CN203153821U - Occluder with included-angle-variable flat disk face - Google Patents

Abstract

The utility model relates to an occluder with an included-angle-variable flat disk face. The occluder comprises a single-layer disk, a plug body and a waist part connecting the single-layer disk and the plug body, wherein the single-layer disk is formed by elastic yarn in a weaving mode and comprises a plurality of supporting rods arranged in a radial shape, a grid formed by elastic yarn in a weaving mode is arranged on the surface of the plug body, and the waist part comprises at least one connecting line; an annular interlocking structure with holes is arranged in the center of the single-layer disk, the supporting rods are connected into a flat whole through the annular interlocking structure, and the connecting lines of the waist part are connected with the annular interlocking structure and the grid of the plug body. The occluder integrates the characteristics of the flat single-layer disk and the characteristics of the supple waist part structure, and the single-layer disk has a self-adaptive shape-adjusting function, so that the occluder can be effectively adapted to various physiological structures and meanwhile reduce complications.

Description

A kind of stopper with flat card of variable angle

Technical field

This utility model relates to a kind of medical apparatus and instruments, be specifically related to a kind of apparatus for shutoff human body internal channel or damaged or opening, the stopper that is particularly useful for patent foramen ovale (PFO) also can be used for shutoff patent ductus arteriosus, atrial septal defect, ventricular septal defect etc.

Background technology

By treat the cardiopathic method of congenital structure through the conduit intervening mode, be widely accepted at present.This method has tangible advantage with respect to traditional surgical method, and it is little to be mainly reflected in wound, recovers fast.

Such as, through conduit interventional therapy atrial septal defect (ASD), it is less that its principle is that the shutoff apparatus that will have elastic characteristic is compressed into a size, perhaps long and narrow structure, be transported to defect location through conduit, the self-expanding of elastic shutoff apparatus is returned to a default shape, and this default shape often comprises two disk-like structures and the syndeton that is connected two disk-like structures.Two disk-like structures place damaged both sides respectively, to damaged formation shutoff.Such shutoff apparatus often is referred to as stopper (occluder or occlusion device).

Early stage disk-like structure adopts the bigger metal of rigidity to make, and such structure is born the cyclic stress effect that heart beating brings in heart, and many apparatuses rupture because of fatigue stress.

A kind of stopper that is formed by many very thin metal wire braidings (hereinafter referred braiding class stopper) is developed out.On the one hand, seem soft owing to the litzendraht wire that adopts is very thin, the stress that is out of shape generation with heart beating is less, and the ability of endurance fracture obviously improves; On the other hand, by this stopper that many litzendraht wires constitute, even wherein crackle appears in the minority several threads, this crackle also is difficult for spreading to other structures, so the performance of whole fatigue-resistance characteristics is good.Though still have the some shortcomings part, when the stopper of this braiding class is applied to the shutoff of atrial septal defect (ASD), good clinical manifestation arranged generally.When but similar design is applied to the shutoff of patent foramen ovale (PFO), shown new deficiency.Atrial septal defect and the patent foramen ovale main distinction on physiological structure is that atrial septal defect is obvious breach, perhaps a cavernous structure from form; Patent foramen ovale is then more as a passage that has overlapping part, because this characteristics, the stopper that is applied to shutoff patent foramen ovale needs submissiveer syndeton.

Fig. 1 is a heart four chamber generalized sections, and the passage of PFO is between right atrium 11 and left atrium 12, and a stopper has been placed at this place.The anatomical structure of patent foramen ovale and general atrial septal defect are had any different, patent foramen ovale be not one poroid damaged, more as a long and narrow passage, secondary septum 1 and septum primum 2 between the left atrium overlap.Concerning majority, grow up after the growth, in secondary septum 1 and septum primum 2 position overlapped, both can be fused into one mutually, and left atrium is isolated.If overlapping part fails to merge, just formed a passage of linking up left atrium, this passage is called patent foramen ovale.Near the patent foramen ovale anatomical structure is big because of individual variation, is mainly reflected in the difference of interatrial septum thickness, such as the thickness of secondary septum 1.In some individuality, the average thickness of secondary septum 1 may be 2mm, and in the other individuality, the average thickness of secondary septum 1 may be 8mm.

The common method for blocking of patent foramen ovale is to implant stopper, adopts to have two disk-like structures (hereinafter referred dish), and be that the document of CN97194488.1 discloses as number of patent application.Double plate stopper 3, the first dishes 31 and second dish 32 among Fig. 1 clamps two interatrial septums (comprising secondary septum 1 and septum primum 2) of not fitting fully, abbreviates waist as by a waist syndeton 33() connect this two dishes, fitted in the interatrial septum.After apparatus was implanted, endothelium can be grown gradually, and the most whole double plate stopper 3 wraps up, forms shutoff completely.

In ideal conditions, after stopper was implanted, first dish, 31 and second dish 32 of the both sides of the PFO that is placed in was close to the wall of both sides, interatrial septum respectively.In the atrium, the part of being close to atrial walls on the dish is covered by endotheliocyte easily quickly, and the protuberance 35 on the protuberance 34 on first dish and second dish is then later capped, often still exposes in blood after other parts have all been covered by endothelium fully.Exposing the protuberance in blood, cause the rejection of health as foreign body, is inflammation and thrombotic major incentive.Before stopper was not covered by endotheliocyte fully, patient need continue to take the anticoagulant medicine, otherwise local thrombosed risk is just arranged.The thrombosis that forms in left atrium 12 can directly enter the body circulation after it comes off, may cause apoplexy, dangerous disease such as acute myocardial infarction.So, the dish of stopper, the dish 31 that especially is placed in the left atrium 12 should have flat architectural feature, and card does not have the part of projection, preferably the braiding disk-like structure of monolayer (hereinafter referred single-layered disk).Second dish and is compared in the left atrium 32 in right atrium 11, and when thrombosis occurring in the right atrium, its degree of danger can be far below the thrombosis that occurs in left atrium.The thrombosis of fritter arrives pulmonary can not cause tangible danger or symptom, has only the thrombosis of bulk just might cause obvious injury to pulmonary.So be placed on the netted knitting disc that the second interior dish 32 of right atrium can adopt bilayer of the prior art, abbreviate dual layer discs as, dual layer discs of the prior art, often be useful on the structure that connects induction system in the outside (away from a side of waist 33) of dish, this structure also tends to become the protuberance 35 on second dish 32, but in right atrium, generally believe that this is acceptable situation.

In addition, different individualities has different interatrial septums thickness, and often upside thickness is bigger, and downside is thinner, and as shown in Figure 1, the thickness of secondary septum 1 is obviously greater than the thickness of septum primum 2.This just requires stopper to have softness waist 33 flexibly, can allow first dish 31 and second dish, 32 relative deflection certain angles, allows simultaneously between two dishes, on the tangent plane direction of dish relativity shift can be arranged.If the improvement prior art, submissive waist 33 can improve the compliance of whole stopper, is conducive to two and coils the next door, room of fitting better.The space that very thin waist 33 occupies is littler, is conducive to the applying between two interatrial septums 1 and 2.If the waist rigidity of stopper is big, flexible position and angle relatively between two dishes may make wherein certain dish only some and interatrial septum applying, and the inside and outside both sides of another part card all are exposed in the blood flow.In Fig. 1, if can not form certain angle and keeping parallelism between first dish 31 and the 2 32, first dish, 31 lower limbs 37 just can not be close to interatrial septum 2 so, perhaps second dish, 32 lower limbs 36 can't be close to interatrial septum 2, and this part that breaks away from the interatrial septum often is difficult to be covered by endothelium, cause the delay of endothelialization, therefore need to lengthen the time of taking the anticoagulant medicine, and the local hemodynamics of influence; In case not withdrawing the anticoagulant medicine under the situation of endothelialization fully, the risk of bringing out thrombosis is arranged then.If stopper be placed with apparent in view deviation, the inboard of two dishes all can partly break away from the interatrial septum, causes higher thrombosis risk.As seen, submissive waist 33 can improve the overall performance of stopper, reduces postoperative risk.

In the prior art, many braiding class stoppers all fail to have concurrently flat single-layered disk and submissive these two key characters of waist.Simply introduce the stopper that many braids of usefulness of the prior art form below.

Application number be 97194488.1 Chinese patents document illustration a kind of stopper, as the double plate stopper 3 among Fig. 1, this stopper comprises a supporting network with shrinkage.Supporting network has constituted this device main body structure, its first dish, 31 and second dish 32 and waist 33 that comprises is an integral weaving structure, one end of the litzendraht wire of supporting network constitutes first dish 31, the mid portion of litzendraht wire converges to and constitutes waist 33 together, and the other end of litzendraht wire constitutes second dish 32.Two dish all is double-deck braiding structure, in order to reach practical plugging effect, needs tens of elasticity litzendraht wires to weave supporting network usually.Because all litzendraht wires are the intensive waist 33 that passed all, makes that the waist rigidity is big, and are not flexible.And then cause the angle of regulation range between two dishes very little, and can not relativity shift be arranged along the card direction, can not adapt to different anatomical structures well, the adherent inadequate situation of card appears easily.In the outside that places the dish of first in the left atrium 31 of this stopper, the end points of litzendraht wire converges and is fixed together simultaneously, forms the protuberance 34 on first dish 31, has destroyed the flat features of the dual layer discs of left atrium one side.This protuberance 34, often than the more late realization endothelialization in other positions, even might be after stopper be implanted the several years endothelialization fully also, and the patient who accepts this implant surgery usually only can take the anticoagulant medicine of half a year.Under the situation that does not have the anticoagulant medicine, the projection of endothelialization might not bring out the formation of thrombosis.Mohaned Egred etc. are at article: described one in " A late complication of a patent foramen ovale amplatzer occluder device " and implanted the example that back thrombosis for many years is attached to the stopper bossing.

Number of patent application is a kind of stopper that 200780010436.7 Chinese patent literature is announced, can be considered as is to be a kind of improvement on 97194488.1 the Chinese patent literature basis in above-mentioned patent application.Difference is that number of patent application is that all ends of litzendraht wire of the stopper announced in 200780010436.7 the Chinese patent literature all are fixed within the protuberance on second dish 32, on first dish 31, then be not used in the fixedly protuberance of litzendraht wire end, just do not had to protrude from the bulge-structure of card yet, improved to some extent in first dish, 31 flat features.But all litzendraht wires of this stopper all pass waist 33 twice, make waist 33 rigidity bigger, not flexible.

Above two kinds of stoppers in the prior art of Jie Shaoing, both have a common characteristic, all are the monolithic constructions that is made of litzendraht wire.Part on same litzendraht wire constitutes first dish, and another part constitutes second dish, and third part constitutes waist.A kind of like this design must cause waist rigidity excessive.The also stopper of the split-type structural that constitutes of useful many litzendraht wires in the prior art, these stopper characteristics are that the litzendraht wire that constitutes first dish constitutes this dish separately, and can not pass waist and participate in constituting second dish, so fundamentally reduced the material of waist, possibility is provided for the optimal design of waist.Yet in the prior art, failed to have concurrently flat single-layered disk and these two features of submissive waist syndeton equally by the stopper of known split-type structural.

Publication number is the stopper with newel feature that the american documentation literature of US20040143291A1 is announced.This stopper comprises two single-layered disk, and each is made of each single-layered disk several flexible shutoff sheets that present the support bar of radial layout and adhere on it, and support bar can be formed by many braids; What connect two single-layered disk is the newel that has the joint.The two ends of newel can be passed for the support bar that constitutes single-layered disk along axially being staggeredly distributed with a plurality of radial holes.A plurality of support bars on the single-layered disk pass radial holes different on the newel respectively, form arranged crosswise.The thickness of this single-layered disk marginal position equals the diameter of support bar, and single-layered disk therein the thickness of heart position equal a plurality of support bar diameter sums, for example when single-layered disk is made of three support bars, the single-layered disk thickness in centre equals three support bar diameter sums at least, and such single-layered disk structure is the good flat features of tool not.But, lacking under the situation of newel, the support bar on the same single-layered disk is in loose condition (of surface), can not constitute independent stable disk-like structure.The newel of this stopper plays two aspect effects, connects two single-layered disk and constitutes waist on the one hand, retrains a plurality of support bars on the single-layered disk on the other hand, makes it constitute stable plate-like mechanism.The newel that the document discloses is that the structure by three sections rigidity connects together and forms with articulated manner, and compliance is relatively poor, and the end of newel can give prominence to the outside in single-layered disk, requires further improvement.

In sum, braiding class stopper of the prior art no matter be monolithic construction or split-type structural, all fails to have concurrently these two key characters of flat single-layered disk and submissive waist.The stopper of monolithic construction of the prior art, all litzendraht wires that constitute first dish all pass through waist and arrive second dish, make waist material intensive, and waist rigidity is inevitable excessive; The end points of litzendraht wire is concentrated to be fixed to a place or two places, and these fixing points are the bulge-structure on the formation dish often, has destroyed the flat features of dish.Split-type structural design of the prior art, litzendraht wire is woven into many support bars earlier, and support bar connects and composes stopper with newel again, and at the overlapping disk center position of support bar, its disc thickness has destroyed the flat features of dish apparently higher than the thickness at edge; For fixing discrete a plurality of support bars, the part that newel is connected with bar need have position and the direction that enough rigidity could retrain each bar, this makes the compliance of newel be restricted again, its deformation position can only occur in joint position, and can't be out of shape self adaptation according to the specific physiological structure of individual patient.

The utility model content

A technical problem to be solved in the utility model is to provide a kind of stopper that has the clinical requirement of flat shutoff dish and submissive these two keys of simple waist simultaneously.

Solving a kind of technical scheme that this technical problem of the present utility model adopts is: a kind of stopper with flat card of variable angle is provided, described stopper comprises a single-layered disk, cock body and the waist that is connected single-layered disk and cock body, described single-layered disk is formed by the elastic yarn braiding, described single-layered disk comprises a plurality of support bars of arranging radially, the grid that flexible silk braiding forms on the surface of described cock body, described waist comprises at least one connecting line, central authorities in described single-layered disk arrange an annular interlocking structure that has hole, described a plurality of support bar connects into flat integral body by described annular interlocking structure, and the connecting line of described waist is connected with the grid of described annular interlocking structure and described cock body.

Preferably, the connecting line of described waist passes the hole on the described annular interlocking structure, and passes the mesh on the described cock body.

Preferably, the quantity of the support bar of described single-layered disk is four to eight, the support bar of described single-layered disk all is configuration in pairs, each is positioned at support bar on same the diameter of single-layered disk and by same group of elastic yarn braiding and forms, and the elastic yarn of described support bar is woven into described annular interlocking structure jointly.

Preferably, described support bar is bent into L type, S type or arc.

Preferably, each described support bar be configured to spring-like near terminal one section, perhaps the end of each described support bar be provided with one blunt nosed.

Preferably, described annular interlocking structure has a centre bore.

Preferably, described single-layered disk also comprises the choked flow film, and described choked flow film covers on described support bar and the described annular interlocking structure.

Preferably, described cock body is plate-like or column, and a fixture is set on the described cock body, and the end of the elastic yarn of described cock body is fixed on the described fixture.

Preferably, the connecting line of described waist is closed hoop.

Preferably, be attached with fiber on the described connecting line.

Compared with prior art, this utility model possesses following advantage: stopper of the present utility model has had the feature of flat single-layered disk and submissive waist structure concurrently, and single-layered disk has the function that self adaptation is regulated form, can effectively adapt to multiple different physiological structure, reduces complication simultaneously.Flat single-layered disk is conducive to reduce the risk that thrombosis adheres to, and accelerates the endothelialization process.Submissive waist is conducive to two and coils fit better atrial walls or blood vessel wall, reduces the disturbance to blood flow, reduces the hyperplasia of tissue.Have self adaptation and regulate the single-layered disk of form, can reduce the counteracting force to surrounding tissue, reduce the risk to tissue injury.

Description of drawings

The utility model is described in further detail below in conjunction with drawings and Examples, in the accompanying drawing:

Fig. 1 is the generalized section of heart four cavity configurations.

Fig. 2 is the rough schematic of a kind of embodiment of stopper of the present utility model.

Fig. 3 is the vertical view of the inboard net of the dual layer discs among a kind of embodiment of stopper of the present utility model.

Fig. 4 is the sketch map of six radial support bars of arranging among a kind of embodiment of stopper of the present utility model.

Fig. 5 is another embodiment of support bar, and wherein, a litzendraht wire on this support bar is being configured to spring-like near the support bar terminal position.

Fig. 6 is the sketch map of a litzendraht wire on a kind of support bar.

Fig. 7 is the rough schematic of another embodiment of the single-layered disk of this utility model stopper.

Fig. 8 is bent to the sketch map of M type for the pair of support rods in the single-layered disk.

Fig. 9 is the side schematic view of another embodiment of this utility model stopper.

Figure 10 is four support bars of the cross radial layout in the stopper of the present utility model.

Figure 11 is each sketch map that support bar is made of four litzendraht wires.

Figure 12 is the cross section of the another kind of embodiment of support bar, and wherein, each constitutes the very thin litzendraht wire of support bar by seven same diameter.

Figure 13 is the compressed sketch map that is placed on afterwards in the delivery sheath of the stopper of a kind of embodiment of the present utility model.

Figure 14 is the aortal ductus arteriosus sketch map of the stopper shutoff of a kind of embodiment of the present utility model.

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 only in order to explaining this utility model, and be not used in restriction this utility model.

The stopper that embodiment of the present utility model discloses is the split-type structural that constitutes with many litzendraht wires.By a single-layered disk and compressible cock body by one independently waist connect to form so that stopper meets the clinical requirement of flat shutoff dish and submissive these two keys of simple waist simultaneously.Wherein single-layered disk is to be made of a plurality of support bars of arranging radially, be equipped with the annular interlocking structure in hole with holes on this single-layered disk near centre bit, described annular interlocking structure is formed around the braiding of single-layered disk center by the litzendraht wire on the support bar, avoid many litzendraht wires to be accumulated in the center of single-layered disk and to cause being multiplied of single-layered disk thickness, thereby obtained very flat single-layered disk structure; Annular interlocking structure has been fixed the relative position of single-layered disk upper support bar simultaneously, makes that under the situation that does not need extra material or structure to fix single-layered disk can become stable relatively independent integral body.The cock body of stopper can have the multiple different specific embodiment, and manufacture method is similar, mainly is the shaper difference.For example, for the PFO stopper, cock body can be dual layer discs; For the PDA stopper, cock body can be the column cock body.Dual layer discs is the latticed dual layer discs that forms with many braids and typing, and the outside of this dual layer discs has a stiff end on the net, and its inboard netting gear has a centre bore, also is stable independent integral body under the situation that does not have additional materials or structure to retrain.The column cock body also is that many braidings are thread, also comprises inboard net and outside net, is the side of column cock body between inboard net and the outside net, and inboard net and outside net are respectively the bottom surfaces of column cock body.

Because single-layered disk and cock body have all possessed stable absolute construction separately, so just make waist only need bear the function of connection, and the form of do not need restraint single-layered disk and cock body, so waist can be arranged to simple submissive structure to greatest extent.Stopper described in the utility model, its single-layered disk and waist between the cock body are to adopt submissive connecting line to pass the braiding hole on single-layered disk and the cock body respectively and be connected with cock body with single-layered disk and constitute.

The stopper that this utility model discloses has had flat single-layered disk and submissive waist feature concurrently.Below the structure that will illustrate this stopper with more detailed description and a plurality of embodiment with and the advantage that embodies when being applied to shutoff different human body organ defect.

First embodiment

Fig. 2 demonstrates the rough schematic that this utility model discloses a kind of embodiment of stopper, this stopper comprises single-layered disk 4 and the netted dual layer discs 6 of a braiding and the waist 5 of a softness with six support bars 40 of radial layout, and the central authorities in the outside of dual layer discs 6 have a stiff end 64.

The dual layer discs 6 of this stopper is the parallel disk-like structure of latticed bilayer that is formed by many elasticity braids, comprises parallel inboard net and outside net, can adopt weaving method of the prior art, the corresponding mould shape of reuse and obtaining.The end points that constitutes the litzendraht wire of this dual layer discs 6 converges at the stiff end 64 in the outside online (away from that side of single-layered disk 4) of dual layer discs 6, and in the inboard of dual layer discs 6 online (side that links to each other with single-layered disk 4), the end points that does not have litzendraht wire, the also fixing structure of litzendraht wire not, do not occupy the waist space, can do waist 5 very thin like this, loose, submissive, be conducive to the adaptability of stopper.Fig. 3 is the vertical view of the inboard net of dual layer discs 6, has a center mesh 61 the inboard online of dual layer discs 6, and a plurality of common mesh, and as mesh 62 and 63, these mesh can pass for the connecting line of waist 5.In the interlayer between the inboard net of this dual layer discs 6 and the outside net, diaphragm material can be arranged, play the effect of auxiliary blocking blood flow.

The waist 5 of this stopper is that the connecting line by softness constitutes.Connecting line has limited the ultimate range between two dishes, allows the swing of the angle between two dishes simultaneously and along the relativity shift of card direction.The annexation of this waist 5 and dual layer discs 6 can realize by the inboard online mesh that connecting line passes through this dual layer discs 6, such as, one end of connecting line can penetrate dual layer discs 6 from the center mesh 61 on the dual layer discs 6, from mesh 63, pass dual layer discs 6 again, tie a knot with the other end of connecting line then, constitute closed hoop.In the manufacturing process of this closed hoop, dual layer discs 6 has three litzendraht wires to be ensphered within this closed hoop, and therefore, the inboard net of dual layer discs 6 has higher intensity with being connected of closed hoop.If the intensity of single litzendraht wire is enough big, then can select to connect with the single litzendraht wire of dual layer discs 6, such as from center mesh 61, penetrating, from mesh 62, pass again, then only ensphered a litzendraht wire of dual layer discs 6 in the closed hoop, the waist 5 that forms like this is just more loose.Selection for the mesh on the dual layer discs 6 is not limited to above-described method, can select the combination of different mesh.These closed hoops can have a plurality of, and preferably, wherein each closed hoop is all realized by an independent connecting line, and waist 5 still keeps enough compliances, especially, even wherein certain closed hoop is destroyed, still do not influence the interconnect function of other separate closing ring, realized Redundancy Design.Also can pass the hole of single-layered disk 4 and the mesh on the dual layer discs 6 repeatedly with a connecting line, constitute the closing coil of multiturn, such design is conducive to enhance productivity.

The single-layered disk 4 of this stopper can comprise six radial support bars of arranging as shown in Figure 4, and two support bars that wherein are distributed on the same diameter constitute pair of support rods, constitutes pair of support rods such as support bar 401 and support bar 404.Each is made of one group of elasticity litzendraht wire support bar, in the present embodiment, each is made of two litzendraht wires support bar, these two litzendraht wires have constituted one group of litzendraht wire, are pair of support rods such as support bar 401 and support bar 404, the one group of litzendraht wire that constitutes this a pair of support bar has comprised litzendraht wire 481 and litzendraht wire 482.Be that example is described concrete manufacturing process with support bar 401, two litzendraht wires 481 from the end of support bar 401,482 are woven together has mutually constituted support bar 401, two litzendraht wires are separated at the center of single-layered disk 4, litzendraht wire 481 always strides across on the litzendraht wire 485 of self-supporting bar 403, always stride across under the litzendraht wire 486 of self-supporting bar 403 again, then from from striding across above the litzendraht wire 483 of another support bar 402, always stride across below the litzendraht wire 484 of self-supporting bar 402 again, therefore, litzendraht wire 481 and many litzendraht wires 485,486,483, the 484th, overlapping in turn.Similarly, litzendraht wire 482 always self-supporting bar 402 litzendraht wire 483 below stride across, again always the litzendraht wire 484 of self-supporting bar 402 above stride across, above the litzendraht wire 485 from another support bar 403, stride across then, always stride across below the litzendraht wire 486 of self-supporting bar 403 again, therefore, litzendraht wire 482 and many litzendraht wires 483,484,485,486 overlapping in turn.Litzendraht wire 481 and 482 both sides from the center of single-layered disk 4 stride across to converge to again behind the near zone of center continues to be woven together mutually together, constitutes support bar 404.As can be seen from Figure 4, near the close center of single-layered disk 4 annular region, each root litzendraht wire is with overlapping in turn from many litzendraht wires in other several groups of litzendraht wires, constitute the annular interlocking structure 7 with hole, be formed naturally described hole between the overlapping litzendraht wire in turn, the center of annular interlocking structure 7 can keep a centre bore 71.By annular interlocking structure 7, got off by relative fixed in the position of six support bars, under the situation that does not need additional materials to fix, six support bars constitute the flat single-layered disk 4 of an integral body, and in annular interlocking structure 7, stay a plurality of holes, such as hole 71 and 72, be convenient to be connected with waist 5.In the braiding process of single-layered disk 4, the existence of centre bore 71 has also made things convenient for litzendraht wire to walk around from side respectively, is conducive to improve make efficiency.Yet in another embodiment that adopts very soft litzendraht wire, the braiding of finishing single-layered disk 4 just can no longer keep centre bore 71 later, and therefore, the feature internal diameter of centre bore 71 can dwindle until just holding a connecting line and pass from centre bore 71.

End at support bar, that is to say at the litzendraht wire terminal position and also can increase preferred setting, position such as the end of the support bar 404 among Fig. 4 is set up one blunt nosed 420, for example, sheath with a flexibility wraps up the litzendraht wire end, and sheath is fixed on the end of support bar 404 with soft stitching thread.Perhaps be solidified into blunt nosedly 420 with the terminal post-heating of ePTFE film wrapped litzendraht wire, perhaps the litzendraht wire end welded together and be processed into slick and sly blunt nosedly 420, avoided sharp-pointed metal knitted line end to the damage of tissue like this.

In another embodiment of support bar 40, as shown in Figure 5, a litzendraht wire 451 on the support bar 40 is being configured to spring-like near support bar 40 terminal positions, it is the terminal spring 457 among Fig. 5, the end of other litzendraht wires 452 on the same support bar 40 all is strapped in the intracavity of terminal spring 457, and the end of terminal spring 457 is processed into blunt nosed 420 of a slyness.Particularly, terminal spring 457 can preboarding on same litzendraht wire, as shown in Figure 6, the two ends of litzendraht wire 451 have a terminal spring 457 respectively, the litzendraht wire 451 that has two terminal springs 457 together constitutes pair of support rods (comprising support bar 40) and annular interlocking structure 7 with all the other litzendraht wires again, makes this a pair of support bar that has same group of litzendraht wire to constitute have better structural stability.

Further, the end at each support bar 40 of this single-layered disk 4 can arrange a L type bending section 454 that is folded to circumferencial direction, as shown in Figure 7.Preferably, described each L shaped bending section 454 all is in the same plane with single-layered disk 4 basically.Preferably, described L shaped bending section 454 is handled through typing by the terminal spring 457 among Fig. 5 and is realized (not showing among Fig. 7).Such L type bending section 454 makes the end of support bar 40 seem more soft when being subjected to radial pressure.After the implanted heart of stopper, beating of heart can make stopper, especially the support bar 40 of single-layered disk 4 and tissue on every side have mutual active force, L type bending section 454 is conducive to increase support bar 40 and the contact area of organizing, lower the pressure that 4 pairs of tissues of single-layered disk apply, reduced the risk to tissue injury.It is pointed out that support bar 40 also can have S type bending section or arc-shaped bend section, the sweep of each support bar 40 is not confined to end, but can be arranged at any position on the whole support bar 40, and its effect is similar to L type bending section 454.

Preferably, above-mentioned single-layered disk 4 can all be made of shape-memory material, such as Nitinol, and can be by heat setting, single-layered disk 4 is become the dish of center projections, the M type longitudinal section of passing central shaft such as single-layered disk shown in Figure 84 that is to say that each is bent to the M type to support bar.Allow the edge 455(of single-layered disk 4 be the end of support bar 40) in dual layer discs 6(Fig. 8, show) bending, and in the annular interlocking structure 7 protruding central authorities to dual layer discs 6 at the center of single-layered disk 4, and, edge 455 is than annular interlocking structure 7 more close dual layer discs 6, such shape facility makes the edge 455 of single-layered disk 4 and the spacing between the dual layer discs 6 less than the spacing between two disk center, and stopper had not only kept showing among waist 5(Fig. 8) suitable length but also make two plate edge spacings more close.Its advantage is that on the one hand, the waist 5 of suitable length is conducive to embody the compliance of waist 5, and allows can have along the card direction between two dishes skew of certain amplitude; On the other hand, after stopper discharged, the edge 455 of single-layered disk 4 and the gap of interatrial septum were reduced in the 455 easier clamping interatrial septums, edge of single-layered disk 4, reduce the thrombosis risk.And the resistance of annular interlocking structure 7 protruding central authorities to dual layer discs 6 when being conducive to reduce single-layered disk 4 income delivery sheaths 80, as shown in figure 13.

Further, adhere to soft diaphragm on the single-layered disk 4 that this braiding forms, as sewing up polyester (polyester) or polytetrafluoroethylene (PTFE) diaphragm, can play the effect of quick blocking blood flow.

Second embodiment

Fig. 9 is the side schematic view of another embodiment of this utility model stopper.The stopper that present embodiment discloses comprises a single-layered disk 4, a dual layer discs 6 and a waist 5.Wherein, dual layer discs 6 and waist 5, all with first embodiment in Fig. 2 and Fig. 3 similar.

But the connecting line of the waist 5 among Fig. 9 is two separate closed hoops, is the optimal way of first embodiment.In the another kind of embodiment of waist 5, connecting line one end only connects near the central authorities of inboard net of dual layer discs 6, and the other end of connecting line only connects single-layered disk 4, rather than the closed connecting line of head and the tail.With a kind of embodiment that is connected of dual layer discs 6 be: an end of connecting line passes near a plurality of mesh the central authorities of the inboard net on the dual layer discs 6 and arrives the stiff end 64 of dual layer discs 6 outsides net, is fixed together with the termination of the litzendraht wire that constitutes dual layer discs 6.As another kind of embodiment, connecting line also can be on the cross point of two litzendraht wires that knotting is fixed on dual layer discs 6 behind the one or more mesh that pass on the dual layer discs 6.Described connecting line is connected with single-layered disk 4, can be that an end of connecting line passes at least one hole on the single-layered disk 4, and is intertwined with one group of litzendraht wire of single-layered disk 4 and is fixed on the single-layered disk 4; Also can be that after an end of connecting line passed one or more holes of single-layered disk 4, this end knotting with connecting line formed a tieing bigger than the pore-size between the braided wires on the single-layered disk 4, prevents that connecting line breaks away from the corresponding hole on the single-layered disk 4.In addition, connecting line repeatedly passes the said minuscule hole on the single-layered disk 4, and the frictional force between connecting line and the single-layered disk 4 also plays auxiliary fastening effect.

This waist 5 all has softness, loose, adjustable characteristics, and its connecting line can be metal material such as Nitinol, rustless steel, platinum etc.Preferably, such as adopting Nitinol, advantage is its shape memory characteristic, through tieing is done heat treatment, can make the shape of tieing relatively stable after the end points knotting is fixing, is difficult for getting loose.The super-elasticity that Nitinol possesses also can make connecting line seem more soft, has enough tensile strength.Connecting line can be nonmetallic materials, and such as nylon, nonmetallic connecting line is often more soft than metal material.Wherein arbitrary connecting line can be that the multiply fiber constitutes.When adopting the metal connecting line, in order to reach good compliance, its diameter is not more than 0.3mm, and preferably, the connecting line diameter is less than 0.2mm.If the connecting line of multiply fiber, each root fibre diameter is not more than 0.12mm, preferably, the about 0.15mm of the equivalent diameter of this connecting line, the Nitinol line that is about 0.05mm by seven diameters twists into.

Especially, the closed hoop that connecting line constitutes or coil can be stretched and be out of shape, when being stretched to long status, each closed hoop or each coil have a major axis, this major axis is perpendicular to dual layer discs 6 or single-layered disk 4, and this major axis is the 2-10 millimeter, and preferred major axis is the 3-5 millimeter.

This waist 5 also can be attached with flexible fiber, and polymer fiber such as PET, can directly twine or be woven on the connecting line often.Such fiber is conducive to fill tissue to be repaired, and for example, the passage blood flow of auxiliary shutoff patent foramen ovale reduces residual shunt, shortens the closed required time.

Be different from first embodiment, single-layered disk 4 can comprise four support bars, i.e. two pairs of support bars.Four support bars 41,42,43,44 of cross radial layout as shown in figure 10, each support bar is formed by two braids, relative two support bars 41 and 42(or support bar 43 and 44 on the same diameter of single-layered disk 4) constituted by one group of common litzendraht wire, each end of organizing litzendraht wire is separately fixed at each support bar 41,42,43,44 end, so the end of these litzendraht wires is fixed on corresponding blunt nosed 420 former capital, inside and can expose support bar 41,42,43,44 outsides.Similar with the method among first embodiment, belong to different support bar 41,42,43,44 litzendraht wire near being overlapping in turn near the center of single-layered disk 4, near the center of single-layered disk 4, constitute an annular interlocking structure 7, four support bars 41,42,43,44 position are interfixed, form very smooth disk-like structure.

Particularly, the pair of support rods 41 and 42 that is distributed on the same diameter is formed by two litzendraht wires 411,412 braidings, and the pair of support rods 43 and 44 that is distributed on another diameter is formed by other two litzendraht wires 431,432 braidings.Two litzendraht wires 411 and 412 far-ends by one of them support bar 41 that constitute support bar 41 and 42 begin, mutually twine braiding and along the center of diametric(al) near single-layered disk 4, these two litzendraht wires 411,412 are near the position at the center of single-layered disk 4 separately.After two litzendraht wires 411 and 412 are walked around central point from the both sides of central point respectively, the other end in support bar 41 place diametrical position, two litzendraht wires 411 and 412 converge to together, again be interweaved, and extend along the direction away from the center of single-layered disk 4 of same diameter, form support bar 42.Same, with perpendicular another of the first pair of support bar support bar 43,44 also is made of one group of litzendraht wire 431,432 braidings.And in the position near the center of single-layered disk 4, four litzendraht wires are overlapping in turn, every litzendraht wire is from from striding across above the litzendraht wire another group litzendraht wire, below another the root litzendraht wire of another group litzendraht wire, stride across again, for example, litzendraht wire 411 strides across below another root litzendraht wire 432 again from from striding across above the litzendraht wire 431 another group litzendraht wire.Litzendraht wire 411,412,431,432 is around the centers of single-layered disk 4, annular interlocking structure 7 of overlapping formation in turn, and surround the centre bore 71 of a sub-circular or approximate polygon.In this annular interlocking structure 7, litzendraht wire 411 has a cross point 471,472 with litzendraht wire 431 and litzendraht wire 432 respectively, litzendraht wire 412 has cross point 473,474 with litzendraht wire 431 and litzendraht wire 432 respectively, as can be seen from Fig. 10, cross point 471,472,473,474 be distributed in annular interlocking structure 7 centre bore 71 around, and be not stacked.At each cross point 471,472,473,474 places, the thickness of single-layered disk 4 equals the diameter sum of two litzendraht wires, consistent with the maximum ga(u)ge of other positions on the single-layered disk 4 (equaling support bar 41,42,43,44 diameter substantially), therefore annular interlocking structure 7 can not increase the thickness of single-layered disk 4.

Constitute each one group of litzendraht wire to support bar among Figure 10 and included only two litzendraht wires, the litzendraht wire negligible amounts that each group litzendraht wire comprises is so in the center of single-layered disk 4, the centre bore 71 that braiding forms seems irregular.In the examples of implementation of different single-layered disk 4, if increase the litzendraht wire quantity of each group litzendraht wire, and select more soft litzendraht wire for use, centre bore 71 more approaching circle or polygons then, structural stability and the symmetry of so annular interlocking structure 7 are better.

In the present embodiment, the thickness of the each several part of single-layered disk 4 is even, and it is similar with support bar 41,42,43,44 diameter, and the maximum ga(u)ge of the annular interlocking structure 7 at center also with the maximum ga(u)ge basically identical of single-layered disk 4, so the thickness of whole card is even, do not have the node that obviously protrudes from card, have good flat features.

In another embodiment of single-layered disk 4, each of formation single-layered disk 4 can be more than two to one group of litzendraht wire of support bar, can be four or the six roots of sensation or more.Suppose that each need have certain rigidity to support bar, so, when constituting each when big to the litzendraht wire quantity of support bar, can select the smaller litzendraht wire of diameter for use, such benefit is that the diameter of support bar does not increase (thickness of single-layered disk 4 does not increase yet) and fatigue-resistance characteristics is improved.

Figure 11 has shown each example that support bar is made of four litzendraht wires.One group of litzendraht wire of formation support bar 40 is begun by the far-end of one of them support bar, and braiding constitutes a support bar 40 mutually, and this group litzendraht wire is separated into two son groups in the position at the center of close single-layered disk 4, and each sub-component does not comprise two litzendraht wires.The litzendraht wire of two son groups is walked around central point from the central point both sides respectively, the other end at support bar 40 place diameters, the litzendraht wire of two son groups converges to together, again be interweaved, and extend along the direction away from the center of single-layered disk 4 of same diameter, form another support bar with support bar 40 pairings.Therefore, the support bar on the single-layered disk 4 can weave out in couples.Similarly, with perpendicular another of the first pair of support bar support bar is also become by two sub-fabrics of another group litzendraht wire.And in the position near the center of single-layered disk 4, four son groups are overlapping in turn, litzendraht wire of each son group from from stride across above the litzendraht wire of a son group another group litzendraht wire and the litzendraht wire of another height group from another group litzendraht wire below stride across, the litzendraht wire of four son groups surrounds a centre bore 71, forms annular interlocking structure 7.Because the quantity of litzendraht wire is more, the slit between the litzendraht wire is littler, and the centre bore 71 of annular interlocking structure 7 is just less relatively, and the effect of interlocking can be stronger.

One group of litzendraht wire described in the present embodiment comprises four litzendraht wires, also can be to be divided into two groups unevenly, comprises a litzendraht wire such as one of them son group, and another height group comprises three litzendraht wires.

Further, the quantity that constitutes the support bar of single-layered disk 4 also can be six, eight, ten or other quantity, even and the quantity of support bar has difference, the braiding process of single-layered disk 4 does not have variation in essence.

It is to be noted, the weaving manner of many litzendraht wire formation support bars can have multiple, weaving manner shown in Figure 11 just for convenience of description, can not be interpreted as restriction of the present utility model, the mode that a plurality of lines are woven into a rod-like structure or multi cord structure has multiplely particularly, and has been known technology.And along with the quantity of the litzendraht wire on each support bar is more many, the mode of braiding is just more flexible, can make support bar have different cross sectional shapes by the difference of weaving manner, when the cross section of support bar is non-rotating symmetric shape, its cross section the moment of inertia difference in different directions, so the rigidity that support bar embodies in different directions is also different.

Figure 12 has shown the cross section of the another kind of embodiment of support bar, and each can be made of the very thin litzendraht wire 51 of seven same diameter support bar, has improved the fatigue proof characteristic of support bar.In the centre of single-layered disk 4, be divided into two son groups from seven litzendraht wires of a support bar, one of them son group comprises three litzendraht wires, and another height group comprises four litzendraht wires.The diameter of seven selected litzendraht wires 51 can be identical, also can be different.Each support bar also can be woven by six roots of sensation litzendraht wire respectively, and the litzendraht wire diameter at support bar cross-section center place can be slightly less than the diameter of its all the other five litzendraht wires on every side at this moment.Each support bar also can be woven by eight litzendraht wires respectively, and the litzendraht wire diameter at support bar cross-section center place can be slightly larger than the diameter of all the other seven litzendraht wires at this moment.

On the single-layered disk 4 with annular interlocking structure 7, the angle between the support bar can have suitable self adaptation adjusting range.For example, in Figure 10, the angle 9 between two support bars 42 and 44 can change, and the contour shape of single-layered disk 4 can be adjusted to ellipse by circle, but the feature of this self adaptation distortion will become the important advantage of stopper in some application scenarios.Here suppose that wherein pair of support rods 41,42 is fixed, and support bar 43 is subjected to the power of circumferencial direction, this power is applied by beating or being out of shape institute of heart or blood vessel, supposes that masterpiece is used in the end of support bar 43, produces a moment and will make support bar 43,44 that the trend that turns clockwise is arranged.In annular interlocking structure 7, two litzendraht wires 431 that support bar 43 is told and 432 overlapping cross point 471,472,473,474 are being subjected to the frictional force of litzendraht wire 411 and 412 in turn with litzendraht wire 411 and 412.In general, this frictional force can't retrain the trend of support bar 43,44 rotations, so the angle 9 between support bar 42 and 44 can diminish, the profile of single-layered disk 4 also no longer keeps circular symmetry, but becomes ellipse.Because the distortion of single-layered disk 4, the counteracting force that makes its support bar 43,44 impose on atrial walls or blood vessel reduces, and the damage risk of heart or blood vessel is also reduced.Than Figure 10, the quantity of support bar in the embodiment shown in fig. 4 increases, the litzendraht wire of each support bar and the litzendraht wire of greater number are overlapping and form more cross point in turn, each support bar is subjected to frictional force that other support bar applies also along with increase, the ability of resistance to deformation strengthens, and Bian Xing amplitude also can reduce simultaneously.In the performance parameter of support bar and the moment that is subjected to all under the roughly the same situation, angle 8 between the support bar 401 and 402 among Fig. 4, more be difficult to change than the angle 9 between the support bar 42 and 44 among Figure 10, that is to say that the single-layered disk 4 of six support bar formations has better structural stability.In addition, if increase litzendraht wire quantity on each support bar, the litzendraht wire in the annular interlocking structure can be more intensive, and the frictional force between the support bar can be bigger and amplitude that it is movable also can reduce.In different application scenarios, can select the count of litzendraht wire quantity, support bar quantity and annular interlocking structure 7 as required, regulate the adaptability of single-layered disk 4 distortion.

Figure 13 shows the compressed form that is placed on afterwards in the delivery sheath 80 of the stopper of this utility model embodiment.Wherein, single-layered disk 4 links together by waist 5 with dual layer discs 6, carries wirerope 70 to set up departing the connection by stiff end 64 with dual layer discs 6.Promote to carry wirerope 70, stopper is discharged into the outside of delivery sheath 80, stopper was just expanded and was reverted to Fig. 2 or shape shown in Figure 9 this moment.

The 3rd embodiment

Patent ductus arteriosus of the prior art (PDA) stopper, the monolithic constructions that constitute of many litzendraht wires often, thicker disk-like structure in the arteries and veins that has the initiative is also arranged, but there is not waist, rigidity is often bigger than normal, angle when between aorta and ductus arteriosus is less, rather than when spending near 90, place the disk-like structure of aorta that meeting perk is on one side often arranged, the blood vessel wall of can not fitting well, and the thickness of disk-like structure is obviously and inadequately more flat, causes the big disturbance to blood flow.In addition, place endaortic disk-like structure self adaptation not to be out of shape, also influenced adherent effect.When bigger circulatory disorders thing was arranged in the aorta, swiftly flowing blood flow strikes obstacles may cause erythrocytic breaking, and causes severe complications.

In above-mentioned second embodiment, the dual layer discs 6 of stopper can be arranged to have columned column cock body 16, and two bottom surfaces of column cock body are respectively inboard net and outside net, are provided with diaphragm in the inside of column cock body 16, and diaphragm plays the effect of blocking blood flow.Four support bars of single-layered disk 4 play the effect of support fixation column cock body 16, can cover the diaphragm of the flexibility of monoblock at four support bars.When being applied to the shutoff patent ductus arteriosus, the stopper of this structure can embody tangible advantage.As shown in figure 14, flat single-layered disk 4 is close on the inwall of aorta 10, and column cock body 16 is placed in the not closed ductus arteriosus 12.Can see from Figure 14, be not that vertical, submissive waist 5 can allow stopper to adapt to this blood vessel structure between the axis of ductus arteriosus 12 and aorta 10.On the other hand, the tightness of the braided wires of annular interlocking structure is optional, and the angle 9 between two support bars of permission single-layered disk 4 changes between 30 ° to 150 °, and the profile of single-layered disk 4 just can become ellipse from initial circle like this.For single-layered disk 4 rounded or the rotation symmetric figure, the doctor can not go to consider the angle of stopper release when placing stopper, be released to when stopper after the inside of aorta 10, single-layered disk 4 is placed in the aorta, and the impulsive force of aortic flow is very big, the single-layered disk 4 that has covered diaphragm can be pushed in the ductus arteriosus 12, at this moment, the aorta 10 of tubulose makes extruding single-layered disk 4 and makes single-layered disk 4 distortion, also will change the angle 9 between the support bar, but single-layered disk 4 still can keep flat pattern preferably.

Even do not cover diaphragm in single-layered disk 4, the shape of blood vessel around the support bar of single-layered disk 4 also can adapt to automatically still can keep flat.At this moment, place the column cock body 16 in the ductus arteriosus 12 to block blood flow, simultaneously because the pressure in the aorta 10 is higher than the pressure in the pulmonary artery 11, so column cock body 16 has been subjected to the thrust of 11 directions from aorta 10 to pulmonary artery, and by waist 5 thrust is passed to single-layered disk 4, make single-layered disk 4 be subjected to being adjacent to the power of the blood vessel wall of aorta 10 downwards.Because aorta is a tubular structure rather than planar structure, so also can being subjected to aorta 10, single-layered disk 4 applies, in the plane of single-layered disk 4, power by the extruding of two side direction centers, the angle 9 that this extruding force can be ordered about between the support bar on the single-layered disk 4 changes, such as becoming 60 ° from default 90 °.Along with the variation of angle 9, single-layered disk 4 presents ellipse, and the long axis of ellipse direction is consistent in the axial trend at this place with aorta 10, and the self adaptation adjustment of this form makes and reduces the disturbance to blood flow by the single-layered disk 4 aortic blood tube wall of fitting better.And this self adaptation distortion of single-layered disk 4 has weakened the counteracting force of support bar to blood vessel, has reduced the damage to tissue.

The above only is preferred embodiment of the present utility model; not in order to limit this utility model; all any modifications of within spirit of the present utility model and principle, doing, be equal to and replace and improvement etc., all should be included within the protection domain of the present utility model.

Claims (10)

1. stopper with flat card of variable angle, described stopper comprises a single-layered disk, cock body and the waist that is connected single-layered disk and cock body, described single-layered disk is formed by the elastic yarn braiding, described single-layered disk comprises a plurality of support bars of arranging radially, the grid that flexible silk braiding forms on the surface of described cock body, described waist comprises at least one connecting line, it is characterized in that: the central authorities in described single-layered disk arrange an annular interlocking structure that has hole, described a plurality of support bar connects into flat integral body by described annular interlocking structure, and the connecting line of described waist is connected with the grid of described annular interlocking structure and described cock body.

2. a kind of stopper with flat card of variable angle as claimed in claim 1, it is characterized in that: the connecting line of described waist passes the hole on the described annular interlocking structure, and passes the mesh on the described cock body.

3. a kind of stopper with flat card of variable angle as claimed in claim 1, it is characterized in that: the quantity of the support bar of described single-layered disk is four to eight, the support bar of described single-layered disk all is configuration in pairs, each is positioned at support bar on same the diameter of single-layered disk and by same group of elastic yarn braiding and forms, and the elastic yarn of described support bar is woven into described annular interlocking structure jointly.

4. a kind of stopper with flat card of variable angle as claimed in claim 1, it is characterized in that: described support bar is bent into L type, S type or arc.

5. a kind of stopper with flat card of variable angle as claimed in claim 1 is characterized in that: each described support bar be configured to spring-like near terminal one section, perhaps the end of each described support bar be provided with one blunt nosed.

6. a kind of stopper with flat card of variable angle as claimed in claim 1, it is characterized in that: described annular interlocking structure has a centre bore.

7. a kind of stopper with flat card of variable angle as claimed in claim 1, it is characterized in that: described single-layered disk also comprises the choked flow film, described choked flow film covers on described support bar and the described annular interlocking structure.

8. a kind of stopper with flat card of variable angle as claimed in claim 1, it is characterized in that: described cock body is plate-like or column, a fixture is set on the described cock body, and the end of the elastic yarn of described cock body is fixed on the described fixture.

9. a kind of stopper with flat card of variable angle as claimed in claim 1, it is characterized in that: the connecting line of described waist is closed hoop.

10. a kind of stopper with flat card of variable angle as claimed in claim 1 is characterized in that: be attached with fiber on the described connecting line.

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