CN109820548A - Plugging device, preparation method and plugging system - Google Patents
Plugging device, preparation method and plugging system Download PDFInfo
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- CN109820548A CN109820548A CN201811575032.9A CN201811575032A CN109820548A CN 109820548 A CN109820548 A CN 109820548A CN 201811575032 A CN201811575032 A CN 201811575032A CN 109820548 A CN109820548 A CN 109820548A
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- overlay film
- plugging device
- frame
- end socket
- closure
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Abstract
The present invention relates to a kind of plugging devices, including blocking frame and overlay film, closure frame is reticular structure, overlay film coats the closure frame completely and forms the cystic structures with an opening, in implantation, liquid contrast agent is injected into cystic structures by the opening of the cystic structures, is realized under X ray image equipment, cystic structures are integrally visual, so as to judge the configuration of plugging device.
Description
Technical field
The present invention relates to insertion type medical instruments fields, more particularly to a kind of plugging device, preparation method and block system
System.
Background technique
Atrial septal defect (Atrial Septal Defect, ASD), ventricular septal defect (Ventricular Septal
Defect, VSD) and patent ductus arteriosus (Patent Ductus Arteriosus, PDA) be common congenital heart defect
Disease.In recent years, heart defect amplatzer (hereinafter referred to as plugging device) oneself be widely used in the Congenital Hearts such as ASD, VSD
The interventional therapy of defect disease.Heart defect amplatzer interventional therapy have that wound is slight, operation safety is quick and it is close, in
The advantages such as the phase is curative for effect.
Plugging device generally comprises the closure frame of reticular structure and is fixed on the choked flow for blocking lower portion by suture
Film.The treatment principle of plugging device is: the heart defect position that plugging device is delivered to patient by intervening operation, plugging device release
After block defect, the tissue around defect also can ingrowing climb and cover, be finally completed the endothelialization to plugging device, by
This repairs heart defect position.
The closure frame of traditional plugging device is made of marmem mostly, for example, being made of Nitinol.When interior
After skin completion, heart defect are repaired, the plugging device to implant cannot be absorbed by tissue, can only be invariably present in scarce
Damage position.Therefore, it is easy to produce that atrioventricular block, valve damage, residual shunt, heart be worn out or metal ion allergy etc. is remote
Phase complication and adverse effect.
The plugging device made using biodegradable high molecular polymer is after a period of time that implants, polyphosphazene polymer
It closes object to degrade and be absorbed by organisms, can be avoided the adverse effect of above-mentioned traditional plugging device.Currently used high molecular polymer
Including polyamide, polyethylene, polypropylene, polylactic acid, polyglycolic acid and polycaprolactone etc..But these high molecular polymers are penetrated in X
Do not have under line visual or visual poor.It is gone on smoothly to perform the operation, current common solution is in plugging device
It is upper to increase some mark structures.However, in order not to dramatically increase the radial dimension after plugging device stretches, the size of mark structure is logical
It is often smaller, and mark structure is not easy to judge plugging device entirety in this way, remaining unchanged in implantation process only in the local setting of plugging device
Form and position, may result in that operating time extends, releasing position form is bad or even operative failure, cause it is serious after
Fruit.
Summary of the invention
Based on this, it is necessary to provide a kind of plugging device that can judge configuration.
A kind of plugging device, including frame is blocked, it further includes overlay film, the overlay film is complete that the closure frame, which is reticular structure,
The closure frame is coated entirely and forms the cystic structures with an opening.
One embodiment wherein, the closure frame is formed by the braiding of degradable braided wires or the closure frame is by can
Degradable material cuts to be formed, and the material of the overlay film is degradable polymer.
One embodiment wherein, the degradable polymer be selected from Poly L-lactic acid, ploy DL lactic caid, polyglycolic acid,
Poly lactide-glycolide acid, poly-hydroxy fatty acid rouge, polydioxanone, polycaprolactone, polydextrose acid, poly- hydroxyl
At least one of butyric acid, polyanhydride, polyphosphate, polyglycolic acid, polydioxanone and polycarbonate.
One embodiment wherein, the overlay film, which also contains, promotees endothelialization substance.
One embodiment wherein, the overlay film with a thickness of 10~50 μm.
One embodiment wherein, has micropore on the overlay film, and the aperture of the micropore is 1~100 μm.
One embodiment wherein, the porosity of the overlay film are 0.1~15%.
One embodiment wherein, the overlay film are elastic membrane.
One embodiment wherein, the sizing grid range for blocking frame are 0.1mm2~16mm2。
One embodiment wherein, the closure frame blocks unit, the second closure unit and waist including first, described
The both ends of waist are separately connected described first and block unit and the second closure unit, and the overlay film coats described first completely
Block unit, the second closure unit and waist.
One embodiment wherein, the plugging device further include the first end socket and the second end socket, and first end socket is set to
Described first blocks on unit, and second end socket is set to described second and blocks on unit, and second end socket offers through-hole,
The overlay film also coats first end socket and the second end socket, and the overlay film does not coat the through-hole, forms the through-hole
The opening of the cystic structures.
A kind of preparation method of plugging device, includes the following steps:
It provides and blocks frame, the closure frame is reticular structure；And
Overlay film is coated on the closure frame, to form the cystic structures with an opening.
One embodiment wherein, it is described to coat overlay film on the closure frame, to form the capsule with an opening
The step of shape structure includes:
Leaching liquor is prepared, the solute of the leaching liquor is the material to form the overlay film；And
The closure frame is impregnated in the leaching liquor, and the closure frame is proposed from the leaching liquor,
After drying, the material for forming the overlay film is attached on the closure frame and forms the cystic structures with an opening.
One embodiment wherein, described that the closure frame is impregnated in the step in the leaching liquor, the envelope
The time that stifled frame is impregnated in the leaching liquor is at least 5 seconds.
One embodiment wherein, it is described and by the closure frame from the leaching liquor propose the step of in, by institute
Stating and blocking the speed that frame is proposed from the leaching liquor is 0.01~0.5 metre per second (m/s).
One embodiment wherein, the solute of the leaching liquor are degradable polymer, the degradable polymer it is dense
Degree is greater than or equal to 1mg/mL.
One embodiment wherein, it is described that the closure frame is impregnated in the leaching liquor, and by the occluder frame
Frame further includes the steps that heat treatment after the step of proposition in the leaching liquor, and the step of heat treatment includes:
5~60min is kept the temperature at a temperature of the occluder frame is placed on 45~110 DEG C.
One embodiment wherein, it is described to coat overlay film on the closure frame, to form the capsule with an opening
The step of shape structure includes:
Overlay film is coated on the closure frame, forms the cystic structures with an opening after hot melt；Alternatively, passing through glue
Overlay film is fixed on the closure frame by viscous method, forms the cystic structures with an opening.
A kind of plugging system, including above-mentioned plugging device, further include driving means, the driving means include conveying cable and with
The connected delivery conduit of the conveying cable, for being detachably connected with the plugging device, the conveying cable has the conveying cable
Inner cavity, the delivery conduit have conveyor chamber, the inner cavity, the conveyor chamber and cystic structures connection.
One embodiment wherein, the conveying cable are to be wound hollow pipe, and the conveying cable by more one metal wires
Be equipped with sealing film, the sealing film is located at the inner wall of the conveying cable or the sealing film is coated on the outer of the conveying cable
On wall.
The overlay film of above-mentioned plugging device coats completely to be blocked frame and forms the cystic structures with an opening, in implantation
In, liquid contrast agent is injected into cystic structures by the opening of the cystic structures, realizes the cryptomere under X ray image equipment
Structure is integrally visual, so as to judge the configuration of plugging device.
Detailed description of the invention
Fig. 1 is the structural schematic diagram of the plugging system of an embodiment；
Fig. 2 is the structural schematic diagram of the plugging device of plugging system shown in FIG. 1；
Fig. 3 is the schematic diagram of another state of plugging device shown in Fig. 2；
Fig. 4 is the structural schematic diagram of the driving means of plugging system shown in FIG. 1；
Fig. 5 is the schematic cross-section of the conveying cable of driving means shown in Fig. 4；
Fig. 6 is the plugging device of plugging system shown in FIG. 1 and the connection schematic diagram of driving means；
Fig. 7~Fig. 8 is the process schematic that liquid contrast agent is injected to plugging device shown in FIG. 1.
Specific embodiment
In order to make the foregoing objectives, features and advantages of the present invention clearer and more comprehensible, with reference to the accompanying drawing to the present invention
Specific embodiment be described in detail.Many details are explained in the following description in order to fully understand this hair
It is bright.But the invention can be embodied in many other ways as described herein, those skilled in the art can be not
Similar improvement is done in the case where violating intension of the present invention, therefore the present invention is not limited to the specific embodiments disclosed below.
Unless otherwise defined, all technical and scientific terms used herein and belong to technical field of the invention
The normally understood meaning of technical staff is identical.Term as used herein in the specification of the present invention is intended merely to description tool
The purpose of the embodiment of body, it is not intended that in the limitation present invention.
Referring to Fig. 1, the plugging system 1 of an embodiment, including plugging device 100 and driving means 200.Plugging device 100
It is connected with driving means 200, driving means 200 is used to plugging device 100 pushing to defect.
Referring to Fig. 2, plugging device 100 includes blocking frame 110 and overlay film (not shown).Blocking frame 110 is by weaving
Reticular structure made of silk braiding.In one embodiment, the material of braided wires is biodegradable material.For example, biology can
Degradable material can be polylactic acid (PLA), ploy DL lactic caid (PDLLA), poly- D-ALPHA-Hydroxypropionic acid (PDLA), poly (l-lactic acid) (PLLA), gather
Glycolic (PGA), poly lactide-glycolide acid (PLGA), poly-hydroxy fatty acid rouge (PHA), polydioxanone (PDO)
Or polycaprolactone (PCL) etc..
In other embodiment, the material of braided wires can be nondegradable metal, for example, braided wires can be
Nitinol alloy wire, cochrome silk or stainless steel wire etc..
In another embodiment, blocking frame 110 can also be by biodegradable material or the nondegradable material of biology
Material cuts and is formed for being formed.For example, the closure frame that reticular structure will be formed after the cutting of degradable polymer tubing by sizing
110。
In one embodiment, blocking frame 110 includes that the first closure unit 112, second blocks unit 114 and waist
116.The both ends of waist 116 are connect with the first closure unit 112 and the second closure unit 114 respectively, form big at both ends and small in middle
Two disks, one waist structure.First closure unit 112, second blocks unit 114 and waist 116 is an integral structure.
It is appreciated that in other embodiments, the structure for blocking frame 110 is not limited to two disks one of big at both ends and small in middle
Waist structure.For example, the number for blocking the closure unit in frame 110 is one, cut at this point, closure unit and waist are connected to form
The substantially t-shaped closure frame in face.
Referring to Fig. 2, plugging device 100 further includes the first end socket 113 on the first closure unit 112 and is set to
Second blocks the second end socket 115 on unit 114.First end socket 113 and the second end socket 115 are used to converge and fix braiding
Silk.Also, the second end socket 115 is equipped with connected components (Fig. 2 does not show), and connected components are used for and driving means 200
It is flexibly connected, to load and fix plugging device 100, and after plugging device 100 is delivered to diseased region, plugging device can be discharged
100.Specifically, screw thread, multiple thread strands etc. can be equipped on the second end socket 115 to be flexibly connected with driving means 200.Implement one
In mode, the outer wall of the second end socket 115 is equipped with external screw thread (not shown).Through-hole 117 is offered on second end socket 115.
Referring to Fig. 2, in one embodiment, plugging device 100 further includes locking piece 118, and locking piece 118 is substantially
Rod-like structure.One end of locking piece 118 is fixedly connected with the first end socket 113, and the other end is free end.In the dress of plugging device 100
Sheath state (state that plugging device 100 is stretched), one end far from the first end socket 113 of locking piece 118 are vacant state.It is inciting somebody to action
After plugging device 100 is implanted into heart defect position, locking piece 118 is pulled, the free end of locking piece 118 is made to pass through the second end socket 115
Through-hole 117 and connect with the second end socket 115, thus lock plugging device 100 first block unit 112 and second block unit
114, so that the distance between the first closure unit 112 and second closure unit 114 are constant, as shown in Figure 3.Locking piece 118
The connection type and first that one end can be grasped by fusion weld, biogum adhesion or mechanical those skilled in the art such as press
End socket 113 is fixedly connected.Locking piece 118 is cooperated with the second end socket 115 by modes such as interference fit, frictional force, so that locking
The proximal end of part 118 is kept fixed with the second end socket 115 and connect.In one embodiment, the second end socket 115 and locking piece 118 it
One have elasticity, with proximally pull locking piece 118 enable locking piece 118 pass through the second end socket 115 in through-hole 117 and with
Second end socket 115 keeps relatively fixed.
Overlay film is continuous membrane structure, and overlay film is coated on completely to be blocked on frame 110 and form the capsule with an opening
Shape structure.In one embodiment, overlay film coats the first closure unit 112, second completely and blocks unit 114 and waist 116.?
In another embodiment, overlay film is also coated on the first end socket 113 and the second end socket 115, and overlay film does not coat in the second end socket 115
Through-hole 117, make through-hole 117 formed cystic structures opening.In implantation, pass through the opening for the cystic structures that overlay film is formed
Liquid contrast agent is injected into cystic structures, is realized in the case where X-ray influences equipment, cystic structures are integrally visual, so as to sentence
The configuration of disconnected plugging device 100.It should be noted that when overlay film also coats the second end socket 115, and set on the second end socket 115
When having external screw thread, overlay film does not cover external screw thread.
There are multiple micropores on overlay film so that overlay film is pore structure so that after the completion of implantation, liquid contrast agent from
It is slowly oozed out in cystic structures.It should be noted that the aperture of micropore and the quantity of micropore should ensure that in implant surgery process
In, liquid contrast agent can be accumulated in the cystic structures to realize that plugging device 100 is visual under X ray image equipment.Also,
After the completion of operation, liquid contrast agent can be infiltrated from cystic structures.
In one embodiment, the aperture of the micropore on overlay film is 1~100 μm.In this way, injecting liquid into cystic structures
After body contrast agent, liquid contrast agent is avoided to flow out from cystic structures quickly and being difficult to play makes plugging device 100 in X-ray shadow
As effect visual under equipment.
In one embodiment, the porosity of overlay film is 0.1~15%, to inject liquid contrast agent into cystic structures
Afterwards, avoid liquid contrast agent quickly from process in cystic structures and being difficult to play makes plugging device 100 under X ray image equipment
Visual effect.Porosity refers to that the total volume of the micropore of overlay film accounts for the percentage of the total volume of overlay film, wherein micropore refers to
Through-hole.
In one embodiment, the aperture of the micropore on overlay film is 10~50 μm, and porosity is 0.1~5%.In this way, one
Aspect can guarantee that liquid contrast agent can accumulate in the cystic structures formed by overlay film, so that plugging device 100 is whole
Under X ray image equipment there is enough radiation impermeability can guarantee the suitable of implantation to obtain relatively clear image
Benefit carries out, the release form of plugging device 100 is good and plugging device 100 well agrees with defect；On the other hand, in implantation
After the completion, liquid contrast agent can slowly be oozed out from cystic structures, can be avoided liquid contrast agent within a short period of time from
It is largely flowed out in cystic structures, avoids the local concentration of the liquid contrast agent in blood excessively high and unfavorable shadow is generated to organism
It rings；In another aspect, the external and internal pressure of cystic structures can be balanced preferably, avoids the internal pressure of cystic structures excessive and cause
Cystic structures rupture, so as to cause the phenomenon visual under X ray image equipment of plugging device 100 is difficult to realize.
In one embodiment, overlay film with a thickness of 10~50 μm, on the one hand, avoid the thickness of overlay film excessive and cause to seal
Stifled device 100 to enter sheath resistance excessive so as to cause being difficult to convey and discharge, alternatively, avoid increasing the size of delivery sheath, thus
Limiting the plugging device 100 can be only applied to the thicker patient of blood vessel, can avoid the application range of limitation plugging device 100；
On the other hand, it avoids the thickness of overlay film too small, when scratching, rub during transmission process and release, avoids overlay film
It is damaged and make cystic structures that cut be presented and lead to the effective accumulation that can not achieve liquid contrast agent, eventually lead to operation be difficult to it is suitable
The phenomenon that benefit carries out.
In one embodiment, the range for blocking the sizing grid of frame 110 is 0.1mm2~16mm2, on the one hand, make to seal
Stifled frame 110 has enough support performances, can resist the impact of blood flow without deforming, with guarantee in real time, continue
Sealing characteristics；On the other hand, guarantee plugging device 100 enters sheath resistance within the acceptable range, does not influence plugging device 100
Conveying and release, also do not dramatically increase the size of delivery sheath；In another aspect, the closure frame 110 of the sizing grid can be compared with
Overlay film is supported well, is not easily broken overlay film.It should be noted that the sizing grid for blocking frame 110 is uniform or non-equal
Even.When the sizing grid for blocking frame 110 is heterogeneous, 0.1mm2~16mm2Refer to that the grid for blocking frame 110 is big
Small mean value is 0.1mm2~16mm2。
In one embodiment, the material of overlay film is degradable polymer.In one embodiment, degradable polymer selects
From Poly L-lactic acid, ploy DL lactic caid, polyglycolic acid, poly lactide-glycolide acid, poly-hydroxy fatty acid rouge, poly- dioxy
Cyclohexanone, polycaprolactone, polydextrose acid, polyhydroxybutyrate, polyanhydride, polyphosphate, polyglycolic acid, polydioxanone and poly-
At least one of carbonic ester.
In other embodiment, the material of overlay film is also possible to nondegradable polymer, for example, poly- terephthaldehyde
Sour second diester (PET) or polybutylene terephthalate (PBT) etc..
In one embodiment, overlay film is elastic membrane.For example, the material of overlay film is the elastic material that medical balloon uses.
Specifically, the material of overlay film is thermoplastic polyurethane elastomer rubber (TPU).When overlay film is elastic membrane, overlay film can be single
Layer can also be double-deck.When overlay film is single layer, in one embodiment, overlay film is located at the inside for blocking frame 110, i.e. overlay film packet
Cover the inner wall for blocking frame 110.In another embodiment, overlay film is located at the outside for blocking frame 110, i.e. overlay film cladding blocks
The outer wall of frame 110.When overlay film is double-deck, one layer of overlay film is located at the outside for blocking frame 110, and one layer of overlay film is located at occluder frame
The inside of frame 110.
In one embodiment, overlay film further includes promoting endothelialization substance, promotees endothelium substance and is scattered in degradable polymer,
It is discharged with the degradation of degradable polymer and promotees endothelialization substance, play long-acting, lasting rush endothelialization effect, in promotion
Chrotoplast rapidly swashes in plugging device 100 attached, is conducive to the formation for avoiding thrombus.
In one embodiment, promote endothelialization substance in phosphatide, growth factor, protein, polypeptide and quaternary ammonium salt
It is at least one.Specifically, wherein phosphatide is selected from lecithin, phosphatidyl choline, phosphatidyl-ethanolamine, phosphatidylserine and phosphorus
At least one of acyl inositol.Growth factor is selected from epithelical cell growth factor (EGF), fibroblast growth factor
(FGF) and at least one of platelet derived growth factor (PDGF).Protein is laminin or fibronectin.Polypeptide is selected from
Tyrosine-Isoleucine-glycine-serine-arginine pentapeptide (YIGSR), ring (arginine-glycine-aspartic acid-junket
Propylhomoserin-lysine) in (Tyr-RGD) and polypeptide comprising sour (RGD) sequence of arginine-glycine-aspartic acid at least one
Kind.Wherein, the polypeptide comprising sour (RGD) sequence of arginine-glycine-aspartic acid can be arginine-glycine-lucid asparagus
Propylhomoserin (RGD) polypeptide, arginine-glycine-aspartic acid acid-serine (RGDS) polypeptide etc..Above-mentioned rush endothelialization substance promotees
The effect of endothelialization is preferable, be conducive to endothelium climb quickly invest block frame 110 on, be effectively prevented from thrombosis.
Referring to Fig. 4, driving means 200 includes the delivery conduit 220 for conveying cable 210 and being connected with conveying cable 210.Specifically
Ground, conveying has opening on the side wall of cable 210,220 both ends open of delivery conduit, the side wall of delivery conduit 220 and conveying cable 210
It is connected, and delivery conduit 220 1 openings are opposite with the opening on side wall.
Conveying cable 210 is detachably connected with plugging device 100, with the energy after plugging device 100 to be delivered to heart defect position
Enough and plugging device 100, which releases, to be connected.Conveying cable 210 has inner cavity.Delivery conduit 220 is for injecting liquid contrast agent.Conveying is led
Pipe 220 has conveyor chamber.When plugging device 100 is connect with conveying cable 210, the overlay film of plugging device 100, which is coated on, blocks frame 110
On be formed by cystic structures, convey cable 210 inner cavity and delivery conduit 220 conveyor chamber connection.
In one embodiment, driving means 200 further includes triple valve 230, and triple valve 230 is set to delivery conduit 220
On, and triple valve 230 is located at one end of the separate conveying cable 210 of delivery conduit 220.By adjusting triple valve 230, so that conveying
The opening of the separate conveying cable 210 of conduit 220 is in close or open state.
In one embodiment, the distal end that conveying cable 210 and plugging device 100 are detachably connected is equipped with internal screw thread, and (figure is not
Show), internal screw thread is matched with the external screw thread on the second end socket 115, realizes that conveying cable 210 is detachably connected with plugging device 100.?
In one embodiment, conveying cable 210 includes the lock tube 214 for conveying main body 212 and being connected with the distal end of conveying main body 212.Conveying
Main body 212 is hollow pipe, and lock tube 214 is also hollow structure, and lock tube 214 and the distal end of conveying main body 212 are fixedly linked, and lock tube
214 are connected to conveying main body 212.Lock tube 214 can be fixedly linked by the modes such as welding or gluing and conveying main body 212.Lock
The inner wall of set 214 is equipped with internal screw thread, which matches with the external screw thread on the second end socket 115, realize conveying cable 210 and
Plugging device 100 is detachably connected.Referring to Fig. 5, in one embodiment, conveying main body 212 is to be twined by more stainless steel wires 213
Made of simultaneously setting treatment, the hollow pipe that cross section is generally circular.Lock tube 214 is penetrated by stainless steel or Nitinol etc. in X
Visual preferable material is formed under line image documentation equipment.In one embodiment, the inner wall for conveying main body 212 is equipped with sealing film
215, sealing film 215 can be improved the sealing performance of conveying cable 210, avoid oozing out in the transmission process of liquid contrast agent.?
In other embodiment, sealing film 215 is coated on the outer wall of conveying main body 212, in this way, being also avoided that in liquid contrast agent
Transmission process in ooze out, and process it is more convenient.Sealing film 215 is polytetrafluoroethylene (PTFE) (PTFE) film, poly terephthalic acid second
Diester (PET) film, polyethylene (PP) film or polypropylene (PE) film etc..
Referring to Fig. 4, driving means 200 further includes handle 240 and haemostatic valve 250, the first behaviour of setting on handle 240
Workpiece 241, the second operating parts 242 and third operating parts 243.The one end opposite with lock tube 214 for conveying main body 212, that is, convey
The proximal end of main body 212 is fixedly connected with handle 240.By unitary rotation handle 240, make to convey the rotation of cable 210, so that lock
External screw thread separation on internal screw thread and the second end socket 115 on set 214, realization plugging device 100 are freed with driving means 200.?
In one embodiment, the conveying main body 212 of conveying cable 210 is rotatably connected by connector 260 with handle 240, connector 260
One end with conveying main body 212 proximal end be connected, the other end is connected with the distal end of handle 240.Haemostatic valve 250 is set to connector
Between 260 and handle 240.Setting connector 260, which makes to convey cable 210 and handle 240, to be reliably connected, guarantee implantation it is smooth into
Row.In implantation, haemostatic valve 250 can guarantee that liquid contrast agent and blood will not flow out, and be further ensured that implantation is smooth
It carries out.After plugging device 100 is delivered to heart defect position, grasped by the first operating parts 241, second of operation handle 240
Workpiece 242 and third operating parts 243 realize the release of plugging device 100.
In one embodiment, driving means 200 further includes control silk 270, and control silk 270 wears conveying cable 210, and controls
Throwing 270 extends proximally into handle 240, and is connected with the first operating parts 241 and third operating parts 243, controls the remote of silk 270
It holds and is detachably connected with one end far from the first end socket 113 of the locking piece 118 of plugging device 100.It includes Filamentous main for controlling silk 270
Body 272 and be set to Filamentous main body 272 distal end tapered end 274.Filamentous main body 272 is solid filamentary structure, tapered end 274
The connection type grasped by those skilled in the art such as welding or gluings is fixedly connected with Filamentous main body 272.Proximally to remote
End, the sectional dimension of Filamentous main body 272 are gradually reduced, so that the flexibility of Filamentous main body 272 is preferable, transportation performance is preferable.Silk
Shape main body 272 and tapered end 274 are visual under X ray image equipment by stainless steel, Nitinol or macromolecule polymer material etc.
The preferable material of property is made.The sectional dimension of Filamentous main body 272 is less than the internal diameter of conveying cable 210 so that Filamentous main body 272 with it is defeated
Sending has enough holes between the inner wall of cable 210.
Control silk 270 is detachably connected by tapered end 274 and the locking piece 118 of plugging device 100.In one embodiment,
The advance of control silk 270 and recession are realized by the operation of the first operating parts 241, and control is realized in the operation for passing through the second operating parts 243
Throwing 270 rotates, so that control silk 270 be made to separate with locking piece 118.By the second operating parts 242 to the first operating parts 241 into
Row limit, prevents maloperation.
Referring to Fig. 6, the tapered end 274 of control silk 270 and one end far from the first end socket 113 of locking piece 118 are detachable
The lock tube 214 of connection, conveying cable 210 is detachably connected with the second end socket 115, to make plugging device 100 and driving means 200 can
Dismantling connection.In transport status, plugging device 100 is stretched and is loaded in delivery sheath, control silk 270 and conveying cable 210
It is contained in delivery sheath, and controls the tapered end 274 of silk 270 and one end phase far from the first end socket 113 of locking piece 118
Even, the lock tube 214 of conveying cable 210 is connected with the second end socket 115.Locking piece 118 is located at the inside of cystic structures, controls silk 270
Filamentous main body 272 pass through the second end socket 115, and the sectional dimension of Filamentous main body 272 is less than the aperture of through-hole 117, so that silk
There is gap between shape main body 272 and the inner wall of the second end socket 115.During transportation, delivery conduit 220 is always positioned at outer
Portion, in order to inject liquid contrast agent.Delivery conduit 220 conveys cable 210, the second end socket 115 and forms cystic structures by overlay film
In connected state.
The distal end of delivery sheath is equipped with mark structure visual under X ray image equipment.For example, mark structure can be
The becket being embedded in the inner wall of delivery sheath.Since control silk 270 and conveying cable 210 are by can under X ray image equipment
It is made depending on the preferable material of property, envelope can be judged by the mark structure of delivery sheath, control silk 270 and conveying cable 210 indirectly
The position of stifled device 100.It, will by driving means 200 after plugging device 100 is delivered to heart defect position by delivery sheath
Plugging device 100 is released from delivery sheath, after plugging device 100 comes out from delivery sheath, control silk 270 and conveying cable 210
Connection status is kept with plugging device 100, as shown in Figure 6.
Referring to Fig. 7, further, locking haemostatic valve 250, triple valve 230 is adjusted, and inject from delivery conduit 220
Liquid contrast agent, liquid contrast agent 300 is successively by delivery conduit 220, connector 260, conveying cable 210 and the second end socket 115
Enter the inside (flow direction that the arrow meaning of Fig. 7 is liquid contrast agent 300) of plugging device 100.Due to the choked flow of overlay film
Effect, in a short time, liquid contrast agent 300 can be largely retained among the cystic structures of plugging device 100, as shown in Figure 8.
In this way, the effect of liquid contrast agent 300 makes plugging device 100 can be integrally visual under ray.Still due to plugging device 100 at this time
It keeps connecting with driving means 200, when the position of plugging device 100 is not accurate enough, the side of overall movement handle 240 can be passed through
The position of formula adjustment plugging device 100.During adjusting the position of plugging device 100, if the operating time is too long, when cryptomere knot
When the visuality that liquid contrast agent can constantly ooze out and cause plugging device 100 whole in structure is poor, in order to guarantee plugging device 100
It is high-visible, liquid contrast agent can be persistently supplemented from delivery conduit 220.
After plugging device 100 is in accurate position, the first operating parts 241 in operation handle 240, recession control silk
270, to drive locking piece 118 to pass through through-hole 117 and be fixedly connected with the second end socket 115, complete locking.Meanwhile 117 quilt of through-hole
The proximal end of locking piece 118 is closed, so that being closed by the cystic structures that overlay film is formed.Then, the third operation in operation handle 240
Part 243 makes to control the rotation of silk 270, frees tapered end 274 with locking piece 118, then rotate entire handle 240, so that lock tube
214 free with the second end socket 115 of plugging device 100, finally withdraw from entire driving means 200.The cryptomere knot of plugging device 100
Liquid contrast agent 300 inside structure can be slowly infiltrated into blood by micropore middle on overlay film.
The overlay film of the plugging device 100 of above-mentioned plugging system 1 coats completely to be blocked frame 110 and forms the capsule with an opening
Shape structure is injected liquid contrast agent into cystic structures by the opening of the cystic structures, is realized in X-ray in implantation
Under image documentation equipment, cystic structures are integrally visual, so as to judge the configuration of plugging device 100.Therefore, above-mentioned plugging system
1 can be accurately located plugging device 100, and plugging device 100 is enable accurately to block heart defect position, improve curative effect.
Also, since overlay film is continuous membrane structure, overlay film itself has choked flow effect, and plugging device 100 is without containing resistance
Film is flowed, i.e. any choked flow film is not arranged extraly in the inside of the closure frame 110 of plugging device 100.So, on the one hand, preparing
In the process, it is convenient to omit choked flow film is sutured in the step blocked on frame 110 using suture, improves preparation efficiency；It is another
Aspect avoids after the implantation, choked flow film impacted by blood flow and when bearing tension, cutting that suture generates choked flow film
It acts on and leads to the tearing of choked flow film or even fall off, to be difficult to play the role of the phenomenon that blocking blood flow；Another aspect, using seam
Choked flow film is fixed on by the mode of conjunction to be blocked on frame 110, is sewn to by the limited stitch of suture with frame 110 is blocked
Together, after plugging device 100 discharges, the edge of choked flow film can have the gap presence, this can reduce the real-time seal-off effect of plugging device 100
Can, and in such a way that overlay film completely coats and blocks frame 110, it can be avoided drawbacks described above, there is good real-time closure
Performance；It blocks on frame 110 in another aspect, being using stitching sutured in choked flow film, stretches when by plugging device 100 to fill
When being loaded in delivery sheath, choked flow film is easy that accumulation is agglomerating, cause plugging device 100 to enter sheath resistance larger, and be possible to damage
Choked flow film.Simultaneously, it is desirable that the size of delivery sheath increases accordingly, and causes to be difficult to be suitable for the thinner individual of blood vessel.Pass through overlay film
Complete cladding blocks the mode of frame 110, can be avoided drawbacks described above, requires the size of sheath lower.
It is appreciated that liquid contrast agent is the common liquid contrast agent of medical field, the including but not limited to Portugal compound Fan Ying
Amine injection, meglumine iotalamate injection, Ioglucomide 370, Ioglucomide 350, Iopamidol etc..
Further, a kind of preparation method of plugging device is provided, is included the following steps:
Step 110: providing and block frame.
Blocking frame is reticular structure made of being woven as braided wires.Block two free ends difference of the braided wires of frame
It is fixed with the first end socket and the second end socket.
Step 120: overlay film is coated on blocking frame, to form the cystic structures with an opening.
In one embodiment, the overlay film that cladding blocks frame is formed using extraction.Firstly, leaching liquor is prepared, extraction
The solute of liquid is the material to form overlay film.In one embodiment, the solute of leaching liquor is degradable polymer.By degradable poly
It closes object to be dissolved in solvent, obtains leaching liquor.
The entire frame that blocks is impregnated in leaching liquor after a certain period of time, frame will be blocked and slowly proposed from leaching liquor,
Due to surface tension, leaching liquor forms a liquid film and is covered on closure frame.After the solvent is volatilized, degradable polymer is precipitated
And it is deposited on to block and blocks overlay film on frame on frame to be formed to be coated on, and formation has cystic structures open at one end.
At this point, overlay film is continuous fine and close film.In one embodiment, the concentration of leaching liquor is greater than 1mg/mL, to guarantee the company of being formed
Continuous film, and film is not easily broken.
In one embodiment, frame will be blocked to immerse in leaching liquor, is retained at least 5 seconds (s), so that leaching liquor sufficiently soaks
Profit blocks frame, is then slowly promoted and will block frame and propose from leaching liquor, and promotion speed is 0.01~0.5 metre per second (m/s)
(m/s)。
In one embodiment, the entire frame that blocks is impregnated in leaching liquor after a certain period of time, frame will be blocked from leaching
The step of slowly proposing in extract is repeated as many times, i.e., multiple dipping and proposition, to obtain continuously, with certain thickness thin
Film.After carrying out first time leaching step by above-mentioned technique, second or when repetitive operation later, dip time is shorter, unsuitable
More than 5s.This is because the solvent in leaching liquor can be by at least partly degradable polymer of first time precipitation when repetitive operation
It re-dissolves.Require promotion speed also very fast when repetitive operation, preferably at 0.05~1 metre per second (m/s) (m/s).
In one embodiment, after carrying out a leaching step, in order to improve the continuity of overlay film, using the side of spraying
Leaching liquor is sprayed on overlay film by method.
In order to make overlay film that there is pore structure, puncture to form micropore on overlay film surface using superfine miniature puncture needle.It is micro-
The size of type puncture needle and the size of the micropore needed to form match.
In one embodiment, the solute of leaching liquor is the discrepant degradable polymer of at least two solubility properties.It will
The discrepant degradable polymer of at least two solubility properties is dissolved in solvent, obtains leaching liquor.
The entire frame that blocks is impregnated in leaching liquor after a certain period of time, frame will be blocked and slowly proposed from leaching liquor,
Due to surface tension, leaching liquor forms a liquid film and is covered on closure frame.After the solvent is volatilized, degradable polymer is precipitated
And it is deposited on to block and blocks overlay film on frame on frame to be formed to be coated on, and formation has cystic structures open at one end.
At this point, overlay film is that overlay film is dissolved in another solvent to make overlay film have pore structure, makes it by continuous fine and close film
A kind of middle degradable polymer is at least partly dissolved, and another degradable polymer is insoluble.One of degradable polymerization
Object is at least partly dissolved so that overlay film metamorphic pore structure.
It should be noted that one of degradable polymer is at least partly dissolved, and another degradable polymer is not
Dissolution, it is not required that another degradable polymer cannot be dissolved in the solvent completely, and be referred to for same solvent,
It differs greatly to the dissolubility of two kinds of degradable polymers；Alternatively, a kind of dissolution speed of degradable polymer in the solvent
Degree is very fast, and another solution rate is slower, and within the time that overlay film is contacted with solvent, a kind of degradable polymer can be rapidly
It is dissolved in the solvent, and the amount that another degradable polymer is dissolved in the solvent is very little, will not destroy overlay film
Continuity or integrality.
It is appreciated that when needing to make overlay film cladding to block frame, the first end socket and the second end socket, frame, the will be blocked
One end socket and the second end socket are entirely impregnated in leaching liquor together, then are slowly extracted.It should be noted that when the overlay film packet formed
When covering the through-hole of the second end socket, need to cut off the part of the covering through-hole of overlay film, so that through-hole is unimpeded.
In one embodiment, the overlay film that cladding blocks frame is formed using electrostatic spinning.
In one embodiment, to make to contain in leaching liquor also containing endothelialization substance is promoted in overlay film and promote endothelialization substance,
Alternatively, containing rush endothelialization substance in the stoste of electrostatic spinning.
In one embodiment, after forming the overlay film with hole, further include the steps that heat treatment.In an embodiment
In, the step of heat treatment includes 5~60min of heat preservation at a temperature of the occluder frame for being coated with overlay film is placed on 45~110 DEG C, with
The crystal property for improving degradable polymer is conducive to improve the reliability that overlay film adheres on blocking frame.
In one embodiment, when overlay film is elastic membrane, using ready-made elastic membrane, elastic membrane is coated on occluder frame
On frame, the cystic structures with an opening are formed.In one embodiment, a TPU membrane is coated on to the outside for blocking frame,
The cystic structures with an opening are formed after hot melt.In one embodiment, braided wires are woven into network management framework, then by two
Layer TPU membrane is respectively coated by the inner and outer wall of network management framework, and after hot melt and after being formed, formation is coated by two layers of TPU membrane
Frame is blocked, and two layers of TPU membrane cladding blocks frame and form the cystic structures with an opening.The temperature of hot melt is 150~250
℃。
In another embodiment, no matter elastic membrane is one layer or two layers, and the mode of gluing can be used by elastic membrane
It is fixed on and blocks on frame and form the cystic structures with an opening.
The preparation method simple process of above-mentioned plugging device, the plugging device being prepared are visual under X ray image equipment
Property is preferable.
Also, the preparation method of above-mentioned plugging device shape on blocking frame by the method for extraction, spraying or electrostatic spinning
At overlay film, avoids traditional plugging device and choked flow film is fixed on to the side for blocking lower portion using the method for suture suture
Formula, preparation efficiency are high.
Above-mentioned plugging device and preparation method thereof is further described below by way of specific embodiment.
Following embodiment is all made of the thickness and porosity of scanning electron microscope (SEM) measurement overlay film.Wherein, the test of porosity
Method is as follows: calculating the opening of micropore in the summation S1 of the shared area on the overlay film surface and surface area S2 of overlay film, (S1/S2)
× 100% value is considered as porosity.
Embodiment 1
20 Poly L-lactic acid (PLLA) braided wires arranged in parallel that one group includes string diameter 0.40mm are compiled as longitude
Knitting silk and one group includes 20 Poly L-lactic acid (PLLA) braided wires arranged in parallel of string diameter 0.40mm as latitude braided wires
Up and down weaving, and two free ends of braided wires are fixed with the first end socket and the second end socket, so that mesh grid is formed, by this
Mesh grid carries out thermal finalization and forms closure frame, blocks frame and includes the first closure unit, the second closure unit and be separately connected
First blocks the waist of unit and the second closure unit, and the first end socket is located at first and blocks on unit, and the second end socket is located at second
It blocks on unit, the sizing grid for blocking frame is 10mm2。
Ploy DL lactic caid (PDLLA) is dissolved in acetonitrile to be configured to concentration be 30mg/mL leaching liquor, frame, the will be blocked
In the leaching liquor that one end socket and the second end socket are impregnated in, impregnate 10s after, will block frame with the speed of 0.5m/s from leaching liquor
It proposes, ploy DL lactic caid, which is deposited on, blocks the upper of frame, after dry, form cladding and blocks frame, the first end socket and the second end socket
Overlay film, the through-hole on overlay film and uncoated second end socket is to form the cystic structures with an opening.Then it is with diameter
100 microns of miniature puncture needle punctures on overlay film at random to form the through-hole that multiple apertures are 100 microns on overlay film.With sweeping
Retouching Electronic Speculum (SEM) and measuring the porosity of overlay film is 0.5%.Overlay film with a thickness of 50 microns.Further, envelope film coated
Stifled frame is heat-treated 5min at 70 DEG C, obtains plugging device.
Embodiment 2
30 Poly L-lactic acid (PLLA) braided wires arranged in parallel that one group includes string diameter 0.10mm are compiled as longitude
Knitting silk and one group includes 30 Poly L-lactic acid (PLLA) braided wires arranged in parallel of string diameter 0.10mm as latitude braided wires
Up and down weaving, and two free ends of braided wires are fixed with the first end socket and the second end socket, so that mesh grid is formed, by this
Mesh grid carries out thermal finalization and forms closure frame, blocks frame and includes the first closure unit, the second closure unit and be separately connected
First blocks the waist of unit and the second closure unit, and the first end socket is located at first and blocks on unit, and the second end socket is located at second
It blocks on unit, the sizing grid for blocking frame is 16mm2。
Ploy DL lactic caid (PDLLA) is dissolved in the ploy DL lactic caid solution that saturation is configured in acetone, by phosphatidyl choline
It is dissolved in ethyl alcohol, is configured to the phosphatidylcholine solution of saturation；Ploy DL lactic caid solution and phosphatidylcholine solution are pressed into body
Product will block in the leaching liquor that frame, the first end socket and the second end socket are impregnated in, leaching than being that 9:1 carries out being mixed to get leaching liquor
After stain 1min, frame will be blocked and propose that ploy DL lactic caid and phosphatidyl choline are deposited on from leaching liquor with the speed of 0.1m/s
The upper of frame is blocked, after dry, forms the overlay film that cladding blocks frame, the first end socket and the second end socket, overlay film and uncoated the
Through-hole on two end sockets is to form the cystic structures with an opening.Then the miniature puncture needle for being 50 microns with diameter is random
It is punctured on overlay film to form the through-hole that multiple apertures are 50 microns on overlay film.The hole of overlay film is measured with scanning electron microscope (SEM)
Gap rate is 5%.Overlay film with a thickness of 40 microns.Further, the closure frame that film coats is heat-treated at 60 DEG C
30min obtains plugging device.
Embodiment 3
It include the Nitinol braided wires arranged in parallel of 30 string diameter 0.05mm as longitude braided wires and one using one group
Arranged in parallel nitinol alloy wire of the group including 30 string diameter 0.05mm is as latitude braided wires up and down weaving, and with first
Two free ends of end socket and the fixed braided wires of the second end socket are formed mesh grid progress thermal finalization to form mesh grid
Frame is blocked, frame is blocked and includes the first closure unit, the second closure unit and be separately connected the first closure unit and the second envelope
The waist of stifled unit, the first end socket are located at first and block on unit, and the second end socket is located at second and blocks on unit, block frame
Sizing grid is 8mm2。
Ploy DL lactic caid (PDLLA) and poly-hydroxy fatty acid rouge (PHA) are dissolved in chloroform and are configured to poly- racemization cream
The concentration of acid is 10mg/mL, and the concentration of poly-hydroxy fatty acid rouge is the leaching liquor of 10mg/mL, will block frame, the first end socket and
In the leaching liquor that second end socket is impregnated in, after impregnating 1min, frame will be blocked and proposed from leaching liquor with the speed of 0.05m/s,
Ploy DL lactic caid and poly-hydroxy fatty acid lipidosis are in blocking the upper of frame, in order to keep the continuity of overlay film, are repeating to extract
Step 2 time, repeat in step, be that entire will block frame, the first end socket and the second end socket continue to be impregnated in extraction every time
After impregnating 2s in liquid, quickly lifted with the speed of 0.2m/s, is required to sufficiently drying every time and repeats next time.After drying, shape
The overlay film of frame, the first end socket and the second end socket is blocked at cladding, the through-hole on overlay film and uncoated second end socket is to form
Cystic structures with an opening.Further, overlay film being impregnated into 5s in acetone, PDLLA can dissolve, and PHA will not dissolve, from
And micropore is formed on overlay film, it is 2 microns with the aperture that scanning electron microscope (SEM) measures micropore, the porosity of overlay film is 1%.It covers
Film with a thickness of 50 microns.Further, the closure frame that film coats is heat-treated 15min at 45 DEG C, obtains plugging device.
Embodiment 4
The polyethylene terephthalate (PET) arranged in parallel that one group includes 20 string diameter 0.05mm is compiled as longitude
Knitting silk and one group includes the polyethylene terephthalate (PET) arranged in parallel of 20 string diameter 0.05mm as latitude braided wires
Up and down weaving, and two free ends of braided wires are fixed with the first end socket and the second end socket, so that mesh grid is formed, by this
Mesh grid carries out thermal finalization and forms closure frame, blocks frame and includes the first closure unit, the second closure unit and be separately connected
First blocks the waist of unit and the second closure unit, and the first end socket is located at first and blocks on unit, and the second end socket is located at second
It blocks on unit, the sizing grid for blocking frame is 0.1mm2。
Poly butyric ester (PHB) is dissolved in the leaching liquor for being configured to that concentration is 1mg/mL in chloroform, frame, the will be blocked
In the leaching liquor that one end socket and the second end socket are impregnated in, after impregnating 1min, frame will be blocked with the speed of 0.1m/s from leaching liquor
Middle proposition, poly butyric ester, which is deposited on, blocks the upper of frame, after dry, form cladding and blocks frame, the first end socket and second
Through-hole on the overlay film of end socket, overlay film and uncoated second end socket is to form the cystic structures with an opening.Then with straight
The miniature puncture needle that diameter is 100 microns punctures at random on overlay film to form the through-hole that multiple apertures are 100 microns on overlay film.
It is 15% with the porosity that scanning electron microscope (SEM) measures overlay film.Overlay film with a thickness of 10 microns.Further, film is coated
Closure frame be heat-treated 15min at 45 DEG C, obtain plugging device.
Embodiment 5
30 Poly L-lactic acid (PLLA) braided wires arranged in parallel that one group includes string diameter 0.10mm are compiled as longitude
Knitting silk and one group includes 30 Poly L-lactic acid (PLLA) braided wires arranged in parallel of string diameter 0.10mm as latitude braided wires
Up and down weaving, and two free ends of braided wires are fixed with the first end socket and the second end socket, so that mesh grid is formed, by this
Mesh grid carries out thermal finalization and forms closure frame, blocks frame and includes the first closure unit, the second closure unit and be separately connected
First blocks the waist of unit and the second closure unit, and the first end socket is located at first and blocks on unit, and the second end socket is located at second
It blocks on unit, the sizing grid for blocking frame is 12mm2。
Frame tube will be blocked first slightly to stretch, so that the first closure unit and the second closure unit will not block waist,
And it is grounded；Then hopper is added in polyethylene terephthalate (PET) raw material, by self weight and pneumatics after heated melting
The effect of machine is delivered to nozzle；Under the action of the high pressure positive supply being connected with nozzle, polymer melt drawn at silk and
The deposition on frame, the first end socket and the second end socket that blocks of ground connection forms cladding closure frame, the first end socket and the second end socket
Overlay film, to form the cystic structures with an opening.The pore size of the micropore of overlay film is 1 micron, the porosity of overlay film
It is 3%, with a thickness of 40 μm.
Embodiment 6
It include the polyethylene terephthalate braided wires arranged in parallel of 14 string diameter 0.30mm as warp using one group
Spending braided wires and one group includes the polyethylene terephthalate braided wires arranged in parallel of 14 string diameter 0.30mm as latitude
Braided wires up and down weaving is spent, and fixes two free ends of braided wires with the first end socket and the second end socket, to form volume
The mesh grid is carried out thermal finalization and forms closure frame by knitmesh, which is carried out thermal finalization formation and blocks frame, occluder frame
Frame includes the first closure unit, the second closure unit and is separately connected the first closure unit and second and blocks the waist of unit, and the
One end socket is located at first and blocks on unit, and the second end socket is located at second and blocks on unit, and the sizing grid for blocking frame is 5mm2。
Poly butyric ester (PHB) is dissolved in the leaching liquor for being configured to that concentration is 1mg/mL in chloroform, frame, the will be blocked
In the leaching liquor that one end socket and the second end socket are impregnated in, impregnate 30s after, will block frame with the speed of 0.1m/s from leaching liquor
It proposes, poly butyric ester, which is deposited on, blocks the upper of frame, after dry, form cladding and blocks frame, the first end socket and the second envelope
The overlay film of head, the through-hole on overlay film and uncoated second end socket is to form the cystic structures with an opening.Then diameter is used
It is punctured at random on overlay film to form the through-hole that multiple apertures are 10 microns on overlay film for 10 microns of miniature puncture needles.With sweeping
Retouching Electronic Speculum (SEM) and measuring the porosity of overlay film is 10%.Overlay film with a thickness of 10 microns.Further, envelope film coated
Stifled frame is heat-treated 10min at 50 DEG C, obtains plugging device.
Embodiment 7
It include the Nitinol braided wires arranged in parallel of 50 string diameter 0.05mm as longitude braided wires and one using one group
Arranged in parallel nitinol alloy wire of the group including 50 string diameter 0.05mm is as latitude braided wires up and down weaving, and with first
Two free ends of end socket and the fixed braided wires of the second end socket are formed mesh grid progress thermal finalization to form mesh grid
Frame is blocked, frame is blocked and includes the first closure unit, the second closure unit and be separately connected the first closure unit and the second envelope
The waist of stifled unit, the first end socket are located at first and block on unit, and the second end socket is located at second and blocks on unit, block frame
Sizing grid is 10mm2。
Poly L-lactic acid is dissolved in the leaching liquor that compound concentration in chloroform is 20mg/mL, will block frame, the first end socket and
In the leaching liquor that second end socket is impregnated in, after impregnating 45s, frame will be blocked and proposed from leaching liquor with the speed of 0.01m/s, gathered
D-lactic acid, which is deposited on, blocks the upper of frame, after dry, forms the overlay film that cladding blocks frame, the first end socket and the second end socket,
Through-hole on overlay film and uncoated second end socket is to form the cystic structures with an opening.It then is 50 microns with diameter
Miniature puncture needle punctures on overlay film at random to form the through-hole that multiple apertures are 50 microns on overlay film.Use scanning electron microscope
(SEM) porosity for measuring overlay film is 0.1%.Overlay film with a thickness of 40 microns.Further, closure frame film coated
It is heat-treated 5min at 110 DEG C, obtains plugging device.
Embodiment 8
Nitinol is cut and is formed for forming closure frame, blocking frame includes the first closure unit, the second closure list
Member and the waist for being separately connected the first closure unit and the second closure unit, further include the first end socket and the second end socket, the first envelope
Head is located at first and blocks on unit, and the second end socket is located at second and blocks on unit.The sizing grid for blocking frame is 16mm2。
Ploy DL lactic caid (PDLLA) is dissolved in acetonitrile and is configured to concentration as 30mg/mL leaching liquor, blocks frame, first
In the leaching liquor that end socket and the second end socket are impregnated in, after impregnating 15s, frame will be blocked and mentioned from leaching liquor with the speed of 0.2m/s
Out, poly butyric ester, which is deposited on, blocks the upper of frame, and leaching liquor is further then sprayed on closure using the method for spraying
On frame, after dry, the overlay film that cladding blocks frame is formed, the through-hole on overlay film and uncoated second end socket has to be formed
The cystic structures of one opening.Then the miniature puncture needle for being 10 microns with diameter punctures at random on overlay film to be formed on overlay film
The through-hole that multiple apertures are 1 micron.It is 0.8% with the porosity that scanning electron microscope (SEM) measures overlay film.Overlay film it is micro- with a thickness of 50
Rice.Further, the closure frame that film coats is heat-treated 60min at 70 DEG C, obtains plugging device.
Embodiment 9
It include the Nitinol braided wires arranged in parallel of 25 string diameter 0.05mm as longitude braided wires and one using one group
Arranged in parallel nitinol alloy wire of the group including 25 string diameter 0.05mm is formed as latitude braided wires up and down weaving to be woven
Then two are respectively coated by the inner and outer wall of woven network tube by network management with a thickness of 25 microns of TPU membrane, and in 200 DEG C
Lower hot melt, is then formed, and obtains including the first closure unit, the second closure unit and being separately connected the first closure unit and second
The closure frame for blocking the waist of unit, the sizing grid for blocking frame is 3mm2, and the closure frame is by two TPU membrane packets
It covers, forms the cystic structures with an opening on frame.Further, the miniature puncture needle for being 30 microns with diameter is at random in overlay film
Upper puncture on overlay film to form the through-hole that multiple apertures are 30 microns.It is with the porosity that scanning electron microscope (SEM) measures overlay film
1.5%.
Each technical characteristic of embodiment described above can be combined arbitrarily, for simplicity of description, not to above-mentioned reality
It applies all possible combination of each technical characteristic in example to be all described, as long as however, the combination of these technical characteristics is not deposited
In contradiction, all should be considered as described in this specification.
The embodiments described above only express several embodiments of the present invention, and the description thereof is more specific and detailed, but simultaneously
It cannot therefore be construed as limiting the scope of the patent.It should be pointed out that coming for those of ordinary skill in the art
It says, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to protection of the invention
Range.Therefore, the scope of protection of the patent of the invention shall be subject to the appended claims.
Claims (20)
1. a kind of plugging device, including frame is blocked, the closure frame is reticular structure, which is characterized in that it further include overlay film, institute
Overlay film is stated to coat the closure frame completely and form the cystic structures with an opening.
2. plugging device according to claim 1, which is characterized in that the closure frame is woven by degradable braided wires
Or the closure frame is cut by degradation material and is formed, and the material of the overlay film is degradable polymer.
3. plugging device according to claim 2, which is characterized in that the degradable polymer is selected from Poly L-lactic acid, gathers
Racemic lactic acid, polyglycolic acid, poly lactide-glycolide acid, poly-hydroxy fatty acid rouge, polydioxanone, polycaprolactone,
At least one in polydextrose acid, polyhydroxybutyrate, polyanhydride, polyphosphate, polyglycolic acid, polydioxanone and polycarbonate
Kind.
4. plugging device according to claim 2, which is characterized in that the overlay film, which also contains, promotees endothelialization substance.
5. plugging device according to claim 1, which is characterized in that the overlay film with a thickness of 10~50 μm.
6. plugging device according to claim 1, which is characterized in that have micropore, the aperture of the micropore on the overlay film
It is 1~100 μm.
7. plugging device according to claim 6, which is characterized in that the porosity of the overlay film is 0.1~15%.
8. plugging device according to claim 1, which is characterized in that the overlay film is elastic membrane.
9. plugging device according to claim 1, which is characterized in that the sizing grid range for blocking frame is 0.1mm2
~16mm2。
10. plugging device according to claim 1, which is characterized in that the closure frame includes the first closure unit, second
Unit and waist are blocked, the both ends of the waist are separately connected described first and block unit and the second closure unit, described
Overlay film coats described first completely and blocks unit, the second closure unit and waist.
11. plugging device according to claim 10, which is characterized in that the plugging device further includes the first end socket and the second envelope
Head, first end socket are set to described first and block on unit, and second end socket is set to described second and blocks on unit, described
Second end socket offers through-hole, and the overlay film also coats first end socket and the second end socket, and the overlay film do not coat it is described
Through-hole makes the through-hole form the opening of the cystic structures.
12. a kind of preparation method of plugging device, which comprises the steps of:
It provides and blocks frame, the closure frame is reticular structure；And
Overlay film is coated on the closure frame, to form the cystic structures with an opening.
13. the preparation method of plugging device according to claim 12, which is characterized in that described to be wrapped on the closure frame
Overlay film, so that the step of forming the cystic structures with an opening includes:
Leaching liquor is prepared, the solute of the leaching liquor is the material to form the overlay film；And
The closure frame is impregnated in the leaching liquor, and the closure frame is proposed from the leaching liquor, it is dry
Afterwards, the material for forming the overlay film is attached on the closure frame and forms the cystic structures with an opening.
14. the preparation method of plugging device according to claim 13, which is characterized in that described to impregnate the closure frame
In step in the leaching liquor, the time that the closure frame is impregnated in the leaching liquor is at least 5 seconds.
15. the preparation method of plugging device described in 3 or 14 according to claim 1, which is characterized in that described and by the occluder frame
Frame from the step of proposition in the leaching liquor, by the speed that is proposed from the leaching liquor of closure frame be 0.01~
0.5 metre per second (m/s).
16. the preparation method of plugging device described in 3 or 14 according to claim 1, which is characterized in that the solute of the leaching liquor is
The concentration of degradable polymer, the degradable polymer is greater than or equal to 1mg/mL.
17. the preparation method of plugging device described in 3 or 14 according to claim 1, which is characterized in that described by the closure frame
It is impregnated in the leaching liquor, and further includes heat treatment by the closure frame after the step of proposition in the leaching liquor
The step of, the step of heat treatment includes:
5~60min is kept the temperature at a temperature of the occluder frame is placed on 45~110 DEG C.
18. the preparation method of plugging device according to claim 12, which is characterized in that described to be wrapped on the closure frame
Overlay film, so that the step of forming the cystic structures with an opening includes:
Overlay film is coated on the closure frame, forms the cystic structures with an opening after hot melt；Alternatively,
Overlay film is fixed on the closure frame by the method for gluing, forms the cystic structures with an opening.
19. a kind of plugging system, which is characterized in that further include pushing away including plugging device as claimed in any one of claims 1 to 11
Device is sent, the driving means includes the delivery conduit for conveying cable and being connected with the conveying cable, and the conveying cable is used for and institute
It states plugging device to be detachably connected, the conveying cable has inner cavity, and the delivery conduit has conveyor chamber, the inner cavity, described defeated
Chamber and the cystic structures is sent to be connected to.
20. plugging system according to claim 19, which is characterized in that the conveying cable is to wind shape by more one metal wires
At hollow pipe, and being equipped with for the conveying cable seals film, inner wall or the sealing of the sealing film positioned at the conveying cable
Film is coated on the outer wall of the conveying cable.
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| CN201811575032.9A CN109820548B (en) | 2018-12-21 | 2018-12-21 | Plugging device, preparation method thereof and plugging system |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
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