CN106955135A - A kind of plugging device choked flow film and its manufacture method - Google Patents
A kind of plugging device choked flow film and its manufacture method Download PDFInfo
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- CN106955135A CN106955135A CN201710224082.1A CN201710224082A CN106955135A CN 106955135 A CN106955135 A CN 106955135A CN 201710224082 A CN201710224082 A CN 201710224082A CN 106955135 A CN106955135 A CN 106955135A
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- 238000000034 method Methods 0.000 title claims abstract description 18
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 14
- 239000000463 material Substances 0.000 claims abstract description 15
- 238000010438 heat treatment Methods 0.000 claims description 29
- 229920006254 polymer film Polymers 0.000 claims description 28
- 238000002203 pretreatment Methods 0.000 claims description 6
- 238000004513 sizing Methods 0.000 claims description 6
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 4
- 239000000741 silica gel Substances 0.000 claims description 4
- 229910002027 silica gel Inorganic materials 0.000 claims description 4
- 239000004642 Polyimide Substances 0.000 claims description 3
- 238000010304 firing Methods 0.000 claims description 3
- 229920000052 poly(p-xylylene) Polymers 0.000 claims description 3
- 229920001230 polyarylate Polymers 0.000 claims description 3
- 229920001721 polyimide Polymers 0.000 claims description 3
- 238000004804 winding Methods 0.000 claims description 3
- 238000006116 polymerization reaction Methods 0.000 claims 1
- 208000007536 Thrombosis Diseases 0.000 abstract description 9
- 239000012528 membrane Substances 0.000 abstract description 7
- 210000001519 tissue Anatomy 0.000 abstract description 4
- 238000004062 sedimentation Methods 0.000 abstract description 3
- 206010061218 Inflammation Diseases 0.000 abstract description 2
- 230000009286 beneficial effect Effects 0.000 abstract description 2
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- 210000003743 erythrocyte Anatomy 0.000 abstract description 2
- 230000004054 inflammatory process Effects 0.000 abstract description 2
- 210000004698 lymphocyte Anatomy 0.000 abstract description 2
- 210000002540 macrophage Anatomy 0.000 abstract description 2
- 210000000329 smooth muscle myocyte Anatomy 0.000 abstract description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 9
- 239000004810 polytetrafluoroethylene Substances 0.000 description 9
- 230000010100 anticoagulation Effects 0.000 description 4
- 238000010586 diagram Methods 0.000 description 4
- -1 polytetrafluoroethylene Polymers 0.000 description 4
- 238000002513 implantation Methods 0.000 description 3
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- 206010003658 Atrial Fibrillation Diseases 0.000 description 2
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12122—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder within the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00526—Methods of manufacturing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- External Artificial Organs (AREA)
Abstract
The invention discloses a kind of plugging device choked flow film and its manufacture method, there are multiple holes on the plugging device choked flow film, the maximum R of the pore-size is 15~600 μm.Beneficial effects of the present invention are：The plugging device choked flow film includes membranous disc and membranous wall, and membrane material is made up of polymeric material, and the maximum of pore-size is 15~600 μm, and preferably 50~300 μm, porosity percentages are 10~60%, preferably 15~50%.When above-mentioned design uses cooperatively the plugging device choked flow film and plugging device skeleton, red blood cell can effectively pass through the plugging device choked flow film, and thrombus can not be by the plugging device choked flow film, thrombus is settled in the side of the plugging device choked flow film, the inflammatory reaction absorbed by macrophage and lymphocyte to sedimentation thrombus, smooth muscle cell infiltrates and fibr tissue generation, plugging device choked flow film can quick endothelialization, shorten patient treat, observing time.
Description
Technical field
The present invention relates to choked flow technical field of membrane, and in particular to a kind of plugging device choked flow film and its manufacture method.
Background technology
Choked flow film is the important component of plugging device, when plugging device reaches the diseased region for needing to block, utilizes envelope
Stifled device framework location, isolates diseased region by choked flow film, and the final endothelialization completely of choked flow film realizes the effect of closure.
Atrial fibrillation is initially identified as old cardiac arrhythmia in 1909, as population in the world is growing, becomes increasingly to weigh
Will.Atrial fibrillation can cause some deleterious effects, and wherein most serious is exactly to be formed to cause the thrombus of apoplexy.Based on implantation instrument,
Percutaneous puncture blocks left auricle of heart and had been found to as effective treatment method.Left atrial appendage occlusion art mainly uses metallic framework to fix
In left auricle of heart, by skeleton outside or intraskeletal choked flow film block left auricle of heart mouthful, left auricle of heart is isolated with atrium sinistrum.
The choked flow film typically used is dense film, after left auricle of heart is sealed, and completely whole resistance is climbed at edge of the cell along choked flow film
Film is flowed, this method causes the time of choked flow film endothelialization longer.What on the one hand endothelialization speed affected anticoagulation takes week
Phase, and then influence treatment time, the security of implantation instrument on the other hand to be influenceed again.
The content of the invention
When being used cooperatively to solve plugging device choked flow film of the prior art and plugging device skeleton, endothelialization is slow, causes to suffer from
The cycle that person takes anticoagulation is longer, and treatment time is longer, improves medical expense, making patients' pain；Have simultaneously higher
Formation apparatus thrombus risk, cause the relatively low defect of percutaneous transcatheter closure security being implanted into based on apparatus, the present invention provides a kind of
The quick plugging device choked flow film of endothelialization and its manufacture method, and then taking the cycle for patient's anticoagulation is reduced, reduce treatment cost
With, mitigate the pain of patient, and apparatus thrombotic risk is reduced, increase implantation blocks the security of operation.
To achieve the above object, the technical solution adopted by the present invention is：
There are multiple holes, the maximum R of the pore-size on a kind of plugging device choked flow film, the plugging device choked flow film
It is 15~600 μm.
It is preferred that, the maximum R of the pore-size is 50~300 μm.So that the plugging device choked flow film endothelialization
Speed reaches most soon, makes blood flow as much as possible by the plugging device choked flow film, makes have dysgenic thrombus to human body again
It can not pass through.
It is preferred that, the plugging device choked flow film has parameter porosity percentages P, the computing formula of the porosity percentages P
It is as follows：
The porosity percentages P of the plugging device choked flow film is 10%~60%.
It is preferred that, the porosity percentages P of the plugging device choked flow film is 15%~50%.
The structure of the plugging device choked flow film can make the quick endothelialization of plugging device choked flow film, and endothelialization is fast on the one hand can be with
Taking the cycle for anticoagulation is effectively reduced, shortens treatment time, medical expense is reduced, mitigates the pain of patient, on the other hand
Make to form the reduction of apparatus thrombotic risk, improve the percutaneous transcatheter closure security being implanted into based on apparatus.
It is preferred that, the plugging device choked flow film is tubular structure, and it includes membranous wall and matching used membranous disc.
It is preferred that, the membranous wall and membranous disc are integral type structure.
A kind of manufacture method of plugging device choked flow film described in any of the above-described, comprises the following steps：
Pretreatment：Polymer film is cut to suitable dimension, the circle of mould rod winding one or multi-turn is attached, and it is fixed；
Heat treatment：The polymer film being fixed on mould rod is put into firing equipment together with mould rod and heated once
Or repeatedly, until the pore-size and porosity percentages of polymer film meet heat treatment requirements；
Sizing：Polymer film after heat treatment is removed from mould rod, suitable dimension is cut to, and will cut suitably
Polymer film covering, the one end for being fixed on shaper, shape one or many in modular system, until the hole of polymer film
Gap size and porosity percentages meet type approval requirements.
It is preferred that, in the pre-treatment step, the size after the polymer film is cut is：Long 20~50cm, wide by 10~
20cm。
It is preferred that, in the pre-treatment step, the polymer film and the mould rod are fixed by fixed cover.
It is preferred that, the material of the fixed cover is exotic material, specially polyimides, polyarylate, Parylene
Or silica gel.
It is preferred that, in the pre-treatment step, the material of the mould rod is rigid exotic material, specially stainless steel
Or polytetrafluoroethylene (PTFE).
It is preferred that, in the heat treatment step, the firing equipment is baking oven or heat-treatment furnace.
It is preferred that, in the heat treatment step, heating-up temperature is 120~250 DEG C, and the heat time is 0.5~60min.
It is preferred that, in the heat treatment step, heating-up temperature is 130~190 DEG C, and the heat time is 5~40min.
It is preferred that, in the heat treatment step, the maximum R for being heated to the pore-size of the polymer film is 12~
480 μm, porosity percentages P is 5~50%.
It is preferred that, in the heat treatment step, the maximum R for being heated to the pore-size of the polymer film is 40~
240 μm, porosity percentages P is 10~40%.
It is preferred that, in the fixating shape step, the size after the polymer film (4) cuts is：Long 6~15cm, wide by 6~
15cm。
It is preferred that, in the fixating shape step, the modular system is water-bath, salt bath/stove, baking oven or heat-treatment furnace.
It is preferred that, in the fixating shape step, setting temperature is 70~120 DEG C, and shaping time is 5~2400s.
It is preferred that, in the fixating shape step, setting temperature is 80~115 DEG C, and shaping time is 5~600s.
It is preferred that, in the fixating shape step, the maximum R shaped to the pore-size of the polymer film is 15~
600 μm, porosity percentages P is 10~60%.
It is preferred that, in the fixating shape step, the maximum R shaped to the pore-size of the polymer film is 50~
300 μm, porosity percentages P is 15~50%.
Beneficial effects of the present invention are：The plugging device choked flow film includes membranous disc and membranous wall, and membrane material is by polymeric material
It is made, the maximum of pore-size is 15~600 μm, and preferably 50~300 μm, porosity percentages are 10~60%, are preferably
15~50%.When above-mentioned design uses cooperatively the plugging device choked flow film and plugging device skeleton, red blood cell can effectively pass through
The plugging device choked flow film, and thrombus can not be by the plugging device choked flow film, thrombus is in the side of the plugging device choked flow film
Sedimentation, the inflammatory reaction absorbed by macrophage and lymphocyte to sedimentation thrombus, smooth muscle cell infiltration and fibr tissue
Generation, plugging device choked flow film can quick endothelialization, shorten patient treat, observing time.
Brief description of the drawings
Fig. 1 is the structural representation of the plugging device choked flow film of the embodiment of the present invention；
Fig. 2 is the maximum R of the pore-size of the plugging device choked flow film of embodiment of the present invention instrumentation plan；
Fig. 3 is the maximum R and endothelialization speed V of the pore-size of the plugging device choked flow film of the embodiment of the present invention relation
Curve；
Fig. 4 for the embodiment of the present invention plugging device choked flow film manufacture method in pre-treatment step schematic diagram；
Fig. 5 for the embodiment of the present invention plugging device choked flow film manufacture method in shaper structural representation；
Fig. 6 for the embodiment of the present invention plugging device choked flow film manufacture method in fixating shape step schematic diagram；
Fig. 7 is the fixating shape step schematic diagram of the plugging device choked flow film of the Split type structure of the embodiment of the present invention；
Fig. 8 is the structural representation after plugging device choked flow film and plugging device the skeleton assembling of the embodiment of the present invention.
In figure,
1- membranous walls；2- membranous discs；3- holes；4- polymer films；5- mould rods；6- fixed covers；7- shapers；71- is fixed
Grooving；8- plugging device skeletons.
Embodiment
Explanation is explained in detail in the structure to the present invention below in conjunction with the accompanying drawings.
As shown in Figure 1 to Figure 2, a kind of plugging device choked flow film provided in an embodiment of the present invention, including membranous disc 2 and membranous wall 1, its
Middle membranous disc 2 and membranous wall 1 are usually integral structure, can also be Split type structure in a few cases.
The membranous disc 2 is not limited to circular or polygon, if membranous disc 2 for it is circular, its diameter D is 5~80mm, preferably 15~
50mm, if membranous disc 2 is polygon, its inscribed circle diameter is 5~80mm, preferably 15~50mm.
The cross sectional shape of membranous wall 1 is not limited to circular or polygon, can be identical with the shape of membranous disc 2, can also be with membranous disc 2
Shape is different.As shown in figure 1, the length dimension L of membranous wall 1 is 1~50mm, preferred length L is 5~25mm.
Membranous disc 2 is not limited to circular, polygon with the hole 3 on membranous wall 1.The maximum R of the size of hole 3 is 15~
600 μm, preferably 50~300 μm, dimensional measurement schematic diagram is as shown in Figure 2.Porosity percentages P be 10~60%, preferably 15~
50%, porosity percentages refer in two dimensional surface, and the gross area of hole 3 accounts for the percentage of the area of plane, porosity percentages calculating side
Method is shown as the following formula：
A kind of plugging device choked flow film provided in an embodiment of the present invention, the maximum R of the size of hole 3 refers to：The hole 3
The distance of the farthest point-to-point transmission of upper distance.
A kind of plugging device choked flow film provided in an embodiment of the present invention, its material is made up of polymeric material, the polymer
Material can refer to for polyethers, polyurethane, polytetrafluoroethylene (PTFE), high density polyethylene (HDPE), polyethylene, poly- to stupid naphthalate
(PET), one or more mixture materials in expanded PTFE (expanded PTFE), preferably gather to stupid two
Formic acid glycol ester (PET) or expanded PTFE (expanded PTFE).
As shown in figure 3, the present invention is according to a large amount of simulated experiments and zoopery, under the premise of pathological tissue is without infarct,
The maximum R and endothelialization speed V of the size of plugging device choked flow membrane pores 3 curve is made.As seen from the figure, the present invention is implemented
The endothelialization speed of the plugging device choked flow film of example.
A kind of manufacture method of plugging device choked flow film provided in an embodiment of the present invention, comprises the following steps：
The polymer bought back is weaved/be woven into nethike embrane, the polymer film 4 with hole 3 also can be directly bought back.
Polymer film 4 is pre-processed, preprocessing process is：Polymer film 4 is cut into suitable dimension, attached
The winding of mould rod 5 two is enclosed, and the upper and lower ends of the polymer film 4 are fixed on mould rod 5 with fixed cover 6, wherein, it is described solid
Surely set 6 can cover 6 surely for silica gel solid, as shown in figure 4, the mould rod 5 is rigid exotic material, can be stainless steel or poly-
Tetrafluoroethene (PTFE) etc., the fixed cover 6 is exotic material, can be polyimides, polyarylate, Parylene or silicon
Glue etc..
Pretreatment post-consumer polymer film 4 is heat-treated, heat treatment can be for once, or repeatedly, up to the chi of hole 3
Very little maximum R is 12~480 μm, and preferably 40~240 μm, porosity percentages P is 5~50%, preferably 10~40%.
The Equipment for Heating Processing can be baking oven or heat-treatment furnace, heat treatment temperature be 120~250 DEG C, preferably 130~
190 DEG C, heat treatment time is 0.5~60min, preferably 5~40min.
Polymer film 4 after heat treatment is shaped：Growth 10cm, wide 10cm polymer film 4 are cut, sizing can be one
It is secondary, or repeatedly, until the maximum R of the size of hole 3 is 15~600 μm, preferably 50~300 μm, porosity percentages P
For 10~60%, preferably 15~50%.
As shown in Figure 5 to Figure 6, sizing can be in following equipment：Enter in water-bath, salt bath/stove, baking oven or heat-treatment furnace
OK, setting temperature is 70~120 DEG C, and preferably 80~115 DEG C, shaping time is 5~2400s, preferably 5~600s.
Concrete numerical value is chosen below to be verified：
Pretreatment：PET raw material sample film is cut and grows into 40cm, a width of 15cm sample film, wound on mould rod 5
On, sample film is attached on mould rod 5, silica gel fixed cover 6 is fixed on the two ends set of sample film.
Heat treatment：Pretreated sample film is put into progress first time heat treatment, first time heat treatment temperature in baking oven
For 180 DEG C, heat treatment time 7min takes out sample film and is cooled to room temperature in atmosphere, then sample film is put into baking oven carries out the
Secondary heat treatment, second of 150 DEG C of heat treatment temperature, heat treatment time 15min takes out sample film and is cooled to room in atmosphere
Temperature, the sample film after heat treatment is shot with industrial camera, and the size of measurement sample membrane pores 3 simultaneously calculates porosity percentages, obtains heat
The maximum of the size of sample membrane pores 3 after processing is 120 μm, and porosity percentages are 16.6%.
Sizing：The sample film after heat treatment is cut, unnecessary sample film is cut along the position of fixed cover 6, then by after cutting
Sample film is cut and grows into 10cm, and it is covered on shaper 7, according to rule by a width of 10cm sample film by Central Symmetry
The fixed grooving 71 of lattice selection, puts fixed cover 6, the sample film after fixation is put into baking oven, setting temperature is 110 DEG C, during sizing
Between be 180s, take out sample film room temperature is cooled in water, along the position of fixed cover 6 cut, obtain a diameter of 30mm of membranous disc 2, film
The length of wall 1 is 10mm, and the maximum of the size of hole 3 is 150 μm, and porosity percentages are 22.2% plugging device choked flow film.
As shown in fig. 7, when the membranous disc 2 and membranous wall 1 are Split type structure, being needed after above-mentioned fixating shape step has been carried out along figure
Shown in 7 on sample film dotted line cut or it is molten cut, when membranous disc 2 is matched with membranous wall 1, need to ensure that the size of membranous disc 2 is big
In or equal to the membranous wall 1 sectional dimension.
To finally obtained plugging device choked flow film be shaped with occluder for left auricle skeleton 8 and suture composition plugging device, be implanted in
Verified in body weight 20kg or so beasle dog left auricle of heart, obtain within 1 month endothelialization plugging device choked flow membrane sample, empirical tests are obtained
Go out, 1 month sample has substantially carried out complete endothelialization, the used time is only 2/3 of 45 days complete endothelializations described in document.
In some occluder for left auricle examples, plugging device skeleton 8 can be braiding structure or be integrally machined structure, block
Device choked flow film is used cooperatively after being assembled with skeleton 8 by suture, hot pressing, welding or other modes, and Fig. 8 is real for one kind after assembling
Apply example.
It is that the most cells of superficial layer of human body itself organ inner membrance forms one to plugging device superficial growth for endothelialization is popular
The membranaceous tissue of layer endothelial cell.
Presently preferred embodiments of the present invention is these are only, is not intended to limit the invention, it is all in substance of the present invention
On any modification, equivalent and the simple modifications made etc., should be included within the scope of the present invention.
Claims (10)
1. a kind of plugging device choked flow film, it is characterised in that there are multiple holes (3), the hole on the plugging device choked flow film
(3) the maximum R of size is 15~600 μm.
2. plugging device choked flow film according to claim 1, it is characterised in that the maximum R of hole (3) size is
50~300 μm.
3. plugging device choked flow film according to claim 1, it is characterised in that the plugging device choked flow film has parameter hole
Percentage P, the computing formula of the porosity percentages P is as follows：
The porosity percentages P of the plugging device choked flow film is 10%~60%.
4. plugging device choked flow film according to claim 1, it is characterised in that the porosity percentages of the plugging device choked flow film
P is 15%~50%.
5. plugging device choked flow film according to claim 1, it is characterised in that the plugging device choked flow film is tubular structure,
It includes membranous wall (1) and matching used membranous disc (2).
6. plugging device choked flow film according to claim 5, it is characterised in that the membranous wall (1) and membranous disc (2) are integral type
Structure.
7. the manufacture method of the plugging device choked flow film described in a kind of any one of claim 1~6, it is characterised in that including following
Step：
Pretreatment：Polymer film (4) is cut to suitable dimension, the circle of mould rod (5) winding one or multi-turn is attached, and it is fixed；
Heat treatment：The polymer film (4) being fixed on mould rod (5) is put into firing equipment together with mould rod (5) and added
Heat is one or many, until hole (3) size and porosity percentages of polymer film (4) meet heat treatment requirements；
Sizing：Polymer film (4) after heat treatment is removed from mould rod (5), suitable dimension is cut to, and will cut properly
Polymer film (4) covering, be fixed on one end of shaper (7), shaped in modular system one or many, until polymerization
Hole (3) size and porosity percentages of thing film (4) meet type approval requirements.
8. the manufacture method of plugging device choked flow film according to claim 7, it is characterised in that in the pre-treatment step,
Size after the polymer film (4) cuts is：Long 20~50cm, wide 10~20cm.
9. the manufacture method of plugging device choked flow film according to claim 7, it is characterised in that in the pre-treatment step,
It is by fixed cover (6) that the polymer film (4) and the mould rod (5) is fixed.
10. the manufacture method of plugging device choked flow film according to claim 7, it is characterised in that the material of the fixed cover (6)
Expect for exotic material, specially polyimides, polyarylate, Parylene or silica gel.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201710224082.1A CN106955135A (en) | 2017-04-07 | 2017-04-07 | A kind of plugging device choked flow film and its manufacture method |
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| CN201710224082.1A CN106955135A (en) | 2017-04-07 | 2017-04-07 | A kind of plugging device choked flow film and its manufacture method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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