CN101642397B - Netty circular tube type intravascular stent - Google Patents

Netty circular tube type intravascular stent Download PDF

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Publication number
CN101642397B
CN101642397B CN2009100419781A CN200910041978A CN101642397B CN 101642397 B CN101642397 B CN 101642397B CN 2009100419781 A CN2009100419781 A CN 2009100419781A CN 200910041978 A CN200910041978 A CN 200910041978A CN 101642397 B CN101642397 B CN 101642397B
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support
circumambient
connecting rod
tube type
grid cell
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CN2009100419781A
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CN101642397A (en
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劳永华
黄岳山
支晓兴
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South China University of Technology SCUT
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South China University of Technology SCUT
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Abstract

The invention discloses a netty circular tube type intravascular stent comprising three to six circumambient rings distributed axially, wherein two adjacent circumambient rings are connected by a plurality of connecting rods; each circumambient ring comprises two grid unit groups of mirror symmetry; the grid unit groups in the rings are connected by a plurality of short straight rods; the grid unit groups are formed by uniformly distributing and arranging eight to twelve grid units in the circumambiency; each grid unit is formed by the circumambient sides of connecting open girders and closed girders in series; each serial connecting port is a semicircular arc; the connecting rods are connected with the top ends of the semicircular arcs of the closed girders in the adjacent circumambient rings and the short straight rods are connected with the top end of each semicircular arc of two different grid unit groups in the same circumambient ring. The stent has the advantages of good mechanical extension property, supporting property and axial flexibility and the like and reduces the reangiostenosis rate. After the stent is expanded, the wall surface of a blood vessel is supported and the stent can avoid damaging the wall of the blood vessel due to overlarge contact stress.

Description

A kind of netty circular tube type intravascular stent
Technical field
The present invention relates to a kind of medical apparatus and instruments, particularly a kind of endovascular stent that is applicable to human vas interventional therapy, expansion and support narrow blood vessel belongs to the technical field that medical device is made.
Background technology
" the global disease burden in 2004 " of World Health Organization's issue shows, cardiovascular disease is the main cause of death in the whole world, the global patient who dies from ischemic heart desease had 7,200,000 approximately in 2004, accounted for 12.2% of general mortality rate, was in first in 20 common mortality rate diseases.Ministry of Health of China is analyzed Chinese city resident principal disease mortality rate in 2007 and is constituted and show that the heart disease mortality rate is 16.29% in " Chinese health statistics yearbook in 2008 ", only arrange after malignant tumor and cerebrovascular disease the 3rd.Cardiovascular death rate and disability rate are higher mainly contains ischemic heart desease and arteria coronaria thromboembolism; Cardiovascular disease needs daily life customs such as good diet, motion to go prevention, but the patient of ischemic heart desease, arteria coronaria thromboembolism etc. then needs cardiovascular surgery or support intervene operation to treat timely.
The interventional therapy that operation on vessels of heart is implanted based on endovascular stent.Stent is on percutaneous puncture transluminal coronary angioplasty art basis, by conduit support is delivered to lesion, and makes its expansion back play the mechanics supporting role to blood vessel.Endovascular stent can prevent postoperative acute obturation effectively, and has reduced the incidence rate of restenosis.Current, endovascular stent mainly contains the bracket for eluting medicament that naked metal rack that rustless steel, titanium and titanium alloy, Nitinol, tantalum alloy etc. make and high molecular polymer substrate are made.In the extensive use clinically, some drawbacks of existing endovascular stent display, form thrombosis in the support and cause vascular restenosis, except patient self and pathological changes reason, mainly have many technical problems, as the support expansion bad, adherent bad, that support is overlapping, support subsides, support is implanted the too small and material biocompatibility of the last tube chamber in back is bad etc.
Endovascular stent implantation process and its support the many abrim complicated factors that are difficult to predict of process at the narrow blood vessel intramedullary expansion, can run into the contact of many tissues and the coupling of blood flow or the like mechanics problem.Therefore, ideal support should possess following characteristic: have the resilience force of enough intensity with the opposing arterial wall; After-poppet length is constant or cripetura is very little discharging, and is beneficial to accurate release; Axially pliability is good, can pass through curved blood vessel; Higher spreading rate; Release conditions do not have less gabarit, are beneficial to by highly narrow diseased region; Side shoot trafficability characteristic and adherent property are good; It is as far as possible little to the damage of blood vessel wall to discharge the back; Endurance etc.But because the limitation on the present supporting structure, function is difficult to reach effective consistent aspect radial support intensity and axial flexibility two, and some support also exists, and spreading performance is unexcellent to be caused the failure of support implantation surgery, rack surface deposition thrombosis to produce support implanting back vascular restenosis phenomenon or the like many defectives.
The inductive method of being said in the existing document can with intravascular stent total be divided into two classes, winding-type (coil) support and webmaster formula (mesh) support.As the term suggests the former is the intravascular stent for twining, and the webmaster cribbing is to adopt the technology of laser engraving to finish on a tensile tubular material to be processed to form surface clocklike repeated unit grid pattern feature.In the webmaster cribbing, can be divided three classes substantially:
(1) closed cell: closely arrange by the bar beam, surround simple enclosed type geometry continuously.The wave design decision of coupling part the overall compliance of induction system, closed design provides full unit to prevent that tampon, tissue etc. come off, however this design can not provide enough compliance to guarantee trafficability characteristic.Though but the support radial dilatation, but in view of the bar beam of firmly arranging, the scope of expansion is not very big, and bigger limitation is arranged.
(2) open cell: generally constitute, or adopt structural design in a zigzag, and, increased unitary size thereby reduce junction point in order to increase the compliance in the design by horizontal and vertical bent stick beam.When being placed on tortuous blood vessel, open cell design can't provide enough metal coverage rates (defective on the framework), but the opposite side branch vessel is useful.Comparing open support with closed type may be slightly more inferior on support performance, all is better than the closed type support in anti-fracture expanding ability with crooked flexibility.
(3) also have closed type and the open design that unites two into one.The disclosed supporting structure of U.S. Pat 20060003201 A1 forms by the waveform rod member with than short N connecting rod, it between the waveform rod member closed type, the N connecting rod then provides open compliance, but this technology lacks the analysis of support being supported mechanical property in process of expansion, and support tends to occur supporting structure expansion unstability and rod member fracture or the like mechanics problem in the intravital process of implant into body.
Summary of the invention
The object of the present invention is to provide a kind of have good rack surface blood flow, spreading performance, radial support intensity and axial flexibility, the endovascular stent of netty circular tube type structure.
Purpose of the present invention is achieved through the following technical solutions:
A kind of netty circular tube type intravascular stent: endovascular stent is made of 3~6 circumferential ring that distribute vertically, connects by a plurality of connecting rods between every two adjacent circumferential ring; Each circumferential ring includes two symmetric grid cell groups of mirror image, connect by a plurality of short straight rods between the grid cell group in the ring, the grid cell group is arranged by 8-12 the circumferential uniform distribution of grid cell and is formed, each grid cell is connected in series with the circumferential side of beam of remaining silent by the opening beam and forms, and serial interface is a semi arch; Connecting rod connects the circular arc top of the beam of remaining silent in the adjacent circumferential ring; Short straight rod connects half and half circular arc top of different two grid cell groups in the same circumferential ring.
For further realizing the object of the invention, described connecting rod is preferably M type connecting rod or S type connecting rod.
Described short straight rod is preferably 1: 2 with connecting rod length ratio~and 1: 4.
The described beam turning circular arc of remaining silent is preferably 200 °~260 °, and side series connection semi arch is preferably 180 °, and opening beam turning circular arc is preferably 100 °~160 °.
The width of described short straight rod and connecting rod is preferably the opening beam or the beam width of remaining silent 1.2~2 times.
Compare with existing endovascular stent, the present invention has following advantage:
(1) unit grid of support is connected in series by the opening beam and the circumferential side of beam of remaining silent and forms, its split shed beam has good radial support performance, the beam of remaining silent then has good expanding ability, and both combine can provide the good mechanical performance to the expansion and the support process of support.
(2) mutual direct-connected extension bar of weak point and mutual S connecting rod or the M connecting rod of circumferential ring of unit grid is used alternatingly, and can be convenient to be transferred by curved blood vessel and branch vessel place so that support has good axial compliance.
(3) bar of supporting structure, the design of beam spare trapezoid cross section, the adherent property on trapezoidal long limit, support cross section is good, and it is very small and weak to the stress damage of blood vessel wall that support discharges the back; In addition, the hemodynamic situation of rack surface is good, and the no blood dead band is that thrombosis can not be deposited on the rack surface corner because of entering the dead band in the blood.Therefore, the impaired or thrombosis of blood vessel wall deposition can be avoided and the vascular restenosis phenomenon that causes in the trapezoid cross section of supporting structure.
Description of drawings
Fig. 1 is the expansion sketch map of the embodiment of the invention 1 endovascular stent cylindraceous.
Fig. 2 is the expansion sketch map of the embodiment of the invention 2 endovascular stents cylindraceous.
Fig. 3 is that Figure 1A-A is to cutaway view.
The specific embodiment
The invention will be further described below in conjunction with drawings and Examples, but the scope of protection of present invention is not limited to the scope that embodiment represents.
Embodiment 1
A kind of netty circular tube type intravascular stent carries out laser engraving by AZ31 Mg alloy thin wall pipe and forms, the magnesium alloy materials of support pattern structure grid gap is removed by cut, pipe need cut the position circumference radial direction of removing and become 56.3 ° with the laser beam vertical direction, forms the netty circular tube type structure at last.Fig. 1 is the planar development sketch map of this netty circular tube type intravascular stent, and as shown in Figure 1, endovascular stent is made of 4 circumferential ring 1 that distribute vertically, connects by a plurality of M type connecting rods 8 between every two adjacent circumferential ring 1.Each circumferential ring 1 includes two symmetric grid cell groups 2 of mirror image, connect by a plurality of short straight rods 3 between the grid cell group in the ring, grid cell group 2 is arranged by the circumferential uniform distribution of 8 grid cells 4 and is formed, and the number of grid cell 4 can be extended arbitrarily, presses the clinical user demand of support and decides.Each grid cell 4 is connected in series with the beam 6 circumferential sides of remaining silent by opening beam 5 and forms, and serial interface is a semi arch 7.M type connecting rod 8 connects the circular arc top of the beam 6 of remaining silent in the adjacent circumferential ring 1; Short straight rod 3 connects each semi arch 7 top of different two grid cell groups 2 in the same circumferential ring 1.
As shown in Figure 3, present embodiment is a balloon expandable formula magnesium alloy arteria coronaria endovascular stent, the bar beam of support was subjected to inflated loading effect when support was implanted, the stressed expansion of its cross section minor face (rack inner wall), the support inside radius increases to normal arteria coronaria vessel radius, be that the space increases between the cradling piece beam, and the bar beam also increase and flexural deformation with the support inside radius; The structural stability that the sacculus unloading is withdrawn after the interior after-poppet of body still keeps expanding supports dredging vascellum, this moment, the limit was grown in the cross section that acts on the cradling piece beam of blood vessel retraction force, and supporting structure is resisted the blood vessel retraction force by the deformation residual stress of its bar beam and the counter-bending ability after the deformation.Support inside radius 9 is 2.94mm, and wall thickness 10 is 0.1mm, and length overall is 17.4mm; The support cross section is trapezoidal, and outer perimeter limit 11 is 0.4mm, and interior all minor faces 12 are 0.1mm; Long limit, the cross section of short direct-connected extension bar 3 is that 0.6mm, minor face are 0.15mm, and length is 0.8mm; The length 0.96mm of M connecting rod 8, long limit, cross section is that 0.48mm, minor face are 0.12mm;
Each unit grid 4 entire length is 2mm, and spreading width is 2mm.Opening beam 5 turning circular arcs are 140 °, radius 0.367mm, the long 0.956mm of side; The beam 6 turning circular arcs of remaining silent are 220 °, radius 0.687mm, the long 1.011mm of side; Side series connection circular arc 7 is 180 °, radius 0.1mm.
The support trapezoid cross section of present embodiment support blood vessels and and blood flow be coupled limited elementary force admittedly when learning simulation, the result shows the no blood eddy region in surface, support trapezoid cross section, and the support square-section of other literature research the blood eddy region all occurs at edge, support trapezoid cross section structure can effectively be improved the velocity of blood flow of rack surface, avoids cell, biomacromolecule and embolus etc. in the eddy current deposition blood to form the probability of blood vessel wall speckle restenosis; The numerical computations experimental analysis is found in addition, and the inside local stress of support trapezoid cross section structure blood vessel wall to vessel wall support the time is less than the square-section, and this also reduces the degree of injury of support to the blood vessel wall.The support original metal coverage rate of present embodiment is 34.22% and expansion back metal coverage rate 8~15%, all less than 36.3% and 11.1~20% of Cordynamic Apolo support, foreign body stimulation to blood vessel reduces greatly, Cordynamic Apolo support also is a rustless steel sacculus expanding endovascular stent, its shape and structure is formed by the connection of beam side connecting rod by successive opening beam, is the commercial clinical product of Spain IBEERHOSPITX company.Support expansion back contraction in length<1% of present embodiment, edge effect coefficient (ratio of expansion displacement and two ends expansion displacement in the middle of the support) approaches 1, there is not " Dogbone " phenomenon, be that support two ends expansion deformation diameter is expanded the deformation diameter greater than support central authorities, can more efficiently expansion support blood vessels in other supports.
Embodiment 2
Referring to Fig. 2, a kind of netty circular tube type intravascular stent carries out laser engraving by AZ91 Mg alloy thin wall pipe and forms, the magnesium alloy materials of support pattern structure grid gap is removed by cut, pipe need cut the position circumference radial direction of removing and become 26.6 ° with the laser beam vertical direction, forms the netty circular tube type structure at last.Constitute by 6 circumferential ring 1 that distribute vertically, connect by S connecting rod 8 between every two adjacent circumferential ring 1.Each circumferential ring 1 includes two symmetric grid cell groups 2 of mirror image, connects between the grid cell group in the ring to be short straight rod 3.Grid cell group 2 is arranged by 12 grid cells, 4 circumferential uniform distribution and is formed, and the number of grid cell 4 is pressed the clinical user demand of support and decided.Each grid cell is connected in series with the beam 6 circumferential sides of remaining silent by opening beam 5 and forms, and serial interface is a semi arch 7.The link of S connecting rod 2 is the circular arc top of the beam 6 of remaining silent of adjacent circumferential ring, and the link of short straight rod 3 is intra-annular each semi arch 7 top of circumference.
Present embodiment is a balloon expandable formula magnesium alloy arteria coronaria endovascular stent, the bar beam of support was subjected to inflated loading effect when support was implanted, the stressed expansion of its cross section minor face (rack inner wall), the support inside radius increases to normal arteria coronaria vessel radius, be that the space increases between the cradling piece beam, and the bar beam also increase and flexural deformation with the support inside radius; The structural stability that the sacculus unloading is withdrawn after the interior after-poppet of body still keeps expanding supports dredging vascellum, this moment, the limit was grown in the cross section that acts on the cradling piece beam of blood vessel retraction force, and supporting structure is resisted the blood vessel retraction force by the deformation residual stress of its bar beam and the counter-bending ability after the deformation.Support inside radius 9 is 3.6mm, and wall thickness 10 is 0.1mm, and length overall is 35.55mm; The support cross section is trapezoidal, and beam outer perimeter limit 11 is 0.4mm, and interior all minor faces 12 are 0.2mm; Long limit, the cross section of short direct-connected extension bar 3 is that 0.8mm, minor face are 0.4mm, and length is 0.8mm; The length 1.04mm of S connecting rod 8, long limit, cross section is that 0.6mm, minor face are 0.3mm.
Each unit grid 4 entire length is 2mm, and spreading width is 2mm.Opening beam 5 turning circular arcs are 100 °, radius 0.176mm, the long 0.816mm of side; The beam 6 turning circular arcs of remaining silent are 260 °, radius 0.815mm, the long 0.679mm of side; Side series connection circular arc 7 is 180 °, radius 0.1mm.
The support trapezoid cross section of present embodiment support blood vessels and and blood flow be coupled limited elementary force admittedly when learning simulation, the result shows the no blood eddy region in surface, support trapezoid cross section, and the support square-section of other literature research the blood eddy region all occurs at edge, support trapezoid cross section structure can effectively be improved the velocity of blood flow of rack surface, avoids cell, biomacromolecule and embolus etc. in the eddy current deposition blood to form the probability of blood vessel wall speckle restenosis; The numerical computations experimental analysis is found in addition, and the inside local stress of support trapezoid cross section structure blood vessel wall to vessel wall support the time is less than the square-section, and this also reduces the degree of injury of support to the blood vessel wall.The support original metal coverage rate of present embodiment is 34.22% and expansion back metal coverage rate 8~15%, all less than 36.3% and 11.1~20% of Cordynamic Apolo support, the foreign body stimulation of blood vessel is reduced greatly.The support of present embodiment expansion back contraction in length<1%, edge effect coefficient (ratio of expansion displacement and two ends expansion displacement in the middle of the support) approaches 1, does not have " Dogbone " phenomenon, can more efficiently expansion support blood vessels in other supports.
Embodiment 3
A kind of netty circular tube type intravascular stent of present embodiment carries out laser engraving by AM60 Mg alloy thin wall pipe and forms, the magnesium alloy materials of support pattern structure grid gap is removed by cut, it is at 45 that pipe need cut position circumference radial direction and the laser beam vertical direction removed, forms the netty circular tube type structure at last.Constitute by 3 circumferential ring 1 that distribute vertically, connect by S connecting rod 8 between every two adjacent circumferential ring 1.Each circumferential ring 1 includes two symmetric grid cell groups 2 of mirror image, connects between the grid cell group in the ring to be short straight rod 3.Grid cell group 2 is arranged by 10 grid cells, 4 circumferential uniform distribution and is formed, and the number of grid cell 4 is pressed the clinical user demand of support and decided.Each grid cell is connected in series with the beam 6 circumferential sides of remaining silent by opening beam 5 and forms, and serial interface is a semi arch 7.The link of S connecting rod 2 is the circular arc top of the beam 6 of remaining silent of adjacent circumferential ring, and the link of short straight rod 3 is intra-annular each semi arch 7 top of circumference.
Present embodiment is a balloon expandable formula magnesium alloy arteria coronaria endovascular stent, the bar beam of support was subjected to inflated loading effect when support was implanted, the stressed expansion of its cross section minor face (rack inner wall), the support inside radius increases to normal arteria coronaria vessel radius, be that the space increases between the cradling piece beam, and the bar beam also increase and flexural deformation with the support inside radius; The structural stability that the sacculus unloading is withdrawn after the interior after-poppet of body still keeps expanding supports dredging vascellum, this moment, the limit was grown in the cross section that acts on the cradling piece beam of blood vessel retraction force, and supporting structure is resisted the blood vessel retraction force by the deformation residual stress of its bar beam and the counter-bending ability after the deformation.Support inside radius 9 is 3.287mm, and wall thickness 10 is 0.1mm, and length overall is 17.775mm; The support cross section is trapezoidal, and outer perimeter limit 11 is 0.3mm, and interior all minor faces 12 are 0.1mm; Long limit, the cross section of short direct-connected extension bar 3 is that 0.54mm, minor face are 0.18mm, and length is 0.8mm; The length 1.12mm of S connecting rod 8, long limit, cross section is that 0.42mm, minor face are 0.14mm.
Each unit grid 4 entire length is 2mm, and spreading width is 2mm.Opening beam 5 turning circular arcs are 100 °, radius 0.448mm, the long 1.379mm of side; The beam 6 turning circular arcs of remaining silent are 260 °, radius 0.424mm, the long 0.779mm of side; Side series connection circular arc 7 is 180 °, radius 0.1mm.
The support trapezoid cross section of present embodiment support blood vessels and and blood flow be coupled limited elementary force admittedly when learning simulation, the result shows the no blood eddy region in surface, support trapezoid cross section, and the support square-section of other literature research the blood eddy region all occurs at edge, support trapezoid cross section structure can effectively be improved the velocity of blood flow of rack surface, avoids cell, biomacromolecule and embolus etc. in the eddy current deposition blood to form the probability of blood vessel wall speckle restenosis; The numerical computations experimental analysis is found in addition, and the inside local stress of support trapezoid cross section structure blood vessel wall to vessel wall support the time is less than the square-section, and this also reduces the degree of injury of support to the blood vessel wall.The support original metal coverage rate of present embodiment is 32.6% and expansion back metal coverage rate 8~15%, all less than 36.3% and 11.1~20% of Cordynamic Apolo support, the foreign body stimulation of blood vessel is reduced greatly.The support of present embodiment expansion back contraction in length<1%, edge effect coefficient (ratio of expansion displacement and two ends expansion displacement in the middle of the support) approaches 1, does not have " Dogbone " phenomenon, can more efficiently expansion support blood vessels in other supports.
Endovascular stent of the present invention can be formed by metal tube or the erosion of macromolecular material pipe carving, and the material of metal tube removes above-mentioned magnesium alloy, also can be Nitinol, rustless steel, titanium alloy, simple metal tantalum or gold; The macromolecular material pipe can be acetone, poly-macromolecule degradation materials such as L-lactic acid.Wherein, adopting the present invention of Nitinol thin-wall circular tube carving erosion is the self-expanding cribbing, adopt rustless steel, titanium alloy, simple metal tantalum or gold, and the present invention of the thin-wall circular tube carving erosion made of acetone, poly-macromolecule degradation materials such as L-lactic acid is a balloon expandable stent, as long as the structure that adopts the present invention to describe all can realize the object of the invention.

Claims (5)

1. netty circular tube type intravascular stent is characterized in that: endovascular stent is made of 3~6 circumferential ring that distribute vertically, connects by a plurality of connecting rods between every two adjacent circumferential ring; Each circumferential ring includes two symmetric grid cell groups of mirror image, connect by a plurality of short straight rods between the grid cell group in the ring, the grid cell group is arranged by 8-12 the circumferential uniform distribution of grid cell and is formed, each grid cell is connected in series with the circumferential side of beam of remaining silent by the opening beam and forms, and serial interface is a semi arch; Connecting rod connects the circular arc top of the beam of remaining silent in the adjacent circumferential ring; Short straight rod connects half and half circular arc top of different two grid cell groups in the same circumferential ring.
2. netty circular tube type intravascular stent according to claim 1 is characterized in that: described connecting rod is M type connecting rod or S type connecting rod.
3. netty circular tube type intravascular stent according to claim 1 is characterized in that: described short straight rod is 1: 2~1: 4 with connecting rod length ratio.
4. netty circular tube type intravascular stent according to claim 1 is characterized in that: the described beam turning circular arc of remaining silent is 200 °~260 °, and side series connection semi arch is 180 °, and opening beam turning circular arc is 100 °~160 °.
5. netty circular tube type intravascular stent according to claim 1 is characterized in that: the width of described short straight rod and connecting rod is the opening beam or the beam width of remaining silent 1.2~2 times.
CN2009100419781A 2009-08-20 2009-08-20 Netty circular tube type intravascular stent Expired - Fee Related CN101642397B (en)

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CN102657564B (en) * 2012-05-10 2014-11-12 大连理工大学 Biodegradable vascular scaffold
CN108814780A (en) * 2015-02-16 2018-11-16 上海微创医疗器械(集团)有限公司 Biodegradable stent and preparation method thereof
CN105496604B (en) * 2016-01-22 2018-04-06 山东省千佛山医院 Heart coronary artery support
CN105559945A (en) * 2016-02-29 2016-05-11 微创心脉医疗科技(上海)有限公司 Covered stent and manufacturing method thereof
CN106618821B (en) * 2017-01-06 2018-03-20 青岛市第三人民医院 A kind of intravascular stent for preventing reangiostenosis and preparation method thereof
CN106580528A (en) * 2017-02-04 2017-04-26 成都鼎信致远科技有限公司 Coronary stent for preventing restenosis
CN108403256B (en) * 2018-03-14 2023-08-22 华南理工大学 Three-dimensional vector expansion cardiovascular stent with memory effect based on 4D printing and manufacturing method
CN109925056B (en) * 2019-04-09 2021-01-08 广州新脉科技有限公司 Method and device for implanting intracranial aneurysm virtual support
CN113274175B (en) * 2021-05-26 2022-07-19 河南科技大学第一附属医院 Displacement-preventing heart stent capable of being unfolded in corrugated manner
CN115501021B (en) * 2021-06-22 2023-08-11 微创神通医疗科技(上海)有限公司 Support and medicine carrying support
CN114305817B (en) * 2022-03-14 2022-05-27 杭州亿科医疗科技有限公司 Anti-collapse intravascular stent
CN116211562B (en) * 2023-05-06 2023-11-21 北京久事神康医疗科技有限公司 Bump support

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