CN203677142U - Double umbrella type self-expansion absorbable amplatzer occluder - Google Patents
Double umbrella type self-expansion absorbable amplatzer occluder Download PDFInfo
- Publication number
- CN203677142U CN203677142U CN201320851393.8U CN201320851393U CN203677142U CN 203677142 U CN203677142 U CN 203677142U CN 201320851393 U CN201320851393 U CN 201320851393U CN 203677142 U CN203677142 U CN 203677142U
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- Prior art keywords
- umbrella
- absorbable
- frames
- stopper
- skeletons
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
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- 229910000861 Mg alloy Inorganic materials 0.000 claims abstract description 7
- 241000283690 Bos taurus Species 0.000 claims description 6
- 210000003516 pericardium Anatomy 0.000 claims description 6
- 239000000956 alloy Substances 0.000 claims description 4
- 238000009432 framing Methods 0.000 claims description 4
- 208000028831 congenital heart disease Diseases 0.000 abstract description 8
- 208000002330 Congenital Heart Defects Diseases 0.000 abstract description 6
- 230000007547 defect Effects 0.000 abstract description 6
- 210000001124 body fluid Anatomy 0.000 abstract description 2
- 239000010839 body fluid Substances 0.000 abstract description 2
- 239000004744 fabric Substances 0.000 abstract 3
- 230000000694 effects Effects 0.000 description 7
- 208000035478 Interatrial communication Diseases 0.000 description 5
- 208000013914 atrial heart septal defect Diseases 0.000 description 5
- 206010003664 atrial septal defect Diseases 0.000 description 5
- 238000001727 in vivo Methods 0.000 description 5
- 208000008883 Patent Foramen Ovale Diseases 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 230000003387 muscular Effects 0.000 description 3
- 102000012422 Collagen Type I Human genes 0.000 description 2
- 108010022452 Collagen Type I Proteins 0.000 description 2
- PXHVJJICTQNCMI-UHFFFAOYSA-N Nickel Chemical compound [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 description 2
- 208000001910 Ventricular Heart Septal Defects Diseases 0.000 description 2
- 239000000427 antigen Substances 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 230000015556 catabolic process Effects 0.000 description 2
- 230000008602 contraction Effects 0.000 description 2
- 238000004132 cross linking Methods 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 210000003725 endotheliocyte Anatomy 0.000 description 2
- 230000006870 function Effects 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 210000004877 mucosa Anatomy 0.000 description 2
- 229910001453 nickel ion Inorganic materials 0.000 description 2
- 229910001000 nickel titanium Inorganic materials 0.000 description 2
- 229920000728 polyester Polymers 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 201000003130 ventricular septal defect Diseases 0.000 description 2
- 206010003671 Atrioventricular Block Diseases 0.000 description 1
- 102000008186 Collagen Human genes 0.000 description 1
- 108010035532 Collagen Proteins 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- JLVVSXFLKOJNIY-UHFFFAOYSA-N Magnesium ion Chemical compound [Mg+2] JLVVSXFLKOJNIY-UHFFFAOYSA-N 0.000 description 1
- 230000009056 active transport Effects 0.000 description 1
- 229910045601 alloy Inorganic materials 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 229920001436 collagen Polymers 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 230000000593 degrading effect Effects 0.000 description 1
- 238000011982 device technology Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- 230000037149 energy metabolism Effects 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 238000002695 general anesthesia Methods 0.000 description 1
- 210000004013 groin Anatomy 0.000 description 1
- 230000036039 immunity Effects 0.000 description 1
- 210000004971 interatrial septum Anatomy 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 229910001425 magnesium ion Inorganic materials 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 210000004379 membrane Anatomy 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 231100000241 scar Toxicity 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
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Abstract
The utility model relates to a double umbrella-type self-expansion absorbable amplatzer occluder. The double umbrella type self-expansion absorbable amplatzer occluder comprises double umbrella-type frames, a middle shaft and two umbrella skirts, every umbrella fabric of the double umbrella frame is composed of a plurality of frames of the same length, the frames are respectively and movably connected with the middle shaft in a diverging mode to enable the umbrella fabrics to be folded or expanded; the umbrella skirts is fixed onto the double umbrella frames through absorbable sutures. According to the double umbrella-type self-expansion absorbable amplatzer occluder, when the amplatzer occluder is fully spread, the double umbrella fabric is in radian and can cover defect areas on different planes; due to a relative large number of frames, the frames can better support the umbrella skirts to fully spread, folding and shrinking of corners of the umbrella skirt can be avoided, and the amplatzer occluder can be applied to a congenital heart disease with relatively large defects. Due to the facts that frames of the amplatzer occluder are made of degradable medical absorbable magnesium alloy and umbrella skirts are made of degradable bovinepericardium, and the medical absorbable magnesium alloy and the bovinepericardium can gradually degrade under the action of body fluid, so that other complications can be avoided.
Description
Technical field
This utility model belongs to medical device technology, is specifically related to a kind of two umbrella shaped self-dilatation formula and can absorbs stopper.
Background technology
Congenital heart disease, mainly comprises atrial septal defect (ASD), ventricular septal defect (VSD) and patent foramen ovale (PFO).In the defective disease of China birth, congenital heart disease occupies first place, approximately has 13~150,000 newly-increased infant every year, approximately has at present more than 200 ten thousand patients with congenital heart etc. to be treated.
The clinical treatment of congenital heart disease, mainly contains surgical operation therapy and two kinds of methods of Surgery under extracorporeal circulation.Surgical operation needs patient to carry out under general anesthesia, low temperature, extracorporeal circulation, and sharp ache after operation in patients recovers slow, and skin scar is obvious; Heart intervention treating only need insert conduit at patient's groin intravenous, and stopper is placed on to heart defect position by conduit, reaches plugging effect.
At present using clinically maximum stoppers, is the plugging device take Amplatzer as representative, and its skeleton is by memory metal---nitinol alloy wire weaves the self-expansion type double disk structure forming, and sews up three layers of polyester sheet between double plate.When use, stopper is placed in conduit and is folded into line style, is transported to patient's heart defect by conduit, and after taking out, stopper self-expanding reverts to two disk-like structures, and double plate is clipped in the middle defect, reaches plugging effect.After one month, the endotheliocyte stopper surface of growing into, after three months, endotheliocyte covers completely, can reach the effect of complete shutoff, and now stopper has completed plugging action.But because Nitinol cannot be degraded in vivo, under the long term of body fluid, can slowly discharge nickel ion, cause blood samples of patients nickel ion concentration higher so that slowly corrode cardiac muscular tissue, patient healthy caused to very large impact; And stopper long-term existence in heart can affect the normal Atrioventricular Conduction of patient's heart, when serious, can cause atrioventricular block, even need to use all the life cardiac pacemaker.In addition, the double disk structure of Amplatzer stopper is in the same plane, is only applicable to damaged congenital heart disease at grade, has greatly dwindled its clinical scope of application.
The biodegradable BioSTAR atrial septal defect plugging device that NMT medical science company uses the polyester fiber film on the alternative stopper of the acellular type i collagen matrix membrane surface that derives from porcine mucosa lower floor to make, its collagen-based plasma membrane can be absorbed by autologous tissue in vivo and substitute, and has advantages of the stopper of minimizing thrombogenicity and improve biocompatibility.This stopper has still retained the stainless steel frame of traditional stopper, therefore can not be degradable.Because the mechanical property of acellular porcine mucosa lower floor is limited, add that this stopper only has 4 support frames, between the chamber that can bear, pressure is less, therefore BioSTAR stopper is only applicable to the interventional therapy of damaged little atrial septal defect and patent foramen ovale.
Utility model content
The defect existing for prior art, the purpose of this utility model is to provide a kind of two umbrella shaped self-dilatation formula can absorb stopper, solve stopper in vivo completely after endothelialization because of the material harmful components that produce of not degrading or degrade, and produce the problem of various complication.
Two umbrella shaped self-dilatation formulas of this utility model can absorb stopper, are made up of two umbrella skeletons, axis and two full skirts.Each umbrella cover of two umbrella skeletons is made up of many skeletons equal in length, and skeleton is divergent shape and links with axis is movable respectively, can make umbrella closing or expansion; Full skirt is fixed on two umbrella skeletons by absorbable suture.
Described full skirt, derives from bovine pericardium, through de-cell, de-antigen, crosslinking Treatment;
The described pair of umbrella skeleton and axis, be Medical absorbable magnesium alloy materials;
Described skeleton equal in length is 6~12; Each skeleton has 2 place's spring-like structures, and the spring-like structure of every place skeleton is located at apart from axis same distance place, and first place's spring-like structure is apart from axis 1~3mm; Whole framing structure collapsible and launch, there is self-expanding function.
This utility model compared with prior art, is characterized in:
1, the skeleton of the stopper of this utility model adopts Medical absorbable magnesium alloy, and full skirt adopts bovine pericardium, is degradation material.Wherein, the catabolite magnesium ion of magnesium alloy is essential a kind of important macroelement in human body, its participate in energy metabolism, macromolecular substances synthetic and metabolism, hereditary information transmission and expression, material Active transport and maintain the various activities such as electrolyte balance, can not cause any toxic action; The type i collagen albumen producing after bovine pericardium degraded can not cause human immunity rejection yet.Therefore, this utility model stopper completes after endothelialization in vivo gradually, through humoral effect meeting slow degradation, can not cause other complication.
2, the stopper of this utility model, there are two umbrella skeletons of spring-like structure, each root skeleton can present different stretching in plane separately, in the time that two umbrella cover full extension of stopper are opened, two umbrella covers have radian, can cover not defect area at grade, the clinical scope of application is more extensive.
3, the stopper of this utility model, skeleton quantity is more, can support better full skirt and launch completely, avoids occurring under moistening in vivo environment the situation such as folding, shrinkage of full skirt edge, guarantees clinical heart plugging effect; In addition, skeleton quantity is more can disperse pressure between chamber more; And the bovine pericardium that this utility model uses also has good mechanical property, can bear pressure between the chamber of defect, so this utility model stopper can be used for large damaged congenital heart disease.
Accompanying drawing explanation
Fig. 1 is that 1 pair of umbrella shaped self-dilatation formula of embodiment can absorb the front schematic view after stopper launches;
Fig. 2 is that 1 pair of umbrella shaped self-dilatation formula of embodiment can absorb the side schematic view after stopper launches;
Fig. 3 is the schematic diagram that 2 pairs of umbrella shaped self-dilatation formulas of embodiment can absorb stopper contraction state;
Fig. 4 is that 3 pairs of umbrella shaped self-dilatation formulas of embodiment can absorb the front schematic view after stopper launches;
Fig. 5 is that 3 pairs of umbrella shaped self-dilatation formulas of embodiment can absorb the side schematic view after stopper launches.
In figure: 1, full skirt; 2, two umbrella skeletons; 3, the spring structure of skeleton; 4, axis.
The specific embodiment
Below in conjunction with accompanying drawing and three embodiment, the utility model is described in further detail.
Fig. 1,2 have shown that shape and the structure of the stopper of the present embodiment: Fig. 1 is stopper front shape structure, skeleton 2 is arranged and is formed a regular hexagon with 60 ° of angles; Fig. 2 is the shape and structure figure of stopper side structure.
The stopper of this embodiment, formed by two umbrella skeletons 2, axis 4 and two full skirts 1, each umbrella cover of two umbrella skeletons 2 is made up of 6 two umbrella skeletons 2 equal in length, and skeleton 2 is divergent shape and combines in the mode of activity link with axis 4 respectively, can make umbrella closing or open; Two umbrella skeletons 2 and axis 4 are Medical absorbable magnesium alloy materials; Full skirt 1 is fixed on two umbrella skeletons 2 by 2-0 absorbable suture;
Described 6 skeletons equal in length, apart from axis same distance place, have spring-like structure 3, and first spring-like structure is apart from axis 2mm.Whole framing structure collapsible and launch, there is self-expanding function;
Described full skirt 1, derives from bovine pericardium, through de-cell, de-antigen, crosslinking Treatment.
The axis 4 of the present embodiment is longer, and skeleton 2 apart from each others of two umbrellas can be not interlaced after contraction.Because muscular part of interventricular septum Musclar layer is thicker, to be therefore applicable to muscular part of interventricular septum damaged for this example stopper.
Fig. 3 is that the framing structure of embodiment 2 is shunk schematic diagram.Example 2 is with the difference of example 1, and the axis 4 of this example stopper is shorter, interlaced after two umbrella skeletons 2 shrink.Due to interatrial septum and membranous part of interventricular septum thinner, therefore this example stopper is applicable to atrial septal defect and membranous part of interventricular septum is damaged.
Fig. 4, Fig. 5 is front and the side structure schematic diagram of embodiment 3.Be with example 1 difference, this example adopts 8 skeletons to arrange and form an octagon with 45 ° of angles, two umbrella skeletons 2 are not because stressed the make umbrella covers of this example stopper different from other 6 skeletons are in same plane, as Fig. 5, thereby stopper is applicable at grade damaged not, expands the clinical applicability of stopper.
Claims (4)
1. pair umbrella shaped self-dilatation formula can absorb stopper, it is characterized in that: formed by two umbrella skeletons (2), axis (4) and two full skirts (1), each umbrella cover of two umbrella skeletons (2) is made up of many skeletons equal in length (2), skeleton (2) is divergent shape and links with axis (4) is movable respectively, can make umbrella closing or expansion; Full skirt (1) is fixed on two umbrella skeletons (2) by absorbable suture.
2. can absorb according to claim 1 stopper, it is characterized in that: described many skeletons equal in length (2), mean 6~12 skeletons; Each skeleton, apart from axis (4) same distance place, is equipped with spring-like structure (3), and first place's spring-like structure is apart from axis 1~3mm; Whole framing structure collapsible and launch.
3. can absorb according to claim 1 stopper, it is characterized in that: two umbrella skeletons (2) and axis (4), be Medical absorbable magnesium alloy materials.
4. can absorb according to claim 1 stopper, it is characterized in that: described full skirt (1), adopts bovine pericardium to make.
Priority Applications (1)
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CN201320851393.8U CN203677142U (en) | 2013-12-20 | 2013-12-20 | Double umbrella type self-expansion absorbable amplatzer occluder |
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CN201320851393.8U CN203677142U (en) | 2013-12-20 | 2013-12-20 | Double umbrella type self-expansion absorbable amplatzer occluder |
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CN203677142U true CN203677142U (en) | 2014-07-02 |
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CN201320851393.8U Expired - Lifetime CN203677142U (en) | 2013-12-20 | 2013-12-20 | Double umbrella type self-expansion absorbable amplatzer occluder |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106491167A (en) * | 2015-09-07 | 2017-03-15 | 先健科技(深圳)有限公司 | Absorbable plugging device |
CN107049373A (en) * | 2017-02-08 | 2017-08-18 | 宁波迪创医疗科技有限公司 | Plugging device |
CN107174321A (en) * | 2017-06-23 | 2017-09-19 | 西安美佳家医疗科技有限责任公司 | A kind of anti-sticking connected device for entering uterine cavity Automatic-expanding by opening of the cervix |
CN108420469A (en) * | 2018-03-16 | 2018-08-21 | 上海形状记忆合金材料有限公司 | A kind of Wholly-degradable plugging device skeleton structure |
CN110251182A (en) * | 2019-06-14 | 2019-09-20 | 凯斯蒂南京医疗器械有限公司 | A kind of umbellate form tissue plug |
WO2023027875A1 (en) * | 2021-08-26 | 2023-03-02 | Edwards Lifesciences Corporation | Defect occluder with wrapping cover |
-
2013
- 2013-12-20 CN CN201320851393.8U patent/CN203677142U/en not_active Expired - Lifetime
Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106491167A (en) * | 2015-09-07 | 2017-03-15 | 先健科技(深圳)有限公司 | Absorbable plugging device |
WO2017041554A1 (en) * | 2015-09-07 | 2017-03-16 | 先健科技(深圳)有限公司 | Absorbable occluder |
US10799245B2 (en) | 2015-09-07 | 2020-10-13 | Lifetech Scientific (Shenzhen) Co. Ltd. | Absorbable occluder |
CN107049373A (en) * | 2017-02-08 | 2017-08-18 | 宁波迪创医疗科技有限公司 | Plugging device |
CN107049373B (en) * | 2017-02-08 | 2023-09-26 | 宁波迪创医疗科技有限公司 | Plugging device |
CN107174321A (en) * | 2017-06-23 | 2017-09-19 | 西安美佳家医疗科技有限责任公司 | A kind of anti-sticking connected device for entering uterine cavity Automatic-expanding by opening of the cervix |
CN108420469A (en) * | 2018-03-16 | 2018-08-21 | 上海形状记忆合金材料有限公司 | A kind of Wholly-degradable plugging device skeleton structure |
CN110251182A (en) * | 2019-06-14 | 2019-09-20 | 凯斯蒂南京医疗器械有限公司 | A kind of umbellate form tissue plug |
WO2023027875A1 (en) * | 2021-08-26 | 2023-03-02 | Edwards Lifesciences Corporation | Defect occluder with wrapping cover |
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C14 | Grant of patent or utility model | ||
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CX01 | Expiry of patent term |
Granted publication date: 20140702 |
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CX01 | Expiry of patent term |