CN101543437A - Method for preparing intravascular stent - Google Patents

Method for preparing intravascular stent Download PDF

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Publication number
CN101543437A
CN101543437A CN 200910082779 CN200910082779A CN101543437A CN 101543437 A CN101543437 A CN 101543437A CN 200910082779 CN200910082779 CN 200910082779 CN 200910082779 A CN200910082779 A CN 200910082779A CN 101543437 A CN101543437 A CN 101543437A
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China
Prior art keywords
lamellar
support
sheet material
preparation
tubulose
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CN 200910082779
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Chinese (zh)
Inventor
崔凯
张正才
翟慎良
蒲忠杰
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Lepu Medical Technology Beijing Co Ltd
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Lepu Medical Technology Beijing Co Ltd
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Priority to CN 200910082779 priority Critical patent/CN101543437A/en
Publication of CN101543437A publication Critical patent/CN101543437A/en
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Abstract

The invention relates to a method for preparing an intravascular stent, which comprises the following process steps: 1) performing laser cutting or etching on a sheet material by using a laser method or a mechanical method; 2) forming the sheet material into a tubular shape in a helix coiling or edge coiling mode; 3) welding nodal points of the sheet material; and 4) performing heat treatment. The method is changed for carving the sheet material from carving a tubular material by the prior method, breaks through the limitation that certain materials are difficult to process the tubular material, and prepares the stent by adopting a method of plate engraving and precise center winding so that more materials can be prepared into the intravascular stent, in particular for magnesium alloy, because a thin-wall tubule material of the magnesium alloy is difficult to obtain but a thin plate material is easy to obtain and the cutting of the plate material is far easier than that of the tubule material; and through refined calculation, in the structural design, a few welding points are formed, and finally a flaky stent is prepared into a tubular stent after coiling and welding so that the preparation of a magnesium alloy stent is possible and the cost is low.

Description

A kind of preparation method of intravascular stent
Technical field
The present invention relates to medical apparatus and instruments and material processing field, be specifically related to a kind of preparation method of intravascular stent.
Background technology
At present, intravascular stent is widely used in diseases such as vascular occlusion, has brought Gospel to the patient, and the especially outstanding performance of coronary artery bracket in coronary heart disease treatment makes the percutaneous interventional therapy become first of coronary heart disease treatment and select.
But along with the development of interventional therapy and the analysis of clinical effectiveness, it is found that there is the danger of advanced thrombus in present coronary artery bracket, this has brought certain resistance for the development of coronary heart disease interventional therapy, for addressing this problem, people wish to relate to a kind of Wholly-degradable support, according to this design concept, support can be absorbed by the body after occluding vascular is cured fully, human body there is not influence, therefore the blood vessel of Hui Fuing will not have any potential danger without any foreign body at last, and the blood vessel pliability returns to normal human's situation, the secondary implant frame is had no effect, and the support that satisfies this kind requirement can be rated as perfect intravascular stent.
At present, existing biodegradable stent all is in clinical experimental stage basically, according to its material, can be divided into that macromolecule can absorb support and metal can absorb two kinds on support.It is serious that macromolecule can absorb the resilience of support, and the cross section is bigger, and present research emphasis mainly concentrates on structural design and material improvement; Metal can absorb support and mainly select magnesium alloy materials for use, and the existing magnesium alloy of Biotronic can absorb the first phase clinical report of support at present, though domestic have how tame unit studying, does not still have relevant report.
It is to adopt traditional method that the prepared magnesium alloy of Biotronic company can absorb support, prepares thin wall tubule earlier, carries out laser engraving then.Because the characteristic of magnesium alloy, the preparation thin wall tubule is very difficult, has only indivedual companies manufacturing experimently abroad, and domestic still do not have this kind technology at present, and cost is too high.Though the research of this respect is the focus of present domestic research magnesium alloy bracket, effect is bad.
On the contrary, magnesium alloy plate obtains easily, the domestic sheet material that just can be met requirement, and through deformation process, plasticity also can increase, so the inventor has walked around the difficult problem of Mg alloy thin wall tubule preparation, by the structural design of exquisiteness, sheet material is shaped to intravascular stent through the axle volume.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of intravascular stent comprises following processing step: 1) sheet material is cut or etching with laser method or Mechanical Method; 2) mode with helix-coil or edge curl is a tubulose with plate forming; 3) node with sheet material welds; 4) heat treatment.
Method of the present invention is 1) afterwards, 2) can also comprise heat treatment before; 2) afterwards, 3) also can comprise heat treatment before.
The sheet material that the present invention selects for use is any material that is applicable to the preparation intravascular stent, and as metal, absorbable metal particularly more especially is difficult to prepare the material of thin wall tubule, as magnesium or magnesium alloy, also can select degradable high polymer material for use; The thickness of the sheet material of selecting for use is 0.1-0.5mm, preferred 0.15-0.25mm.Concerning the sheet material of metal material, method of the present invention also comprises: 5) polishing.
It is this area technology commonly used that described laser method or Mechanical Method cutting or etching prepare intravascular stent, but prior art mainly is used on the tubing, and the present invention is used in this technology on the sheet material, and technology difficulty decreases, as long as change anchor clamps, just can process sheet material very easily;
Cut or etching processing after sheet material can have the various patterns that are suitable for compressing, and reserve solder joint, the position of the welding node after pattern need be considered to curl preferably makes the solder joint of the tubing that makes not bear the expansible maximum, force of support when stent applications.
Described have a pattern that is suitable for compressing, and the sheet material of reserving solder joint is preferably one or more the combination in the lamellar closed cell of tetragon lamellar support, flower shape.
Described tetragon lamellar support is the tetragon lamellar support formed of the band that forms of end to end " S " shape that is parallel to each other and has node to connect shown in Fig. 1,2,4 preferably; And one or more the combination in the tetragon lamellar support formed of as shown in Figure 3 " M " by end to end that be parallel to each other and have node to connect band of forming; The preferably lamellar closed cell of the flower shape shown in Fig. 5,6,8 or the combination of two groups of lamellar closed cells of the lamellar closed cell of described flower shape; And the one group of lamellar support as shown in figure 10 and the combination of two groups of lamellar closed cells;
Described tetragon preferred class parallelogram and class rectangle;
Described helix-coil is that the cylinder with certain diameter is an axle, with certain of tetragon lamellar support on one side as the girth of tube section, curl for tubulose,, finally form tubular bracket as the lamellar support of class parallelogram being carried out spiral winding around the cylinder of special diameter; Also the orthogonal lamellar support of class can be reeled with special diameter along suitable limit, finally form tubular bracket.
Described edge curl is that " petal " of the lamellar closed cell of flower shape curled (as Fig. 7 and shown in Figure 9) to the same side, and the angle of curling can be 80-120 °, and preferred 90 °, forming with " fickle in love " is the tubulose at the end.
Described welding is to adopt method well known in the art, and the phase of solder joint of reserving is connected, and as concerning magnesium alloy, can adopt the method for laser spot welding and transistor type electric current welding to carry out, the preferred latter; Concerning macromolecular material, can adopt the method for various suitable bonding macromolecular materials, preferred laser weld.
Described heat treatment is in order to eliminate the stress that the front operation introduces and the plasticity of reinforcing material, can to adopt variety of way well known in the art to carry out, and is example with the WE43 of magnesium alloy, behind engraving, can carry out full annealing before curling handles: 623-673K, be incubated 3-5 hour, and stove is cold; Can carry out the stress relief annealing of following condition: 533k after welding, 0.25 hour, stove was cold; Can adopt solution hardening to handle: 798K, 4-8 hour, air cooling as plasticising.
Described polishing also is the general knowledge of this area, preferred chemical method polishing.
The present invention can be curled two groups of lamellar closed cell combinations with two groups of lamellar closed cells by the mode of edge curl in opposite directions, is shaped to the tubulose that end face closure and end face do not have solder joint; Or with one group of lamellar support and the combination of one group of lamellar closed cell, the mode by helix-coil and edge curl is the tubulose that an end face closure and end face do not have solder joint with plate forming; Also can be with one group of lamellar support and the combination of two groups of group lamellar closed cells, lamellar closed cell edge curl is an end face, the lamellar stent helix is curled and is tubulose, in conjunction with after be the closed tubulose that two end face closures and end face all do not have solder joint with plate forming.
The support of the present invention preparation be after can be compressed after the chemical polishing and be convenient to carry, and carries and can pass through balloon expandable after finishing, thereby obtain the effect of support blood vessels, and described support can directly use or be used for preparing the other medicines support.
In fact, the key of the preparation method of support of the present invention is the structural design of support, and the structure of the structures shape cut of support and the pattern of etching influences axle and rolls up the quality of distortion, determines how much reaching the position and being subjected to force direction of solder joint.Cut will be accomplished the influence of sheet material little, the cutting accuracy height; Axle volume distortion is in order finally to make the lamellar support become tubular bracket, can to take any suitable way, such as pipe around certain diameter, according to structure Design reel, positive folding or other distortion.
Major advantage of the present invention be with the method for traditional engraving preparation of pipes intravascular stent change into engraving sheet material, curling is the method for intravascular stent, has so just broken the drawback that some material is difficult to process tubing, makes more material can be used as intravascular stent; Method of the present invention is specially adapted to specific function but can't satisfies the material that the thin wall tubule preparation requires, as magnesium alloy.With the magnesium alloy is example, because magnesium alloy is active and fragility is big, does not have the Mg alloy thin wall tubule of industrialization so far, abroad also is hard to buy very much, have only to be in conceptual phase on a small quantity, and cost is higher; But magnesium alloy is as the optimal material of biodegradable stent of new generation, its degradability and biological activity have all determined magnesium alloy to be expected to become the innovation material of intravascular stent, can be rated as perfect vascular stent material, method of the present invention has broken through this limitation, the method of adopt dull and stereotyped engraving, accurately curling prepares support, because magnesium alloy thin sheet material is easy to obtain, and the cutting of sheet material is more a lot of easily than the cutting of tubing.With crossing accurate Calculation, project organization is reserved a spot of solder joint, and the lamellar support is prepared into tubular bracket the most at last, makes the preparation of magnesium alloy bracket become possibility and with low cost.
Description of drawings
Fig. 1 is the pattern structure of laser ablation of the present invention and the coiling method of intending employing;
Fig. 2 is the pattern structure of laser ablation of the present invention;
Fig. 3 is the pattern structure of laser ablation of the present invention;
Fig. 4 is the pattern structure figure of laser ablation of the present invention and the coiling method of intending employing;
Fig. 5 is a kind of planar structure of lamellar closed cell of the present invention;
Fig. 6 is the another kind of planar structure of lamellar closed cell of the present invention;
Fig. 7 is with the planar bracket of Fig. 6 structure tubular bracket structure after the edge curl of center;
Fig. 8 is the planar structure that the present invention is the lamellar closed cell with two unit;
Fig. 9 carries out tubular bracket structure after the edge curl with two flat units shown in Figure 8 with direction in opposite directions respectively;
Figure 10 is the plane structure chart of the pattern after Fig. 1 and the combination of Fig. 7 method.
Among the figure: 1 is the axle that curls; 2-12,14,15,17-19, the solder joint of 21-24 for reserving; 13 curl directions for expectation; 16 is the connecting rod of two groups of lamellar closed cells; 20 is the lamellar closed cell.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
Referring to Fig. 1-10, the way that the present invention prepares support as shown in the figure.
Fig. 1 is one embodiment of the present of invention, be magnesium alloy WE43 at first with material, thickness is that the sheet material of 0.2mm carries out cut and etching, be engraved as and have the class parallelogram lamellar support of decorative pattern as shown in Figure 1, with the girth of parallelogram minor face as tubular bracket, the lamellar support is carried out helical form around fixed axis 1 twine, winding direction as shown in Figure 1.The lamellar support leaves pad, and as shown in Figure 1,2,3 is an assembly welding contact, and 4,5 is an assembly welding contact, and by that analogy, behind lamellar support cans, every assembly welding point contacts, with the welding of transistor type electric current welding.
Lamellar support that will be the same with Fig. 1 decorative pattern cuts into shape as shown in Figure 2, still adopts transistor type electric current welding that pad is welded after curling.
With above-mentioned support through heat treatment: in the 798K insulation after 8 hours, air cooling, polishing then is immersed in support in the dilute hydrochloric acid of 0.01mol/L and soaked 2 minutes.Make the support product.
Embodiment 2
The various all available methods by helix-coil of pattern structure that satisfy the support requirement prepare support.At first get Poly-L-lactic acid (PLLA), thickness is the sheet material of 0.2mm, and sheet material is carried out machine cuts, be engraved as the lamellar support of structure as shown in Figure 3,, reserve solder joint according to design for the class parallelogram sturcutre, carry out the hand of spiral then and twine, form tubular bracket at last.
In addition, above-mentioned plate with laser is etched into the class rectangle, pattern makes the winding axle parallel with orthogonal long limit as shown in Figure 4, reels, and solder joint is welded with laser method, obtains tubular bracket.
Above-mentioned support heat-treated finalize the design, under the 300K temperature, kept 20 minutes, make the support product.
Embodiment 3
Getting thickness is the 316L stainless steel materials of 0.25mm, sheet material is carried out cut and etching, engraving is the closed carrier unit of the lamellar of flower shape, vertically from middle upright support, " petal " curled 90 ° to same direction, formation is the tubular bracket unit at the end with " fickle in love ", as shown in Figure 5 and Figure 6, among the figure two kinds of lamellar carrier unit structures, Fig. 7 is the carrier unit of Fig. 6 after curling, 14,15 solder joints for reservation can adopt transistor type electric current weldings that a plurality of element solder are got up to form support by these two solder joints at last.
1050 ℃ of insulations 1 hour, stove is cold heat-treated then.
Adopt commercial stainless steel chemical polishing solution to polish at last.
Embodiment 4
In order to reduce solder joint, also embodiment 3 described lamellar closed cells can be combined into support.Getting thickness is the magnesium alloy AZ31 sheet material of 0.10mm, laser method is processed into the welding unit that two embodiment, 3 described lamellar closed cells as shown in Figure 8 link together, according to mode shown in Figure 9 two closed cells are curled in opposite directions then, Fig. 9 is the welding unit of Fig. 8 after curling, 16 is unjointed connecting rod between the closed carrier unit of two lamellars, 17,18 is a pair of pad, the 19th, be connected the solder joint of usefulness with other unit.
With method of laser welding welding 17 and 18, to heat-treat in 4 hours in the 533K insulation then, air cooling is immersed in support then to soak in the dilute hydrochloric acid of 0.01mol/L and carried out chemical polishing in 2 minutes, makes the support product at last.
Embodiment 5
Structure shown in Figure 10 is a most preferred embodiment of the present invention, the pattern of lamellar support wherein as shown in figure 10, two groups of lamellar closed cells 20 selecting for use are connected two relative end points of lamellar support.
Because the pad at the tubular bracket edge shown in the embodiment 1 can have influence on the overall performance of support, and as 12 among Fig. 1, solder joint shown in 8 may directly be subjected to expansive force, therefore the method with closed carrier unit is applied in the support preparation method shown in Figure 1, two closed cells are added at two at the lamellar support, shown in 20 among Figure 10, form support by closed cell from the center edge curl, the unit of accomplishing the support two ends does not have solder joint, and the solder joint of entire bracket is not in main load direction.As shown in figure 10,22,21 is a butt welding point, and 23,24 is a butt welding point.Like this when support is expansible, the longitudinal force that solder joint will directly not bear expansion and be brought avoids support to rupture from solder joint.
Be magnesium alloy WE43 with material at first, thickness is that the sheet material of 0.2mm carries out cut and etching, is engraved as to have the support pattern of decorative pattern as shown in figure 10, anneals then: 400 ℃, be incubated 4 hours, and stove is cold.
With annealing after pattern shown in embodiment 1, carrying out helical form earlier twines, behind lamellar support cans, two groups of lamellar closed cells 20 are carried out edge curl according to embodiment 3 described modes respectively, each the assembly welding point in the pattern is contacted, with the welding of transistor type electric current welding, carrying out stress relief annealing and plasticising then handles: 260 ℃, 0.25 hour, the cold back of stove is at 525 ℃ of insulations 4 hours, air cooling.
The support of gained is immersed in soak in the dilute hydrochloric acid of 0.005mol/L and polished in 5 minutes, make the support product.

Claims (10)

1, a kind of preparation method of intravascular stent comprises following processing step: 1) sheet material is cut or etching with laser method or Mechanical Method; 2) mode with helix-coil or edge curl is a tubulose with plate forming; 3) node with sheet material welds; 4) heat treatment.
2, preparation method as claimed in claim 1 is characterized in that, described sheet material is absorbable metal or degradable high polymer material.
3, preparation method as claimed in claim 2 is characterized in that, described absorbable metal is magnesium or magnesium alloy.
4, preparation method as claimed in claim 1 is characterized in that, is to have the pattern that is suitable for compressing through the sheet material after described cutting of step 1) or the etching processing, and reserves the sheet material of solder joint.
5, preparation method as claimed in claim 4 is characterized in that, described have a pattern that is suitable for compressing, and the sheet material of reserving solder joint is one or more the combination in the lamellar closed cell of tetragon lamellar support, flower shape.
6, preparation method as claimed in claim 5 is characterized in that, described tetragon lamellar support is to be parallel to each other and tetragon lamellar support that band that end to end " S " shape of having node to connect forms is formed; And be parallel to each other and tetragon lamellar support that band that " M " by end to end that have node to connect forms is formed in one or more combination.
As claim 5 or 6 described preparation methoies, it is characterized in that 7, described tetragon is class parallelogram and class rectangle.
As the arbitrary described preparation method of claim 5-7, it is characterized in that 8, described helix-coil is that the cylinder with certain diameter is an axle, tetragon lamellar support is curled is tubulose.
9, as the arbitrary described preparation method of claim 5-7, it is characterized in that described edge curl is that " petal " of the lamellar closed cell of flower shape is curling to the same side, the angle of curling can be 80-120 °, preferred 90 °, forming with " fickle in love " is the tubulose at the end.
10, preparation method as claimed in claim 1 is characterized in that, with the combination of two groups of lamellar closed cells, by the mode of edge curl two groups of lamellar closed cells is curled 90 ° in opposite directions, and it is closed and do not have a tubulose of solder joint to be shaped to end face; Or with one group of lamellar support and the combination of one group of lamellar closed cell, the mode by helix-coil and edge curl is that an end face is closed and do not have a tubulose of solder joint with plate forming; Or with one group of lamellar support and two groups of group lamellar closed cell combinations, lamellar closed cell edge curl is an end face, and the lamellar stent helix is curled and is tubulose, is two end faces closures and the closed tubulose that does not all have solder joint with plate forming.
CN 200910082779 2009-04-29 2009-04-29 Method for preparing intravascular stent Pending CN101543437A (en)

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102973342A (en) * 2012-12-08 2013-03-20 西北有色金属研究院 Preparation method of degradable magnesium alloy interventional stent
CN103300945A (en) * 2013-06-06 2013-09-18 上海交通大学 Medical porous composite material
WO2017012386A1 (en) * 2015-07-20 2017-01-26 上海交通大学 Biodegradable metal vascular scaffold and use thereof
CN106825945A (en) * 2017-03-15 2017-06-13 山东吉威医疗制品有限公司 A kind of cutting technique of angiocarpy bracket
CN108814781A (en) * 2015-02-16 2018-11-16 上海微创医疗器械(集团)有限公司 Biodegradable stent and preparation method thereof
CN108814780A (en) * 2015-02-16 2018-11-16 上海微创医疗器械(集团)有限公司 Biodegradable stent and preparation method thereof
CN113020908A (en) * 2021-03-08 2021-06-25 沛县盛玛特新材料研究院有限公司 Preparation method of medical stent and medical stent
CN116919685A (en) * 2023-09-14 2023-10-24 乐普(北京)医疗器械股份有限公司 Metal vascular stent, stent production method, press-holding forming device and protective sleeve

Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102973342A (en) * 2012-12-08 2013-03-20 西北有色金属研究院 Preparation method of degradable magnesium alloy interventional stent
CN102973342B (en) * 2012-12-08 2014-10-08 西北有色金属研究院 Preparation method of degradable magnesium alloy interventional stent
CN103300945A (en) * 2013-06-06 2013-09-18 上海交通大学 Medical porous composite material
CN108814781A (en) * 2015-02-16 2018-11-16 上海微创医疗器械(集团)有限公司 Biodegradable stent and preparation method thereof
CN108814780A (en) * 2015-02-16 2018-11-16 上海微创医疗器械(集团)有限公司 Biodegradable stent and preparation method thereof
WO2017012386A1 (en) * 2015-07-20 2017-01-26 上海交通大学 Biodegradable metal vascular scaffold and use thereof
CN106825945A (en) * 2017-03-15 2017-06-13 山东吉威医疗制品有限公司 A kind of cutting technique of angiocarpy bracket
CN113020908A (en) * 2021-03-08 2021-06-25 沛县盛玛特新材料研究院有限公司 Preparation method of medical stent and medical stent
CN113020908B (en) * 2021-03-08 2023-12-12 沛县盛玛特新材料研究院有限公司 Preparation method of medical stent and medical stent
CN116919685A (en) * 2023-09-14 2023-10-24 乐普(北京)医疗器械股份有限公司 Metal vascular stent, stent production method, press-holding forming device and protective sleeve
CN116919685B (en) * 2023-09-14 2023-12-15 乐普(北京)医疗器械股份有限公司 Metal vascular stent, stent production method, press-holding forming device and protective sleeve

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