CN109730819A - The bracket for eluting medicament and production method that surface has hydrophobic structure degradable - Google Patents
The bracket for eluting medicament and production method that surface has hydrophobic structure degradable Download PDFInfo
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- CN109730819A CN109730819A CN201910166111.2A CN201910166111A CN109730819A CN 109730819 A CN109730819 A CN 109730819A CN 201910166111 A CN201910166111 A CN 201910166111A CN 109730819 A CN109730819 A CN 109730819A
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Abstract
The bracket for eluting medicament and production method that surface of the present invention has hydrophobic structure degradable belong to the field of medical instrument technology, are related to the design and production method of a kind of bracket for eluting medicament that the surface applied to blood vessel intervention medical field has the hydrophobic type of micro-structure degradable.The supporting structure is made of the basic support unit of waveform, straight-bar connection unit, left arc connection unit and right arc connection unit.Equally distributed microtrabeculae is processed using injection molding or extrusion molding collocation laser engraving or 3D printing technique in bracket single or double;Make it have hydrophobic, drag reduction, the biology functions such as self-cleaning.Drug-carried coat is processed using spraying or dipping method.The bracket has good supportive and flexibility, and surface hydrophobicity micro-structure can also effectively slow down blood flow to the soil washing of drug in coating, reduce extracellular matrix and blood platelet in the aggregation and absorption of branch frame peripheral, to reduce in-stent restenosis risk.
Description
Technical field
The invention belongs to the field of medical instrument technology, being related to a kind of surface applied to blood vessel intervention medical field has
The design and production method of the degradable bracket for eluting medicament of the hydrophobic type of micro-structure.
Background technique
The whole world has millions of people to die of cardiovascular disease every year, and stent technology is treatment hemadostewnosis class disease
Effective means.The bare mental stents that early stage occurs will be used as the permanent companion of foreign matter once be implanted into organism to take out again
With organism, the security risk of organism is greatly increased.Later, there is degradable polymer bracket, because it is in biology
Final catabolite is carbohydrate in vivo, is now used widely.However, can occur in some months after stenting serious
In-stent restenosis phenomenon, often in one layer of the stent surface coated coating containing the drugs such as anti-inflammatory, antiproliferative, it is this containing
The bracket of medication coat is exactly bracket for eluting medicament.
Secondly, intravascular carried stent can make some drugs with loss of blood under the soil washing of blood flow, greatly
Reduce effective drug release time.Simultaneously in stent implantation procedure, intraluminal damage can induce immunization inflammatory reaction, cause
Smooth muscle cell proliferation causes thrombotic phenomena, so that restenosis phenomenon odds increases in postoperative support.
In recent years, it is inspired by the biological surfaces micro nano structure such as lotus leaf, common nepenthes, when the contact angle of liquid and contact surface
When greater than 150 °, slide angle is less than 10 °, contact surface has hydrophobic effect, in addition to having the characteristic of automatically cleaning, dirt-resistant, it
Also possess freezing, drag reduction, anti-attrition, inhibit the characteristics such as surface oxidation corrosion.The preparation method of hydrophobic surface mainly has mould at present
Modeling method, phase separation method, chemical attack, laser ablation, hydrothermal growth, self assembly, vapour deposition process and Electrospinning Method etc..If this is received
Rice hydrophobic structure, which is applied to bracket for eluting medicament surface, will be helpful to reduce cellular matrix and blood platelet around intravascular stent
Assemble and stick, reduces the risk of in-stent restenosis, meanwhile, reduce the loss of drug in bracket coating, raising is effectively released
The medicine time.
Meanwhile bracket also to consider after its flexibility and stent-expansion during being implanted into organism its both ends to
Influence of the outer expenditure phenomenon to vascular wall.Therefore by using the pre- place of the design of reasonable supporting structure and rack surface structure
Reason can effectively improve the application effect of bracket for eluting medicament.
Summary of the invention
The technical problem to be solved by the present invention is to overcome existing intravascular stent structures to design existing defect, invents a kind of table
Face has the biodegradable bracket for eluting medicament of hydrophobic structure.Meanwhile proposing rationally effective production method.The medicament elution
Bracket is made of the basic support unit 1 of contour waveform, connection unit 2, left arc connection unit 3 and right arc connection unit 4,
Middle connection unit 2 can be straight rod-shaped, S-shaped or reverse-s shape.It is bigger swollen that the contour basic support unit 1 of waveform has supporting structure
Swollen range.And using reasonable 2 form of connection unit and distribution mode is effectively improved the flexibility of bracket and both ends are propped up outward
Out to the influence of vascular wall.Meanwhile the structure of bracket for eluting medicament using injection molding or extrusion molding collocation laser engraving or
3D printing technique is processed.Drug-carried coat is processed using spraying or dipping method.
The technical scheme is that the bracket for eluting medicament that a kind of surface has hydrophobic structure degradable, characterized in that
Bracket for eluting medicament is by the basic support unit 1 of contour waveform, connection unit 2, left arc connection unit 3 and right arc connection unit
4 composition tubulars;Each basic support unit 1 of contour waveform plays the role of radial support, the quantity m of waveform, 6≤m≤16;
In addition to head and the tail two contour waveform support unit forward direction arrangements, the contour waveform support unit of other every rows is arranged using out-phase
Mode, phase difference are 90 °;The shape of the connection unit 2 of head and the tail two sides is straight rod-shaped, S-shaped or reverse-s shape connection unit;Left arc
Connection unit 3 and right arc connection unit 4 are made of two straightways and an arc section respectively, left 3 He of arc connection unit
The straightway of right arc connection unit 4 is connected with the straightway midpoint of the contour waveform support unit of adjacent two rows respectively;It is left
Arc connection unit and the right every row of arc connection unit are alternately arranged;
The basic support unit 1 of contour waveform and connection unit 2, left arc connection unit 3, right arc connection unit 4 cross
Cross-sectional width is equal, and thickness range is 0.06~0.2mm;Bracket for eluting medicament diameter is 2~10mm;Bracket for eluting medicament
Length is controlled by increasing or decreasing the quantity of contour basic support unit, and according to the increase and decrease of stent length come adjusting bracket
The connection unit quantity of length direction;
To make rack surface that there is hydrophobic function, in bracket single or double using laser cutting, method of molding processing or 3D
Print equally distributed microtrabeculae;Micro-pillar shapes are " cylinder ", " cone ", " pyramid " or " hat ";Medicament elution branch
The micro post diameter range of frame surface hydrophobicity structure is 0.3~1.5mm, and altitude range is 0.2~1.2mm, and microtrabeculae center spacing is
0.50mm;
The material of bracket for eluting medicament and drug-carried coat is degradable polymer.
There are three types of the production methods that the bracket for eluting medicament that surface has hydrophobic structure degradable uses, and specific steps are such as
Under:
Production method one:
(1) using biodegradable medicine FirebirdTM and table designed by the 3D printing technique one-pass molding present invention
Face micro-structure;
(2) bracket for eluting medicament with surface micro-structure made will be mixed using ultrasound spraying or dipping means
There is the polymer solution even application of drug in rack surface, after drying, repeatable spraying forms multilayer drug-loaded coating;
(3) coating prepare after the completion of, can carry out disinfection according to actual needs, Drug absorbability or other processing.
Production method two:
(1) it is produced and the isodiametric micro-pipe of rest body structure using extrusion mechanism;
(2) micro-pipe surface is cut using laser-engraving technique, processes rest body structure;
(3) micro-structure processing is carried out to rack surface using laser ablation or 3D printing method again;
(4) bracket for eluting medicament with surface micro-structure made will be mixed using ultrasound spraying or dipping means
There is the polymer solution even application of drug in rack surface, after drying, repeatable spraying forms multilayer drug-loaded coating;
(5) coating prepare after the completion of, can carry out disinfection according to actual needs, Drug absorbability or other processing.
Production method three:
(1) injection mold is made using wire cutting technology, the bracket of micro-column structure is had with injection mold production;Injection mould
Have the moving die insert as needed for micro-column structure bracket and fixed die insert, the moving template and cover half of standard are pulled and required side is taken out
It is formed with Tiebar structure;
(2) injection mold is installed in injection molding machine, injection temperature needed for adjusting timbering material and injection pressure, into
Row injection molding takes out the intravascular stent with micro-column structure processed after cooling die sinking;
(3) bracket for eluting medicament with surface micro-structure made will be mixed using ultrasound spraying or dipping means
There is the polymer solution even application of drug in rack surface, after drying, repeatable spraying forms multilayer drug-loaded coating;
(4) coating prepare after the completion of, can carry out disinfection according to actual needs, Drug absorbability or other processing.
The production method three that the bracket for eluting medicament that surface has hydrophobic structure degradable uses, characterized in that in method
In three (1), injection mold is made using wire cutting technology, only makes rest body structure, and rack surface with injection mold
The forming of micro-structure is that the processing of surface micro-structure is carried out using laser ablation or 3D printing after the completion of injection molding;Other steps
With (two) and (three) step in production method one.
The invention has the advantages that bracket for eluting medicament of the invention uses the basic support unit 1 of contour waveform, connects
Order member 2, left arc connection unit 3 and right arc connection unit 4, can be effective using reasonable arrangement mode and type of attachment
Improve the flexibility of bracket for eluting medicament.Symmetrical connection unit form can effectively reduce institute after stent-expansion simultaneously
The axial cripetura phenomenon of generation, the connection of the contour waveform support unit of head and the tail are expanded using straight-bar, S-shaped or reverse-s shape connection in bracket
Bracket both ends expenditure effect can be effectively reduced after.It is arranged in pairs or groups in bracket single or double using injection molding or extrusion molding
Laser engraving or 3D printing technique process equally distributed microtrabeculae, make it have hydrophobic, drag reduction, the biology functions such as self-cleaning.Branch
The hydrophobic micro-structure processing on frame surface can effectively slow down blood flow to the soil washing of drug in coating, improve medicine in vascular wall
Effective residence time of object reduces extracellular matrix and blood platelet in the aggregation and absorption of branch frame peripheral, to reduce in bracket
Restenosis risk.Meanwhile this surface hydrophobicity micro-structure can also reduce support in blood-vessel to the resistance of blood flow, reduce bracket
Internal stress.Bracket mass is conducive to using the method for injection molding or extrusion molding production biodegradable bracket for eluting medicament
Production reduces energy consumption.
Detailed description of the invention
Attached drawing 1 is bracket for eluting medicament planar development schematic diagram of the present invention.Wherein, the basic support unit of the high waveform such as 1-,
2- straight rod-shaped connection unit, the left arc connection unit of 3-, the right arc connection unit of 4-.
Attached drawing 2 is bracket for eluting medicament surface hydrophobicity status diagram.Wherein, 1- drop, 2- drug-carried coat, 3- bracket table
Face micro-structure schematic diagram, 4- rest body.
Attached drawing 3 is bracket for eluting medicament surface micro-structure type diagrammatic cross-section.Wherein, 3a- is cylindrical;3b- cone
Or pyramid;3c- hat.
Attached drawing 4 designs for bracket for eluting medicament and processing method flow diagram.
Specific embodiment
Specific embodiments of the present invention are described in detail below in conjunction with technical solution and attached drawing.
Attached drawing 1 is the planar structure schematic diagram of bracket for eluting medicament of the invention.Supporting structure of the invention is by contour wave
Shape support unit 1, straight-bar connection unit 2, left arc connection unit 3 and right arc connection unit 4 form tubular, each unit
Material be and the preferable degradable high polymer of biocompatible.
Attached drawing 2 is bracket for eluting medicament surface hydrophobicity status diagram.Wherein, 1- drop, 2- drug-carried coat, 3- bracket table
Face micro-structure schematic diagram, 4- rest body.
In following example, the height of the contour waveform support unit 1 of bracket is 1.8mm.Contour 1 He of waveform support unit
Straight-bar connection unit 2, left arc connection unit 3, the thickness of right arc connection unit 4 are equal, with a thickness of 0.06mm.Left arc connects
Order member 3 and right arc connection unit 4 are made of two straightways and an arc section respectively, left arc connection unit 3 and the right side
The straightway of arc connection unit 4 is connected with the straightway midpoint of the contour waveform support unit of adjacent two rows respectively.Left arc
Shape connection unit 3 and the every row of right arc connection unit 4 are alternately arranged, as shown in Figure 1.The diameter of bracket is 2mm, passes through adjusting etc.
The quantity of high 1 waveform of waveform support unit is to meet the blood vessel demand of different-diameter.
Attached drawing 4 designs for bracket for eluting medicament and processing method flow diagram, in conjunction with Fig. 4 tool that the present invention will be described in detail
Body is implemented.Surface have hydrophobic structure biodegradable bracket for eluting medicament the production method is as follows:
Embodiment 1:
(1) the integrally formed injection mold of designed supporting structure, injection mould can be realized using the production of wire cutting means
Have the moving die insert as needed for micro-column structure bracket and fixed die insert, the moving template and cover half of standard are pulled and required side is taken out
It is formed with Tiebar structure;
(2) injection mold is installed in injection molding machine, injection temperature needed for adjusting timbering material and injection pressure, into
Row injection molding, takes out the bracket with micro-column structure processed after cooling die sinking, the micro-pillar shapes of micro-structure are " cylinder
Shape ".Micro post diameter is 0.3mm, is highly 0.2mm, and microtrabeculae center spacing is 0.50mm.Liquid contact angle is contour greater than 150 °
The quantity m=6 of 1 waveform of waveform support unit, rack surface micro-structure is as shown in 3a in Fig. 3.This surface has hydrophobic structure
Bracket for eluting medicament can effectively slow down blood flow to the soil washing of drug in coating, improve the effective of drug in vascular wall
Residence time, meanwhile, this surface hydrophobicity micro-structure can also reduce support in blood-vessel to the resistance of blood flow, reduce in bracket
Stress.
(3) bracket for eluting medicament with surface micro-structure made will be mixed using ultrasound spraying or dipping means
There is the polymer solution even application of drug in rack surface, after drying, repeatable spraying forms multilayer drug-loaded coating;
(4) coating prepare after the completion of, can carry out disinfection according to actual needs, Drug absorbability or other processing.
Embodiment 2
(1) there is using extruder manufacture with bracket the micro-pipe of same diameter;
(2) micro-pipe surface is cut using laser-engraving technique, processes bracket for eluting medicament structure;
(3) micro-structure processing, the microtrabeculae of micro-structure are carried out to rack surface using laser ablation or 3D printing method again
Shape is " cone ", as shown in 3b in Fig. 3.This micro-structure reduces support in blood-vessel to the resistance of blood flow, reduces bracket
Internal stress.
(4) and (5) step is the same as (3) and (4) step in embodiment 1.
Embodiment 3
(1) using biodegradable medicine FirebirdTM and table designed by the 3D printing technique one-pass molding present invention
The micro-pillar shapes of face micro-structure, micro-structure are " hat ", as shown in 3c in Fig. 3.
Remaining step is the same as (3) and (4) step in embodiment 1.
Claims (3)
1. a kind of surface have hydrophobic structure biodegradable medicine FirebirdTM, characterized in that bracket for eluting medicament by etc.
The high basic support unit of waveform (1), connection unit (2), left arc connection unit (3) and right arc connection unit (4) composition circle
It is tubular;Each basic support unit of contour waveform (1) plays the role of radial support, and the quantity of waveform is m, 6≤m≤16,;It removes
From beginning to end other than two contour waveform support unit forward direction arrangements, the contour waveform support unit of other every rows uses out-phase arrangement side
Formula, phase difference are 90 °;The shape of the connection unit (2) of head and the tail two sides is straight rod-shaped, S-shaped or reverse-s shape connection unit;Left arc
Connection unit (3) and right arc connection unit (4) are made of two straightways and an arc section respectively, left arc connection unit
(3) and the straightway of right arc connection unit (4) the straightway midpoint phase with the contour waveform support unit of adjacent two rows respectively
Connection;Left arc connection unit (3) and right arc connection unit (4) every row are alternately arranged;
The contour basic support unit of waveform (1) and connection unit (2), left arc connection unit (3), right arc connection unit (4)
Cross-sectional width it is equal, thickness range be 0.06~0.2mm;The diameter of each unit is 2~10mm;The length of bracket passes through
The quantity of contour basic support unit (1) is increased or decreased to control, and according to the increase and decrease of stent length come adjusting bracket length
The connection unit quantity in direction;
To make bracket for eluting medicament surface that there is hydrophobic function, in bracket single or double using laser cutting, method of molding processing
Or 3D printing goes out equally distributed microtrabeculae;Micro-pillar shapes are " cylinder ", " cone ", " pyramid " or " hat ";Bracket table
The micro post diameter range of face hydrophobic structure is 0.3~1.5mm, and altitude range is 0.2~1.2mm, and microtrabeculae center spacing is
0.50mm;
The material of bracket for eluting medicament and drug-carried coat is degradable polymer.
2. the bracket for eluting medicament that surface according to claim 1 has hydrophobic structure degradable, characterized in that surface tool
There are three types of the production methods that the bracket for eluting medicament for having hydrophobic structure degradable uses, the specific steps are as follows:
Production method one:
(1) micro- using biodegradable medicine FirebirdTM designed by the 3D printing technique one-pass molding present invention and surface
Structure;
(2) bracket for eluting medicament with surface micro-structure made will be mixed with medicine using ultrasound spraying or dipping means
The polymer solution even application of object is in rack surface, and after drying, repeatable spraying forms multilayer drug-loaded coating;
(3) coating prepare after the completion of, can carry out disinfection according to actual needs, Drug absorbability or other processing;
Production method two:
(1) it is produced and the isodiametric micro-pipe of rest body structure using extrusion mechanism;
(2) micro-pipe surface is cut using laser-engraving technique, processes rest body structure;
(3) micro-structure processing is carried out to rack surface using laser ablation or 3D printing method again;
(4) bracket for eluting medicament with surface micro-structure made will be mixed with medicine using ultrasound spraying or dipping means
The polymer solution even application of object is in rack surface, and after drying, repeatable spraying forms multilayer drug-loaded coating;
(5) coating prepare after the completion of, can carry out disinfection according to actual needs, Drug absorbability or other processing;
Production method three:
(1) injection mold is made using wire cutting technology, the bracket of micro-column structure is had with injection mold production;Injection mold by
Moving die insert needed for micro-column structure bracket and fixed die insert, the moving template and cover half of standard are pulled and required side is taken out and drawn
Rod structure composition;
(2) injection mold is installed in injection molding machine, injection temperature needed for adjusting timbering material and injection pressure are infused
Modeling processing takes out the intravascular stent with micro-column structure processed after cooling die sinking;
(3) bracket for eluting medicament with surface micro-structure made will be mixed with medicine using ultrasound spraying or dipping means
The polymer solution even application of object is in rack surface, and after drying, repeatable spraying forms multilayer drug-loaded coating;
(4) coating prepare after the completion of, can carry out disinfection according to actual needs, Drug absorbability or other processing.
3. the bracket for eluting medicament that surface according to claim 1 or 2 has hydrophobic structure degradable, characterized in that table
In (1) in production method three that the bracket for eluting medicament that face has hydrophobic structure degradable uses, using wire cutting technology system
Make injection mold, only makes rest body structure with injection mold;And the forming of rack surface micro-structure be after the completion of injection molding,
The processing of surface micro-structure is carried out using laser ablation or 3D printing;Other steps are the same as (two) and (three) in production method one
Step.
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CN201910166111.2A CN109730819B (en) | 2019-03-06 | 2019-03-06 | Degradable drug eluting stent with hydrophobic structure on surface and manufacturing method thereof |
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Cited By (1)
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