CN101703812A - Polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold and preparation method thereof - Google Patents
Polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold and preparation method thereof Download PDFInfo
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- CN101703812A CN101703812A CN 200910199194 CN200910199194A CN101703812A CN 101703812 A CN101703812 A CN 101703812A CN 200910199194 CN200910199194 CN 200910199194 CN 200910199194 A CN200910199194 A CN 200910199194A CN 101703812 A CN101703812 A CN 101703812A
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- 229920002302 Nylon 6,6 Polymers 0.000 title claims abstract description 76
- 229910001000 nickel titanium Inorganic materials 0.000 title claims abstract description 20
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 239000012528 membrane Substances 0.000 title description 11
- 230000002792 vascular Effects 0.000 claims abstract description 39
- 239000011521 glass Substances 0.000 claims abstract description 26
- BDAGIHXWWSANSR-UHFFFAOYSA-N methanoic acid Natural products OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 0.000 claims abstract description 18
- 239000002904 solvent Substances 0.000 claims abstract description 17
- OSWFIVFLDKOXQC-UHFFFAOYSA-N 4-(3-methoxyphenyl)aniline Chemical compound COC1=CC=CC(C=2C=CC(N)=CC=2)=C1 OSWFIVFLDKOXQC-UHFFFAOYSA-N 0.000 claims abstract description 9
- 235000019253 formic acid Nutrition 0.000 claims abstract description 9
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 8
- 239000011248 coating agent Substances 0.000 claims abstract description 8
- 238000000576 coating method Methods 0.000 claims abstract description 8
- 239000004952 Polyamide Substances 0.000 claims 1
- 229920002647 polyamide Polymers 0.000 claims 1
- 239000010408 film Substances 0.000 abstract description 41
- 239000010409 thin film Substances 0.000 abstract description 19
- 239000000463 material Substances 0.000 abstract description 11
- 230000007812 deficiency Effects 0.000 abstract description 3
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 abstract 1
- 229910001285 shape-memory alloy Inorganic materials 0.000 abstract 1
- 208000032843 Hemorrhage Diseases 0.000 description 17
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- 238000000034 method Methods 0.000 description 7
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- 206010028980 Neoplasm Diseases 0.000 description 1
- 244000030765 Phaleria macrocarpa Species 0.000 description 1
- 229910000831 Steel Inorganic materials 0.000 description 1
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Abstract
一种聚酰胺66覆膜镍钛合金血管支架及其制备方法。该血管支架包括：镍钛合金支架和聚酰胺66膜：该血管支架具有管形血管状结构或圆柱形血管状结构；支架内外壁表面覆有薄膜，厚0.2mm～5mm。其制备方法包括：以甲酸为溶剂配制1～20％的聚酰胺66溶液；在玻璃棒上涂覆一层聚酰胺66溶液，使溶剂挥发；将镍钛形状记忆合金扩张支架套在该玻璃棒上；再涂覆一层聚酰胺66溶液，使溶剂挥发；将聚酰胺66薄膜及镍钛合金血管支架从玻璃棒上剥离，然后真空干燥后得到聚酰胺66覆膜血管支架。本发明所制备的血管支架结构稳定，具有良好的机械性能、可输送性和防渗漏性，克服了单一材料性能方面的不足，制备工艺简单。
A polyamide 66 coated nickel-titanium alloy vascular stent and a preparation method thereof. The vascular stent includes: a nickel-titanium alloy stent and a polyamide 66 film: the vascular stent has a tubular vascular structure or a cylindrical vascular structure; the inner and outer walls of the stent are coated with a thin film with a thickness of 0.2 mm to 5 mm. The preparation method comprises: preparing a 1-20% polyamide 66 solution with formic acid as a solvent; coating a layer of polyamide 66 solution on a glass rod to volatilize the solvent; covering the glass rod with a nickel-titanium shape memory alloy expansion stent and then apply a layer of polyamide 66 solution to volatilize the solvent; peel off the polyamide 66 film and the nickel-titanium alloy vascular stent from the glass rod, and then dry it in vacuum to obtain the polyamide 66 covered vascular stent. The blood vessel stent prepared by the invention has a stable structure, good mechanical properties, transportability and leakage resistance, overcomes the deficiency in the performance of a single material, and has a simple preparation process.
Description
Technical field
The invention belongs to vascular stent material and preparation field thereof, particularly relate to a kind of polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold and preparation method thereof.
Background technology
In the daily life, the disappearance of tissue and organ, breakage or nonfunction are very common, and health of people and life have been constituted serious threat.People's exploration constantly for a long time and research material and biotechnology its objective is the relevant issues that solve in the medical science, ensure human health, are prevention, diagnosis, treatment and the rehabilitation service of disease.
The tumor that is taken place by vascular tissue is called hemangioma, and wherein 80% genus is geneogenous.If face or surrounding skin growth, except influence attractive in appearance, there is no other harm; If hepatic haemangioma if hemangioma is very big, can influence digestive function, hemangioma is broken and can be caused massive hemorrhage, life threatening; If it is encephalic angioma all has disruptive possibility at any time, so dangerous more.At different hemangioma, different Therapeutic Method is arranged.Traditional Therapeutic Method comprises: 1. excision; 2. cold therapy; 3. radiation and isotope therapy; 4. sclerosing agent treatment; 5. laser therapy; 6. hemangioma copper needle therapy.But this several method all has weak point.The film-coated vascular support is the endovascular mesh-like structure rustless steel of a kind of implant into body (or other a metal such as cobalt alloy) tube as a kind of novel therapeutic device.The implantation of support is that the film-coated vascular support is installed in the tube chamber of fiber liner, be installed in then in the special-purpose delivery device, under the operating direct-view or under the X-ray monitoring by the intervention method, the system of broadcasting is delivered to the pathological changes target vessel, discharge the film-coated vascular support then.For the disruptive blood vessel of possibility, overlay film frame can be played a supporting role, and the thin film on the overlay film frame can reach the effect of mending-leakage.
In the research of film-coated vascular support, focus on selecting for use and preparing of membrane material.In the preparation of membrane material, prevent that film-coated vascular support internal hemorrhage due to trauma from being FAQs.1996, the comparatively strict definition of having leaked down in white gives: relevant with the endoluminal vascular graft, outside the graft chamber, and the phenomenon that the persistence blood flow appears in the aneurysm cavity for the treatment of at transplanted thing and adjacent blood vessel intracavity was called internal hemorrhage due to trauma.Internal hemorrhage due to trauma is divided into: support two ends internal hemorrhage due to trauma, branch's internal hemorrhage due to trauma, support defective or stake body division internal hemorrhage due to trauma, the excessive internal hemorrhage due to trauma of stake body material void.Lasting internal hemorrhage due to trauma can cause hemangioma to increase, the blood vessel wall attenuation, and even break, finally cause death [Fu Weiguo etc. can prevent the artificial blood vessel bracket (CN200520046225.7) of internal hemorrhage due to trauma].
At present; for preceding two kinds of internal hemorrhage due to trauma, the repairing method of mainly taking in the world has: adjust the support off-position, carry out balloon expandable, additional bare bracket is overlapping, secondary is repaired and surgical operation etc. [Chang Hui etc. prevent the aorta overlay film frame (CN02138385.5) of internal hemorrhage due to trauma].Said method has reduced the incidence rate of internal hemorrhage due to trauma to a certain extent, and for back two types internal hemorrhage due to trauma, just must change the material of support or structure to prevent the generation of internal hemorrhage due to trauma.
Intravascular stent has multiple material and structure.Introduced a kind of in the patent of people such as Ainsworth application by cylinder ring and the intravascular stent that links together of spring flexibly.Closing the energy-conservation assembly of support that makes flexibly struts enough big so that good enabling capabilities to be provided.It is said that this support is flexible at length direction, can keep its rigidity simultaneously in radial direction, impaired when implanting to prevent to fold.【Ainsworth?etc.，Intravascular?stent(US?6626935)】。Introduced a kind of diversification support that forms by the link of waveform cylinder ring in the patent of people such as Gomez application.This support axially has high resiliency, and has enough blood vessel wall coverage rates and radial strength and be enough to strut blood vessel [Gomez in tremulous pulse or other body; Andreina P.etc., Intravascular stent (US 6929657)].
At home in the patent: people such as Nie Honglin adopt and the isolating independent reinforcement of brace sections, reinforcement is connected the risk of breakage that may cause with head and the tail brace sections one in the prior art thereby overcome, reduced the obstruction that entire bracket produces in discharging installation process, help the installation of overlay film frame and release [Nie Honglin etc. a kind of overlay film frame (CN200710170837.0)]. also the someone has designed a kind of overlay film frame that is used for operation on aorta, comprise sutural margin, support overlay film and metal rack, this support overlay film is round tubular structure, one end of support overlay film is sewed with one section sutural margin, be sewed with on the inwall of this support overlay film remainder a plurality of annular metal supports [Xu Shangdong etc. in a kind of aorta art with overlay film frame (CN200720173762.7)]. seven first-class people sieve disclose a kind of main body rack section of overlay film frame and the preparation method of overlay film frame, this main body rack section is the Phaleria macrocarpa shape structure that contains a plurality of waveforms, and all lower floor summits of brace sections waveform all are positioned on the axial vertical same circumference with this structure; All summits, upper strata of waveform all are positioned on the same clinoplain of axial off plumb with this structure. it is said that this overlay film frame embodies stronger crooked compliance, can be applied to the very serious lesion vessels of vascular bending, enlarged overlay film frame indication [sieve seven first-class. a kind of main body rack section of overlay film frame and overlay film frame (CN200520041828.8)].
Summary of the invention
Technical problem to be solved by this invention provides a kind of polyamide 66 (PA66) membrane covered nickel-titanium alloy intravascular scaffold and preparation method thereof, prepared intravascular stent Stability Analysis of Structures, have favorable mechanical effect, conveying property and antiseep, can be used as and prevent the disruptive mending-leakage intravascular stent of hemangioma, this preparation method combines the characteristics of existing intravascular stent, overcome the deficiency of homogenous material aspect of performance, preparation technology is simple.
A kind of polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold of the present invention comprises nick-eltitanium alloy stent and polyamide 66 film: this intravascular stent has tubular vessel-like structure or cylindrical vessel-like structure; Support inside and outside wall surface is covered with thin film, thick 0.2mm～5mm.
Outer film is the polyamide 66 thin film in the described support.
The preparation method of a kind of polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold of the present invention comprises:
(1) polyamide 66 is dissolved in makes polyamide 66 solution in the formic acid solvent, polyamide 66 and formic acid mass percent are 1～20: 90～95;
(2) on Glass rod, evenly apply described polyamide 66 solution, under 20 ℃～80 ℃, treat to form after the solvent evaporates internal layer membrane of intravascular stent;
(3) nickel-titanium alloy intravascular scaffold evenly is enclosed within on the Glass rod that has been coated with the polyamide 66 thin film;
(4) evenly apply described polyamide 66 solution, under 20 ℃～80 ℃, treat to form after the solvent evaporates the outer polyamide 66 thin film of intravascular stent;
(5) described thin film and described intravascular stent are peeled off from Glass rod, under 20 ℃～80 ℃, vacuum drying, obtaining internal diameter is that 5～50mm, length are 10～200mm polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold.
Can make reduced to 8 millimeter after PA66 film-coated vascular support of the present invention folded, be installed in then in the special-purpose delivery device, under the X-ray monitoring, get involved method by surgical operation, delivery device is delivered to the pathological changes target vessel, discharge the present invention's film-coated vascular support then, promptly accuse operation behind the withdrawal delivery device and finish.
The invention provides a kind of preparation method that can effectively prevent the PA66 membrane covered nickel-titanium alloy intravascular scaffold of internal hemorrhage due to trauma, by the repeatedly coating of PA66 solution, nickel-titanium alloy intravascular scaffold is coated by inside and outside two-layer PA66 film, can effectively prevent the internal hemorrhage due to trauma that support defective and support film body break and cause.This type of adopts casting method to carry out the way that PA66 solution applies preparation film-coated vascular support on bare metal stent at home and abroad there is no relevant patent report at present.
Beneficial effect
(1) PA66 has good impact flexibility, moulding processability preferably, the tensile strength height, self-lubricating, heat-resisting, wear-resisting, corrosion-resistant, the present invention combines the characteristics of existing intravascular stent, with the covering material of PA66 as intravascular stent, overcome the deficiency of homogenous material aspect of performance, prepared intravascular stent Stability Analysis of Structures has favorable mechanical performance, conveying property and antiseep.
(2) casting method prepares simple to operationly, and can change mechanical performance, flexibility, foldability and the elastic recovery properties of film-coated vascular support by the number of times that changes polyamide 66 solution concentration, Glass rod diameter and coating.
Description of drawings
Fig. 1 is a PA66 film-coated vascular support sketch map
The specific embodiment
Below in conjunction with specific embodiment, further set forth the present invention.Should be understood that these embodiment only to be used to the present invention is described and be not used in and limit the scope of the invention.Should be understood that in addition those skilled in the art can make various changes or modifications the present invention after the content of having read the present invention's instruction, these equivalent form of values fall within the application's appended claims institute restricted portion equally.
Embodiment 1
It is to make the PA66 solution that concentration is 6wt% in 90% the formic acid that PA66 is dissolved in concentration; The PA66 solution of gained is coated on the Glass rod that diameter is 15mm several times, places under 65 ℃ of temperature, make solvent evaporates form the internal layer PA66 thin film of intravascular stent; The niti-shaped memorial alloy expandable stent evenly is enclosed within on the Glass rod that has been coated with the PA66 thin film; Once more Glass rod is carried out the repeatedly coating of PA66 solution, place the outer PA66 thin film that makes solvent evaporates form intravascular stent under 65 ℃ of temperature; The film-coated vascular support is peeled off from Glass rod, after 60 ℃ of following evacuation were removed residual solvent in 5 hours, just obtained PA66 film-coated vascular support.
Embodiment 2
It is to make the PA66 solution that concentration is 9wt% in 92% the formic acid that PA66 is dissolved in concentration; The PA66 solution of gained is coated on the Glass rod that diameter is 25mm several times, places under 70 ℃ of temperature, make solvent evaporates form the internal layer PA66 thin film of intravascular stent; The niti-shaped memorial alloy expandable stent evenly is enclosed within on the Glass rod that has been coated with the PA66 thin film; Once more Glass rod is carried out the repeatedly coating of PA66 solution, place the outer PA66 thin film that makes solvent evaporates form intravascular stent under 70 ℃ of temperature; The film-coated vascular support is peeled off from Glass rod, after 60 ℃ of following evacuation were removed residual solvent in 5 hours, just obtained PA66 film-coated vascular support.
Embodiment 3
It is to make the PA66 solution that concentration is 12wt% in 95% the formic acid that PA66 is dissolved in concentration; The PA66 solution of gained is coated on the Glass rod that diameter is 35mm several times, places under 75 ℃ of temperature, make solvent evaporates form the internal layer PA66 thin film of intravascular stent; The niti-shaped memorial alloy expandable stent evenly is enclosed within on the Glass rod that has been coated with the PA66 thin film; Once more Glass rod is carried out the repeatedly coating of PA66 solution, place the outer PA66 thin film that makes solvent evaporates form intravascular stent under 75 ℃ of temperature; The film-coated vascular support is peeled off from Glass rod, after 70 ℃ of following evacuation were removed residual solvent in 5 hours, just obtained PA66 film-coated vascular support.
Embodiment 4
It is to make the PA66 solution that concentration is 15wt% in 95% the formic acid that PA66 is dissolved in concentration; The PA66 solution of gained is coated on the Glass rod that diameter is 40mm several times, places under 80 ℃ of temperature, make solvent evaporates form the internal layer PA66 thin film of intravascular stent; The niti-shaped memorial alloy expandable stent evenly is enclosed within on the Glass rod that has been coated with the PA66 thin film; Once more Glass rod is carried out the repeatedly coating of PA66 solution, place the outer PA66 thin film that makes solvent evaporates form intravascular stent under 80 ℃ of temperature; The film-coated vascular support is peeled off from Glass rod, after 80 ℃ of following evacuation were removed residual solvent in 5 hours, is just obtained PA66 film-coated vascular support.
Claims (3)
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200910199194 CN101703812B (en) | 2009-11-20 | 2009-11-20 | Polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold and preparation method thereof |
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| CN 200910199194 CN101703812B (en) | 2009-11-20 | 2009-11-20 | Polyamide 66 membrane covered nickel-titanium alloy intravascular scaffold and preparation method thereof |
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Cited By (10)
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| CN103537415A (en) * | 2013-11-12 | 2014-01-29 | 四会精准五金制品有限公司 | Method for coating tape band with nylon |
| CN105435314A (en) * | 2015-12-14 | 2016-03-30 | 李雷 | Preparation method of covered endovascular stent-graft |
| CN105559944A (en) * | 2015-12-14 | 2016-05-11 | 李雷 | Covered endovascular stent-graft |
| CN105816215A (en) * | 2015-12-10 | 2016-08-03 | 北京泰杰伟业科技有限公司 | Regional blood flow guiding device as well as preparation method and use method thereof |
| WO2016206561A1 (en) * | 2015-06-25 | 2016-12-29 | 李雷 | Manufacturing method and system of covered stent |
| CN108236512A (en) * | 2016-12-27 | 2018-07-03 | 先健科技(深圳)有限公司 | Overlay film frame |
| WO2018121364A1 (en) * | 2016-12-28 | 2018-07-05 | 先健科技(深圳)有限公司 | Covered stent |
| CN112043875A (en) * | 2020-08-06 | 2020-12-08 | 苏州大学 | A kind of vascular stent covering for in situ intimal regeneration and preparation method thereof |
| CN112043876A (en) * | 2020-08-06 | 2020-12-08 | 苏州大学 | Reproducible and repairable vascular stent covering film and preparation method thereof |
| CN115192780A (en) * | 2022-07-22 | 2022-10-18 | 苏州中天医疗器械科技有限公司 | Rapamycin drug balloon and preparation method and application thereof |
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| US7445629B2 (en) * | 2002-01-31 | 2008-11-04 | Boston Scientific Scimed, Inc. | Medical device for delivering biologically active material |
| CN1191099C (en) * | 2002-04-26 | 2005-03-02 | 维科医疗器械(苏州)有限公司 | Medicine coated support frame of blood vessel |
| CN100352406C (en) * | 2004-08-17 | 2007-12-05 | 微创医疗器械(上海)有限公司 | Combined membrane-covered stent capable of being bent in any direction |
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2009
- 2009-11-20 CN CN 200910199194 patent/CN101703812B/en not_active Expired - Fee Related
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| CN103537415A (en) * | 2013-11-12 | 2014-01-29 | 四会精准五金制品有限公司 | Method for coating tape band with nylon |
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| CN106264781A (en) * | 2015-06-25 | 2017-01-04 | 李雷 | The manufacture method of overlay film frame, system |
| CN105816215A (en) * | 2015-12-10 | 2016-08-03 | 北京泰杰伟业科技有限公司 | Regional blood flow guiding device as well as preparation method and use method thereof |
| US10695164B2 (en) | 2015-12-14 | 2020-06-30 | Evans Scientific (Beijing) Co., Ltd | Covered endovascular stent-graft |
| CN105559944A (en) * | 2015-12-14 | 2016-05-11 | 李雷 | Covered endovascular stent-graft |
| WO2017101582A1 (en) * | 2015-12-14 | 2017-06-22 | 李雷 | Covered endovascular stent-graft |
| WO2017101583A1 (en) * | 2015-12-14 | 2017-06-22 | 李雷 | Method for preparing membrane-covered intravascular stent |
| CN105435314A (en) * | 2015-12-14 | 2016-03-30 | 李雷 | Preparation method of covered endovascular stent-graft |
| CN108236512B (en) * | 2016-12-27 | 2020-05-05 | 先健科技(深圳)有限公司 | stent graft |
| WO2018120874A1 (en) * | 2016-12-27 | 2018-07-05 | 先健科技(深圳)有限公司 | Covered stent |
| CN108236512A (en) * | 2016-12-27 | 2018-07-03 | 先健科技(深圳)有限公司 | Overlay film frame |
| WO2018121364A1 (en) * | 2016-12-28 | 2018-07-05 | 先健科技(深圳)有限公司 | Covered stent |
| US11273061B2 (en) | 2016-12-28 | 2022-03-15 | Lifetech Scientific (Shenzhen) Co., Ltd | Covered stent |
| CN112043875A (en) * | 2020-08-06 | 2020-12-08 | 苏州大学 | A kind of vascular stent covering for in situ intimal regeneration and preparation method thereof |
| CN112043876A (en) * | 2020-08-06 | 2020-12-08 | 苏州大学 | Reproducible and repairable vascular stent covering film and preparation method thereof |
| CN112043876B (en) * | 2020-08-06 | 2022-05-31 | 苏州大学 | A regenerative repairable vascular stent coating and preparation method thereof |
| CN115192780A (en) * | 2022-07-22 | 2022-10-18 | 苏州中天医疗器械科技有限公司 | Rapamycin drug balloon and preparation method and application thereof |
| CN115192780B (en) * | 2022-07-22 | 2023-10-31 | 苏州中天医疗器械科技有限公司 | Rapamycin drug balloon, and preparation method and application thereof |
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| CN101703812B (en) | 2013-01-02 |
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