CN109730819B - Degradable drug eluting stent with hydrophobic structure on surface and manufacturing method thereof - Google Patents
Degradable drug eluting stent with hydrophobic structure on surface and manufacturing method thereof Download PDFInfo
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Abstract
The invention discloses a degradable drug eluting stent with a hydrophobic structure on the surface and a manufacturing method thereof, belongs to the technical field of medical instruments, and relates to a design and manufacturing method of a hydrophobic degradable drug eluting stent with a microstructure on the surface, which is applied to the field of vascular interventional medical treatment. The support structure consists of a wave-shaped basic support unit, a straight rod connecting unit, a left arc-shaped connecting unit and a right arc-shaped connecting unit. Processing micro-columns which are uniformly distributed on one side or two sides of the bracket by adopting injection molding or extrusion molding and laser engraving or 3D printing technology; so that the composite material has the functions of dewatering, drag reduction, biological self-cleaning and the like. The drug-loaded coating is processed by adopting a spraying or dipping method. The stent has good support property and flexibility, and the hydrophobic microstructure on the surface can also effectively slow down the elution of blood flow to the medicine in the coating, and reduce the aggregation and adsorption of extracellular matrix and platelets around the stent, thereby reducing the risk of restenosis in the stent.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and relates to a design and a manufacturing method of a hydrophobic degradable drug eluting stent with a microstructure on the surface, which is applied to the field of vascular interventional medicine.
Background
Millions of people die from cardiovascular diseases every year around the world, and the vascular stent technology is an effective means for treating vascular stenosis diseases. The early-appearing bare metal stent cannot be taken out again once being implanted into a living body, and is permanently accompanied with the living body as a foreign body, so that the potential safety hazard of the living body is greatly increased. Later, degradable polymer scaffolds appeared, and are now widely used because their final degradation products in the organism are carbohydrates. However, severe in-stent restenosis occurs within a few months after stent operation, and often a coating containing anti-inflammatory, anti-proliferative, etc. drugs is applied to the stent surface, and such drug-coated stents are drug-eluting stents.
Secondly, the intravascular drug-loaded stent can cause partial drugs to be lost along with blood under the elution action of blood flow, thereby greatly reducing the effective drug release time. Meanwhile, in the process of stent implantation, the injury in the tube cavity can induce immune inflammatory reaction, so that smooth muscle cells are proliferated, the phenomenon of thrombus is caused, and the probability of occurrence of restenosis phenomenon in the stent after operation is increased.
In recent years, inspired by the biological surface micro-nano structure of lotus leaves, pitcher plant and the like, when the contact angle of liquid and the contact surface is more than 150 degrees and the sliding angle is less than 10 degrees, the contact surface has a hydrophobic effect, and besides the characteristics of self-cleaning and contamination resistance, the contact surface also has the characteristics of anti-icing, drag reduction, antifriction, surface oxidation corrosion inhibition and the like. The preparation method of the hydrophobic surface mainly comprises a molding method, a phase separation method, chemical corrosion, laser etching, hydrothermal growth, self-assembly, a vapor deposition method, an electrospinning method and the like. If the nano hydrophobic structure is applied to the surface of a drug eluting stent, the aggregation and adhesion of cell matrixes and blood platelets around the intravascular stent can be reduced, the risk of restenosis in the stent is reduced, meanwhile, the loss of drugs in a stent coating is reduced, and the effective drug release time is prolonged.
Meanwhile, the flexibility of the stent is also considered in the process of implanting the stent into an organism, and the influence of the images appearing on the blood vessel wall is generated when the two ends of the stent are outwards supported after the stent is expanded. Therefore, the application effect of the drug eluting stent can be effectively improved by adopting reasonable stent structure design and pretreatment of the stent surface structure.
Disclosure of Invention
The invention aims to overcome the defects of the structural design of the existing blood vessel stent and invents a biodegradable drug eluting stent with a hydrophobic structure on the surface. Meanwhile, a reasonable and effective manufacturing method is provided. The drug eluting stent is composed of a basic supporting unit 1 with equal-height waveforms, a connecting unit 2, a left arc-shaped connecting unit 3 and a right arc-shaped connecting unit 4, wherein the connecting unit 2 can be in a straight rod shape, an S shape or an inverse S shape. The contoured primary support cells 1 provide a greater range of expansion for the stent structure. And the reasonable form and distribution mode of the connecting units 2 are adopted to effectively improve the flexibility of the stent and the influence of outward expenditure of two ends on the vessel wall. Meanwhile, the structure of the drug eluting stent is processed by adopting injection molding or extrusion molding and matching with laser engraving or 3D printing technology. The drug-loaded coating is processed by adopting a spraying or dipping method.
The invention has the technical scheme that the degradable drug eluting stent with the surface provided with the hydrophobic structure is characterized in that the drug eluting stent is in a circular tube shape and consists of a basic supporting unit 1 with equal-height waveforms, a connecting unit 2, a left arc-shaped connecting unit 3 and a right arc-shaped connecting unit 4; each equal-height waveform basic supporting unit 1 plays a role in radial supporting, and the number m of the waveforms is more than or equal to 6 and less than or equal to 16; except that the head and the tail of the equal-height waveform supporting units are arranged positively, the equal-height waveform supporting units in other rows are arranged in an out-of-phase mode, and the phase difference is 90 degrees; the connecting units 2 at the head and the tail are straight rod-shaped, S-shaped or reverse S-shaped connecting units; the left arc-shaped connecting unit 3 and the right arc-shaped connecting unit 4 are respectively composed of two straight line segments and one arc segment, and the straight line segments of the left arc-shaped connecting unit 3 and the right arc-shaped connecting unit 4 are respectively connected with the middle points of the straight line segments of two adjacent rows of equal-height waveform supporting units; the left arc-shaped connecting units and the right arc-shaped connecting units are alternately arranged in each row;
the equal-height waveform basic supporting unit 1 is equal to the connecting unit 2, the left arc-shaped connecting unit 3 and the right arc-shaped connecting unit 4 in cross section width, and the thickness range of the equal-height waveform basic supporting unit is 0.06-0.2 mm; the diameter of the drug eluting stent is 2-10 mm; the length of the drug eluting stent is controlled by increasing or decreasing the number of the equal-height basic supporting units, and the number of the connecting units in the length direction of the stent is adjusted according to the increase and decrease of the length of the stent;
in order to enable the surface of the bracket to have a hydrophobic function, uniformly distributed micro-columns are processed on one side or two sides of the bracket by adopting laser cutting and molding method or 3D printing; the micro-column is in a shape of cylinder, cone, pyramid or cap; the diameter range of the micro-column of the hydrophobic structure on the surface of the drug eluting stent is 0.3-1.5 mm, the height range is 0.2-1.2 mm, and the center distance of the micro-column is 0.50 mm;
the drug eluting stent and the drug-loaded coating are made of degradable polymers.
The degradable drug eluting stent with the hydrophobic structure on the surface adopts three manufacturing methods, and the specific steps are as follows:
the manufacturing method comprises the following steps:
(1) the biodegradable drug eluting stent and the surface microstructure designed by the invention are formed in one step by adopting a 3D printing technology;
(2) uniformly spraying a polymer solution mixed with a medicament on the surface of the prepared medicament eluting stent with a surface microstructure by adopting an ultrasonic spraying or dipping method, and repeatedly spraying to form a multi-layer medicament-carrying coating after drying;
(3) after the coating is prepared, disinfection, drug adsorption or other treatment can be carried out according to actual requirements.
The second manufacturing method comprises the following steps:
(1) manufacturing a micro-tube with the same diameter as the support matrix structure by using an extruder;
(2) cutting the surface of the micro tube by adopting a laser engraving technology to process a support matrix structure;
(3) processing the microstructure on the surface of the support by adopting a laser etching or 3D printing method;
(4) uniformly spraying a polymer solution mixed with a medicament on the surface of the prepared medicament eluting stent with a surface microstructure by adopting an ultrasonic spraying or dipping method, and repeatedly spraying to form a multi-layer medicament-carrying coating after drying;
(5) after the coating is prepared, disinfection, drug adsorption or other treatment can be carried out according to actual requirements.
The third preparation method comprises the following steps:
(1) manufacturing an injection mold by adopting a linear cutting process, and manufacturing a bracket with a micro-column structure by using the injection mold; the injection mold consists of a movable mold insert and a fixed mold insert required by the micro-column structure support, a standard movable mold plate and a standard fixed mold plate, and a required side draw and pull rod structure;
(2) installing an injection mold in an injection molding machine, adjusting the injection molding temperature and the injection molding pressure required by the stent material, performing injection molding processing, cooling and opening the mold, and taking out the processed vascular stent with the microcolumn structure;
(3) uniformly spraying a polymer solution mixed with a medicament on the surface of the prepared medicament eluting stent with a surface microstructure by adopting an ultrasonic spraying or dipping method, and repeatedly spraying to form a multi-layer medicament-carrying coating after drying;
(4) after the coating is prepared, disinfection, drug adsorption or other treatment can be carried out according to actual requirements.
The manufacturing method is characterized in that in the method (1), an injection mold is manufactured by adopting a linear cutting process, only the injection mold is used for manufacturing a support matrix structure, and the forming of the support surface microstructure is to process the surface microstructure by adopting laser etching or 3D printing after the injection molding is finished; the other steps are the same as the steps (two) and (three) in the first manufacturing method.
The drug eluting stent has the advantages that the basic supporting units 1, the connecting units 2, the left arc-shaped connecting units 3 and the right arc-shaped connecting units 4 with equal-height waveforms are adopted, and the flexibility of the drug eluting stent can be effectively improved by utilizing a reasonable arrangement mode and a reasonable connection mode. Meanwhile, the axial shortening phenomenon after the stent is expanded can be effectively reduced by the aid of the left and right symmetrical connecting units, the head and the tail of the high-altitude waveform supporting units are connected by the straight rods or the S-shaped or reverse S-shaped connecting units, and the expenditure effects at two ends of the stent can be effectively reduced after the stent is expanded. The microcolumns which are uniformly distributed are processed on one side or two sides of the bracket by adopting injection molding or extrusion molding and laser engraving or 3D printing technology, so that the bracket has the functions of dewatering, reducing drag, biological self-cleaning and the like. The hydrophobic microstructure treatment on the surface of the stent can effectively slow down the elution effect of blood flow on the medicine in the coating, improve the effective residence time of the medicine in the blood vessel wall, and reduce the aggregation and adsorption of extracellular matrix and platelets around the stent, thereby reducing the risk of restenosis in the stent. Meanwhile, the surface hydrophobic microstructure can also reduce the resistance of the stent in a blood vessel cavity to blood flow and reduce the internal stress of the stent. The biodegradable drug eluting stent is manufactured by adopting an injection molding or extrusion molding method, so that the mass production of the stent is facilitated, and the energy consumption is reduced.
Drawings
FIG. 1 is a schematic plane development view of a drug eluting stent of the present invention. The device comprises a 1-equal-height waveform basic supporting unit, a 2-straight rod-shaped connecting unit, a 3-left arc-shaped connecting unit and a 4-right arc-shaped connecting unit.
FIG. 2 is a schematic view of the hydrophobic state of the surface of a drug eluting stent. The method comprises the following steps of 1-liquid drop, 2-drug-loaded coating, 3-stent surface microstructure schematic diagram and 4-stent matrix.
FIG. 3 is a schematic cross-sectional view of the microstructure type of the surface of a drug eluting stent. Wherein, 3 a-is cylindrical; 3 b-conical or pyramidal; 3 c-hat shape.
FIG. 4 is a schematic flow chart of a drug eluting stent design and a processing method.
Detailed Description
The following detailed description of the embodiments of the invention refers to the accompanying drawings.
FIG. 1 is a schematic plan view of a drug eluting stent of the present invention. The support structure of the invention is in a circular tube shape consisting of a constant-height waveform support unit 1, a straight rod connecting unit 2, a left arc-shaped connecting unit 3 and a right arc-shaped connecting unit 4, and the units are made of degradable high polymer with better biocompatibility with organisms.
FIG. 2 is a schematic view of the hydrophobic state of the surface of a drug eluting stent. The method comprises the following steps of 1-liquid drop, 2-drug-loaded coating, 3-stent surface microstructure schematic diagram and 4-stent matrix.
In the following embodiments, the height of the contoured support unit 1 of the stent is 1.8 mm. The equal-height waveform supporting unit 1, the straight rod connecting unit 2, the left arc-shaped connecting unit 3 and the right arc-shaped connecting unit 4 are equal in thickness, and the thickness is 0.06 mm. The left arc-shaped connecting unit 3 and the right arc-shaped connecting unit 4 are respectively composed of two straight line segments and one arc segment, and the straight line segments of the left arc-shaped connecting unit 3 and the right arc-shaped connecting unit 4 are respectively connected with the middle points of the straight line segments of two adjacent rows of equal-height waveform supporting units. The left arc-shaped connection units 3 and the right arc-shaped connection units 4 are alternately arranged in each row as shown in fig. 1. The diameter of the stent is 2mm, and the requirements of blood vessels with different diameters can be met by adjusting the number of the waveforms of the equal-height waveform supporting units 1.
FIG. 4 is a schematic flow chart of a pharmaceutical elution stent design and a processing method, and the specific implementation of the present invention is described in detail with reference to FIG. 4. The preparation method of the biodegradable drug eluting stent with the hydrophobic structure on the surface comprises the following steps:
example 1:
(1) an injection mold capable of realizing the integrated molding of the designed support structure is manufactured by adopting a linear cutting means, and the injection mold consists of a movable mold insert and a fixed mold insert which are required by a micro-column structure support, a standard movable mold plate and a standard fixed mold plate, and a required side draw and pull rod structure;
(2) installing the injection mold in an injection molding machine, adjusting the injection molding temperature and the injection molding pressure required by the support material, performing injection molding processing, cooling and opening the mold, and taking out the processed support with the micro-pillar structure, wherein the micro-pillar of the micro-structure is in a cylindrical shape. The diameter of the microcolumn is 0.3mm, the height of the microcolumn is 0.2mm, and the center distance of the microcolumn is 0.50 mm. The liquid contact angle is more than 150 degrees, the number m of the wave forms of the equal-height wave form supporting unit 1 is 6, and the microstructure of the surface of the support is shown as 3a in fig. 3. The drug eluting stent with the hydrophobic structure on the surface can effectively slow down the elution effect of blood flow on drugs in the coating, improve the effective residence time of the drugs in the blood vessel wall, and simultaneously, the hydrophobic microstructure on the surface can also reduce the resistance of the stent in a blood vessel cavity on the blood flow and reduce the internal stress of the stent.
(3) Uniformly spraying a polymer solution mixed with a medicament on the surface of the prepared medicament eluting stent with a surface microstructure by adopting an ultrasonic spraying or dipping method, and repeatedly spraying to form a multi-layer medicament-carrying coating after drying;
(4) after the coating is prepared, disinfection, drug adsorption or other treatment can be carried out according to actual requirements.
Example 2
(1) Manufacturing a micro tube with the same diameter as the stent by using an extruder;
(2) cutting the surface of the micro-tube by adopting a laser engraving technology to process a drug eluting stent structure;
(3) and processing the microstructure on the surface of the support by adopting a laser etching or 3D printing method again, wherein the shape of the microcolumn of the microstructure is conical, as shown in 3b in figure 3. The microstructure reduces the resistance of the stent in the blood vessel cavity to blood flow and reduces the internal stress of the stent.
(4) And (5) the same steps as (3) and (4) in example 1.
Example 3
(1) The biodegradable drug eluting stent and the surface microstructure designed by the invention are formed in one step by adopting a 3D printing technology, and the shape of the microcolumn of the microstructure is a cap shape, as shown in 3c in figure 3.
The rest of the steps are the same as the steps (3) and (4) in example 1.
Claims (3)
1. A biodegradable drug eluting stent with a hydrophobic structure on the surface is characterized in that the drug eluting stent is in a circular tube shape and consists of a basic supporting unit (1) with equal-height waveforms, a connecting unit (2), a left arc-shaped connecting unit (3) and a right arc-shaped connecting unit (4); each equal-height wave-shaped basic supporting unit (1) plays a role in radial supporting, the number of the wave forms is m, and m is more than or equal to 6 and less than or equal to 16; except head and tailExcept for the forward arrangement of the equal-height wave-shaped supporting units, the equal-height wave-shaped supporting units in other rows adopt an out-of-phase arrangement mode, and the phase difference is 900(ii) a The connecting units (2) at the head and the tail are straight rod-shaped, S-shaped or reverse S-shaped; the left arc-shaped connecting unit (3) and the right arc-shaped connecting unit (4) are respectively composed of two straight line segments and one arc segment, and the straight line segments of the left arc-shaped connecting unit (3) and the right arc-shaped connecting unit (4) are respectively connected with the middle points of the straight line segments of two adjacent rows of equal-height waveform supporting units; the left arc-shaped connecting units (3) and the right arc-shaped connecting units (4) are alternately arranged in each row;
the equal-height waveform basic supporting unit (1) is equal to the connecting unit (2), the left arc-shaped connecting unit (3) and the right arc-shaped connecting unit (4) in cross section width, and the thickness range of the equal-height waveform basic supporting unit is 0.06-0.2 mm; the diameter of each unit is 2-10 mm; the length of the bracket is controlled by increasing or decreasing the number of the equal-height basic supporting units (1), and the number of the connecting units in the length direction of the bracket is adjusted according to the increase and decrease of the length of the bracket;
in order to enable the surface of the drug eluting stent to have a hydrophobic function, uniformly distributed micro-columns are processed on one side or two sides of the stent by adopting a laser cutting and molding method or 3D printing; the micro-column is in a shape of cylinder, cone, pyramid or cap; the diameter of the microcolumn of the hydrophobic structure on the surface of the bracket is 0.3mm, the height range is 0.2-1.2 mm, and the center distance of the microcolumns is 0.50 mm;
the drug eluting stent and the drug-loaded coating are made of degradable polymers.
2. The degradable drug eluting stent with the surface having the hydrophobic structure according to claim 1, wherein the degradable drug eluting stent with the surface having the hydrophobic structure is manufactured by three methods, which comprises the following steps:
the manufacturing method comprises the following steps:
(1) the biodegradable drug eluting stent and the surface microstructure designed by the invention are formed in one step by adopting a 3D printing technology;
(2) uniformly spraying a polymer solution mixed with a medicament on the surface of the prepared medicament eluting stent with a surface microstructure by adopting an ultrasonic spraying or dipping method, and repeatedly spraying to form a multi-layer medicament-carrying coating after drying;
(3) after the coating is prepared, disinfection, drug adsorption or other treatment can be carried out according to actual requirements;
the second manufacturing method comprises the following steps:
(1) manufacturing a micro-tube with the same diameter as the support matrix structure by using an extruder;
(2) cutting the surface of the micro tube by adopting a laser engraving technology to process a support matrix structure;
(3) processing the microstructure on the surface of the support by adopting a laser etching or 3D printing method;
(4) uniformly spraying a polymer solution mixed with a medicament on the surface of the prepared medicament eluting stent with a surface microstructure by adopting an ultrasonic spraying or dipping method, and repeatedly spraying to form a multi-layer medicament-carrying coating after drying;
(5) after the coating is prepared, disinfection, drug adsorption or other treatment can be carried out according to actual requirements;
the third preparation method comprises the following steps:
(1) manufacturing an injection mold by adopting a linear cutting process, and manufacturing a bracket with a micro-column structure by using the injection mold; the injection mold consists of a movable mold insert and a fixed mold insert required by the micro-column structure support, a standard movable mold plate and a standard fixed mold plate, and a required side draw and pull rod structure;
(2) installing an injection mold in an injection molding machine, adjusting the injection molding temperature and the injection molding pressure required by the stent material, performing injection molding processing, cooling and opening the mold, and taking out the processed vascular stent with the microcolumn structure;
(3) uniformly spraying a polymer solution mixed with a medicament on the surface of the prepared medicament eluting stent with a surface microstructure by adopting an ultrasonic spraying or dipping method, and repeatedly spraying to form a multi-layer medicament-carrying coating after drying;
(4) after the coating is prepared, disinfection, drug adsorption or other treatment can be carried out according to actual requirements.
3. The degradable drug eluting stent with a hydrophobic structure on the surface according to claim 2, wherein the degradable drug eluting stent with a hydrophobic structure on the surface is manufactured by (1) manufacturing an injection mold by using a linear cutting process, and only the injection mold is used for manufacturing a stent matrix structure; the forming of the surface microstructure of the bracket is to process the surface microstructure by adopting laser etching or 3D printing after the injection molding is finished; the other steps are the same as the steps (two) and (three) in the first manufacturing method.
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