CN108201474A - Valvuloplasty ring - Google Patents

Valvuloplasty ring Download PDF

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Publication number
CN108201474A
CN108201474A CN201611179674.8A CN201611179674A CN108201474A CN 108201474 A CN108201474 A CN 108201474A CN 201611179674 A CN201611179674 A CN 201611179674A CN 108201474 A CN108201474 A CN 108201474A
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CN
China
Prior art keywords
parylene
layer
valvuloplasty
coating
valvuloplasty ring
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Pending
Application number
CN201611179674.8A
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Chinese (zh)
Inventor
向冬
陈文俊
孙杨
刘香东
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Priority to CN201611179674.8A priority Critical patent/CN108201474A/en
Publication of CN108201474A publication Critical patent/CN108201474A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0077Special surfaces of prostheses, e.g. for improving ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28Materials for coating prostheses
    • A61L27/34Macromolecular materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54Biologically active materials, e.g. therapeutic substances
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G61/00Macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain of the macromolecule
    • C08G61/02Macromolecular compounds containing only carbon atoms in the main chain of the macromolecule, e.g. polyxylylenes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/216Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/41Anti-inflammatory agents, e.g. NSAIDs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/42Anti-thrombotic agents, anticoagulants, anti-platelet agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606Coatings
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08GMACROMOLECULAR COMPOUNDS OBTAINED OTHERWISE THAN BY REACTIONS ONLY INVOLVING UNSATURATED CARBON-TO-CARBON BONDS
    • C08G2261/00Macromolecular compounds obtained by reactions forming a carbon-to-carbon link in the main chain of the macromolecule
    • C08G2261/10Definition of the polymer structure
    • C08G2261/11Homopolymers

Abstract

The invention discloses a kind of valvuloplasty rings, belong to the field of medical instrument technology.The valvuloplasty ring includes metal inner tube layer, is coated on the layer of silica gel middle layer of the metal tube inner layer outer surface and is coated on the woven dacron outer layer of the layer of silica gel middle layer outer surface, and the outer surface of the woven dacron outer layer is coated with the Parylene coating of 0.01 100 μ m-thicks.The Parylene coating material that the present invention is used with woven dacron combination power is strong and own biological compatibility is good, by the thickness for controlling Parylene coating, so that the valvuloplasty ring with polyxylene coating being prepared is while inflammatory reaction is reduced, and being capable of effective antithrombotic.

Description

Valvuloplasty ring
Technical field
The present invention relates to the field of medical instrument technology, more particularly to a kind of valvuloplasty ring, the valve forming ring Surface be coated with can reduce inflammation again antithrombotic coating.
Background technology
It for valvular inadequacy, backflows, common treatment method is valve reparation plasty.In order to keep long-term treatment Effect, after valve reparation plasty, surgeon is often implanted into an artificial valve forming ring in the annulus position of patient, To ensure the good moulding of self annulus, while prevent annulus from further expanding, with maintaining treatment effect.
Existing artificial valve forming ring mainly has a three-decker, and innermost layer is metal or high molecular material supporter, in Interbed is silica gel, and outermost layer is polyester dacron cloth;Wherein woven dacron plays the role of contributing to raw in tissue, can fix artificial Annulus simultaneously reduces the risk split.
Although polyester dacron cloth has certain biocompatibility in itself, work as bio-medical material made of polyester fiber Be implanted into human body after, long period of soaking, blood compatibility can not fully meet requirement in blood, there are blood coagulation formed thrombus with The risk compared with hyperphlogosis is generated, directly affects the service life of material, jeopardizes the safety of patient.At present, the above problem does not obtain yet It is solved to thorough.
Invention content
Based on this, it is necessary to provide a kind of valvuloplasty ring in view of the foregoing drawbacks.The forming ring is in woven dacron outer layer Outer surface coating Parylene coatings, again can antithrombotic while inflammation is reduced.
The present invention provides a kind of valvuloplasty ring, including metal inner tube layer, is coated on the metal inner tube layer appearance The layer of silica gel middle layer in face and the woven dacron outer layer for being coated on the layer of silica gel middle layer outer surface;The woven dacron outer layer Outer surface is coated with Parylene (Parylene) coating of 0.01~100 μ m-thick.
The Parylene is Parylene C or Parylene N in one of the embodiments,.
The thickness of the Parylene coating is 0.1~50 μm in one of the embodiments,.
In one of the embodiments, when the Parylene is Parylene C, the Parylene coating Thickness be 0.5~30 μm.
In one of the embodiments, when the Parylene is Parylene C, the Parylene coating Thickness be 1~20 μm.
In one of the embodiments, when the Parylene is Parylene N, the Parylene coating Thickness be 0.5~35 μm.
In one of the embodiments, when the Parylene is Parylene N, the Parylene coating Thickness be 1~25 μm.
The thickness of the Parylene coating is 1~10 μm in one of the embodiments,.
The metal tube is NiTi cutting pipe in one of the embodiments,.
The Parylene coating material that the present invention is used with woven dacron combination power is strong and own biological compatibility is good Material, by the thickness for controlling Parylene coating so that the valvuloplasty with polyxylene coating being prepared Ring, and being capable of effective antithrombotic while inflammatory reaction is reduced.
Description of the drawings
Fig. 1 is the structure diagram of valvuloplasty ring in the prior art;
Fig. 2 is the structure diagram of the valvuloplasty ring of the coating Parylene C coatings of embodiment 1;
Fig. 3 is that the valvuloplasty ring of embodiment 3 is implanted into the histopathology result that the inferior caval vein of pig taken out after 7 days Figure;
Fig. 4 is that the valvuloplasty ring of embodiment 4 is implanted into the histopathology result that the inferior caval vein of pig taken out after 7 days Figure;
Fig. 5 is that the valvuloplasty ring of embodiment 5 is implanted into the histopathology result that the inferior caval vein of pig taken out after 7 days Figure;
Fig. 6 is that the valvuloplasty ring of embodiment 10 is implanted into the histopathology knot that the inferior caval vein of pig taken out after 7 days Fruit is schemed;
Fig. 7 is that the valvuloplasty ring of embodiment 11 is implanted into the histopathology knot that the inferior caval vein of pig taken out after 7 days Fruit is schemed;
Fig. 8 is that the valvuloplasty ring of embodiment 12 is implanted into the histopathology knot that the inferior caval vein of pig taken out after 7 days Fruit is schemed;
Fig. 9 is that the valvuloplasty ring of comparative example 1 is implanted into the histopathology that the inferior caval vein of pig taken out after 7 days Result figure;
Figure 10 is that the valvuloplasty ring of comparative example 2 is implanted into the tissue disease that the inferior caval vein of pig taken out after 7 days Manage result figure.
Specific embodiment
For a clearer understanding of the technical characteristics, objects and effects of the present invention, now control attached drawing is described in detail The specific embodiment of the present invention.
Unless otherwise defined, all of technologies and scientific terms used here by the article belongs to the skill of the technical field of the present invention The normally understood meaning of art personnel is identical.Used term is intended merely to description specific embodiment in the description herein Purpose, it is not intended that in the limitation present invention.
A kind of domestic and international common structure of valvuloplasty ring as shown in Figure 1, the valve forming ring by becket, can It sutures ring edge and lining cloth is formed.The material of becket is Ti-6Al-4V, and ring edge is made of one layer of silicon rubber, outer surface covering Polyester lining cloth.
The surface modifying method of conventional polyester material is the unifunctional bionic coating of surface construction in polyester material, past Toward only having antithrombotic or promoting endothelialization or the simple function of reduction inflammation, it is difficult to ensureing coating and woven dacron binding force Realize multi-function action simultaneously.During to woven dacron surface applying coating, it should ensure the binding force of coating and woven dacron, Ensure that valve forming ring after applying coating, can reduce inflammation and realize antithrombotic again.
Parylene (Parylene) can be divided into Parylene C (Parylene C, chlorine substitution), Parylene D (Parylene D, dichloro substitution), Parylene N (Parylene N, unsubstituted) and Parylene HT (Parylene HT, fluoride), it is mostly prepared using chemical vapor deposition method (CVD), entire preparation process is gas under vacuum State is reacted, thus can obtain highly uniform coating.The vapor deposition processes of Parylene are generally divided into three steps:(1) in true Dummy status, 120 DEG C solid feed is sublimed into gaseous feed;(2) being cracked into 680 DEG C of gaseous feeds by step (1) has The activated monomer of response characteristic;(3) it deposits and polymerize in 25 DEG C of activated monomers by step (2).Activated monomer is spread in first The surface of workpiece after activated monomer is adsorbed onto the surface everywhere of workpiece, starts to polymerize and crystallize, directly form solid, pass through Sedimentation time controls the thickness of coating, about 1 μm/60min of general deposition velocity.Parylene and woven dacron contain phenyl ring knot Structure, mutual model ylid bloom action power is stronger, ensure that the bonding strength of Parylene coatings and woven dacron.
It coats uneven, for example generates the situations such as bubble, impurity or abnormity, easily influence coating and the connection of woven dacron is strong Degree.In the above process, without the appearance of liquid phase, the defects of common in the uneven and coating of thickness is overcome, coating uniform applies It covers, also ensures the bonding strength of coating and matrix.
Parylene C are a chlorine substituent of Parylene N, and polarity is stronger, with the binding force of woven dacron compared with Parylene N are big.When using Parylene C applying coatings, overweight coating can cause the Surface hardened layer of woven dacron, therefore, The scope of application of Parylene C is smaller compared with Parylene N.
The thickness of Parylene coating is 0.01~100 μm, preferably 0.1~50 μm.Coating is too thin, with woven dacron Binding force it is weaker, coating easily comes off;Overweight coating easily hardens woven dacron.By the thickness control of Parylene coating System can ensure the effect of coating so that coating can play anti-while inflammatory reaction is reduced at 0.01~100 μm The effect of thrombus.
Embodiment 1
Fig. 2 is referred to, a kind of valvuloplasty ring including NiTi cutting inner tube layer 1, is coated on NiTi cutting inner tube layer The silica gel middle layer 2 with sutural margin 5 of 1 outer surface and the woven dacron outer layer 3 for being coated on 2 outer surface of silica gel middle layer, are washed The outer surface of synthetic fibre cloth outer layer 3 is uniformly coated with the Parylene C coatings 4 of 0.01 μ m-thick.
The preparation method of Parylene C coatings 4 includes the following steps:(1) chlorine is replaced in vacuum state, 120 DEG C The solid feed of paraxylene ring disome is sublimed into gaseous feed;(2) it is cracked into tool in 680 DEG C of gaseous feeds by step (1) There is a chlorine substituted monomer biradical of response characteristic;(3) it deposits 36s in 25 DEG C of monomer biradicals by step (2) and gathers It closes, obtains Parylene C coatings 4;The thickness of its floating coat is controlled by sedimentation time, and general deposition velocity is 1 μm/60min. It is reacted as shown in formula one.
Embodiment 2
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene C coatings of 0.1 μ m-thick.
The preparation method of Parylene C coatings is similar with the preparation method of the Parylene C coatings of embodiment 1, difference It is 6min to be its sedimentation time.
Embodiment 3
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene C coatings of 1 μ m-thick.
The preparation method of Parylene C coatings is similar with the preparation method of the Parylene C coatings of embodiment 1, difference It is 60min to be its sedimentation time.
Embodiment 4
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene C coatings of 10 μ m-thicks.
The preparation method of Parylene C coatings is similar with the preparation method of the Parylene C coatings of embodiment 1, difference It is 600min to be its sedimentation time.
Embodiment 5
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene C coatings of 20 μ m-thicks.
The preparation method of Parylene C coatings is similar with the preparation method of the Parylene C coatings of embodiment 1, difference It is 1200min to be its sedimentation time.
Embodiment 6
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene C coatings of 50 μ m-thicks.
The preparation method of Parylene C coatings is similar with the preparation method of the Parylene C coatings of embodiment 1, difference It is 3000min to be its sedimentation time.
Embodiment 7
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene C coatings of 100 μ m-thicks.
The preparation method of Parylene C coatings is similar with the preparation method of the Parylene C coatings of embodiment 1, difference It is 6000min to be its sedimentation time.
Embodiment 8
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene N coatings of 0.01 μ m-thick.
The preparation method of Parylene N coatings includes the following steps:(1) in vacuum state, 120 DEG C by paraxylene ring The solid feed of disome is sublimed into gaseous feed;(2) it is cracked into 680 DEG C of gaseous feeds by step (1) with response characteristic Activated monomer biradical;(3) it deposits 36s in 25 DEG C of activated monomer biradicals by step (2) and polymerize, obtain Parylene N coatings;The thickness of its floating coat is controlled by sedimentation time, and general deposition velocity is 1 μm/60min.It is reacted such as Shown in formula two.
Embodiment 9
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene N coatings of 0.1 μ m-thick.
The preparation method of Parylene N coatings is similar with the preparation method of the Parylene N coatings of embodiment 8, difference It is 6min to be its sedimentation time.
Embodiment 10
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene N coatings of 1 μ m-thick.
The preparation method of Parylene N coatings is similar with the preparation method of the Parylene N coatings of embodiment 8, difference It is 60min to be its sedimentation time.
Embodiment 11
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene N coatings of 10 μ m-thicks.
The preparation method of Parylene N coatings is similar with the preparation method of the Parylene N coatings of embodiment 8, difference It is 600min to be its sedimentation time.
Embodiment 12
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene N coatings of 25 μ m-thicks.
The preparation method of Parylene N coatings is similar with the preparation method of the Parylene N coatings of embodiment 8, difference It is 1500min to be its sedimentation time.
Embodiment 13
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene N coatings of 50 μ m-thicks.
The preparation method of Parylene N coatings is similar with the preparation method of the Parylene N coatings of embodiment 8, difference It is 3000min to be its sedimentation time.
Embodiment 14
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with the Parylene N coatings of 100 μ m-thicks.
The preparation method of Parylene N coatings is similar with the preparation method of the Parylene N coatings of embodiment 8, difference It is 6000min to be its sedimentation time.
Comparative example 1
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer does not have applying coating.
Comparative example 2
The valvuloplasty ring of the present embodiment has similar structure, area with the valvuloplasty ring of embodiment 1 It is not, the outer surface of woven dacron outer layer is uniformly coated with PTFE (polytetrafluoroethylene (PTFE), Teflon) coating of 25 μ m-thicks.
The preparation method of PTFE coatings includes the following steps:It, will using vapour deposition process using PTFE powder as evaporation material PTFE raw materials are first thermally cracked to free radical or excitation state, and finally deposition polymerization is PTFE coatings on woven dacron.
Effect example
Above-described embodiment 3~5,10~12 and the valvuloplasty ring of comparative example 1 and 2 are implanted into pig respectively In inferior caval vein, corresponding implanting tissue is taken out after 7 days, carries out paraffin section, HE dyeing (hematoxylin eosin staining), Yu Xian The degree of the inflammation of tissues observed and thrombosis under micro mirror, as a result as shown in figs. 3-10.
From above-mentioned it can be seen from the figure that, the inflammatory reaction for being implanted into the tissue of uncoated valvuloplasty ring is apparent, blood Suberification degree is higher;The inflammatory reaction of the tissue of the valvuloplasty ring of implantation PTFE coatings and thrombosis degree are with respect to the former It is relatively light;The inflammatory reaction for being implanted into the tissue of the valvuloplasty ring of ParyleneC types and N-type coating is most light, thrombosis journey It spends minimum.
The embodiment of the present invention is described above in conjunction with attached drawing, but the invention is not limited in above-mentioned specific Embodiment, above-mentioned specific embodiment is only schematical rather than restricted, those of ordinary skill in the art Under the enlightenment of the present invention, present inventive concept and scope of the claimed protection are not being departed from, can also made very much Form, these are belonged within the protection of the present invention.

Claims (9)

1. a kind of valvuloplasty ring including metal inner tube layer, is coated in the layer of silica gel of the metal tube inner layer outer surface Interbed and the woven dacron outer layer for being coated on the layer of silica gel middle layer outer surface, which is characterized in that the woven dacron outer layer Outer surface is coated with the Parylene coating of 0.01~100 μ m-thick.
2. valvuloplasty ring according to claim 1, which is characterized in that the Parylene is Parylene C or Parylene N.
3. valvuloplasty ring according to claim 2, which is characterized in that the thickness of the Parylene coating is 0.1~50 μm.
4. valvuloplasty ring according to claim 2, which is characterized in that when the Parylene to be poly- to diformazan During benzene C, the thickness of the Parylene coating is 0.5~30 μm.
5. valvuloplasty ring according to claim 2, which is characterized in that when the Parylene to be poly- to diformazan During benzene C, the thickness of the Parylene coating is 1~20 μm.
6. valvuloplasty ring according to claim 2, which is characterized in that when the Parylene to be poly- to diformazan During benzene N, the thickness of the Parylene coating is 0.5~35 μm.
7. valvuloplasty ring according to claim 2, which is characterized in that when the Parylene to be poly- to diformazan During benzene N, the thickness of the Parylene coating is 1~25 μm.
8. valvuloplasty ring according to claim 2, which is characterized in that the thickness of the Parylene coating is 1~10 μm.
9. valvuloplasty ring according to claim 1, which is characterized in that the metal tube is NiTi cutting pipe.
CN201611179674.8A 2016-12-19 2016-12-19 Valvuloplasty ring Pending CN108201474A (en)

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CN201611179674.8A Pending CN108201474A (en) 2016-12-19 2016-12-19 Valvuloplasty ring

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CN113440311A (en) * 2021-07-23 2021-09-28 上海欣吉特生物科技有限公司 Annuloplasty ring

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