CN105149888A - Machining method for degradable polymer intravascular stent - Google Patents
Machining method for degradable polymer intravascular stent Download PDFInfo
- Publication number
- CN105149888A CN105149888A CN201510670847.5A CN201510670847A CN105149888A CN 105149888 A CN105149888 A CN 105149888A CN 201510670847 A CN201510670847 A CN 201510670847A CN 105149888 A CN105149888 A CN 105149888A
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- degradable polymer
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- rest body
- blood vessel
- vessel stent
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B23—MACHINE TOOLS; METAL-WORKING NOT OTHERWISE PROVIDED FOR
- B23P—METAL-WORKING NOT OTHERWISE PROVIDED FOR; COMBINED OPERATIONS; UNIVERSAL MACHINE TOOLS
- B23P15/00—Making specific metal objects by operations not covered by a single other subclass or a group in this subclass
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2420/00—Materials or methods for coatings medical devices
- A61L2420/02—Methods for coating medical devices
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
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- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Vascular Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Medicinal Chemistry (AREA)
- Biomedical Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Mechanical Engineering (AREA)
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Abstract
The invention provides a machining method for a degradable polymer intravascular stent. The machining method comprises the following steps that firstly, a pipe is formed; secondly, a stent base body is formed through laser engraving; thirdly, the surface of the stent base body is polished. In the first step, the pipe is formed through the extrusion technology that cold pressurization is carried out on a plastic pipe, wherein polymer raw materials for the stent base body are heated in a plastic extruder to the temperature higher than the corresponding melting point temperature Tm and lower than the extruding temperature in the normal pressure extruding technology by 5-15 DEG C, 5-20 MPa pressure is applied at the same time, the raw materials are extruded out of a mold of the extruder with the temperature and the pressure maintained, and slow cooling is carried out. Compared with the prior art, by means of the machining method for the degradable polymer intravascular stent, the strength of the obtained intravascular stent is higher, the overall radial supporting force is higher, and the surface of the stent is smoother and free of flaws.
Description
Technical field
The present invention relates to materials processing and Implantable Medical Device field, specifically, relate to a kind of processing method of degradable polymer blood vessel stent.
Background technology
At present, the degradable biomaterials such as PLA (PLA), PLLA (PLLA) for the preparation of peripheral vascular support, with improve metallic support exist deficiency, as metallic support easily causes reangiostenosis, second operation etc.
The mechanical performance compare of common biodegradable polymer material (as PLA, polyglycolic acid, polycaprolactone etc.) is weak, and its Young's modulus only has about 0.1-4GPa, and intensity only has 40-80MPa.Because the mechanical strength of material is low, after making support by these materials, the radial support power of support is less, generally all under 100KPa, is thus difficult to the effect playing support blood vessels.Further, the elastic range of these materials is greater than traditional metallic stent material, and make the support that the is prepared into rebound degree after expansion higher, this is also a very large problem.In addition, the plastically deforming area of these materials is little, poor toughness, makes support easily occur the adverse events such as fracture in process of expansion.
The existing method preparing degradable polymer support mainly comprises: Direct stenting injection molding forming method, by the establishment of polymer filament material, thermoset forming etc., the mould of these preparation methods owing to all needing precision higher, and due to die space little, and the viscosity of polymer is higher, be unfavorable for the flowing of polymer, therefore easily cause the defects such as supporting structure is uneven, mechanic properties is not enough.
Summary of the invention
In view of this, the present invention is intended to the processing method proposing a kind of degradable polymer blood vessel stent, to solve prior art Problems existing.
For achieving the above object, technical scheme of the present invention is achieved in that
A processing method for degradable polymer blood vessel stent, comprises the steps: (1) tube forming; (2) laser engraving becomes rest body; (3) rest body surface finish; Wherein, step (1) adopts the expressing technique of the cold pressurization of plastic tube to make: rest body polymer raw materials is heated to corresponding melting temperature T in plastic extruder
mabove, and lower than the extrusion temperature 5-15 DEG C in normal pressure expressing technique, apply the pressure of 5-20MPa simultaneously, keep said temperature and pressure to be extruded from extruding machine mold by raw material, and Slow cooling.
Further, step (1) adopts the expressing technique of plastic tube cold pressurization to be that medical PLLA between 200000-800000 is heated to 190-200 DEG C in plastic extruder by mole, and apply the pressure of 5-20MPa, said temperature and pressure is kept to be extruded from extruding machine mold by raw material, and Slow cooling.
Further, what the polishing of step (3) medium-height trestle matrix surface adopted is Ultrasonic Cleaning polishing processes: be suspended in ultrasonic device by the rest body after laser engraving in step (2), with Ultrasonic spraying equipment, detergent solution is evenly sprayed at described rest body surface, ultrasonic surface cleaning polishing is carried out to rest body.
Further, described Ultrasonic Cleaning polishing time is 20-40min.
Further, described detergent solution is one or both the mixed liquor in ethanol or acetone, and the dilution ratio of inert gas and detergent solution is 10:1-30:1.
Further, described processing method also comprises the step of the coated medicament coating on rest body surface.
Further, described medication coat comprises medicine and pharmaceutical acceptable carrier.
Relative to prior art, the processing method of degradable polymer blood vessel stent of the present invention has following advantage:
(1) extrusion temperature is reduced in tube forming step in the present invention and after pressurized operation, the segment of polymer is more stable, reduce the palliating degradation degree of PLLA polymer (PLLA) in extrusion, thus make the molecular weight extruding post-consumer polymer reduce reduction, make the structure of polymer tightr, and then improve the intensity of extruding pipe material, the final radial support power improving support entirety.
(2) what adopt rest body surface finish to adopt in the present invention in tube forming step is Ultrasonic Cleaning polishing processes, cleaning performance is good, comparatively the technique such as electrobrightening, chemical polishing, magnetic grinding is simple, and the rack surface obtained than methods such as 3 D stereo shot-peening polishings is more smooth and rack surface is indefectible.
Accompanying drawing explanation
The accompanying drawing forming a part of the present invention is used to provide a further understanding of the present invention, and schematic description and description of the present invention, for explaining the present invention, does not form inappropriate limitation of the present invention.In the accompanying drawings:
Fig. 1 is photo under the microscope before the support ultrasonic polishing of the embodiment of the present invention 1 gained;
Fig. 2 is photo under the microscope after the support ultrasonic polishing of the embodiment of the present invention 1 gained.
Detailed description of the invention
It should be noted that, when not conflicting, the embodiment in the present invention and the feature in embodiment can combine mutually.
The processing method of conventional polymer blood vessel stent is: (1) chooses the PLLA polymeric material of molar average molecular weight within the scope of material requirements as rest body material, and material is heated to melting temperature T in plastic shaping extruder
mabove, general extrusion temperature is 200-210 DEG C (melting temperature of PLLA is 180 DEG C), under normal temperature and pressure, melts to completely after homogeneous state until material, is inserted in tubular article formation mould, injection mo(u)lding; (2) using laser engraving instrument to carry out degradable polymer tubing laser engraving becomes support to obtain rest body; (3) adopt conventional method to carry out surface finish to rest body, obtain the flawless polymer support matrix of smooth surface (wherein conventional finishing method comprises fluid polishing, machine glazed finish, chemical polishing, electrobrightening, ultrasonic polishing and magnetic grinding and polishing etc.); (4) using the polymer support matrix that obtains as pharmaceutical carrier, carry out drug coat, be namely worth the intravascular stent being coated with medication coat.
The present invention is described in detail below in conjunction with embodiment.
Embodiment 1
A kind of degradable polymer blood vessel stent, with PLLA as raw material, the molecular weight of PLLA is 800,000, concrete procedure of processing is as follows: (1) tube forming: choosing molar average molecular weight is that the PLLA PLLA of 800,000 is as rest body material, material is heated in plastic shaping extruder 196 DEG C (melting temperature of PLLA is 180 DEG C), pressure setting is 9MPa, other condition is all identical with conventional extrusion processes, melt to after homogeneous state completely until material, it is extruded from mould, obtaining external diameter is 3.3mm, wall thickness is the tubing of 0.21mm.
(2) laser engraving becomes rest body: to obtain in step (1) shaping after tubing adopt laser light source device to carry out laser engraving and obtain rest body.
(3) rest body surface finish: the rest body after laser engraving in step (2) is suspended in ultrasonic device, with Ultrasonic spraying equipment, detergent solution is evenly sprayed at described rest body surface, ultrasonic surface cleaning polishing is carried out to rest body, polishing time is 40min, and wherein detergent solution is ethanol.
Finally obtain clean polymer blood vessel stent, and its mechanical property and surface roughness are detected, reach a conclusion: under the pressure effect of 82kPa, the technical scheme gained stent diameter rate of change adopting the present embodiment 1 is 14.1%, wherein, the diameter rate of change of the identical structure stand of common process gained under the pressure effect of 82kPa is adopted to be 14.5%; To the support before and after polishing carry out microscope take pictures after photo as illustrated in fig. 1 and 2.
Embodiment 2
A kind of degradable polymer blood vessel stent, with embodiment 1, difference is: in step (1), the molecular weight of PLLA is 200,000, this polymeric material is heated to 192 DEG C (melting temperature of PLLA is 180 DEG C) in plastic shaping extruder, and pressure setting is 14MPa, and other condition is all identical with conventional extrusion processes, melt to after homogeneous state completely until material, it extruded from mould, obtaining external diameter is 3.3mm, and wall thickness is the tubing of 0.21mm.
Step (3) is carried out ultrasonic surface cleaning polishing to rest body, and polishing time is 20min, and wherein detergent solution is ethanol.
Finally obtain clean polymer blood vessel stent, and its mechanical property is detected, reach a conclusion: under the pressure effect of 82kPa, the technical scheme gained stent diameter rate of change adopting the present embodiment 1 is 13.7%, wherein, the diameter rate of change of the identical structure stand of common process gained under the pressure effect of 82kPa is adopted to be 14.5%.
Can draw from above-described embodiment: the intensity of the extruding pipe material adopting the technical scheme in the present invention to obtain is comparatively large, and the radial support power of frame entirety increases; Can draw from Fig. 1 and 2 contrast, the Ultrasonic Cleaning polishing processes in the present invention, cleaning performance is better simultaneously, the stent surface smoothing obtained and rack surface is indefectible.
The foregoing is only preferred embodiment of the present invention, not in order to limit the present invention, within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (7)
1. a processing method for degradable polymer blood vessel stent, is characterized in that: comprise the steps: (1) tube forming; (2) laser engraving becomes rest body; (3) rest body surface finish; Wherein, step (1) adopts the expressing technique of the cold pressurization of plastic tube to make: rest body polymer raw materials is heated to corresponding melting temperature T in plastic extruder
mabove, and lower than the extrusion temperature 5-15 DEG C in normal pressure expressing technique, apply the pressure of 5-20MPa simultaneously, keep said temperature and pressure to be extruded from extruding machine mold by raw material, and Slow cooling.
2. the processing method of degradable polymer blood vessel stent according to claim 1, it is characterized in that: step (1) adopts the expressing technique of plastic tube cold pressurization to be that medical PLLA between 200000-800000 is heated to 190-200 DEG C in plastic extruder by mole, and apply the pressure of 5-20MPa, said temperature and pressure is kept to be extruded from extruding machine mold by raw material, and Slow cooling.
3. the processing method of degradable polymer blood vessel stent according to claim 2, it is characterized in that: what the polishing of step (3) medium-height trestle matrix surface adopted is Ultrasonic Cleaning polishing processes: the rest body after laser engraving in step (2) is suspended in ultrasonic device, with Ultrasonic spraying equipment, detergent solution is evenly sprayed at described rest body surface, ultrasonic surface cleaning polishing is carried out to rest body.
4. the processing method of degradable polymer blood vessel stent according to claim 3, is characterized in that: described Ultrasonic Cleaning polishing time is 20-40min.
5. the processing method of degradable polymer blood vessel stent according to claim 3, is characterized in that: described detergent solution is one or both the mixed liquor in ethanol or acetone, and the dilution ratio of inert gas and detergent solution is 10:1-30:1.
6. the processing method of the degradable polymer blood vessel stent according to any one of claim 1-5, is characterized in that: described processing method also comprises the step of the coated medicament coating on rest body surface.
7. the processing method of degradable polymer blood vessel stent according to claim 6, is characterized in that: described medication coat comprises medicine and pharmaceutical acceptable carrier.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510670847.5A CN105149888A (en) | 2015-10-15 | 2015-10-15 | Machining method for degradable polymer intravascular stent |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510670847.5A CN105149888A (en) | 2015-10-15 | 2015-10-15 | Machining method for degradable polymer intravascular stent |
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| CN105149888A true CN105149888A (en) | 2015-12-16 |
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| CN201510670847.5A Pending CN105149888A (en) | 2015-10-15 | 2015-10-15 | Machining method for degradable polymer intravascular stent |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106041434A (en) * | 2016-08-16 | 2016-10-26 | 上海蓝佩得模具科技有限公司 | Novel base material surface treatment technology |
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| JP3239127B2 (en) * | 1995-12-25 | 2001-12-17 | タキロン株式会社 | Composite high-strength implant material and method for producing the same |
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| CN102354662A (en) * | 2011-08-10 | 2012-02-15 | 长春理工大学 | Method for cleaning positive (P) surface of chip of semiconductor laser and polishing negative (N) surface |
| CN105992571A (en) * | 2014-07-07 | 2016-10-05 | 美利奴生命科学有限公司 | Thin strut stent from bioabsorbable polymer with high fatigue and radial strength and method to manufacture thereof |
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2015
- 2015-10-15 CN CN201510670847.5A patent/CN105149888A/en active Pending
Patent Citations (7)
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| GB862966A (en) * | 1956-07-11 | 1961-03-15 | Dow Chemical Co | Making uniformly oriented polymer film |
| JP3239127B2 (en) * | 1995-12-25 | 2001-12-17 | タキロン株式会社 | Composite high-strength implant material and method for producing the same |
| CN1569261A (en) * | 2004-05-13 | 2005-01-26 | 哈尔滨工业大学 | Novel use of ploy-L-lactic acid as medical shape memory material |
| CN101508831A (en) * | 2008-12-17 | 2009-08-19 | 深圳市科聚新材料有限公司 | Toughening modified polylactic acid composite material and method for producing the same |
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| CN102354662A (en) * | 2011-08-10 | 2012-02-15 | 长春理工大学 | Method for cleaning positive (P) surface of chip of semiconductor laser and polishing negative (N) surface |
| CN105992571A (en) * | 2014-07-07 | 2016-10-05 | 美利奴生命科学有限公司 | Thin strut stent from bioabsorbable polymer with high fatigue and radial strength and method to manufacture thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106041434A (en) * | 2016-08-16 | 2016-10-26 | 上海蓝佩得模具科技有限公司 | Novel base material surface treatment technology |
| CN106041434B (en) * | 2016-08-16 | 2018-07-31 | 江苏蓝佩得工业科技有限公司 | A kind of substrate surface treatment technique |
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