CN1194577A - Bifurcated endovascular stent and method and apparatus for placement thereof - Google Patents

Abstract

A graft fixing module in bifurcated blood vessel is formed by a pair of independent tube component graft fixing modules which can independently arranged in the bifurcated regions of blood vessel in human body in order to form the bifurcated graft fixing modules. A first mounted component graft fixing module includes a side opening and can be set to the near end and far end of an extend bifurcated combine part; the side opening is facing the inlet of the bifurcated blood vessel. The first component graft fixing module is made to expand in the blood vessel. Then the second component graft fixing module is made to move forward and then enters the bifurcated blood vessel through the first component graft fixing module and the side opening, then is made to expand in the blood vessel. The part of the first and second component graft fixing modules enclosing the blood combine region is made to transverse support for supply enhancement to the blood wall of the combine region. A transmission conduit is provided which includes a wire pipe groove for making a wire enter the bifurcated blood vessel in order to mount the first component graft fixing module in anther vessel cavity of the blood vessel.

Description

The endovascular stent of bifurcated and the method and apparatus of arrangement thereof

Invention field

The present invention relates to be implanted in the endovascular prosthese of the bifurcated in the passage of human body or animal body, and relate to method and the equipment of settling these prostheses to use, these prostheses are commonly referred to " stent (Stent) ".

Background of invention

Many medical approaches relate to settles intraluminal prosthesis or can be by settling intraluminal prosthesis as a supplement, and this intraluminal prosthesis is commonly referred to stent, and they can be implanted in an individual intracavity, in other natural lane as blood vessel or patient body.This type of stent is made a tubular basically configuration usually, and can be expanded to a major diameter from a less diameter (low profile).When in its low profile configuration, stent can utilize carrying device to advance to the position of waiting to settle this stent by body cavity in inner chamber.Can make stent be expanded to a bigger diameter then, it can engage the inwall of body cavity securely in this diameter.Remove carrying device then, the stent of transplanting is stayed in the position.By this way, stent can be used to stay open a blood vessel or other natural conduit, and the latter's function may be owing to pathological changes occurring or wound suffers damage.

In enlarging the medical approaches of using stent, wear chamber angioplasty (PTA) with percutaneous and especially to wear chamber coronary angioplasty (PTCA) relevant with percutaneous.PTA and PCTA relate to by the patient artery insertion and operate a dilating catheter, so that the expanded balloon of conduit is placed in the part (narrow) of being obstructed of blood vessel.Force air bag at the part intramedullary expansion that is obstructed then, so that part of blood vessel dilating makes restoration of blood flow pass through blood vessel thus.In the significant complex situations that may cause owing to this kind angioplasty, under considerable occasion, be obstructed again in the position of expansion.By a stent being placed on the position that was subjected to treatment in the blood vessel, may reduce this kind narrow tendency of stenosis again.

Narrowly often may in the branch zone of patient's blood vessel, develop.May there be many additional difficulties in narrow in the treatment branch zone when the narrow device of design expansion branch location.

In this technology, proposed and developed many kinds of stents, comprised the bifurcated graft sheet fixed die in the single stent that forms single body cavity passage and formation branch passage and the predetermined branch zone that is placed in blood vessel.Compare with single stent, owing to the branch configuration with in the regional difficulty that transmits and settle bifurcated graft sheet fixed die of vascular arborization, thereby there are many difficulties in the development of bifurcated graft sheet fixed die.

In the disclosed a kind of device of the international application No.PCT/IB96/00569 that is entitled as " endovascular stent of bifurcated " of submit applications on the 7th June in 1996, a kind of stent of bifurcated by two originally independently the constituent element stent form.In a preferred embodiment, each constituent element stent is formed by silk, and an elongated pillar and a plurality of assembly that forms pipe are basically arranged, and this assembly is connected on the pillar with the form of vertical order array.Each constituent element stent forms a piped basically configuration.Arrangement of components on two constituent element stents becomes to make them can be combined into the configuration of bifurcated in position.Each constituent element stent can be thought the assembly of the assembly of one group of near-end and a group far end.Assembly in the near-end group of a constituent element stent longitudinally disposes, and they can be cooperatively interacted with the complementary component groups on the proximal end of another constituent element stent.

This device is placed in the vascular crotch, and method is at first to insert a constituent element stent, with its near-end component placement in common blood vessel and its distal component is placed in the branch blood vessel.At first the constituent element stent of An Zhiing is provided with a side direction perforate between its two ends, and is positioned to and makes this side direction perforate be positioned at the joint portion of blood vessel, so that enter the branch blood vessel.Make the assembly expansion in the first constituent element stent then, so that the first constituent element stent fix in position.The second constituent element stent is entered and by the first constituent element stent and the laterally side direction perforate by first stent, so that the distal component of the second constituent element stent stretches into second branch of blood vessel.After the second constituent element stent is settled like this, its near-end assembly is cooperated with the near-end assembly alignment of complementary type with the first constituent element stent, can make the expansion of the second constituent element stent in place.

The present invention proposes a kind of improved method and apparatus, is used for bifurcated configuration constituent element stent is placed in the branch vascular.Another object of the present invention is to improve the structure of stent, and by this structure, stent can provide successive basically supporting for vascular (comprising the vascular joint portion).

Disclosure of an invention

In one aspect of the invention, provide a kind of delivery catheter to transmit and to settle the first constituent element stent, make side direction perforate between near-end component groups and the distal component group be placed in the place, joint portion of (public) blood vessel and branch blood vessel jointly, the side direction perforate is exposed to the inlet of branch blood vessel.This delivery catheter comprises a handle, at the far-end of handle a stent expanding mechanism such as air bag is arranged.The first constituent element stent can be installed on the expanding mechanism with low profile.Delivery catheter also comprises an elongated cellular conductor tube seat, and the latter is also in parallel along the handle extension of delivery catheter, and the far-end of lead tube seat ends at about middle part of air bag and is placed in the air bag outside.When the first constituent element stent was installed on the delivery catheter, it was settled around air bag, the remote area of lead tube seat is positioned to the side direction perforate of the first constituent element stent aligns.

After the first constituent element stent is installed on the air bag, can pass through patient's blood vessel by guide catheter, the value of moving sheet fixed die is placed in the vascular bifurcation place, its near-end component groups is placed in the common blood vessel and the distal component group is placed in one of branch blood vessel of surmounting the joint portion.Use conventional wire-control delivery catheter to enter a position, the side direction perforate is alignd with the body cavity of another branch blood vessel.When such arrangement, one second lead is pushed and then stretches into the branch blood vessel by lead tube seat and the guidewire port by lead tube seat far-end.Operate expanding mechanism then, the first constituent element stent is expanded to and the blood vessel firm engagement.Can cancel the effect of expanding mechanism then and can in the patient body, withdraw from delivery catheter and second lead is remained on the position of branch blood vessel.The second constituent element stent that is installed on the air bag carrying device can be installed on the carrying device then, the latter can advance along second lead, carrying device (as balloon catheter) is introduced the first constituent element stent, along side direction by the first constituent element stent lateral openings and enter the branch blood vessel.Settle the second constituent element stent like this, its near-end component groups is aimed at complementary formations with the near-end assembly stent of the first constituent element stent.Can expand the second constituent element stent then, make the near-end component groups of its near-end component groups and the first constituent element stent mesh and the distal component group is deployed in the branch blood vessel.Settle the first and second constituent element stents like this, they are cooperatively interacted,, be used to support branched blood vessel to form the stent structure of a bifurcated.

In another aspect of this invention, be placed in assembly formation, be area of joinder from the lateral-supporting blood vessel near one or two constituent element stent at place, blood vessel joint portion.

One of purpose of the present invention provides a kind of endovascular stent of the bifurcated that can easily settle.

Another object of the present invention provides a kind of stent that can be placed in the bifurcated in coronary artery and other branch vascular.

Another object of the present invention provides a kind of stent of the bifurcated that is formed by the constituent element stent, and it can constitute in the branch zone of patient's blood vessel on the spot.

An attached purpose of the present invention provides a kind of endovascular stent that is formed by two tubular basically parts, at least one of them has a side direction perforate between its two ends, makes the part of another stent partly cross out this side direction perforate by this first stent and edge.

Another object of the present invention provides a kind of like this stent of bifurcated, and it can be according to waiting that the patient's blood vessel anatomical features of implanting this device comes customized.

Another purpose of the present invention provides a kind of like this blood vessel transplantation sheet fixed die of bifurcated, and it has good film radiography feature, so that it is settled and can see stent subsequently.

Another purpose of the present invention provides a kind of delivery catheter, be fit to be convenient to settle the first constituent element stent and lead that extends in another branch blood vessel that extends into a branch blood vessel, one second constituent element stent can be introduced in this another branch blood vessel along its lead.

Another object of the present invention provides complementary constituent element stent, and in the time of in being placed in blood vessel, they provide tangible transplanting fixed bearing in the area of joinder of branch blood vessel and in blood vessel itself.

The description of accompanying drawing

Can understand above and other objects of the present invention and advantage more fully from following description with reference to the accompanying drawings, in the accompanying drawing:

Fig. 1 illustration is placed in the far-end of the delivery catheter in one of branch blood vessel and the lead in another branch blood vessel with the first constituent element stent;

Fig. 2 is the part figure of the part of a constituent element stent, and illustration is connected a pair of adjacent component on the pillar;

Fig. 3 is the enlarged drawing of Fig. 6 encircled, and the calmodulin binding domain CaM of expression branch blood vessel and constituent element stent are at the fit system of this joint portion;

Fig. 4 a-4g can settle the first and second constituent element stents with vertical sector mode illustration and form the series of steps of the stent of bifurcated;

Fig. 5 is the vertical section figure that has wherein settled the branch blood vessel of the first constituent element stent;

Fig. 6 is similar to Fig. 5, has wherein settled the second constituent element stent;

Fig. 7 is the sketch map of another stent expanding mechanism, and this mechanism uses electric energy to expand stent;

Fig. 8 is the side view of one first constituent element stent in another embodiment of the present invention;

Fig. 9 is the side view that is suitable for one second constituent element stent of the complementary coupling of the constituent element stent of Fig. 8;

Figure 10 is the first and second constituent element stents assembling in Fig. 8 and 9 and form the side view of the stent of bifurcated in the bifurcated body cavity vascular;

Figure 11 be a constituent element stent another embodiment assembly is deployed in view in the horizontal plane, be illustrated in the configuration that forms the side direction perforate in the constituent element stent better;

Figure 12 illustration is a kind of to be formed in the blood vessel of bifurcated and localized and comprise the endovascular stent of the bifurcated that Figure 11 constructs;

Other details of an assembly in the stent shown in Figure 13 illustration Figure 12; And

The a pair of assembly of the device shown in Figure 14 illustration Figure 12.

The description of illustrated embodiment

Fig. 2 and Fig. 5 illustration can be used to implement the type of prosthese 1 (stent) in the assembly type of present embodiment.Should in prosthese can be regarded as and limited a cage shapetubular unit 10, form and a centrallongitudinal axis 2 arranged bythread parts.Stent 1 is made along the interconnectivesingle component 7 of a pillar by a plurality of, and this pillar can be regarded as and comprises a longitudinal supportingsilk 6 and a plurality of adapter 9.Assembly 7 can be convenient to that stent is placed in the low profile configuration of endoceliac contraction from one, and (Fig. 4 a) is expanded to an enlarged diameter (Fig. 4 b), wherein assembly can with the inner surface firm engagement of thewall 11 ofbody cavity 3, to keep body cavity to open, be convenient to blood flow.In the preferred embodiment, assembly can be expanded non-resiliently.The tubular basicallyassembly 7 that can radially expand is installed on the supportingwire 6 by theadapter 9 that connects with eachassembly 7 in the mode of vertical order array and aims at.In the time of on being installed in supportingwire 6, these assemblies can be regarded as and form an imaginarycircumferential surface 12, and the latter's lateral cross section is around the imaginary closed curve oflongitudinal axis 2 or the form ofloop wire 8.

Eachassembly 7 is formed bysilk 13, andsilk 13 is shaped and makes cylindricalcircumferential surface 12 is radially expanded.The formation of assembly can be made the flattened flex configuration withsilk 13 earlier, and the silk with bending is wound into the loop wire configuration then.The terminal of crooked silk is freely.Silk 13 free end can be interconnection and be connected on the supportingwire 6 by adapter 9.The curved configuration of each assembly can be regarded as and comprise that a series of and bending section are alternately and theelongated sections 14 that is connected by bending section, these bending sections can be that curve (as circle) maybe can compriseshort jointing 15, and the latter is connected toelongated sections 14 atbending point 17 places.Vertically the connection bending section between thesection 14 can be settled and forms this track along the track of closed loop wire 8.Preferably,silk 13 forms like this, makes the configuration of bending section to makeassembly 7 have uniform intensity along the direction ofcrosscut supporting wire 6 around imaginary closedloop wire 8 along the even interval of circumference.

When assembly is in the configuration of not expanding of its low profile, form the bending section the 15, the 17th that connects between adjacent vertical section, such, make thatelongated section 14 will be parallel to each other basically, form an angle near zero degree.This angle will increase when assembly is expanded.The configuration that comprises the connection bending section ofbending point 17 can change, to change this angle or to change its number along circumference around closedloop wire 8, thereby change the feature ofassembly 7, comprise and change assembly the resistance of compressive load radially, make and further specifically to manufacture interior prosthese, it is met ideally interior prosthese is transplanted inparticular body cavity 3 wherein.

Only example as an illustration can provide a kind of stent, makes it comprise theassembly 7 that forms with the about 0.15 millimeter silk of diameter, has the elongated sections 14 (not comprising the connection bending section between the adjacent sections 14) that is about 1.8 millimeters.When the connection bending section between the adjacentelongated section 14 was crooked glossily, they can have about 0.15 millimeter radius before expansion.Stent with above-mentioned size is scheduled to be expanded to the diameter between about 2.5 to about 4.0 millimeters and can not be overextended, this stent presents significant resistance to the radial deformation much larger than the maximum radial compressive load, and this radial deformation can be expected and is applied on the stent owing to having about 2.5 contractions to the tremulous pulse of about 4.0 millimeters body cavity diameter.

In the preferred embodiment,adapter 9 can be made by it being utilized screw thread be screwed on thesilk 6 and be installed on the longitudinal supporting silk 6.Adapter 9 preferably can comprise a little pipe or ring, and the latter forms enough inner spaces, to hold and around the free end ofsilk 13, to be connected securely on the longitudinal supportingsilk 6 and will encircle simultaneously.The free end ofring adapter 9, silk can utilize nonvolatil distortion such as crimping to be connected securely with supportingwire 6, maybe can interconnect by spot welding.When using the laser spot welding assembling, preferably elder generation is welded in the free end of thesilk 13 ofassembly 7 on thering 9, will encircle 9 then and be welded on the supporting wire 6.In some cases, preferably change stent, make one or more assemblies (but being not the assembly of least significant end) not be connected on the supporting wire securely, and allow certain free sliding degree is arranged on the contrary along supporting wire.After device had been placed in the patient's blood vessel, if desired, this can adjust the position of assembly at last.

Ring 9 can be the quite short section of a pipe, can hold the free end of supporting wire 6a and assembly 7.The shape ofring 9 inner surface can be made the free end formed shape of close match by supportingwire 6 and thesilk 13 byadapter 9.

Above-mentioned structure makes it possible to a stent specialized groups is dressed up the particular anatomical features that accurately meets the patient who waits to settle stent.Assembly can be settled along supportingwire 6 on demand, and can be fixed in this configuration.Can select supportingwire 6 to provide the vertical flexible and available flexible great silk of required degree to make, so that device is placed in the untouchable relatively body cavity.Have the above-mentioned structure ofseparate support silk 6 for stent wherein, can select the rigidity or the degree of flexibility of supporting wire, make it irrelevant with the silk that forms tube assembly 7.Supportingwire 6 can highly flexible, and stent can be supported by narrow zigzag vascular such as coronary artery.

Be to be understood that, though currently preferred embodiment of the present invention comprises a kind of metal support silk 6 (as rustless steel), but assembly structure of the present invention can be made a kind of like this stent, wherein supporting wire can be used nonmetallic materials such as polymeric material, and for example nylon or material that can bio-absorbable form.Can select other material, comprise that As time goes on those can be gone into material in the vascular tissue by bio-absorbable in classification suitable aspect mechanical aspects and biology.For supportingwire 6 that can bio-absorbable, should be chosen in and keep its required mechanical features in the time enough, so thatassembly 7 is embedded in the blood vessel wall securely.Stent can be made with Nitinol (nitinol) and so on shape-memory material, utilizes this material can realize the expansion of assembly by a heat-resistant component 105 (Fig. 7).Therefore, assembly structure of the present invention enlarges markedly the material of single parts and the scope of performance, and each is selected to provide optimum.The parts of stent can apply one deck protective material such as carbon or anticoagulation material such as heparin.This variation of material is the mechanical strength and the elastic limit of balancetubular structure 10 by this way, makes stent can be fit to single patient's characteristic needs.

Connectingring 9 especially when its quality that provides during around two end regions assemblings ofassembly 7 and supportingwire 6 significantly greater than the quality of thesilk 13 of making assembly.Therefore, comprise the radiopacitys that the radiopacity of its demonstration of post area of connectingring 9 significantly shows greater than thesilk 13 of relevant assembly.The radiography ofprosthese 1 control in the radiopacity that enlarges markedly of join domain has increased between transplanting stage significantly.The time observes prosthese and need not use ultrasonic method with film radiography afterwards simultaneously for it.The configuration of stent can maketubular frame 10 make to have high mechanical properties and simultaneously device expanded between its low profile and maximum extension configuration, but wherein thesilk 13 ofassembly 7 in the method on the normally used radiation level to the X ray substantially transparent.

Before Fig. 5 and 6 is illustrated in ring is fixed on the supportingwire 6 at each to the arrangement spacer (distance piece) 50 between thering 9 in succession.Spacer is preferably cylindrical shape and a centre bore is arranged, and can make spacer withsilk 6 slips longitudinally onvertical silk 6 of beading mode by this centre bore.When a series ofadapters 9 andspacer 50 be placed on the supportingwire 6, in succession the every pair of adapter or spacer can surround mutually.Length that can the predetermined isolated thing so that can accurately control two intervals between the assembly in succession, reduces simultaneously that supportingwire 6 is twisted or impaired danger.In most of the cases, the interval of adjacent component preferably makes them can closely be adjacent to settle (for example make theirbending point 15 adjacent), provides successive basically supporting toblood vessel wall 11 when being positioned in the patient body with convenient stent.In addition, usespacer 50 to make stent can only utilize two leastsignificant end adapters 9 that are securely fixed on the supportingwire 6 just can assemble.In this embodiment, intermediate member (adapter 9 and spacer 50) will be held in place on supporting wire and can not separate.No matter be alladapters 9 or onlyadapter 9 of least significant end is fixed on the longitudinal supporting silk, intermediate spacer does not need directly to be fixed on thesilk 6, and can be held in place between itsadjacent adapter 9 by itsadjacent adapter 9 on the contrary.As the example of size, can be about long 1.10 millimeters with thecylindrical shape spacer 50 that the device with above-mentioned size uses, 0.30 millimeter of external diameter, about 0.075 millimeter of wall thickness.

Thespacer 50 of circular cross-section can be configured to the rounded outer surface substantial alignment with adjacent Connection Element.Use another advantage ofspacer 50 to be, with the part that ring extends of pass through ofring 9 and silk, this of configuration formation presents the pillar of successive elongated quality basically, and its ray opacity is significantly greater than the ray opacity ofindentation silk 13.

All parts of device should be with compatible and material that can not form micro cell is made, and this micro cell makes arbitrary part of device produce electrochemical corrosion after may be in the device implantable intravascular.Longitudinal supportingsilk 6,silk 13 preferably should have identical chemical constituent withadapter 9 or have each other can compatible composition biologically.

The preferential exemplary materials that adopts comprises following various material in the prosthese in making: annealed rustless steel, titanium alloy, golden nickel alloy, nichrome and titanium chrome alloy.

Can handle and be shaped supportingwire 6 andassembly 7, changing its mechanical property and functional character independently of one another, thereby obtain to be suitable for to treat the required configuration of concrete patient's anatomical features.For example, thesilk 13 that the forms assembly heat treatment of can annealing is with the ductility of control silk.

Fig. 5 and 6 illustrations can be placed in a bifurcated graft sheet fixed die mode in the branch vessel.In this embodiment, separately theconstituent element stent 1P (Fig. 5) and the 1S (Fig. 6) of (promptly not bifurcated) make this bifurcated graft sheet fixed die by two.The firstconstituent element stent 1P can make in the above described manner, comprises an elongated pillar, connects a plurality of assemblies that can radially expand 7 above.Theassembly 7 ofstent 1P can be regarded as and is configured to two groups, is included in first (near-end) the group 1Pa of 1P near-end and at second (far-end) the group 1Pb of theother end.Assembly 7 among first group of 1Pa is settled with predetermined space along pillar.As following described in more detail, the distance L among first group of 1Pa between theadjacent assembly 7 should be enough to make theassembly 7 of another stent to be installed between first group ofassembly 7 among the 1Pa.In the preferred embodiment, this preset distance is not less than the length L M of anassembly 7 that records along the direction that is parallel to pillar.Can longitudinally come in close proximity to each other ground or with other arranged spaced ofassembly 7 among second group of 1Pb is as long as can be suitable for specific branch situation with its blood vessel of packing into.The firstconstituent element stent 1P also makes the space 1Pc that has to form side direction perforate SF between first and second groups of 1Pa, 1Pb of assembly 7.This side direction perforate SF can cross out outside the 1Pc of space the second constituent element stent of a low profile configuration by first constituent element stent (in first constituent element stent expansion back) and edge.By side direction perforate SF being placed in the joint portion of branch blood vessel, one second constituent element stent is advanced among the branch tremulous pulse 3c.In a preferred embodiment, the length of side direction perforate SF can be similar to the diameter ofsection 3s of branchpassage 3c.Assembly 7 in first group also can connect by one second vertical pillar silk 6P, as the assembly among second group of 1Pb of the first group of components 1P.When using two pillar silks, the seriality of the second pillar silk 6P (being placed in the top among Fig. 5) is interrupted, and interruption length equals the length of the side direction perforate SF between component groups 1Pa and the 1Pb.The second constituent element stent preferably only is provided with an independent vertical pillar silk 6s.Stent can be based upon in the patient body on the spot, method is at first to settle and expand the firstconstituent element stent 1P, one ofbranch 3c that makes side direction perforate SF and body cavity aligns, insert the second constituent element stent 1s then by the firstconstituent element stent 1P, and along laterally entering anotherbranch body cavity 3c by side direction perforate SF.The near-end of two constituent element stents is preferably made works in coordination, to form a common single pipe.

Thefirst stent 1P can be sent to and be placed in the tremulous pulse by a carrying device (describing below), and this carrying device has an expanding part that can comprise air bag 104.Stent is installed on theair bag 104 with low profile.

The structure of the firstconstituent element stent 1P comprises the configuration of pillar, and this pillar can be regarded as by longitudinal supportingsilk 6 andadapter 9 and forms.Between adjacent pairedadapter 9, alsospacer 50 can be set.The distribution pattern ofadapter 9 oradapter 9 andspacer 50 can be made in the pars intermedia office of stent can see space 1Pc significantly with film radiography, so that this part is placed in the position of wanting in the vascular arborization zone.

Can notice that in illustrated embodiment, the side direction perforate SF zone among thefirst stent 1P can be distinguished with the other parts of film radiography and stent.In illustrated embodiment, this is by obtaining along that part of elliptical spacer between nearly component groups 1Pa of extending in of pillar and the component groups 1Pb far away or the parts of other available rays photographic process observation.Therefore, the pillar among the regional 1Pc is only formed by supportingwire 6, and its quality is significantly less than the other parts of pillar, so this zone can be with ray according to the collimation method difference.

Thesecond stent 1S can similarly make with thefirst stent 1P, first group of 1Sa and second group of 1Sb of comprisingassembly 7, first group of 1Sa longitudinally settle at interval and and the space between the assembly among first group of 1Pa of the first constituent element stent work in coordination, second group of 1Sb can closely be adjacent to configuration mutually.The first component groups 1Sa and the second component groups 1Sb can be separated by a space 1Sc, and the length of 1Sc is similar to the diameter of thecross section 3s of branch passage 3c.After at least the first group assembly 1Pa had been expanded to inner surface firm engagement withblood vessel 3, the second constituent element stent can be settled by an air bag delivery catheter as described below.The second constituent element value of moving sheet fixeddie 1S longitudinally is placed in the blood vessel, make the second constituent element stent near-endgroup 1Sa assembly 7 longitudinally and the spacial alignment between theassembly 7 on first group of 1Pa of the first constituent element stent 1P.Relative localization between the component groups can owing to pillar particularly the zone ofadapter 9 and (if you are using) spacer 50 the ray opaque section and can carry out easily.Behind the assembly alignment of first group of 1Pa, 1Sa, can makeassembly 7 expansions on second group.Synthetic bifurcated graft sheet fixed die structure can be made and form a successive basically proximal graft sheet fixed die part in blood vessel.Equally, second ofassembly 7 group of 1Pb, 1Sb are expanded to and the vascular arborization part firm engagement of wherein settling them.

In order to strengthen the supporting toblood vessel wall 11 at place, the joint portion ofvascular arborization 3,3c, one or two ofconstituent element stent 1P, 1S can be provided with theassembly 7 of special manufacturing, and thisassembly 7 will become the border of side direction perforate SF when it is settled.In theassembly 7 of this kind remodeling, can make thelongitudinal component 14,14 ' that forms imaginarycircumferential surface 12 have length inequality, make them can stretch in the area of joinder and bigger supporting is provided, especially at the sidepiece in the zone that forms by side direction perforate SF.Therefore, theassembly 7 at blood vessel area of joinder place can be regarded imaginary cylindrical surface of formation as, and this surface comprises apecker 108 that longitudinally protrudes, and the wall to the joint portion provides additional support thus, but does not block side direction perforate SF.Or an imaginary cylinder that is formed by such assembly can be considered to form an imaginary surface, and the latter andlongitudinal axis 2 obliques are also formed by thebending point 15 of component groups.Therefore, the end assembly of each component groups 1Pa, 1Pb among the firstconstituent element stent 1P can dispose like this, makes theirbending point 15 can settle to such an extent that be close to mutually.If desired, the pecker ofassembly 7 can insert mutually and interlock, shown in 108a among Fig. 3.By this way, thewall 11 of affected blood vessel can be subjected to better supporting, along the seriality less interruption of passage length or not interruption.Equally, on theassembly 7 by the second constituent element stent 1s that is provided with at place, the joint portion ofbranch passage 3c a pecker 108 ' is set, can with the bonded area of joinder ofbranch passage 3c in enhanced supporting is provided.Haspecker 108 or 108 ' bysilk 13 making that are different from the used silk of other assembly with diameter, perhaps, by making assembly before being assembled into stent, accept proper heat treatment, can further improve the mechanical strength ofstent 1 and the balance between its elastic buckling ability.

Fig. 1 illustration one delivery catheter is particularly suitable for transmitting and settling the first constituent element stent of bifurcated graft sheet fixed die of the present invention.Comprise the expanding mechanism ofexpansive air bag 104 forms though should be appreciated that illustratedconduit 100, also can use other expanding mechanism, for example only use a resistance heater 105 (Fig. 7).Delivery catheter 100 can have a co-axial handle (bar), and this handle comprises aninterior pipe 101 that is placed in the outer tube 110.Inpipe 101 extend toterminal part 100t and in its distal openings by air bag.Theend 104e of air bag is fixed on the far-end of inner and outer pipes 101,110, as usual manner in the coaxial balloon catheter.The annular space that forms betweeninterior pipe 101 and theouter tube 110 forms first body cavity, and air bag can expand and contraction by first body cavity.Body cavity (being called second) byinterior pipe 101 is accepted a lead G1, so that the guiding ofconduit 100.

Delivery catheter comprises an elongated cellularconductor tube seat 102 simultaneously, andlead tube seat 102 is along the extension of delivery catheter handle and adistal portions 102d is arranged, and its terminal is shorter than thedistal portions 101d of interior pipe 101.The far-end oflead tube seat 102 comprisesoutlet 102e, and its orientation can make the second leadG2 leave conduit 100 along extending laterally.Expanding mechanism such asair bag 104 are installed on the conduit, make theguidewire port 102e at thedistal portions 102d place oflead tube seat 102 keep exposing.When stent was contained on the conduit, air bag was folded, and as by twobooklets 106, made and surrounded lead tube seat 102.Orlead tube seat 102 can be conducted through expansiblefirst body cavity 110 and the leading edge of the point (as shown in phantom in Figure 1) that is fixed at air bag appears.As following described in more detail, in the time of in device is placed in the patient body, one second lead G2 can advance and advances among thebranch passage 3c along extending laterally byguidewire port 102e by lead tube seat 102.Be appreciated that when stent is installed on the air bag, thedistal section 102d oflead tube seat 102 will be fixed between stent and the air bag.Guidewireport 102e settles like this with respect to stent, makes it to align with the side direction perforate SF of the first constituent element stent.

When expanding mechanism comprised aresistance heater 105, the preparation ofconduit 100 can be included in the step (Fig. 7) of settlingheater 105 between first pipe, 101 andsecond pipe 102.

Stent 1 can be with being installed on the far-end of conduit just like the loading device of describing among the international application No.PCT/1B96/00918, this international application is that JIUYUE in 1996 proposed on the 13rd, be entitled as " endovascular stent is installed in the Apparatus and method for of using on the balloon catheter ", it has been carried out reference.In sequence chart Fig. 4 a-4g illustration the arrangement and the formation of bifurcated graft sheet fixed die at the scene.Usually, before being placed inconstituent element stent 1P, 1S in the blood vessel, inblood vessel 3,3c, carry out angioplasty.Delivery catheter will at first be settled with the first lead G1 and extend through theinterior pipe 101 of conduit handle.Then the firstconstituent element stent 1P is installed in expanding mechanism 104,105 on theconduit 100 around, theguidewire port 102e oflead tube seat 102 is alignd with side direction perforate SF.Thenconduit 100 is inserted patient's blood vessel and advance, settle assembly, makeguidewire port 102e be placed in the joint portion of vascular arborization and (Fig. 4 a) in the face ofbranch passage 3c with lead G1 and under it helps.Then the second lead G2 is insertedwire conduit 102, lead G2 is advanced, its tip is appeared from guidewire port 102e.Make lead G2 enterbranch passage 3c (Fig. 4 b) then.Operate expanding mechanism 104,105 then, make firstconstituent element stent 1P expansion and its position stability (Fig. 4 c) in blood vessel 3.Can fromblood vessel 3, withdraw fromconduit 100 and lead G1 then, and the second lead G2 is remained on the position in thebranch passage 3c (Fig. 4 c).Then the secondconstituent element stent 1S is installed on the same conduit or another conduit of low profile.Advance this conduit along the second lead G2 then, be placed in (Fig. 4 d) among thebranch passage 3c up to second group of 1Sb of the secondconstituent element stent 1S and especially assembly 7.Operate expanding mechanism 104,105 then with the secondconstituent element stent 1S (Fig. 4 e) in expansion andstable branch passage 3c and the main channel 3.Can make the contraction of second conduit then and withdraw from (Fig. 4 f).Withdraw from the second lead G2 (Fig. 4 g) simultaneously.

Should be appreciated that because can quite easily monitor theConnection Element 9 of pillar, so the first and second constituent element stents can be orientated in blood vessel aligned with each otherly with fluorescence method.Use twin props to increase this stability to the first constituent element stent 1P.The secondconstituent element stent 1S would rather be with an independent pillar.The ray opacity of pillar makes the doctor can settle the secondconstituent element stent 1S to put into theassembly 7 of first group of 1Pa and 1Sa separately, and making single vertical 6 two pillars of the second constituent element stent rotate 90 ° with respect to the first constituent element stent, all parts of borrowed structure all are easy to identification (seeing Fig. 4 d-4g).

Fig. 8-10 illustration a kind of remodeling of the present invention.The label mode of Fig. 8-10 is similar to the label of illustrative embodiment in Fig. 5 and 6, but has increased the numerical value of " 200 ".Therefore, as shown in Fig. 8-10, thin portion of the present invention and label thereof are as follows:

Space (between two assemblies) 200sv

The value of moving sheet fixeddie 201

The firstconstituent element stent 201P

The near-end component groups 201Pa of the first constituent element stent

The distal component group 201Pb of the first constituent element stent

Space (between near-end and the distal component group) 201Pc

The second constituent element stent 201S

The near-end component groups 201Sa of the second constituent element stent

The distal component group 201Sb of the second constituent element stent

Space (between near-end and the distal component group) 201Sc

Longitudinal axis 202

Common body cavity 203

Branch blood vessel 203c

Branch blood vessel section 203s

Pillar silk 206

Assembly 207

Imagination loop wire 208

Cage shapetubular unit 210

Blood vessel wall 211

Imaginarycylindrical surface 212

Silk 213

Vertical section assembly 214

Bending point 215

Connectingring 219

The effect of parts described in the illustrative embodiment is substantially the same in the effect of above-mentioned parts and Fig. 5 and 6.But, in the remodeling of in Fig. 8-10, describing, the near-end component groups 201Sa of the second constituent element stent 201S includes only asingle assembly 207, and the latter is suitable for being placed in the single complementary space 200sv among the near-end component groups 201Pa of the first constituent element stent 201P.In this embodiment, the L space of 200sv is at least corresponding to the width LM of assembly 207.The near-end group 201Sa of single component is connected on the distal component group 201Sb by a quite long pillar silk 206.It should be noted that, though the second constituent element stent shown in Fig. 9 is the case of bending in (Figure 10) its occupied configuration when two constituent element stent assemblings, it will be straight basically when the second constituent element stent inserts among the previous firstconstituent element stent 201P that settles.

Figure 11-14 illustration is to another remodeling of above-mentioned stent, and wherein the constituent element stent is made the supporting that further strengthens them blood vessel in the area of joinder of blood vessel 203,203c is provided.For this reason, the assembly 207 of next-door neighbour's side direction perforate 300 (being called SF in Fig. 5 and Fig. 6) arrangement is to be assembled by the silk of two indentations (snakelike), wherein one (207 ') have than the bigger amplitude of another root (207 "); just, an indentation silk has the longitudinal component 214 shorter than another root.This is configured in clear demonstration the among Figure 11, Figure 11 illustration first constituent element stent, and its component table is shown as expansion and is placed in the plane.The indentation silk of the assembly on each end of formation side direction perforate 300 (SF) is made by two rhizoids, and the longitudinal component 214 of this two rhizoid has different length and forms different spacing, as 301 ' and 301 " shown in.The silk that forms side direction perforate 300 (SF) is that the indentation silk that length is shorter by spacing is tightr forms.When the first constituent element stent (Figure 11) during for columnar cage shape configuration basically, two assemblies that next-door neighbour's side direction perforate SF settles can be regarded each as and made by two parts, and every part forms an imaginary dome element 207 ', 207 ".Arch wire element 207 ', 207 " can interconnect by adapter 219a.In addition, be preferably in annular connector 219a and go up the vertical adapter silk pillar 206a that connects a weak point.Pillar silk 206, short adapter silk 206a and section 207 " configuration work in coordination; forms one and has the highly cage structure of local strength; in side direction perforate 300 (SF) zone, when device was implanted, the inlet of vascular arborization 203c was led to formation in this side direction perforate 300 (SF) especially.In addition, form a mechanism with the visible connector ring 219 of four fluorescence, the 219a that rectangular array is provided with, can verify the position and the orientation of side direction perforate by this mechanism with fluorescent method around perforate 300 (SF).

As shown in Figure 12, the second constituent element stent 201S comprises the assembly of a public blood vessel of next-door neighbour and branch blood vessel joint portion, and wherein thelongitudinal component 214p ofsilk 13 extends and forms one as the tongue configuration among above-mentioned Fig. 3,5,6 embodiment.This assembly relevant with the second constituent element stent can be formed by an independent rhizoid fully, rather than is formed by two indentation silks with the differentvertical section 214 of length.

Should be appreciated that foregoing description of the present invention only is used for illustration, obviously other embodiment, remodeling and equivalents can be arranged and not depart from principle of the present invention for these those skilled in the art.

Claims (31)

1. the method used of the stent of a bifurcated of formation in having a common part and two and branched body cavity that this common ground is communicated with, it comprises:

The first tubular constituent element stent of a both ends open is provided, a side direction perforate is arranged between its two ends, it can be expanded to an expanded configuration from a low profile;

Provide one at its far-end conduit and a lead tube seat of an expandable member to be arranged, the latter has a guidewire port that is placed between the expanding part two ends, makes the far-end of lead can stretch out guidewire port;

The first constituent element stent is installed on the parts that can expand, the side direction perforate is alignd with guidewire port;

The molectron of the conduit and the first constituent element stent is advanced to the common ground and the branched area of joinder of body cavity and makes the side direction perforate in the face of a branched inlet, the proximal part of this constituent element stent is positioned in the common ground of body cavity and the distal portions of the first constituent element stent is positioned in the branch of body cavity;

Operate these parts that can expand to expand the endoceliac first constituent element stent, make the surface engagement of itself and body cavity;

Advance lead by lead tube seat, guidewire port and enter another branch of body cavity;

The locational while in another branch that lead is remained on body cavity, in the patient body, take out conduit;

The second constituent element stent is pushed body cavity, guide the second constituent element stent by lead, a distal portions of settling the second constituent element stent at least by the first constituent element stent the side direction perforate and enter another branch of body cavity; And

Expand the second constituent element stent, it is engaged with body lumen wall.

2. method described in claim 1, it is characterized in that, these parts that can expand comprise an air bag, before this method also is included in the first constituent element stent is installed on the air bag part of air bag is folded in the lead tube seat distal portions around, air bag is folding like this, makes guidewire port keep appearing.

3. the method described in claim 2 is characterized in that, the step of folded airbag be included in carry out at least on each side of lead tube seat one folding.

4. the method described in claim 1 is characterized in that, this mechanism that can expand comprises a resistance heater, comprises this heater is placed between the handle and lead tube seat of conduit and wherein stent is installed in supravasal step.

5. method described in claim 1, it is characterized in that, conduit comprises a handle, this handle comprises a guidewire lumen at the far-end opening of handle, and the progressive step of assembly of the conduit and the first constituent element stent is comprised from the far-end of conduit extension wire and the path of lead to provide one to be used for conduit is advanced and is directed to the installation position in advance of stent is provided in advance.

6. method that the constituent element stent of settling the stent assembly of a bifurcated is used, it comprises:

This constituent element stent is installed on the carrying device that the parts that can expand are arranged at its far-end, a side direction perforate is arranged between the two ends of this constituent element stent;

Between the parts that can expand of this carrying device and stent, settle a lead tube seat, this lead tube seat with wire outlet is alignd with the side direction perforate of constituent element stent with wire outlet;

Carrying device and the constituent element stent common ground and the branched area of joinder that are advanced to body cavity with assembling make this side direction perforate and the wire outlet inlet in the face of one of branch.

7. constituent element stent that is suitable for being placed in the bifurcation region of body cavity, it comprises:

Parts that form elongated pipe, these parts have a proximal section, a distal section and a side direction perforate that forms between proximal section and distal section;

This near-end and distal section have along the adjacent part that laterally forms the border of side direction perforate, and these adjacent parts extend relative to each other and closely, and these lateral parts can be supported body lumen wall basically continuously thus.

8. constituent element stent described in claim 7 also comprises:

Each proximal section and distal section comprise the assembly that at least one can radially be expanded, and form the side direction perforate between the penetralia assembly of each proximal section and distal section, and at least one penetralia assembly has axial dimension part inequality.

9. constituent element stent described in claim 8 also comprises:

Described assembly forms with the silk that is configured to the indentation figure, comprises the vertical part that connects with being one another in series, and at least some longitudinal components at least one penetralia assembly are longer than other longitudinal component of this penetralia assembly.

10. the constituent element stent described in claim 9 is characterized in that, and is longer than other longitudinal component of this penetralia assembly along the longitudinal component of the penetralia assembly of the horizontal arrangement of side direction perforate.

11. the stent of a bifurcated that is formed by two constituent element stents, each constituent element stent comprises a plurality of assemblies, their sequence arrangement and form a tubular basically configuration;

The assembly that a pair of order is settled is configured to form betwixt a side direction perforate;

The second constituent element stent extends through a part and the edge of the first constituent element stent and laterally stretches out by the side direction perforate;

Described a pair of assembly on the first constituent element stent has the side direction part, and these side direction part is along the horizontal arrangement of side direction perforate, and they extend and adjacent toward each other.

12. the stent of the bifurcated described in claim 11 also comprises:

Each assembly of each constituent element stent that settle the branch joint portion of two constituent element stents of next-door neighbour has protuberance, and they extend towards area of joinder vertically.

13. the stent of the bifurcated described in claim 11, it is characterized in that, described assembly forms with silk, these silks are arranged in zigzag pattern, to comprise the vertical part that connects by bending point with being one another in series, vertical part of described assembly disposes like this, makes their some bending points settle with being closely adjacent to each other.

14. the stent of the bifurcated described in claim 13 is characterized in that, some bending points of an assembly are superimposed and extend across at least one bending point of other assembly.

15. the constituent element stent described in claim 9 is characterized in that, vertically the silk part is interconnection at the bending point place for these, and wherein the bending point of assembly is settled with being closely adjacent to each other.

16. the constituent element stent described in claim 9 also is included in the interconnected vertical part in bending point place, wherein at least one bending point of one of assembly is superimposed and extend across at least one bending point of other assembly.

17. a conduit that is used to transmit the constituent element stent of bifurcated graft sheet fixed die, wherein the constituent element stent comprises a side direction perforate, and this conduit comprises:

A flexible elongated handle;

The parts that can expand on far-end that is installed in this handle can be installed the constituent element stent with the low profile configuration around it;

Elongated lead tube seat along the longitudinal extension of this handle, this lead tube seat has one to be exposed to the far-end of the parts outside that can expand and to form a wire outlet on one between the two ends of these parts that can expand position of longitudinally settling, and this wire outlet is made lead can be exposed with conduit axis direction at angle from the lead tube seat along one.

18. the delivery catheter described in claim 17 is characterized in that, the handle of this conduit is co-axial and comprises pipe and an outer tube in one.

19. the delivery catheter described in claim 17 is characterized in that this stent is suitable for expanding after applying heat, wherein these parts that can expand comprise the mechanism that is used for the constituent element stent is applied heat by the conduit carrier band.

20. the delivery catheter described in claim 17 is characterized in that, these parts that can expand comprise an air bag.

21. the delivery catheter described in claim 17 also comprises a constituent element stent that is installed in low profile on the parts that can expand in combination, the latter has a side direction perforate of settling alignedly with the wire outlet of lead tube seat.

22. the constituent element stent of the stent of a bifurcated, it comprises:

The assembly of a plurality of loop wire shapes sequentially is connected on this pillar along a pillar and forms a tubular basically configuration;

Thereby in these assemblies at least two are included on the bending point silk of interconnected vertical section and make by being configured to the indentation figure;

The assembly that the order of a pair of formation one side direction perforate is settled;

In the described a pair of assembly at least one has the different longitudinal component of length.

23. the constituent element stent described in claim 22 is characterized in that described assembly has a pair of indentation silk, one of them has than another longer section, and less indentation silk is connected on the end of bigger indentation silk.

24. the constituent element stent described in claim 23 is characterized in that, less indentation silk forms the axial end portion of side direction perforate.

25. the constituent element stent described in claim 23 is characterized in that, bigger indentation silk forms the horizontal part that is placed in the side direction perforate of constituent element stent.

26. the constituent element stent described in claim 24 also comprises:

One end of each little indentation silk is connected on the pillar, and the other end of each little indentation silk is connected on the end of big indentation silk.

27. the constituent element stent described in claim 26 is characterized in that, this little indentation silk significantly is connected on the pillar greater than the adapter place of the radiographic quality of silk at its radiographic quality.

28. the constituent element stent described in claim 27 is characterized in that, this little indentation silk significantly is connected on the big indentation silk greater than the adapter place of the radiographic quality of silk at its radiographic quality.

29. the constituent element stent described in claim 28 is characterized in that, little indentation silk is connected to the figure that adapter on pillar and the big indentation silk forms a substantial rectangular, this figure limits the bight of side direction perforate.

30. the constituent element stent described in claim 29 also comprises:

The connecting filament that extends longitudinally of a weak point is connected on the joint portion of big and little indentation silk.

31. the constituent element stent described in claim 23 is characterized in that the pitch of little indentation silk is less than the pitch of big indentation silk.

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