CN114668899B - Ureteral stent tube based on bacterial cellulose composite coating and preparation method thereof - Google Patents
Ureteral stent tube based on bacterial cellulose composite coating and preparation method thereof Download PDFInfo
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- CN114668899B CN114668899B CN202210144587.8A CN202210144587A CN114668899B CN 114668899 B CN114668899 B CN 114668899B CN 202210144587 A CN202210144587 A CN 202210144587A CN 114668899 B CN114668899 B CN 114668899B
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- bacterial cellulose
- cellulose membrane
- tubular
- hollow tubular
- ureteral stent
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Abstract
本发明涉及一种基于细菌纤维素复合包覆的输尿管支架管及其制备方法，首先制备中空管状细菌纤维素膜Ⅲ，然后将可降解纤维编织在中空管状细菌纤维素膜Ⅲ的外壁上形成可降解纤维编织管，最后将中空管状细菌纤维素膜Ⅲ从沿长度方向的一端向另一端翻折形成管状细菌纤维素膜Ⅰ和管状细菌纤维素膜Ⅱ，使可降解纤维编织管位于两层管状细菌纤维素膜之间，即制得基于细菌纤维素复合包覆的输尿管支架管；制得的输尿管支架管为三层中空管状结构，中间层为可降解纤维编织管，外层和内层分别为管状细菌纤维素膜Ⅰ和管状细菌纤维素膜Ⅱ。本发明从结构上避免了降解碎片脱落所引起的安全问题，且制得的输尿管支架管综合性能较好。
The present invention relates to a ureteral stent tube based on bacterial cellulose composite coating and a preparation method thereof, firstly preparing a hollow tubular bacterial cellulose membrane III, then weaving degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III to form a degradable fiber braided tube, and finally folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction to form a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II, so that the degradable fiber braided tube is located between two layers of tubular bacterial cellulose membranes, that is, a ureteral stent tube based on bacterial cellulose composite coating is prepared; the prepared ureteral stent tube is a three-layer hollow tubular structure, the middle layer is a degradable fiber braided tube, and the outer layer and the inner layer are tubular bacterial cellulose membrane I and tubular bacterial cellulose membrane II, respectively. The present invention structurally avoids the safety problem caused by the falling of degradation fragments, and the prepared ureteral stent tube has good comprehensive performance.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and relates to a ureteral stent tube based on bacterial cellulose composite coating and a preparation method thereof.
Background
The ureteral stent has very wide application in urology surgery, is mainly used for the operations such as nephroureteral calculus, hydronephrosis, ureteral tumor, kidney transplantation and the like and the dilatation treatment of ureteral stenosis, and can play an important role in draining urine and preventing ureteral stenosis and adhesion blockage after being implanted into a ureter. The ureteral stent tube in clinical application is mostly made of silicon rubber or polyurethane polymer composite materials which cannot be degraded in human bodies, and has some defects which cannot be overcome in clinical application, such as the defect that the ureteral stent tube must be pulled out through invasive operation, namely cystoscope operation, but patients cannot feel pain in the operation, and more seriously, the ureteral stent tube can cause different degrees of damage to urinary tissues during the tube pulling, so that infection and edema occur, and emergency treatment is often needed.
The retention time of the ureteral stent is generally 4 weeks, and the existing ureteral stent is a non-degradable polyurethane stent in clinic, and the ureteral stent needs to be taken out after 4 weeks by secondary operation, so that the urinary tract system of a patient is damaged. Such as prolonged placement of the stent tube, can lead to more serious consequences such as loss of kidney function, or even the need to resect the kidney. Bringing great physical, mental and economic damage to patients. Non-degradable ureteral stent tubes also often cause complications, as the ureteral stent tube residence time is prolonged, these composite materials begin to affect the urothelium and urine components, leading to the formation of coatings around the ureteral stent tube, bacterial biofilms, and infections, all due to foreign body reactions caused by the non-degradable catheter in the body for a long period of time. In addition, the surface friction coefficient of the silicone rubber ureteral stent tube is high, the intubation is difficult during operation, and the silicone rubber ureteral stent tube is easy to slide after being placed in a body, so that the requirements of practical application cannot be well met.
Over the past several decades, the research and clinical use of degradable urethral and ureteral stents has evolved and has found wider application. The main materials are PLA, PGA and PLLA or PLGA. Degradation times are 2 to 12 months, depending on the material and process. In the early stage research, single material is adopted, and the obtained stent tube is difficult to control in degradation time, and has poor mechanical property and poor elasticity. After the composite material is adopted, the situation is improved. For example, chinese patent CN103041454B, adopts L-lactide/epsilon-caprolactone copolymer and crosslinked polyvinylpyrrolidone as raw materials, and obtains a degradable ureteral stent tube through blending extrusion. The wet friction of the surface of the stent tube added with polyvinylpyrrolidone is greatly reduced, the degradation rate is improved, the degradable component is promoted to be disintegrated into small fragments, and the ureter is prevented from being blocked by the degraded fragments to a certain extent. Chinese patent CN102266594B weaves two kinds of PGA and PGLA fibers with different degradation rates into a tube, and coats chitosan in the tube to obtain a gradually degradable weaved ureteral stent tube. The Chinese patent CN103211671B adds a heat treatment process on the basis of braiding into a tube, so that the low-melting-point component in the tube wall fiber material is fused into a film and is tightly and uniformly combined with other fiber components in the tube wall to strengthen the tube wall of the braided tube. The prepared ureteral stent tube has excellent axial stretching and flexibility of the fiber stent tube and excellent mechanical supporting performance of the film material stent tube. In summary, these methods solve the problems of gradual degradation and mechanical strength to some extent, but structurally, the problem of debris safety concerning degradation of the pipe wall material still remains. As reported by Boston Scientific company, a biodegradable ureteral drainage system based on bioabsorbable sodium alginate was developed that would remain for 48 hours before degradation, but faced serious problems in the clinical trial of the remaining debris, which caused discontinuation of the project. It is therefore necessary to avoid this problem fundamentally in ureteral stent tube designs.
Disclosure of Invention
The invention aims to solve the problems in the prior art and provides a ureteral stent tube based on bacterial cellulose composite coating and a preparation method thereof.
In order to achieve the above purpose, the invention adopts the following technical scheme:
a ureteral stent tube based on bacterial cellulose composite coating is of a three-layer hollow tubular structure, a middle layer is a degradable fiber woven tube, an outer layer and an inner layer are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II, and the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube;
the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are formed by folding a hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, and the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III.
The material used for coating the degradable fiber braided tube is bacterial cellulose (Bacterial cellulose, BC), is a natural nanofiber material obtained by bacterial fermentation, and has great application potential in the biomedical field. BC is very similar to natural plant cellulose in chemical composition and fiber structure, with glucose groups linked to the backbone by β -1, 4-glycosidic linkages and polymerized as a polymer. But the BC has high purity and does not contain lignin, pectin, hemicellulose and other associated products. When in static culture, BC forms a hydrogel-like membrane with a three-dimensional structure by using random coil nanofiber bundles, and the water content can reach more than 99%. The BC has extremely high strength and tearing resistance, the elastic modulus can be tens times that of common plant fibers, the BC has higher mechanical strength, high tensile strength and elastic modulus, and a large number of hydroxyl groups on the surface of the nanofiber enable the bacterial cellulose to have high water-holding capacity and high wet strength. BC has good biocompatibility and biodegradability, has good cell compatibility to various cells, and can promote proliferation and growth of cells.
As a preferable technical scheme:
According to the ureteral stent tube based on the bacterial cellulose composite coating, the outward surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves (the shapes of the grooves include but are not limited to rectangular, semicircular, conical and the like) which are uniformly arranged in parallel, the length direction of each rectangular groove is parallel to the axial direction of the tubular bacterial cellulose membrane I, the surface friction during insertion and extraction of the tubular bacterial cellulose membrane I is reduced, and the surface of the tubular bacterial cellulose membrane II is smooth.
The ureteral stent tube based on the bacterial cellulose composite coating, the degradable fiber braided tube is obtained by adopting a diamond braiding or regular braiding method from degradable fibers capable of slowly releasing functional substances, and the wall thickness of the tube wall can be properly reduced by adopting the diamond braiding or regular braiding method;
The degradable fiber capable of slowly releasing the functional substance is a blend fiber of synthetic fiber and chitosan fiber, the synthetic fiber is PLA, PLGA, PGA, PCL or polydioxanone fiber, the synthetic fiber contains silver ions or nano silver particles, and the chitosan fiber contains copper ions and zinc ions.
According to the ureteral stent tube based on the bacterial cellulose composite coating, the content of chitosan fibers in degradable fibers capable of slowly releasing functional substances is 3-15wt%;
The content of zinc ions is 0.1-5wt% of the chitosan fiber, the molar ratio of zinc ions to copper ions is 2:1-1.4, and the content of silver ions or nano silver particles is 0.1-2wt% of the chitosan fiber.
Zinc ion (Zn 2+) as an essential component of enzymes that maintain protein structural integrity and regulate gene expression, is involved in the regulation of immunity, cell growth and migration, plays a key role in tissue healing, and therefore, it is required that zinc ion is able to penetrate the entire tissue healing process and meet the release of a large amount in the early stage and also have a better sustained release ability in the middle and late stages. Copper ions (Cu 2+) can induce the expression of vascular endothelial growth factor in the proliferation and remodeling stages of tissue healing in the middle and later stages, promote angiogenesis and maintain the stability of collagen. Silver ions or nano silver particles have good antibacterial effect.
According to the ureteral stent tube based on the bacterial cellulose composite coating, the length of the rectangular grooves is equal to that of the tubular bacterial cellulose membrane I, the width is 50-200 nm, the height is 50-100 nm, and the distance between two adjacent rectangular grooves is 50-200 nm. The size of the rectangular groove is mainly set according to the experience of the prior study, the micro-nano scale is identified by endothelial cells, and the endothelial cells grow and proliferate rapidly along the groove, so that rapid endothelialization is achieved, and scar tissue generation is reduced.
The ureteral stent tube based on the bacterial cellulose composite coating has the length of 15-40 cm, the diameter of 1.5-3.5 mm, and the wall thickness of the ureteral stent tube of 0.1-0.5 mm, wherein the wall thickness of the degradable fiber woven tube of the middle layer is 0.08-0.45 mm, the wall thickness of the tubular bacterial cellulose membrane I and the wall thickness of the tubular bacterial cellulose membrane II are the same, and the general thickness is 0.02-0.2 mm.
The invention also provides a preparation method of the ureteral stent tube based on the bacterial cellulose composite coating, which comprises the steps of firstly preparing a hollow tubular bacterial cellulose membrane III, then braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III to form a degradable fiber braided tube, and finally turning the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction to form a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II, so that the degradable fiber braided tube is positioned between the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II, thus obtaining the ureteral stent tube based on the bacterial cellulose composite coating;
The woven area of the degradable fiber is the outer wall of the tubular bacterial cellulose membrane II.
As a preferable technical scheme:
The method comprises the following specific preparation steps of the ureteral stent tube based on bacterial cellulose composite coating:
(1) Uniformly mixing a fermentation strain and a fermentation culture solution, putting the mixture into a hollow tubular fermentation device, fermenting for 5-9 days, and purifying to obtain a hollow tubular bacterial cellulose membrane III; the hollow tubular fermentation device is a double-layer sleeve, the inner layer is a silica gel film with oxygen permeability (the test standard of the oxygen permeability is GB/T1038-2000, the differential pressure method of a plastic film and sheet gas permeability test method is set in the specification), the fermentation strain and the fermentation culture solution are placed between the double layers of the hollow tubular fermentation device, the inner layer of the hollow tubular fermentation device is filled with mixed gas, the pressure of the mixed gas is 1.1-1.5X10 5 Pa, the volume ratio of oxygen in the mixed gas is 25-40% (the set purpose is that the fermentation strain is oxygen consuming bacteria, and the fermentation speed can be improved under the condition of sufficient oxygen); 2, adopting mixed gas mainly for the consideration of cost and benefit, wherein other gases in the mixed gas are inert gases and the like, 3, keeping certain pressure to enable oxygen to better pass through a silica gel film, simultaneously enabling a part contacted with the silica gel film to be more compact and smooth in surface, dividing a hollow tubular fermentation device into A, B hollow tubular objects, enabling the silica gel film of the inner layer of the hollow tubular object A to have a smooth surface, enabling the silica gel film of the inner layer of the hollow tubular object B to have a patterning structure on the outward surface, wherein the patterning structure is a micro/nano forming patterning technology, forming a plurality of rectangular bulges on the surface of the silica gel film and uniformly arranged along the axial direction of the hollow tubular object B, wherein the length of each rectangular bulge is equal to the length of the hollow tubular object B, and the width of each rectangular bulge is 50-200 nm, the height is 50-100 nm, and the distance between two adjacent rectangular bulges is 50-200 nm;
(2) Placing a polytetrafluoroethylene rod in the hollow tubular bacterial cellulose membrane III after purification treatment (the pure bacterial cellulose is a hydrogel-like material and is supported by the polytetrafluoroethylene rod), braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III under the support of the polytetrafluoroethylene rod, and forming a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube, wherein the outer layer of the three-layer composite tube is a tubular bacterial cellulose membrane I, the inner layer of the three-layer composite tube is a tubular bacterial cellulose membrane II, and the outer wall of the tubular bacterial cellulose membrane I is provided with the rectangular groove;
(4) And sterilizing the three-layer composite tubular object to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The method comprises the steps that the fermentation strain is one or more of acetobacter xylinum, rhizobium, sarcina, pseudomonas, achromobacter, alcaligenes, aerobacter and azotobacter, the density of the fermentation strain added into the fermentation culture solution is 10 10～1013/ml, and the production efficiency is influenced by the too low density or the too high density;
The fermentation culture solution comprises, per 100ml, 5-30 g of glucose, 1-5 g of peptone, 1-5 g of yeast extract, 0.5-2 g of citric acid, 0.2-5 g of sodium dihydrogen phosphate, 3-5 g of magnesium sulfate, 3-5 g of sodium alginate and the balance of water, wherein the pH value of the fermentation culture solution is 4.0-6.0.
According to the method, the purification treatment is to soak the fermentation product into a sodium hydroxide solution with the concentration of 3-10wt%, keep the fermentation product at the temperature of 30-100 ℃ for 3-24 hours, and then wash the fermentation product with water to the pH value of 7.0. A great deal of researches prove that the bacterial cellulose membrane subjected to sodium hydroxide purification treatment has the purity of cellulose reaching more than 99 percent, has good biological safety and can be applied to the biomedical field.
The principle of the invention is as follows:
According to the research and the demand at present, the ideal ureteral stent has the following properties of 1, draining urine, having a certain mechanical support to prevent ureteral stenosis and adhesion blockage, 2, controllable degradation property, being capable of avoiding the safety problem caused by degradation fragments from the structural design point of view, 3, low surface wet friction coefficient, being easy to implant and take out the ureteral stent, reducing uncomfortable feeling of a patient, 4, keeping the ureteral stent for one month, and about 1/3 of the patient can generate urinary tract infection, so that the ideal ureteral stent has long-acting antibacterial, broad-spectrum antibacterial and low drug resistance, 5, the ureteral stent is used for replacing ureteral function due to the diseases of the urinary system of the patient, and has great practical significance if the ureteral stent can promote ureteral healing through the ureteral stent.
The ureteral stent tube based on bacterial cellulose composite coating is obtained by compositing bacterial cellulose with a degradable fiber woven tube capable of slowly releasing functional substances. The ureteral stent tube can drain urine and has a certain mechanical support to prevent ureter stenosis and adhesion blockage (the mechanical support is mainly provided by a degradable fiber woven tube, compared with the traditional stent tube, the stent tube obtained by adopting a fiber woven method has better mechanical property, and the using amount of materials and the wall thickness of a tube wall can be reduced). The biggest problem restricting the use of the degradable ureteral stent tube at present is uncontrollable risk caused by material degradation and shedding when the stent tube is used in vivo, but the invention uses bacterial cellulose with good biocompatibility in vivo to carry out surface recombination on the degradable braided tube, and the degradable braided tube is formed into an inner coating and an outer coating by folding one end of a hollow tubular bacterial cellulose membrane along the length direction to the other end. After being implanted into a body, when the degradable braided tube in the middle layer is degraded in the body, the degraded fragments can be prevented from falling off and directly entering the body due to a compact structure formed by the bacterial cellulose three-dimensional nano fiber, so that the safety requirement is met. The surface patterning design of the outer tubular bacterial cellulose reduces surface friction (on one hand, the surface patterning is along the axial direction, is more beneficial to the entry of a ureteral stent tube when the ureteral stent tube is inserted into the urethra, on the other hand, the surface patterning structure is more beneficial to the growth of surface cells after implantation, so that the formation of scar tissues by fibroblasts is inhibited, and the surface friction force is reduced when the ureteral stent tube is pulled out, so that the ureteral healing can be promoted). In addition, the slowly-released functional ions of the degradable fiber have the functions of antibiosis, immunoregulation and the like.
The beneficial effects are that:
(1) According to the ureteral stent tube based on the bacterial cellulose composite coating, the safety problem caused by falling of degradation fragments is structurally avoided through the wrapping of the bacterial cellulose on the braided tube, and the ureteral stent tube has good practical significance;
(2) The preparation method of the ureteral stent tube based on the bacterial cellulose composite coating is simple and feasible, can realize industrial production, has good comprehensive performance, and can meet various requirements.
Drawings
Fig. 1 is a schematic structural view of a ureteral stent tube based on bacterial cellulose composite coating of the present invention;
FIG. 2 is a schematic illustration of a hollow tubular bacterial cellulose membrane III folded over coated degradable fiber woven tube;
FIG. 3 is a schematic illustration of the surface patterning of a tubular bacterial cellulose membrane I (having a plurality of rectangular grooves uniformly arranged in parallel);
Fig. 4 is a graph showing the results of an ion release performance test of the ureteral stent tube based on the bacterial cellulose composite coating prepared in example 1;
Wherein, 1-outer layer, 2-middle layer, 3-inner layer, 4-hollow tubular bacterial cellulose membrane III.
Detailed Description
The application is further described below in conjunction with the detailed description. It is to be understood that these examples are illustrative of the present application and are not intended to limit the scope of the present application. Furthermore, it should be understood that various changes and modifications can be made by one skilled in the art after reading the teachings of the present application, and such equivalents are intended to fall within the scope of the application as defined in the appended claims.
Example 1
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing a fermentation strain (acetobacter xylinum) with a fermentation culture solution (each 100ml of fermentation culture solution contains 5g of glucose, 1g of peptone, 1g of yeast extract, 0.5g of citric acid, 0.2g of sodium dihydrogen phosphate, 3g of magnesium sulfate, 3g of sodium alginate and the balance of water), putting into a hollow tubular fermentation device, fermenting for 5 days, purifying (by soaking a fermentation product into a sodium hydroxide solution with the mass concentration of 3wt%, maintaining the fermentation product at 100 ℃ for 3 hours, and then washing with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III, wherein the density of the fermentation strain is 10 10 pieces/ml, the hollow tubular fermentation device is a double-layer sleeve, the inner layer is a silica gel membrane with the oxygen permeability of 1×10 5cm3/24 h & 0.1MPa, the fermentation strain and the fermentation culture solution are placed between the hollow tubular fermentation device, the inner layer is filled with a mixed gas, the pressure of 1.1×10 5 Pa, the volume of the mixed gas is equal to that of the hollow tubular membrane is 25 nm, the hollow tubular membrane is formed by forming a hollow tubular membrane with a rectangular tubular pattern with the length of 50nm, the two hollow tubular pattern structures of the hollow tubular pattern B and the hollow tubular pattern B is formed by two parallel tubular patterns, and the hollow tubular pattern structures are parallel to the hollow tubular pattern B and the hollow tubular pattern has a large-shaped tubular pattern surface structures and the hollow tubular pattern is 50nm and the hollow tubular pattern is formed by two hollow tubular film;
(2) Placing a polytetrafluoroethylene rod in a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a diamond braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half length along the length direction, so as to form a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III, wherein the degradable fibers are blend fibers of PLA fibers containing silver ions and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 3wt%, the content of zinc ions is 0.1wt% of the chitosan fibers, the molar ratio of zinc ions to copper ions is 2:1, and the content of silver ions is 0.8wt% of the chitosan fibers;
(3) As shown in fig. 2, the hollow tubular bacterial cellulose membrane III4 is folded from one end to the other end along the length direction, so that the degradable fiber woven tube is wrapped in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 15cm, the diameter of the ureteral stent tube is 1.5mm, the thickness of the tube wall is 0.1mm, the middle layer 2 is a degradable fiber woven tube with the tube wall thickness of 0.08mm, the outer layer 1 and the inner layer 3 are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of each rectangular groove is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 50nm, the length of each rectangular groove is 7.5cm, the width of each rectangular groove is 50nm, and the height of each rectangular groove is 50nm, as shown in FIG. 3.
And (3) detecting the correlation performance:
Biocompatibility detection, namely, referring to biological evaluation of GB/T16886 medical equipment, respectively evaluating cytotoxicity, guinea pig delayed contact sensitization, skin irritation and the like of a ureteral stent tube based on bacterial cellulose composite coating of a final product. The evaluation method comprises the following steps of testing the cytotoxicity test according to GB/T16886-5 medical instrument biological evaluation part 5 in-vitro cytotoxicity test, testing the guinea pig delayed type contact sensitization test according to GB/T16886-10 medical instrument biological evaluation part 10 stimulation and delayed type hypersensitivity test, and adopting a maximum test Magnusson method and a Kligman method. Skin irritation test the test was carried out according to GB/T16886-10 medical device biological evaluation part 10 irritation and delayed hypersensitivity test. The evaluation result shows that the ureteral stent tube based on the bacterial cellulose composite coating, which is prepared in the embodiment 1, has cytotoxicity less than 1 level, no skin sensitization reaction, no intradermal stimulation reaction and good biosafety.
In vitro degradation experiments an artificial urine formulation was prepared according to the method of experiments on YY/T0872-2013 ureteral stents, appendix A, formulation 1. The ureteral stent tube based on the bacterial cellulose composite coating, which is prepared in the embodiment 1 of the invention, is sterilized and then placed into a simulated urine, a constant temperature and constant speed shaking table at 37 ℃ and 60r/min is subjected to in-vitro simulated degradation test, and the degradation condition of the ureteral stent tube within 5 weeks is observed. The results show that the test sample was completely degraded in the tubular structure within 4 weeks, wherein the middle layer 2 began to loose and break the fiber weave structure at 3 weeks, and further the degraded fibrous material was observed to be packed between the outer layer 1 and the inner layer 3, and no release of degradation fragments occurred, indicating that the present invention structurally avoids the safety problem caused by the falling of degradation fragments.
And (3) testing ion release performance, namely testing the content of silver ions, zinc ions and copper ions released by the sample in the simulated urine by using an atomic absorption spectrometer, wherein the test lasts for 12 days. The test time points are 6h, 12h, 18h, 24h, 48h, 96h, 144h, 192h, 240h and 288h respectively. Ion release rate = the ion content in the simulated urine/total ion content in the sample at different time points, the test results are shown in fig. 4, and the test results show that the ureteral stent tube of the present invention can continuously and effectively release a plurality of ions. The silver ion can provide continuous and effective antibacterial performance, the zinc ion can penetrate through the whole tissue healing process, can meet the requirement of larger release in the early stage and has better continuous release capability in the middle and later stages, and copper ion (Cu 2+) can induce the expression of vascular endothelial growth factor in the proliferation and remodeling stages of tissue healing in the middle and later stages, promote angiogenesis and maintain the stability of collagen.
Antibacterial property test the ureteral stent tube based on the bacterial cellulose composite coating, which is prepared in the embodiment 1, is tested by adopting AATCC-100 to have the antibacterial property of 99 percent, and is tested by adopting AATCC-100 to have the antibacterial property of 99 percent after being continuously used for 21 days. The test strain is Escherichia coli and Staphylococcus aureus.
Example 2
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing a fermentation strain (rhizobia) with a fermentation culture solution (each 100ml of the fermentation culture solution contains 5g of glucose, 1g of peptone, 1g of yeast extract, 0.5g of citric acid, 0.2g of sodium dihydrogen phosphate, 3g of magnesium sulfate, 3g of sodium alginate and the balance of water), putting into a hollow tubular fermentation device, fermenting for 5 days, and purifying (namely soaking a fermentation product into a sodium hydroxide solution with the mass concentration of 4wt% for 3 hours at the temperature of 80 ℃, and then washing with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III; the method comprises the steps of adding fermentation strains with the density of 5X 10 10/ml into fermentation culture solution, dividing the fermentation culture solution into A, B hollow tubular objects, wherein the inner layer of the hollow tubular object A is provided with a double-layer sleeve, the outer surface of the inner layer of the hollow tubular object B is provided with a patterning structure, the patterning structure is a plurality of rectangular protrusions which are formed on the surface of the silica gel film and are uniformly arranged along the axial direction of the hollow tubular object B in parallel by adopting a micro/nano forming patterning technology, the space between every two adjacent rectangular protrusions is 50nm, the length of each rectangular protrusion is equal to the length of the hollow tubular object B, the width of each rectangular protrusion is 50nm, and the height of each rectangular protrusion is 60nm;
(2) Placing a polytetrafluoroethylene rod in a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a diamond braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half length along the length direction, so as to form a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III, wherein the degradable fibers are blend fibers of PLGA fibers containing silver ions and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 4wt%, the content of the zinc ions is 0.3wt% of the chitosan fibers, the molar ratio of the zinc ions to the copper ions is 2:1, and the content of the silver ions is 1.1wt% of the chitosan fibers;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 20cm, the diameter of the ureteral stent tube is 1.5mm, the thickness of the tube wall is 0.1mm, the middle layer of the ureteral stent tube is a degradable fiber woven tube with the tube wall thickness of 0.10mm, the outer layer and the inner layer of the ureteral stent tube are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward facing surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of the rectangular grooves is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 50nm, the length of the rectangular grooves is 10cm, the width of each rectangular groove is 50nm, and the height of each rectangular groove is 60nm.
Example 3
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing fermentation strains (sarcina and acetobacter xylinum in a ratio of 1:1) with fermentation culture solution (10 g glucose, 2g peptone, 2g yeast extract, 1g citric acid, 0.8g sodium dihydrogen phosphate, 3.4g magnesium sulfate, 3g sodium alginate and the balance of water are contained in each 100ml fermentation culture solution), putting into a hollow tubular fermentation device, fermenting for 6 days, purifying (namely soaking fermentation products into a sodium hydroxide solution with a mass concentration of 5wt%, keeping the fermentation products at 70 ℃ for 6 hours, and then washing with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III; wherein, the fermentation culture solution is added with a fermentation strain with the density of 8 multiplied by 10 10/ml, the hollow tubular fermentation device is a double-layer sleeve, the inner layer is a silica gel film with the oxygen permeability of 2.4 multiplied by 10 5cm3/24 h.0.1 MPa, the fermentation strain and the fermentation culture solution are placed between the double layers of the hollow tubular fermentation device, the inner layer of the hollow tubular fermentation device is filled with mixed gas with the pressure of 1.2 multiplied by 10 5 Pa, the volume ratio of oxygen in the mixed gas is 28 percent, and the rest is argon, the hollow tubular fermentation device is divided into A, B hollow tubular objects, the silica gel film of the inner layer of the hollow tubular object A is provided with a smooth surface, the outward surface of the silica gel film of the inner layer of the hollow tubular object B is provided with a patterning structure, the patterning structure refers to a micro/nano forming patterning technology, the rectangular protrusions which are uniformly arranged on the surface of the silica gel film along the axial direction of the hollow tubular object B, the distance between the two adjacent rectangular protrusions is 80nm, the length of the rectangular protrusions is equal to the length of the hollow tubular object B, the width is 60nm, and the height is 60nm;
(2) Placing a polytetrafluoroethylene rod in a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a diamond braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half length along the length direction, so as to form a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III, wherein the degradable fibers are blend fibers of PGA fibers containing silver ions and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 6wt%, the content of zinc ions is 0.8wt% of the chitosan fibers, the molar ratio of zinc ions to copper ions is 2:1.2, and the content of silver ions is 1.4wt% of the chitosan fibers;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 30cm, the diameter of the ureteral stent tube is 2.0mm, the thickness of the tube wall is 0.2mm, the middle layer of the ureteral stent tube is a degradable fiber woven tube with the tube wall thickness of 0.15mm, the outer layer and the inner layer of the ureteral stent tube are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward facing surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of the rectangular grooves is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 80nm, the length of the rectangular grooves is 15cm, the width of each rectangular groove is 60nm, and the height of each rectangular groove is 60nm.
Example 4
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing a fermentation strain (pseudomonas) with a fermentation culture solution (each 100ml of fermentation culture solution contains 10g of glucose, 2g of peptone, 2g of yeast extract, 1g of citric acid, 1.2g of sodium dihydrogen phosphate, 3.6g of magnesium sulfate, 4g of sodium alginate and the balance of water), putting into a hollow tubular fermentation device, fermenting for 8 days, purifying (by which is meant that a fermentation product is soaked into a sodium hydroxide solution with the mass concentration of 6wt%, the fermentation product is kept for 6 hours at the temperature of 60 ℃, and then is washed with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III, wherein the density of the fermentation strain is 2×10 11 per ml, the hollow tubular fermentation device is a double-layer sandwich pipe, the inner layer is a silica gel film with the oxygen permeability of 4×10 5cm3/24 h.0.1 MPa, the inner layer of the hollow tubular fermentation device is filled with mixed gas, the pressure of the mixed gas is 1.2×10 Pa, the volume of the mixed gas is 60 ℃ and the volume of the mixed gas is equal to that of the hollow tubular film is formed into a hollow tubular film with the hollow tubular pattern with the length of 80nm, the hollow tubular pattern is formed by two parallel tubular patterns, the hollow tubular patterns are formed by two hollow tubular patterns with the hollow tubular patterns of a rectangular tubular patterns with the length of 35 nm, and the hollow tubular patterns are formed by the hollow tubular patterns, and the hollow tubular patterns are respectively, and the hollow tubular hollow tubular film has a hollow tubular film-shaped hollow tubular film structures and a hollow tubular film;
(2) Placing a polytetrafluoroethylene rod in a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a diamond braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half of the length in the length direction, so that a degradable fiber braided tube is formed on the hollow tubular bacterial cellulose membrane III, the degradable fibers are blend fibers of PCL fibers containing silver ions and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 7.5wt%, the content of the zinc ions is 1.2wt% of the chitosan fibers, the molar ratio of the zinc ions to the copper ions is 2:1.2, and the content of the silver ions is 2wt% of the chitosan fibers;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 30cm, the diameter of the ureteral stent tube is 2.0mm, the thickness of the tube wall is 0.2mm, the middle layer of the ureteral stent tube is a degradable fiber woven tube with the tube wall thickness of 0.2mm, the outer layer and the inner layer of the ureteral stent tube are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward facing surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of the rectangular grooves is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 100nm, the length of the rectangular grooves is 15cm, the width of each rectangular groove is 80nm, and the height of each rectangular groove is 80nm.
Example 5
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing a fermentation strain (Achromobacter) with a fermentation culture solution (each 100ml of the fermentation culture solution contains 16g of glucose, 3g of peptone, 3g of yeast extract, 1.2g of citric acid, 2.4g of sodium dihydrogen phosphate, 4.1g of magnesium sulfate, 4g of sodium alginate and the balance of water), putting into a hollow tubular fermentation device, fermenting for 9 days, and purifying (namely soaking a fermentation product into a sodium hydroxide solution with the mass concentration of 7wt% for 8 hours at the temperature of 50 ℃, and then washing with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III; the method comprises the steps of adding a fermentation strain with the density of 6×10 11/ml into a fermentation culture solution, dividing the fermentation culture solution into A, B two hollow tubes in the fermentation culture solution, wherein the inner layer is a silica gel film with the oxygen permeability of 6×10 5cm3/24 h.0.1 MPa, placing the fermentation strain and the fermentation culture solution between the double layers of the fermentation culture solution in the fermentation culture solution, filling mixed gas into the inner layer of the fermentation culture solution, wherein the pressure of the mixed gas is 1.2×10 5 Pa, the volume ratio of oxygen in the mixed gas is 32%, and the balance is argon, dividing the fermentation culture solution into A, B two hollow tubes in the fermentation culture solution, the silica gel film of the inner layer of the hollow tube A has a smooth surface, the outer surface of the silica gel film of the inner layer of the hollow tube B has a patterning structure, wherein the patterning structure refers to a micro/nano-shaped patterning technology, a plurality of rectangular protrusions which are uniformly arranged along the axial direction of the hollow tube B and are formed on the surface of the silica gel film, the distance between every two adjacent rectangular protrusions is 120nm, the length of the rectangular protrusions is equal to the length of the hollow tube B, and the width is 100nm, and the height is 80nm;
(2) Placing a polytetrafluoroethylene rod in a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a regular braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half of the length in the length direction, so as to form a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III, wherein the degradable fibers are blend fibers of PLA fibers containing nano silver particles and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 8wt%, the content of the zinc ions is 1.5wt% of the chitosan fibers, the molar ratio of the zinc ions to the copper ions is 2:1.2, and the content of the nano silver particles is 0.1wt% of the chitosan fibers;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 35cm, the diameter of the ureteral stent tube is 2.5mm, the thickness of the tube wall is 0.3mm, the middle layer of the ureteral stent tube is a degradable fiber woven tube with the tube wall thickness of 0.25mm, the outer layer and the inner layer of the ureteral stent tube are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward facing surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of the rectangular grooves is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 120nm, the length of the rectangular grooves is 17.5cm, the width of the rectangular grooves is 100nm, and the height of the rectangular grooves is 80nm.
Example 6
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing fermentation strains (alcaligenes, rhizobium and acetobacter xylinus, wherein the ratio of the numbers of the three strains is 1:1:1) with fermentation culture fluid (18 g of glucose, 4g of peptone, 4g of yeast extract, 1.5g of citric acid, 4.2g of sodium dihydrogen phosphate, 4.5g of magnesium sulfate, 4g of sodium alginate and the balance of water are contained in each 100ml of fermentation culture fluid), putting the mixture into a hollow tubular fermentation device, fermenting for 9 days, and then purifying the mixture (namely soaking a fermentation product into a sodium hydroxide solution with the mass concentration of 8wt% for 10 hours at the temperature of 40 ℃, and then washing the fermentation product with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III; wherein the fermentation culture solution is added with fermentation strain with the density of 10 12/ml, the hollow tubular fermentation device is a double-layer sleeve, the inner layer is a silica gel film with the oxygen permeability of 8×10 5cm3/24 h.0.1 MPa, the fermentation strain and the fermentation culture solution are placed between the double layers of the hollow tubular fermentation device, the inner layer of the hollow tubular fermentation device is filled with mixed gas with the pressure of 1.3×10 5 Pa, the volume ratio of oxygen in the mixed gas is 36 percent, and the rest is argon, the hollow tubular fermentation device is divided into A, B two hollow tubular objects, the silica gel film of the inner layer of the hollow tubular object A is provided with a smooth surface, the outward surface of the silica gel film of the inner layer of the hollow tubular object B is provided with a patterning structure, the patterning structure refers to a micro/nano forming patterning technology, a plurality of rectangular bulges which are uniformly arranged along the axial direction of the hollow tubular object B and are formed on the surface of the silica gel film, the distance between every two adjacent rectangular bulges is 150nm, the length of the rectangular bulges is equal to the length of the hollow tubular object B, 100nm wide and 90nm high;
(2) Placing a polytetrafluoroethylene rod into a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a regular braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half length along the length direction, so as to form a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III, wherein the degradable fibers are blend fibers of polydioxanone fibers containing nano silver particles and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 10wt%, the content of the zinc ions is 2.2wt% of the chitosan fibers, the molar ratio of the zinc ions to the copper ions is 2:1.3, and the content of the nano silver particles is 0.4wt% of the chitosan fibers;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 35cm, the diameter of the ureteral stent tube is 2.5mm, the thickness of the tube wall is 0.3mm, the middle layer of the ureteral stent tube is a degradable fiber woven tube with the tube wall thickness of 0.3mm, the outer layer and the inner layer of the ureteral stent tube are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward facing surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of the rectangular grooves is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 150nm, the length of the rectangular grooves is 17.5cm, the width of the rectangular grooves is 100nm, and the height of the rectangular grooves is 90nm.
Example 7
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing a fermentation strain (aerobacillus) with a fermentation culture solution (25 g of glucose, 4.5g of peptone, 4g of yeast extract, 1.8g of citric acid, 4.6g of sodium dihydrogen phosphate, 5g of magnesium sulfate and the balance of water are contained in each 100ml of fermentation culture solution), putting the mixture into a hollow tubular fermentation device, fermenting for 9 days, purifying (namely, soaking a fermentation product into a sodium hydroxide solution with the mass concentration of 9wt%, keeping the fermentation product for 12 hours at the temperature of 35 ℃ and then washing the fermentation product with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III, wherein the density of the fermentation strain added into the fermentation culture solution is 8×10 12/ml, the hollow tubular fermentation device is a double-layer sandwich tube, the inner layer is a silica gel membrane with the oxygen permeability of 9.3×10 5cm3/24 h & 0.1MPa, the inner layer of the hollow tubular fermentation device is filled with mixed gas, the pressure of the mixed gas is 355×10 Pa, the volume of the mixed gas is equal to 35 nm, the volume of the mixed gas is equal to that of the hollow tubular membrane is 35 nm, the hollow tubular membrane is formed into a rectangular tubular membrane with the space between two tubular bulge structures, and the two hollow tubular bulge structures are formed, the hollow tubular bulge structures are formed, wherein the hollow tubular bulge structures are formed by the hollow tubular bulge structures and the hollow tubular bulge structures are parallel to the hollow tubular structures and the hollow tubular bulge structures are 100nm, and the hollow tubular bulge structures are formed, and the hollow tubular structures are the hollow tubular membrane structures are the hollow tubular structures are formed;
(2) Placing a polytetrafluoroethylene rod into a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a regular braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half of the length in the length direction, so as to form a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III, wherein the degradable fibers are blend fibers of PLGA fibers containing nano silver particles and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 12.3wt%, the content of the zinc ions is 3.6wt% of the chitosan fibers, the molar ratio of the zinc ions to the copper ions is 2:1.4, and the content of the nano silver particles is 0.6wt% of the chitosan fibers;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 40cm, the diameter of the ureteral stent tube is 3.0mm, the thickness of the tube wall is 0.4mm, the middle layer of the ureteral stent tube is a degradable fiber woven tube with the tube wall thickness of 0.4mm, the outer layer and the inner layer of the ureteral stent tube are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward facing surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of the rectangular grooves is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 150nm, the length of the rectangular grooves is 20cm, the width of each rectangular groove is 120nm, and the height of each rectangular groove is 100nm.
Example 8
A preparation method of a ureteral stent tube based on bacterial cellulose composite coating comprises the following specific steps:
(1) Uniformly mixing a fermentation strain (nitrogen fixing bacteria) with a fermentation culture solution (30 g of glucose, 5g of peptone, 5g of yeast extract, 2g of citric acid, 5g of sodium dihydrogen phosphate, 5g of magnesium sulfate, 5g of sodium alginate and the balance of water are contained in each 100ml of fermentation culture solution), putting the mixture into a hollow tubular fermentation device, fermenting for 9 days, purifying the mixture (namely, soaking the fermentation product into 10wt% sodium hydroxide solution, keeping the mixture at the temperature of 30 ℃ for 24 hours, and then washing the mixture with water until the pH value is 7.0) to obtain a hollow tubular bacterial cellulose membrane III, wherein the density of the fermentation strain added into the fermentation culture solution is 10 13 pieces/ml, the hollow tubular fermentation device is a double-layer sleeve, the inner layer is a silica gel membrane with oxygen permeability of 10×10 5cm3/24 h.1 MPa, the pressure of the mixed gas is 1.5×1035 Pa, the volume of the rest of the mixed gas is equal to that of oxygen in the mixed gas is 30 ℃, the inner layer of the hollow tubular fermentation device is a rectangular tubular membrane with the length of 200nm, and the hollow tubular membrane is a rectangular tubular membrane with a parallel and a hollow tubular pattern with a large axial length of 200nm, and a hollow tubular pattern is formed by two-shaped and a hollow tubular membrane with a rectangular tubular pattern with a large axial length of 200nm and a large-diameter and a hollow tubular membrane is formed;
(2) Placing a polytetrafluoroethylene rod in a hollow tubular bacterial cellulose membrane III after purification treatment, braiding degradable fibers on the outer wall of the hollow tubular bacterial cellulose membrane III by adopting a regular braiding method under the support of the polytetrafluoroethylene rod, wherein the braiding area is all the area of the hollow tubular bacterial cellulose membrane III from one end to half of the length in the length direction, so as to form a degradable fiber braided tube on the hollow tubular bacterial cellulose membrane III, wherein the degradable fibers are blend fibers of PCL fibers containing nano silver particles and chitosan fibers containing copper ions and zinc ions, the content of the chitosan fibers in the blend fibers is 15wt%, the content of the zinc ions is 5wt% of the chitosan fibers, the molar ratio of the zinc ions to the copper ions is 2:1.4, and the content of the nano silver particles is 0.1wt% of the chitosan fibers;
(3) Folding the hollow tubular bacterial cellulose membrane III from one end to the other end along the length direction, so that the degradable fiber woven tube is coated in the middle to form a three-layer composite tube;
(4) And (3) sterilizing the three-layer composite tube obtained in the step (3) to obtain the ureteral stent tube based on bacterial cellulose composite coating.
The ureteral stent tube based on the bacterial cellulose composite coating is of a three-layer hollow tubular structure, the length of the ureteral stent tube is 40cm, the diameter of the ureteral stent tube is 3.5mm, the thickness of the tube wall is 0.5mm, the middle layer of the ureteral stent tube is a degradable fiber woven tube with the tube wall thickness of 0.45mm, the outer layer and the inner layer of the ureteral stent tube are respectively a tubular bacterial cellulose membrane I and a tubular bacterial cellulose membrane II with the same wall thickness, the tubular bacterial cellulose membrane I and the tubular bacterial cellulose membrane II are respectively attached to the inner wall and the outer wall of the degradable fiber woven tube, the length of the tubular bacterial cellulose membrane I is half of that of the hollow tubular bacterial cellulose membrane III, the outward facing surface of the tubular bacterial cellulose membrane I is provided with a plurality of rectangular grooves which are uniformly arranged in parallel, the length direction of the rectangular grooves is parallel to the axial direction of the tubular bacterial cellulose membrane I, the distance between every two adjacent rectangular grooves is 200nm, the length of the rectangular grooves is 20cm, the width of each rectangular groove is 200nm, and the height of each rectangular groove is 100nm.
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| CN103007344A (en) * | 2012-12-26 | 2013-04-03 | 东华大学 | Hollow heterotype bacteria cellulose artificial blood vessel stent material with gradient structure and preparation method thereof |
| CN106540327A (en) * | 2016-12-06 | 2017-03-29 | 北京航空航天大学 | A kind of three layers of artificial blood vessel bracket of imitative nature blood vessel and preparation method thereof |
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