CN110432935A - Degradable plugging device and preparation method thereof - Google Patents

Degradable plugging device and preparation method thereof Download PDF

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Publication number
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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China
Prior art keywords
degradable
plugging device
silk
tail end
clinkering
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CN201910721466.3A
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Chinese (zh)
Inventor
耿聪颖
曾凡艳
杨永森
丁正
陈娟
蒲忠杰
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Shanghai Shape Memory Alloy Material Co Ltd
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Shanghai Shape Memory Alloy Material Co Ltd
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Publication of CN110432935A publication Critical patent/CN110432935A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004(bio)absorbable, (bio)resorbable or resorptive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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
    • A61B2017/00597Implements comprising a membrane
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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
    • A61B2017/00601Implements entirely comprised between the two sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00575Implements 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
    • A61B2017/00606Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements 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
    • A61B2017/00646Type of implements
    • A61B2017/00654Type of implements entirely comprised between the two sides of the opening

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  • 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

Degradable plugging device and preparation method thereof
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).
CN201910721466.3A 2019-08-01 2019-08-06 Degradable plugging device and preparation method thereof Pending CN110432935A (en)

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CN111110288A (en) * 2020-01-14 2020-05-08 赵天力 Ventricular septal defect occluder and preparation method thereof
CN112773419A (en) * 2020-12-31 2021-05-11 上海锦葵医疗器械股份有限公司 Heart patent foramen ovale plugging device with flat two end surfaces and manufacturing method thereof
CN112773418A (en) * 2020-12-31 2021-05-11 上海锦葵医疗器械股份有限公司 Degradable heart foramen ovale closure device and manufacturing method thereof
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
CN112932567A (en) * 2021-03-15 2021-06-11 上海捍宇医疗科技股份有限公司 Plugging device
CN112932562A (en) * 2021-02-01 2021-06-11 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
CN113208685A (en) * 2020-02-05 2021-08-06 江苏暖阳医疗器械有限公司 Degradable braided body system for embolizing aneurysm
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WO2022252463A1 (en) * 2021-06-03 2022-12-08 上海形状记忆合金材料有限公司 Implantable instrument having vertical double-concave structure
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CN205322380U (en) * 2015-12-31 2016-06-22 上海锦葵医疗器械有限公司 Degradable heart ventricular septal defect plugging device
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