftwise cross-sectional schematic diagram of the sinus part of the integrated aortic root graft according to the embodiment of the present application;

[0024] Figure 3 FIG. 3 is a warpwise cross-sectional schematic diagram of the sinus part of the integrated aortic root graft according to the embodiment of the present application;

[0025] Figure 4 FIG. 4 is a weftwise cross-sectional schematic diagram of the sinus part of the integrated aortic root graft according to another embodiment of the present application;

[0026] Figure 5 FIG. 5 is a warpwise cross-sectional schematic diagram of the sinus part of the integrated aortic root graft according to the other embodiment of the present application;

[0027] Figure 6 This is a schematic diagram of the sinus section of an integrated sinus-supported artificial blood vessel provided in Embodiment 3 of the present invention;

[0028] Figure 7 This is a schematic diagram of the sinus section of an integrated sinus-supported artificial blood vessel according to Embodiment 3 of the present invention;

[0029] Among them: 1. Tube; 2. Sinus; 3. Sinus-Tube junction. Detailed Implementation

[0030] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. It should be noted that, unless otherwise specified, the embodiments and features described herein can be combined with each other.

[0031] The following detailed description is exemplary and intended to provide further detailed explanation of the invention. Unless otherwise specified, all technical terms used in this invention have the same meaning as commonly understood by one of ordinary skill in the art. The terminology used in this invention is for describing particular embodiments only and is not intended to limit the scope of exemplary embodiments according to the invention.

[0032] Example 1:

[0033] like Figure 1 As shown, the integrated sinus-supported artificial blood vessel provided by this invention comprises, from top to bottom, a tube section 1, a sinus-tube junction 3, and a sinus section 2. Tube section 1 and sinus section 2 share the same longitudinal axis. Tube section 1 has annular folds or corrugations, allowing it to move or extend axially. Tube section 1 can be divided into an upper sinus section and a lower sinus section, with the lower sinus section being selectable based on actual conditions. Sinus section 2 has longitudinally extending folds or corrugations, forming a radially extendable structure. A selectable valve ring is located below sinus section 2. The valve ring is made of the same material as other parts. The materials of tube section 1 and sinus section 2 are selected from polyester, polytetrafluoroethylene, and silk, but the valve ring has no textured structure.

[0034] Sinus 2 has a dense structure consisting of interconnected upper and lower layers, with a fabric coverage of 80%-95%. The fabric weave of the upper and lower layers is selected from one or two of plain weave, twill weave, and square plain weave, and at least one of the fabric weaves used in the upper and lower layers is a 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 ratio should be selected from one or two of 1:1, 2:1, and 3:1.

[0035] The diameter change of sinus 2 is achieved by altering the number of yarns, including the following steps:

[0036] (1) The knitting yarn is fixed on the knitting machine, and the knitting of the tube part 1 is first carried out to the sinus-tube junction 3;

[0037] (2) The fabric diameter is gradually increased along the axial direction to the maximum diameter of the sinus part 2 by gradually increasing the yarn operation;

[0038] (3) Then the yarn operation is reduced to gradually reduce the fabric diameter along the axial direction to the same diameter as the tube part 1, and an integrated sinus artificial blood vessel is obtained.

[0039] Please refer to Figures 2-3 In each fabric organization cycle, the upper layer warp yarns are numbered one, two and three, the upper layer weft yarns are numbered I, II and III, the lower layer warp yarns are numbered A, B and C, and the lower layer weft yarns are numbered a, b and c. The upper layer of the sinus part 2 is a right diagonal weave of two upper and one lower, and the lower layer is a right diagonal weave of one upper and two lower. The yarn density of the upper and lower layers is 80 roots / cm, and the warp and weft arrangement ratio of the upper and lower layers is 1:1. The connecting points connecting the upper and lower layers are formed by the upper floating of the lower layer warp yarns and the knitting of the upper layer weft yarns. This structure design can obtain a sinus part 2 with a dense structure, and the sinus part 2 obtained by integrated knitting has good morphology, which is beneficial to simulate the blood flow dynamics of the aortic root after being placed in the body. It can ensure the elastic performance while having strong structural support, prevent long-term radial overexpansion, improve the service life of the artificial blood vessel and the autograft valve, and reduce the possibility of postoperative secondary intervention.

[0040] In this embodiment, the inner diameter of the tube part 1 and the sinus-tube junction 3 of the artificial blood vessel is 30 mm, the height of the sinus part 2 is 30 mm, the maximum inner diameter is 36 mm, and the overall diameter change of the sinus part 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] Example Two:

[0042] Please refer to Figures 4-5, each weave cycle, the upper layer warp yarns are numbered as 1, 2, 3, 4, the upper layer weft yarns are numbered as I, II, III, IV, the lower layer warp yarns are numbered as A, B, C, D, and the lower layer weft yarns are numbered as a, b, c, d. Different from the first embodiment, in the present embodiment, the upper layer weave of the sinus portion 2 is 2 / 2 basket weave, and the lower layer weave is two-over-two under left twill weave. The yarn density of the upper layer and the lower layer is both 80 yarns / cm, the warp yarn arrangement ratio of the upper layer and the lower layer is 1:1, the weft yarn arrangement ratio is 2:1, and the connecting points connecting the upper layer and the lower layer are formed by the upper-floating of the lower layer warp yarns and the weaving of the upper layer weft yarns. The structure design can also obtain the sinus portion 2 with dense structure, and since the upper layer weave of the sinus portion 2 is basket weave and the lower layer weave is left twill weave, compared with the structure of the first embodiment, the lower layer twill weave of the present embodiment can provide better effect of preventing the sinus portion from over-expanding on the basis of ensuring a certain elastic property.

[0043] Embodiment three:

[0044] Please refer to Figures 6-7 , each weave cycle, the upper layer warp yarns are numbered as 1, 2, 3, 4, 5, 6, the upper layer weft yarns are numbered as I, II, III, IV, V, VI, the lower layer warp yarns are numbered as A, B, C, D, E, F, and the lower layer weft yarns are numbered as a, b, c, d, e, f. Different from the first embodiment, in the present embodiment, the upper layer weave and the lower layer weave of the sinus portion 2 are both three-over-three under right twill weave, the yarn density of the upper layer and the lower layer is both 80 yarns / cm, the warp yarn arrangement ratio and the weft yarn arrangement ratio of the upper layer and the lower layer are both 1:1, and the connecting points connecting the upper layer and the lower layer are formed by the under-sinking of the upper layer warp yarns and the weaving of the lower layer weft yarns. Compared with the structure of the first embodiment, the twill weave dimension in the present embodiment is larger, and thus a relatively large expansion dimension can be provided.

[0045] The integrated type artificial blood vessel with sinus provided by the present application has the following characteristics: the sinus portion obtained by one-piece forming and weaving has good shape, and is beneficial to simulating the blood flow dynamics of the aortic root after being placed in the body. In addition, the dense weave structure of the sinus portion can provide good mechanical elasticity and structural stability during use, prevent long-term radial over-expansion of the sinus portion pipe wall, and reduce the risk of secondary surgery.

[0046] It is to be understood by those skilled in the art that the present application can be realized by other embodiments without departing from the spirit or essential characteristics thereof. Therefore, the above-described embodiments are merely exemplary in all aspects and are not the only ones. All changes within the scope of the present application or within the equivalent scope of the present application are intended to be embraced by the present application.

[0047] It should be pointed out finally that the above embodiments are only used to illustrate the technical solutions of the present application but not to limit it. Although the present application has been described in detail with reference to the above embodiments, it should be understood by those skilled in the art that the specific embodiments of the present application can be modified or replaced equivalently without departing from the spirit and scope of the present application, and any modification or equivalent replacement without departing from the spirit and scope of the present application should be covered in the protection scope of the claims of the present application.

Claims

1. An integrated artificial blood vessel with sinuses, characterized in that, It includes an integrally woven tube, a sinus junction, and a sinus, with the tube and sinus having the same longitudinal axis. The sinus has a dense structure composed of interconnected upper and lower layers of fabric, with the connection point located at the overlap of the upper and lower layers. The fabric coverage of the dense structure is 80%-95%. Both the upper and lower layers of fabric are woven in a loop from multiple fabrics with a yarn density of not less than 80 yarns / cm, and both layers of fabric contain twill weave.

2. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The warp and weft yarn arrangement ratio of the upper and lower layers of fabric is selected from one or two of 1:1, 2:1, and 3:

1.

3. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The joints of the upper and lower layers of fabric are formed by the weaving of the upper and lower warp and weft yarns, wherein the weaving structure includes the lower warp yarns floating up and the upper weft yarns being woven together, and the upper warp yarns sinking down and the lower weft yarns being woven together.

4. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The upper and lower layers of fabric also include plain weave or square plain weave.

5. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The fabric structure includes three-yarn repeat, four-yarn repeat, and six-yarn repeat. The three-yarn repeat structure includes a right-hand twill weave with two up and one down in the upper layer and a right-hand twill weave with one up and two down in the lower layer. The four-yarn repeat structure includes a 2 / 2 square plain weave in the upper layer and a left-hand twill weave with two up and two down in the lower layer. The six-yarn repeat structure includes a right-hand twill weave with three up and three down in both the upper and lower layers.

6. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The sinus has longitudinally extending folds or ripples, forming a radially extensible structure.

7. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, Below the sinus is a valve ring made of the same material as the sinus, and the valve ring has no textured structure.

8. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The tube has annular folds or corrugations, allowing it to move or extend axially.

9. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The tube is divided into an upper tube and a lower tube, with the lower tube selected based on the actual situation.

10. The integrated sinus-supported artificial blood vessel according to claim 1, characterized in that, The fabric material includes polyester, polytetrafluoroethylene and silk.

Images