CN203634215U - Plugging device - Google Patents

Plugging device Download PDF

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Publication number
CN203634215U
CN203634215U CN201320850515.1U CN201320850515U CN203634215U CN 203634215 U CN203634215 U CN 203634215U CN 201320850515 U CN201320850515 U CN 201320850515U CN 203634215 U CN203634215 U CN 203634215U
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CN
China
Prior art keywords
wavy annular
annular thing
waist
end disk
stopper
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Expired - Lifetime
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CN201320850515.1U
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Chinese (zh)
Inventor
刘香东
张德元
陈杰
付明娟
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Lifetech Scientific Shenzhen Co Ltd
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Lifetech Scientific Shenzhen Co Ltd
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Abstract

The utility model discloses a plugging device comprising at least one disc-shaped structure and a waist part connected with the at least one disc-like structure. The waist part comprises at least one waveform ring. The central axis of the at least one waveform ring and the central axis of the at least one disc-like structure are parallel. The waist part has the at least one waveform ring so that when the waist part bears the effect of a radial acting force, the waveform ring uses the waveform structure thereof to apply a radial effect on the waist part to make the radial acting force be transmitted along the circumferential direction of the waveform body, i.e., the ring. Thus, the circumferential length of the waist part is basically kept unchanged under the effect of the radial acting force and the axial stretching is reduced as much as possible. The waist part can be attached perfectly even in a defect part of which the shape of the cross section is irregular, and the gap between the waist part and the defect part is narrowed as much as possible. Therefore, the residual split flow is reduced and the plugging effect is improved.

Description

Stopper
Technical field
This utility model belongs to technical field of medical instruments, relates in particular to a kind of stopper.
Background technology
Along with the development of intervention material apparatus and intervention cardiology, the congenital heart diseases such as transcatheter occlusion device minimally-invasive treatment atrial septal defect, ventricular septal defect, patent ductus arteriosus and patent foramen ovale have become important method.Carrying out Endovascular shutoff with intervening mode is also well accepted treatment means.
Application number be the disclosed stopper of the Chinese patent literature of CN97194488.1 as shown in Figure 1, stopper 300 comprises bolt head 310, end socket 308, left dish 302, right dish 304 and waist 306; Left dish 302, right dish 304 and waist 306 are formed by many one metal wire braidings.In preparation process, each tinsel forms two groups of totally spiral tinsels vertically, and one group of direction of rotation wiry is contrary with another group, forms like this tubular braid of coiling vertically, finally obtains the stopper in Fig. 1 by heat treatment shaping.
Fig. 2 shows the schematic diagram of the tubular braid (being the metal knitted webmaster 18 in Fig. 2) of above-mentioned axial coiling, and in metal knitted webmaster 18, on the one hand, tinsel is coiling vertically all; On the other hand, between each tinsel, without rigid effect can relative sliding, so the object of design is that metal knitted webmaster 18 can overall shrinkage and conveniently enter and compare in the little a lot of delivery sheath of its diameter dimension.This stopper is put into human heart or vascular defects position by induction system in use, from induction system discharges, it is the shape shown in Fig. 1, waist 306 supports defect, and left dish 302 and right dish 304 cover respectively damaged in damaged both sides, final blocking blood flow and complete shutoff.
In actual using, need select to implant for concrete defect the size of stopper, conventionally select the size of corresponding waist 306 according to the internal diameter of measuring damaged cross section, the girth of waist 306 and the girth in damaged cross section are matched, but facts have proved, the waist 306 of the stopper of this braiding structure can not adapt to cross section completely and be erose defect, and especially damaged cross section is the situation of flat thin-and-long.
The stressing conditions of waist 306 after release is described as an example of the metal knitted webmaster 18 in Fig. 2 example.When metal knitted webmaster 18 is subject to radial force to do the used time, on the one hand, because of tinsel coiling vertically, this radial effect power is transmitted along coiling direction, makes metal knitted webmaster 18 axial tension distortion, thus radial contraction, specifically as shown in Figure 3, dotted line 7 represents the shape of cross section of metal knitted webmaster 18 before stressed, and solid line 8 represents the shape after stressed, and the perimeter of section of visible metal knitted webmaster 18 has dwindled after stressed; On the other hand, because of between each tinsel without rigid constraint, if defect is irregularly shaped, the axial tension distortion at certain stress point place, by driving other tinsel axial tension distortion simultaneously not stressed or stressed less position, makes these not stressed or stressed less positions produce equally radial contraction.Finally cause waist 306 and whole irregular damaged edge laminating closely even can not fit completely so that leave gap between the two, the girth that cannot guarantee waist 306 is substantially constant to adapt to the shape in irregular damaged cross section, thereby cause residual shunt, affect plugging effect.
Publication number be the another kind of stopper that relates to of the patent documentation of WO2010151510A1 as shown in Figure 4, this stopper comprises metal framework 49, choked flow film 50, stomidium 45 and 46, lock ring 47, metal framework 49 is for supporting whole stopper, the waist 51 of metal framework 49 provides the shutoff tension force to defect while use, left and right two dishes cover respectively damaged at damaged two ends, final blocking blood flow completes shutoff.Above-mentioned metal framework 49 is made up of some spiral metal wires, all unidirectional extensions in the same direction and without bending after spiral metal wire launches along periphery, between spiral metal wire, nothing is intersected, therefore do not have each other rigid constraint, so design is to compare in the little a lot of delivery sheath of its diameter dimension in order to facilitate stopper to enter equally.
Similarly, the waist 51 of the stopper of this braiding structure also cannot be guaranteed that its girth is substantially constant and is erose defect, particularly cross section and is the damaged of flat thin-and-long to adapt to cross section.Particularly, this metal framework 49 is done the used time being subject to a pair of radial force in opposite directions, spiral metal wire can not impact other spiral metal wire of side, therefore metal framework 49 only the diameter at stressed place can dwindle but almost not change with the radial diameter of its substantially vertical direction, this metal framework 49 can not guarantee that when stressed its girth at this force part circumference is substantially constant.Specifically as shown in Figure 5, dotted line 14 represents stressed front shape, and solid line 15 represents stressed rear shape.This stopper its waist 51 after implant into body also cannot be complied with the cross sectional shape of irregular defect thus, can cause certain residual shunt, affects plugging effect.
As can be seen from the above, although all can entering easily, the stopper of above each class formation compares in the little a lot of delivery sheath of its diameter dimension, after release, realize heart septal defect or blood vessel are carried out to shutoff, but be erose defect in shutoff cross section, its waist can not guarantee that its girth is substantially constant to comply with the irregular defect of cross sectional shape.In the time that the waist of the stopper of said structure is subject to the active force of maximum inner diameter direction, its waist can shrink to internal diameter in the size at stressed place, but the size of non-stress place or stressed smaller part or simultaneously dwindle, remain unchanged, being waist circumference reduces relatively afterwards stressed, thereby causes this type of stopper waist defect of cannot fitting completely, after stopper is implanted and between defect, has gap, thereby formation residual shunt, impact operation plugging effect.
Utility model content
The purpose of this utility model is to overcome above-mentioned the deficiencies in the prior art, a kind of stopper is provided, this stopper is complied with the irregular defect of cross sectional shape by the axial tension of effectively controlling waist in shutoff, thereby reduces as far as possible residual shunt, improves plugging effect.
The technical solution of the utility model is: a kind of stopper is provided, the waist that comprises at least one disk-like structure and be connected with described at least one disk-like structure, described waist comprises at least one wavy annular thing, and described at least one wavy annular thing, both axis of described at least one disk-like structure are parallel to each other.
Alternatively, described at least one disk-like structure comprises near-end disk-like structure and far-end disk-like structure, described waist is located between described near-end disk-like structure and described far-end disk-like structure, and described at least one wavy annular thing, described near-end disk-like structure and far-end disk-like structure three's axis is parallel to each other.
Alternatively, described waist comprises the described wavy annular thing of at least two mutual lap wounds.
Alternatively, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, and interlaced coiling between wavy annular thing described in adjacent sets coordinates and forms net; Described first group of wavy annular thing comprises that at least one and described near-end disk-like structure twine the described wavy annular thing connecing, and described second group of wavy annular thing comprises that at least one and described far-end disk-like structure twine the described wavy annular thing connecing.
Alternatively, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, is spaced and is connected by connector described in adjacent sets between wavy annular thing; Described first group of wavy annular thing comprises that at least one and described near-end disk-like structure twine the described wavy annular thing connecing, and described the second group far end wavy annular thing comprises that at least one and described far-end disk-like structure twine the described wavy annular thing connecing.
Alternatively, described waist also comprises the net tubular body being connected with between described near-end disk-like structure and far-end disk-like structure, described at least one wavy annular thing and coaxial sheathed being connected of described body.
Alternatively, described waist comprises the described wavy annular thing of at least two mutual lap wounds.
Alternatively, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, described in every group, wavy annular thing comprises wavy annular thing described at least one, interlaced coiling between wavy annular thing described in adjacent sets, coordinate and form net, described net covers described body wholly or in part.
Alternatively, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, described in every group, wavy annular thing comprises wavy annular thing described at least one, described in adjacent sets, wavy annular thing is spaced and is connected by connector along described body, coordinate and form net, described net covers described body wholly or in part.
Alternatively, described wavy annular thing extends and twines and connects in described far-end disk-like structure and/or described near-end disk-like structure.
Alternatively, described waist also comprises at least two-layer sheathed net tubular body mutually, and described at least two-layer body two ends are connected with far-end disk-like structure with described near-end disk-like structure all respectively, and described wavy annular thing is located between adjacent two-layer body.
Alternatively, described waist also comprises the net tubular body being connected with between described near-end disk-like structure and far-end disk-like structure, described net tubular body comprise many interlaced and along the braided wires of the central shaft helically coiling of described body, described wavy annular thing coordinates and forms by fixing the predetermined multiple cross points of each braided wires and the braided wires section between each cross point.
The waist of stopper provided by the utility model has at least one wavy annular thing, when waist is subject to the radial effect masterpiece used time, this wavy annular thing is by its waveform configuration control waist axial tension, waist its circumference circle under the effect of radial effect power is remained unchanged substantially, even also can be better adherent in the irregular defect of cross sectional shape, reduce as far as possible the gap between waist and defect, thereby reduce residual shunt, improve plugging effect.
Accompanying drawing explanation
Fig. 1 is the structural representation of a kind of stopper in prior art;
Fig. 2 is the structural representation of preparing the metal knitted webmaster of stopper in prior art;
Fig. 3 is that the metal knitted webmaster in Fig. 2 is subject to the change of shape schematic diagram after a pair of radial force effect in opposite directions;
Fig. 4 is the structural representation of another kind of stopper in prior art;
Fig. 5 is that in Fig. 4, the waist of stopper is subject to the change of shape schematic diagram after a pair of radial force effect in opposite directions;
Fig. 6 is the schematic perspective view of the stopper of this utility model the first embodiment;
Fig. 7 is the floor map of stopper in Fig. 6;
Fig. 8 is the schematic diagram of the wavy annular thing in Fig. 6 and Fig. 7;
Fig. 9 is that the waist of stopper in Fig. 6 and Fig. 7 is subject to change of shape schematic diagram after a pair of radial force effect in opposite directions;
Figure 10 is the schematic perspective view of the stopper of this utility model the second embodiment;
Figure 11 is the floor map of stopper in Figure 10;
Figure 12 is the schematic diagram of the wavy annular thing of multiple mutual lap wounds in Figure 10 and Figure 11;
Figure 13 be multiple mutual lap wounds in Figure 10 and Figure 11 wavy annular thing prepare schematic diagram;
Figure 14 is the schematic diagram of the stopper of this utility model the 3rd embodiment;
Figure 15 is the schematic diagram that in Figure 14, stopper is provided with choked flow film;
Figure 16 is the schematic diagram of the bolt head of stopper in Figure 14;
Figure 17 is the schematic diagram of preparing the metal knitted webmaster with wavy annular thing of stopper in Figure 14;
Figure 18 is that the two ends of metal knitted webmaster in Figure 17 are by the fixing schematic diagram of steel bushing;
Figure 19 is the schematic diagram of preparing the mould of stopper in Figure 14;
Figure 20 is the schematic diagram of preparing the metal knitted webmaster with wavy annular thing of stopper in the Figure 14 with multilamellar body;
Figure 21 is the schematic diagram to the metal net tube covering membrane in Figure 20;
Figure 22 is the schematic diagram according to the stopper of this utility model the 4th embodiment;
Figure 23 is the schematic diagram according to the stopper of this utility model the 5th embodiment;
Figure 24 is the schematic diagram according to the stopper of this utility model the 6th embodiment;
Figure 25 is the schematic diagram of preparing the waist of the stopper in Figure 24;
Figure 26 is the schematic diagram according to the stopper of this utility model the 7th embodiment;
Figure 27 is the schematic diagram according to the stopper of this utility model the 8th embodiment;
Figure 28 is the schematic diagram in the cross point of stopper in Figure 27.
The specific embodiment
In order to make the purpose of this utility model, technical scheme and advantage clearer, below in conjunction with drawings and Examples, this utility model is further elaborated.Should be appreciated that specific embodiment described herein is only in order to explain this utility model, and be not used in restriction this utility model.
It should be noted that, when element is called as " being fixed on " or " being arranged at " another element, it can be directly on another element or may have centering elements simultaneously.When an element " being connected in " another element of being known as, it can be directly connected to another element or may have centering elements simultaneously.Getting involved medical field, definition is near-end apart from the relatively near one end of operator, is far-end apart from operator one end relatively far away.In addition, the orientation term such as left and right, upper and lower, inside and outside in the present embodiment, is only relative concept or take the normal operating condition of product as reference each other, and should not be regarded as have restrictive.
The waist that comprises at least one disk-like structure and be connected with at least one disk-like structure according to stopper of the present utility model, waist comprises at least one wavy annular thing, and the axis of at least one wavy annular thing and at least one disk-like structure is parallel to each other.For example, patend ductus arteriosus occluder comprises a disk-like structure and is communicated with this disk-like structure the waist being connected; For some type stopper, above-mentioned at least one disk-like structure comprises near-end disk-like structure and far-end disk-like structure, waist is located between near-end disk-like structure and far-end disk-like structure, and at least one wavy annular thing, near-end disk-like structure and far-end disk-like structure three's axis is parallel to each other.Below the stopper to comprise far-end disk-like structure and near-end disk-like structure is described as example; Should know, below describe and only use for examplely, be not to restriction of the present utility model, and the ordinary skill human eye of this area can, based on following description, not paying on the basis of creative work, be adapted to various waist structures on multiple stopper as required.
Referring to Fig. 6 and Fig. 7, according to the stopper 100 of this utility model the first embodiment comprise far-end disk-like structure 110, near-end disk-like structure 120 and be located at near-end disk-like structure 120 and far-end disk-like structure 110 between waist 130.Waist 130 comprises at least one wavy annular thing 131, and this at least one wavy annular thing 131, near-end disk-like structure 120 and far-end disk-like structure 110 threes' axis is parallel to each other.
Near-end disk-like structure 120 and far-end disk-like structure 110 all can be formed by tinsel or other silk filamentary material braiding being applicable to, and also can be formed by metal pipe material cut.Preferably adopt super-elastic shape memory alloy material, as Nitinol, make stopper 100 can automatically revert to original shape from discharging than the little delivery sheath of self diameter, block heart septal defect or artery-clogging, and keep enough radial support power, avoid stopper 100 to be shifted.
Near-end and far-end at stopper 100 can be fixed with respectively bolt head 150 and end socket 140, end socket 140 be used for converging and stationary remote disk-like structure 110 near the tinsel of far-end, bolt head 150 be used for converging and fixing near-end disk-like structure 120 near the tinsel of near-end and connect induction system.
Waist 130 comprises at least one wavy annular thing 131, and waveform includes but not limited to sine wave, V-arrangement ripple or Z-shaped ripple.As shown in Figure 8, this wavy annular thing 131 is by the crest 131a replacing and trough 131b and be connected crest 131a and the pillar 131c closure of trough 131b forms, and bending angle 131d, crest 131a(or the trough 131b of waveform can be set according to the type of stopper 100) between span 131f and wave height 131e.
The adjacent peaks 131a(of wavy annular thing 131 or trough 131b) between span 131f and the bending angle 131d of ripple can determine according to the support strength of stopper 100 waist 130 demands.As waist 130 needs larger support strength, can keep span 131f constant and increase bending angle 131d, or keep bending angle 131d constant and reduce span 131f, also can increase bending angle 131d simultaneously and reduce adjacent peaks 131a(or trough 131b) between span 131f.Conventionally, in order to guarantee into sheath in guaranteeing support strength, the span of bending angle 131d can be selected 20 ° to 160 °, preferable range is 30 ° to 90 °, for example 45 °, 60 °, 75 ° etc., certainly, understandably, the angle value of bending angle 131d also can be selected other suitable scope, numerical value.
After stopper 100 discharges, in the time that wavy annular thing 131 is subject to radial compression power somewhere, this extruding force is transmitted along the coiling direction of wavy annular thing 131, drive 131 distortion in its coiling direction of wavy annular thing, make the path length at its stressed place in dwindling, the path length of other non-stress place or stressed smaller part not only can not dwindle because of distortion but also expand to some extent.
Particularly, wavy annular thing 131 is the sealing entirety that waveform is continuous, in the time that it is subject to radial compression power somewhere, can produce herein the inner tensions of transmitting continuously along the circumferencial direction of ring, and the tension force of circumferencial direction can be resisted the girth of wavy annular thing 131 and dwindles, thereby cause the span 131f at these wavy annular thing 131 stressed places not only can not dwindle but also expansion to some extent.Meanwhile, not being subject to external force or can slightly reduce by the span 131f of external force smaller part of wavy annular thing 131, still, the whole perimeter of wavy annular thing 131 is substantially constant.
As shown in Figure 9, because tubulose waist 130 comprises at least one wavy annular thing 131, its waveform configuration makes waist 130 be difficult to axial tension, like this when waist 130 is subject to a pair of radial force in opposite directions to do the used time, wavy annular thing 131 can guarantee that the girth of waist 130 roughly remains unchanged, wherein dotted line 16 represents the shape of cross section of tubulose waist 130 before stressed, and solid line 17 represents the shape after stressed.Like this, under the substantially constant condition of waist 130 girths, after stopper 100 discharges, can be better to comply with the irregular defect in cross section, reduce as far as possible that stopper 100 is not fitted with defect and the residual shunt that produces, thereby improve plugging effect.
Meanwhile, wavy annular thing 131 is also easy to radial compression, can shrink and enter than in the little a lot of delivery sheath of the development size of stopper 100, has guaranteed the serviceability of this stopper 100 in intervene operation process.Entering in delivery sheath process, wavy annular thing 131 is subject to the radial compression power of circle direction, and the drift angle of its ripple all diminishes, and wavy annular thing 131 is inwardly contracted to delivery sheath internal diameter and adapts like this.
Referring to Figure 10 and Figure 11, on the basis of the stopper 100 of the first embodiment, comprise the wavy annular thing 231 of at least two mutual lap wounds according to the waist 230 of the stopper 200 of this utility model the second embodiment.Referring to Figure 12, multiple wavy annular things 231 by the mutual lap wound of weaving together.The wavy annular thing 231 of above-mentioned at least two mutual lap wounds coordinates formation net, and the direct waist 230 as stopper 200.The end (crest or trough) of wavy annular thing 231 twines and connects with far-end disk-like structure 210 and near-end disk-like structure 220 respectively.Now can, by increasing the reticular density of wavy annular thing 231, improve the support strength of stopper 200 waists 230.Otherwise stopper 200 waist 230 support strengths reduce.
In preparation, near-end disk-like structure 220 and far-end disk-like structure 210 all can adopt braid to form, and at least two wavy annular things 231 that waist 230 is weaved into by litzendraht wire form.Referring to Figure 13, the braiding process of waist 230 is as follows: the mould rod 19 that the hanging wire bar 21 with two circle mutual dislocation is provided; Particularly, regularly arranged several holes 20 on mould rod 19, certain angle evenly staggers between every layer of hole 20, this hole 20 can be two-layer or two-layer more than, and then the distance of plugging uniformly two circle hanging wire bar 21, two circle hanging wire bars 21 on mould rod 19 in the hole 20 of having accomplished fluently can be determined according to the height of stopper 200 waists 230.Use tinsel to walk around successively upper and lower two-layer hanging wire bar 21 to form wavy annular thing, this wavy annular thing is along the circumferential direction fixedly connected to form closed loop around final head and the tail after a few, and the multi-turn wavy annular thing weaving mutually staggering coordinates to form together strengthens webmaster 22 using directly as waist 230.
Referring to Figure 14, compared with stopper 200 in the second embodiment, waist 430 according to the stopper 400 of this utility model the 3rd embodiment comprises at least one wavy annular thing 431 and is connected with the net tubular body 432 between near-end disk-like structure 420 and far-end disk-like structure 410, this at least one wavy annular thing 431 and coaxial sheathed being connected of body 432.
Near-end disk-like structure 420, far-end disk-like structure 410 for example, are integrally formed by metal knitted webmaster (the metal knitted webmaster 18 in Fig. 2) with body 432, metal knitted webmaster can be woven by braider and be formed by metal wire etc., be preferably super-elastic shape memory alloy material and weave, such as nitinol alloy wire etc.Use subsequently mould 40 that metal knitted webmaster is heat-treated to sizing and form near-end disk-like structure 420, far-end disk-like structure 410 and body 432, obtain overall wire netting framework 30.Wavy annular thing 431 can weave between outside, inner side or the multilamellar body 432 that is wound on body 432; Also can adopt suture on body 432.
Said structure is not only applicable to the present embodiment, is applicable to other embodiment yet., the waist 430 of stopper 400 can directly be formed by wavy annular thing 431; Also can comprise that net tubular body 432 and coaxial sleeve are located at the wavy annular thing 431 on body 432.
Alternatively, near-end disk-like structure 420, far-end disk-like structure 410 can be formed by tubing cutting with body 432.Particularly, can adopt metal pipe material to carry out cut and obtain near-end disk-like structure 420, far-end disk-like structure 410 and body 432.Or near-end disk-like structure 420, far-end disk-like structure 410 and body 432 can be distinguished independent molding, and by connecting line, proximal disk shape structure 420 and far-end disk-like structure 410 are connected in to the two ends of body 432.Or near-end disk-like structure 420 adopts the molding of litzendraht wire integrated woven with body 432, the independent molding of far-end disk-like structure 410, and be connected with body 432 by connecting line.
Above-mentioned wavy annular thing 431 has variform.Referring to Fig. 8 or Figure 12, filamentary material head and the tail two ends in wave shape are connected to form wavy annular thing 431.Or, in winding process, the head and the tail two ends of filamentary material in wave shape being individually fixed on the same filament of body 432 of waist 430 and forming closed loop, two kinds of wavy annular things 431 have essentially identical technique effect.It will be appreciated by those skilled in the art that ground, the above winding process about wavy annular thing 431, closed manners, waveform are only used for example, are not to restriction of the present utility model.
As shown in figure 15, in order to possess better plugging effect, stopper 400 also comprises choked flow film, choked flow film can make in or be located in described near-end disk-like structure 420 or/and far-end disk-like structure 410 or/and waist 430.Particularly, choked flow film is sewn in the inner chamber that wire netting framework 30 forms, for example, in the inner chamber that, the first choked flow film 461 is sutured in the inner chamber of far-end disk-like structure 410, the second choked flow film 462 is sutured in near-end disk-like structure 420 and the 3rd choked flow film 463 be sutured in the inner chamber of waist 430 positions.
In the time that the waist 430 of stopper 400 comprises two-layer body 432, choked flow film also can clamping extending between double layer body 432 and in the axial length of whole body 432, not shown.Say from manufacture method, this choked flow film can be first be sewn between double layer body before stopper 400 sizings, and then sizing becomes the final shape of stopper 400, after also can shaping, is sewn between double layer body again.Because choked flow film is between double layer body, after stopper 400 molding, whole wire netting framework 30 all has choked flow film by its inside and outside spatial separation so, and therefore plugging effect is better.
Near-end disk-like structure 420 and far-end disk-like structure 410 for example, are worked out by filamentary material (tinsel), and in near-end disk-like structure 420, free end wiry is assembled and fixed by bolt head 450; In far-end disk-like structure 410, free end wiry is assembled and is fixed by end socket 440.Referring to Figure 16, bolt head 450 one end are provided with the steel bushing 25 for the fixing free end wiry 31 near near-end disk-like structure 420, in the blind hole 11 of steel bushing 25 embedding in bolt head 450 one end and be welded and fixed by solder joint 12, so that whole wire netting framework 30 is linked together with bolt head 450, be provided with internal thread hole 13 at the other end of bolt head 450, this internal thread hole 13 is for being connected and fixed the device of carrying stopper 400.These bolt head 450 structures are equally applicable to other embodiment.
The method of producing above-mentioned stopper 400 comprises the following steps: prepare body 432, connect the wavy annular thing 431 along body 432 circumferencial directions and winding in wave shape on body 432; Preparation is one-body molded and be positioned at near-end disk-like structure 420 and the far-end disk-like structure 410 at body 432 two ends with body 432, or prepares separately near-end disk-like structure 420 and far-end disk-like structure 410, and it is connected with body 432; Body 432, near-end disk-like structure 420 and far-end disk-like structure 410 are shaped.
Particularly, making step can be with reference to as follows:
(1) braiding of metal knitted webmaster: first with braider, many wire are woven into metal webmaster, and heat treatment shaping becomes stable latticed circular tube structure, namely traditional weaving manner (structure as shown in Figure 2);
(2) braiding of wavy annular thing 431: as shown in figure 17, metal knitted webmaster 18 is enclosed within on mould rod 19, on this mould rod 19, accomplish fluently in advance two-layer along several regularly arranged holes 20 of circumference, hole 20 between the every layer certain angle that staggers uniformly in the axial direction, this hole can be two-layer can be also two-layer more than.And then in the hole 20 of having accomplished fluently, plug uniformly two circle hanging wire bars 21 on mould rod 19, the height of waist 430 can determine or be a bit larger tham according to the height of waist 430 to the distance of two circle hanging wire bars 21, use tinsel walk around successively two-layer hanging wire bar 21 neighbouring or that be separated by form waveform and according to the circumferencial direction of mould rod 19 around after a few by the fixing two ends closed loop that forms, it is wavy annular thing 431, the waveform that guarantees each circle in closed loop is mutually evenly to stagger and be woven together, and wavy annular thing 431 coordinates to form strengthens webmaster 22.
When winding wavy annular thing 431, litzendraht wire can, along circumferentially winding at least two circles of mould rod, then be fixed the head and the tail two ends of litzendraht wire, and respectively encloses the litzendraht wire braiding of staggering.Or described in winding when wavy annular thing 431, litzendraht wire is along the circumferential direction successively through the mesh of metal knitted webmaster 18, or separately directly winding wavy annular thing 431 and by wavy annular thing 431 use linear slits on described metal knitted webmaster 18.
The tinsel of above-mentioned reinforcement webmaster 22 can be along circumference successively through the mesh on metal knitted webmaster in braiding process, make to strengthen webmaster 22 and metal knitted webmaster is woven together, can certainly use line that reinforcement webmaster 22 is directly sutured on metal knitted webmaster.Having woven rear use heat fixation makes these reinforcement webmaster 22 indiffusion to keep reservation shape, heat fixation can adopt various heat-treatment furnaces or various heater, in order further to strengthen the anti-contracility energy of waist 430 under external force condition, the position that the tinsel that each can also be staggered intersects is fixed by the means such as line or welding simultaneously.
Strengthen directly coiling or be fixed on that to carry out " mould shape " on metal knitted webmaster 18 be Optimization Technology again of webmaster 22, it also can independently weave to form strengthens webmaster, and is directly adopted the fixing mode of line to be fixed on waist 430 positions after " mould shape " operation completes.
(3) fixing termination: as shown in figure 18, use the end of two openings of steel bushing 25 fixing metal braiding webmasters, and use bonding machine that the tinsel of two ends and corresponding steel bushing 25 are welded.Also one end of fixing webmaster only of this step, the other end keeps open state, and in stiff end welding steel bushing 25.If this webmaster one end is enclosed construction, if fixing one end, and the upper steel bushing 25. of welding
(4) mould shape: as shown in figure 19, the metal knitted webmaster that is woven with reinforcement webmaster 22 is inserted in mould 40, heat-treat sizing in heat-treatment furnace, finally form metal framework 30.Mould 40 inner chambers comprise two chamber and the chambers that diameter is smaller that diameter is larger, in the time of molding, make reinforcement webmaster 22 on the metal framework 30 smaller chamber of diameter that mediates, metal knitted webmaster is placed in the chamber that two diameters are larger, form near-end disk-like structure 420, far-end disk-like structure 410 near near-end and far-end in stopper 400, between near-end disk-like structure 420 and far-end disk-like structure 410, the smaller chamber of diameter forms the waist 430 of stopper 400.
Heat-treatment furnace can be selected various types of Equipments for Heating Processing, heat treatment temperature and time can regulate according to the soft or hard degree that will form stopper 400, for example adopt approximately 450 to 550 ℃ of approximately 1 to 30 minutes persistent period of heat treatment temperature of the stopper 400 that nickel-titanium metal silk braiding forms, can be fixed on its strained state be mould 40 cavity shapes to nickel-titanium metal webmaster goods with this understanding.Heat treatment time can extend at a lower temperature, and under higher temperature, heat treatment time can shorten, and these parameters can be adjusted in the composition of nickel-titanium metal material and ratio, and this is known to those skilled in the art.For improving the accuracy of this stopper 400 sizes, can in the chamber corresponding to the waist 430 of wire netting framework 30, add core 35 on 40 li, mould, the gap size capable of regulating between this core 35 and the internal chamber wall of peripheral mould 40 is to determine the degree of accuracy of this stopper 400 sizes;
For the stopper 400 with choked flow film, can after " mould shape " step, increase " sewing up choked flow film " operation.Use stitching thread that the edge of choked flow film is sutured in the inner chamber of two disk-like structures and waist 430, after stopper 400 freely launches, choked flow film can be opened by Uniform Tension.This choked flow film can be the also two-layer or multilamellar of monolayer, the material of choked flow film can be high molecular also can be for metal.
Comprise two-layer or two-layer above sheathed latticed body 432 successively for the waist 430 of stopper 400, wavy annular thing 431 is located between adjacent body 432, and be provided with choked flow film between adjacent body 432, the difference of its preparation method is: referring to Figure 20 and 21, prepare body 432 and comprise the first webmaster 23 of being formed by braid of preparation and the second webmaster 24 being formed by braid, and on the first webmaster 23, connect wavy annular thing 431 or wavy annular thing 431 and coordinate the reinforcement webmaster 22 forming, the second webmaster 24 is placed on to the first webmaster 23 outsides, the first webmaster 23 and the second webmaster 24 are partly overlapped, and make to strengthen webmaster 22 and be positioned at the overlapping region of the first webmaster 23 and the second webmaster 24, from the first webmaster 23 of lap and the second webmaster 24, intercept and comprise one section of webmaster strengthening webmaster 22, make the webmaster of lap all remain with webmaster at the two ends of strengthening webmaster 22, and use steel bushing to fix the end of the first webmaster 23 and 24 two openings of the second webmaster, and use bonding machine that the litzendraht wire of the end of two openings and corresponding steel bushing are welded, and then bolt head is welded on the steel bushing of one end wherein.
Particularly, before the second webmaster 24 is placed on the first webmaster 23 outsides, the first webmaster 23 that is connected with reinforcement webmaster 22 is placed on mould rod or excellent upper knitting forming the first webmaster 23 of mould and reinforcement webmaster 22; Adopt metal knitted cloth to be wrapped on the first webmaster 23 as choked flow film; The second webmaster 24 is placed on to described the first webmaster 23 and metal knitted cloth outside.
Manufacture method is two steps below having increased between above-mentioned steps (2) and (3):
(A): overlapping dual webmaster: as shown in figure 20, middle part has been carried out to the first webmaster 23(that wavy annular thing 431 weaves reinforcement have been comprised metal knitted webmaster 18 and has strengthened webmaster 22) and another do not carry out that the second webmaster 24 that wavy annular thing 431 weaves radially overlaps and the second webmaster 24 in periphery, the second webmaster 24 is herein identical with traditional metal knitted webmaster 18 structures.
(B): intercept webmaster, fixing two ends: intercept the one section of webmaster that comprises the suitable length of strengthening webmaster 22 from the metal knitted webmaster of lap, make the metal knitted webmaster of lap all remain with certain length at the two ends of strengthening webmaster 22, and use steel bushing 25 to fix the end of two openings, and use bonding machine that the tinsel of two ends and corresponding steel bushing 25 are welded, welding manner can have multiple choices, such as argon arc welding, electric resistance welding and Laser Welding etc., and then bolt head 450 is welded on the steel bushing 25 of one end wherein, welding manner has multiple choices equally, such as electric resistance welding and Laser Welding etc.
The method arranging before stopper 400 sizings for choked flow film is as follows: can between " braiding of the reinforcement webmaster of waist location " and " overlapping dual webmaster " these two steps, increase " overlay film " operation, reduce the step of last " sewing up choked flow film " simultaneously.As shown in figure 21, after completing steps " braiding of the reinforcement webmaster of waist location ", all hanging wire bars 21 are removed from mould rod 19, and metal knitted webmaster 18 is retained on mould rod 19 simultaneously, and uses adhesive tape 36 that metal knitted webmaster 18 is fixed on mould rod 19 and prevents that it is free to slide.Then use resistant to elevated temperatures metal knitted cloth 37(to be equivalent to choked flow film) will in later stage process, need the webmaster length range intercepting to wrap up, parcel can be that one deck can be also multilamellar.Metal knitted cloth 37 similar tradition longitude and latitude textile cloths, metal knitted cloth 37 can bear the high temperature of 550 ℃ of left and right simultaneously, and material can be selected rustless steel, platinumiridio, Nitinol etc., metal woven 37 materials preferably have hyperelastic Nitinol.Also can use metal or macromolecule stitching thread that metal knitted cloth 37 and metal knitted webmaster 18 are fixed together for preventing from coming off, then another is not carried out to webmaster and its radially overlap (i.e. " overlapping dual webmaster " step) that wavy annular thing 431 weaves and remove adhesive tape 36 simultaneously, subsequent step is the same.
Referring to Figure 22, compared with above-described embodiment, difference according to the stopper 500 of this utility model the 4th embodiment is, wavy annular thing 531 extends into far-end disk-like structure 510 or near-end disk-like structure 520, or extend into far-end disk-like structure 510 or near-end disk-like structure 520 simultaneously, and mutually twine and connect to fix with it in far-end disk-like structure 510 and/or near-end disk-like structure 520, preferably twine and connect with the outward flange of disk-like structure.
In the above-mentioned first to the 3rd embodiment, the two ends (crest and trough) of wavy annular thing extend to respectively the junction of waist and near-end disk-like structure, far-end disk-like structure, wavy annular thing is just overlapping with whole waist, can make like this wavy annular thing be difficult for being subjected to displacement.In the present embodiment, two ends (crest 531a and trough 531b) of wavy annular thing 531 extend to respectively the outer edge of near-end disk-like structure 520 and far-end disk-like structure 510, two disk-like structures of the overlapping covering of wavy annular thing 531 and waist 530, wavy annular thing 531 can make the larger distortion of the more stable and difficult generation of expansion shape of near-end disk-like structure 520 and far-end disk-like structure 510 like this.
Referring to Figure 23, compared with above-described embodiment, difference according to the stopper 600 of this utility model the 5th embodiment is, one end of wavy annular thing 631 for example, twines and connects at the intersection of a disk-like structure (near-end disk-like structure 620) and waist 630 and this disk-like structure or waist, the other end twines and connects with waist 630 in waist 630, does not extend through whole waist 630.Certainly, the position of wavy annular thing 631 in waist 630 can arrange as required.
According to the type of stopper and model or actual user demand, the height that waist design needs is not quite similar, in order to reach desired height in guaranteeing support force, waist comprises at least the first group wavy annular thing and second group of wavy annular thing, interlaced coiling between adjacent sets wavy annular thing, and arrange successively along central axis direction, coordinating and form net, every group of wavy annular thing comprises at least one wavy annular thing.Above-mentioned many group wavy annular things can be formed directly in waist, or waist comprise net tubular body and with the coaxial sheathed many groups wavy annular of this body thing.
Referring to Figure 24, comprise first group of wavy annular thing 730a, second group of wavy annular thing 730b and be located at the 3rd group of wavy annular thing 730c between above-mentioned two groups of wavy annular things according to the waist 730 of the stopper 700 of this utility model the 6th embodiment.Every group of wavy annular thing comprises at least one wavy annular thing 731, and interlaced coiling between adjacent sets wavy annular thing coordinates and forms net, using directly as waist 730.And first group of wavy annular thing 730a and far-end disk-like structure 710 twine and connect, second group of wavy annular thing 730b and near-end disk-like structure 720 twine and connect.Certainly, stopper also can comprise and the coaxial sheathed body of above-mentioned net, and net covers body wholly or in part.
Referring to Figure 25, the braiding process of waist 730 is as follows: the mould rod 19 that the hanging wire bar 21 with at least two circle mutual dislocation is provided, adopt litzendraht wire circumferentially to walk around successively neighbouring two-layer hanging wire bar 21 to form wavy annular thing 731 along mould rod 19, litzendraht wire can be along circumferential winding at least two circles of mould rod 19, then the head and the tail two ends of litzendraht wire are fixed, and respectively enclose the litzendraht wire braiding of staggering, strengthen webmaster 22 thereby form, using directly as waist 730; Then proximal disk shape structure 720 and far-end disk-like structure 710 are connected in to the two ends of strengthening webmaster 22 by stitching thread, form stopper 700.
Referring to Figure 26, comprise first group of wavy annular thing 830a, second group of wavy annular thing 830b and be located at the 3rd group of wavy annular thing 830c between above-mentioned two groups of wavy annular things according to the waist 830 of the stopper 800 of this utility model the 7th embodiment.Between adjacent sets wavy annular thing, being intervally arranged and passing through connector 832 is connected, and coordinates and forms net, using directly as waist 830.And first group of wavy annular thing 830a and far-end disk-like structure 810 twine and connect, second group of wavy annular thing 830b and near-end disk-like structure 820 twine and connect.Certainly, stopper also can comprise and the coaxial sheathed body of above-mentioned net, and net covers body wholly or in part.
Particularly, wavy annular thing can be formed by filamentary material braiding, or cuts into hollow out net to form many group wavy annular things by tubing.For example, the hollow out eyed structure of waist 830 for being formed by a complete metal pipe material cut in preparation, this hollow out eyed structure can be to use metal tube (for example NiTi pipe) to form the metal pattern of waist 830 according to predetermined design cutting, decorative pattern after cutting comprises several wavy annular things 831 being axially spaced successively along waist 830, these wavy annular things 831 are to be formed by cut, therefore have closed loop characteristic.
The connector 832 that connects adjacent two wavy annular things 831 is connecting rod or filamentous, each connector 832 can be between the crest of one group of wavy annular thing 831 wherein and the trough of adjacent another group wavy annular thing 831, also can be between the crest of one group of wavy annular thing 831 wherein and the crest of adjacent another group wavy annular thing 831, these wavy annular things 831 and connector 832 form an entirety.Then connect respectively far-end disk-like structure 810 and near-end disk-like structure 820 at the two ends of the waist 830 with said structure, finally form stopper 800.In addition the operation of sewing up choked flow film is identical with previous embodiment.
Referring to Figure 27, waist 930 according to the stopper 900 of this utility model the 8th embodiment comprises the net tubular body 932 being connected with between near-end disk-like structure 920 and far-end disk-like structure 910, net tubular body 932 comprises that many interlaced and along the braided wires 933 of the central shaft helically coiling of body 932, wavy annular thing 931 is coordinated and formed by the predetermined multiple cross point 931a of fixing each braided wires and the braided wires section 931b between each cross point 931a.
The cross point 931a of same circle can be in same braided wires 933, and cross point 931a adjacent on same circle can be alternately as crest and trough.Body 932 can form with near-end disk-like structure 920 and far-end disk-like structure 910 integrated wovens, by forming the cross point 931a of constraint braided wires 933 on the braiding structure at body 932, to form the wavy annular thing 931 along its circumferencial direction coiling of at least one equivalence on the braiding structure at body 932, this equivalence wavy annular thing 931 is made up of continuous V-arrangement ripple, the crest of this V-arrangement ripple and trough point are the cross point 931a of litzendraht wire of constraint, connect be connected crest and the braided wires section 931b of trough and be the braided wires 933 that weaves body 932 self.Herein, without extra connecting line, directly on body 932, select predetermined point to twine and hand over or weld the braided wires of intersecting to form cross point 931a, form wavy annular thing 931 in conjunction with the braided wires section 931b between the 931a of cross point.
Distance between adjacent two the cross point 931a of wavy annular thing 931 can be selected, general crest and the equally distributed closed loop of trough of adopting, if the support strength that waist 930 needs is larger, can reduce the span between selected adjacent peaks (or adjacent trough), if instead the support strength that stopper 900 waists 930 need is less, increase the span between selected adjacent intersections 931a.This structure can guarantee that the circumference circle of waist 930 substantially remains unchanged in the time that radial force is asymmetric equally, prevent its be subject to force compresses after diameter dimension entirety dwindle.
In addition, the cross point 931a of above-mentioned constraint braided wires 933 makes two braided wires 933 can not arbitrarily slide at infall, guarantees that its angle is constant simultaneously.Can fixedly realize this constraint by line, referring to Figure 28, use connecting line 934 and take the mode of decussation to be fixed the cross point 931a of two braided wires 933, finally make it form one or more complete wavy annular thing 931 structures.
The waist of stopper provided by the utility model has at least one wavy annular thing, when waist is subject to the radial effect masterpiece used time, this wavy annular thing for example, carries out axial action by its waveform configuration (crest of end and trough structure) to waist, make the circumferencial direction transmission of this radial effect power along ring, thereby waist circumference circle under the effect of radial effect power remains unchanged substantially, therefore this stopper waist can be closely adherent with defect, thereby adapt to the irregular defect of cross sectional shape, for the damaged plugging effect that improved of this type, reduce the residual shunt of defect, postoperative hemolysis rate and related complication are reduced, improve the stability of stopper in defect location, also improved, in operation process, stopper model has been selected to wrong problem.Waist also can easily enter than in the little a lot of delivery sheath of its development size along with metal framework shrinks simultaneously, has guaranteed the serviceability of this stopper in intervene operation process; And after stopper discharges, waist returns to predetermined shape, and enough lumbar support power can be provided, make tubulose waist better coincide and be closely attached on the inwall at tissue defect position, further improve plugging effect.
The foregoing is only preferred embodiment of the present utility model; not in order to limit this utility model; all any modifications of doing within spirit of the present utility model and principle, be equal to and replace or improvement etc., within all should being included in protection domain of the present utility model.

Claims (12)

1. a stopper, the waist that comprises at least one disk-like structure and be connected with described at least one disk-like structure, it is characterized in that, described waist comprises at least one wavy annular thing, and the axis of described at least one wavy annular thing and described at least one disk-like structure is parallel to each other.
2. stopper as claimed in claim 1, it is characterized in that, described at least one disk-like structure comprises near-end disk-like structure and far-end disk-like structure, described waist is located between described near-end disk-like structure and described far-end disk-like structure, and described at least one wavy annular thing, described near-end disk-like structure and far-end disk-like structure three's axis is parallel to each other.
3. stopper as claimed in claim 2, is characterized in that, described waist comprises the described wavy annular thing of at least two mutual lap wounds.
4. stopper as claimed in claim 2, is characterized in that, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, and interlaced coiling between wavy annular thing described in adjacent sets coordinates and forms net; Described first group of wavy annular thing comprises that at least one and described near-end disk-like structure twine the described wavy annular thing connecing, and described second group of wavy annular thing comprises that at least one and described far-end disk-like structure twine the described wavy annular thing connecing.
5. stopper as claimed in claim 2, is characterized in that, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, is spaced and is connected by connector described in adjacent sets between wavy annular thing; Described first group of wavy annular thing comprises that at least one and described near-end disk-like structure twine the described wavy annular thing connecing, and described the second group far end wavy annular thing comprises that at least one and described far-end disk-like structure twine the described wavy annular thing connecing.
6. stopper as claimed in claim 2, is characterized in that, described waist also comprises the net tubular body being connected with between described near-end disk-like structure and far-end disk-like structure, described at least one wavy annular thing and coaxial sheathed being connected of described body.
7. stopper as claimed in claim 6, is characterized in that, described waist comprises the described wavy annular thing of at least two mutual lap wounds.
8. stopper as claimed in claim 6, it is characterized in that, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, described in every group, wavy annular thing comprises wavy annular thing described at least one, interlaced coiling between wavy annular thing described in adjacent sets, coordinate and form net, described net covers described body wholly or in part.
9. stopper as claimed in claim 6, it is characterized in that, described waist comprises at least the first group wavy annular thing and second group of wavy annular thing, described in every group, wavy annular thing comprises wavy annular thing described at least one, described in adjacent sets, wavy annular thing is spaced and is connected by connector along described body, coordinate and form net, described net covers described body wholly or in part.
10. stopper as claimed in claim 2, is characterized in that, described wavy annular thing extends and twines and connects in described far-end disk-like structure and/or described near-end disk-like structure.
11. stoppers as claimed in claim 2, it is characterized in that, described waist also comprises at least two-layer sheathed net tubular body mutually, described at least two-layer body two ends are connected with far-end disk-like structure with described near-end disk-like structure all respectively, and described wavy annular thing is located between adjacent two-layer body.
12. stoppers as claimed in claim 2, it is characterized in that, described waist also comprises the net tubular body being connected with between described near-end disk-like structure and far-end disk-like structure, described net tubular body comprise many interlaced and along the braided wires of the central shaft helically coiling of described body, described wavy annular thing coordinates and forms by fixing the predetermined multiple cross points of each braided wires and the braided wires section between each cross point.
CN201320850515.1U 2013-12-20 2013-12-20 Plugging device Expired - Lifetime CN203634215U (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103705274A (en) * 2013-12-20 2014-04-09 先健科技(深圳)有限公司 Plugging device
CN105748127A (en) * 2016-04-27 2016-07-13 中国人民解放军第二军医大学 Diaphragm type body cavity blocking equipment
CN106308867A (en) * 2015-07-01 2017-01-11 先健科技(深圳)有限公司 Closure device manufacturing method and closure device manufacturing mold

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103705274A (en) * 2013-12-20 2014-04-09 先健科技(深圳)有限公司 Plugging device
CN106308867A (en) * 2015-07-01 2017-01-11 先健科技(深圳)有限公司 Closure device manufacturing method and closure device manufacturing mold
CN106308867B (en) * 2015-07-01 2019-02-12 先健科技(深圳)有限公司 Plugging device production method and plugging device make mold
CN105748127A (en) * 2016-04-27 2016-07-13 中国人民解放军第二军医大学 Diaphragm type body cavity blocking equipment

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