CN1441654A

CN1441654A - Guide wire introducer sheath

Info

Publication number: CN1441654A
Application number: CN01809885A
Authority: CN
Inventors: G·M·瓦尔蒂; E·威廉斯; E·查维滋; H·鲍兰格; N·U·贝汉
Original assignee: Advanced Stent Technologies Inc
Current assignee: Advanced Stent Technologies Inc
Priority date: 2000-03-22
Filing date: 2001-03-22
Publication date: 2003-09-10
Also published as: WO2001070299A2; AU2001252966A1; KR20030020264A; WO2001070299A3; JP2004501675A; IL151861A0; CA2403826A1; EP1267751A2; HK1052289A1

Abstract

Systems and methods for positioning a first guidewire (25) in a primary vessel (M) and a second guidewire (27) in a branch vessel (B). One embodiment comprises an introducer (10) having first (12) and second lumens (14) adapted to slidably receive the first guidewire within the first lumen and the second guidewire within the second lumen. One method embodiment includes inserting the first guidewire into the main vessel, introducing the introducer over the first guidewire, and inserting the second guidewire within the second lumen such that the second guidewire extends into the branch vessel. The introducer is withdrawn while maintaining the first and second guidewires in the respective vessels.

Description

Guide wire introducer sheath

The mutual ginseng person of related application

The present invention relates to following U.S. Patent application requirement and enjoy its senior interest, these apply for disclosed complete content by this paper with reference to quoting:

Application number 09/533,616 (attorney docket 19601-000700) is in submit applications on March 22nd, 2000;

Temporary patent application number 60/208,399 (attorney docket 19601-000710) is in submit applications on May 30th, 2000; And

Other relevant cases, its disclosure with reference to quoting, is comprised Application No. 08/744,022 by this paper, in submit applications on November 4th, 1996, now abandons; 08/935,383, in JIUYUE in 1997 submit applications on the 23rd; 09/007,265, in submit applications on January 14th, 1998; 09/325,996, in submit applications on June 4th, 1999; 09/455,299, in December in 1999 submit applications on the 6th; 60/088,301, in submit applications on June 5th, 1998; And PCT number of patent application PCT/US 99/00835, in submit applications on January 14th, 1999.

Technical field

The present invention relates to be used for to position the wire in endoceliac system and method and the conduit system that is used for introducing support (stent).

Background of the present invention

A kind of built-in pipe device that is commonly called support can be placed or be implanted in vein, tremulous pulse or other tubular body organs, wall by strengthening blood vessel or the obturation that blood vessel dilating can be used to treat blood vessel, narrows down or aneurysm.Support was used to once treat that incision that causes and the elastic rewinding that prevents blood vessel wall and refigure improve the effect of angioplasty owing to the balloon angioplasty of coronary artery and peripheral arterial in blood vessel wall.There are two multiple center trials at random once to illustrate recently, with the coronary artery of stent in the treatment with only compare with the situation of balloon angioplasty, have the lower rate that narrows down again and (see Serruys, PW etc. show, be published in " New England Journal of Medicine " 331:489-405 (1994) and Fischman, DL etc. show, and are published in " New England Journal of Medicine " 331:496-501 (1994)).Support once successfully was implanted in urinary tract, bile duct, esophagus and the tracheobronchial tree to strengthen these organs, also was implanted within the system or the like of neural blood vessel, peripheral blood vessel, coronal, the heart and kidney." support " speech be used in mean among the application interior intracavity that a kind of device is implanted to body vessel be used for to that wither, that cut, part is inaccessible, blood vessel wall expansible or segment that die down, ill or undesired reinforced.

One of shortcoming of conventional stent is that they generally are made into straight tubulose.The danger of using this support to come bifurcation (branch point) or the ill blood vessel of contiguous treatment at blood vessel may cause the complete openness that must take into account main blood vessel and/or its branch or bifurcation also can limit branch's support is inserted into ability in the side branch so that the therapeutic effect of main blood vessel can only be a suboptimum.The suboptimum effect takes place may be caused by several mechanisms, if any skew, the blood vessel slurry of the displacement of diseased tissues, speckle, have or not with the incision of inner membrance flap, the formation and the thromboembolism of thrombosis.

As illustrated in following relevant common unsettled Application No.: 08/744,022, in submit applications on November 4th, 1996, abandon now; 09/007,265, in submit applications on January 14th, 1998; 08/935,383, in JIUYUE in 1997 submit applications on the 23rd; With 60/088,301, in submit applications on June 5th, 1998; And at PCT patent application gazette WO 99/00835, illustrated on January 14th, 1998 submit applications; Once researched and developed such system, promptly the infall in main blood vessel and branch vessel launches main support and by the side openings on the main support branch's support is extend in the branch vessel in main blood vessel.

Explanation according to these systems, in first method, at first insert first lead, then insert second lead, respectively main support and branch's support are inserted into bifurcation then on these two leads, second lead moves through the lateral orifices in the main support and enters in the branch vessel at that time.In the second approach, at first insert first lead, a molectron (comprise main support and be used for making the localized system of second lead as a double channel catheter) is inserted into bifurcation thereon then.After this, second lead is transfused to the lateral orifices that it is moved through in the main support by its navigation system and enters in the branch vessel.

Regrettably, in first method, before will having or not reaching the main support location of the branch's support in the branch vessel, in the time will at first being inserted into two leads that separate in main blood vessel and the secondary blood vessel, exist some difficulties with lateral orifices by main support.

Specifically, when guiding two leads that separate when making wherein one to enter in the branch vessel by main blood vessel, these two leads can be reeled and mat mutually usually.In addition, need spended time and energy that these two leads are successively located respectively.

Another shortcoming of conventional stent is, is difficult to see support upon deployment with after launching, and in general, they are not easy with inexpensive and easy method such as X ray or ultrasound wave display image.

Summary of the present invention

The present invention includes a two-chamber guide wire introducer system can be used to lead is incorporated into bifurcation in main blood vessel and the branch vessel.The two-chamber of this guide wire introducer system respectively has a distal openings, and they are set on the diverse location on the introducer length.Specifically, the far-end of the first chamber opening preferably is located on the far-end of introducer, and the far-end of the second chamber opening preferably is located at a segment distance place of leaving the introducer far-end.Like this, the far-end of the first chamber opening just is located at the far-end place far away of leaving the second chamber opening.Therefore, the far-end of second lead is nearer from the position that introducer stretches out than the far-end of first lead from the position that introducer stretches out.First chamber and second chamber all receivability lead are passed through.

Also to illustrate as following, the advantage of this double channel catheter system is positioned at second lead in the branch vessel for it can be used to first lead is positioned in the main blood vessel, so that can accomplish following both one of: (1) main support can launch in main blood vessel, branch's support launches in branch vessel, and branch's support is to launch by the lateral orifices in the main support, this lateral orifices is aimed at the branch vessel mouth at that time, or (2) main support can launch in main blood vessel, and the lateral orifices align fingers blood vessel mouth in the main support and being positioned.System of the present invention first and second leads are positioned at respectively separately main blood vessel and branch vessel in after, the finder of alternative main support and/or branch's support also can be employed.The present invention can in conjunction with any existing mounting system comprise " touching " or " near " air bag and mounting system and be used.

Should be understood that use of the present invention is not limited to the placement of support.Native system in fact can be used to any surgical use, and it can advantageously be positioned at first and second leads in the different branches of vascular bifurcation point.

The significant advantage that this two-chamber lead is introduced conduit system is that it can avoid must one time in a main blood vessel and branch vessel that dividually first and second leads is positioned at separately.Because first and second leads potential may just can preventing entangled to each other like this.For example native system can be used to the use support of expansion, " contact " airbag technology and the kidney of distal embolic protection device, and a lead is positioned in kidney nearby at that time, and second lead rested in the kidney blood vessel.First lead is used to support or protection device are issued to kidney nearby, and second lead is used to provide for example ultrasonic system of support or other devices.

And, adopt the present invention, when initial, only need individual conductor is placed in the main blood vessel, use this guide wire introducer system easily second lead to be positioned in the branch vessel subsequently.Because having two-chamber can be with first and second leads separately, therefore when these two leads were inserted in the bifurcation, this wiring system can prevent the entanglement of lead effectively.

As some preferred aspects, radio opaque markers can be located at the distal openings place in second chamber, the position that the far-end that makes second lead stretches out in the introducer can be in sight on fluorescent screen.Can randomly also radio opaque markers can be located at the distal openings place in first chamber, make the surgeon can determine whether he has advanced enough far away so that the process bifurcation.

As optional preferred aspect, radio opaque markers can be located on the both sides of introducer axle of the second chamber far-end close position.This radio opaque markers can be aimed at the lateral orifices in the main support with helping the surgeon effectively with the branch vessel mouth.

As optional preferred aspect of the present invention, an air bag can be positioned at the far-end of guide wire introducer system, this air bag can be used for making the main blood vessel of vascular bifurcation point to expand in advance effectively.This point is particularly useful during when the speckle on the compression blood vessel wall or with additive method pretreatment blood vessel.

The present invention also comprises a kind of main traverse line is inserted in the main blood vessel and offset is inserted into method in the branch vessel that in main blood vessel and branch vessel intersection this method comprises: (a) order about first lead and advance and make it the far-end of first lead is positioned in the intersection that surpasses (perhaps another kind of way is approaching) main blood vessel and branch vessel by main blood vessel; (b) order about the two-chamber guide wire introducer and advance it is enclosed within on first lead by main blood vessel, first lead is received within first intracavity of two-chamber guide wire introducer; (c) make the far-end in first chamber be arranged on the intersection of crossing main blood vessel and branch vessel two-chamber guide wire introducer location, and the far-end in second chamber just is located at said intersection; And (d) order about second lead and advance and make it the far-end of second lead comes out to enter in the branch vessel from the distal openings in second chamber by second chamber.

As the optional aspect of method for optimizing, the airbag inflation that is positioned at the guide wire introducer far-end can be made main blood vessel expand in advance.The expansion of air bag can be preferably before being inserted into second lead in the branch vessel, carry out afterwards or simultaneously.

As the preferred aspect of this method, the two-chamber guide wire introducer is so positioned, and makes the far-end in second chamber be located at the intersection of main blood vessel and branch vessel and far-end vicinity in second chamber has a radio opaque markers to see; And the distal openings that makes first chamber is located at as far as the intersection that surpasses main blood vessel and branch vessel and the far-end vicinity in second chamber has a radio opaque markers to see.

As an optional preferred aspect of the present invention, guide wire introducer is taken away easily and first and second leads is stayed on the position in main blood vessel and the branch vessel.As the explanation in following relevant common pending application file: Application No. 08/744,022, in submit applications on November 4th, 1996, now abandon; 09/007,265, in submit applications on January 14th, 1998; 08/935,383, in JIUYUE in 1997 submit applications on the 23rd; Temporary patent application number 60/088,301 is in submit applications on June 5th, 1998; With PCT patent application gazette WO99/00835, in submit applications on January 14th, 1998; So first and second conduits can be enclosed within main support and the branch support location that is pushed on separately first and second leads as a means of making separately.

As another preferred aspect of the present invention, guide wire introducer is made by peelable material, and the lengthwise part of introducer is separated by peelable sealing, and therefore the operator need only hold lead and can prevent that just lead is drawn out when taking away introducer.

The additional advantage of this stripping system is that it(?) can not need use the lead with long exchange length, because the surgeon can be near lead on more near the position on patient body surface.

The application of native system comprises blood vessels such as the heart, crown, kidney and periphery, system and brains such as gastrointestinal, lung, urinary system and neural blood vessel.The other advantage of this double channel catheter system is that the improved support sending trap that it provides can be issued to main support and branch's support: 1) cover the bifurcated vessels bifurcation fully; 2) pathological changes that is used to treat in the branch of bifurcated keeps entering in another branch so that carry out following treatment simultaneously; 3) allow the support in the support sending trap of a bifurcated that different sizes can be arranged, can be like this even main support is implanted still; 4) bifurcated lesions in the treatment branch vessel branch vessel of stretching out from main blood vessel side; And 5) make labelling or at least a portion is to make with a kind of material with a kind of material, this material can be with common interior observational technique (including, but are not limited to ultrasound wave or the X ray) display image of conduit cavity commonly used.

Brief description of drawings

Figure 1A is the sketch map of a two-chamber guide wire introducer;

Figure 1B is the sketch map according to the alternate embodiments of two-chamber guide wire introducer of the present invention;

Fig. 2 is the cutaway view that the system of Figure 1A cuts along the 2-2 line;

Fig. 3 is for being placed on first lead main endovascular sketch map;

Fig. 4 is that a sketch map illustrates the two-chamber guide wire introducer and is enclosed within and advances to a position on first lead, and it is contiguous with the branch vessel mouth that the remote stomidium in this second chamber, position is positioned in vascular bifurcation point;

Fig. 5 be a sketch map illustrate second lead by second chamber of introducer before so that its far-end is positioned in the branch vessel;

Fig. 6 for this guide wire introducer by the sketch map after taking away, the near-end that introducer is shown is separated into the part that extends longitudinally for many;

Fig. 7 advances to sketch map in the bifurcation for main support is enclosed in progressive first conduit on first lead, second lead is shown moves through the lateral orifices of main support and enter in the branch vessel;

Fig. 8 is at the unfolded sketch map of the main support of bifurcation, branch's support is shown is enclosed in that progressive second conduit advances in the bifurcation on second lead.

Fig. 9 is that first and second conduits are taken away back main support and branch's support at the unfolded sketch map of bifurcation.

Figure 10 illustrates the method that main support and branch's support is advanced to a kind of alternative use in the bifurcation that is enclosed within on first and second leads simultaneously;

Figure 11 is the sketch map of a two-chamber guide wire introducer, and this introducer is in the contiguous position of the second chamber far-end, be provided with radio opaque markers in the both sides of introducer axle;

Figure 12 A is the end-view of Figure 11 system in operator's eye;

Figure 12 B is the impervious image of the ray on fluorescent screen corresponding to Figure 12 A;

Figure 13 A is system's end-view operator's eye when the position from Figure 12 A turns over 90 ° of Figure 11;

Figure 13 B is the image that can not see through ray on fluorescent screen corresponding to Figure 13 A;

Figure 14 A is system's end-view operator's eye when the position from Figure 13 A turns over 90 ° again of Figure 11;

Figure 14 B is the image that can not see through ray on fluorescent screen corresponding to Figure 14 A;

Figure 15 is system's end-view in operator's eye when being positioned at vascular bifurcation point of Figure 11; And

Figure 16 is the sketch map with two-chamber guide wire introducer of far-end air bag.

The explanation of specific embodiment

The invention provides two-chamber guide wire introducer and using method thereof, can be used to lead is incorporated into vascular bifurcation point in main blood vessel and the branch vessel.Like this, the present invention just can position the wire and make after guide wire introducer is taken away, and main support and branch's support can be unfolded at the vascular bifurcation point.Perhaps, main support can be so positioned, and the inboard lateral opening location of support is aimed at the branch vessel mouth.

Consult Fig. 1 and 2, guide wire introducer 10 has two chambeies of running through 12 and 14.There is a distal openings 13 in chamber 12, and this opening preferably is located at the far-end of introducer.There is a distal openings 15 in chamber 14, and this opening preferably is located at and leaves the position that the introducer far-end has a segment distance.

As what illustrate below in conjunction with this method for optimizing, first lead 25 is admitted by chamber 12, and second lead 27 is admitted by chamber 14.

A radio opaque markers 20 can randomly be located at the vicinity of chamber 12 distal openings 13, and another radio opaque markers can randomly be located at the vicinity of chamber 14 distal openings 15, and those skilled in the art will know that the labelling 20,22 that increases according to the present invention also can be used.

In one embodiment, introducer 10 also comprises near the rotary bending piece 16 of position distal openings 15.Rotary bending piece 16 can comprise the part of seam 18 between chamber 12 and 14.Perhaps, rotary bending piece 16 can comprise one by angular structure identical, similar with

chamber

12,14 or that different component is made.Rotary bending piece 16 makes conductor wire end come out to deflect into easily required direction from distal openings 15.In an embodiment was arranged, rotary bending piece 16 was with the angle orientation of the longitudinal axis that is not parallel to said chamber 14.In a specific embodiment, this angle is about 45 degree, but within the scope of the invention, this angle is changeable.Rotary bending piece 16 can have a surface straight or curve makes conductor wire end deflection.

In one embodiment, also with the angle orientation of the longitudinal axis that is not parallel to chamber 14, this angle is about 45 degree to distal openings 15 in a specific embodiment.In another embodiment, rotary bending piece 16 and distal openings 15 are positioned as each other angle and are about 90 degree.

Further will discuss as this paper, in one embodiment, the branch vessel lead is transferred by chamber 14 and enters in the branch vessel.The far-end of branch vessel lead can contact or not contact rotary bending piece 16 when being turned to branch vessel drawing opening 15.

Fig. 3 to 5 illustrates in order to be included in when using this guide wire introducer and first lead 25 is inserted in the main blood vessel and second lead 27 is inserted into step in the branch vessel.Fig. 6 illustrates the preferred steps of interpolation, and this step is taken away guide wire introducer 10, stays first and second leads on the position of vascular bifurcation point.Fig. 7 to 9 illustrates optional step, and these steps can be positioned in bifurcation and guide wire introducer carries out after being taken away at first and second leads.

Main traverse line is inserted in the main blood vessel and offset is inserted into method for optimizing in the branch vessel of main blood vessel and branch vessel intersection, now be described as follows shown in Fig. 3 to 5.Consult Fig. 3, first lead 25 inserts the back and advances in main blood vessel M and make its far-end 26 through the intersection of main blood vessel M and branch vessel B and be positioned.

Consult Fig. 4, two-chamber guide wire introducer 10 is enclosed within on first lead 25 and first lead 25 is received in advances by main blood vessel M in its first chamber 12, because can see the position of radio opaque markers 22 on fluorescent screen, the surgeon can easily make the position in the distal openings 15 in bifurcation chamber 14.Like this, two-chamber guide wire introducer 10 preferably is so positioned the far-end that makes chamber 12 and is located at place away from bifurcation one segment distance of main blood vessel M and branch vessel B.

Radio opaque markers 20 makes the surgeon can determine whether the distal openings 13 in chamber 12 moves through bifurcation to the distant place.

Consult Fig. 5, second lead 27 is advanced come out to move in the branch vessel B from the distal openings 15 in second chamber 14 by second chamber 14 so that its far-end 29.

After this, guide wire introducer 10 is withdrawn, first lead 25 is stayed (its far-end 26 is located at the position through main blood vessel and branch vessel intersection) in the main blood vessel M, and second lead 27 is stayed in the branch vessel B.Simultaneously first lead 25 is remained on when in one embodiment, introducer 10 being withdrawn its far-end 26 is located on process or the position away from bifurcation or blood vessel intersection.Similarly in one embodiment, simultaneously second lead 27 is remained on when introducer is withdrawn make in the branch vessel its far-end 29 be located at through or away from the blood vessel intersection.

Fig. 6 illustrate when with guide wire introducer 10 when patient withdraws on one's body, an optional details of introducer, situation is as follows.In a preferred version, guide wire introducer 10 is made by a kind of peelable material, constitutes a plurality of part 30A that extend longitudinally and 30B and is kept together by peelable seam 32.Seam 32 can comprise that (should be understood that introducer 10 can be made of the longitudinal extension part 30 more than two, the present invention does not limit the concrete number of these parts to the seam 18 shown in Figure 1B.This paper illustrates just for convenience of explanation with two

part

30A and 30B).According to this preferable methods, the operator can become

divided portion

30A and 30B with introducer 10 strip ofves when withdrawing introducer 10, and simultaneously the operator is held in and makes on

lead

25 and 27 that these leads do not move when introducer is withdrawn.

The advantage that guide wire introducer 10 is separated into a plurality of separate sections for can make the surgeon with the contiguous position of patient P body surface on can make it surpass the total length of

lead

25 and 27 to spurring introducer nearby near

lead

25 and 27, thereby be drawn out fully.

Like this surgeon with regard to available short line free operant and can be on more near the position of patient body near lead 25 and 27 (thereby needing can to avoid with long switch type lead).

Fig. 7 to 9 illustrates optional support insertion technology, this technology can lead 25 and 27 be inserted into by bifurcation put in place after and after guide wire introducer 10 is withdrawn, carry out.

Consult Fig. 7, first conduit 50 that main support 40 with lateral orifices 42 can be enclosed on first lead 25 drives advance (second lead 27 moves through lateral orifices 42 as figure at that time).As shown in Figure 8, then main support 40 can vascular bifurcation point when its lateral orifices 42 and branch vessel B mouth to being launched by first conduit 50 on time.If desired, second conduit 52 that branch's support 45 can be on being enclosed in second lead 27 launches when driving the position that advances to bifurcation shown in Figure 9, locates it at this and can be launched fully by conduit 52.First and second conduits 50,52 can be withdrawn then.

According to the lead placement shown in Fig. 7 to 9, various optional aspects of the present invention and use have more complete explanation in following common unsettled Application No.: 08/744,022, in submit applications on November 4th, 1996, now abandon; 08/935,383, in JIUYUE in 1997 submit applications on the 23rd; 09/007,265, in submit applications on January 14th, 1998; U.S. Provisional Patent Application numbers 60,/08 8,301 is in submit applications on June 5th, 1998; PCT number of patent application PCT/US99/00835 is in submit applications on January 14th, 1999; Application No. 09/325,996 is in submit applications on June 24th, 1999; With 09/455,299, in December in 1999 submit applications on the 3rd, these apply for that disclosed content is that various purposes are intactly with reference to quoting by this paper.

Optional air bag (not shown) on the far-end of first and second conduits 50,52 can be used for launching main support 40 and branch's support 45 respectively.

According to some optional aspects, from the edge of lateral orifices 42 along side direction stretch out and unfolded can radially expansible part (not shown) can be used to with aligned lateral orifices 42 grapplings of branch vessel B mouth.This complete description that can radially expansible part (this part is pressed on the wall of branch vessel B) can be seen in the PCT patent application WO99/00835 that publishes of 1998.01.14 submit applications, this application by this paper intactly with reference to quoting.

Equally can be randomly, branch's support 45 also can have a contact site (not shown), this one still rests in the lateral orifices 42 after support 40 and 45 is unfolded, thereby the near-end of support 45 can be fixed on the lateral orifices 42 of support 40, thereby can cover bifurcation fully.This contact site has further instruction in the common unsettled PCT patent application WO 99/00835 of 1998.01.14 submit applications.

Figure 10 illustrates main support and branch's support 40 and 45 is enclosed within the another kind of alternative method that is inserted on first lead 25 and second lead 27 in the bifurcation, and main support 40 and branch's support 45 are inserted in the bifurcation together simultaneously at that time.This method can replace the method for successively inserting in order shown in Fig. 7 and 8, but also can obtain identical final result as shown in Figure 9.Specifically, as shown in figure 10, branch's support 45 can be at first by warpage in main support 40, make main support and branch's support 40,45 can be used as the unit that assembles and be inserted in the bifurcation together.After main support 40 to small part is launched by conduit 50 (for example being expanded by the air bag 50 at conduit 50 far-ends), branch's support 45 will be no longer by on the fixed position of warpage in main support 40, but will from the warpage clamping of main support 40, free, cause conduit 52 to advance, so just can branch's support 45 be launched in branch vessel by the lateral orifices 42 in the main support 40 to the distant place.

In the optional preferred version shown in Figure 11 to 15, both sides at the introducer axle of the second chamber far-end close position are provided with radio opaque markers, these labellings can be aimed at the lateral orifices in the main support with helping the surgeon effectively with the branch vessel mouth, situation is as follows:

Consult Figure 11, radio

opaque markers

60 and 62 is positioned in the far-end 15 of the both sides of introducer 10 near second chamber 14.When observing with X ray, the operator can see radio opaque markers 60 and 62.Preferably these two labellings are made by different labellings, and for example one can be made of gold and another is made by platinum, can provide degree different radiopacitys like this.Adopt different materials to comprise different metals, this also belongs in the scope of the present invention.

As Figure 12 A, the operator from shown in angle can show the image (introducer 10 can not see with X ray, now be shown in broken lines for reference to) shown in Figure 12 B of seeing

labelling

60 and 62 at screen when observing introducer 10 with X ray.Figure 13 A illustrates the similar image that can see when introducer 10 rotates to 14B.

The advantage that labelling 60 and 62 has the different radiopacity of degree is, as shown in figure 15, as long as rotate introducer 10 on direction R labelling 60 is aimed at branch vessel B mouth.Specifically, when on time, the operator observes introducer 10 from one with branch vessel B from the vertical angle of angle that main blood vessel M stretches out, and the labelling of at this moment seeing 60 and 62 has maximum interval.

In the scheme of a demonstration of the present invention, the diameter of introducer 10 is about 6 French (French is the unit of tiny diameters such as fiber illuminated) in the scope of about 8 French.

In a scheme of the present invention, first and second leads 25 and 27 diameter about 0.014 inch in about 0.038 inch scope, and the diameter of first and second chambeies 12 and 14 about 0.016 inch in about 0.038 inch scope.In a specified scheme of the present invention, the distance between the first and second chamber distal openings arrives in about 2.5 inches scope at about 0.039 inch.

Consult Figure 16, in one embodiment, air bag 21 is positioned in the far-end of introducer 10.Air bag 21 can be before second lead 27 be inserted in the branch vessel B, expanding afterwards or simultaneously expands main blood vessel M in advance.In one embodiment, as when the angiostenosis, air bag 21 is inflated to such an extent that speckle or other materials (not shown) are flattened or be compressed to be pressed on the main blood vessel M wall.In one embodiment, introducer 10 comprises that also an expansion chamber (not shown in Figure 16) is coupling on the air bag so that inflation fluid is offered swelling gasbag.

In another embodiment, chamber 14 has enough big I and penetratingly admits second air bag.In one embodiment, be inserted in the chamber 14 at the conduit (not shown in Figure 16) that has second air bag near its far-end, this insertion can occur in second lead 27 introduce before, afterwards or simultaneously.Second air bag can be inflated to impel speckle or other blockages to be pressed on the blood vessel wall of main blood vessel M and/or branch vessel B.In also having another embodiment, second air bag and air bag 21 all are inflated to impel speckle or other blood vessel blockages to be pressed on the blood vessel wall.In a certain embodiments, second air bag and air bag 21 are by in " soft-touch type " airbag technology of all knowing with industry expert.This technology can be used to the intersection of branch vessel and main blood vessel.For example, in one embodiment, second air bag is introduced in the branch vessel B and air bag 21 is introduced in the main blood vessel, and two air bags are all in the inflated around of main blood vessel and branch vessel intersection.Use introducer 10 to help to make endovascular air bag to accomplish suitable aligning easily in conjunction with the soft-touch type airbag technology.

The present invention also has the complete outfit that comprises apparatus of the present invention and using method explanation.

In order to understand fully and to understand the present invention, describe the present invention in the above in detail.But should know that the present invention within the scope of the appended claims can make some change and modification.For example, the present invention can find purposes in the blood vessel of various bifurcateds, and is not limited to the intersection of main blood vessel and branch vessel.

Claims

1. one kind is inserted into main traverse line in the main blood vessel and offset is inserted into method in the branch vessel of main blood vessel and branch vessel intersection, and said method comprises:

Ordering about first lead is positioned near main blood vessel and the branch vessel intersection by the advance far-end that makes first lead of main blood vessel;

Order about guide wire introducer and be enclosed within on first lead by main blood vessel and advance, first lead is received within first intracavity of guide wire introducer;

With guide wire introducer location, the far-end in its first chamber is located at surpasses main blood vessel and branch vessel intersection, and the far-end in its second chamber be located at main blood vessel and branch vessel intersection near; And

Order about second lead and advance, make its far-end by the contiguous remote stomidium of the second chamber far-end and enter in the branch vessel by second chamber.

2. the method for claim 1 is characterized in that first lead is positioned in above main blood vessel and branch vessel intersection.

3. the method for claim 1 is characterized in that the location of said guide wire introducer is arranged on above main blood vessel and branch vessel intersection the far-end in first chamber, also comprises:

Watch and be positioned at the contiguous radio opaque markers of the first chamber far-end.

4. the process of claim 1 wherein the distal openings with second chamber orientated as of said guide wire introducer, to be positioned at the neck of main blood vessel and branch vessel intersection near, also comprises:

Watch and be positioned at the contiguous radio opaque markers of the second chamber far-end.

5. the method for claim 1 is characterized in that also comprising:

Withdraw the guide wire introducer that is enclosed within on first and second leads, thereby in main blood vessel, take away guide wire introducer, simultaneously the far-end of main traverse line is stayed in the main blood vessel, and the far-end of offset is stayed in the branch vessel.

6. the method for claim 5 is characterized in that also comprising:

Guide wire introducer is separated into a plurality of parts that extend longitudinally.

7. the method for claim 6 is characterized in that the step of separating conductive wires introducer comprises that the two-chamber guide wire introducer is torn seam along one or more to be separated.

8. the method for claim 5 is characterized in that also comprising main support and branch's support are positioned near the intersection that said positioning step comprises:

Ordering about main support advances along first lead; With

Ordering about branch's support advances along second lead; Wherein second lead to small part moves past the inside of main support and the lateral orifices in main support is come out.

9. the method for claim 8 is characterized in that,

Ordering about main support by first conduit advances along first lead; And

Ordering about branch's support by second conduit advances along second lead.

10. the method for claim 9 is characterized in that main support to small part is arranged on first airbag deployment of first distal end of catheter, yet wherein the far-end of second conduit is advanced to the main support of small part by being unfolded to small part by being driven.

11. one kind is used for offset is incorporated into system in the branch vessel of main support and branch support intersection, said system comprises:

Guide wire introducer with first and second chambeies, respectively there is a distal openings in said first and second chambeies, wherein the distal openings in first chamber is located at along guide wire introducer than on the farther position of the distal openings in second chamber, and wherein first chamber and second chamber all respectively are suitable for admitting one by the lead in it.

12. the system of claim 11 is characterized in that the far-end in first chamber is located on the far-end of guide wire introducer.

13. the system of claim 11 is characterized in that also comprising:

One is located at the contiguous radio opaque markers of the second chamber distal openings.

14. the system of claim 11 is characterized in that also comprising:

One is located at the contiguous radio opaque markers of the first chamber distal openings.

15. the system of claim 11 is characterized in that also comprising:

One can be by first lead of first chamber admittance; With

One can be by second lead of second chamber admittance.

16. the system of claim 11 is characterized in that said guide wire introducer has a plurality of parts that extend longitudinally, the seam of tearing that these parts are suitable for extending is along the longitudinal separated.

17. the system of claim 11 is characterized in that also comprising:

A main support that is enclosed within on first lead; With

Branch's support that is enclosed within on second lead.

18. the system of claim 17 is characterized in that also comprising:

One is used for along first conduit of first lead introducing main support; With

One is used for along second conduit of second lead introducing branch support.

19. a cover device comprises:

System by claim 11 regulation; With

Use indication by claim 1 method regulation.

20. the method for claim 1, the location that it is characterized in that said guide wire introducer make the far-end in second chamber be located at main blood vessel and branch vessel intersection near, also comprise:

Watch a pair of radio opaque markers that is located at this introducer two opposite sides, this is near the first chamber far-end radio opaque markers.

21. the system of claim 11 is characterized in that also comprising:

The a pair of radio opaque markers that is located at this introducer two opposite sides, this is located near the first chamber distal openings radio opaque markers.

22. the system of claim 11 is characterized in that the diameter of this introducer is in about 6 French in the scope of about 8 French.

23. the system of claim 15, the diameter that it is characterized in that first and second leads be in about 0.014 inch in about 0.035 inch scope.

24. the system of claim 11, it is characterized in that distance between the distal openings in first chamber and second chamber about 0.039 in about 2.5 inches scope.

25. the system of claim 11, the diameter that it is characterized in that first and second chambeies be in about 0.016 inch in about 0.038 inch scope.

26. the method for claim 1 is characterized in that also comprising:

Make guide wire introducer first chamber airbag inflation on every side that is located at this guide wire introducer far-end.

27. the system of claim 11 is characterized in that also comprising:

Guide wire introducer first chamber air bag on every side that is located at this guide wire introducer far-end.

28. one kind is incorporated into system in the branch vessel with lead, said system comprises:

Guide wire introducer with first chamber and second chamber, respectively there is a distal openings in said first and second chambeies;

Wherein said second chamber comprises that is located near the deflection piece of the said second chamber distal openings, and the shape of said deflection piece is designed to make the lead termination through the said second chamber distal openings deflection.

29. the system of claim 28 it is characterized in that said second chamber comprises a longitudinal axis, and said deflection piece is to be not parallel to the angle orientation of said longitudinal axis.

30. the system of claim 29 is characterized in that the angle of the capable longitudinal axis of said irrelevancy is about 45 degree.

31. the system of claim 28 is characterized in that also comprising one first conduit, an air bag is located near this first distal end of catheter, and said first conduit is suitable for being inserted into slidably said first intracavity.

32. the system of claim 28 is characterized in that also comprising one second conduit, an air bag is located near this second distal end of catheter, and said second conduit is suitable for being inserted into slidably said second intracavity.

33. the system of claim 28 is characterized in that also comprising that at least one is located at the radio opaque markers of the vicinity of at least one opening in the said distal openings.

34. the system of claim 28 is characterized in that also comprising one and is suitable for along first lead and second lead that is suitable for being positioned in slidably said second intracavity of the arrangement of said first chamber.

35. the system of claim 28 is characterized in that the distal openings in first chamber is located at than on the farther position of the second chamber distal openings along this guide wire introducer.

36. the system of claim 29 is characterized in that the said second chamber distal openings is to be not parallel to the angle orientation of said longitudinal axis.

37. one kind is incorporated into method in the branch vessel with lead, said method comprises:

First lead is inserted in the main blood vessel;

Order about guide wire introducer and pass through said main blood vessel along said first lead, said guide wire introducer has first chamber that engages said first lead slidably;

With the guide wire introducer location, the far-end in first chamber is located at after main blood vessel and the branch vessel bifurcation;

Order about second lead and introduce the chamber by second lead, there are a deflection piece and an opening in said second chamber near its far-end;

The wherein said progressive step of second lead of ordering about comprises with said deflection piece deflection second lead, and its termination is entered in the said branch vessel.

38. the method for claim 37 is characterized in that also comprising first conduit is inserted into said first intracavity, and when said air bag is near said bifurcation, air bag is expanded on said first conduit.

39. the method for claim 37 is characterized in that also comprising second conduit is inserted into said second intracavity, and when said air bag is near said bifurcation, air bag is expanded on said second conduit.

40. the method for claim 39 is characterized in that said expansion step comprises when said second catheter air bag is arranged in the said branch vessel to small part, makes this airbag inflation.

41. the method for claim 38 is characterized in that also comprising second conduit is inserted into said second intracavity, and when said air bag is near said bifurcation, air bag is expanded on said second conduit.

42. the method for claim 41 is characterized in that the said step of said first and second airbag inflations that makes comprises a kind of technology of touching air bag.

43. the method for claim 41 is characterized in that the said step that makes said first and second airbag inflations is included in to make said first airbag inflation in the said main blood vessel and make said second airbag inflation in said branch vessel.

44. the method for claim 37 is characterized in that also comprising when the radiopaque labelling on the said guide wire introducer arrives near the said bifurcation, interrupts the location of said guide wire introducer.