CN110432935A - Degradable plugging device and preparation method thereof - Google Patents
Degradable plugging device and preparation method thereof Download PDFInfo
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- CN110432935A CN110432935A CN201910721466.3A CN201910721466A CN110432935A CN 110432935 A CN110432935 A CN 110432935A CN 201910721466 A CN201910721466 A CN 201910721466A CN 110432935 A CN110432935 A CN 110432935A
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- Prior art keywords
- degradable
- plugging device
- silk
- tail end
- clinkering
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- 238000002360 preparation method Methods 0.000 title claims abstract description 8
- 238000010438 heat treatment Methods 0.000 claims abstract description 18
- 210000003660 reticulum Anatomy 0.000 claims abstract description 18
- 238000007493 shaping process Methods 0.000 claims abstract description 5
- 230000005540 biological transmission Effects 0.000 claims abstract description 4
- 238000002844 melting Methods 0.000 claims abstract description 4
- 230000008018 melting Effects 0.000 claims abstract description 4
- JVTAAEKCZFNVCJ-REOHCLBHSA-N L-lactic acid Chemical compound C[C@H](O)C(O)=O JVTAAEKCZFNVCJ-REOHCLBHSA-N 0.000 claims description 21
- 229920000747 poly(lactic acid) Polymers 0.000 claims description 17
- 239000004626 polylactic acid Substances 0.000 claims description 17
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 claims description 15
- 229920000954 Polyglycolide Polymers 0.000 claims description 13
- 239000004745 nonwoven fabric Substances 0.000 claims description 11
- 229920001610 polycaprolactone Polymers 0.000 claims description 11
- 239000004632 polycaprolactone Substances 0.000 claims description 11
- 239000002253 acid Substances 0.000 claims description 10
- 239000000463 material Substances 0.000 claims description 8
- 229920002463 poly(p-dioxanone) polymer Polymers 0.000 claims description 7
- 239000000622 polydioxanone Substances 0.000 claims description 7
- 239000004633 polyglycolic acid Substances 0.000 claims description 7
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 6
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 6
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 6
- 239000000835 fiber Substances 0.000 claims description 5
- 238000003466 welding Methods 0.000 claims description 5
- 239000004744 fabric Substances 0.000 claims description 4
- RBMHUYBJIYNRLY-UHFFFAOYSA-N 2-[(1-carboxy-1-hydroxyethyl)-hydroxyphosphoryl]-2-hydroxypropanoic acid Chemical compound OC(=O)C(O)(C)P(O)(=O)C(C)(O)C(O)=O RBMHUYBJIYNRLY-UHFFFAOYSA-N 0.000 claims description 3
- 229920001244 Poly(D,L-lactide) Polymers 0.000 claims description 3
- 229920004933 Terylene® Polymers 0.000 claims description 3
- 238000009954 braiding Methods 0.000 claims description 3
- 230000015556 catabolic process Effects 0.000 claims description 3
- 238000006731 degradation reaction Methods 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 229920001434 poly(D-lactide) Polymers 0.000 claims description 3
- 229920001432 poly(L-lactide) Polymers 0.000 claims description 3
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 claims description 3
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 3
- -1 polytetrafluoroethylene Polymers 0.000 claims description 3
- 238000004804 winding Methods 0.000 claims description 3
- 241000251468 Actinopterygii Species 0.000 claims description 2
- 239000004952 Polyamide Substances 0.000 claims description 2
- 229920002647 polyamide Polymers 0.000 claims description 2
- 239000006071 cream Substances 0.000 claims 1
- 229920000642 polymer Polymers 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 1
- 238000001727 in vivo Methods 0.000 abstract description 4
- 230000004060 metabolic process Effects 0.000 abstract description 4
- 229910001000 nickel titanium Inorganic materials 0.000 abstract description 3
- 238000000034 method Methods 0.000 description 3
- 208000002330 Congenital Heart Defects Diseases 0.000 description 2
- 239000000956 alloy Substances 0.000 description 2
- 229910045601 alloy Inorganic materials 0.000 description 2
- 208000028831 congenital heart disease Diseases 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 210000003038 endothelium Anatomy 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- QQZOPKMRPOGIEB-UHFFFAOYSA-N 2-Oxohexane Chemical compound CCCCC(C)=O QQZOPKMRPOGIEB-UHFFFAOYSA-N 0.000 description 1
- 241000790917 Dioxys <bee> Species 0.000 description 1
- 206010020751 Hypersensitivity Diseases 0.000 description 1
- 208000035478 Interatrial communication Diseases 0.000 description 1
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 1
- 208000001910 Ventricular Heart Septal Defects Diseases 0.000 description 1
- HZEWFHLRYVTOIW-UHFFFAOYSA-N [Ti].[Ni] Chemical compound [Ti].[Ni] HZEWFHLRYVTOIW-UHFFFAOYSA-N 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- 230000007815 allergy Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 208000013914 atrial heart septal defect Diseases 0.000 description 1
- 206010003664 atrial septal defect Diseases 0.000 description 1
- 230000008859 change Effects 0.000 description 1
- 230000009194 climbing Effects 0.000 description 1
- 210000003017 ductus arteriosus Anatomy 0.000 description 1
- 238000002592 echocardiography Methods 0.000 description 1
- 210000002889 endothelial cell Anatomy 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- SORGMJIXNUWMMR-UHFFFAOYSA-N lanthanum(3+);propan-2-olate Chemical compound [La+3].CC(C)[O-].CC(C)[O-].CC(C)[O-] SORGMJIXNUWMMR-UHFFFAOYSA-N 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000006855 networking Effects 0.000 description 1
- 229910001453 nickel ion Inorganic materials 0.000 description 1
- 229920000728 polyester Polymers 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 238000004513 sizing Methods 0.000 description 1
- 230000003746 surface roughness Effects 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
- 210000001519 tissue Anatomy 0.000 description 1
- 201000003130 ventricular septal defect Diseases 0.000 description 1
- PAPBSGBWRJIAAV-UHFFFAOYSA-N ε-Caprolactone Chemical compound O=C1CCCCCO1 PAPBSGBWRJIAAV-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00601—Implements entirely comprised between the two sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00646—Type of implements
- A61B2017/00654—Type of implements entirely comprised between the two sides of the opening
Landscapes
- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Cardiology (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a kind of degradable plugging devices and preparation method thereof.Integral network structure made of the degradable plugging device is woven as degradable silk, its structure includes upper disk surface, lower disk and waist connecting the two, it is characterised in that, it is located at lower disk bottom surface at the closing in of the reticular structure, is melted by the degradable silk at the position and form clinkering tail end;Upper disk surface, waist, lower disk are sewed with the degradable choked flow film of multilayer by degradable suture;In degradable plugging device transmission process, clinkering tail end is connected with driving means.The preparation method comprises the following steps: the tubular reticulum that will be woven by degradable silk, one end of opening carries out heating melting, forms clinkering tail end;Tubular reticulum with clinkering tail end carries out heat treatment shaping, filling degradable choked flow film.The present invention, can be gradually degradable after being implanted into human body, and catabolite is excreted with body metabolism, avoids the problem that a series of NiTi plugging device extended stationary periods caused complication in vivo.
Description
Technical field
The present invention relates to a kind of degradable plugging devices and preparation method thereof to belong to doctor for the treatment of congenital heart disease
Treat instrument field.
Background technique
Plugging device is a kind of medical instrument for being mainly used for congenital heart disease treatment, mainly includes echocardiography in atrial septal defect
Device, ventricular septal defect, patend ductus arteriosus occluder, occluder for left auricle etc..Plugging device one on domestic market
As be made of nick-eltitanium alloy stent and choked flow film group, nick-eltitanium alloy stent is that networking is woven by titanium-nickel wire, passes through heat in a mold
Processing is formed.Choked flow film is usually nondegradable polyester material.
After plugging device implants, a bridge beam action is primarily served, promotes surrounding tissue in plugging device surface
Pi Hua, to realize the closure of defect.But after endothelialization is complete, the mission of plugging device is completed, and continues to stay in the body, have
Cause a series of danger of complication, including nickel ion that caused allergy, arrhythmia cordis etc. is precipitated, therefore, it is necessary to close NiTi
Golden bracket and choked flow film are substituted by degradable high polymer material, develop a kind of degradable plugging device, in plugging device surface endothelium
After changing completely, degradable plugging device is gradually degraded, and catabolite is discharged with body metabolism, to avoid metal plugging device in vivo
It is long-term to retain brought hidden danger.
Summary of the invention
Problem to be solved by this invention is: a kind of degradable plugging device is provided, after plugging device surface endothelialization is complete,
It can gradually degrade, and catabolite is discharged with body metabolism, to avoid brought by metal plugging device in vivo reservation for a long time
Hidden danger.
In order to solve the above technical problems, present invention provide the technical scheme that a kind of degradable plugging device, by degradable silk
Integral network structure made of braiding, structure include upper disk surface, lower disk and waist connecting the two, which is characterized in that institute
It states and is located at lower disk bottom surface at the closing in of reticular structure, melted by the degradable silk at the position and form clinkering tail end;Upper disk surface,
Waist, lower disk are sewed with the degradable choked flow film of multilayer by degradable suture;In degradable plugging device transmission process, clinkering tail
End is connected with driving means;Two free ends of safety rope from top to bottom penetrate from any two on upper disk surface and pass through waist
Behind portion, it is pierced by from lower disk.
Preferably, the top surface of the upper disk surface is the structure that arc surface of plane or protrusion or both combines.
Preferably, the maximum gauge of the upper disk surface is greater than the minimum diameter of waist;The maximum gauge of lower disk be greater than or
Equal to the minimum diameter of waist.
Preferably, the welding tail end indent is protruded inside lower disk or from the bottom of lower disk.
Preferably, the degradable silk uses amorphous polylactic acid, l-lactic acid, dextrorotation polylactic acid, gathers to dioxy ring
Hexanone, polycaprolactone, polyglycolic acid PGA or poly lactide-glycolide acid.
Preferably, the material of the degradable choked flow film or degradable suture is polydioxanone, polycaprolactone, gathers
Any one in glycolic, poly lactide-glycolide acid or amorphous polylactic acid, l-lactic acid and dextrorotation polylactic acid or
Two or more blends;The structure of degradable choked flow film is spunlace non-woven cloth, needle punched non-woven fabrics, spun-bonded non-woven fabrics, heat seal nonwoven
Cloth, wet nonwoven fabrics or electrospun fibers film;The number of plies of degradable choked flow film is 2~6 layers.
Preferably, the contact surface of the clinkering tail end and driving means is equipped with lines, to increase its surface roughness, increases
With the frictional force of driving means, the safety of conveying is further ensured that.
It is highly preferred that the lines is shape of threads, wavy or fish scale-shaped.
Preferably, the material of the safety rope is amorphous polylactic acid PDLLA, l-lactic acid PLLA, dextrorotation polylactic acid
PDLA, polydioxanone PDO, polycaprolactone (PCL), polyglycolic acid PGA, poly lactide-glycolide acid PLGA, terylene
PET, polyamide fibre PA or polytetrafluoroethylene PTFE.
The present invention also provides the preparation methods of degradable plugging device, which is characterized in that the pipe that will be woven by degradable silk
Shape net, one end carry out necking with degradable silk or degradable silk are woven into smooth reticular structure, and one end is the tubulose of opening
Net;One end of opening is fastened with copper wire, and regular length is 1~5mm, heating device is opened, only to copper wire wound section
Degradable silk carries out continuous heating, and heating temperature is 110~250 DEG C, and heating time is 1~15s, until degradable in copper wire
Silk melting, while the degradable silk other than copper wire winding is not destroyed again;Copper wire is removed, clinkering tail end, the clinkering are formed
The lines that tail end has;Shaper is fitted into the tubular reticulum with clinkering tail end, heat treatment shaping is carried out, setting temperature is
50~100 DEG C, setting time is 10~100min, it is ensured that modular shapes can well keep while not break the degradable silk of ring again
Performance prevents temperature excessively high, and setting time is too long, accelerates the degradation of degradable silk, or leads to the degradable silk on tubular reticulum
Clinkering;Mold is removed, degradable plugging device bracket is obtained;Degradable choked flow film is filled into degradable plugging device bracket and is formed
Upper disk surface, lower disk and waist are fixed degradable choked flow film with degradable suture;Finally, by two free ends of safety rope
After from top to bottom being penetrated from any two on upper disk surface and passing through waist, it is pierced by from lower disk.
Compared with prior art, the method have the advantages that:
Degradable plugging device is made of degradation material completely, can gradually degradable, catabolite after being implanted into human body
It is excreted with body metabolism, avoids the problem that a series of NiTi plugging device extended stationary periods caused complication in vivo.Separately
Outside, degradable plugging device upper disk surface is smooth plane, is more advantageous to the climbing of endothelial cell, accelerates the endothelium on plugging device surface
Change, reaches good plugging effect.The clinkering tail end of disk is melted by degradable silk under degradable plugging device, and surface has
Coarse lines can have good connection effect with conveying device.
Detailed description of the invention
Fig. 1 is the main view for the degradable plugging device that embodiment 1 provides;
Fig. 2 is the top view of Fig. 1;
Fig. 3 is the main view for the degradable plugging device that embodiment 2 provides;
Fig. 4 is the top view of Fig. 3;
Fig. 5 is the main view for the degradable plugging device that embodiment 3 provides;
Fig. 6 is the top view of Fig. 5;
Fig. 7 is the main view for the degradable plugging device that embodiment 4 provides;
Fig. 8 is the top view of Fig. 7;
Fig. 9 is the main view of the tubular reticulum woven in embodiment 1-4 by degradable silk;
Figure 10 is the side view of Fig. 9;
Figure 11 is the main view for the degradable plugging device that embodiment 5 provides;
Figure 12 is the top view of Figure 11;
Figure 13 is the main view for the degradable plugging device that embodiment 6 provides;
Figure 14 is the top view of Figure 13;
Figure 15 is the main view for the degradable plugging device that embodiment 7 provides;
Figure 16 is the top view of Figure 16;
Figure 17 is the main view for the degradable plugging device that embodiment 8 provides;
Figure 18 is the top view of Figure 17.
Figure 19 is the main view for the tubular reticulum woven by degradable silk that embodiment 5-8 is provided;
Figure 20 is the side view of Figure 19.
Specific embodiment
In order to make the present invention more obvious and understandable, hereby with preferred embodiment, and attached drawing is cooperated to be described in detail below.
The preparation method for the degradable plugging device that embodiment 1-8 is provided: the tubular reticulum (embodiment that will be woven by degradable silk
As shown in Figures 9 and 10, the tubular reticulum woven in embodiment 5-8 by degradable silk is as schemed for the tubular reticulum woven in 1-4 by degradable silk
19, shown in 20), one end carries out necking with degradable silk or degradable silk is woven into smooth reticular structure, and one end is opening
Tubular reticulum;One end of opening is fastened with copper wire, and regular length is 1~5mm, opens heating device, is only wound to copper wire
Partial degradable silk carries out continuous heating, and heating temperature is 110~250 DEG C, and heating time is 1~15s, until in copper wire
Degradable silk melting, while the degradable silk other than copper wire winding is not destroyed again;Copper wire is removed, clinkering tail end 6 is formed,
The clinkering tail end 6 has lines;Shaper is fitted into the tubular reticulum with clinkering tail end 6, heat treatment shaping, sizing are carried out
Temperature is 50~100 DEG C, and setting time is 10~100min;Mold is removed, degradable plugging device bracket is obtained;By degradable resistance
Stream film 2, which is filled into degradable plugging device bracket, forms upper disk surface 3, lower disk 5 and waist 4, will be degradable with degradable suture
Choked flow film 2 is fixed.
Setting temperature, setting time and degradable silk string diameter corresponding relationship such as table 1 used in the heat treatment shaping technique
It is shown.
Table 1
Degradable silk diameter (mm) | Setting temperature (DEG C) | Setting time (min) |
0.250-0.339 | 40-100 | 50-100 |
0.200-0.249 | 40-100 | 50-100 |
0.150-0.199 | 40-100 | 10-80 |
0.095-0.149 | 40-100 | 10-80 |
Embodiment 1
It as shown in Figure 1, 2, is a kind of degradable plugging device provided in this embodiment, it is whole as made of the braiding of degradable silk 1
Body reticular structure, structure include upper disk surface 3, lower disk 5 and waist connecting the two 4, which is characterized in that the reticular structure
Closing at be located at lower 5 bottom surface of disk, melted by the degradable silk at the position and form clinkering tail end 6;Upper disk surface 3, waist 4,
Lower disk 5 is sewed with the degradable choked flow film 2 of multilayer by degradable suture;In degradable plugging device transmission process, clinkering tail end 6
It is connected with driving means, realizes conveying of the degradable plugging device to defect location.Two free ends of safety rope are from upper disk surface 3
On any two at from top to bottom penetrate and pass through waist 4 after, be pierced by from lower disk 5.
The top surface of upper disk surface 3 is plane;Upper disk surface 3, the maximum gauge of lower disk 5 are identical, and are all larger than the minimum of waist 4
Diameter.6 indent of welding tail end is inside lower disk 5.
The degradable silk uses amorphous polylactic acid, l-lactic acid, dextrorotation polylactic acid, polydioxanone, gathers
Caprolactone, polyglycolic acid PGA or poly lactide-glycolide acid.
The material of the degradable choked flow film 2 or degradable suture is polydioxanone, polycaprolactone, polyethanol
Any one in acid, poly lactide-glycolide acid or amorphous polylactic acid, l-lactic acid and dextrorotation polylactic acid or two kinds
Above blend;The structure of degradable choked flow film 2 be spunlace non-woven cloth, needle punched non-woven fabrics, spun-bonded non-woven fabrics, heat seal non-woven fabrics,
Wet nonwoven fabrics or electrospun fibers film;The number of plies of degradable choked flow film 2 is 2~6 layers.
The contact surface of the clinkering tail end 6 and driving means is equipped with screw thread.
The material of the safety rope is amorphous polylactic acid PDLLA, l-lactic acid PLLA, dextrorotation polylactic acid PDLA, gathers
Lanthanum Isopropoxide PDO, polycaprolactone (PCL), polyglycolic acid PGA, poly lactide-glycolide acid PLGA, terylene PET, brocade
Synthetic fibre PA or polytetrafluoroethylene PTFE.
Embodiment 2
The present embodiment difference from example 1 is that, the top surface of upper disk surface 3 is the arc surface of protrusion;Upper disk surface 3
Maximum gauge is less than or equal to lower disk 5, and is both greater than the minimum diameter of waist 4.Welding tail end 6 is from the bottom of lower disk 5
Portion's protrusion.
Embodiment 3
The present embodiment difference from example 1 is that, the top surface of upper disk surface 3 is the truncated cone-shaped that top surface is plane, on
The surrounding of disk 3, which extends downwardly, surrounds waist 4;The maximum gauge of upper disk surface 3 is bigger than lower disk 5, and is both greater than waist 4
Minimum diameter.Welding tail end 6 is protruded from the bottom of lower disk 5, and the surrounding of lower disk 5 equally extends downwardly.
Embodiment 4
The present embodiment difference from example 1 is that, the maximum gauge of upper disk surface 3 is bigger than lower disk 5, and lower disk
5 diameter is identical as the diameter of waist 4, i.e., lower part is at tubular.
Embodiment 5
The present embodiment difference from example 1 is that, since to weave rule different for tubular reticulum, so 3 net of upper disk surface
Shape is different.
Embodiment 6
The present embodiment and embodiment 2 the difference is that, since to weave rule different for tubular reticulum, so 3 net of upper disk surface
Shape is different.
Embodiment 7
The present embodiment and embodiment 3 the difference is that, since to weave rule different for tubular reticulum, so 3 net of upper disk surface
Shape is different.
Embodiment 8
The present embodiment and embodiment 4 the difference is that, since to weave rule different for tubular reticulum, so 3 net of upper disk surface
Shape is different.
Claims (10)
1. a kind of degradable plugging device, the integral network structure as made of degradable silk (1) braiding, structure includes upper disk surface
(3), lower disk (5) and waist connecting the two (4), which is characterized in that be located at lower disk (5) at the closing in of the reticular structure
Bottom surface is melted by the degradable silk at the position and forms clinkering tail end (6);Upper disk surface (3), waist (4), lower disk (5) pass through
Degradable suture is sewed with the degradable choked flow film (2) of multilayer;In degradable plugging device transmission process, clinkering tail end (6) and push
Device is connected;Two free ends of safety rope from top to bottom penetrate from any two on upper disk surface (3) and pass through waist (4)
Afterwards, it is pierced by from lower disk (5).
2. degradable plugging device as described in claim 1, which is characterized in that the top surface of the upper disk surface (3) is plane or convex
The structure that arc surface risen or both combines.
3. degradable plugging device as described in claim 1, which is characterized in that the maximum gauge of the upper disk surface (3) is greater than waist
The minimum diameter in portion (4);The maximum gauge of lower disk (5) is greater than or equal to the minimum diameter of waist (4).
4. degradable plugging device as described in claim 1, which is characterized in that welding tail end (6) indent is in lower disk (5)
Inside is protruded from the bottom of lower disk (5).
5. degradable plugging device as described in claim 1, which is characterized in that the degradable silk using amorphous polylactic acid,
L-lactic acid, dextrorotation polylactic acid, polydioxanone, polycaprolactone, polyglycolic acid PGA or poly lactic-co-glycolic acid are total
Polymers.
6. degradable plugging device as described in claim 1, which is characterized in that the degradable choked flow film (2) or degradable seam
The material of line is polydioxanone, polycaprolactone, polyglycolic acid, poly lactide-glycolide acid or amorphous poly- cream
Any one in acid, l-lactic acid and dextrorotation polylactic acid or two or more blends;The structure of degradable choked flow film (2) is water
Prick nonwoven cloth, needle punched non-woven fabrics, spun-bonded non-woven fabrics, heat seal non-woven fabrics, wet nonwoven fabrics or electrospun fibers film;Degradable resistance
The number of plies for flowing film (2) is 2~6 layers.
7. degradable plugging device as described in claim 1, which is characterized in that the clinkering tail end (6) connects with driving means
Contacting surface is equipped with lines.
8. degradable plugging device as claimed in claim 7, which is characterized in that the lines is that lines described in screw thread is screw thread
Shape, wavy or fish scale-shaped.
9. degradable plugging device as described in claim 1, which is characterized in that the material of the safety rope is amorphous polylactic acid
PDLLA, l-lactic acid PLLA, dextrorotation polylactic acid PDLA, polydioxanone PDO, polycaprolactone (PCL), polyglycolic acid
PGA, poly lactide-glycolide acid PLGA, terylene PET, polyamide fibre PA or polytetrafluoroethylene PTFE.
10. a kind of preparation method of degradable plugging device described in any one of claim 1-9, which is characterized in that will be by can
The tubular reticulum that degradation silk is woven into, one end carry out necking with degradable silk or degradable silk are woven into smooth reticular structure,
One end is the tubular reticulum of opening;One end of opening is fastened with copper wire, and regular length is 1~5mm, opens heating device, only
Continuous heating is carried out to the degradable silk of copper wire wound section, heating temperature is 110~250 DEG C, and heating time is 1~15s, directly
Degradable silk melting into copper wire, while the degradable silk other than copper wire winding is not destroyed again;Copper wire is removed, is formed
Clinkering tail end (6), the lines which has;Shaper is fitted into the tubular reticulum with clinkering tail end (6),
Heat treatment shaping is carried out, setting temperature is 50~100 DEG C, and setting time is 10~100min;Mold is removed, degradable envelope is obtained
Stifled device bracket;Degradable choked flow film (2) is filled into degradable plugging device bracket and forms upper disk surface (3), lower disk (5) and waist
Portion (4), it is with degradable suture that degradable choked flow film (2) is fixed;Finally, by two free ends of safety rope from upper disk surface (3)
On any two at from top to bottom penetrate and pass through waist (4) after, be pierced by from lower disk (5).
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CN201921282181.6U Active CN211155935U (en) | 2019-08-01 | 2019-08-06 | Degradable plugging device |
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CN112932589A (en) * | 2021-02-01 | 2021-06-11 | 上海锦葵医疗器械股份有限公司 | Patent heart artery duct plugging device with two smooth end surfaces and manufacturing method thereof |
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CN112932562B (en) * | 2021-02-01 | 2022-06-28 | 上海锦葵医疗器械股份有限公司 | Heart atrial septal defect occluder with flat two end surfaces and manufacturing method thereof |
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CN114559642A (en) * | 2022-02-28 | 2022-05-31 | 上海形状记忆合金材料有限公司 | Preparation method and preparation device for closing end of plugging device |
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