An artificial blood vessel that is resistant to bending and can be punctured at will

Abstract

The present invention provides an artificial blood vessel that is resistant to bending and can be punctured at will. The artificial blood vessel includes a blood vessel wall and a blood vessel cavity; according to the radial outward direction of the blood vessel cavity, the blood vessel wall includes a blood vessel wall inner layer, a blood vessel wall middle layer and a blood vessel wall outer layer that are sequentially connected in a bonded manner; the blood vessel wall middle layer includes a puncturable support layer with a grid structure; the puncturable support layer includes a support rib trunk and branch lines extending from the side surface of the support rib trunk and side branches extending from the branch line surface. The artificial blood vessel is provided with a silica gel or polyurethane grid structure in the middle layer, so that the support rib trunk has the performance of being puncturable at will, and the bending resistance of the tube body is improved, and the effective puncture area of ​​the tube body is increased; the grid structure in the middle layer of the blood vessel wall can provide the blood vessel wall with automatic pinhole closing performance through the mutual auxiliary pulling effect of the support rib trunk, branch lines and side branches, thereby reducing the risk of blood leakage in the blood vessel wall after the puncture needle is pulled out.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedical devices and relates to an artificial blood vessel, in particular to an artificial blood vessel which is anti-bending and can be punctured at will. Background Art

[0002] Currently, for renal patients who need hemodialysis, establishing an autologous arteriovenous fistula is the preferred type of hemodialysis patient. However, when the autologous fistula is not suitable for the patient, an artificial blood vessel is needed to establish an arteriovenous fistula.

[0003] All existing artificial blood vessels for dialysis on the market use expanded polytetrafluoroethylene as the basic material of artificial blood vessels. Expanded polytetrafluoroethylene is a non-elastic material. The tube made of this single material has poor bending resistance and is prone to bending and deformation under stress, and even the tube is flattened. Gore's ACUSEAL vascular graft uses a thickened silicone dense layer to wrap a FEP-reinforced PTFE reinforcement ring similar to hard plastic to improve the bending resistance of the tube body. However, the material is hard and cannot be punctured, resulting in the inability to puncture the reinforcement ring position, reducing the effective puncture area of ​​the tube body. LeMaitre's Life Span artificial blood vessel enhances the bending and bending resistance of the tube body by wrapping a hard reinforcement wire around the expanded polytetrafluoroethylene tube body. However, the reinforcement support wire will hinder the puncture needle from penetrating the blood vessel wall during the actual puncture and use of the artificial blood vessel, or it will be impossible to puncture at the location where the hard reinforcement wire is, reducing the actual effective puncture area of ​​the blood vessel at the same length, and ultimately resulting in a decrease in the service life of the blood vessel. In addition, when puncturing artificial blood vessels with hard support wires, it is inevitable that the puncture needle will be forced into the lower edge of the support wire. Considering that the conventional puncture needle is 16-18G, when it is forced into the lower edge of the support ring, it will cause irreversible stratification of the vascular lumen and the support ring, leading to collapse of the area, and ultimately leading to vascular stenosis or even occlusion. In order to increase the effective puncture area of ​​the blood vessel, Maquet's Advanta VXT artificial vascular graft is equipped with a removable hard support wire in the tube body, but the removal process has the risk of damaging the vascular structure, increasing the permeability of the vascular wall, and easily causing hematoma after implantation, delaying the patient's first puncture dialysis time, and the patient may also have to endure the pain of central venous dialysis.

[0004] Therefore, a penetrable hard support member with radial support is needed to replace the existing non-puncturable hard support members on the market to ensure that the product has anti-bending performance while increasing the effective puncture area of ​​the product. Summary of the invention

[0005] In view of the deficiencies of the prior art, the purpose of the present invention is to provide an artificial blood vessel that is resistant to bending and can be punctured at will. The artificial blood vessel has a radially supporting grid structure composed of a main support rib trunk, branch lines extending from the side surface of the main support rib trunk, and side branches extending from the side of the branch lines; when the puncture needle is separated from the blood vessel wall, the grid structure in the artificial blood vessel can provide automatic needle hole closure performance for the blood vessel wall through the mutual auxiliary pulling action of the main support rib trunk, branch lines, and side branches, thereby reducing the risk of blood vessel wall leakage after the puncture needle is pulled out; at the same time, after the main support rib trunk is penetrated multiple times, the branch lines at its edges and the side branches on the branch lines pull the main support rib trunk to keep the main support rib trunk stable.

[0006] To achieve this object, the present invention adopts the following technical solutions:

[0007] The present invention provides an artificial blood vessel that is anti-bending and can be punctured at will, the artificial blood vessel comprising a blood vessel wall and a blood vessel cavity;

[0008] In the direction from the blood vessel cavity to the outside, the blood vessel wall includes a blood vessel wall inner layer, a blood vessel wall middle layer and a blood vessel wall outer layer which are sequentially attached and connected;

[0009] The middle layer of the blood vessel wall includes a puncturable support layer having a grid structure; the Shore A hardness of the material of the middle layer of the blood vessel wall is 10 to 80, for example, it can be 10, 20, 30, 40, 50, 60, 70 or 80, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable;

[0010] The puncturable support layer includes a support rib trunk and branch lines and side branch lines extending from the side surface of the support rib trunk.

[0011] The vascular cavity in the artificial blood vessel provided by the present invention provides a channel for blood flow, and the inner layer of the vascular wall and the outer layer of the vascular wall are bonded together to form a tight integrated structure (the inner layer of the vascular wall, the middle layer of the vascular wall and the outer layer of the vascular wall are tightly attached and inseparable), which increases the bending resistance of the tube body and reduces the risk of blood leakage from the vascular wall after the puncture needle is removed.

[0012] In the present invention, the bending resistance means that when the tube body is bent under force, the diameter of the tube cavity will not be reduced to less than 50% of the original diameter, which can be expressed by the kink diameter. The smaller the kink diameter, the better the bending resistance of the tube body; the arbitrary means that the doctor can blindly puncture the tube body without considering the structure of the tube body and can perform puncture at any position on the surface of the tube body.

[0013] As a preferred technical solution of the present invention, the thickness of the blood vessel wall is 350~800μm, for example, it can be 350mm, 400mm, 500mm, 600mm, 700mm or 800mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0014] In the present invention, a blood vessel wall with a thickness of 350 to 800 μm has a better puncture effect. If the thickness of the blood vessel wall is too thick, it will cause difficulty in puncture. If the thickness of the blood vessel wall is too thin, the blood vessel will not be able to withstand higher blood pressure after puncture, which may directly damage the blood vessel wall and increase the risk of inducing pseudoaneurysm or hematoma.

[0015] Preferably, the kink diameter of the artificial blood vessel is 6 to 100 mm, for example, 6 mm, 20 mm, 40 mm, 60 cm, 80 mm or 100 mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0016] In the present invention, the kink diameter refers to the curvature diameter of the blood vessel bend when the minimum diameter of the tube lumen is reduced to 50% of the original diameter when the tube is bent. The kink diameter range set by the present invention can be used in different positions of the human body, and tubes with different kink diameters can be selected in different parts. If the kink diameter is too large, there is a risk of the tube being blocked when in use.

[0017] As a preferred technical solution of the present invention, the inner layer of the blood vessel wall includes a polymer fiber layer.

[0018] Preferably, the material of the polymer fiber layer includes any one of expanded polytetrafluoroethylene, polyurethane, polyglycerol sebacate, polycaprolactone or polylactic acid.

[0019] In the present invention, the polymer fiber layer is composed of oriented and / or non-oriented fiber filaments, and the fiber structure on the surface is conducive to the adhesion, growth and diffusion of endothelial cells. Among them, polytetrafluoroethylene molecules have biological stability, and medical products made of it will not cause biological contamination in the body. The surface of expanded polytetrafluoroethylene-based vascular grafts has good anti-thrombotic properties and biological stability; polycaprolactone and polylactic acid are both biodegradable materials, which are non-toxic when degraded in the body, and the degradation rate is controllable.

[0020] Preferably, the inner diameter of the inner layer of the blood vessel wall is 4 to 10 mm, for example, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm or 10 mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0021] In the present invention, the inner diameter refers to the diameter of the inner layer of the blood vessel wall, excluding the inner wall thickness; the inner diameter of the inner layer of the blood vessel wall is determined based on the peripheral blood vessel data of the human body, and being too large or too small will lead to incompatibility between the blood vessel and the human body.

[0022] Preferably, the thickness of the inner layer of the blood vessel wall is 5 to 200 μm, for example, it can be 5 μm, 15 μm, 25 μm, 50 μm, 80 μm, 110 μm, 140 μm, 170 μm or 200 μm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0023] In the present invention, the inner layer of the blood vessel wall has a thickness of 25-200 μm, which can make the tube body better adapt to the dynamic environment of the human body and ensure the normal circulation of blood. If the thickness is too thick, the tube body has poor compliance and cannot adapt to the bending and movement of the body; if the thickness is too thin, the strength and durability of the tube body are reduced, increasing the risk of rupture.

[0024] Preferably, the porosity of the inner layer of the blood vessel wall is 75-99%, for example, 75%, 80%, 85% or 99%, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0025] In the present invention, the porosity range of the inner layer of the blood vessel wall can provide more space for cell growth and migration, promote the endothelialization process, and be beneficial to the long-term stability of the blood vessel; and can improve the flexibility and compliance of the blood vessel, which helps to adapt to the dynamic environment in the body. If the porosity of the inner layer of the blood vessel wall is too small, the tube body will be too hard to bend, hindering the endothelialization process.

[0026] As a preferred technical solution of the present invention, the thickness of the middle layer of the blood vessel wall is 100~600μm, for example, it can be 150μm, 200μm, 300μm, 400μm, 500μm or 600μm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0027] Preferably, the thickness of the middle layer of the blood vessel wall is the same as the thickness of the main trunk of the supporting ribs.

[0028] In the present invention, the middle layer of the vascular wall has good anti-bending and anti-bleeding properties within the thickness range. If the thickness of the layer is too thick, it may not be easy to bend, while if it is too thin, the risk of bleeding may be increased.

[0029] As a preferred technical solution of the present invention, the material of the middle layer of the blood vessel wall includes silicone or polyurethane.

[0030] In the present invention, the material of the middle layer of the blood vessel wall (i.e., the puncture support layer) is silicone or polyurethane, which can provide mechanical support while being puncturable, compared with other support materials currently used for artificial blood vessels, which are extremely difficult to puncture; in addition, the Shore A hardness of the material of the puncturable support rib trunk, branch line and side branch line of the present invention is 10~80, the purpose is that the silicone or polyurethane within this hardness range can be easily penetrated by the puncture needle while providing mechanical support, and the silicone or polyurethane above this range will cause the puncture needle to passively deviate from the established puncture point due to the high hardness during puncture. If the hardness of the puncturable support rib is too low, it will lead to insufficient radial support force of the artificial blood vessel body, too large kink diameter, and not in line with the actual application of the product in clinical practice.

[0031] As a preferred technical solution of the present invention, the diameter range of the inscribed circle of the polygon formed by the grid of the grid structure in the middle layer of the blood vessel wall is 0.1~1.6mm, for example, it can be 0.1mm, 0.2mm, 0.4mm, 0.6mm, 0.8mm, 1.0mm, 1.2mm, 1.4mm or 1.6mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0032] It is worth noting that the diameter of the inscribed circle ranges from 0.1 to 1.6 mm, including the maximum diameter and the minimum diameter of the inscribed circle. The inscribed circle refers to the inscribed circle of the grid of the projection of the middle-layer grid structure on the inner layer of the blood vessel in the radial direction of the artificial blood vessel; the grid structure includes a three-dimensional grid structure and / or a two-dimensional grid structure.

[0033] Preferably, under the premise of ensuring that the branch line is in full contact with the inner layer of the blood vessel wall, one end of the branch line is connected to the adjacent support rib trunk, and the other end is connected to the adjacent support rib trunk or other branch lines.

[0034] The sufficient contact means that each branch line has at least one tight fit site with the inner layer of the blood vessel wall. Preferably, the minimum contact length between a single branch / side branch line and the inner layer of the blood vessel wall is 0.05 mm.

[0035] Preferably, the number of branch lines in the main length of 1 cm supporting rib is in the range of 13-130, for example, it can be 13, 20, 40, 60, 80, 100, 120 or 130, but is not limited to the listed values, and other values ​​not listed in the numerical range are also applicable.

[0036] Preferably, the branch line surface is provided with side branch lines.

[0037] Preferably, under the premise of ensuring that the side branch line is in full contact with the inner layer of the blood vessel wall, one end of the branch line is connected to the adjacent supporting rib trunk, and the other end is connected to the adjacent supporting rib trunk or other branch lines.

[0038] It is worth noting that the other branch lines are arranged between the support rib trunk connected to the branch line and the support rib trunk adjacent to it.

[0039] Preferably, the number of the side branches in a branch line length of 1 cm ranges from 12 to 180, for example, 12, 20, 40, 60, 80, 100, 120, 140, 160 or 180, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0040] In the present invention, the branch lines and side branch lines are both extended irregularly, and the irregularity means that the starting point of the branch line is random and can extend from any point on the surface of the supporting rib trunk, and the end point of the branch line extension is also random and ends at any point on the surface of the adjacent supporting rib trunk; the side branch line extends from a random point on the surface of the branch line and ends at any point on the surface of another branch line.

[0041] More specifically, the branch lines extending from the surface of the main trunk of the support rib described in the present invention extend from the main trunk of the support rib and firmly adhere to the inner layer of the blood vessel wall (the number of adhered points is greater than or equal to 1) and then extend to the surface of the adjacent main trunk of the support rib and end; the surface of the branch line also has side branch lines extending from the side branch lines, which extend and firmly adhere to the inner layer of the blood vessel wall (the number of adhered points is greater than or equal to 1) and then extend to the adjacent branch line or side branch line and end; the branch lines extending from the surface of the main trunk of the support rib and firmly adhere to the inner layer of the blood vessel wall (the number of adhered points is greater than or equal to 1) and then extend to the surface of the adjacent branch line or side branch line and end. The formed mesh structure provides automatic pinhole closure performance for the blood vessel wall through the mutual auxiliary pulling action of the main trunk of the support rib, the branch lines, and the side branch lines, thereby reducing the risk of blood vessel wall leakage after the puncture needle is pulled out.

[0042] In the present invention, adjacent refers to two supporting rib trunks that are closest to each other.

[0043] As a preferred technical solution of the present invention, the radial dimension of the main trunk of the supporting rib is ≥ the radial dimension of the branch line ≥ the radial dimension of the side branch line.

[0044] Preferably, the thickness of the grid structure formed by the branch lines and the side branch lines is less than or equal to the thickness of the main trunk of the supporting ribs.

[0045] It is worth noting that the thickness of the grid structure formed by the branch lines and the side branch lines and the thickness of the main trunk of the supporting ribs are both radial dimensions.

[0046] As a preferred technical solution of the present invention, the main trunk of the supporting ribs is distributed in a spiral shape or an annular shape on the outer wall of the inner layer of the blood vessel wall.

[0047] In the present invention, the spiral distribution or the parallel circular distribution has equivalent functions, both of which can meet the mechanical requirements of blood vessels and provide artificial blood vessels with better bending and compression resistance, so that they can better cope with various deformations during implantation and possible pressures after implantation.

[0048] Preferably, the annular distribution is a parallel circular annular distribution.

[0049] Preferably, the cross-sectional shape of the main body of the supporting rib comprises any one of a semicircle, an ellipse, a multi-angle arc or a polygon, or a combination of at least two of them. Typical but non-limiting combinations include: a combination of a semicircle, an ellipse and a multi-angle arc, a combination of a multi-angle arc and a polygon, a combination of a semicircle and an ellipse, or a combination of a semicircle, an ellipse, a multi-angle arc and a multi-angle arc.

[0050] Preferably, the cross-sectional shapes of the branch line and the side branch line are both circular and / or elliptical.

[0051] As a preferred technical solution of the present invention, the spacing between adjacent support rib trunks is 1.5~15mm, for example, it can be 1.5mm, 3mm, 5mm, 7mm, 9mm, 11mm, 13mm or 15mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0052] In the present invention, the spacing between adjacent support rib trunks refers to: the pitch of the support rib trunks in a spiral distribution, the closest surface distance along the axial direction; or the axial distance between two surfaces close to the reinforcement ribs in an annular distribution. In addition, when the spacing is 1.5-15mm, a stable supporting force can be given to the tube body, so that the artificial blood vessel can maintain a circular shape when subjected to pressure, avoid collapse or deformation, and achieve different anti-bending effects.

[0053] Preferably, the cross-sectional height of the main trunk of the support rib is 0.1~0.6mm, for example, it can be 0.1mm, 0.2mm, 0.3mm, 0.4mm or 0.5mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0054] Preferably, the cross-sectional width of the main trunk of the support rib is 0.5~1.5mm, for example, it can be 0.5mm, 0.6mm, 0.7mm, 0.8mm, 0.9mm or 1mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0055] In the present invention, the value range of the cross-sectional width of the main support rib affects the mechanical support and bending resistance required by the artificial blood vessel body; if the cross-sectional width is too narrow, the mechanical strength of the tube body will be insufficient, which may cause the tube to be flattened and blocked during use; if the cross-sectional width is too wide, the tube body will be too hard and unable to bend. In addition, if the cross-sectional shape of the main support rib is semicircular, the cross-sectional width is the widest part (diameter) of the cross-sectional width.

[0056] As a preferred technical solution of the present invention, the gap range between adjacent branch lines is 0~0.5mm, for example, it can be 0mm, 0.1mm, 0.2mm, 0.3mm, 0.4mm or 0.5mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0057] Preferably, the radial dimension of the cross section of the branch line is 0.05-0.2 mm, for example, it can be 0.05 mm, 0.08 mm, 0.11 mm, 0.14 mm, 0.17 mm or 0.2 mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0058] Preferably, the gap between adjacent side branch lines ranges from 0 to 0.5 mm, for example, 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm or 0.5 mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0059] Preferably, the radial dimension of the cross section of the side branch line is 0.01-0.1 mm, for example, 0.01 mm, 0.02 mm, 0.04 mm, 0.06 mm, 0.08 mm or 0.1 mm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0060] In the present invention, the middle layer of the blood vessel wall of the present invention includes multiple branch lines, and the gap between adjacent branch lines can be 0 mm, but cannot be all 0 mm; when the gap is 0 mm, it means that the branch lines (or side branch lines) are in contact with each other and there is no spacing; and the gap between the branch lines (or side branch lines) is not a fixed single value, that is, the gap size between adjacent branch lines (or side branch lines) can be within this range.

[0061] In addition, the cross-sectional radial dimension of the side branch line is smaller than that of the branch line. The side branch line connects two adjacent branch lines to form an interlaced grid structure with the branch lines. Similar to the branch line diameter requirements, if the diameter of the side branch line is too large, the hardness of the tube body will be too high and it will be difficult to bend.

[0062] As a preferred technical solution of the present invention, the outer layer of the blood vessel wall includes a polymer fiber layer.

[0063] Preferably, the material of the polymer fiber layer includes any one of expanded polytetrafluoroethylene, polyurethane, polyethylene terephthalate or polyamide.

[0064] Preferably, the thickness of the outer layer of the blood vessel wall is 100-200 μm, for example, 100 μm, 120 μm, 140 μm, 160 μm, 180 μm or 200 μm, but is not limited to the listed values, and other values ​​not listed within the numerical range are also applicable.

[0065] In the present invention, the thickness of the outer layer of the blood vessel wall is 100-200 μm, which can provide a suitable interface for the artificial blood vessel to contact and combine with human tissue while meeting the mechanical strength condition of wrapping the middle layer of the blood vessel wall.

[0066] It is worth noting that the grid structure with a puncturable support layer described in the present invention not only includes: grid I formed by the main support ribs and branch lines and grid II formed by the branch lines and branch lines; it also includes any one or a combination of at least two of grid III formed by the main support ribs, branch lines and side branches, grid IV formed by the branch lines and side branches, or grid V formed by the side branches and side branches. Furthermore, the formation of the grid structure of the middle layer of the blood vessel wall described in the present invention includes the following situations: (1) a combination of grid I and grid II; (2) a combination of grid I, grid II and grid III; (3) a combination of grid I, grid II and grid IV; (4) a combination of grid I, grid II and grid V; (5) a combination of grid I, grid II, grid III and grid V; (6) a combination of grid I, grid II, grid III and grid IV; or (7) a combination of grid I, grid II, grid III, grid IV and grid V.

[0067] The numerical range described in the present invention not only includes the point values ​​listed above, but also includes any point values ​​between the above numerical ranges that are not listed. Due to space limitations and for the sake of simplicity, the present invention no longer exhaustively lists the specific point values ​​included in the range.

[0068] Compared with the prior art, the present invention has the following beneficial effects:

[0069] In the artificial blood vessel provided by the present invention, a mesh structure made of silicone or polyurethane is arranged in the middle layer of the blood vessel wall, which is bonded to the inner layer of the blood vessel wall to form an integrated structure: (1) The main support ribs can enhance the overall anti-bending property of the blood vessel, while the punctureability of the silicone or polyurethane material can directly increase the effective puncture area of ​​the blood vessel; (2) The mesh structure can provide automatic needle hole closure performance for the blood vessel wall through the mutual auxiliary pulling effect of the main support ribs, branch lines, and side branch lines, thereby reducing the risk of blood vessel wall leakage after the puncture needle is removed. BRIEF DESCRIPTION OF THE DRAWINGS

[0070] Figure 1 This is a schematic diagram of the overall structure of the anti-bending and arbitrarily puncturable artificial blood vessel provided in Example 1 of the present invention;

[0071] Figure 2 This is a cross-sectional view of the bending-resistant and arbitrarily puncturable artificial blood vessel provided in Example 1 of the present invention;

[0072] Figure 3 is an axial cross-sectional view of the bending-resistant and arbitrarily puncturable artificial blood vessel provided in Example 1 of the present invention;

[0073] Figure 4 It is a circumferential cross-sectional view of the middle layer (grid structure) of the vascular wall of the bending-resistant and arbitrarily puncturable artificial blood vessel provided in Example 1 of the present invention;

[0074] Figure 5 This is an axial cross-sectional view of the middle layer (grid structure) of the vascular wall of the bending-resistant and puncturable artificial blood vessel provided in Example 1 of the present invention.

[0075] Figure 6 This is an axial cross-sectional view of the bending-resistant and arbitrarily puncturable artificial blood vessel wall provided in Example 1 of the present invention;

[0076] Figure 7 Schematic diagram of the inscribed circle of the grid structure in the middle layer of the vascular wall of the bending-resistant and arbitrarily puncturable artificial blood vessel provided in Example 1 of the present invention;

[0077] Figure 8 An axial cross-sectional view of the bending-resistant and arbitrarily puncturable artificial blood vessel provided in Example 2 of the present invention;

[0078] Fig. 9 It is a circumferential cross-sectional view of the middle layer (grid structure) of the vascular wall of the bending-resistant and arbitrarily puncturable artificial blood vessel provided in Example 5 of the present invention;

[0079] Among them, 1 is the vascular cavity, 2 is the vascular wall, 3 is the inner layer of the vascular wall, 4 is the middle layer of the vascular wall (grid structure), 5 is the outer layer of the vascular wall, 6 is the main trunk of the supporting ribs, 7 is the branch line, and 8 is the side branch. DETAILED DESCRIPTION

[0080] The technical solution of the present invention is further described below in conjunction with the accompanying drawings and through specific implementation methods. It should be understood by those skilled in the art that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0081] Example 1

[0082] This embodiment provides a Figure 1 The anti-bending and arbitrarily puncturable artificial blood vessel shown comprises a blood vessel wall 2 and a blood vessel cavity 1;

[0083] In the radial direction from the blood vessel cavity 1 to the outside, the blood vessel wall 2 includes a blood vessel wall inner layer 3, a blood vessel wall middle layer 4 and a blood vessel wall outer layer 5 which are sequentially attached and connected; the blood vessel wall middle layer 4 includes Figure 4 and Figure 5 The puncturable support layer with a grid structure shown in the figure; the puncturable support layer includes a support rib trunk 6 and branch lines 7 and side branches 8 extending from the side surface of the support rib trunk; one end of the branch line 7 is connected to the adjacent support rib trunk 6, and the other end is connected to the adjacent support rib trunk 6 or other branch lines 7; the two ends of the side branches are respectively connected to the branch line, or to the branch line and other side branches, or to other side branches. The grid structure is a three-dimensional grid, which means that at least one branch line or side branch line is not on the same circular curved surface with the axis of the artificial blood vessel as the axis.

[0084] The thickness of the blood vessel wall 2 is 650 μm ± 75 μm;

[0085] The inner layer 3 of the blood vessel wall is an expanded polytetrafluoroethylene tube; the inner diameter of the inner layer 3 of the blood vessel wall is 6 mm; the thickness of the inner layer 3 of the blood vessel wall is 100 μm±25 μm; the porosity of the inner layer 3 of the blood vessel wall is 95±4%;

[0086] The thickness of the middle layer 4 of the blood vessel wall is 400 μm±25 μm; the thickness of the middle layer 4 of the blood vessel wall is the same as the thickness of the supporting rib trunk 6; the thickness of the grid structure formed by the branch lines 7 and the side branch lines 8 is ≤ the thickness of the supporting rib trunk 6;

[0087] The material of the puncturable support layer includes silica gel with a Shore A hardness of 50; the inscribed circle of the grid structure in the puncturable support layer (such as Figure 7 The diameter of the support rib trunk 6 is 1.0±0.2mm; the support rib trunk 6 is provided with a branch line 8, and the branch line 7 extends from the support rib trunk 6 and firmly adheres to the inner layer of the blood vessel wall (the number of adhered points is 2), and then extends to the surface of the adjacent support rib trunk 6 and ends. The side branch line 8 extends from the branch line 7 and firmly adheres to the inner layer 3 of the blood vessel wall (the number of adhered points is 1), and then extends to the adjacent branch line 7 and ends;

[0088] Under the premise of ensuring that the branch line 7 is in full contact with the inner layer 3 of the blood vessel wall, one end of the branch line 7 is connected to the adjacent support rib trunk 6, and the other end is connected to the adjacent support rib trunk 6 or other branch lines 7; the number of the branch lines 7 in the length of 1 cm of the support rib trunk 6 ranges from 15 to 20;

[0089] The branch line 7 is provided with a side branch line 8 on its surface; on the premise of ensuring that the side branch line 8 is in full contact with the inner layer 3 of the blood vessel wall, the two ends of the side branch line 8 are connected to adjacent branch lines 7 and / or side branch lines 8; the number of the side branch lines 8 in a length of 1 cm of the branch line 7 ranges from 15 to 25;

[0090] The supporting rib trunk 6 is distributed in parallel circular rings on the outer wall of the inner layer 3 of the blood vessel wall; the cross-sectional shape of the supporting rib trunk 6 is semicircular;

[0091] like Figure 6 As shown, the spacing between adjacent support rib trunks 6 is 5mm; the cross-sectional height of the support rib trunk 6 is 0.4mm; the cross-sectional width of the support rib trunk 6 is 0.8mm; the gap between adjacent branch lines 7 is 0-0.3mm; the radial dimension of the cross section of the branch line 7 is 0.1mm; the gap between adjacent side branch lines 8 is 0-0.3mm; the radial dimension of the cross section of the side branch line 8 is 0.05mm;

[0092] The outer layer 5 of the blood vessel wall includes a polycaprolactone fiber layer; the thickness of the outer layer 5 of the blood vessel wall is 150±25 μm.

[0093] The cross-sectional view of the anti-bending and arbitrarily puncturable artificial blood vessel provided in this embodiment is as follows: Figure 2 As shown, the axial cross-section view is as follows Figure 3 shown.

[0094] Example 2

[0095] This embodiment 1 provides an artificial blood vessel that is resistant to bending and can be punctured at will, and the artificial blood vessel that is resistant to bending and can be punctured at will comprises a blood vessel wall 2 and a blood vessel cavity 1;

[0096] In the radially outward direction from the blood vessel cavity 1, the blood vessel wall 2 includes a blood vessel wall inner layer 3, a blood vessel wall middle layer 4 and a blood vessel wall outer layer 5 which are sequentially attached and connected; the blood vessel wall middle layer 4 includes a puncturable support layer having a grid structure;

[0097] The puncturable support layer includes a support rib trunk 6 and branch lines 7 and side branch lines 8 extending from the side surface of the support rib trunk;

[0098] The thickness of the blood vessel wall 2 is 450 μm;

[0099] The inner layer 3 of the blood vessel wall is an expanded polytetrafluoroethylene tube; the inner diameter of the inner layer 3 of the blood vessel wall is 4 mm; the thickness of the inner layer 3 of the blood vessel wall is 200 μm, and the porosity of the inner layer 3 of the blood vessel wall is 80±5%;

[0100] The thickness of the middle layer 4 of the blood vessel wall is 150 μm, which is the same as the thickness of the main support rib 6; the thickness of the grid structure formed by the branch lines 7 and the side branch lines 8 is ≤ the thickness of the main support rib 6;

[0101] The material of the puncturable support layer includes silicone with a Shore A hardness of 60; the diameter of the inscribed circle of the grid structure in the puncturable support layer is 1.0±0.2mm; the grid structure is arranged on the side close to the inner layer of the blood vessel wall, and the surface of the main trunk of the support rib is provided with a branch line, which extends from the surface of the main trunk of the support rib and firmly adheres to the inner layer of the blood vessel wall (the number of adhered points is 1) and then extends to the surface of the adjacent main trunk of the support rib and ends. The side branch line extends from the surface of the branch line and firmly adheres to the inner layer of the blood vessel wall (the number of adhered points is 2) and then extends to the adjacent branch line;

[0102] Under the premise of ensuring that the branch line 7 is in full contact with the inner layer 3 of the blood vessel wall, one end of the branch line 7 is connected to the adjacent support rib trunk 6, and the other end is connected to the adjacent support rib trunk 6 or other branch lines 7; the number of the branch lines 7 in the length of 1 cm of the support rib trunk 6 ranges from 20 to 30;

[0103] The branch line 7 is provided with a side branch line 8 on its surface; on the premise of ensuring that the side branch line 8 is in full contact with the inner layer 3 of the blood vessel wall, the two ends of the side branch line 8 are connected to adjacent branch lines 7 and / or side branch lines 8; the number of the side branch lines 8 in a length of 1 cm of the branch line 7 ranges from 25 to 35;

[0104] The supporting rib trunk 6 is distributed in a spiral shape on the outer wall of the inner layer 3 of the blood vessel wall; the cross-sectional shape of the supporting rib trunk 6 is an ellipse;

[0105] The spacing between adjacent support rib trunks 6 is 2 mm; the cross-sectional height of the support rib trunk 6 is 0.15 mm; the cross-sectional width of the support rib trunk 6 is 1 mm; the gap between adjacent branch lines 7 is 0.3-0.5 mm; the radial dimension of the cross section of the branch line 7 is 0.05 mm; the gap between adjacent side branch lines 8 is 0.3-0.5 mm; the radial dimension of the cross section of the side branch line 8 is 0.01 mm;

[0106] The outer layer 5 of the blood vessel wall is a polyamide fiber layer; the thickness of the outer layer 5 of the blood vessel wall is 100 μm.

[0107] The axial cross-sectional view of the anti-bending and arbitrarily puncturable artificial blood vessel provided in this embodiment is as follows: Figure 8 shown.

[0108] Example 3

[0109] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0110] In this embodiment, the inner diameter of the tube body is adjusted to 10 mm, and the width of the main cross-section of the supporting rib is adjusted to 1.5 mm.

[0111] Example 4

[0112] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0113] In this embodiment, the material of the inner tube wall is changed to polyurethane, and the distribution mode of the main support ribs is changed to a spiral distribution with equal spacing along the axial direction.

[0114] Example 5

[0115] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0116] In this embodiment, the side branch lines arranged on the surface of the branch lines are omitted.

[0117] The circumferential cross-sectional view of the middle layer (grid structure) of the vascular wall of the bending-resistant and arbitrarily puncturable artificial blood vessel provided in this embodiment is as follows: Fig. 9 shown.

[0118] Example 6

[0119] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0120] In this embodiment, the thickness of the inner layer of the blood vessel wall is adjusted to 450 μm.

[0121] Example 7

[0122] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0123] In this embodiment, the spacing between the main trunks of adjacent supporting ribs is adjusted to 18 mm.

[0124] Example 8

[0125] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0126] In this embodiment, the average diameter of the inscribed circle of the grid structure in the puncturable support layer is 2 mm.

[0127] Example 9

[0128] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0129] The grid structure in the punctureable support layer of this embodiment is a two-dimensional grid structure, that is, there is no height difference between the radial branch line and the side branch line. The radial dimension of the cross section of the branch line 7 is 0.1mm; the radial dimension of the cross section of the side branch line 8 is 0.05mm; the thickness of the middle layer of the blood vessel wall is equal to the thickness of the main trunk of the support rib, forming a two-dimensional structure, that is, the branch line and the side branch line are both attached to the inner layer of the blood vessel wall.

[0130] Example 10

[0131] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0132] In this embodiment, the material of the pierceable support layer includes silicone with a Shore A hardness of 10.

[0133] Embodiment 11

[0134] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0135] In this embodiment, the material of the punctureable support layer includes silicone with a Shore A hardness of 30.

[0136] Example 12

[0137] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0138] In this embodiment, the material of the punctureable support layer includes silicone with a Shore A hardness of 65.

[0139] Embodiment 13

[0140] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0141] In this embodiment, the material of the punctureable support layer includes silicone with a Shore A hardness of 80.

[0142] Embodiment 14

[0143] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0144] In this embodiment, the diameter of the inscribed circle of the grid structure in the support layer that can be punctured is 0.3±0.2 mm.

[0145] Embodiment 15

[0146] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0147] In this embodiment, the diameter of the inscribed circle of the grid structure in the support layer that can be punctured is 1.4±0.2 mm.

[0148] Example 16

[0149] This embodiment provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and the embodiment 1 is that:

[0150] The material of the puncturable support layer in this embodiment is polyurethane with a Shore A hardness of 50.

[0151] Comparative Example 1

[0152] This comparative example provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and Example 1 is that:

[0153] The material of the puncturable support layer in this comparative example includes silicone with a Shore A hardness of 5.

[0154] Comparative Example 2

[0155] This comparative example provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and Example 1 is that:

[0156] The material of the punctureable support layer in this comparative example includes silicone with a Shore A hardness of 85.

[0157] Comparative Example 3

[0158] This comparative example provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and Example 1 is that:

[0159] In this comparative example, the middle layer of the blood vessel wall is adjusted to only include the main support ribs distributed in a spiral shape on the outside of the inner layer of the blood vessel wall, and does not have a grid structure.

[0160] Comparative Example 4

[0161] This comparative example provides an artificial blood vessel that is resistant to bending and can be punctured at will. The difference between the artificial blood vessel that is resistant to bending and can be punctured at will and Example 1 is that:

[0162] In this comparative example, the middle layer of the blood vessel wall is adjusted so that the main trunk of the supporting ribs is removed, and only the grid formed by the branch lines and the side branch lines exists in the middle layer.

[0163] Performance testing:

[0164] (1) Puncture randomness test: Three new artificial blood vessels provided in Example 1 were punctured at different positions using a 16-gauge dialysis needle; and then subjected to a bending resistance test and a leakage test after puncture, respectively. The results are shown in Table 1.

[0165] The puncture process includes: (a) within 1 / 3 of the circumference of the vascular prosthesis, puncturing the grid structure between the main trunks of the supporting ribs of Example 1 twice and puncturing the main trunk of the supporting ribs once, wherein the puncture position of the main trunk of the supporting ribs is in the middle, and the other two punctures are respectively made in the middle of the grid structure between two main trunks adjacent to the main trunk, and the three puncture positions are parallel to the axis of the artificial blood vessel and are equally spaced; (b) within 1 / 3 of the circumference of the vascular prosthesis, selecting a new blood vessel with the parameters of Example 1 and puncturing it twice on two adjacent main trunks of the supporting ribs and puncturing it in the middle of the grid structure between the two main trunks, and the three puncture positions are parallel to the axis of the artificial blood vessel and are equally spaced; (c) within 1 / 3 of the circumference of the vascular prosthesis, selecting a new blood vessel with the parameters of Example 1 and puncturing it three times at equal distances on three consecutively adjacent main trunks of the supporting ribs, and the three puncture positions are parallel to the axis of the artificial blood vessel;

[0166] (2) The artificial blood vessels provided by Examples 1-16 and Comparative Examples 1-4 that were not punctured and punctured were subjected to anti-bending tests, and the results are shown in Table 2.

[0167] Among them, the puncture treatment of the embodiments 1-16 and the comparative examples 1-2 is as follows: within 1 / 3 of the circumference of the vascular prosthesis, the grid structure of the artificial blood vessel between the supporting rib trunks is punctured twice, and the supporting rib trunk is punctured once, wherein the puncture position of the supporting rib trunk is in the middle, and the other two times are punctured in the middle of the grid structure between the two trunks adjacent to the trunk, and the three puncture positions are parallel to the axis of the artificial blood vessel and are equally spaced; the puncture treatment of comparative example 3 is as follows: puncture once on the supporting rib trunk and puncture twice in the gap between the supporting rib trunks, wherein the puncture position of the supporting rib trunk is in the middle, and the other two times are punctured in the middle of the gap between the two trunks adjacent to the trunk, and the three puncture positions are parallel to the axis of the artificial blood vessel and are equally spaced; the puncture treatment of comparative example 4 is to puncture three times at equal intervals on the grid structure, and the spacing between the three puncture positions is the same as that of embodiment 1, and is parallel to the axis of the artificial blood vessel.

[0168] (3) The artificial blood vessels provided in Examples 1-16 and Comparative Examples 1-4 were respectively tested for leakage after puncture. The results are shown in Table 2.

[0169] Among them, the puncture treatment is: within 1 / 3 of the circumference of the vascular prosthesis, the grid structure of the artificial blood vessel between the supporting ribs is punctured twice, and the supporting rib trunk is punctured once, one of which is in the middle of the supporting rib trunk, and the other two are punctured in the middle of the grid structure between the two trunks adjacent to the trunk. The three puncture positions are parallel to the axis of the artificial blood vessel and are equally spaced.

[0170] The anti-bending test method is: according to the standard, YY-T 0500, a cylindrical shaft of known diameter is used to measure the curvature diameter of the artificial blood vessel starting to kink before and after puncture treatment, and "kink" is defined as the discontinuity of the inner diameter, or the data is recorded after the sample is deformed to 50% of the lumen diameter;

[0171] The post-puncture leakage test method is as follows: detect the post-puncture water leakage of the artificial blood vessel after puncture, connect the proximal end of the sample to an adapter with a specific inner diameter to ensure sealing. Connect the adapter and the vascular prosthesis to a fixture for pressure generation and measurement. Gradually increase the intraluminal pressure of the sample to expel trapped air. Make the pressure reach 16.0kPa±0.3kPa (120mmHg±2mmHg), keep the pressure or flow stable, and measure the water penetration of the blood vessel wall within 1 minute to evaluate the leakage of the tube body after puncture. Take the maximum penetration value after three tests.

[0172] Table 1

[0173]

[0174] According to Table 1, after puncturing any position of the artificial blood vessel provided in Example 1, whether the artificial blood vessel is punctured on the grid structure between the main trunks of the supporting ribs or only on the main trunks of the supporting ribs, the kink diameter test results are not much different from those of the artificial blood vessels that have not been punctured, and both can achieve different degrees of anti-bending and anti-leakage effects, indicating that the artificial blood vessel can be punctured at any position without affecting the kink diameter and leakage.

[0175] Table 2

[0176]

[0177] According to Table 2, we can know the following points:

[0178] (1) Comprehensive analysis of the performance test data of the punctured and unpunctured artificial blood vessels revealed that the kink diameter test results of the artificial blood vessels before and after puncture were similar, and both achieved different degrees of anti-bending and anti-leakage effects, indicating that the artificial blood vessels can be punctured at any position;

[0179] (2) Comprehensive analysis of Examples 1-4 shows that the artificial blood vessel support ribs provided by the present invention can provide good anti-bending performance for the tube body in the form of parallel circular rings or equally spaced spirals. Changes in the spacing between the support ribs and the width of the support rib cross section will affect the anti-bending performance of the blood vessel. The water leakage after puncture also shows that the tube body has a significant closure effect at the pinhole after puncture, and basically no water leakage.

[0180] (3) Comprehensive analysis of Example 1 and Example 4 shows that the difference in the material of the inner layer and the outer layer of the blood vessel wall will have little effect on the anti-bending performance and pinhole closure of the tube body;

[0181] (4) Comprehensive analysis of Example 1, Example 5 and Comparative Examples 3 and 4 shows that the side branch wire and the branch wire are both important components of the puncturable support ribs. If the puncturable support ribs do not have a grid structure, the auxiliary pulling effect of the branch wire and the side branch wire on the inner layer of the blood vessel wall will disappear, and the needle hole will not be completely closed after the tube body is punctured, resulting in blood leakage; if the tube body does not have a support rib trunk (such as Comparative Example 4), the resulting tube body kink diameter is too large;

[0182] (5) Comprehensive analysis of Examples 1, 6 and 7 shows that the thickness of the vascular wall or the distance between the main trunks of the supporting ribs in the artificial blood vessel provided by the present invention will affect the anti-bending performance of the artificial blood vessel; as described in Example 6, when the thickness of the inner layer of the vascular wall is too large, the kinking diameter of the tube body will increase and the anti-bending performance will decrease;

[0183] (6) Comprehensive analysis of Example 1 and Examples 8, 14, and 15 shows that the size of the middle-layer grid structure (the diameter of the inscribed circle of the grid on the projection of the middle-layer grid structure on the inner layer of the blood vessel in the radial direction of the artificial blood vessel) will affect the anti-leakage effect of the tube body. If the diameter of the inscribed circle is too large, the traction force on the blood vessel wall during puncture is insufficient, which may cause incomplete closure of the puncture hole and increase the risk of leakage;

[0184] (7) Comprehensive analysis of Example 1 and Example 9 shows that when only branch lines or both branch lines and side branches exist, the overall three-dimensional grid structure of the blood vessel has a better anti-bending effect than the two-dimensional grid structure, that is, the kink diameter is smaller;

[0185] (8) Comprehensive analysis of Examples 1, 2, 10-13 and Comparative Examples 1-2 shows that the hardness of the silicone constituting the middle layer of the blood vessel wall has a great influence on the overall kink diameter of the blood vessel. If the hardness of the silicone is too small (less than 10), the tube body is too soft, the kink diameter is large, and the bending resistance is poor; if the hardness of the silicone is too large (greater than 80), the tube body is too hard, the kink diameter is also large, and the bending resistance is poor. Further analysis of Examples 1, 10-13 and Comparative Examples 1-2 shows that as the hardness of the silicone constituting the middle layer of the blood vessel wall gradually increases, the overall kink diameter of the blood vessel first decreases and then increases.

[0186] (9) Compared with Example 1, the artificial blood vessels provided in Comparative Examples 3 and 4 respectively verified the role of the supporting rib trunk and the middle-layer grid structure; Comparative Example 3 only had the supporting rib trunk and no network structure, and although the anti-bending performance did not change significantly, after the grid structure was removed, the amount of water leakage from the pinhole after the tube body was punctured increased significantly, while in Comparative Example 4, only the middle-layer grid structure was retained, and the tube body was difficult or impossible to bend; this shows that the supporting rib trunk plays a decisive role in the anti-bending of the tube body, while the grid structure affects the closure of the pinhole after puncture of the blood vessel wall;

[0187] (10) Comprehensive analysis of Example 1 and Example 16 shows that silicone and polyurethane can be used as puncture-resistant support layers of artificial blood vessels to achieve the effects of anti-bending and arbitrary puncture when the specified Shore A hardness value is met.

[0188] In summary, the middle layer of the vascular wall of the artificial blood vessel provided by the present invention is provided with a grid structure, which is bonded with the inner layer of the vascular wall to form an integrated structure: (1) The main support ribs can enhance the overall anti-bending property of the blood vessel, and its punctureability can directly increase the effective puncture area of ​​the blood vessel; (2) The grid structure can provide automatic needle hole closure performance for the vascular wall through the mutual auxiliary pulling effect of the main support ribs, branch lines, and side branch lines, thereby reducing the risk of blood vessel wall leakage after the puncture needle is removed.

[0189] The applicant declares that the above is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Those skilled in the art should understand that any changes or substitutions that can be easily thought of by those skilled in the art within the technical scope disclosed by the present invention shall fall within the protection scope and disclosure scope of the present invention.

Claims

1. An artificial blood vessel that is resistant to bending and can be punctured at will, characterized in that: The artificial blood vessel comprises a blood vessel wall and a blood vessel cavity; According to the radial outward direction of the blood vessel cavity, the blood vessel wall includes a blood vessel wall inner layer, a blood vessel wall middle layer and a blood vessel wall outer layer which are sequentially attached and connected; The middle layer of the blood vessel wall includes a puncturable support layer with a grid structure; the Shore A hardness of the material of the middle layer of the blood vessel wall is 10-80; the material of the middle layer of the blood vessel wall includes silicone or polyurethane; The puncturable support layer includes a support rib trunk and branch lines extending from the side surface of the support rib trunk.

2. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The thickness of the blood vessel wall is 350-800 μm; The kink diameter of the artificial blood vessel is 6-100 mm.

3. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The inner layer of the blood vessel wall includes a polymer fiber layer; The inner diameter of the inner layer of the blood vessel wall is 4 to 10 mm; The thickness of the inner layer of the blood vessel wall is 5 to 200 μm; The porosity of the inner layer of the blood vessel wall is 75-99%.

4. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The thickness of the middle layer of the blood vessel wall is 100-600 μm; The thickness of the middle layer of the blood vessel wall is the same as the thickness of the main trunk of the supporting ribs.

5. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The diameter of the inscribed circle of the polygon formed by the grid of the grid structure in the middle layer of the blood vessel wall is in the range of 0.1 to 1.6 mm.

6. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The branch line is in full contact with the inner layer of the blood vessel wall, one end of the branch line is connected to the adjacent support rib trunk, and the other end is connected to the adjacent support rib trunk or other branch lines; The number of branch lines on the main support rib length of 1 cm ranges from 13 to 130; The branch line surface is provided with a side branch line; On the premise of ensuring that the side branch line is in full contact with the inner layer of the blood vessel wall, the two ends of the side branch line are connected to adjacent branch lines and / or side branch lines; The number of the side branches ranges from 12 to 180 over a branch line length of 1 cm.

7. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 6, characterized in that: The radial dimension of the main trunk of the supporting rib is greater than or equal to the radial dimension of the branch line and greater than or equal to the radial dimension of the side branch line; The thickness of the grid structure formed by the branch lines and the side branch lines is less than or equal to the thickness of the main trunk of the supporting ribs.

8. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The main trunk of the supporting ribs is distributed in a spiral shape or an annular shape on the outer wall of the inner layer of the blood vessel wall.

9. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The spacing between adjacent support rib trunks is 1.5-15 mm; The cross-sectional height of the main support rib is 0.1-0.6 mm; The cross-sectional width of the main trunk of the support rib is 0.5-1.5 mm.

10. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 6, characterized in that: The gap between adjacent branch lines ranges from 0 to 0.5 mm; The radial dimension of the cross section of the branch line is 0.05-0.2 mm; The gap between adjacent side branch lines ranges from 0 to 0.5 mm; The radial dimension of the cross section of the side branch line is 0.01-0.1 mm.

11. The anti-bending and arbitrarily puncturable artificial blood vessel according to claim 1, characterized in that: The outer layer of the blood vessel wall includes a polymer fiber layer; The thickness of the outer layer of the blood vessel wall is 100-200 μm.

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