CN109938801A - A kind of thrombus takes bolt device - Google Patents
A kind of thrombus takes bolt device Download PDFInfo
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- CN109938801A CN109938801A CN201711393018.2A CN201711393018A CN109938801A CN 109938801 A CN109938801 A CN 109938801A CN 201711393018 A CN201711393018 A CN 201711393018A CN 109938801 A CN109938801 A CN 109938801A
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- self
- connecting rod
- expanding stent
- reducer
- delivery guidewire
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- 238000003698 laser cutting Methods 0.000 claims description 3
- 229910052751 metal Inorganic materials 0.000 claims description 3
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- 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 2
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- 206010056292 Androgen-Insensitivity Syndrome Diseases 0.000 description 1
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Abstract
The present invention provides a kind of thrombus to take bolt device.It is described that bolt device is taken to include the tubular self-expanding stent (1) of both ends open, delivery guidewire (2) and import sheath (3), the wall (11) of the self-expanding stent is that the grid (12) of hollow out forms, and the self-expanding stent (1) is divided into three parts: proximal end (15), interlude (14) and distal end (13) along its length from delivery guidewire (2) junction;The single grid area of interlude (14) grid is greater than the single grid area of distal end (13) and proximal end (15), smooth edge connecting rod (161) is set at self-expanding stent (1) proximal edge, and the wall ratio of the self-expanding stent forms the big 0.01-0.04mm of width of the connecting rod (16) at the non-proximal edge of grid (12).
Description
Technical field
The present invention relates to Medical Devices, and specifically, the present invention relates to a kind of thrombus to take bolt device.
Background technique
Stroke is to cause the mankind lethal and one of the main reason for disable, acute ischemic stroke (acute ischemic
Stroke, AIS) account for about the 80% of whole strokes.Studies have shown that there are about 7,500,000 stroke crowds, annual new stroke people for China
It is 2,500,000, wherein dead people has seriously endangered the life of the mankind there are about 1,600,000.Treat AIS key be it is open-minded as early as possible
Occluding vascular saves cerebral ischemic penumbra.It is injected intravenously rt-PA (recombinant tissue
Plasminogen activator, rt-PA) thrombolysis have been found be effective treatment AIS method, treatment time is more early, benefits
It is more.But its requirement for being limited to stringent time window and idicatio, contraindication, receives the Proportion of patients of thromboembolism treatment relatively
It is low, and most vessel occlusion cerebral apoplexy, to rt-PA and insensitive, only only 6%-30% can reach and close
The purpose of revascularization is filled in, limitation is benefited.The drawbacks of to solve intravenous thrombolysis, domestic and foreign scholars are to endovascular method
Clinical research is carried out.Result of study shows in endovascular method that the mode of Arterial thrombolysis can not only determine practical blood
The position of bolt lesion, moreover it is possible to extend time window.But this therapeutic modality still has a big drawback, it is possible to due to operating reason cause it is molten
Bolt time delay, and have the risk in the presence of intervention related complication, increase the ratio of symptomatic intracranial bleeding.Therefore it is controlled in clinic
In treatment, Arterial thrombolysis can not be determined than intravenous thrombolysis with more superiority.
The drawbacks of for clinical treatment, takes the result of study of the endovascular treatment based on bolt to obtain everybody recognize with machinery
Can, for multinomial foreign countries' randomized control study as a result, it was confirmed that in the change of intracranial vessel occlusion venereal disease, early stage, which implements, takes bolt with support rack type
Device is that the intravascular Interventional Treatment of representative can significantly improve patient's prognosis, improves the success rate for the treatment of, especially takes bolt
The design of bracket, even more clinical treatment are successfully crucial.
China takes the research of bolt bracket also to achieve periodic result at present.
Thrombectomy device disclosed in CN104840235A is made of the spring of conical helical pattern, and controlled shape takes bolt
Principle be that Intravascular Thrombus is cut off using the helical spring of taper.But the patented product excessively idealizes, particularly with original
Position thrombus, it is larger with the binding force of vascular wall, it is difficult with the product and takes out thrombus.
It is equally the design of helical structure, CN10662533A invention disclosed patent medium vessels take pin device to be easier to take out
Thrombus.It is the netted or cage structure of multiple units composition that this, which takes bolt device, and side has axial clearance, and axial clearance is along netted
Or cage structure outer surface spiral extension.But it may there is a phenomenon where thrombus breaks looses during taking bolt.
The problem of in order to avoid taking bolt to fall off, CN105476689A disclose a kind of device for taking bolt bracket, this dress
It sets including preceding taking bolt bracket and rear protective cradle, and the two takes bolt in succession, prevents thrombus breaks loose.But the patented product includes taking bolt
Bracket and protective cradle greatly reduce the effective length for taking bolt bracket, increase the length of bracket entirety, have seriously affected production
The flexibility of product.The same flexibility for influencing product there are also a kind of intracranial vessels disclosed in patent CN104068909A to take bolt device
And take pin device.Although product has the structure of indent or evagination, can be played during capturing thrombus and recycling solid
Determine the effect of thrombus, but the structure can seriously affect the whole flexibility of the outer diameter after product pressure is held and product, make it difficult to lead to
Tortuous blood vessel is crossed, and outer male structure may make angiogenesis spasm, causes the damage of blood vessel.
CN103284775B discloses a kind of Intracranial thrombus withdrawing device, takes bolt rack far end controllable, and closure anti-can stop blooding
Bolt, which falls off, blocks distal vessels, also openable to be used as blood flow remodeling device.But it is the product structure, complicated for operation, influence blood vessel
Lead to the time again.
The thrombus that CN105997314A discloses a kind of complex function eliminates system, the system include one in network management shape,
And the bracket and a stent delivery system that can be released and retract from delivery conduit.The bracket can recall bracket conveying completely
System, repositioning simultaneously discharge, can be efficiently multiple take thrombus;Bracket overlay film section can also temporary block blood flow, avoid small
Thrombus blocks distal vessels.But the patent bracket leads to bracket radial force very little using weaving manner in this way, grabs thrombus
It is easy to cause thrombus to rupture or fall off, the thrombus to fall off needs that crawl is repeated several times, and the smaller thrombus of rupture may cause
Blood vessel more distant blockade.Bracket overlay film section will increase the outer diameter of bracket upon compression simultaneously, influence the flexibility of whole system, more
Hardly possible passes through farther tortuous blood vessel.
Though therefore domestic take the product of bolt bracket more, its product structure is complicated, cumbersome, flexibility is poor, and clinic is answered
With often there is the phenomenon that more difficult taking-up of thrombus or thrombus breaks loose, it is unable to satisfy clinical application, and studies one kind and is more suitable for clinic and answer
Taking bolt holder device is the hot and difficult issue of current clinical research.
Summary of the invention
The purpose of the present invention is to provide a kind of thrombus to take bolt device.This takes bolt device that can effectively improve thrombus capture rate, solution
Vascular wall patch certainly existing in the prior art and broken thrombi be easy to fall off and cause distal vessels again embolism the problem of;Together
When, pressure holds that rear outer diameter is smaller, flexibility is high, can reach quickly through curved blood vessel in-position thinner vascular site farther out
To the purpose for the treatment of.
For ease of description, it is described below and has used term " proximal end " and " distal end ", wherein " proximal end " is referred to close to behaviour
One end of author distally refers to one end far from operator.
In order to achieve the above object, take bolt device the present invention provides a kind of thrombus, described to take bolt device include the tubular of both ends open
Self-expanding stent 1, delivery guidewire 2 and importing sheath 3, wherein the wall 11 of the self-expanding stent is that the grid 12 of hollow out forms,
The self-expanding stent 1 is divided into three parts along its length from 2 junction of delivery guidewire: proximal end 15, interlude 14 and
Distally 13;The single grid area of 14 grid of interlude is greater than the single grid area of distal end 13 and proximal end 15, self-expanding stent 1
Smooth edge connecting rod 161 is set at proximal edge, and the wall thickness (δ of Fig. 4) of the self-expanding stent is than forming the non-of grid 12
Width (w1 of Fig. 4) big 0.01-0.04mm of connecting rod 16 at proximal edge.
It self-expanding stent 1 of the invention, delivery guidewire 2 and imports the connection relationship of sheath 3 and can refer to the prior art, example
Assembled delivery guidewire and bracket pressure are held in importing sheath in this way.
Some specific embodiments according to the present invention, wherein the self-expanding stent and the delivery guidewire are connected with each other,
First developing ring or development spring are through in delivery guidewire, then the modes such as hold for developing ring or the spring that develops with welding, bonding, pressure
Proximal end is fixed with delivery guidewire, finally the modes such as holds for developing ring or development spring distal end and expansion branch with welding, bonding, pressure
Frame, delivery guidewire distal end are fixed together.
The material that developing ring and the spring that develops wherein is made can be visual under X-ray, facilitates doctor during surgery can be clear
The position that clear observation bracket reaches in the blood vessel.
Entire bracket wall thickness of the invention is wide greater than bar, and such bracket has better size recoverability, provides simultaneously
Biggish radial support power is embedded in thrombus convenient for bracket.
Sparse grid among bracket of the invention is bracket body part, and grid is big, most of convenient for crawl, insertion
Thrombus;The dense grid of distal end be primarily used to pick up small volume thrombus, when withdraw take bolt device when, thrombus can be sent out with bracket
Raw relative movement, causes thrombus to fall off in rack far end.It is wide that proximal end increases open slope mouthful bar using fine grid simultaneously, mainly
Effect to provide the transfer performance of preferable power in taking bolt device transmission process enables that bolt bracket is taken smoothly to reach lesion
Position;The dense grid of distal end can effectively solve the problems, such as that thrombus is slipped in rack far end, prevent secondary embolism.
Some specific embodiments according to the present invention, wherein the single grid area of intermediate segment mesh is 7-13mm2。
Some specific embodiments according to the present invention, wherein the single grid area of intermediate segment mesh is 10mm2。
Some specific embodiments according to the present invention, wherein the wall thickness δ ratio of the self-expanding stent forms the company of grid 12
The big 0.02mm of width w1 of bar 16.
Some specific embodiments according to the present invention, wherein the width w1 for forming the connecting rod 16 of grid 12 is 0.05-
0.09mm。
Some specific embodiments according to the present invention, wherein the wall thickness δ of the self-expanding stent is 0.06-0.11mm.
Some specific embodiments according to the present invention, wherein the wall thickness δ of the self-expanding stent is 0.07-0.10mm.
Some specific embodiments according to the present invention, wherein smooth side is set at 1 proximal edge of self-expanding stent
Edge connecting rod 161 is open at remote edge.
The distal end of the self-expanding stent is open design, and rack far end can be more soft, it is excessively curved to be conducive to bracket, while not hindering
Hinder the circulation of blood.
Wherein it is understood that the remote edge be it is open, refer to remote edge directly by the company of grid 12
Bar 16 is constituted, without edge connecting rod is specially arranged.
Wherein it will also be appreciated that the smooth edge connecting rod 161 being arranged at 1 proximal edge of self-expanding stent, described
Be smoothly it is substantially smooth, and nisi smooth, described is smoothly the relatively direct substantially zigzag being made of connecting rod 16
Remote edge for.
Some specific embodiments according to the present invention, wherein interlude 14 accounts for the 1/2-2/3 of 1 total length of self-expanding stent.
Some specific embodiments according to the present invention, wherein the distal end 13 of the self-expanding stent 1 and the length of proximal end 15
Than for 1:1-1:2.
Some specific embodiments according to the present invention, wherein the distal end 13 of the self-expanding stent 1 and the length of proximal end 15
Than for 1:1.
Some specific embodiments according to the present invention, wherein the length (l as shown in Figure 2) of self-expanding stent 1 is
28.0-42.0mm。
Some specific embodiments according to the present invention, wherein the interlude 14 of the self-expanding stent 1 and the list of proximal end 15
A grid area ratio is 2:0.5-1.5;The single grid area ratio of proximal end 15 and distal end 13 is 1:1-1.9:1.
Some specific embodiments according to the present invention, wherein the interlude 14 of the self-expanding stent 1 and the list of proximal end 15
A grid area ratio is 2:1.
It is taken in bolt device above-mentioned, it is preferable that the grid area in the proximal end of the self-expanding stent is the same;Net in distal end
Lattice area is the same;Intermediate sparse grid area is the same and is the integer relation of distal end small grid area (preferably multiple is 2).
Wherein it is understood that due to being provided with edge connecting rod 161 in proximal edge, so that edge connecting rod 161 becomes
The part connecting rod for constituting the grid at proximal edge, wherein it also will be understood that can be as needed to the grid at proximal edge
Size carry out appropriate adjustment, for example when the new grid area of edge connecting rod 161 and the grid protocol of edge is less than proximal end
Grid area 1/2 when, then the bracket between new grid and former edge grid is removed, to form the somewhat larger net of area
Lattice.
Some specific embodiments according to the present invention, wherein grid of the invention is arranged in the shape of a spiral.
Some specific embodiments according to the present invention, wherein the width (w2 as shown in Figure 5) of edge connecting rod 161 is than certainly
The big 0.01-0.03mm of width w1 of connecting rod 16 at the non-proximal edge of expanding stent.
Some specific embodiments according to the present invention, wherein the width w2 of edge connecting rod 161 is more non-near than self-expanding stent
The big 0.025-0.03mm of width w1 of connecting rod 16 at end margin.
Some specific embodiments according to the present invention, wherein the width w2 of edge connecting rod 161 is 0.06-0.12.
Some specific embodiments according to the present invention, wherein the width w2 of edge connecting rod 161 is 0.07-0.11.
Some specific embodiments according to the present invention, wherein the opposite delivery guidewire 2 of the edge connecting rod 161 forms slope surface
162。
Some specific embodiments according to the present invention, wherein the angle α of delivery guidewire 2 and the slope surface 162 is 135 °-
150°。
Wherein it is understood that the angle α of the delivery guidewire 2 and the slope surface 162, refers to delivery guidewire in institute
State the angle of the upright projection and delivery guidewire in slope surface.
Some specific embodiments according to the present invention, wherein the slope surface 162 is close to the end of user 163 by connecting
The formation of grid 164, the connection grid are made of two connection connecting rods 165 and two support links 166, two connection connecting rod categories
In a part of edge connecting rod, the delivery guidewire 2 is that the intersection point for connecting connecting rod 165 with two connects.
Some specific embodiments according to the present invention, wherein the width (w3 as shown in Figure 5) of the support link 166
It is 0.01-0.02mm bigger than the width w1 of connecting rod 16.
Some specific embodiments according to the present invention, wherein the width w3 of the support link 166 is 0.06-0.11.
Some specific embodiments according to the present invention, wherein the delivery guidewire 2 is made of metal.
Some specific embodiments according to the present invention, wherein the delivery guidewire 2 is made of the alloy of nickel and/or titanium.
Some specific embodiments according to the present invention, wherein the delivery guidewire 2 is made from a nickel alloy.
Some specific embodiments according to the present invention, wherein the delivery guidewire 2 is made of titanium alloy.
Some specific embodiments according to the present invention, wherein the delivery guidewire 2 is made of the alloy of nickel and titanium.
Some specific embodiments according to the present invention, wherein the importing sheath 3 is made of high molecular polymer.
Some specific embodiments according to the present invention, wherein the importing sheath 3 is made of polytetrafluoroethylene (PTFE).
Some specific embodiments according to the present invention, wherein the self-expanding stent 1 is made of memorial alloy.
Some specific embodiments according to the present invention, wherein the self-expanding stent 1 is made of Nitinol.
Some specific embodiments according to the present invention, wherein the self-expanding stent 1 is made by memorial alloy through laser cutting
At.
Some specific embodiments according to the present invention, wherein the self-expanding stent 1 is made by Nitinol through laser cutting
At.
In conveying, bracket can be held by pressure into importing sheath or microtubular under external force;When importing sheath or micro-
When the constraint external force of conduit disappears, bracket can self-expanding at complete tubular structure.
Some specific embodiments according to the present invention, wherein the delivery guidewire 2 sequence from close to user one end is wrapped
Include the first sizing section 21, the first reducer 22, the second reducer 28, the second sizing section 23 and third reducer 24, third variable diameter
Development silk 25 is arranged with the second sizing section outer surface in section, poly- in the outer surface coated high molecular of development silk 25 and the second reducer 28
Close object heat-shrink tube 26.
Wherein the first sizing section 21 is connect with 22 one end of the first reducer, 22 other end of the first reducer and the second reducer
The connection of 28 one end, the second reducer other end are connect with third reducer one end, the third reducer other end and the second sizing section
One end connection, the second sizing section other end are connect with third reducer again.
Some specific embodiments according to the present invention, wherein the development silk is spring like or developing ring.
Some specific embodiments according to the present invention, wherein the length of the first sizing section 21 is delivery guidewire total length
0.6-0.7 times, the length of the first reducer 22 and the second reducer 28 respectively stands alone as the 0.1- of delivery guidewire total length respectively
0.2 times, 23 length of the second sizing section is 0.05-0.1 times of delivery guidewire total length, and 24 length of third reducer is delivery guidewire
0.03 times of total length.
Some specific embodiments according to the present invention, wherein the first reducer 22 is by diameter by the first sizing section 21
Diameter becomes 0.5-0.6 times of original diameter, and diameter is gradually become 0.4-0.48 times of the first sizing section 21 by the second reducer 28,
Diameter is become 0.2-0.3 times of the first sizing section diameter from the diameter of the second sizing section 23 by third reducer 24.
Some specific embodiments according to the present invention, wherein the first reducer 22 is by diameter by the first sizing section 21
Diameter becomes 0.56 times of original diameter.
Some specific embodiments according to the present invention, wherein diameter is gradually become the first sizing section by the second reducer 28
0.42 times of 21.
Some specific embodiments according to the present invention, wherein diameter is become from the second sizing section by third reducer 24
0.28 times of one sizing section 21.
Wherein it is understood that original diameter of the present invention, refers to that each reducer in the diameter of initial position, i.e., should
The diameter of reducer and the preceding paragraph (a upper sizing section or a upper reducer) junction.
Some specific embodiments according to the present invention, wherein the first reducer 22 is by diameter by the first sizing section 21
Diameter becomes 0.56 times of original diameter, and diameter is become the 0.42 of the diameter of the first sizing section 21 by the second reducer 28 from original diameter
Times.
The shape and structure of delivery guidewire 2 of the invention is referred to the prior art, and some specific implementations according to the present invention
Scheme, 2 proximal end of delivery guidewire are isometrical design, etc. electrical path lengths be 0.6-0.7 times of delivery guidewire overall length, distally for gradually
The design to attenuate, distal length are 0.3-0.4 times of delivery guidewire total length, distally mainly there is a variable diameter design at three, at first
It is connect with proximal end, diameter dimension is gradient to 0.56 times of proximal diameter, and tapered length is 0.1 times of delivery guidewire overall length, and then
Reducer at second, diameter dimension fade to 0.42 times of proximal diameter, and tapered length is 0.1 times of delivery guidewire overall length, third
Immediately this second sizing section, diameter dimension fade to 0.28 times of the first sizing section diameter to secondary variable diameter, and tapered length is that conveying is led
0.03 times of silk overall length.
Delivery guidewire distal end is variable diameter design, smaller, flexibility is more preferable, have during surgery well guiding make
With;Proximal end is isometrical design, and size is bigger, more rigid, can provide better transfer performance, make entirely to take bolt device more accessible to
Vascular lesion position.
It is taken in bolt device above-mentioned, it is preferable that the whole length direction of the self-expanding stent has development silk to run through, and can make to prop up
Frame clearly shows its state opened under X-ray.
The connection type of the self-expanding stent and delivery guidewire is referred to existing conventional connection type, for example will
The two bonding or welding.
And some specific embodiments according to the present invention, the point of intersection of two connection connecting rods 165 of the self-expanding stent 1
Connecting rod 167 is set, and connecting rod 167 is inserted into the gap between the third reducer 24 of delivery guidewire 2 and development silk 25.
Some specific embodiments according to the present invention, the connecting rod 167 and third reducer 24 can also pass through bonding
Or the mode of welding is connected with each other.
Some specific embodiments according to the present invention can be also arranged again in connecting rod 167 and delivery guidewire junction periphery
Connecting sleeve 4, a part of connecting sleeve the covering connecting rod 167 and delivery guidewire distal end.
Some specific embodiments according to the present invention, the connecting sleeve 4 are development pipe or development spring.
Some specific embodiments according to the present invention can also further use bonding or the method for welding by 4 He of casing
The distal end of connecting rod 167 and delivery guidewire is fixed.
Some specific embodiments according to the present invention, the internal diameter at connecting sleeve both ends respectively with the size of connecting rod 167,
And the outer diameter of the distal end of delivery guidewire 2 matches, and the distal portions of connecting rod 167 and delivery guidewire 2 are inserted into connector sleeve
In pipe 4.
In conclusion the present invention provides a kind of thrombus to take bolt device.Thrombus of the invention takes bolt device to have the advantages that
Design structure of the present invention, compared with existing machinery takes bolt technology, advantage is: taking bolt bracket wall thickness
Wide greater than bar, different parts have different size of grid, and these grids are helically arranged on bracket circumferencial direction, intermediate
Big grid crawl is embedded in most of thrombus, is distally in same vertical plane, reduces the unnecessary length of bracket, while distal end is small
Grid is used for the lesser thrombus of trapping volume, moreover it is possible to anti-tampon secondary embolism problem caused by falling off in rack far end.Increase
Proximal edge connecting rod 161 can previously be set with the width of support link 166 to take the conveying of bolt device to provide better transfer performance
It is calculated as proximal edge connecting rod 161 with the width of 166 width of support link and the connecting rod 16 of grid 12 is, when test pushes
Resistance is big, behind by 161 width of edge connecting rod increase 0.025-0.03mm, 166 width of support link increase 0.01-0.02mm,
Resistance is pushed in test becomes very smooth from more smooth before.Transfer performance can make that bolt bracket is taken smoothly to reach lesion well
Position is realized and is accurately positioned;The whole development of bracket provides a great convenience condition for the operation of operation, and operator can be clear
The clear relative position for observing bracket and thrombus, bracket expansion state, ensure that and take bolt process more accurate and reliable;The present invention
Take bolt device structure simple, the outer diameter after product pressure is held is smaller, and flexibility is higher, can more easily reach tortuous
Lesion vessels position;Product operation is simple, not only alleviates the workload of operator, has also striven for treasured for the revascularization of patient
The expensive time.
Detailed description of the invention
Fig. 1 is to take bolt device overall schematic;
Fig. 2 is the self-expanding stent schematic diagram for taking bolt device;
Fig. 3 is the self-expanding stent planar development schematic diagram for taking bolt device;
Fig. 4 is the grid partial schematic diagram of self-expanding stent;
Fig. 5 is the edge connecting rod schematic diagram of self-expanding stent proximal edge;
Fig. 6 is to take bolt device delivery guidewire schematic diagram;
Fig. 7 is that bolt device is taken to import sheath schematic diagram;
Fig. 8 is the self-expanding stent for taking bolt device and the connection relationship diagram of delivery guidewire;
Fig. 9 a is that bolt device bracket is taken to be connect with delivery guidewire with development spring schematic diagram;
Fig. 9 b is to take bolt device bracket and delivery guidewire connection developing ring schematic diagram;
Figure 10 takes bolt device to import intrathecal push resistance measurement figure for number Q201704214020002's;
Figure 11 is that resistance measurement figure is pushed in number Q201704214020002 microtubular;
Figure 12 is that number Q201704214020005 imports intrathecal push resistance measurement figure;
Figure 13 is that resistance measurement figure is pushed in number Q201704214020005 microtubular;
Figure 14 is that number Q201705114020001 imports intrathecal push resistance measurement figure;
Figure 15 is that resistance measurement figure is pushed in number Q201705114020001 microtubular;
Figure 16 is that number Q201707044020002 imports intrathecal push resistance measurement figure;
Figure 17 is that resistance measurement figure is pushed in number Q201707044020002 microtubular;
Figure 18 is that number Q201707044020004 imports intrathecal push resistance measurement figure;
Figure 19 is that resistance measurement figure is pushed in number Q201707044020004 microtubular.
Specific embodiment
Below by way of the beneficial effect of the specific embodiment implementation process that the present invention will be described in detail and generation, it is intended to which help is read
Reader more fully understands essence and feature of the invention, does not limit the scope of the present invention.
Embodiment 1
For ease of description, it is described below and has used term " proximal end " and " distal end ", wherein " proximal end " is referred to close to behaviour
One end of author distally refers to one end far from operator.
Fig. 1 is to take bolt device device, including self-expanding stent 1, delivery guidewire 2 and import sheath 3, wherein delivery guidewire and branch
Frame is linked together in a manner of welding, being bonded, press and hold etc. by developing ring or development spring, and Fig. 1, which is shown as bracket release, to be unfolded
State afterwards;It is assembled that bolt product is taken to be held in and import in sheath for bracket and delivery guidewire pressure.
Fig. 2 and Fig. 3 is bracket grid, and sparse 12 area of grid of bracket interlude 14 is significantly greater than 15 grid of proximal end and remote
The area of 13 grids is held, the area of intermediate segment mesh is twice of proximally and distally grid;The intermediate segment length of sparse grid accounts for
The half of bracket overall length, length ratio proximally and distally are 1:1, total stent length 35mm;Distal end grid is in circumference side
To circulation of at least arranging;Proximal end grid at least one be located at the crotch on bracket most proximal end slope mouthful.It thus can be with
Guarantee that grid broad in the middle as stud portion is mainly taken, grabs or be embedded in most of thrombus;Distal end grid for trapping volume compared with
Small thrombus, thus the problem of thrombus for preventing grid from capturing slides from rack far end and causes secondary embolism;When conveying takes bolt
When device, the push power of operator can be transmitted to bracket from delivery guidewire by the grid of proximal end, in order to take bolt bracket smoothly to reach
Diseased region.
Distal end is proximally arrived on the skeleton of Fig. 2 and Fig. 3 bracket through development circle, this circle is by with impermeable X-ray
Material be made, be conducive to determine bracket and thrombus relative position, facilitate observation perform the operation when bracket opening form, more guarantee
The combination degree of bracket and thrombus.
Fig. 3 is bracket development circle coiling position view, and entire bracket includes 9 development points, and 9 development points can construct
The outer diameter of bracket is with finite length.
Fig. 4 is the grid partial enlarged view of bracket;For 161 enlarged drawing of edge connecting rod at proximal edge, (this figure only shows Fig. 5
Edge connecting rod is gone out and has connected the respective link of grid, other grids and respective link is omitted in order to keep clear).Its
In, one section connecting rod (i.e. connection connecting rod 165) as formation connection grid 164 of the edge connecting rod 161 close to delivery guidewire.Support
The width w3 of connecting rod 166 is 0.02mm bigger than the width w1 of connecting rod 16.
The width w1 of connecting rod 16 at non-proximal edge of the wall thickness δ of the self-expanding stent than forming grid 12 is big
0.02mm, the width w1 for forming the connecting rod 16 of grid 12 is 0.08.The width w2 of edge connecting rod 161 is more non-near than self-expanding stent
The big 0.028mm of width w1 of connecting rod 16 at end margin.
Wherein the opposite delivery guidewire 2 of the edge connecting rod 161 forms slope surface 162, delivery guidewire 2 and the slope surface 162
Angle α is 140 °.
Fig. 6 is the schematic diagram for taking bolt device delivery guidewire 2, mainly by core filaments, roentgenopaque development spring 25 and high score
Sub- polymer heat-shrink tube 26 forms.Core filaments by it is soft, be made with certain rigid diameter metal wire material, both ensure that and take
Support and transfer performance in the conveying of bolt device, and certain flexibility is provided, be conducive to bracket and pass through tortuous blood vessel
And diseased region, realize accurate positionin.
The delivery guidewire 2 sequence from close to user one end is divided into the first sizing section 21, the first reducer 22, second
Reducer 28, the second sizing section 23 and third reducer 24, the second sizing section and third reducer outer surface setting development spring
25, in the outer surface coated high molecular polymer heat-shrink tube 26 of development spring 25 and the second reducer 28.First sizing section 21
Length is 0.57 times of delivery guidewire total length, and the length of the first reducer 22 and the second reducer 28 is respectively that delivery guidewire is total
0.15 times of length, the second sizing segment length are 0.1 times of delivery guidewire total length, and third variable diameter segment length is that delivery guidewire is total
0.03 times of length.First reducer 22 is that diameter is become 0.56 times of original diameter from the diameter of the first sizing section 21, second
Diameter is become 0.42 times of the first sizing section diameter by reducer 28, and third reducer 24 is by diameter by the straight of the second sizing section 23
Diameter becomes 0.28 times of the first sizing section.
Fig. 7 is to import sheath 3, is the extruding pipe of high molecular polymer material, has lesser coefficient of friction, not only exist
When packaging can protective cradle, bolt device will be taken to imported into microtubular when guaranteeing its stability, and being more advantageous to operation, reached
The purpose quickly conveyed.
Fig. 9 a and Fig. 9 b are the device of two kinds of different structures, can be used for the connection of bracket and delivery guidewire.Fig. 9 a is development
Spring, Fig. 9 b are developing ring, and connection type is to set the connecting rod 167 of self-expanding stent and the third reducer 24 of delivery guidewire
In development spring 9a or developing ring 9b (as shown in Figure 8), then by welding, bonding or presses and the modes such as hold the two is connected.
Development spring 9a and developing ring 9b is made of roentgenopaque material, is conducive to the accurate positionin of bracket, improves operation
Success rate.
Test case
Table 1, stent size to be measured
Number is Q201704214020002 and the roomy body one of the bar of the product of Q201704214020005 in upper table table 1
It causes;Other number product the wide parameter of bar meet the present invention claims.
System compliance, pushability and withdraw performance test
Test method: it is tested according to " taking the push of bolt device, submissive and withdrawing property test method ".
Receive standard: bracket should be able to push in simulated blood vessel model along the lumen for importing sheath and microtubular, not bend
Or designated identification position should be able to be reached in the case where fold, and process pushes power≤150gf.Curve graph is referring to Figure 10-19.
Test result is as shown in table 2:
Table 2 takes bolt device performance test
As shown in Table 2, each size takes the bolt device to reach target position along sheath or microtubular is imported, and flexibility is qualified;
It takes bolt device that can normally withdraw out and imports sheath or microtubular, withdrawing property is qualified.But number be Q201704214020002 and
The flexibility of the product of Q201704214020005 pushes, recalls performance and want poor compared with product of the present invention.Of the invention takes bolt device
It can have more excellent operating characteristics.
Claims (10)
1. a kind of thrombus takes bolt device, it is described take bolt device include the tubular self-expanding stent (1) of both ends open, delivery guidewire (2) and
It imports sheath (3), wherein the wall (11) of the self-expanding stent is that the grid (12) of hollow out forms, the self-expanding stent (1)
It is divided into three parts: proximal end (15), interlude (14) and distal end (13) along its length from delivery guidewire (2) junction;
(the single grid area of preferably intermediate segment mesh is 7-13mm to the single grid area of interlude (14) grid2;More preferably
10mm2) it is greater than the single grid area of distal end (13) and proximal end (15), it is arranged smoothly at self-expanding stent (1) proximal edge
Edge connecting rod (161), the wall ratio of the self-expanding stent form the width of the connecting rod (16) at the non-proximal edge of grid (12)
Spend big 0.01-0.04mm (preferably big 0.02mm) (width for being preferably formed as the connecting rod (16) of grid (12) is 0.05-0.09mm).
2. thrombus according to claim 1 takes bolt device, wherein interlude (14) accounts for the 1/ of self-expanding stent (1) total length
(the length ratio of the distal end (13) of the preferably described self-expanding stent (1) and proximal end (15) is 1:1-1:2 (preferably 1:1))
(preferably the length of self-expanding stent (1) is 28.0-42.0mm).
3. thrombus according to claim 1 takes bolt device, wherein the interlude (14) of the self-expanding stent (1) and proximal end
(15) single grid area ratio is 2:(0.5-1.5) (preferably 2:1);The single grid area of proximal end (15) and distal end (13)
Than for 1:1-1.9:1.
4. thrombus according to claim 1 takes bolt device, wherein the width of edge connecting rod (161) is more non-than self-expanding stent
The big 0.01-0.03mm of width of connecting rod (16) at proximal edge.
5. thrombus according to claim 1 takes bolt device, wherein the edge connecting rod (161) is formed with respect to delivery guidewire (2)
Slope surface (162) (preferably the angle α of delivery guidewire (2) and the slope surface (162) is 135 ° -150 °).
6. thrombus according to claim 5 takes bolt device, wherein the slope surface (162) close to user end (163) by
Grid (164) are connected to be formed, the connection grid is made of two connection connecting rods (165) and two support links (166), and two
Connection connecting rod belongs to a part of edge connecting rod, and the delivery guidewire (2) is that the intersection point for connecting connecting rod (165) with two connects
(width of the preferably described support link (166) is 0.01-0.02mm bigger than the width of connecting rod (16)).
7. thrombus according to claim 1 takes bolt device, wherein the delivery guidewire (2) by metal (preferably nickel and/or
The alloy of titanium) it is made.
8. thrombus according to claim 1 takes bolt device, wherein the importing sheath (3) by high molecular polymer (preferably
Polytetrafluoroethylene (PTFE)) it is made.
9. thrombus according to claim 1 takes bolt device, wherein the self-expanding stent (1) is by memorial alloy (preferably nickel
Titanium alloy) it is made and (is preferably made of memorial alloy through laser cutting).
10. thrombus according to claim 1 takes bolt device, wherein the delivery guidewire (2) is suitable from close to user one end
Sequence includes the first sizing section (21), the first reducer (22), the second reducer (28), the second sizing section (23) and third reducer
(24), (the preferably described development silk is spring like or development for the second sizing section and third reducer outer surface setting development silk (25)
Ring), development silk (25) and the second reducer (28) outer surface coated high molecular polymer heat-shrink tube (26) (preferably first determine
The length of diameter section (21) is 0.6-0.7 times of delivery guidewire total length, the length of the first reducer (22) and the second reducer (28)
Degree respectively stands alone as 0.1-0.2 times of delivery guidewire total length respectively, and the second sizing segment length is delivery guidewire total length
0.05-0.1 times, third variable diameter segment length is 0.03 times of delivery guidewire total length, and (preferably the first reducer (22) is by diameter
Become 0.5-0.6 times (preferably 0.56 times) of original diameter from the diameter of the first sizing section (21), the second reducer (28) will be straight
Diameter is become 0.4-0.48 times (preferably 0.42 times) of original diameter from the diameter of the first sizing section (21), and third reducer (24) will
Diameter is become 0.2-0.3 times (preferably 0.28 times) of the first sizing section from the diameter of the second sizing section (23))).
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CN201711393018.2A CN109938801A (en) | 2017-12-21 | 2017-12-21 | A kind of thrombus takes bolt device |
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Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112155658A (en) * | 2020-10-29 | 2021-01-01 | 上海加奇生物科技苏州有限公司 | Thrombus taking bracket and thrombus catcher |
CN112842434A (en) * | 2020-12-30 | 2021-05-28 | 杭州唯强医疗科技有限公司 | Intra-cavity blocking device |
WO2022002282A1 (en) * | 2020-06-30 | 2022-01-06 | 微创神通医疗科技(上海)有限公司 | Developing structure, stent, and thrombectomy system |
CN114451959A (en) * | 2022-01-12 | 2022-05-10 | 北京泰杰伟业科技有限公司 | Thrombus catching device |
CN114869407A (en) * | 2022-06-17 | 2022-08-09 | 惠州市顺美医疗科技有限公司 | Bolt taking device |
CN110974351B (en) * | 2019-12-17 | 2023-03-17 | 禾木(中国)生物工程有限公司 | Curve opening thrombus taking device |
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CN107049420A (en) * | 2017-05-09 | 2017-08-18 | 心凯诺医疗科技(上海)有限公司 | One kind takes bolt support and thrombus withdrawing device |
CN208741066U (en) * | 2017-12-21 | 2019-04-16 | 新昕医药科技(上海)有限公司 | A kind of thrombus takes bolt device |
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Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN110974351B (en) * | 2019-12-17 | 2023-03-17 | 禾木(中国)生物工程有限公司 | Curve opening thrombus taking device |
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CN112842434A (en) * | 2020-12-30 | 2021-05-28 | 杭州唯强医疗科技有限公司 | Intra-cavity blocking device |
CN114451959A (en) * | 2022-01-12 | 2022-05-10 | 北京泰杰伟业科技有限公司 | Thrombus catching device |
CN114869407A (en) * | 2022-06-17 | 2022-08-09 | 惠州市顺美医疗科技有限公司 | Bolt taking device |
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