Kink-resistant vascular graft and method of making same

Abstract

The application discloses an anti-bending artificial blood vessel, which comprises an artificial blood vessel inner layer, a synthetic polymer anti-bending ring and an artificial blood vessel outer layer; the artificial blood vessel inner layer is a synthetic polymer tube body; the artificial blood vessel outer layer is a synthetic polymer fiber membrane; the shape of the synthetic polymer anti-bending ring is a non-equidistant spiral structure; the synthetic polymer anti-bending ring is wound on the outer wall of the artificial blood vessel inner layer, is between the artificial blood vessel inner layer and the artificial blood vessel outer layer, and is fixed by being covered by the artificial blood vessel inner layer and the artificial blood vessel outer layer. The application further discloses a preparation method of the artificial blood vessel. The application can make the artificial blood vessel to be bent by 180 degrees in a full ring without flat collapse and kinking, can ensure that the whole artificial blood vessel has good anti-bending performance, can effectively improve the anti-bending performance of the artificial blood vessel, and can effectively improve the compliance of the artificial blood vessel.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and specifically to an anti-bending artificial blood vessel and its preparation method. Background Technology

[0002] Epidemiological statistics show that the incidence of chronic kidney disease in my country is as high as 10.8%, affecting approximately 130 million people, of whom about 3 million are in end-stage renal disease. Clinically, hemodialysis is one of the main treatment methods for patients with end-stage renal disease. Establishing appropriate vascular access is of great significance for end-stage renal disease patients to successfully receive dialysis treatment.

[0003] However, with the improvement of living standards and medical technology in China, the lifespan of hemodialysis patients has increased, and their own blood vessels suffer irreversible damage as the dialysis period progresses. Limited by the quality and quantity of their own blood vessels, artificial arteriovenous fistulas are an ideal treatment for maintaining high-quality dialysis. However, after implantation, artificial blood vessels may bend or twist with the patient's limb movements. If there is a lack of good mechanical support, there is a risk of blood clotting and blockage of the artificial blood vessel, leading to thrombosis and necessitating thrombectomy or a second surgery. This directly affects the patient's postoperative dialysis and quality of life.

[0004] Currently, the most commonly used artificial blood vessels in clinical practice in China include products from companies such as Bard, Nicast, and Gore. Bard achieves resistance to bending and kinking by wrapping a rigid, full-ring suture around an expanded PTFE tube. However, this rigid, high-density suture significantly enhances the overall mechanical strength of the artificial blood vessel, drastically reducing the mechanical compatibility between the artificial and autologous blood vessels. This can lead to tearing and traction of the autologous blood vessel at the anastomosis site, resulting in bleeding. Nicast's artificial blood vessel, with a 400mm length, only has an anti-bending ring in the middle 80mm. Therefore, only this 80mm section provides bending resistance; the remaining sections without the ring lack adequate bending resistance. Furthermore, the short length of the anti-bending section limits the harvestable length for clinical applications. Gore uses a dense silicone layer to thicken the artificial blood vessel body, improving mechanical properties and achieving bending resistance. However, due to the low mechanical strength of silicone elastomers, it cannot achieve 180° bending, and the thick silicone layer makes clinical suturing difficult. In Chinese patent document CN112472361B, Wuhan Janssen Co., Ltd. uses a high-temperature extrusion process above 300℃ to prepare anti-bending rings. High temperature is not conducive to the absorption of electrospun materials and will seriously affect the state of nanofibers, causing the inner layer of nanofibers to break and deform due to high temperature. Therefore, the first and second dense layers are added, making the preparation process complicated and not conducive to industrialization. Summary of the Invention

[0005] The technical problem to be solved by this invention is to enable artificial blood vessels to bend arbitrarily 180° around the entire circumference without collapsing or twisting, ensuring that the entire artificial blood vessel has good bending resistance, effectively improving the bending resistance of artificial blood vessels, and at the same time effectively improving the compliance of artificial blood vessels.

[0006] To solve the above-mentioned technical problems, the present invention provides an anti-bending artificial blood vessel, which includes an inner layer 1 of the artificial blood vessel, a synthetic polymer anti-bending ring 2, and an outer layer of the artificial blood vessel.

[0007] The inner layer 1 of the artificial blood vessel is a synthetic polymer tubular body;

[0008] The outer layer of the artificial blood vessel is a synthetic polymer fiber membrane;

[0009] The synthetic polymer bending-resistant ring 2 has a non-equidistant helical structure.

[0010] The synthetic polymer anti-bending ring 2 is wrapped around the outer wall of the inner layer 1 of the artificial blood vessel, between the inner layer 1 and the outer layer of the artificial blood vessel, and is covered and fixed by the inner layer 1 and the outer layer of the artificial blood vessel.

[0011] Preferably, the spacing between the synthetic polymer anti-bending rings 2 gradually increases from the middle part of the artificial blood vessel along the center line of the artificial blood vessel to both ends of the artificial blood vessel.

[0012] Preferably, the length of the synthetic polymer anti-bending ring 2 is consistent with the length of the artificial blood vessel centerline;

[0013] The length of the synthetic polymer bending-resistant ring 2 is 400mm to 600mm.

[0014] Preferably, the inner layer 1 of the artificial blood vessel is prepared by electrospinning using a synthetic polymer material;

[0015] The outer layer of the artificial blood vessel is made of synthetic polymer material through an electrospinning process.

[0016] Preferably, the inner diameter of the artificial blood vessel inner layer 1 is 3mm to 6mm, and the wall thickness is 0.3 to 1mm.

[0017] Preferably, the thickness of the outer layer of the artificial blood vessel is 0.1 mm to 0.5 mm.

[0018] Preferably, the synthetic polymer material includes polyurethane, siloxane-terminated polycarbonate, nylon, polytetrafluoroethylene, polyvinyl alcohol, polylactic acid, polyethylene, and polycaprolactone.

[0019] Preferably, the synthetic polymer material includes polyurethane, siloxane-terminated polycarbonate, polyethylene terephthalate, and perfluoroethylene propylene copolymer.

[0020] Preferably, the synthetic polymer bending-resistant ring 2 is made of solid filaments wound together, with a filament diameter of 0.2 mm to 0.4 mm;

[0021] The spacing between the synthetic polymer bending-resistant rings 2 is 1 mm to 8 mm.

[0022] To solve the above-mentioned technical problems, the present invention provides a method for preparing an anti-bending artificial blood vessel, comprising the following steps:

[0023] S1. Dissolve the polymer material in an organic solvent to prepare a spinning solution;

[0024] S2. The spinning solution prepared in step S1 is received on a metal shaft by electrospinning to prepare a synthetic polymer tube as the inner layer 1 of an artificial blood vessel;

[0025] S3. Using an encircling device, a synthetic polymer anti-bending ring 2 with a non-equidistant spiral structure is wound onto the outer wall of the inner layer 1 of the artificial blood vessel;

[0026] S4. On the outside of the synthetic polymer anti-bending ring 2 and the inner layer 1 of the artificial blood vessel, a layer of random nanofibers is electrospun using the spinning solution prepared in step S1 to form the outer layer of the artificial blood vessel, thereby forming the artificial blood vessel.

[0027] Preferably, after step S4, the artificial blood vessel inner layer 1, the synthetic polymer anti-bending ring 2, and the artificial blood vessel outer layer, which are combined from the inside out, are soaked in an ethanol solution and baked at high temperature to increase the surface abrasion resistance.

[0028] Preferably, in step S1, the polymer material is dissolved in an organic solvent to prepare a spinning solution of 10-30%.

[0029] Preferably, in step S1, an aliphatic polyurethane material with a weight-average molecular weight of 210,000 is dissolved in hexafluoroisopropanol to prepare a 15% spinning solution.

[0030] Preferably, in step S1, an aromatic polyurethane material with a weight-average molecular weight of 320,000 is dissolved in N,N-dimethylamide to prepare a 13.5% spinning solution.

[0031] Preferably, in step S1, the polytetrafluoroethylene material is dissolved in N,N-dimethylamide to prepare a 15% spinning solution.

[0032] Preferably, in step S1, polycaprolactone and polyurethane are dissolved in tetrafluoroethylene material dissolved in N,N-dimethylamide to prepare a 15% spinning solution.

[0033] Preferably, in step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 3 mm to 6 mm by electrospinning to prepare a synthetic polymer tube with a wall thickness of 0.3 mm to 1 mm, which serves as the inner layer 1 of the artificial blood vessel.

[0034] Preferably, in step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 6 mm and a receiving length of 400 mm by electrospinning to prepare a synthetic polymer tube with a wall thickness of 0.3 mm to 1 mm, which serves as the inner layer 1 of the artificial blood vessel.

[0035] Preferably, in step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 4 mm and a receiving length of 400 mm by electrospinning to prepare a synthetic polymer tube with a wall thickness of 0.6 mm, which serves as the inner layer 1 of the artificial blood vessel.

[0036] Preferably, in step S3, 0.2 mm to 0.4 mm diameter filaments extruded from melt are non-equidistantly wound onto a stainless steel screw with a pitch of 1 mm to 8 mm, and treated at a high temperature of 100 to 200°C for 60 to 100 minutes to fix them into a spiral structure, thereby obtaining a synthetic polymer anti-bending ring 2. The synthetic polymer anti-bending ring 2 is then wound onto the outer wall of the inner layer 1 of the artificial blood vessel using a spiral winding device.

[0037] Preferably, in step S3, the 0.25mm diameter wire extruded from the melt is wound around five sequentially connected stainless steel screws, each 80mm long, with pitches of 2.5mm-2.0mm-1.5mm-2.0mm-2.5mm and an outer diameter of 6.5mm. The screws are then heat-treated at 150℃ for 90 minutes to fix them into a spiral structure, resulting in a 400mm long synthetic polymer anti-bending ring 2 with ring spacings of 2.5mm-2.0mm-1.5mm-2.0mm-2.5mm. The synthetic polymer anti-bending ring 2 is then wound around the outer wall of the inner layer 1 of the artificial blood vessel using a spiral winding device.

[0038] Preferably, in step S3, the 0.37mm diameter wire extruded from the melt is wound around five sequentially connected stainless steel screws, each 80mm long, with pitches of 3.0mm-2.0mm-1.0mm-2.0mm-3.0mm and an outer diameter of 5mm. The screws are then heat-treated at 120℃ for 60 minutes to fix them into a spiral structure, resulting in a 400mm long synthetic polymer anti-bending ring 2 with interlocking distances of 3.0mm-2.0mm-1.0mm-2.0mm-3.0mm. The synthetic polymer anti-bending ring 2 is then wound around the outer wall of the inner layer 1 of the artificial blood vessel using a spiral winding device.

[0039] Preferably, in step S3, the 0.37mm diameter wire extruded from the melt is wound around five sequentially connected stainless steel screws, each 80mm long, with pitches of 5.0mm-2.5mm-1.5mm-2.5mm-5.0mm and an outer diameter of 5mm. The screws are then heat-treated at 120℃ for 60 minutes to fix them into a spiral structure, resulting in a 400mm long synthetic polymer anti-bending ring 2 with interlocking spacings of 5.0mm-2.5mm-1.5mm-2.5mm-5.0mm. The synthetic polymer anti-bending ring 2 is then wound around the outer wall of the inner layer 1 of the artificial blood vessel using a spiral winding device.

[0040] Preferably, in step S4, on the outside of the synthetic polymer anti-bending ring 2, the spinning solution prepared in step S1 is electrospun into a layer of random nanofibers with a thickness of 0.1 mm to 0.5 mm as the outer layer of the artificial blood vessel by electrospinning.

[0041] Preferably, in step S4, on the outside of the synthetic polymer anti-bending ring 2, the spinning solution prepared in step S1 is electrospun into a layer of random nanofibers with a thickness of 0.3 mm as the outer layer of the artificial blood vessel using an electrospinning method.

[0042] Preferably, in step S4, on the outside of the synthetic polymer anti-bending ring 2, the spinning solution prepared in step S1 is electrospun into a layer of random nanofibers with a thickness of 0.2 mm as the outer layer of the artificial blood vessel using an electrospinning method.

[0043] The anti-bending artificial blood vessel of this invention features a non-equidistant spiral structure for the anti-bending ring, allowing the artificial blood vessel to bend 180° freely throughout the ring without collapsing or twisting. This ensures that the entire artificial blood vessel has excellent anti-bending performance, effectively improving its compliance and mitigating the risk of tearing and bleeding of autologous blood vessels caused by the high-density full-ring design. Doctors can cut the vessel at any point between the rings, facilitating the fulfillment of diverse clinical length requirements and effectively preventing bending or twisting of the artificial blood vessel after implantation. Attached Figure Description

[0044] To more clearly illustrate the technical solution of the present invention, the accompanying drawings used in the present invention will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0045] Figure 1 This is a schematic diagram of the structure of an embodiment of the anti-bending artificial blood vessel of the present invention without an outer layer of artificial blood vessel;

[0046] Figure 2This is a morphological diagram of the inner layer fibers of an artificial blood vessel according to an embodiment of the present invention.

[0047] Figure 3 This is a morphological diagram of the outer layer fibers of an embodiment of the anti-bending artificial blood vessel of the present invention.

[0048] Figure 4 This is a diagram illustrating the bending resistance performance of an embodiment of the bending-resistant artificial blood vessel of the present invention.

[0049] Explanation of the reference numerals in the figure:

[0050] 1 is the inner layer of an artificial blood vessel; 2 is a synthetic polymer anti-bending ring. Detailed Implementation

[0051] The technical solutions of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0052] Example 1

[0053] like Figure 1 As shown, the anti-bending artificial blood vessel includes an inner layer 1, a synthetic polymer anti-bending ring 2, and an outer layer.

[0054] The inner layer 1 of the artificial blood vessel is a synthetic polymer tubular body;

[0055] The outer layer of the artificial blood vessel is a synthetic polymer fiber membrane;

[0056] The synthetic polymer bending-resistant ring 2 has a non-equidistant helical structure.

[0057] The synthetic polymer anti-bending ring 2 is wrapped around the outer wall of the inner layer 1 of the artificial blood vessel, between the inner layer 1 and the outer layer of the artificial blood vessel, and is covered and fixed by the inner layer 1 and the outer layer of the artificial blood vessel.

[0058] The artificial blood vessel in Example 1 has a three-layer structure: the inner layer is a synthetic polymer tubular body, the outer layer is a synthetic polymer fiber membrane, and the space between the inner and outer layers is a synthetic polymer anti-bending ring. The anti-bending ring is fixed by the above-mentioned inner and outer layer structures, and the shape of the synthetic polymer anti-bending ring 2 is a non-equidistant spiral structure.

[0059] The artificial blood vessel in Example 1 employs a non-equidistant spiral structure for its anti-bending ring, allowing the artificial blood vessel to bend arbitrarily 180° without collapsing or twisting, ensuring excellent anti-bending performance throughout the entire artificial blood vessel. Figure 4As shown, it can effectively improve the bending resistance of artificial blood vessels and improve their compliance. It can effectively alleviate the situation of autologous blood vessels being pulled and torn, and bleeding caused by the high-density full-ring design. Doctors can cut between any rings to meet the diverse length requirements of clinical practice. It can effectively prevent the artificial blood vessels from bending or twisting after being implanted in the human body.

[0060] Example 2

[0061] Based on the artificial blood vessel of Example 1, the spacing between the synthetic polymer anti-bending rings 2 gradually increases from the middle part of the artificial blood vessel along the center line of the artificial blood vessel to both ends of the artificial blood vessel.

[0062] Preferably, the length of the synthetic polymer anti-bending ring 2 is consistent with the length of the artificial blood vessel centerline.

[0063] Preferably, the length of the synthetic polymer bending-resistant ring 2 is 400 mm to 600 mm.

[0064] In Example 2, the synthetic polymer anti-bending ring 2 is a spirally wound, gradually increasing ring spacing structure with anti-bending properties. The ring spacing of the synthetic polymer anti-bending ring 2 gradually increases from the middle part of the artificial blood vessel to both ends. The ring spacing of the synthetic polymer anti-bending ring 2 in the middle part of the artificial blood vessel is smaller, while the ring spacing increases towards both ends. This can effectively reduce the mechanical properties of the artificial blood vessel and improve its compliance.

[0065] Example 3

[0066] Based on the artificial blood vessel of Example 1, the inner layer 1 of the artificial blood vessel is prepared using a synthetic polymer material through an electrospinning process, such as... Figure 2 As shown;

[0067] The outer layer of the artificial blood vessel is prepared using a synthetic polymer material through an electrospinning process, such as... Figure 3 As shown.

[0068] Preferably, the inner diameter of the artificial blood vessel inner layer 1 is 3mm to 6mm, and the wall thickness is 0.3 to 1mm.

[0069] Preferably, the thickness of the outer layer of the artificial blood vessel is 0.1 mm to 0.5 mm.

[0070] Preferably, the synthetic polymer material includes, but is not limited to, polyurethane (aromatic, aliphatic, etc.), siloxane-terminated polycarbonate (aliphatic, aromatic), nylon, polytetrafluoroethylene, polyvinyl alcohol, polylactic acid, polyethylene, and polycaprolactone.

[0071] Preferably, the synthetic polymer material includes polyurethane (aromatic, aliphatic, etc.), siloxane-terminated polycarbonate (aliphatic, aromatic), polyethylene terephthalate (PET), and perfluoroethylene propylene copolymer (FEP).

[0072] The artificial blood vessel in Example 3 is prepared by electrospinning of synthetic polymer materials for both the inner layer 1 and the outer layer of the artificial blood vessel.

[0073] Example 4

[0074] Based on the artificial blood vessel of Example 1, the synthetic polymer anti-bending ring 2 is made of solid filaments wound together, with a filament diameter of 0.2 mm to 0.4 mm;

[0075] The spacing (pitch) of the synthetic polymer anti-bending ring 2 is 1 mm to 8 mm.

[0076] Example 5

[0077] The method for preparing any one of the artificial blood vessels in Examples 1 to 4 includes the following steps:

[0078] S1. Dissolve the polymer material in an organic solvent to prepare a spinning solution;

[0079] S2. The spinning solution prepared in step S1 is received on a metal shaft by electrospinning to prepare a synthetic polymer tube as the inner layer 1 of an artificial blood vessel;

[0080] S3. Using an encircling device, a synthetic polymer anti-bending ring 2 with a non-equidistant spiral structure is wound onto the outer wall of the inner layer 1 of the artificial blood vessel;

[0081] S4. On the outside of the synthetic polymer anti-bending ring 2 and the inner layer 1 of the artificial blood vessel, a layer of random nanofibers is electrospun using the spinning solution prepared in step S1 to form the outer layer of the artificial blood vessel, thereby forming the artificial blood vessel.

[0082] Preferably, the artificial blood vessel inner layer 1, the polymer anti-bending ring 2, and the artificial blood vessel outer layer, which are combined from the inside out, are soaked in an ethanol solution and baked at high temperature to increase the surface abrasion resistance.

[0083] The method for preparing the artificial blood vessel in Example 5 involves using a looping device (spiral winding device) to wind a synthetic polymer anti-bending ring onto the inner layer 1 of the artificial blood vessel.

[0084] Example 6

[0085] Based on the artificial blood vessel preparation method of Example 5, in step S1, the polymer material is dissolved in an organic solvent to prepare a spinning solution of 10-30%.

[0086] Preferably, in step S1, an aliphatic polyurethane material with a weight-average molecular weight of 210,000 is dissolved in hexafluoroisopropanol (HFIP) to prepare a 15% spinning solution.

[0087] Preferably, in step S1, an aromatic polyurethane material with a weight-average molecular weight of 320,000 is dissolved in N,N-dimethylamide (DMF) to prepare a 13.5% spinning solution.

[0088] Preferably, in step S1, the polytetrafluoroethylene material is dissolved in N,N-dimethylamide to prepare a 15% spinning solution.

[0089] Preferably, in step S1, polycaprolactone and polyurethane are dissolved in tetrafluoroethylene material dissolved in N,N-dimethylamide to prepare a 15% spinning solution.

[0090] Example 7

[0091] Based on the artificial blood vessel preparation method of Example 5, in step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 3 mm to 6 mm by electrospinning to prepare a synthetic polymer tube with a wall thickness of 0.3 mm to 1 mm, which serves as the inner layer 1 of the artificial blood vessel.

[0092] Preferably, in step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 6 mm and a receiving length of 400 mm by electrospinning to prepare a synthetic polymer tube with a wall thickness of 0.3 mm to 1 mm, which serves as the inner layer 1 of the artificial blood vessel.

[0093] Preferably, in step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 4 mm and a receiving length of 400 mm by electrospinning to prepare a synthetic polymer tube with a wall thickness of 0.6 mm, which serves as the inner layer 1 of the artificial blood vessel.

[0094] Example 8

[0095] In the preparation method of the artificial blood vessel in Example 5, in step S3, 0.2 mm to 0.4 mm diameter filaments extruded by melt extrusion are non-equidistantly wound onto a stainless steel screw with a pitch of 1 mm to 8 mm, and treated at a high temperature of 100 to 200°C for 60 to 100 minutes to fix it into a spiral structure to obtain a synthetic polymer anti-bending ring 2. The synthetic polymer anti-bending ring 2 is wound onto the outer wall of the inner layer 1 of the artificial blood vessel through a spiral winding device.

[0096] Preferably, in step S3, the 0.25mm diameter wire extruded from the melt is wound around five sequentially connected stainless steel screws, each 80mm long, with pitches of 2.5mm-2.0mm-1.5mm-2.0mm-2.5mm and an outer diameter of 6.5mm. The screws are then heat-treated at 150℃ for 90 minutes to fix them into a spiral structure, resulting in a 400mm long synthetic polymer anti-bending ring 2 with ring spacings of 2.5mm-2.0mm-1.5mm-2.0mm-2.5mm. The synthetic polymer anti-bending ring 2 is then wound around the outer wall of the inner layer 1 of the artificial blood vessel using a spiral winding device.

[0097] Preferably, in step S3, the 0.37mm diameter wire extruded from the melt is wound around five sequentially connected stainless steel screws, each 80mm long, with pitches of 3.0mm-2.0mm-1.0mm-2.0mm-3.0mm and an outer diameter of 5mm. The screws are then heat-treated at 120℃ for 60 minutes to fix them into a spiral structure, resulting in a 400mm long synthetic polymer anti-bending ring 2 with interlocking distances of 3.0mm-2.0mm-1.0mm-2.0mm-3.0mm. The synthetic polymer anti-bending ring 2 is then wound around the outer wall of the inner layer 1 of the artificial blood vessel using a spiral winding device.

[0098] Preferably, in step S3, the 0.37mm diameter wire extruded from the melt is wound around five sequentially connected stainless steel screws, each 80mm long, with pitches of 5.0mm-2.5mm-1.5mm-2.5mm-5.0mm and an outer diameter of 5mm. The screws are then heat-treated at 120℃ for 60 minutes to fix them into a spiral structure, resulting in a 400mm long synthetic polymer anti-bending ring 2 with interlocking spacings of 5.0mm-2.5mm-1.5mm-2.5mm-5.0mm. The synthetic polymer anti-bending ring 2 is then wound around the outer wall of the inner layer 1 of the artificial blood vessel using a spiral winding device.

[0099] The method for preparing artificial blood vessels in Example 8 involves processing filaments into a gradient spiral ring using a thermoforming process to obtain a synthetic polymer anti-bending ring.

[0100] Example 9

[0101] In the preparation method of the artificial blood vessel in Example 5, in step S4, on the outside of the synthetic polymer anti-bending ring 2, the spinning solution prepared in step S1 is electrospun into a layer of random nanofibers with a thickness of 0.1 mm to 0.5 mm as the outer layer of the artificial blood vessel using an electrospinning method.

[0102] Preferably, in step S4, on the outside of the synthetic polymer anti-bending ring 2, the spinning solution prepared in step S1 is electrospun into a layer of random nanofibers with a thickness of 0.3 mm as the outer layer of the artificial blood vessel using an electrospinning method.

[0103] Preferably, in step S4, on the outside of the synthetic polymer anti-bending ring 2, the spinning solution prepared in step S1 is electrospun into a layer of random nanofibers with a thickness of 0.2 mm as the outer layer of the artificial blood vessel using an electrospinning method.

[0104] The above are merely preferred embodiments of this application and are not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A kink-resistant vascular prosthesis, characterized by, It includes artificial blood vessel inner layer (1), synthetic polymer anti-bending ring (2) and artificial blood vessel outer layer; The artificial blood vessel inner layer (1) is a synthetic polymer pipe body; The artificial blood vessel outer layer is a synthetic polymer fiber membrane; the shape of the synthetic polymer anti-bending ring (2) is a non-equidistant spiral structure; The synthetic polymer anti-bending ring (2) is wound on the outer wall of the artificial blood vessel inner layer (1) and is between the artificial blood vessel inner layer (1) and the artificial blood vessel outer layer and is fixed by the artificial blood vessel inner layer (1) and the artificial blood vessel outer layer; From the middle part of the artificial blood vessel to both ends of the artificial blood vessel along the center line of the artificial blood vessel, the ring spacing of the synthetic polymer anti-bending ring (2) gradually increases; The length of the synthetic polymer anti-bending ring (2) is consistent with the length of the center line of the artificial blood vessel; the length of the synthetic polymer anti-bending ring (2) is 400mm-600mm; The artificial blood vessel inner layer (1) is prepared by electrospinning process using synthetic polymer material; the artificial blood vessel outer layer is prepared by electrospinning process using synthetic polymer material; the synthetic polymer material includes polyurethane, silicone-terminated polycarbonate, polyethylene terephthalate and perfluoroethylene propylene copolymer; The inner diameter of the artificial blood vessel inner layer (1) is 3mm-6mm, and the pipe wall thickness is 0.3-1mm; The thickness of the artificial blood vessel outer layer is 0.1mm-0.5mm.

2. The kink-resistant vascular graft of claim 1, wherein, The synthetic polymer anti-bending ring (2) is a solid wire winding, and the wire diameter is 0.2mm-0.4mm; the ring spacing of the synthetic polymer anti-bending ring (2) is 1mm-8mm.

3. A method of producing the kink-resistant vascular prosthesis of claim 1, characterized by, It includes the following steps: S1. Dissolve the polymer material in the organic solvent to prepare the spinning solution; S2. The spinning solution prepared in step S1 is received on the metal shaft by electrospinning method to prepare the synthetic polymer pipe body as the artificial blood vessel inner layer (1); S3. The synthetic polymer anti-bending ring (2) with non-equidistant spiral structure is wound on the outer wall of the artificial blood vessel inner layer (1) by ring winding equipment; S4. On the outside of the synthetic polymer anti-bending ring (2) and the artificial blood vessel inner layer (1), the spinning solution prepared in step S1 is electrospun to form a random nanofiber as the artificial blood vessel outer layer to form the artificial blood vessel.

4. The method of producing a kink-resistant vascular prosthesis according to claim 3, characterized in that, After step S4, the artificial blood vessel inner layer (1), the synthetic polymer anti-bending ring (2) and the artificial blood vessel outer layer combined together from inside to outside are soaked in ethanol solution and baked at high temperature to increase the surface friction resistance.

5. The method for producing an artificial blood vessel according to claim 2, characterized by, In step S1, the polymer material is dissolved in the organic solvent to prepare 10-30% spinning solution.

6. The method of producing a kink-resistant vascular prosthesis according to claim 5, characterized in that, In step S1, the aliphatic polyurethane material with a weight average molecular weight of 210,000 is dissolved in hexafluoroisopropanol to prepare 15% spinning solution.

7. The method of producing a kink-resistant vascular prosthesis according to claim 5, characterized in that, In step S1, the aromatic polyurethane material with a weight average molecular weight of 320,000 is dissolved in N,N dimethylformamide to prepare 13.5% spinning solution.

8. The method of producing a kink-resistant vascular prosthesis according to claim 5, characterized by, In step S1, the polytetrafluoroethylene material is dissolved in N,N dimethylformamide to prepare 15% spinning solution.

9. The method of producing a kink-resistant vascular prosthesis according to claim 5, characterized by, In step S1, polycaprolactone and polyurethane are dissolved in tetrafluoroethylene material dissolved in N, N dimethylamide to prepare a 15% spinning solution.

10. The method of producing a kink-resistant vascular prosthesis according to claim 5, characterized in that, In step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 3mm-6mm by electrospinning to prepare a synthetic polymer tube body with a wall thickness of 0.3mm-1mm as an artificial blood vessel inner layer (1).

11. The method of producing a kink-resistant vascular prosthesis according to claim 10, characterized in that, In step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 6mm by electrospinning to prepare a synthetic polymer tube body with a wall thickness of 0.3mm-1mm as an artificial blood vessel inner layer (1).

12. The method of producing a kink-resistant vascular prosthesis according to claim 10, characterized in that, In step S2, the spinning solution prepared in step S1 is received on a metal shaft with an outer diameter of 4mm by electrospinning to prepare a synthetic polymer tube body with a wall thickness of 0.6mm as an artificial blood vessel inner layer (1).

13. The method of producing a kink-resistant vascular prosthesis according to claim 3, characterized in that, In step S3, the melt-extruded wire with a diameter of 0.2mm-0.4mm is wound non-equidistantly on a stainless steel screw with a pitch of 1mm-8mm, and is treated at a high temperature of 100-200℃ for 60min-100min to fix it into a spiral structure to obtain a synthetic polymer anti-bending ring (2), and the synthetic polymer anti-bending ring (2) is wound on the outer wall of the artificial blood vessel inner layer (1) by a spiral winding device.

14. The method of producing a kink-resistant vascular prosthesis according to claim 13, characterized in that, In step S3, the melt-extruded wire with a diameter of 0.25mm is wound on a stainless steel screw with an outer diameter of 6.5mm, which is connected in sequence by five segments with a length of 80mm, and the pitch of each segment is 2.5mm-2.0mm-1.5mm-2.0mm-2.5mm, and the wire is heat treated at a high temperature of 150℃ for 90min to fix it into a spiral structure to obtain a synthetic polymer anti-bending ring (2) with a length of 400mm and ring spacings of 2.5mm-2.0mm-1.5mm-2.0mm-2.5mm, and the synthetic polymer anti-bending ring (2) is wound on the outer wall of the artificial blood vessel inner layer (1) by a spiral winding device.

15. The method of producing a kink-resistant vascular prosthesis according to claim 13, characterized in that, In step S3, the melt-extruded wire with a diameter of 0.37mm is wound on a stainless steel screw with an outer diameter of 5mm, which is connected in sequence by five segments with a length of 80mm, and the pitch of each segment is 3.0mm-2.0mm-1.0mm-2.0mm-3.0mm, and the wire is heat treated at a high temperature of 120℃ for 60min to fix it into a spiral structure to obtain a synthetic polymer anti-bending ring (2) with a length of 400mm and ring spacings of 3.0mm-2.0mm-1.0mm-2.0mm-3.0mm, and the synthetic polymer anti-bending ring (2) is wound on the outer wall of the artificial blood vessel inner layer (1) by a spiral winding device.

16. The method of producing a kink-resistant vascular prosthesis according to claim 13, characterized in that, In step S3, the melt-extruded wire with a diameter of 0.37 mm is wound on a stainless steel screw with an outer diameter of 5 mm, and the five sections with a length of 80 mm are connected in sequence, and the pitches of the sections are 5.0 mm-2.5 mm-1.5 mm-2.5 mm-5.0 mm in sequence. The wire is heat-treated at a high temperature of 120°C for 60 min to fix the spiral structure, and a synthetic polymer anti-bending ring (2) with a length of 400 mm and ring intervals of 5.0 mm-2.5 mm-1.5 mm-2.5 mm-5.0 mm is obtained. The synthetic polymer anti-bending ring (2) is wound on the outer wall of the inner layer (1) of the artificial blood vessel by a spiral winding device.

17. The method of producing a kink-resistant vascular prosthesis according to claim 3, characterized in that, In step S4, a layer of random nanofibers with a thickness of 0.1 mm-0.5 mm is electrospun as an outer layer of the artificial blood vessel on the outside of the synthetic polymer anti-bending ring (2) by using the spinning solution prepared in step S1 and the electrospinning method.

18. The method of producing a kink-resistant vascular prosthesis according to claim 17, characterized in that, In step S4, a layer of random nanofibers with a thickness of 0.3 mm is electrospun as an outer layer of the artificial blood vessel on the outside of the synthetic polymer anti-bending ring (2) by using the spinning solution prepared in step S1 and the electrospinning method.

19. The method of producing a kink-resistant vascular prosthesis according to claim 17, characterized in that, In step S4, a layer of random nanofibers with a thickness of 0.2 mm is electrospun as an outer layer of the artificial blood vessel on the outside of the synthetic polymer anti-bending ring (2) by using the spinning solution prepared in step S1 and the electrospinning method. In step S4, a layer of random nanofibers with a thickness of 0.2 mm is electrospun as an outer layer of the artificial blood vessel on the outside of the synthetic polymer anti-bending ring (2) by using the spinning solution prepared in step S1 and the electrospinning method.

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