CN106175980A - Biodegradable high-molecular film single-layer metal overlay film frame - Google Patents

Biodegradable high-molecular film single-layer metal overlay film frame Download PDF

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Publication number
CN106175980A
CN106175980A CN201510220159.9A CN201510220159A CN106175980A CN 106175980 A CN106175980 A CN 106175980A CN 201510220159 A CN201510220159 A CN 201510220159A CN 106175980 A CN106175980 A CN 106175980A
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overlay film
film frame
layer metal
rack body
biodegradable
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CN201510220159.9A
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聂绍平
王晓
师树田
甄雷
胡平
齐宏旭
李齐方
殷光中
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Abstract

The present invention provides a kind of Biodegradable high-molecular film single-layer metal overlay film frame, including the single-layer metal rack body of tubulose, the braid of rack surface, and covers the overlay film outside described rack body;Wherein, described braid is on whole rack body surface, by the network structure of electrostatic spinning braiding;Described overlay film is welded as a whole with rack body by hot pressing.The Biodegradable high-molecular film single-layer metal overlay film frame that the present invention provides, solve overlay film frame profile in prior art compared with big, compliance is poor with by property, thromboembolism preventing is poor, endothelialization process length and the high problem of restenosis rate.

Description

Biodegradable high-molecular film single-layer metal overlay film frame
Technical field
The invention belongs to technical field of medical instruments, be specifically related to a kind of Biodegradable high-molecular film single-layer metal overlay film frame.
Background technology
Overlay film frame, is also called covered stnet, the film of support with thin layer collectively constitute, graft in referring to bare mental stents inner face or exterior portion or the prosthesis of film material being completely covered;Utilize the support function of support and the covering function of film, play and close the blood vessel function rupturing or boring a hole, it may also be used for closure aneurysm or fistula of artery.Overlay film frame had both remained the support function of ordinary stent, had again film properties of materials, can be effectively improved the abnormal blood flow kinetics of lesion vessels.
In the treatment of acute and chronic blood vessel injury and peripheral blood vessel pathological changes, overlay film frame is widely used.In addition to coronary arterial perforation, coronary artery fistula, true aneurysm, dissection of aorta, aortic ulcer, aortic pseudoaneurysm, aortic rupture, aorta are tortuous, also scholar uses it for percutaneous transluminal angioplasty, through jugular vein liver interior door cavities bypass, dialysis pipeline false aneurysm, the treatment of Congenital Aortic Coarctation Combined with Patent Ductus Arteriosus.
Coronary arterial perforation is one of severe complication of vascular interventional treatment, and along with increasing and the development of new technique Yu new apparatus of complex lesions interventional therapy, the incidence rate of coronary arterial perforation has the trend day by day increased.Along with the application of the new apparatus such as support, rotary-cut, turnery with new technique, its incidence rate is up to 0.5%~3.0%.Before covered stnet comes out, its death, cardiac tamponade, myocardial infarction are respectively 10%, 31%, 34% and 39% with emergency surgery operability.Research confirms, overlay film frame can play isolation blood vessel wall and the artificial barrier effect of blood, is highly suitable for processing coronary arterial perforation.Insert overlay film frame during serious perforation and can effectively block cut, reduce mortality rate.At present, overlay film frame has become one of indispensable apparatus processing conduit room's severe complication.
In addition to for coronary artery pipe wall discontinuity damage (such as rupture or bore a hole), overlay film frame can be additionally used in closure coronary aneurysm or coronary artery fistula, also has certain advantage for thrombosis or degeneration great saphenous vein bridge pathological changes.In peripheral blood vessel, also have and be used for overlay film frame processing false aneurysm, arteriovenous fistula, angiostenosis and occlusive disease and the Case report of the foundation in hemodialysis road.
Covering material in early days is mainly polyethylene, nylon, terylene, polyurethane and ePTFE etc., owing to degrading, is unfavorable for cell adhesion, easily causes neointimal hyperplasia, luminal stenosis and the untoward reaction caused by foreign body, because being gradually eliminated.At present, the Biodegradable polymer material with polylactic acid (PLA), polyglycolic acid, PCL and its modified copolymer etc. as representative, increasingly it is used widely in field of tissue engineering technology.This kind of material can decompose in vivo, participates in the metabolism of human body, and finally excretes.
The coronary artery overlay film frame being presently used for clinic has vascular aid company of Abbott Laboratories (Abbott Vascular Instruments Deutschland GmbH) the JOSTENT GraftMaster that produces pre-installs covered stnet system.This system uses " sandwich " design, clamps one layer of ePTFE overlay film, for sacculus expansion type (balloon-expandable) support between two-layer 316 rustless steel tubulose engraving metal rack.EPTFE is that PTFE is heated to 400 degree of after-drawing and forms, and can tolerate the stretching within 4 times, thus can meet the basic demand such as completely of stent-expansion and overlay film.This system provides five active lengths such as 9mm, 12mm, 16mm, 19mm and 26mm, thickness 0.3mm, diameter range 3.0~5.0mm, and pathological changes is passed through external diameter 0.018 inch, specified burst pressure 12~14atm, pressed and hold rear external diameter 1.5~1.7mm.Typically recommend the release of 7F guiding catheter, but much the most compatible the big chamber guiding catheter of inner chamber >=0.070 inch is.Abroad have and use overlay film frame to block self coronary artery, great saphenous vein transplantation bridge and the report of IMA perforation.Mulvihill etc. study display, use stifled II type or the not only simple operation of type III coronary arterial perforation, the success rate of closing in PCI art of this system the highest.
But this system still suffers from shortcomings: 1. owing to using the sandwich design of double-level-metal support and ePTFE, gross thickness is up to 0.3mm, and its compliance is the most poor with by property, is generally unsuitable for processing distal section vascular puncture or the perforation of diameter < 2.75mm;When the proximal segment of perforation exists severe calcification, serious distortion or Stent Implantation, often it is difficult to covered stnet is delivered to site of perforation.Owing to its release property (deliverability) is poor, if cannot discharge rapidly, easily cause cardiac tamponade the most dead.2. cannot effectively degrade due to covering material ePTFE, be difficult to complete endothelialization, it is possible to increase tardy thrombotic risk.Zoopery shows, compared with ordinary stent, after inserting ePTFE covered stnet, the endothelium cover time completely is longer.The research of Gercken etc. shows, after inserting overlay film frame, associating Antiplatelet therapy (aspirin and Ticlopidine or Effect of Clopidogrel in Treating) is used 1 month even if conventional, the incidence rate inserting after-poppet thrombosis is still up to 5.7%(4/78, mostly occur 7~70 days after surgery), reach 0.3%~1.9% far above bare mental stents.3. inserting the restenosis rate after overlay film frame and exceed 31.6%, and be positioned at bracket edge more, the incidence rate such as bracket edge and central authorities is respectively 29.8% and 8.8%.There is also expensive (often set is roughly equal to 2.4 ten thousand yuan), and be completely dependent on external import, the problem being difficulty with conventional stock.
In addition, although large artery trunks overlay film frame is made up of single-layer metal support and covering material (ePTFE membrane, terylene overlay film and linear polyester film), mechanically overlay film is sutured on self-expansion type (self-expandable) support frequently with medical nonabsorbable stitching thread.Owe closely, to add internal fistula risk owing to coupling;Owing to Coronary Artery Width is less, after using suture load mode, external diameter can be bigger, it is impossible to meets clinical demand;Further, since suture and covering material are all subjected to relatively hightension during stent expansion, suture is fixing also has high requirement, general Biodegradable material cannot meet requirement material at all.
Present stage, the research of domestic overlay film frame product focuses primarily upon aorta, entocranial artery and peripheral arterial.Rack beams holostrome structure uses 316L rustless steel, cobalt-base alloys, Ultimum Ti or Conichrome alloy etc.;Covering material uses ePTFE membrane, terylene overlay film and linear polyester film etc..Such as, the WILLIS intracranial overlay film frame system of Shanghai Wicresoft is the overlay film frame product for treating intracranial aneurysm, is made up of cobalt-base alloys support and ePTFE membrane, gross thickness 0.13mm;Hercules overlay film frame uses recalled nitinol alloy stent and linear polyester film;Aegis branch type large artery trunks overlay film frame uses Conichrome alloy bracket and ePTFE membrane;Grind hundred million gold medal Grinking dissection of aorta special stands, use without beam tapered property support, terylene overlay film.But domestic being still in blank in terms of processing the overlay film frame research and development of coronary arterial perforation, the coronary artery overlay film frame system making controlled degradation overlay film at single-layer metal rack surface waits research and development.
Therefore, for improving process level and the effectiveness of vascular interventional treatment complication, preferably ensure and get involved safety, need to overcome that contoured cradle is relatively big, compliance with by shortcomings such as property differences, it is achieved the controlled degradation of covering material, make reliable support overlay film at single-layer metal rack surface, both the integrity of overlay film had been ensured when stent-expansion, ensure that support is integrated with overlay film, can effectively control again overlay film thickness, it is ensured that mounting system has less external diameter, good compliance and the property passed through.This also will further improve the application space of overlay film frame.
Summary of the invention
For the deficiencies in the prior art, it is an object of the invention to provide a kind of Biodegradable high-molecular film single-layer metal overlay film frame, solve overlay film frame profile in prior art compared with big, compliance is poor with by property, thromboembolism preventing is poor, endothelialization process length and the high problem of restenosis rate.
For achieving the above object, the technical solution adopted in the present invention is:
A kind of Biodegradable high-molecular film single-layer metal overlay film frame, including the single-layer metal rack body of tubulose, the braid of rack surface, and covers the overlay film outside described rack body;Wherein, described braid is on whole rack body surface, by the network structure of electrostatic spinning braiding;Described overlay film is welded as a whole with rack body by hot pressing.
Preferably, described braid uses Electrospun Nanofibrous Materials: An.
Preferably, described overlay film is for can be biodegradable into membrane material.
Preferably, can be biodegradable into membrane material described in and include polylactic acid, polyglycolic acid or polycaprolactone.
Preferably, the temperature of described hot pressing is 160 DEG C-240 DEG C.
The Biodegradable high-molecular film single-layer metal overlay film frame that the present invention provides, including single-layer tubular metal rack main body, the network surface weave layer of electrostatic spinning braiding, and cover the overlay film being welded as a whole outside described rack body, by hot pressing and rack body.By electrostatic spinning technique weave mesh, on the one hand can play again, as the supportive skeleton of overlay film, the effect being connected as a single entity by whole overlay film.On the basis of weave mesh, by being hot pressed into membrane technology, can realize easily at single-layer metal rack surface overlay film.Electrostatic spinning is combined at single-layer metal rack surface making overlay film with being hot pressed into membrane technology, had both enhanced the compliance of overlay film frame and by property, and in turn ensure that the draftability of overlay film, it is ensured that support overlay film after expansion keeps good integrity.By thermal compression welding, membrane material and bare mental stents are realized strong bonded, covering material is combined together with braid grid material, form monolayer overlay film integrated, with skeleton.The overlay film frame that the present invention provides, has good pliability and draftability, is adapted to different types of blood vessel and pathological changes;There is good biocompatibility and the blood vessel compatibility, to body and blood vessel nonhazardous.
Accompanying drawing explanation
Fig. 1 is the rack body schematic diagram of Biodegradable high-molecular film single-layer metal overlay film frame of the present invention;
Fig. 2 is the organization level schematic diagram of the rack surface of Biodegradable high-molecular film single-layer metal overlay film frame of the present invention;
Fig. 3 is the overall schematic of the rack body of Biodegradable high-molecular film single-layer metal overlay film frame of the present invention.
Detailed description of the invention
Below in conjunction with accompanying drawing, technical scheme is further described.
As Figure 1-3, a kind of Biodegradable high-molecular film single-layer metal overlay film frame, including the single-layer metal rack body 1 of tubulose, the braid 2 of rack surface, and cover the overlay film 3 outside described rack body 1;Wherein, described braid 2 is on whole rack body 1 surface, by the network structure of electrostatic spinning braiding;Described overlay film 3 is welded as a whole with rack body by hot pressing.
Electrostatic spinning is combined with hot pressing film forming and makes overlay film 3 at single-layer metal rack surface, both enhanced the compliance of overlay film frame and by property, and in turn ensure that the draftability of overlay film 3, it is ensured that support overlay film 3 after expansion keeps good integrity.Using degradable filmogen as overlay film 3, biological controlled degradation, after inserting overlay film frame several months, blood vessel injury reparation, covering material can be degradable, reduces stent thrombosis and restenosis incidence rate.Wherein, make braid 2 by Electrospinning, grid shape stent can be directly obtained;Can also be by the surface of the material spraying of biocompatibility, anticoagulant property and cell excellent adsorption to tubular bracket, so that the surface property of overlay film frame is significantly improved.
Described braid 2 uses Electrospun Nanofibrous Materials: An.Described electrospinning fibre is generally of nanometer grade diameter, and specific surface area is big, and homogeneity is high, also has the characteristic of high-strength light stretch-proof.Receive Electrospun, obtain the non-woven fabrics that fiber weaving becomes.This non-woven fabrics both can be the orientations of fiber in microstructure, it is also possible to is the network structure being woven into according to certain rule.The dense degree of fiber and the size of diameter determine the size of non-woven fabrics mesopore and the height of porosity.These construction featuress of electrospinning fibre make material not only have certain mechanical property, and have good bionic so that single-layer metal overlay film frame of the present invention meets it to cell adhesion and the requirement of membrane permeation effect of mass transmitting.
Described overlay film 3 is for can be biodegradable into membrane material.Using degradable filmogen as overlay film 3, the most controlled decomposition, participate in the metabolism of human body, and finally excrete;Biological controlled degradation, after inserting overlay film frame several months, blood vessel injury reparation, covering material can be degradable, reduces stent thrombosis and restenosis incidence rate.
Can be biodegradable into membrane material and include polycaprolactone.The described membrane material that can be biodegradable into includes the degradable high polymer materials such as polylactic acid (PLA), polyglycolic acid or polycaprolactone (PCL).PCL is hemicrystalline macromolecule, easily polymer blended with other;PCL is as aliphatic polyester family macromolecule, and biocompatibility is good, and degradable and controllable-rate have certain hole and mechanical strength, have higher toughness.The present invention utilizes PCL to prepare the overlay film of single-layer metal overlay film frame, single-layer metal overlay film frame is made to have controlled degradation characteristic, pliability and good draftability, can effectively block tremulous pulse cut, overlay film can be realized after blood vessel cut is repaired completely again degradable, thus effectively reduce stent thrombosis and the incidence rate of restenosis.
The temperature of described hot pressing is 160 DEG C-240 DEG C, it is ensured that the combined strength bination between film and support, ensures that the microstructure of film is not destroyed simultaneously, strengthens the support bulk strength after being combined.
Elaborate a lot of detail in the above description so that fully understanding the present invention.But above description is only presently preferred embodiments of the present invention, the present invention can implement to be much different from alternate manner described here, and therefore the present invention is not limited by disclosed above being embodied as.The most any those skilled in the art are without departing under technical solution of the present invention ambit, technical solution of the present invention is made many possible variations and modification by the method and the technology contents that all may utilize the disclosure above, or is revised as the Equivalent embodiments of equivalent variations.Every content without departing from technical solution of the present invention, the technical spirit of the foundation present invention, to any simple modification made for any of the above embodiments, equivalent variations and modification, all still falls within the range of technical solution of the present invention protection.

Claims (5)

1. a Biodegradable high-molecular film single-layer metal overlay film frame, it is characterised in that include the single-layer metal rack body of tubulose, the braid of rack surface, and cover the overlay film outside described rack body;Wherein, described braid is on whole rack body surface, by the network structure of electrostatic spinning braiding;Described overlay film is welded as a whole with rack body by hot pressing.
Overlay film frame the most according to claim 1, it is characterised in that described braid uses Electrospun Nanofibrous Materials: An.
Overlay film frame the most according to claim 1, it is characterised in that described overlay film is for can be biodegradable into membrane material.
Overlay film frame the most according to claim 3, it is characterised in that described in can be biodegradable into membrane material and include polylactic acid, polyglycolic acid or polycaprolactone.
Overlay film frame the most according to claim 1, it is characterised in that the temperature of described hot pressing is 160 DEG C-240 DEG C.
CN201510220159.9A 2015-05-04 2015-05-04 Biodegradable high-molecular film single-layer metal overlay film frame Pending CN106175980A (en)

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Cited By (6)

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Publication number Priority date Publication date Assignee Title
CN106667621A (en) * 2017-02-20 2017-05-17 郭伟 Novel biological absorbable coated drug carrying stent applied to femoral-popliteal arteries
CN107951595A (en) * 2017-12-27 2018-04-24 上海心至医疗科技有限公司 A kind of intravascular stent with absorbable overlay film
CN108836585A (en) * 2018-05-28 2018-11-20 上海长海医院 A kind of absorbable Y type carotid stents from Tu Mo branch of band
CN109199636A (en) * 2018-11-07 2019-01-15 北京市神经外科研究所 Overlay film compound rest
CN109875735A (en) * 2019-03-08 2019-06-14 王翔宇 A kind of Wholly-degradable overlay film frame and overlay film frame system
CN110923825A (en) * 2019-09-02 2020-03-27 上海大学 Preparation system and preparation method of high-elasticity drug-loaded thin film intravascular stent

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106667621A (en) * 2017-02-20 2017-05-17 郭伟 Novel biological absorbable coated drug carrying stent applied to femoral-popliteal arteries
CN107951595A (en) * 2017-12-27 2018-04-24 上海心至医疗科技有限公司 A kind of intravascular stent with absorbable overlay film
CN108836585A (en) * 2018-05-28 2018-11-20 上海长海医院 A kind of absorbable Y type carotid stents from Tu Mo branch of band
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CN109875735A (en) * 2019-03-08 2019-06-14 王翔宇 A kind of Wholly-degradable overlay film frame and overlay film frame system
CN109875735B (en) * 2019-03-08 2023-11-21 王翔宇 Completely degradable tectorial membrane support and tectorial membrane support system
CN110923825A (en) * 2019-09-02 2020-03-27 上海大学 Preparation system and preparation method of high-elasticity drug-loaded thin film intravascular stent
CN110923825B (en) * 2019-09-02 2021-11-09 上海大学 Preparation system and preparation method of high-elasticity drug-loaded thin film intravascular stent

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Application publication date: 20161207