CN103462726A - Novel covered stent and manufacturing method thereof - Google Patents
Novel covered stent and manufacturing method thereof Download PDFInfo
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- CN103462726A CN103462726A CN2013103817166A CN201310381716A CN103462726A CN 103462726 A CN103462726 A CN 103462726A CN 2013103817166 A CN2013103817166 A CN 2013103817166A CN 201310381716 A CN201310381716 A CN 201310381716A CN 103462726 A CN103462726 A CN 103462726A
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Abstract
The invention discloses a novel covered stent, and particularly relates to a self-expandable covered stent whose diameter can be further enlarged through an inflatable balloon when the covered stent is implanted into blood vessels of a human body. The covered stent adopts a covered film which can be an ePTFE thin film, a spinning PET thin film and a urethane film. The film is characterized in that the self-expandable stent can still be enlarged by 0.5-5.0mm in diameter through the inflatable balloon after being implanted into the blood vessels of the human body. The stent can be a self-expandable stent made of metal materials, and can be made into types such as a Zig-Zag screw type, a knitted type and a laser cutting type. The stent is characterized in that the stent can still be enlarged by 0.5-5.0mm in diameter through the inflatable balloon after being implanted into the blood vessels of the human being. By the aid of the self-expandable covered stent, lesions of all kinds of main arteries and peripheral vessels can be effectively treated. The invention further discloses a manufacturing method of three kinds of covered stents.
Description
Technical field:
The present invention relates to a kind of medical apparatus and instruments, relate to or rather a kind of Wicresoft wound and get involved Novel film coating support of medical human implant and preparation method thereof, belong to the medical apparatus and instruments scope.
Background technology
The network of medical alloy silk braiding can be applied to esophagus, trachea, blood vessel, the gallbladder road, the positions such as urethra between therapy, reconstruction at the human body inner gateway plays an important role, but effective acting time is shorter, restenosis rate is high, for the stimulation to the tissue inwall of the netted Medical rack that reduces medical alloy silk braiding, reduce tissue regeneration, reduce thrombosis rate again, people adopt the method for sewn by hand to coat a skim at rack outer surface, this tunic can be medicine carrying membrane, effectively extended the operational use time of support, but owing between support and film, there is no adhesion, in use film easily breaks away from support, form new obstruction, late period, the support thrombosis rate was higher, the elastic loss of support is more simultaneously.Research shows, the speed of Medical rack endothelialization is to cause the Medical rack key factor that thromboembolism forms again.It is unique blood-compatible material of knowing at present that the human body interior conduit that human endothelial cells forms is organized inwall, also can effectively suppress the pipeline tissue regeneration, and the endothelialization on the Medical rack surface in implant into body is the basis of framework's through engineering approaches simultaneously.
That accomplishes that quick endothelialization can do only has preferred covering material and optimizes micro structure.The Medical rack overlay film adopts solution casting or braiding to form at present, China Patent Publication No. CN1194776C, open day on March 30th, 2005, the name of innovation and creation is called medical internal marmem frame coated by high-molecular film for penetration therapy and processing method thereof, this application case discloses the processing method of medical internal support made of memory alloy coated by high-molecular film, its weak point is that coated by high-molecular film is to adopt the method for solution casting to prepare, overlay film micro structure ability of regulation and control is limited, adhesion between support and overlay film is not firm, and the purpose of overlay film has just been improved the biocompatibility of support.Textile journal, the 30th volume o. 11th, open day in November, 2009, paper: the polyurethane electrostatic spinning based on oxolane/dicarbaldehyde Methanamide, text 18-19 page, disclose the preparation method of Static Spinning polyurethane fiber film, determined structure and the performance characteristic of polyurethane fiber film, and specifically disclose technical characterictic, and can obtain the Static Spinning polyurethane fiber film of wishing thickness by setting technological parameter.Its weak point is to embrace the Static Spinning polyurethane film that covers different-thickness inside and outside medical alloy mesh-like support, requirement to the biologic applications technical characterictic that reaches the modification after-poppet can not realize, do not have to propose how to utilize the regulation and control of micro structure to meet the requirement of biologic applications feature.China Patent Publication No. CN1240349C, open day on February 8th, 2006, the name of innovation and creation is called type great vessel strut, and this application case discloses a kind of intravascular stent that comprises the fabricated structure of the interior village of fiber and expandable stent, and its weak point is that resulting overlay film micro structure ability of regulation and control is limited; China Patent Publication No. CN101732117A, in open day on June 16th, 2010, the name of innovation and creation is called a kind of biliary tract prosthesis and preparation method thereof, and this application case discloses the biliary tract prosthesis with non-woven overlay film prepared by a kind of method that adopts Static Spinning.Its weak point is from the regulation and control of Static Spinning overlay film microstructure features, not promote the absorption of endotheliocyte, and slewing is bred, and realizes the quick endothelialization of support.The orientation fibers film has the characteristic of inducing endothelial cell in fibre orientation arragement direction priority migration, differentiation, and the orientation fibers film that is compounded with natural material more is conducive to sticking and breeding of cell.But Static Spinning need be to material dissolves, and natural material derives from organism, the matrix condition that endotheliocyte is grown in intrinsic approximation is destroyed, has reduced original cellular affinity, but does not dissolve and can't machine-shaping.
2 kinds of overlay film frames are arranged in the market:
(1) sacculus expands swollen formula: for example its shortcoming of the V12 of Atrium is that (a) sacculus expands swollen support and lacks anti-flat, resistance to compression, elastic returning, is not suitable for doing periphery, especially SFA application; (b) sacculus expands that the anti-fatigue performance of swollen support is lower, easy fracture; (c) length that sacculus expands swollen support generally, in 5 centimetres, is no more than 10 centimetres.
(2) self-inflated: the WallGraft of the Viabe of Gore and Boston Scientific for example
Its shortcoming is (a) owing to implanting later diameter (in order to obtaining required radial force) 5%-20% that must diminish from swollen support, and therefore the ePTFE of its covering or PET thin film, also produce fold, and produce thus thrombosis and restenosis; (b) do not launched fully due to ePTFE or PET overlay film, had a strong impact on the release from the radial force of swollen support.Therefore, the radial force of Self-expanding covered stent is generally on the low side; (c) due to the inhomogeneities of blood vessel diameter, during implantation generally the intermediate value according to blood vessel diameter select overlay film frame, cause the position support that blood vessel diameter is large enough radial forces can't be provided and cause restenosis, the position support that blood vessel diameter is little provides too large radial force and the injured blood vessel wall.
Summary of the invention
For above-mentioned deficiency of the prior art, we have invented and disclose the Novel film coating support that a kind of Wicresoft wound gets involved the medical human implant.This is the overlay film frame that a kind of self-inflated mixes with ball expansion formula, and this overlay film frame, after implant into body blood vessel self-expanding, can further increase diameter by inflating balloon.
The present invention is by the following technical solutions:
The overlay film frame that a kind of self-inflated mixes with ball expansion formula, is characterized in that this overlay film frame is after implant into body blood vessel self-expanding, can further increase diameter by inflating balloon.The overlay film that overlay film frame adopts, can be ePTFE thin film, weaving PET thin film, polyurethanes thin film, and at support, after expansion is discharged into human vas, overlay film frame still can increase by inflating balloon the diameter of 0.5-5.0 millimeter.Support can be the self-expandable stent that metal material is made, and the shape of overlay film frame can be that Zig-Zag is screw type, braiding, the type of cut etc.Preferably, support is to be made by Nitinol, rustless steel.
Preferably, overlay film frame is comprised of 3-tier architecture: internal layer and the outer ePTFE thin film that can expand under the radial tension condition that is, the metal rack of intermediate layer for expanding under the radial tension condition, that internal layer and outer field ePTFE thin film adopt is bonding, bind or fused method, the metal rack in intermediate layer is combined closely, shape all-in-one-piece overlay film frame.
Preferably, overlay film frame is comprised of 2 layers of structure: wherein one deck is braiding and the tatting macromolecular fibre thin film that can expand under the radial tension condition, and its diameter that can possess the 0.5-5.0 millimeter expands surplus; One deck is the metal rack that can expand under the radial tension condition in addition; Combination between two-layer, can take the method for binding or use stitching thread, fiber membrane is sewn on metal rack, thus the overlay film frame of acquisition one.
Preferably, overlay film frame is comprised of 2 layers of structure: wherein one deck is the microvoid polyurethane thin film that can expand under the radial tension condition, and it can adopt the method preparation of Static Spinning; One deck is the metal rack that can expand under the radial tension condition in addition; Combination between two-layer, take to bind or hot-press method, and thin film is attached on metal rack securely, thereby obtain the overlay film frame of one.
Useful technique effect of the present invention is: synthetically have all advantages that all sacculus expand swollen formula and Self-expanding covered stent, overcome all shortcomings that all sacculus expand swollen formula and Self-expanding covered stent, have good practicality and application prospect.
The accompanying drawing explanation:
The schematic diagram that Fig. 1 discharges while being the Self-expanding covered stent implant into body;
The schematic diagram that Fig. 2 discharges while being the present invention (from swollen, with ball, expanding the hybridization formula) moral overlay film frame implant into body;
A kind of metal rack of Fig. 3;
A kind of metal rack of Fig. 4;
Fig. 5 is a kind of metal rack;
Fig. 6 is the schematic diagram of Wave spiral cribbing;
A kind of braiding overlay film with extendible surplus that Fig. 7 is described in the invention;
The ePTFE overlay film with extendible surplus of the various diameters that Fig. 8 is described in the invention.
The specific embodiment:
The overlay film frame of a kind of self-inflated and the hybridization of ball expansion formula (being called for short hybridization formula overlay film frame), this overlay film frame, after implant into body blood vessel self-expanding, can further increase diameter by inflating balloon.
The overlay film that overlay film frame adopts, can (but being not limited to) be the ePTFE(expanded PTFE) thin film, weaving PET(polyester) thin film, polyurethanes thin film.The principal character of thin film is after expansion is discharged into human vas, still can increase by inflating balloon the diameter of 0.5-5.0 millimeter at support.
Support can (but being not limited to) be the self-expandable stent that metal material (Nitinol, rustless steel etc.) is made, and its shape can (but being not limited to) be that Zig-Zag is screw type, braiding, the type of cut (as Smart Stent or Life Science etc.) etc.The principal character of support is that, after the implant into body blood vessel carries out certainly expanding, its diameter still can increase the 0.5-5.0 millimeter via inflating balloon.
The invention still further relates to the manufacture method of three kinds of hybrid overlay film frames:
(1) method one: covering material adopts ePTFE thin film, support with extendible surplus to adopt the metal rack with expansion surplus;
Specific implementation method:
Overlay film frame is comprised of 3-tier architecture: internal layer and the outer ePTFE thin film that can expand under the radial tension condition that is, the metal rack of intermediate layer for expanding under the radial tension condition.That internal layer and outer field ePTFE thin film adopt is bonding, bind or fused method, the metal rack in intermediate layer is combined closely, and shape all-in-one-piece overlay film frame.
(2) method two: covering material adopts the braiding (Braiding) with extendible surplus to adopt and have the metal rack that expands surplus with tatting (Weaving) macromolecule fibre micro-(as polyester) thin film, support;
Specific implementation method:
Overlay film frame is comprised of 2 layers of structure: the wherein braiding (Braiding) and tatting (Weaving) macromolecular fibre thin film of one deck (can be internal layer or skin) for expanding under the radial tension condition.This fiber membrane, the diameter that can possess the 0.5-5.0 millimeter expands surplus, for example is, because adopted the specialty fibers that large stretching can be arranged under a small amount of pulling force condition, non-complete orientation fibers (partially Oriented Yarn, or POY).One deck (can be internal layer or skin) is the metal rack that can expand under the radial tension condition in addition.Combination between two-layer, can take the method for binding, but more general method is to use stitching thread, and fiber membrane is sewn on metal rack, thereby obtain the overlay film frame of one.
(3) method three: covering material adopts microvoid polyurethane (PU) thin film, support with extendible surplus to adopt the metal rack with expansion surplus;
Specific implementation method:
Overlay film frame is comprised of 2 layers of structure: wherein one deck (can be internal layer or skin) is microvoid polyurethane (PU) thin film that can expand under the radial tension condition.This thin film, can adopt the method preparation of Static Spinning.Because the single file modulus of the material of polyurethanes can reach very little, the diameter that thin film is easy to be issued at very little radial tension the 0.5-5.0 millimeter expands surplus.One deck (can be internal layer or skin) is the metal rack that can expand under the radial tension condition in addition.Combination between two-layer, generally can only take to bind or hot-press method, and thin film is attached on metal rack securely, thereby obtain the overlay film frame of one.
Finally explanation is, although more than described the specific embodiment of the present invention, but those of ordinary skill in the art is to be understood that, these only illustrate, those skilled in the art is under the prerequisite that does not deviate from principle of the present invention and essence, can make various changes or modifications to embodiments of the present invention, but these changes or modification all should be encompassed in the middle of claim scope of the present invention.
Claims (7)
1. the overlay film frame that self-inflated mixes with ball expansion formula, is characterized in that this overlay film frame is after implant into body blood vessel self-expanding, can further increase diameter by inflating balloon.
2. overlay film frame according to claim 1, it is characterized in that the overlay film that overlay film frame adopts, can be ePTFE thin film, weaving PET thin film, polyurethanes thin film, at support, after expansion is discharged into human vas, overlay film frame still can increase by inflating balloon the diameter of 0.5-5.0 millimeter.
3. overlay film frame according to claim 1, it is characterized in that support can be the self-expandable stent that metal material is made, the shape of overlay film frame can be Zig-Zag type screw type, braiding, cut etc., at the implant into body blood vessel, carry out after expanding, its diameter still can increase the 0.5-5.0 millimeter via inflating balloon.
4. overlay film frame according to claim 1, is characterized in that support is to be made by Nitinol, rustless steel.
5. overlay film frame according to claim 1, it is characterized in that overlay film frame is comprised of 3-tier architecture: internal layer and the outer ePTFE thin film that can expand that is under the radial tension condition, the metal rack of intermediate layer for expanding under the radial tension condition, that internal layer and outer field ePTFE thin film adopt is bonding, bind or fused method, the metal rack in intermediate layer is combined closely, shape all-in-one-piece overlay film frame.
6. overlay film frame according to claim 1, it is characterized in that overlay film frame is comprised of 2 layers of structure: wherein one deck is braiding and the tatting macromolecular fibre thin film that can expand under the radial tension condition, and its diameter that can possess the 0.5-5.0 millimeter expands surplus; One deck is the metal rack that can expand under the radial tension condition in addition; Combination between two-layer, can take the method for binding or use stitching thread, fiber membrane is sewn on metal rack, thus the overlay film frame of acquisition one.
7. overlay film frame according to claim 1 is characterized in that overlay film frame is comprised of 2 layers of structure: the microvoid polyurethane thin film of one deck for expanding under the radial tension condition wherein, and it can adopt the method preparation of Static Spinning; One deck is the metal rack that can expand under the radial tension condition in addition; Combination between two-layer, take to bind or hot-press method, and thin film is attached on metal rack securely, thereby obtain the overlay film frame of one.
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Cited By (10)
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| CN103720529A (en) * | 2013-12-30 | 2014-04-16 | 先健科技(深圳)有限公司 | Arcus aortae intraoperative stent and method for manufacturing stent |
| CN106175980A (en) * | 2015-05-04 | 2016-12-07 | 聂绍平 | Biodegradable high-molecular film single-layer metal overlay film frame |
| CN106937895A (en) * | 2016-01-05 | 2017-07-11 | 上海微创医疗器械（集团）有限公司 | Overlay film frame and preparation method thereof |
| CN107811726A (en) * | 2016-09-13 | 2018-03-20 | 先健科技(深圳)有限公司 | Overlay film frame |
| CN108136078A (en) * | 2015-10-01 | 2018-06-08 | 谢尔蒂斯有限公司 | The method that electrostatic spinning applies and inner cavity prosthese is laminated |
| CN109419570A (en) * | 2017-08-30 | 2019-03-05 | 先健科技(深圳)有限公司 | Overlay film frame and preparation method thereof |
| CN109908401A (en) * | 2019-03-11 | 2019-06-21 | 武汉杨森生物技术有限公司 | A kind of production method of artificial blood vessel and products thereof for promoting endothelial cell to seek connections with |
| CN110946626A (en) * | 2019-12-04 | 2020-04-03 | 山东大学齐鲁医院 | Expansion type tectorial membrane bracket for obtaining specimen through natural cavity channel, use method and application |
| CN111388760A (en) * | 2020-03-25 | 2020-07-10 | 华东交通大学 | Small blood vessel stent with nano fibers oriented along circumferential direction and preparation method |
| WO2023125434A1 (en) * | 2021-12-31 | 2023-07-06 | 元心科技(深圳)有限公司 | Covered stent system and preparation method therefor |
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| US10548709B2 (en) | 2013-12-30 | 2020-02-04 | Lifetech Scientific (Shenzhen) Co. Ltd. | Aortic arch intraoperative stent and manufacturing method thereof |
| CN105873543A (en) * | 2013-12-30 | 2016-08-17 | 先健科技(深圳)有限公司 | Aortic arch intraoperative stent and manufacturing method thereof |
| CN103720529B (en) * | 2013-12-30 | 2017-02-08 | 先健科技(深圳)有限公司 | Arcus aortae intraoperative stent and method for manufacturing stent |
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| CN106175980A (en) * | 2015-05-04 | 2016-12-07 | 聂绍平 | Biodegradable high-molecular film single-layer metal overlay film frame |
| CN108136078A (en) * | 2015-10-01 | 2018-06-08 | 谢尔蒂斯有限公司 | The method that electrostatic spinning applies and inner cavity prosthese is laminated |
| CN106937895A (en) * | 2016-01-05 | 2017-07-11 | 上海微创医疗器械（集团）有限公司 | Overlay film frame and preparation method thereof |
| CN107811726A (en) * | 2016-09-13 | 2018-03-20 | 先健科技(深圳)有限公司 | Overlay film frame |
| WO2018049868A1 (en) * | 2016-09-13 | 2018-03-22 | 先健科技(深圳)有限公司 | Tectorial stent |
| CN109419570A (en) * | 2017-08-30 | 2019-03-05 | 先健科技(深圳)有限公司 | Overlay film frame and preparation method thereof |
| WO2019042302A1 (en) * | 2017-08-30 | 2019-03-07 | 先健科技(深圳)有限公司 | Covered stent and preparation method therefor |
| CN109908401A (en) * | 2019-03-11 | 2019-06-21 | 武汉杨森生物技术有限公司 | A kind of production method of artificial blood vessel and products thereof for promoting endothelial cell to seek connections with |
| CN110946626A (en) * | 2019-12-04 | 2020-04-03 | 山东大学齐鲁医院 | Expansion type tectorial membrane bracket for obtaining specimen through natural cavity channel, use method and application |
| CN110946626B (en) * | 2019-12-04 | 2022-08-09 | 山东大学齐鲁医院 | Expansion type tectorial membrane bracket for obtaining specimen through natural cavity channel, use method and application |
| CN111388760A (en) * | 2020-03-25 | 2020-07-10 | 华东交通大学 | Small blood vessel stent with nano fibers oriented along circumferential direction and preparation method |
| WO2023125434A1 (en) * | 2021-12-31 | 2023-07-06 | 元心科技(深圳)有限公司 | Covered stent system and preparation method therefor |
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Application publication date: 20131225 |