CN116831780A

CN116831780A - Corrugated small-caliber artificial blood vessel and manufacturing method thereof

Info

Publication number: CN116831780A
Application number: CN202310812929.3A
Authority: CN
Inventors: 樊瑜波; 丁希丽; 赵丹璐; 沙冬宇
Original assignee: Beihang University
Current assignee: Beihang University
Priority date: 2023-07-05
Filing date: 2023-07-05
Publication date: 2023-10-03

Abstract

The application provides a corrugated small-caliber artificial blood vessel and a manufacturing method thereof. The corrugated small-caliber artificial blood vessel comprises a blood vessel main body, wherein the outer wall of the blood vessel main body forms a first corrugated structure, and the inner wall of the blood vessel main body forms a smooth surface. The compliance, the supportability and the elasticity of the small-caliber artificial blood vessel can be improved through the first corrugated structure, the smooth blood flow in the small-caliber artificial blood vessel can be ensured through the smooth surface, and the possibility of thrombus occurrence is reduced.

Description

Corrugated small-caliber artificial blood vessel and manufacturing method thereof

Technical Field

The application relates to the technical field of artificial vascular grafts, in particular to a corrugated small-caliber artificial vascular and a manufacturing method thereof.

Background

When a blood vessel in a human body cannot perform normal physiological functions due to occlusive disease, aging, breakage, or the like, it is necessary to perform vascular graft to replace a diseased blood vessel. Data statistics show that over 60 tens of thousands of people need vascular graft surgery every year worldwide. Among them, the large-caliber artificial blood vessel (d is more than 6 mm) has more mature products applied to clinical treatment, but the small-caliber artificial blood vessel graft (d is less than or equal to 6 mm) has very little problems of acute thrombosis and long-term restenosis, which enter clinical tests, and the small-caliber artificial blood vessel which can be applied to clinical treatment is still a worldwide difficult problem.

At present, epsilon polycaprolactone, silk fibroin and other materials with better biocompatibility are mostly adopted in a laboratory to prepare tissue engineering artificial blood vessels so as to improve the endothelialization degree of the artificial blood vessels and prevent thrombus, and good two-year patency rate is obtained in animal experiments. However, most of the small-caliber vascular grafts prepared at present are designed with smooth inner and outer walls, so that the vascular grafts can be shrunken when the blood flow is insufficient, and the vascular grafts are easy to block completely when being bent.

Disclosure of Invention

The application mainly aims to provide a corrugated small-caliber artificial blood vessel and a manufacturing method thereof, which are used for solving the technical problem that a human hematopoietic tube is easy to collapse or block when being bent in the prior art.

In order to achieve the above object, the present application provides a corrugated small-caliber artificial blood vessel, comprising a blood vessel main body, wherein the outer wall of the blood vessel main body forms a first corrugated structure, and the inner wall of the blood vessel main body forms a smooth surface.

In one embodiment, the first corrugation is a wavy or a threaded structure.

In one embodiment, the vessel body has a caliber of 6mm or less.

In order to achieve the above object, the present application also provides a method for manufacturing an artificial blood vessel having a corrugated shape, the method for manufacturing an artificial blood vessel being manufactured using an artificial blood vessel manufacturing mold comprising: an outer sleeve mold, wherein a second corrugated structure is formed on the inner wall of the outer sleeve mold; the outer wall of the inner column body mold is a smooth surface; the outer sleeve mold can be sleeved outside the inner cylinder mold, an artificial blood vessel manufacturing space is formed between the outer sleeve mold and the inner cylinder mold, and the inner cylinder mold is used for sleeving a main body structure for manufacturing the artificial blood vessel. The manufacturing method of the artificial blood vessel comprises the following steps: s10: braiding silk fibers into a tubular object matched with the outer diameter of the inner cylinder mould; s20: sleeving the tubular object on the inner cylinder mould; s30: inserting an inner cylinder mould sleeved with a tubular object into an outer sleeve mould; s40: preparing a sulfated silk fibroin solution, mixing the silk fibroin solution and polyethylene glycol diglycidyl ether to form a mixed solution, and injecting the mixed solution between an inner cylinder mold and an outer sleeve mold; s50: refrigerating and preserving the artificial blood vessel manufacturing mould injected with the mixed solution for a certain time, and then taking out the implant obtained between the inner column mould and the outer sleeve mould; s60: the graft is placed in water to remove the polyethylene glycol diglycidyl ether.

In one embodiment, in S40, the sulfated silk protein solution is a 5% to 8% sulfated silk protein concentration solution; the silk fibroin solution is a solution with the concentration of 5% -8% of silk fibroin; the ratio of the sulfated silk fibroin solution to the polyethylene glycol diglycidyl ether is 1:1:2-1:1:4.

In one embodiment, in S50, the temperature of the refrigerated storage is-18 ℃ to-24 ℃ and the time of the refrigerated storage is greater than 20 hours.

In one embodiment, in S10, the tubing is treated with Na2CO3 solution to remove sericin.

In one embodiment, the second corrugated structure is a wave-like structure or a thread-like structure.

In one embodiment, the outer sleeve mold is made of a resin material or a plastic material, and the inner cylinder mold is made of a metal material or a glass material.

In one embodiment, the ratio of the corrugation height to the corrugation pitch of the second corrugation structure is 1: 1-1:1.5.

By applying the technical scheme of the application, in the process of manufacturing the blood vessel by using the artificial blood vessel manufacturing die, the inner cylinder die is used for sleeving and manufacturing the main body structure of the artificial blood vessel, and the main body structure is usually woven by silk fibers with good biocompatibility so as to provide good mechanical property and biocompatibility. The outer sleeve mold may be fitted over the outer portion of the inner cylinder mold to form an artificial blood vessel manufacturing space between the two molds. The second corrugated structure formed on the inner wall of the outer sleeve mold can form a corrugated effect on the outer wall of the manufactured artificial blood vessel so as to improve the flexibility and the bendability of the artificial blood vessel. The outer wall of the inner cylinder mould is designed to be a smooth surface, so that the inner wall of the manufactured artificial blood vessel is smooth, and the resistance and the potential coagulation risk during blood flow are reduced to the greatest extent.

In addition to the objects, features and advantages described above, the present application has other objects, features and advantages. The present application will be described in further detail with reference to the drawings.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification, illustrate embodiments of the application and together with the description serve to explain the application. In the drawings:

fig. 1 shows a schematic structural view of an artificial blood vessel manufacturing mould according to the present application in use;

fig. 2 shows a schematic structural view of an outer sleeve mold of the artificial blood vessel manufacturing mold of fig. 1.

Wherein the above figures include the following reference numerals:

10. an outer sleeve mold; 20. an inner cylinder mold; 11. a second corrugated structure.

Detailed Description

It should be noted that, without conflict, the embodiments of the present application and features of the embodiments may be combined with each other. The application will be described in detail below with reference to the drawings in connection with embodiments.

In order that those skilled in the art will better understand the present application, a technical solution in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in which it is apparent that the described embodiments are only some embodiments of the present application, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the present application without making any inventive effort, shall fall within the scope of the present application.

It should be noted that the terms "first," "second," and the like in the description and the claims of the present application and the above figures are used for distinguishing between similar objects and not necessarily for describing a particular sequential or chronological order. It is to be understood that the terms so used are interchangeable under appropriate circumstances such that the embodiments of the application described herein are, for example, capable of operation in other environments. Furthermore, the terms "comprises," "comprising," and "having," and any variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, system, article, or apparatus that comprises a list of steps or elements is not necessarily limited to those steps or elements expressly listed but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of exemplary embodiments according to the present application. As used herein, the singular is also intended to include the plural unless the context clearly indicates otherwise, and furthermore, it is to be understood that the terms "comprises" and/or "comprising" when used in this specification are taken to specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof.

In view of the defects in the prior art, the application designs the small-caliber artificial blood vessel with the corrugated outer wall and the smooth inner wall by a brand new method, and designs the appearance of the artificial blood vessel into the first corrugated structure, so that the technical problem that the artificial blood vessel is easy to collapse or block when being bent in the prior art can be effectively solved, and the appearance of the first corrugated structure can improve the compliance, the support and the elasticity of the artificial blood vessel, so as to improve the bending property and the compliance of the artificial blood vessel and overcome the defects of the original corrugating treatment.

Specifically, the corrugated small-caliber artificial blood vessel comprises a blood vessel main body, wherein the outer wall of the blood vessel main body forms a first corrugated structure, and the inner wall of the blood vessel main body forms a smooth surface. The compliance, the supportability and the elasticity of the small-caliber artificial blood vessel can be improved through the first corrugated structure, the smooth blood flow in the small-caliber artificial blood vessel can be ensured through the smooth surface, and the possibility of thrombus occurrence is reduced.

As a preferred embodiment, the first corrugation is a wave-like structure or a thread-like structure. Both structures can effectively improve the elasticity of the artificial blood vessel, thereby enabling the artificial blood vessel to adapt to the bending of the blood vessel in the body. The wave-like structure resembles a natural wave, with successive peaks and valleys. The thread-like structure resembles a spiral or helical thread with a continuous rotation. The main purpose of the second corrugated structure 11 is to increase the flexibility and elasticity of the stent so that it can adapt to the shape and curvature of the vessel without compromising the stability of the stent.

Optionally, in the technical scheme of the embodiment, the caliber of the vessel main body is less than or equal to 6mm, and the technical scheme of the application has excellent improvement effect on the small-caliber artificial blood vessel.

The application provides an artificial blood vessel manufacturing mould, which comprises an outer sleeve mould 10 and an inner cylinder mould 20, wherein a second corrugated structure 11 is formed on the inner wall of the outer sleeve mould 10, and the outer wall of the inner cylinder mould 20 is a smooth surface. The outer sleeve mold 10 can be sleeved outside the inner cylinder mold 20, an artificial blood vessel manufacturing space is formed between the outer sleeve mold 10 and the inner cylinder mold 20, and the inner cylinder mold 20 is used for sleeving a main body structure for manufacturing the artificial blood vessel.

In the process of manufacturing a blood vessel by using the artificial blood vessel manufacturing mold of the present application, the inner cylinder mold 20 is used for sheathing a main body structure of manufacturing the artificial blood vessel, and the main body structure is generally woven by silk fibers with good biocompatibility so as to provide good mechanical properties and biocompatibility. The outer sleeve mold 10 may be fitted over the outer portion of the inner cylinder mold 20 to form a vascular manufacturing space between the two molds. The second corrugation 11 formed on the inner wall of the outer tube mold 10 may form a first corrugation on the outer wall of the manufactured artificial blood vessel to improve flexibility and bendability of the artificial blood vessel. The outer wall of the inner cylinder mold 20 is designed to be smooth, so that the inner wall of the manufactured artificial blood vessel can be smooth, and the resistance and the potential coagulation risk during blood flow can be reduced to the greatest extent.

As a preferred embodiment, the corresponding second corrugation 11 is a wave-like structure or a thread-like structure. The design and manufacture of the vascular prosthesis may choose a different second corrugation 11 depending on the particular situation and needs of the vessel. For example, for vessels of smaller diameter or greater curvature, the undulating configuration may be selected to increase the flexibility of the stent; whereas for vessels requiring more uniform support, a thread-like structure may be selected to improve stability.

Alternatively, the outer sleeve mold 10 is made of a resin material or a plastic material, and the inner cylinder mold 20 is made of a metal material or a glass material. The outer sleeve mold 10 may be made of a resin material or a plastic material. Both materials have good plasticity and can be made into various shapes, such as the second corrugation 11 in this patent. The inner cylinder mold 20 may be made of a metal material or a glass material. Both metal and glass have high hardness and durability, and can well maintain the shape and smoothness of the inner cylinder mold 20.

Resins and plastics are very desirable materials for the manufacture of the outer sleeve mold 10. Their physical properties allow us to fabricate molds of specific shape and size by heat, pressure, or other physical processes. This is particularly important when manufacturing a mould having a complex shape, such as the second corrugation 11. Metals and glass are desirable choices for making the inner cylindrical mold 20 due to their hardness and smoothness. The metal has high strength and wear resistance, which allows the metal mold to maintain its shape and dimensional stability during the manufacturing process. At the same time, the smooth surface of the metal and glass also contributes to an improved quality of the finished product, since it can reduce the surface roughness of the vascular prosthesis and thus reduce possible thrombosis.

Optionally, the ratio of the corrugation height to the corrugation pitch of the second corrugation 11 is 1: 1-1:1.5. In the technical solution of the present embodiment, the ratio of the height of the corrugations to the pitch of the corrugations of the second corrugated structure 11 is 1:1.

the second corrugation 11 is characterized by the height of the corrugations and the spacing of the corrugations, the setting of this ratio being of importance for the manufacturing process and the function of the final vascular prosthesis. First, a stable and consistent ratio may ensure consistency and predictability of the various parts in the manufacturing process, which is critical to a fine manufacturing process, from a manufacturing standpoint. In addition, this ratio also affects the functionality of the vascular prosthesis. A uniform corrugation pattern may provide a stable and consistent support force, which is critical to the function of the vascular prosthesis in the body. The shape and size of the corrugations can affect the flexibility and strength of the vascular prosthesis. An appropriate height and spacing ratio ensures that the vascular prosthesis provides adequate support while also providing flexibility to accommodate bending and stretching of the vessel. Thus, this ratio is selected taking into account the size and shape of the vessel, as well as the intended location and condition of use of the vascular prosthesis.

The application also provides a manufacturing method with the corrugated shape, which adopts the artificial blood vessel manufacturing mould to manufacture, and comprises the following steps:

s10: braiding silk fibers into a tube adapted to the outer diameter of the inner cylinder mould 20;

s20: sleeving the tubular object on the inner cylinder mould 20;

s30: inserting the inner cylinder mold 20 sleeved with the tubular object into the outer sleeve mold 10;

s40: preparing a sulfated silk fibroin solution, mixing the silk fibroin solution and polyethylene glycol diglycidyl ether to form a mixed solution, and injecting the mixed solution between the inner cylinder mold 20 and the outer sleeve mold 10;

s50: refrigerating and preserving the artificial blood vessel manufacturing mould injected with the mixed solution for a certain time, and then taking out the implant obtained between the inner cylinder mould 20 and the outer sleeve mould 10;

s60: the graft is placed in water to remove the polyethylene glycol diglycidyl ether.

The main materials used in the manufacturing method of the application are biological materials such as silk fiber, sulfated silk fibroin and the like. The silk fiber has excellent biocompatibility and biodegradability, and can be used as a good artificial blood vessel material. The addition of sulfated silk fibroin and silk fibroin further improves the biocompatibility of the scaffold and provides good mechanical properties. The manufacturing method comprises the steps of braiding silk fibers into a tubular object, performing shape setting through an outer sleeve mold 10 and an inner cylinder mold 20, and injecting a specific solution. After a certain period of cold storage, the graft in the vascular prosthesis manufacturing mold is removed, forming a vascular prosthesis having a corrugated profile. The artificial blood vessel not only has good biocompatibility, but also has good flexibility provided by the corrugated shape, and can adapt to the bending of the blood vessel. Finally, the graft is placed in water to remove polyethylene glycol diglycidyl ether, so that the potential harm of the chemical substance to human body is avoided, and the safety of the final artificial blood vessel is ensured.

Optionally, in S40, the sulfated silk fibroin solution is a solution with a sulfated silk fibroin concentration of 5% -8%; the silk fibroin solution is a solution with the concentration of 5% -8% of silk fibroin; the ratio of the sulfated silk fibroin solution to the polyethylene glycol diglycidyl ether is 1:1:2-1:1:4.

In the manufacture of vascular grafts, the biological materials used and their solution concentrations are critical to the biocompatibility, mechanical properties of the stent, and performance in the human body. In this process, the sulfated silk fibroin solution and the silk fibroin solution are used in order to increase the biocompatibility of the final product. The sulfated silk fibroin is a modified silk protein, and can provide better mechanical properties and durability. The polyethylene glycol diglycidyl ether may act as a solvent or stabilizer to help better distribute the silk fibroin and sulfated silk fibroin in the mixed solution, thereby covering the silk fiber woven tubing more uniformly to form a uniform vascular prosthesis. The above proportions are based on a large amount of experimental data, aiming at finding the optimal proportions in order to obtain artificial blood vessels with good biocompatibility and good mechanical properties.

Optionally, in S50, the temperature of the cold storage is-18 ℃ to-24 ℃, and the time of the cold storage is more than 20 hours. Frozen storage plays an important role in the manufacturing process of vascular grafts. This step was used during the experiment to fix and preserve the components in the mixed solution and allow them to form a uniform vascular prosthesis structure on the silk fiber braided tube. The low temperature may cause the proteins in the mixed solution to coagulate, forming a firm structure, which is important for the subsequent processing steps. In addition, the time factor is also critical in this process. According to a summary of the summarized properties, the time of cold storage is greater than 20 hours. Such a length of time ensures that the mixed solution has sufficient time to form a uniform and stable scaffold under low temperature conditions. At this stage, care is also taken to prevent ice crystal formation, as ice crystals may cause structural damage to the vascular graft. That is why the refrigeration is carried out at a relatively low temperature interval of-18 ℃ to-24 ℃, which temperature avoids the rapid formation of ice crystals and makes the scaffold easier to handle after removal.

Optionally, in S10, the tube is treated with Na2CO3 solution to remove sericin. In this process, na2CO3 solution is used to treat the woven tube of silk fibers. In alkaline sodium carbonate solution, sericin is dissolved and removed from the fiber, leaving a tube composed mainly of sericin. The treatment not only eliminates sericin, but also helps to improve hygroscopicity of the sericin, so that the sericin can be better combined with other components in the mixed solution, and a uniform and stable artificial blood vessel structure is formed.

From the above, the application provides a corrugated small-caliber artificial blood vessel and a corresponding manufacturing method, the manufacturing method is convenient and quick, the generated corrugation structure is stable, the uniformity is good, and the prepared vascular graft has a woven silk fiber structure and a porous silk fibroin sponge coating. The small-caliber artificial blood vessel with the corrugated outer wall prepared by the application can obviously improve the compliance, elasticity, bending property and supporting property of a blood vessel graft, can achieve the performance of not being shrunken when the blood flow is insufficient, can be bent according to the mechanical environment without blocking when being stressed, improves the mechanical property of the artificial blood vessel, and provides a basis for improving the long-term patency rate of the artificial blood vessel. In addition, the biocompatibility is good, the porous silk fibroin sponge is prepared by adopting silk fibroin, and the main structure of the blood vessel is woven by adopting silk fiber, so that the immunogenicity can be reduced, and the patency rate can be improved. The corrugating method provided by the application is convenient and quick, is simple and convenient to operate, can stably and uniformly prepare the corrugated structure of the outer wall of the vascular graft, does not obviously change the original vascular structure, does not need expensive instruments and equipment, is economical and is suitable for popularization.

The application provides a specific manufacturing method, which specifically comprises the following steps:

(1) Preparation of sulfated silk fibroin solution: taking 5g of silk fiber, boiling for 3 times in 0.1% Na2CO3 water solution, and removing sericin; dissolving the treated silk fibroin fibers in a LiBr solution with the concentration of 10mol/L at 60 ℃ and placing the solution in distilled water of a dialysis tube for balancing for 3 days to generate a silk fibroin solution, freeze-drying the silk fibroin solution for 24 hours to form silk fibroin sponge, and storing the silk fibroin sponge in a vacuum dryer for standby; slowly adding 10mL of chlorosulfonic acid into a beaker filled with 60mL of pyridine, adding 10g of silk fibroin sponge, heating to gradually raise the temperature to 80 ℃, and stirring for 1h at the temperature; after the reaction is finished, 100mL of distilled water is added into a beaker to stop the reaction, and NaOH solution with the same mole number is added for neutralization; removing insoluble parts in the system by vacuum filtration, and adding 500mL of ethanol to precipitate soluble silk fibroin sulfate; the precipitated silk fibroin is collected by centrifugation, dissolved with a small amount of water, and placed in a dialysis tube to be desalted by dialysis with distilled water to produce a sulfated silk fibroin solution.

(2) Preparation of silk fibroin vascular graft braided structures: silk fiber with the diameter of 0.075mm is selected, a 40-shaft braiding machine is used for braiding a tubular object with the required diameter, the braided structure is treated for 30 minutes at 98-100 ℃ by using 0.1% Na2CO3 solution, and the process is repeated for 3 times to remove sericin. The porosity of the knitting structure can be changed by adjusting the knitting angle.

(3) The preparation of the outer sleeve mold 10 for the corrugated small-caliber artificial blood vessel comprises the following steps: the outer sleeve mold 10 for forming the corrugating effect is designed in SolidWorks, the corrugating parameters can be adjusted according to the needs, the ratio of the corrugation height h to the corrugation pitch p is preferably about 1:1, in the outer sleeve mold of this example, the corrugation height h and the corrugation pitch p are both 0.5mm, the mold length is 30mm, the total thickness is 1mm, the diameter at the corrugation peak is 5mm, and the diameter at the corrugation trough is 4mm. And (3) exporting the STL format from the designed model, and performing 3D printing by using white photosensitive resin, wherein the printing precision is 0.05mm.

(4) Preparation of vascular grafts with corrugated outer walls: sleeving the braided tube prepared in the step (2) on a steel rod, wherein the steel rod is an inner cylindrical die 20, and the diameter of the steel rod is the inner diameter of a required small-caliber artificial hematopoietic tube, and in the example, the diameter of the inner cylindrical die is 3mm; and then inserted into the 3D printed outer sleeve mold 10. Mixing 5% concentration sulfuric acid acidified silk fibroin and 5% concentration silk fibroin solution 1:1 to form a blending solution, uniformly mixing the blending solution and polyethylene glycol diglycidyl ether according to a ratio of 1:1 to prepare a modified solution, and carefully adding the modified solution into a gap between a steel bar and an outer sleeve mold 10; the mould after the treatment is kept at the temperature of minus 20 ℃ for 24 hours, and then the implant is taken out of the steel bar and outer sleeve mould 10; the prepared corrugated vascular graft was then placed in water to remove the polyethylene glycol diglycidyl ether.

The intermediate layer of the graft prepared by the method is braided silk fiber, the inner layer and the outer layer are porous silk fibroin sponge, the inner wall is smooth, the outer wall is uniform in ripple effect, the inner diameter of the artificial blood vessel with ripple appearance is 3mm, the outer diameter is 4mm minimum and 5mm maximum, and the ripple height and the ripple distance are both 0.5mm.

The relative arrangement of the components and steps, numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present application unless it is specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective parts shown in the drawings are not drawn in actual scale for convenience of description. Techniques, methods, and apparatus known to one of ordinary skill in the relevant art may not be discussed in detail, but should be considered part of the specification where appropriate. In all examples shown and discussed herein, any specific values should be construed as merely illustrative, and not a limitation. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numerals and letters denote like items in the following figures, and thus once an item is defined in one figure, no further discussion thereof is necessary in subsequent figures.

Spatially relative terms, such as "above … …," "above … …," "upper surface at … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial location relative to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "above" or "over" other devices or structures would then be oriented "below" or "beneath" the other devices or structures. Thus, the exemplary term "above … …" may include both orientations of "above … …" and "below … …". The device may also be positioned in other different ways (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

In the description of the present application, it should be understood that the azimuth or positional relationships indicated by the azimuth terms such as "front, rear, upper, lower, left, right", "lateral, vertical, horizontal", and "top, bottom", etc., are generally based on the azimuth or positional relationships shown in the drawings, merely to facilitate description of the present application and simplify the description, and these azimuth terms do not indicate and imply that the apparatus or elements referred to must have a specific azimuth or be constructed and operated in a specific azimuth, and thus should not be construed as limiting the scope of protection of the present application; the orientation word "inner and outer" refers to inner and outer relative to the contour of the respective component itself.

The above description is only of the preferred embodiments of the present application and is not intended to limit the present application, but various modifications and variations can be made to the present application by those skilled in the art. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application should be included in the protection scope of the present application.

Claims

1. The corrugated small-caliber artificial blood vessel is characterized by comprising a blood vessel main body, wherein the outer wall of the blood vessel main body forms a first corrugated structure, and the inner wall of the blood vessel main body forms a smooth surface.

2. The corrugated small caliber artificial blood vessel according to claim 1, wherein the first corrugated structure is a wavy structure or a screw-like structure.

3. The corrugated small-caliber artificial blood vessel according to claim 1, wherein the caliber of the blood vessel main body is less than or equal to 6mm.

4. A method for manufacturing a corrugated small-caliber artificial blood vessel, characterized in that the manufacturing method is used for manufacturing the corrugated small-caliber artificial blood vessel according to any one of claims 1 to 3, and the manufacturing method is manufactured by using an artificial blood vessel manufacturing mold comprising:

an outer sleeve mold (10), wherein a second corrugated structure (11) is formed on the inner wall of the outer sleeve mold (10);

an inner cylinder mould (20), wherein the outer wall of the inner cylinder mould (20) is a smooth surface;

the outer sleeve mold (10) can be sleeved outside the inner column mold (20), an artificial blood vessel manufacturing space is formed between the outer sleeve mold (10) and the inner column mold (20), and the inner column mold (20) is used for sleeving and manufacturing a main body structure of the artificial blood vessel;

the manufacturing method comprises the following steps:

s10: braiding silk fibers into a tubular object matched with the outer diameter of an inner cylinder mould (20);

s20: sleeving the tubular object on the inner cylinder mould (20);

s30: inserting an inner cylindrical die (20) sleeved with the tubular object into the outer sleeve die (10);

s40: preparing a sulfated silk fibroin solution, a silk fibroin solution and polyethylene glycol diglycidyl ether, mixing the above mixed solutions, and injecting the mixed solutions between the inner cylinder mold (20) and the outer sleeve mold (10);

s50: refrigerating and preserving the artificial blood vessel manufacturing mould injected with the mixed solution for a certain time, and then taking out the implant obtained between the inner cylinder mould (20) and the outer sleeve mould (10);

5. The method according to claim 4, wherein, in S40,

the sulfated silk fibroin solution is a solution with 5% -8% of sulfated silk fibroin concentration;

the silk fibroin solution is a solution with the concentration of 5% -8% of silk fibroin;

the ratio of the sulfated silk fibroin solution to the polyethylene glycol diglycidyl ether is 1:1:2-1:1:4.

6. The method according to claim 4, wherein the temperature of the cold storage is-18 ℃ to-24 ℃ and the time of the cold storage is more than 20 hours in S50.

7. The method according to claim 4, wherein in S10, na is used ₂ CO ₃ The tube is treated with a solution to remove sericin.

8. The manufacturing method according to claim 4, characterized in that the second corrugated structure (11) is a wave-like structure or a thread-like structure.

9. The manufacturing method according to claim 4, wherein the outer sleeve mold (10) is made of a resin material or a plastic material, and the inner cylinder mold (20) is made of a metal material or a glass material.

10. The method of manufacturing according to claim 4, characterized in that the ratio of the corrugation height to the corrugation pitch of the second corrugated structure (11) is 1: 1-1:1.5.