CN107233632B - Degradable and recoverable 4D printing linear organic human body stent and preparation method thereof - Google Patents
Degradable and recoverable 4D printing linear organic human body stent and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a degradable and recoverable 4D printing linear organic human body stent and a preparation method thereof, wherein the human body stent comprises a skeleton part, a functional protein membrane and a chitosan membrane; the surface layer of the framework part is covered with a functional protein film, and the surface layer of the functional protein film is covered with a chitosan film; the skeleton part is prepared by polylactic acid and carboxymethyl chitosan. According to the human body stent provided by the invention, the adopted polylactic acid and chitosan have good human body compatibility, and no rejection reaction occurs; the adopted functional protein can play a role in ablating thrombus and has good biocompatibility and bioabsorbability; the 4D memorable deformation printing material of adoption after implanting the stenosis position, can provide effectual support earlier stage, guarantees that the blood vessel is unobstructed, and after later stage support absorbs, its decomposition product can be absorbed by the health, utilizes or discharge extracorporeally, and the target blood vessel is interior to have no residual foreign matter, and the at utmost resumes vascular function of stretching back to leave leeway for secondary intervention.
Description
Technical Field
The invention relates to the technical field of human body stents, in particular to a degradable and recoverable 4D printing linear organic human body stent and a preparation method thereof.
Background
According to the data of Chinese sanitary statistics essences, the number of patients suffering from cardiovascular and cerebrovascular diseases exceeds 2.7 hundred million at present, the number of deaths caused by the cardiovascular and cerebrovascular diseases is close to 40 percent of the total number of deaths in the whole country, and the traditional Chinese cardiovascular and cerebrovascular disease is a healthy first killer of the Chinese. The main causes of cardiovascular diseases are that excessive fat substances and calcium deposit on the vascular wall to thicken the vascular wall, so that the blood vessel is narrowed or blocked to cause difficulty in blood circulation, and further angina pectoris and myocardial infarction are generated until death. The main means for resisting cardiovascular diseases is interventional therapy which adopts a percutaneous puncture approach to insert a special stent into a lesion area for diagnosis and treatment. The principle is that the stent is implanted into a narrowed blood vessel to generate continuous radial pressure on the inner wall of the blood vessel, so that deposits attached to the wall of the blood vessel are forced to be concentrated and supported to open the blood vessel.
Some existing vascular stents are made of metal materials and are not degradable, and Chinese patent 201410266420.4 discloses a vascular stent which is made of non-degradable metal materials. Patients implanted with such metal vascular stents are not able to do nuclear magnetic resonance. The stent typically completes its life of supporting the vessel for several months, after which the vessel returns to normal and no longer needs a stent. Patients who have implanted non-degradable vascular stents are then at risk of secondary stenosis, once which must be subjected to the pain of a bypass surgery.
Hirudin is a small molecular protein (polypeptide) extracted from Hirudo and its salivary gland. Hirudin has strong anticoagulant effect, and can be tightly combined with thrombin at a ratio of 1:1 to form a compound, so as to inactivate thrombin. Unlike heparin, its anticoagulant effect does not require the presence of AT III in plasma and is indicated for patients who lack AT III but require anticoagulant therapy. Has weak effect on platelets, does not cause thrombocytopenic purpura like heparin, and can be used for patients with thrombocytopenia but needing anticoagulation treatment. However, hirudin has a short serum half-life in use, and is difficult to continuously exert an antithrombotic effect by direct injection or oral administration. The lumbrokinase has special affinity with thrombus (fibrin), can track thrombolysis, effectively dissolve thrombus, improve microcirculation, strengthen collateral circulation of cerebral vessels, openly repair damaged endothelial cells of blood vessels, increase elasticity of blood vessels, improve oxygen supply function of blood vessels, reduce blood viscosity, reduce platelet aggregation rate, and inhibit thrombus from forming again. The current clinical application of lumbrukinase is mainly in the form of oral medicine, and side effects include causing digestive tract reaction and low absorption efficiency through digestive tract.
Besides vascular stents, the same problems are faced in the field of human stents such as intestinal stents, biliary stents and the like.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a degradable and recoverable 4D printing linear organic human body stent and a preparation method thereof, so as to improve the compatibility of the human body stent and a human body, reduce the stimulation to the vessel wall and avoid the occurrence of rejection reaction; in addition, the chitosan, the polylactic acid and the protein adopted by the invention are all substances which can be decomposed or degraded in vivo, so that the pain of taking a bypass operation after secondary stenosis is avoided.
In order to achieve the purpose, the technical scheme provided by the invention is as follows:
in a first aspect, the present invention provides a human body scaffold comprising a scaffold, a functional protein membrane and a chitosan membrane; the surface layer of the framework part is covered with a functional protein film, and the surface layer of the functional protein film is covered with a chitosan film; the framework part is prepared from levorotatory polylactic acid, dextrorotatory polylactic acid and carboxymethyl chitosan.
In a further embodiment of the invention, the body contour structure of the body scaffold is in the shape of a helical tube, the body scaffold comprising a helix and a mounting ring; wherein, the collar is located the both ends of spiral portion, is equipped with a fixed orifices on the collar.
In a further embodiment of the present invention, the spiral part comprises a plurality of spiral units connected in series, each spiral unit comprising a circumferential unit and a plurality of support units; the supporting units are arched bulges parallel to the axial direction of the human body support, the circumferential units are spiral, the supporting units are uniformly distributed on the circumferential units, the interval angle of each supporting unit is equal, and the directions of two adjacent supporting units are opposite.
In a further embodiment of the invention, a chamfer is provided between the mounting ring and the spiral; a chamfer is arranged between the supporting unit and the circumferential unit.
In a further embodiment of the invention, in each helical unit: the number of the supporting units is even number, and is preferably 4; the interval angle of each supporting unit is 90 degrees.
In a further embodiment of the invention, the mounting ring is formed by a support unit closed with the circumferential unit.
In a further embodiment of the invention, the body scaffold is used for support of blood vessels, pancreatic ducts, bile ducts, intestines, ureters, oesophagus or nasal cavities.
In a further embodiment of the present invention, the shape of the shaft axis of the supporting unit includes one or more of a sine wave shape, an arc shape, a U shape, and a parabolic shape.
In a second aspect, the present invention provides a method for preparing a human body scaffold, comprising the steps of: s1: uniformly mixing the levorotatory polylactic acid and the dextrorotatory polylactic acid to obtain mixed powder; s2: heating and melting the mixed powder, and then extruding and molding the 4D printing raw material wire by using a mold; s3: printing the 4D printing raw material wire into a preset human body support shape by adopting a 4D printing technology to obtain a human body support blank; s4: immersing the human body stent blank into the functional protein film-hanging liquid, taking out and carrying out freeze-drying treatment to obtain a human body stent semi-finished product; s5: and (3) immersing the semi-finished human body stent into the chitosan film-hanging liquid, and taking out the semi-finished human body stent for freeze-drying treatment to obtain the finished human body stent.
In a further embodiment of the invention, in S1, the mass ratio of the L-polylactic acid to the D-polylactic acid to the carboxymethyl chitosan is 1 (0.8-1.1): (0.4-0.5); in S2, the heating temperature is 130-155 ℃, and the diameter of the 4D printing raw material wire is 1-3 mm; in S4, the immersion time is 2-5 seconds, and the freeze-drying temperature is-40 ℃; in S5, the immersion time is 2-5 seconds, and the freeze-drying temperature is-40 ℃.
In a further embodiment of the present invention, in S4, the functional protein membrane-hanging solution comprises the following raw material components: 20 parts of hirudin, 20 parts of lumbrokinase, 2 parts of thickener and 160 parts of hexafluoroisopropanol; wherein the thickening agent comprises polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the polyvinylpyrrolidone to the polyvinyl alcohol is 1: 1; the preparation method of the functional protein membrane-hanging liquid comprises the following steps: s101: mixing hexafluoroisopropanol, hirudin and lumbrokinase, and stirring until the hexafluoroisopropanol, the hirudin and the lumbrokinase are completely dissolved to obtain a functional protein solution; s102: adding a thickening agent into the functional protein solution, and uniformly stirring to obtain the functional protein membrane-hanging solution. The polyvinylpyrrolidone is preferably PVP-K30, and the polyvinyl alcohol has a number average molecular weight of preferably 15000 to 16000.
In a further embodiment of the present invention, in S5, the raw material components of the chitosan coating solution include: a chitosan solution and a thickening agent; in the chitosan solution: the mass percent of the sol chitosan is 8-20%, the solvent is hexafluoroisopropanol and trifluoroacetic acid, and the volume ratio of the hexafluoroisopropanol to the trifluoroacetic acid is 9: 1; the thickening agent comprises polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the polyvinylpyrrolidone to the polyvinyl alcohol is 1: 1; the preparation method of the chitosan film-coating liquid comprises the following steps: s201: mixing hexafluoroisopropanol and trifluoroacetic acid to obtain a chitosan solvent; s202: adding chitosan into a chitosan solvent, and then stirring until the chitosan is completely dissolved to obtain a chitosan solution; s203: adding a thickening agent into the chitosan solution, and uniformly stirring to obtain the chitosan film-coating solution.
The technical scheme provided by the invention has the following beneficial effects: (1) according to the human body stent provided by the invention, the adopted polylactic acid and chitosan have good human body compatibility, and no rejection reaction occurs; chitosan, polylactic acid and protein are all substances which can be decomposed or degraded in vivo, so that the pain of taking a bypass operation after secondary stenosis is avoided; (2) the functional protein adopted by the invention can play a role in ablating thrombus and has human-friendly property; (3) the 4D printing material adopted by the invention can not stimulate the vessel wall.
Additional aspects and advantages of the invention will be set forth in part in the description which follows and, in part, will be obvious from the description, or may be learned by practice of the invention.
Drawings
FIG. 1 is a schematic view of a body support according to a first embodiment of the present invention;
FIG. 2 is a cross-sectional view of a body support according to the present invention;
fig. 3 is a schematic view of a single helical element of a body scaffold to which the present invention relates.
Reference numerals:
1-mounting a ring; 2-fixing holes; 3-a circumferential unit; 4-a support unit; 5-a skeleton portion; 6-functional protein membrane; 7-chitosan film; 8-helical portion.
Detailed Description
The technical solution in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. The following examples are only for illustrating the technical solutions of the present invention more clearly, and therefore are only examples, and the protection scope of the present invention is not limited thereby.
The experimental procedures in the following examples are conventional unless otherwise specified. The test materials used in the following examples were purchased from a conventional biochemical reagent store unless otherwise specified. In the quantitative tests in the following examples, three replicates were set, and the data are the mean or the mean ± standard deviation of the three replicates. The polylactic acid adopted by the embodiment of the invention is dextrorotatory polylactic acid provided by Shanghai Liang chemical company Limited and levorotatory polylactic acid with CAS number of 33135-50-1, and the chitosan is medical-grade chitosan provided by Qingdao Boyite Haichio biological pharmacy.
The invention provides a human body stent, which comprises a skeleton part, a functional protein membrane and a chitosan membrane; the surface layer of the framework part is covered with a functional protein film, and the surface layer of the functional protein film is covered with a chitosan film; the framework part is prepared from levorotatory polylactic acid and dextrorotatory polylactic acid.
Preferably, the body contour structure of the body support is in the shape of a helical tube, the body support comprising a helical portion and a mounting ring; wherein, the collar is located the both ends of spiral portion, is equipped with a fixed orifices on the collar.
Preferably, the spiral part includes a plurality of spiral units connected in sequence, each spiral unit including a circumferential unit and a plurality of support units; the supporting units are arched bulges parallel to the axial direction of the human body support, the circumferential units are spiral, the supporting units are uniformly distributed on the circumferential units, the interval angle of each supporting unit is equal, and the directions of two adjacent supporting units are opposite.
Preferably, a chamfer is arranged between the mounting ring and the spiral part; a chamfer is arranged between the supporting unit and the circumferential unit.
Preferably, the mounting ring is formed by one supporting unit closed with the circumferential unit.
Preferably, the body scaffold is used for support of blood vessels, pancreatic ducts, bile ducts, intestinal ducts, ureters, oesophagus or nasal cavities.
Preferably, in each helical unit: the number of the supporting units is even number, and is preferably 4; the interval angle of each supporting unit is 90 degrees.
Preferably, the shape of the shaft axis of the supporting unit includes one or more of a sine wave shape, an arc shape, a U shape, and a parabolic shape.
In addition, the invention also provides a preparation method of the human body stent, which comprises the following steps:
s1: the preparation method comprises the following steps of mixing (1) (0.8-1.1): (0.4-0.5) to obtain mixed powder;
s2: heating and melting the mixed powder at 130-155 ℃, and then extruding and molding by using a mold to obtain a 4D printing raw material wire with the diameter of 1-3 mm;
s3: printing the 4D printing raw material wire into a preset human body support shape by adopting a 4D printing technology to obtain a human body support blank;
s4: immersing the human body stent blank into the functional protein film-hanging liquid for 2-5 seconds, and then taking out the human body stent blank for freeze-drying treatment at-40 ℃ to obtain a semi-finished human body stent; the functional protein membrane-hanging liquid comprises the following raw material components: 20 parts of hirudin, 20 parts of lumbrokinase, 2 parts of thickener and 160 parts of hexafluoroisopropanol; wherein the thickening agent comprises polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the polyvinylpyrrolidone to the polyvinyl alcohol is 1: 1; the preparation method of the functional protein membrane-hanging liquid comprises the following steps: s101: mixing hexafluoroisopropanol, hirudin and lumbrokinase, and stirring until the hexafluoroisopropanol, the hirudin and the lumbrokinase are completely dissolved to obtain a functional protein solution; s102: adding a thickening agent into the functional protein solution, and uniformly stirring to obtain a functional protein membrane-hanging solution;
s5: immersing the semi-finished human body stent into the chitosan film-hanging liquid for 2-5 seconds, and then taking out the semi-finished human body stent for freeze-drying treatment at-40 ℃ to obtain a human body stent finished product; the chitosan film-hanging liquid comprises the following raw material components: a chitosan solution and a thickening agent; in the chitosan solution: the mass percent of the sol chitosan is 8-20%, the solvent is hexafluoroisopropanol and trifluoroacetic acid, and the volume ratio of the hexafluoroisopropanol to the trifluoroacetic acid is 9: 1; the thickening agent comprises polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the polyvinylpyrrolidone to the polyvinyl alcohol is 1: 1; the preparation method of the chitosan film-coating liquid comprises the following steps: s201: mixing hexafluoroisopropanol and trifluoroacetic acid to obtain a chitosan solvent; s202: adding chitosan into a chitosan solvent, and then stirring until the chitosan is completely dissolved to obtain a chitosan solution; s203: adding a thickening agent into the chitosan solution, and uniformly stirring to obtain the chitosan film-coating solution.
The body support and the method for making the same according to the present invention will be further described with reference to the following embodiments.
Example one
The present embodiment provides a human body scaffold, as shown in the structures of fig. 1, 2 and 3, comprising a skeleton part, a functional protein membrane and a chitosan membrane; the surface layer of the framework part is covered with a functional protein film, and the surface layer of the functional protein film is covered with a chitosan film; the framework part is prepared from levorotatory polylactic acid, dextrorotatory polylactic acid and carboxymethyl chitosan.
Specifically, the body support has a main body contour structure in the shape of a spiral pipe, and comprises a spiral part 8 and a mounting ring 1; wherein, the mounting ring 1 is positioned at two ends of the spiral part 8, and the mounting ring 1 is provided with a fixing hole 2; a chamfer is provided between the mounting ring 1 and the helical portion 8.
Specifically, the spiral part 8 comprises a plurality of spiral units connected in sequence, each spiral unit comprises a circumferential unit 3 and 4 supporting units 4, and a chamfer is arranged between each supporting unit 4 and the circumferential unit 3; the shape of the supporting units 4 is an arch-shaped bulge parallel to the axial direction of the human body support, the shape of the circumferential unit 3 is a spiral shape, the supporting units 4 are uniformly distributed on the circumferential unit 3, the directions of two adjacent supporting units 4 are opposite, the interval angle of each supporting unit 4 is 90 degrees, and the shape of the axial lead of each supporting unit 4 is an arc shape.
Example two
The embodiment provides a method for preparing a human body stent shown in the first embodiment, which comprises the following steps:
s1: uniformly mixing levorotatory polylactic acid, dextrorotatory polylactic acid and carboxymethyl chitosan according to the mass ratio of 1:0.8:0.4 to obtain mixed powder;
s2: heating and melting the mixed powder at 130 ℃, and then extruding and molding by utilizing a die to obtain a 4D printing raw material wire with the diameter of 1 mm;
s3: printing the 4D printing raw material wire into a preset human body support shape by adopting a 4D printing technology to obtain a human body support blank;
s4: immersing the human body stent blank into the functional protein membrane-hanging liquid for 2 seconds, and then taking out the human body stent blank for freeze-drying treatment at the temperature of minus 40 ℃ to obtain a semi-finished human body stent; the preparation method of the functional protein membrane-hanging liquid comprises the following steps: s101: taking 160g of hexafluoroisopropanol, adding 20g of hirudin and 20g of lumbrokinase, and stirring until the materials are completely dissolved to obtain a functional protein solution; s102: adding a thickening agent (1 g of polyvinylpyrrolidone and 1g of polyvinyl alcohol) into the functional protein solution, and uniformly stirring to obtain a functional protein membrane-hanging solution;
s5: immersing the semi-finished human body stent into the chitosan film-hanging liquid for 2 seconds, and then taking out the semi-finished human body stent for freeze-drying treatment at the temperature of minus 40 ℃ to obtain a finished human body stent; the preparation method of the chitosan film-coating liquid comprises the following steps: s201: taking 90ml of hexafluoroisopropanol, and adding 10ml of trifluoroacetic acid to obtain 100ml of chitosan solvent; s202: adding chitosan into a chitosan solvent, and stirring until the chitosan is completely dissolved to prepare a chitosan solution with the mass fraction of 8%; s203: adding a thickening agent (1 g of polyvinylpyrrolidone and 1g of polyvinyl alcohol) into the chitosan solution, and uniformly stirring to obtain the chitosan film-coating solution.
EXAMPLE III
The embodiment provides a preparation method of a human body stent, which comprises the following steps:
s1: uniformly mixing levorotatory polylactic acid, dextrorotatory polylactic acid and carboxymethyl chitosan according to the mass ratio of 1:1.1:0.5 to obtain mixed powder;
s2: heating and melting the mixed powder at 155 ℃, and then extruding and molding the mixed powder by using a mold to obtain a 4D printing raw material wire with the diameter of 3 mm;
s3: printing the 4D printing raw material wire into a preset human body support shape by adopting a 4D printing technology to obtain a human body support blank;
s4: immersing the human body stent blank into the functional protein membrane-hanging liquid for 5 seconds, and then taking out the human body stent blank for freeze-drying treatment at the temperature of minus 40 ℃ to obtain a semi-finished human body stent; the preparation method of the functional protein membrane-hanging liquid comprises the following steps: s101: taking 160g of hexafluoroisopropanol, adding 20g of hirudin and 20g of lumbrokinase, and stirring until the materials are completely dissolved to obtain a functional protein solution; s102: adding a thickening agent (1 g of polyvinylpyrrolidone and 1g of polyvinyl alcohol) into the functional protein solution, and uniformly stirring to obtain a functional protein membrane-hanging solution;
s5: immersing the semi-finished human body stent into the chitosan film-hanging liquid for 5 seconds, and then taking out the semi-finished human body stent for freeze-drying treatment at the temperature of minus 40 ℃ to obtain a finished human body stent; the preparation method of the chitosan film-coating liquid comprises the following steps: s201: taking 90ml of hexafluoroisopropanol, and adding 10ml of trifluoroacetic acid to obtain 100ml of chitosan solvent; s202: adding chitosan into a chitosan solvent, and stirring until the chitosan is completely dissolved to prepare a chitosan solution with the mass fraction of 20%; s203: adding a thickening agent (1 g of polyvinylpyrrolidone and 1g of polyvinyl alcohol) into the chitosan solution, and uniformly stirring to obtain the chitosan film-coating solution.
Example four
The embodiment provides a preparation method of a human body stent, which comprises the following steps:
s1: uniformly mixing levorotatory polylactic acid, dextrorotatory polylactic acid and carboxymethyl chitosan according to the mass ratio of 1:1:0.45 to obtain mixed powder;
s2: heating and melting the mixed powder at 139 ℃, and then extruding and molding the mixed powder into a 4D printing raw material wire with the diameter of 2mm by using a mold;
s3: printing the 4D printing raw material wire into a preset human body support shape by adopting a 4D printing technology to obtain a human body support blank;
s4: immersing the human body stent blank into the functional protein membrane-hanging liquid for 4 seconds, and then taking out the human body stent blank for freeze-drying treatment at the temperature of minus 40 ℃ to obtain a semi-finished human body stent; the preparation method of the functional protein membrane-hanging liquid comprises the following steps: s101: taking 160g of hexafluoroisopropanol, adding 20g of hirudin and 20g of lumbrokinase, and stirring until the materials are completely dissolved to obtain a functional protein solution; s102: adding a thickening agent (1 g of polyvinylpyrrolidone and 1g of polyvinyl alcohol) into the functional protein solution, and uniformly stirring to obtain a functional protein membrane-hanging solution;
s5: immersing the semi-finished human body stent into the chitosan film-hanging liquid for 4 seconds, and then taking out the semi-finished human body stent for freeze-drying treatment at the temperature of minus 40 ℃ to obtain a finished human body stent; the preparation method of the chitosan film-coating liquid comprises the following steps: s201: taking 90ml of hexafluoroisopropanol, and adding 10ml of trifluoroacetic acid to obtain 100ml of chitosan solvent; s202: adding chitosan into a chitosan solvent, and stirring until the chitosan is completely dissolved to prepare a chitosan solution with the mass fraction of 14%; s203: adding a thickening agent (1 g of polyvinylpyrrolidone and 1g of polyvinyl alcohol) into the chitosan solution, and uniformly stirring to obtain the chitosan film-coating solution.
The human body stents prepared in the second to fourth embodiments of the invention are systematically evaluated for their effects by functional tests.
1. Radial supporting force
And detecting the radial supporting force of the degradable human body stent prepared in the second embodiment to the fourth embodiment of the invention through a mechanical test. The results obtained by the measurement are shown in table 1 below.
TABLE 1 radial support force
| Group of | Example two | EXAMPLE III | Example four |
| Radial support force (N) | 17.84 | 18.02 | 18.91 |
2. Dissolution time window
The degradable human body stents prepared from the degradable human body stents prepared in the second to fourth embodiments of the present invention were soaked in simulated blood (environmental conditions: 37 ℃, 3% CO)2Humidity 99%), measuring the time for the radial supporting force of the degradable human body stent to be reduced to 12N and the maximum dissolving time. The results obtained by the measurement are shown in table 2 below.
TABLE 2 dissolution time Window
| Group of | Example two | EXAMPLE III | Example four |
| Time (day) for lowering supporting force to 12N | 210 | 213 | 215 |
| Maximum dissolution time (day) | 374 | 378 | 382 |
The technical scheme provided by the invention has the following beneficial effects: (1) according to the human body stent provided by the invention, the adopted polylactic acid and chitosan have good human body compatibility, and no rejection reaction occurs; chitosan, polylactic acid and protein are all substances which can be decomposed or degraded in vivo, so that the pain of accepting the bypass surgery again is avoided; (2) the functional protein adopted by the invention can play a role in ablating thrombus and has human-friendly property; (3) the deformation of the 4D printing material adopted by the invention is slower than the rebound speed of the metal wire, and the vascular wall can not be stimulated.
It is to be noted that, unless otherwise specified, technical or scientific terms used herein shall have the ordinary meaning as understood by those skilled in the art to which the invention pertains. Unless specifically stated otherwise, the relative steps, numerical expressions, and values of the components and steps set forth in these embodiments do not limit the scope of the present invention. In all examples shown and described herein, unless otherwise specified, any particular value should be construed as merely illustrative, and not restrictive, and thus other examples of example embodiments may have different values.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention, and all of the technical solutions are covered in the protective scope of the present invention.
Claims (8)
1. A human body scaffold, comprising:
the human body stent comprises a skeleton part, a functional protein membrane and a chitosan membrane; the surface layer of the framework part is covered with the functional protein film, and the surface layer of the functional protein film is covered with the chitosan film; the framework part is prepared from levorotatory polylactic acid, dextrorotatory polylactic acid and carboxymethyl chitosan;
the body support is in a spiral tubular shape and comprises a spiral part and a mounting ring; the mounting rings are positioned at two ends of the spiral part, and a fixing hole is formed in each mounting ring;
the spiral part comprises a plurality of spiral units which are connected in sequence, and each spiral unit comprises a circumferential unit and a plurality of supporting units; the shape of the supporting units is an arch-shaped bulge parallel to the axial direction of the human body support, the shape of the circumferential unit is a spiral shape, the supporting units are uniformly distributed on the circumferential unit, the interval angle of each supporting unit is equal, and the directions of two adjacent supporting units are opposite; a chamfer is arranged between the mounting ring and the spiral part; a chamfer is arranged between the supporting unit and the circumferential unit.
2. The body brace of claim 1, wherein:
the mounting ring is formed by closing a supporting unit and a circumferential unit.
3. The body brace of claim 1, wherein:
the human body stent is used for supporting blood vessels, pancreatic ducts, bile ducts, intestinal tracts, ureters, esophagus or nasal cavities.
4. The body brace of any of claims 1-3, wherein:
the shape of the axial lead of the supporting unit comprises one or more of a sine wave shape, an arc shape, a U shape and a parabola shape.
5. A method of making a body scaffold according to any of claims 1 to 4 comprising the steps of:
s1: uniformly mixing levorotatory polylactic acid, dextrorotatory polylactic acid and carboxymethyl chitosan to obtain mixed powder;
s2: heating and melting the mixed powder, and then extruding and molding the 4D printing raw material wire by using a mold;
s3: printing the 4D printing raw material wire into a preset human body support shape by adopting a 4D printing technology to obtain a human body support blank;
s4: immersing the human body stent blank into a functional protein film-hanging liquid, taking out and carrying out freeze-drying treatment to obtain a human body stent semi-finished product;
s5: and (3) immersing the semi-finished human body stent into chitosan film-hanging liquid, and then taking out the semi-finished human body stent for freeze-drying treatment to obtain the finished human body stent.
6. The method of making a body scaffold according to claim 5 wherein:
in the S1, the mass ratio of the levorotatory polylactic acid to the dextrorotatory polylactic acid to the carboxymethyl chitosan is 1 (0.8-1.1) to 0.4-0.5;
in the S2, the heating temperature is 130-155 ℃, and the diameter of the 4D printing raw material wire is 1-3 mm;
in the S4, the immersion time is 2-5 seconds, and the freeze-drying temperature is-40 ℃;
in the step S5, the immersion time is 2-5 seconds, and the freeze-drying temperature is-40 ℃.
7. The method of making a body scaffold according to claim 5 wherein:
in S4, the functional protein membrane-hanging solution includes the following raw material components: 20 parts of hirudin, 20 parts of lumbrokinase, 2 parts of thickener and 160 parts of hexafluoroisopropanol; the thickening agent comprises polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the polyvinylpyrrolidone to the polyvinyl alcohol is 1: 1;
the preparation method of the functional protein membrane-hanging solution comprises the following steps:
s101: mixing hexafluoroisopropanol, hirudin and lumbrokinase, and stirring until the hexafluoroisopropanol, the hirudin and the lumbrokinase are completely dissolved to obtain a functional protein solution;
s102: and adding a thickening agent into the functional protein solution, and uniformly stirring to obtain the functional protein membrane-hanging solution.
8. The method of making a body scaffold according to claim 5 wherein:
in the step S5, the chitosan film-coating solution comprises the following raw material components: a chitosan solution and a thickening agent; in the chitosan solution: the mass percent of the sol chitosan is 8-20%, the solvent is hexafluoroisopropanol and trifluoroacetic acid, and the volume ratio of the hexafluoroisopropanol to the trifluoroacetic acid is 9: 1; the thickening agent comprises polyvinylpyrrolidone and polyvinyl alcohol, and the mass ratio of the polyvinylpyrrolidone to the polyvinyl alcohol is 1: 1;
the preparation method of the chitosan film-coating liquid comprises the following steps:
s201: mixing hexafluoroisopropanol and trifluoroacetic acid to obtain a chitosan solvent;
s202: adding chitosan into the chitosan solvent, and then stirring until the chitosan is completely dissolved to obtain a chitosan solution;
s203: and adding a thickening agent into the chitosan solution, and uniformly stirring to obtain the chitosan film-hanging solution.
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