CN1441654A - Introducer sheath wire - Google Patents

Introducer sheath wire Download PDF

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Publication number
CN1441654A
CN1441654A CN 01809885 CN01809885A CN1441654A CN 1441654 A CN1441654 A CN 1441654A CN 01809885 CN01809885 CN 01809885 CN 01809885 A CN01809885 A CN 01809885A CN 1441654 A CN1441654 A CN 1441654A
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CN
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CN 01809885
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Chinese (zh)
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G·M·瓦尔蒂
E·威廉斯
E·查维滋
H·鲍兰格
N·U·贝汉
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先进扩张技术公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/954Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09Guide wires
    • A61M25/09041Mechanisms for insertion of guide wires
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00469Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/856Single tubular stent with a side portal passage
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006Additional features; Implant or prostheses properties not otherwise provided for modular
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/018Catheters having a lateral opening for guiding elongated means lateral to the catheter

Abstract

将第一导线(25)定位在主血管(M)内并将第二导线(27)定位在分支血管(B)内的系统和方法。 The first wire (25) positioned within the main vessel (M) and (27) a positioning system and method in the branch vessel (B) a second conductor. 其一个实施例包括一个具有第一(12)和第二(14)腔、适于将第一和第二导线分别可滑动地安置在第一腔和第二腔内的引入器(10)。 One embodiment includes a thereof having a first (12) and second (14) chamber, the first and second conductors adapted are slidably disposed in the first chamber and the second introduction chamber (10). 而实施方法则包括将第一导线插入到主血管内,沿第一导线引入引入器,再将第二导线插入到第二腔内,使第二导线延伸到分支血管内,然后抽出引入器而将第一和第二导线留在各自的血管内。 The method of the embodiment comprises the first wire is inserted into the main vessel, the introducer is introduced along a first conductor, second conductor and then inserted into the second cavity, extending the second wire into the branch vessel, and the introducer is then withdrawn the first and second conductors remain in the respective blood vessel.

Description

导线引入器套 Introducer sheath wire

相关申请的相互参者本发明涉及下列美国专利申请要求享有其优先权益,这些申请所公开的完整内容被本文参考引用:申请号09/533,616(代理人卷号19601-000700),于2000年3月22日提交申请;临时专利申请号60/208,399(代理人卷号19601-000710),于2000年5月30日提交申请;及另一些有关案件,其公开内容被本文参考引用,包括美国专利申请号08/744,022,于1996年11月4日提交申请,现已放弃;08/935,383,于1997年9月23日提交申请;09/007,265,于1998年1月14日提交申请;09/325,996,于1999年6月4日提交申请;09/455,299,于1999年12月6日提交申请;60/088,301,于1998年6月5日提交申请;及PCT专利申请号PCT/US 99/00835,于1999年1月14日提交申请。 By cross-reference to Related Application The present invention relates to the following U.S. patent application claims the benefit of priority, the entire contents of which are herein disclosed by reference herein: Application Serial No. 09 / 533,616 (Attorney Docket No. 19601-000700), 3 2000 application filed on the 22nd May; provisional Patent application No. 60 / 208,399 (Attorney Docket No. 19601-000710), 2000 May 30 filing; and other related cases, the disclosure of which is incorporated herein by reference, including US Patent application Serial No. 08 / 744,022, on November 4, 1996 submission, now abandoned; 08 / 935,383, filed the application on September 23, 1997; 09 / 007,265, filed the application on January 14, 1998; 09 / 325,996 in 1999 June 4 filing; 09 / 455,299, 1999 December 6 filing; 60 / 088,301, in 1998 June 5 filing; and PCT Patent application No. PCT / US 99 / 00835, 1999 January 14 filing.

技术领域 FIELD

本发明涉及用来将导线定位在体腔内的系统和方法以及用来引入支架(stent)的导管系统。 The present invention relates to a wire positioning system and method, and a body cavity catheter system for introducing the stent (stent) is.

本发明的背景一种通常被称为支架的内置管器件可被安置或植入到静脉、动脉或其他管状体器官内,通过增强血管的壁或扩张血管可用来治疗血管的闭塞、变窄、或动脉瘤。 BACKGROUND Built-tube device of the present invention is generally referred to as a stent may be placed or implanted into the vein, artery or other tubular body organ, vessel or by reinforcing walls vasodilator useful in the treatment of vascular occlusion is narrowed, or aneurysm. 支架曾被用来治疗由于冠状动脉和外周动脉的气囊血管成形术而在血管壁内造成的切开及防止血管壁的弹性重绕和重新塑造而改善血管成形术的效果。 Stent has been cut for the treatment and preventing the elastic vessel wall due balloon angioplasty and coronary angioplasty of peripheral arteries caused by the vessel wall and rewinding improve vascular surgery to reshape the shaping effect. 最近有两个随机的多中心试验曾经示出,用支架治疗的冠状动脉与只用气囊血管成形术的情况相比,具有较低的再变窄率(见Serruys,PW等所著,发表在《新英格兰医学杂志》331:489-405(1994)及Fischman,DL等所著,发表在《新英格兰医学杂志》331:496-501(1994))。 Two recent randomized multicenter trials have shown, as compared with the case where only the angioplasty with coronary balloon angioplasty with stents, has a lower rate of re-narrowing (see Serruys, PW et book, published in "new England Journal of Medicine," 331: 489-405 (1994) and Fischman, DL, etc. book, published in the "new England Journal of Medicine," 331: 496-501 (1994)). 支架曾被成功地植入到泌尿道、胆管、食管和气管支气管树内以增强这些身体器官,还被植入到神经血管、外周血管、冠状的、心的、和肾的系统等等之内。 Stent was successfully implanted in the urinary tract, bile duct, esophagus and tracheobronchial tree to enhance the body organs, nerves and blood vessels are also implanted, peripheral vascular, coronary, heart, and kidney systems and so forth . “支架”一词用在本申请中意为一种器件被植入到身体血管的内腔内用来对萎陷的、切开的、部分闭塞的、变弱的、有病的、或不正常膨胀的或小段的血管壁予以加固。 The term "scaffold" as used in the present application taken to mean a device to be implanted within the lumen of a body vessel used to collapse and cut, partially occluded, weakened, diseased, or abnormal swelling of the blood vessel wall or small pieces to be reinforced.

传统支架的缺点之一为,它们一般被制成笔直的管状。 One disadvantage of conventional stents is that they are generally made of a straight tube. 使用这种支架来在血管的分叉点(分支点)或邻近治疗有病的血管可能会造成须兼顾主血管及/或其分支或分叉点的完全开放度的危险,还会限制将分支支架插入到侧边分支内的能力以致主血管的治疗效果只能是次优的。 In using such stents to the bifurcation point (branch point) of a blood vessel or adjacent the treatment of diseased blood vessels may cause danger shall take into account the main vessel and / or its branches or bifurcation point of completely open, but also limits the branch capacity in the stent is inserted into the side branch vessel so that the main therapeutic effect can be suboptimal. 发生次优效果可能由数种机制造成,如有病组织的位移、斑块的偏移、血管浆、带有或不带内膜皮瓣的切开、血栓的形成、和栓塞。 Suboptimal results may occur caused by several mechanisms, if the displacement of diseased tissues, offset plaque, vascular pulp, cut with or without intimal flaps, thrombosis, and embolism.

如同在下列相关的共同未决的美国专利申请号中所说明的:08/744,022,于1996年11月4日提交申请,现在已放弃;09/007,265,于1998年1月14日提交申请;08/935,383,于1997年9月23日提交申请;和60/088,301,于1998年6月5日提交申请;及在PCT专利申请公报号WO 99/00835,于1998年1月14日提交申请中所说明的;曾经研发这样的系统,即在主血管和分支血管的交叉处将主支架在主血管内展开而通过主支架上的侧边开口将分支支架伸入到分支血管内。 As related in the following co-pending US Patent Application No. explained: 08 / 744,022, on November 4, 1996 submission, now abandoned; 09 / 007,265, filed the application on January 14, 1998; 08 / 935,383, 1997 application filed September 23; and 60 / 088,301, filed on filed on June 5, 1998; and 99/00835, on January 14, 1998, filed in PCT application Publication No. WO Patent application as described; have developed such a system that will open the branch stent extending into the branch vessel through the side of the main stent is deployed main stent in a main vessel at the intersection of the main vessel and the branch vessel.

按照这些系统的说明,在第一种方法中,首先插入第一导线,接着插入第二导线,然后在这两根导线上分别将主支架和分支支架插入到分叉点,其时第二导线移动通过主支架内的侧边孔而进入到分支血管内。 Follow the instructions of these systems, in the first method, the first wire is first inserted, then insert the second wire, respectively, and then the main stent and the branch stent is inserted into the bifurcation point on the two wires, the second wires which moves into the branch vessel through the side hole in the main stent. 在第二种方法中,首先插入第一导线,然后在其上将一个组合件(包括主支架和一个用来使第二导线定位的系统如一个双腔导管)插入到分叉点。 In the second method, the first wire is inserted first, and then on a combination thereof (including the main bracket and a second wire positioning system used to as a dual lumen catheter) into the branch point. 此后,第二导线通过其定位系统被输入使它移动通过主支架内的侧边孔而进入到分支血管内。 Thereafter, the second conductive line through which the positioning system is inputted to move it into the branch vessel through the side hole in the main stent.

遗憾的是,在第一种方法中,在将带有或不带通过主支架的侧边孔伸出到分支血管内的分支支架的主支架定位之前,当要将两根分开的导线首先插入到主血管和副血管内时存在着若干困难。 Unfortunately, in the first method, prior to, with or without the main stent is positioned to protrude branch stent in the branch vessel through the side hole of the main stand, when you want to separate the two wires inserted first when the main vessel and the auxiliary vessel there is a number of difficulties.

具体地说,当要导引两根分开的导线通过主血管使其中一根进入分支血管内时,这两根导线通常会互相卷绕而缠结在一起。 Specifically, when two separate wires to the guide by making wherein a main vessel into the branch vessel, usually two wires wound around each other entangled. 另外,需要花费时间和精力使这两根导线先后分别定位。 In addition, it takes time and effort to make these two wires are positioned successively.

传统支架的另一个缺点是,在展开时和展开后很难看到支架,一般地说,它们不容易用价廉而简便的方法如X射线或超声波显示图像。 Another shortcoming of conventional stents is that, after deployment and upon deployment the stent is difficult to see, in general, they are not easy to use inexpensive and simple methods such as X-ray or ultrasonic display image.

本发明的综述本发明包括一个双腔导线引入器系统可用来将导线引入到主血管和分支血管内的分叉点。 Summary of the Invention The present invention comprises a double lumen introducer system may be used to wire the wire into the main vessel and the branch vessel bifurcation point. 这个导线引入器系统的双腔各有一个远端开口,它们被设置在引入器长度上的不同位置上。 This wire lumen introducer system each have a distal end opening, which are arranged at different positions on the length of the introducer. 具体地说,第一腔开口的远端最好设在引入器的远端上,而第二腔开口的远端最好设在离开引入器远端的一段距离处。 Specifically, the distal opening of the first chamber is preferably provided on the distal end of the introducer, and the distal end opening of the second chamber is preferably provided at some distance from the distal end of the introducer. 这样,第一腔开口的远端就设在离开第二腔开口的远端较远的地方。 Thus, a first lumen distal opening is located in the place away from the distal opening of second lumen farther. 因此,第二导线的远端从引入器伸出的位置比第一导线的远端从引入器伸出的位置近。 Thus, the position of the distal end of the second lead extending from the first lead than the distal end of the introducer extending from a position near the introducer. 第一腔和第二腔都可接纳导线通过。 The first and second chambers can receive a wire passing.

如同下面还要说明,这个双腔导管系统的优点为它可被用来将第一导线定位在主血管内而将第二导线定位在分支血管内,以致可以做到下列两者之一:(1)主支架可在主血管内展开,分支支架在分支血管内展开,而分支支架是通过主支架内的侧边孔展开,其时该侧边孔与分支血管口对准,或(2)主支架可在主血管内展开,而主支架内的侧边孔对准分支血管口而被定位。 As also described below, the advantage of this dual lumen catheter system which may be used for the first wire is positioned within the main vessel and the second conductor is positioned within the branch vessel, so that both can do one of the following :( 1) the main stent may be deployed within the main vessel, to expand the branch stent in the branch vessel, the side branch stent through the hole in the main stent deployment, during which the side branch vessel opening aligned with the aperture, or (2) the main stent may be deployed in the main vessel, while the side hole in the main stent is aligned with a branch vessel opening positioned. 在本发明的系统将第一和第二导线分别定位在各自的主血管和分支血管内后,可替代的主支架及/或分支支架的定位程序也可被应用。 In the system of the present invention after the first and second conductors are positioned within a respective branch vessel and the main vessel, the stent can replace the primary and / or the locator branch stent may also be applied. 本发明可结合任何一种现有的支架系统包括“轻触”或“紧靠”气囊和支架系统而被使用。 The present invention may incorporate any of the existing stent system comprising "touch" or "against" the stent and balloon system is used.

应该知道,本发明的使用并不限于支架的放置。 It should be understood that the present invention is not limited to the placement of the stent. 本系统事实上可被用于任何一种外科手术用途,它能有利地将第一和第二导线定位在血管分叉点的不同分支内。 This system in fact be used in any surgical use, it is advantageous to first and second conductors positioned in the different branches of the vessel bifurcation point.

这个双腔导线引入导管系统的一个重要优点是它可避免必须一次一根分开地将第一和第二导线定位在各自的主血管和分支血管内。 An important advantage of this dual lumen catheter system introduced wire is that it avoids having to separately once a first and second conductors positioned in the respective main vessel and branch vessel. 由于这样,第一和第二导线互相缠结的潜在可能就可防止。 Because of this, the first and second conductors of intertwined potential can be prevented. 例如本系统可被用于远端保护器件的展开、“接触”气囊技术和肾的使用支架,其时一根导线被定位在肾的近处,而第二根导线被停留在肾血管内。 For example, the present system may be used to expand the distal protection device, "contacting" airbag technology and the use of renal stent, a wire is positioned in the vicinity thereof when the kidney, while the second wire is staying within the renal vasculature. 第一根导线被用来将支架或保护器件发放到肾的近处,而第二根导线被用来发放支架或其他器件例如超声系统。 The first wire is used to issue a stent or kidney protection device to close, while the second wire is 911,000 stent or other devices such as ultrasound systems.

而且,采用本发明,在起始时只需把单独导线放置到主血管内,随后使用本导线引入器系统可方便地将第二根导线定位在分支血管内。 Further, the present invention, at the start only the individual wires are placed into the main vessel, followed by use of the lead introducer system may be conveniently positioned within the second wire branch vessel. 由于具有双腔可将第一和第二导线分开,因此当这两根导线被插入到分叉点内时,这个导线系统能有效地防止导线的缠结。 Because lumen may separate first and second conductors, so that when two wires are inserted into the bifurcation point, the system can effectively prevent the lead wire entanglement.

作为一些优选方面,可将不透射线的标记设在第二腔的远端开口处,使第二导线的远端从引入器内伸出的位置能在荧光屏上被看到。 As some preferred aspects, radiopaque markers may be provided at the distal end of the second chamber opening, the distal end of the second lead extending from the inner position the introducer can be seen on the screen. 可任选地,也可将不透射线的标记设在第一腔的远端开口处,使外科医生能够确定他是否已前进足够远以致经过分叉点。 Optionally, the marker may be radiopaque lumen disposed at the distal end of the first opening, so that the surgeon can determine if he has proceeded far enough that after the branching point.

作为任选的优选方面,可将不透射线的标记设在第二腔远端邻近位置的引入器轴的两侧上。 As an optional preferred aspect, radiopaque markers may be provided on both sides of the introducer lumen adjacent the distal end shaft of the second position. 这种不透射线的标记可被有效地用来帮助外科医生将主支架内的侧边孔与分支血管口对准。 Such radiopaque markers can be effectively used to help the surgeon side of the hole in the main stent is aligned with branch vessel opening.

作为本发明的任选优选方面,可将一个气囊定位在导线引入器系统的远端,这种气囊可被有效地用来使血管分叉点的主血管预先膨胀。 As an optional preferred aspect of the present invention, a balloon may be positioned at the distal end of the lead introducer system, this balloon may be used to effectively main vessel pre-expansion vessel bifurcation point. 当压缩血管壁上的斑块或用其他方法预处理血管时这一点特别有用。 This is particularly useful when compressed vessel wall plaque or other vascular pretreatment methods.

本发明还包括一种将主导线插入到主血管内而将分支导线在主血管和分支血管相交处插入到分支血管内的方法,该方法包括:(a)驱使第一导线前进使它通过主血管而第一导线的远端被定位在超过(或者另一种做法为接近)主血管和分支血管的相交处;(b)驱使双腔导线引入器前进使它套在第一导线上通过主血管,第一导线被接纳在双腔导线引入器的第一腔内;(c)将双腔导线引入器定位使第一腔的远端被设在越过主血管和分支血管的相交处,而第二腔的远端就设在所说相交处;及(d)驱使第二导线前进使它通过第二腔而第二导线的远端从第二腔的远端开口出来进入到分支血管内。 The present invention further comprises a method of the main wire is inserted into the main vessel and the branch wires are inserted into the branch vessel in the method of the main vessel and the branch vessel intersection, the method comprising: (a) a first driving it forward through the main wire distal vessel and the first conductor is positioned over (or another close approach) and the main vessel at the intersection of the branch vessel; (b) driving wire lumen introducer sheath so that it proceeds through the primary conductor on the first blood vessels, the first wire is received in the first chamber of the dual chamber lead introducer; (c) the wire lumen distal end of the introducer is positioned so that the first chamber is provided in the main vessel beyond the branch vessel and the intersection, and the distal end of the second chamber is located at said intersection; and (d) a second conductor drives it forward and the distal end of the second wire within a branch vessel through the second lumen from the opening of the distal end of the second chamber out into the .

作为优选方法的任选方面,可将定位在导线引入器远端的气囊膨胀使主血管预先膨胀。 As an optional aspect of the preferred method, the wire may be positioned at the distal end of the introducer balloon is inflated in advance so that expansion of the main vessel. 气囊的膨胀可优选地在将第二导线插入到分支血管内之前、之后或同时进行。 Balloon prior to expansion may preferably be inserted into the second wire branch vessel, after, or simultaneously.

作为该方法的优选方面,双腔导线引入器被这样定位,使第二腔的远端设在主血管和分支血管的相交处而在第二腔的远端邻近有一不透射线的标记可以看见;并且使第一腔的远端开口设在远到超过主血管和分支血管的相交处而在第二腔的远端邻近有一不透射线的标记可以看见。 As a preferred aspect of this method, the introducer wire lumen is positioned such that the distal end of the second chamber is provided at the intersection of a main vessel and a branch blood vessel at the distal end adjacent the second chamber has a radiopaque marker can be seen ; and the distal end opening provided in the first chamber away over the intersection of the main vessel and the branch vessel and adjacent the distal end of the second chamber has a radiopaque marker can be seen.

作为本发明的一个任选的优选方面,导线引入器容易被拿掉而将第一和第二导线留在主血管和分支血管内的位置上。 As an optional preferred aspect of the present invention, the introducer wire is easily removed while leaving the first and second conductors in position within the main vessel and the branch vessel. 如同在下列相关的共同未决的申请文件中的说明:美国专利申请号08/744,022,于1996年11月4日提交申请,现已放弃;09/007,265,于1998年1月14日提交申请;08/935,383,于1997年9月23日提交申请;临时专利申请号60/088,301,于1998年6月5日提交申请;和PCT专利申请公报号WO99/00835,于1998年1月14日提交申请;第一和第二导管于是可套在各自的第一和第二导线上被推进以资使各自的主支架和分支支架定位。 As described in the following related co-pending application documents: US Patent Application No. 08 / 744,022, on November 4, 1996 submission, now abandoned; 09 / 007,265, filed the application on January 14, 1998 ; 08 / 935,383, 1997 September 23 filing; provisional Patent application No. 60 / 088,301, filing in 1998 June 5; and PCT Patent application Publication No. WO99 / ​​00835, 1998 January 14, submission; first and second conduits can then be fitted over the respective first and second conductors are provided for being advanced so that the respective positioning main stent and the branch stent.

作为本发明的另一优选方面,导线引入器由可撕开的材料制成,引入器的纵长部分被可撕开的封口隔开,因此在拿掉引入器时操作者只须握住导线便可防止导线被拉出。 As another preferred aspect of the present invention, the introducer wire is made of a tearable material, the peelable seal spaced apart from the longitudinal portion of the introducer, the introducer removed and therefore when the operator need only hold the wire can prevent the wires from being pulled out.

这种剥离系统的另外的优点是可不需使用具有长的交换长度的导线,因为外科医生能在更为接近病人身体表面的位置上接近导线。 An additional advantage of this system is to be peeled off without using exchange wires having a long length, because the surgeon to position the wire in closer proximity to the patient's body surface.

本系统的应用包括心、冠状、肾和外周等血管,胃肠、肺、泌尿和神经血管等系统及脑。 Application of the system including the heart, coronary, renal and peripheral and other vascular, gastrointestinal, pulmonary, urinary and neurovascular systems and the brain. 这个双腔导管系统的另外一些优点是它所提供的改进的支架发放器可将主支架和分支支架发放到:1)完全覆盖分叉血管分叉点;2)被用来治疗分叉的一个分支中的病变同时保持可进入到另一个分支内以便进行未来的治疗;3)允许在一分叉的支架发放器内的支架可以有不同的大小,即使主支架已被植入仍可如此;4)治疗分支血管从主血管侧边伸出处的分支血管内的分叉病变;及5)用一种材料制出标记或至少一部分是用一种材料制成,该材料能用普通常用的导管管腔内的观察技术(包括但并不限于超声波或X射线)显示图像。 Other advantages of this dual lumen catheter system is an improved dispenser it provides stents may be distributed branch stent and the main stent to: 1) completely cover the bifurcation point of bifurcation vessels; 2) is used to treat a bifurcation while maintaining branch lesions may enter into the other branch for future treatment; 3) allows the stent in a bifurcated bracket dispenser can have different sizes, even if the main stent has been implanted so still; bifurcation lesions within the branch vessel 4) treating a branch vessel extending from a main vessel at the sides; and 5) made of a material with a marker or a portion at least is made of a material, the material can be used in ordinary catheter observation technology intraluminal (including but not limited ultrasound or X-ray) image display.

附图的简要说明图1A为一双腔导线引入器的示意图;图1B为按照本发明的双腔导线引入器的可替代实施例的示意图;图2为图1A的系统沿2-2线切开的剖视图;图3为将第一导线放置在主血管内的示意图;图4为一示意图示出双腔导线引入器套在第一导线上前进到一个位置,在该位置第二腔的远端孔被定位在血管分叉点与分支血管口邻近;图5为一示意图示出第二导线通过引入器的第二腔前进而将其远端定位在分支血管内;图6为这个导线引入器被拿掉后的示意图,示出引入器的近端被分开成为多条沿纵向延伸的部分;图7为主支架被套在第一导线上前进的第一导管前进到分叉点内的示意图,示出第二导线移动通过主支架的侧边孔而进入到分支血管内;图8为在分叉点的主支架展开的示意图,示出分支支架被套在第二导线上前进的第二导管前进到分叉点内。 BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1A is a schematic view of one pair of wires of the introducer lumen; FIG. 1B is a schematic diagram in accordance with an alternative embodiment of the introducer wire lumen of the present invention; FIG. 2 is a system of FIG 1A taken along the line 2-2 the cross-sectional view; 3 is a diagram of the first conductor is positioned within the main vessel; Figure 4 is a schematic diagram illustrating a dual lumen introducer sheath wire is advanced to a position on the first wire, the distal end position of the second chamber holes are positioned in the branch vessel of the bifurcation point adjacent the opening; FIG. 5 is a schematic diagram illustrating a second wire through a second lumen of the introducer and advancing its distal end positioned within the branch vessel; FIG. 6 for the introducer wire after a schematic been removed, illustrating the proximal end of the introducer is separated into a plurality of portions extending in the longitudinal direction; a schematic diagram in FIG. 7 of the first catheter branch point based on the forward bracket quilt proceeds to the first conductor, shows a second wire moving into the holes by the side of the main stent into the branch vessel; FIG. 8 is a front schematic view of the stent expanded in a diverging point, the second catheter branch shown on the second stent fitted over the wire advancing forward into the bifurcation point.

图9为第一和第二导管拿掉后主支架和分支支架在分叉点展开的示意图。 9 is a schematic view of a first and a second rear main stent and the catheter removed branch stent deployment at the bifurcation point.

图10示出套在第一和第二导线上同时将主支架和分支支架前进到分叉点内的一种可替代使用的方法;图11为一双腔导线引入器的示意图,该引入器在第二腔远端邻近的位置、在引入器轴的两侧设有不透射线的标记;图12A为操作者眼中的图11系统的端视图;图12B为对应于图12A的在荧光屏上的射线不能透过的图像;图13A为图11的系统当从图12A的位置转过90°时在操作者眼中的端视图;图13B为对应于图13A的在荧光屏上的不能透过射线的图像;图14A为图11的系统当从图13A的位置再转过90°时在操作者眼中的端视图;图14B为对应于图14A的在荧光屏上的不能透过射线的图像;图15为图11的系统当定位在血管分叉点时操作者眼中的端视图;及图16为具有远端气囊的双腔导线引入器的示意图。 Figure 10 shows the first and second sets of wires for both the main stent and the branch stent is advanced to the bifurcation point of an internal process can alternatively be used; one pair of conductor insertion cavity schematic diagram of FIG. 11, the lead-in position adjacent the distal end of the second chamber, at both sides of the introducer shaft is provided with radiopaque marker; FIG. 12A is an end view of the eyes of the operator of the system 11; FIG. 12B corresponding to FIG. 12A on the phosphor screen impermeable ray image; FIG. 13A is a system diagram 11 when rotated 90 ° from the position of FIG. 12A is an end view of the operator's eyes; FIG. 13B corresponding to FIG. 13A on the screen of a radiopaque image; FIG. 14A is a system diagram 11 when rotated 90 ° further from the position in FIG. 13A is an end view of the operator's eyes; FIG. 14B corresponding to FIG. 14A impermeable ray image on the phosphor screen; FIG. 15 11 is a system diagram when positioned at the bifurcation point of an end view of the operator's eyes; and FIG. 16 is a schematic wire lumen introducer having a distal end balloon.

具体实施例的说明本发明提供双腔导线引入器及其使用方法,可用来将导线引入到主血管和分支血管内的血管分叉点。 Illustrate specific embodiments of the present invention provides a lead introducer lumen and methods of use, it can be used to lead into the main vessel and the branch vessel bifurcation point within the vessel. 这样,本发明便能将导线定位使在导线引入器被拿掉后,主支架和分支支架能在血管分叉点被展开。 Thus, the present invention is able to make the wire is positioned after the introduction of the wire is removed, the main stent and the branch stent can be deployed in the vessel bifurcation point. 或者,主支架可被这样定位,使支架内侧边孔的定位与分支血管口对准。 Alternatively, the main stent may be positioned such that the inner edge of the positioning hole of the bracket aligned with branch vessel opening.

参阅图1和2,导线引入器10具有两个贯穿的腔12和14。 Figures 1 and 2, the wire 10 is introduced into the cavity having two 12 and 14 therethrough. 腔12有一远端开口13,该开口最好设在引入器的远端。 Chamber 12 has a distal opening 13, the opening is preferably provided at the distal end of the introducer. 腔14有一远端开口15,该开口最好设在离开引入器远端有一段距离的位置。 Chamber 14 has a distal opening 15, the opening is preferably provided at the position away from the introducer distal end a distance.

如同下面将结合该优选方法说明的那样,第一导线25通过腔12被接纳,而第二导线27通过腔14被接纳。 As will be below in conjunction with the preferred method described above, the first wire 2512 is received by the cavity, and the second chamber 14 through the line 27 is received.

一个不透射线的标记20可任选地设在腔12远端开口13的邻近,而另一个不透射线的标记可任选地设在腔14远端开口15的邻近,本行业的行家将可知道按照本发明增添的标记20、22也可被使用。 A radiopaque marker 20 can optionally be provided at the distal end of chamber 12 adjacent the opening 13, and the other radiopaque markers may optionally be provided at the distal end of chamber 14 adjacent the opening 15, the industry experts will know 20,22 may also be used according to the present invention is added to the tag.

在一个实施例中,引入器10还包括一个位在远端开口15附近的转折件16。 In one embodiment, introducer 10 further includes a bit 15 at the distal end near the opening 16 of the turning member. 转折件16可包括腔12和14之间接缝18的一部分。 Transition member 16 may include a portion 14 between the chamber 12 and the joint 18. 或者,转折件16可包括一个由与腔12、14相同、相似、或不同构件制成的角形结构。 Alternatively, transition member 16 may include a similar chamber 12, 14 by the same or different member made of angled design. 转折件16使导线端从远端开口15出来容易偏转到所需方向。 Turn the wire end member 16 to be easily deflected in a desired direction out from the distal opening 15. 在有一实施例中,转折件16以不平行于所说腔14的纵轴线的角度定位。 In a embodiment, the turning member 16 to an angle not parallel to the longitudinal axis of said chamber 14 is positioned. 在一具体的实施例中,该角度约为45度,但在本发明的范围内,该角度是可改变的。 In a particular embodiment, the angle is about 45 degrees, but within the scope of the present invention, the angle is changeable. 转折件16可具有一个平直或曲线的表面来使导线端偏转。 Transition member 16 may have a flat or curved surface to deflect the wire ends.

在一个实施例中,远端开口15也以不平行于腔14的纵轴线的角度定位,该角度在一具体的实施例中约为45度。 In one embodiment, the distal end opening 15 is also at an angle not parallel to the longitudinal axis of the chamber 14 is positioned, the angle is about 45 degrees in a particular embodiment. 在另一实施例中,转折件16和远端开口15被定位为相互之间的角度约为90度。 In another embodiment, the transition member 16 and distal opening 15 is positioned at an angle between about 90 degrees to each other.

如同本文进一步要论述,在一实施例中,分支血管导线被输送通过腔14而进入到分支血管内。 As to be discussed further herein, in one embodiment, the wire branch vessel is delivered into the chamber 14 through the branch vessel. 分支血管导线的远端在被引出开口15而转向分支血管时可以接触或不接触转折件16。 The distal end of the wire in the branch vessels 15 is drawn out and the opening may or may not contact turning member 16 is turned to a branch vessel.

图3到5按次序示出使用本导线引入器时包括在将第一导线25插入到主血管内并将第二导线27插入到分支血管内的步骤。 FIGS. 3 to 5 in order, in the illustrated comprises a first lead wire 25 is inserted into the main vessel and the second conductor 27 is inserted into the branch vessel when the step of using the introducer wire. 图6示出添加的优选步骤,该步骤将导线引入器10拿掉,留下第一和第二导线在血管分叉点的位置上。 FIG. 6 shows a preferred added step, the step of introducing the wire 10 is removed, leaving the first and second conductors in position on the vessel bifurcation point. 图7到9示出可任选的步骤,这些步骤可在第一和第二导线被定位在分叉点而导线引入器被拿掉后进行。 7 to 9 show an optional step, these steps may be positioned at the bifurcation point after the introduction of the wire is removed in the first and second conductors.

将主导线插入到主血管内而将分支导线插入到主血管和分支血管相交处的分支血管内的优选方法在图3到5中示出,现说明如下。 The main wire is inserted into the main vessel and the branch wires into the branch vessel and the main vessel at the intersection of a preferred method of the branch vessel in FIG. 3 to 5 is shown, it will now be described below. 参阅图3,第一导线25插入后在主血管M内前进使其远端26经过主血管M和分支血管B的相交处而被定位。 Referring to Figure 3, a first lead wire 25 is inserted so that the distal end 26 advances through the intersection of main vessel M and branch vessel B is positioned within the main vessel M.

参阅图4,然后使双腔导线引入器10套在第一导线25上而将第一导线25接纳在其第一腔12内通过主血管M前进,由于在荧光屏上能看到不透射线的标记22的位置,外科医生能够容易地定出在分叉点腔14的远端开口15的位置。 Referring to Figure 4, and then the wire lumen introducer sheath 10 to the first conductor 25 and the first wire 25 receiving in its advanced through a main vessel M in the first chamber 12, since the screen can be seen radiopaque position marker 22, the surgeon can easily fix the position of the branching point 15 at the distal end opening of the cavity 14. 这样,双腔导线引入器10最好被这样定位使腔12的远端设在远离主血管M和分支血管B的分叉点一段距离的地方。 Thus, the introducer wire lumen 10 are preferably positioned such that the distal end of chamber 12 is provided at the branching point a distance away from main vessel M and branch vessel B is.

不透射线的标记20使外科医生能确定腔12的远端开口13是否已向远处移动经过分叉点。 Radiopaque markers 20 so that the surgeon can determine whether the distal end opening 13 of the chamber 12 has moved past the branching point distance.

参阅图5,然后使第二导线27前进通过第二腔14以致其远端29从第二腔14的远端开口15出来移动到分支血管B内。 Referring to Figure 5, a second wire 27 is then advanced through the second lumen 14 such that its distal end 29 from the distal end of the second chamber 14 moves out of opening 15 to branch vessel B.

此后,将导线引入器10撤走,将第一导线25留在主血管M内(其远端26设在经过主血管和分支血管相交处的位置),而将第二导线27留在分支血管B内。 Thereafter, the wire 10 is introduced into the withdrawal remain in the first wire 25 within the main vessel M (which is provided at the distal end 26 of the main vessel and branch vessel location at the intersection through), whereas the second wire 27 remain in the branch vessel within B. 在一个实施例中,将引入器10撤走时同时将第一导线25保持在主血管内使其远端26设在经过或远离分叉点或血管相交处的位置上。 While the first wire 25 is held with its distal end 26 is provided at a position or away from the branching point through a blood vessel or in the intersection of the main vessel In one embodiment, the withdrawal device 10 will be introduced. 类似地在一个实施例中,将引入器撤走时同时将第二导线27保持在分支血管内使其远端29设在经过或远离血管相交处。 Similarly, in the embodiment, when the withdrawal of the introducer to a second embodiment of the wire 27 while holding it in the branch vessel through the distal end 29 disposed away from the intersection of the vessel.

图6示出当将导线引入器10从病人身上撤走时,引入器的一个可任选的细节,情况如下。 Figure 6 shows the introducer when the wire 10 is withdrawn from the patient, the introducer may be optionally detail, as follows. 在一优选方案中,导线引入器10由一种可撕开的材料制成,构成多个沿纵向延伸的部分30A和30B被可撕开的接缝32保持在一起。 In a preferred embodiment, the introducer wire 10 made of a peelable material constituting the portions 30A and 30B are peelable seam 32 extending longitudinally along a plurality of holding together. 接缝32可包括图1B中示出的接缝18(应该知道,引入器10可由多于两个的纵向延伸部分30构成,本发明并不限制这些部分的具体数目。本文用两个部分30A和30B示出只是为了便于说明)。 32 may include the seam shown in FIG. 1B seam 18 (will be appreciated that introducer 10 may be more than two longitudinally extending portions 30 constituting, the present invention is not limited such specific number of portions. In this paper, the two portions 30A and 30B show merely for convenience of explanation). 按照这个优选的方法,操作者在撤走引入器10时可将引入器10剥开成分开的部分30A和30B,同时操作者握持在导线25和27上使当引入器被撤走时这些导线并不移动。 According to this preferred method, the operator 10 is introduced into the withdrawal of the introducer 10 may be peeled into separate portions 30A and 30B, while the operator holds so that when the introducer is withdrawn on the wire 25 and 27 wire does not move.

将导线引入器10分隔成多个分开部分的优点为可使外科医生在与病人P身体表面邻近的位置上接近导线25和27而可不必向近处拉动引入器使它超过导线25和27的全长,从而完全被拉出。 The wire 10 is introduced into separate partitioned into a plurality of portions of the advantages allow the surgeon to access the patient P in the wire adjacent the body surface 25 and a position 27 may not be necessary to pull the introducer proximally that it exceeds the wires 25 and 27 full-length, thereby completely pulled out.

这样外科医生就可用较短的线自由操作而可在更接近病人身体的位置上接近导线25和27(从而可避免需用较长的交换式的导线)。 Thus the surgeon can be accessible at a position closer to the body of the patient 25 and the wire 27 (thereby avoiding the need to use long leads switched) lines with shorter free operation.

图7到9示出可任选的支架插入技术,该技术可在导线25和27通过分叉点被插入到位之后并在导线引入器10被撤走之后进行。 7 to 9 show an optional stent insertion technique, this technique can be inserted into position after the branching point and after the introduction of the wire 10 is withdrawn through the wires 25 and 27.

参阅图7,一个具有侧边孔42的主支架40可被套在第一导线25上的第一导管50带动前进(其时第二导线27移动通过侧边孔42如图)。 Referring to Figure 7 the main bracket, a side edge 40 of aperture 42 may have slipped over the first wire 25 driven by a first conduit 50 proceeds (the time the second wire 27 moves through the hole 42 as shown in FIG side). 如图8所示,然后主支架40可在血管分叉点当其侧边孔42与分支血管B口对准时被第一导管50展开。 8, the main stent 40 and side holes 42 which may be a branch vessel B and port 50 is aligned with the first conduit when deployed in a vessel bifurcation point. 如果需要,分支支架45可在被套在第二导线27上的第二导管52带动前进到图9所示分叉点的位置时展开,在该处它可被导管52完全展开。 If necessary, the branch stent in the second conduit 45 may be fitted over the second wire 27 is led to the position of the branching point 52 as shown in FIG. 9 proceeds to expand, which may be where the conduit 52 is fully deployed. 然后第一和第二导管50、52可被撤走。 Then the first and second conduits 50, 52 may be withdrawn.

按照图7到9所示的导线安置,本发明的各种任选方面和使用在下列共同未决的美国专利申请号中有较完整的说明:08/744,022,于1996年11月4日提交申请,现已放弃;08/935,383,于1997年9月23日提交申请;09/007,265,于1998年1月14日提交申请;美国临时专利申请号60/08 8,301,于1998年6月5日提交申请;PCT专利申请号PCT/US99/00835,于1999年1月14日提交申请;美国专利申请号09/325,996,于1999年6月24日提交申请;和09/455,299,于1999年12月3日提交申请,这些申请所公开的内容被本文为各种目的完整地参考引用。 Wire placement shown in FIG. 7 to 9, and various optional aspects of the present invention is used in the following co-pending U.S. Patent Application No. a more complete description: 08 / 744,022, filed November 4, 1996 application, now abandoned; 08 / 935,383, filed the application on September 23, 1997; 09 / 007,265, in 1998 January 14 filing; US provisional Patent application No. 60/08 8,301, on June 5, 1998 the filing date of the application; PCT Patent application No. PCT / US99 / 00835, filed the application in 1999 January 14; US Patent application Serial No. 09 / 325,996, filed applications in 1999, June 24; and 09 / 455,299, in 1999 submit an application on December 3, the contents of these applications are disclosed herein for all purposes entirety by reference.

在第一和第二导管50、52的远端上的可任选的气囊(未示出)可被分别用来展开主支架40和分支支架45。 On the distal end of the first and second conduits 50, 52 may optionally airbag (not shown), respectively, may be used to expand the main stent and the branch stent 40 45.

按照一些任选的方面,从侧边孔42的边缘沿侧向向外延伸而展开的可沿径向膨胀的部分(未示出)可被用来将与分支血管B口对准的侧边孔42锚定。 According to some optional aspects, the edges extending laterally outward from the side hole 42 can be expanded radially expandable portion (not shown) may be used to align the side branch vessel opening B anchor hole 42. 这种可沿径向膨胀的部分(该部分抵压在分支血管B的壁上)的完整说明可在1998.01.14提交申请的刊出的PCT专利申请WO99/00835中见到,该申请被本文完整地参考引用。 Such a complete description of the radially expanded portion (the portion pressed against the wall of the branch vessel B) may be submitted in 1998.01.14 application published PCT Patent Application WO99 / ​​00835 are seen, which application is herein entirety by reference.

同样可任选地,分支支架45还可具有一个接触部(未示出),该部在支架40和45被展开后仍停留在侧边孔42内,从而可将支架45的近端固定在支架40的侧边孔42上,从而可完全覆盖分叉点。 Also optionally, a branch stent 45 may also have a contact portion (not shown), which after stent portion 45 is deployed and 40 remains in the side of the hole 42, thereby fixing the proximal end of the stent 45 bracket 42 on the side of the hole 40 so as to completely cover the bifurcation point. 这种接触部在1998.01.14提交申请的共同未决的PCT专利申请WO 99/00835中有进一步的说明。 The contact portion 1998.01.14 filing in co-pending PCT patent application WO 99/00835 described further.

图10示出将主支架和分支支架40和45套在第一导线25和第二导线27上插入到分叉点内的另一种可替代的方法,其时主支架40和分支支架45被一起同时插入到分叉点内。 Figure 10 shows the main stent and the branch stent 40 and sleeve 45 Another alternative method to the first conductor 25 and second conductor 27 is inserted into the bifurcation point, which is the main branch stent 45 and the stent 40 is together simultaneously inserted into the bifurcation point. 这种方法可以取代图7和8所示的按次序先后插入的方法,但也可得到相同的最终结果如图9所示。 This method can replace the method of FIG 7 and 8 in sequence as shown successively inserted, but the same end result can be obtained as shown in FIG. 具体地说,如图10所示,分支支架45可首先被折曲在主支架40内,使主支架和分支支架40、45可作为组装好的单元一起被插入到分叉点内。 Specifically, as shown in FIG. 10, branch stent 45 may be bent in a first main stand 40, the main stand 40, 45 and the branch stent can be inserted together as an assembled unit to the branching point. 在主支架40至少部分被导管50(例如被在导管50远端的气囊50膨胀)展开后,分支支架45将不再被折曲在主支架40内的固定位置上,而是将从主支架40的折曲夹持中解放出来,致使导管52可向远处前进,这样就可通过主支架40内的侧边孔42使分支支架45在分支血管内展开。 After the main stent 40 is at least partially conduit 50 (e.g., the balloon 50 is inflated in the distal end 50 of the catheter) to expand the branch stent 45 will not be bent in a fixed position within the main bracket 40, but the main stand from 40 bent clamping liberate, so that the catheter 52 may be advanced distally so that the sides can through the hole in the main stent 4042 of the branch stent 45 deployed within branch vessel.

在图11到15示出的任选的优选方案中,在第二腔远端邻近位置的引入器轴的两侧设有不透射线的标记,这些标记可被有效地用来帮助外科医生将主支架内的侧边孔与分支血管口对准,情况如下:参阅图11,不透射线的标记60和62被定位在引入器10的两侧靠近第二腔14的远端15。 In Figures 11 to 15 shows a preferred optional embodiment, at both sides of the introducer lumen adjacent the distal end shaft of the second position is provided with radiopaque markers, these markers can be effectively used to help the surgeon the side branch vessel opening aligned with the hole in the main stent, as follows: Referring to Figure 11, the radiopaque markers 60 and distal end 62 are positioned on either side of the introducer 10, 15 adjacent the second chamber 14. 当用X射线观察时,操作者将能看到不透射线的标记60和62。 When the X-ray observation, the operator will not be able to see the radiopaque markers 60 and 62. 最好这两个标记由不同的标记制成,例如其一可由金制成而另一由铂制成,这样可提供程度不同的射线不透性。 Preferably these markers made from two different labels, for example, made of gold and the other one may be made of platinum, which can provide different degrees of radiopacity. 采用不同的材料包括不同的金属,这也属于本发明的范围内。 Different materials include different metals, which are also within the scope of this invention.

如图12A,操作者从所示角度用X射线观察引入器10时将可在屏幕上显示上看到标记60和62的图像如图12B所示(引入器10不能用X射线看到,现用虚线示出供参照)。 FIG. 12A, from the viewpoint of the operator as shown by X-ray observed introducer will be visible on the display mark 10 on the screen 60 and the image shown in FIG. 62 (the introducer 10 can not be seen by X-ray 12B, now shown in dashed lines for reference). 图13A到14B示出当引入器10转动时可以看到的类似图像。 13A to 14B illustrates a similar image is rotated when the introducer 10 can be seen.

标记60和62具有程度不同的射线不透性的优点在于,如图15所示,只要在方向R上转动引入器10便可容易地使标记60与分支血管B口对准。 Numerals 60 and 62 having different degrees of advantage radiopacity that shown in Figure 15, as long as rotation in the direction of introduction of R 10 can be easily and the marking 60 aligned with branch vessel B port. 具体地说,当对准时,操作者是从一个与分支血管B从主血管M伸出的角度垂直的角度来观察引入器10的,这时看到的标记60和62具有最大的间隔。 Specifically, when the observed angle aligned, from the perspective of an operator and a B branch vessel extending from a main vessel M perpendicular to the introducer, this time to see the marks 60 and 10, 62 have a maximum spacing.

在本发明的一个示范的方案中,引入器10的直径在约6弗伦奇到约8弗伦奇的范围内(弗伦奇为纤维光束等细小直径的单位)。 In one exemplary embodiment of the present invention, the introduction of a diameter of about 10 to a range of about 6 French to 8 French (French unit of small beam diameter of the fiber or the like).

在本发明的一个方案中,第一和第二导线25和27的直径在约0.014英寸到约0.038英寸的范围内,而第一和第二腔12和14的直径在约0.016英寸到约0.038英寸的范围内。 In one embodiment of the present invention, the diameter of the first and second conductors 25 and 27 in the range of from about 0.014 inches to about 0.038 inches, while the diameter of the first and second chambers 12 and 14 is about 0.016 inches to about 0.038 inch range. 在本发明的一个特定方案中,第一和第二腔远端开口之间的距离在约0.039英寸到约2.5英寸的范围内。 In a particular embodiment of the invention, the distance between the first and second chambers opening at the distal end in the range of from about 0.039 inches to about 2.5 inches.

参阅图16,在一个实施例中,气囊21被定位在引入器10的远端。 Referring to Figure 16, in one embodiment, the balloon 21 is positioned at the distal end of the introducer 10. 气囊21可在第二导线27被插入到分支血管B内之前、之后或同时膨胀使主血管M预先膨胀。 Before the balloon 21 may be a second wire 27 is inserted into the branch vessel B, after or simultaneously with the expansion of the main vessel M pre-expansion. 在一个实施例中,如在血管狭窄时,气囊21被膨胀得将斑块或其他材料(未示出)压扁或压缩到抵压在主血管M壁上。 In one embodiment, as in the stenosis, the balloon 21 is inflated to give the plaque or other material (not shown), crushed or compressed to press against the wall of main vessel M. 在一个实施例中,引入器10还包括一个膨胀腔(未在图16中示出)耦合在气囊上以便将膨胀液提供给膨胀气囊。 In one embodiment, the introducer further comprises an expansion chamber 10 (not shown in FIG. 16) is coupled to the balloon inflation fluid is supplied to the inflatable balloon.

在另一个实施例中,腔14具有足够的大小可贯穿地接纳第二气囊。 In another embodiment, the cavity 14 may be of sufficient size to receive the second balloon through. 在一实施例中,在靠近其远端具有第二气囊的导管(未在图16中示出)被插入到腔14内,这个插入可发生在第二导线27引入之前、之后或同时。 In one embodiment, the catheter (not shown in FIG. 16) having a second balloon near its distal end is inserted into the cavity 14, this may occur before the insertion of the second wire 27 is introduced, after or simultaneously. 第二气囊可被膨胀以促使斑块或其他阻碍物抵压在主血管M及/或分支血管B的血管壁上。 The second balloon may be inflated to cause the plaque or other obstruction is pressed against the main vessel M and / or branch vessel B of the vascular wall. 在还有另一个实施例中,第二气囊和气囊21都被膨胀以促使斑块或其他血管阻碍物抵压在血管壁上。 In yet another embodiment, the second balloon is inflated and balloon 21 are implemented to cause vascular plaque or other obstruction is pressed against the vessel wall. 在一特定的实施例中,第二气囊和气囊21被用本行业行家都知的“轻触式”气囊技术中。 In a specific embodiment, the balloon and the second balloon 21 is used in the industry experts are known "touch" airbag art. 这种技术可被用于分支血管和主血管的相交处。 This technique may be used for the branch vessel and the main vessel at the intersection. 例如,在一实施例中,第二气囊被引入到分支血管B内而气囊21被引入到主血管内,两个气囊都在主血管和分支血管相交处的周围膨胀。 For example, in one embodiment, the second balloon is introduced into the branch vessel balloon 21 and B is introduced into the main blood vessel in the two balloons around the branch vessel and the main vessel at the intersection of expansion. 使用引入器10结合轻触式气囊技术有助于使血管内的气囊容易做到适当的对准。 10 using the combined touch introducer airbag technology contributes to an intravascular balloon proper alignment easy to do.

本发明还具有包括本发明的器械和使用方法说明的成套配备。 The present invention further includes a kit comprising the present invention is equipped with an instrument and methods of use described.

为了弄清和理解本发明,已在上面详细说明了本发明。 In order to clarify understanding of the invention and has been described in detail above, according to the present invention. 但应知道在所附权利要求书的范围内本发明可以作出某些改变和修改。 It should be understood that certain changes may be made to the present invention and modifications within the scope of the appended claims. 例如,本发明可在各种分叉的血管中找到用途,而不限于主血管和分支血管的相交处。 For example, the present invention may find use in a variety of bifurcated blood vessels, but not limited to the main vessel and the branch vessel intersection.

Claims (44)

  1. 1.一种将主导线插入到主血管内而将分支导线插入到主血管和分支血管相交处的分支血管内的方法,所说方法包括:驱使第一导线通过主血管前进使第一导线的远端定位在主血管和分支血管相交处附近;驱使导线引入器通过主血管而套在第一导线上前进,第一导线被接纳在导线引入器的第一腔内;将导线引入器定位,使其第一腔的远端设在超过主血管和分支血管相交处,而其第二腔的远端设在主血管和分支血管相交处的附近;及驱使第二导线通过第二腔前进,使其远端通过第二腔远端邻近的远端孔并进入到分支血管内。 1. A main wire is inserted into the main blood vessel in the method of the branch wires into the branch vessel and the main vessel at the intersection of the branch vessel, said method comprising: driving a first wire advancement through the main vessel of the first wire positioned in the vicinity of the distal end of the main vessel and the branch vessel intersection; wire driven by the main vessel and the introducer sheath advanced over the first lead, the first lead wire is received in a first lumen of the introducer; positioning the conductor insertion, so that the distal end than the first chamber provided in the main vessel and the branch vessel intersection, while the distal end of the second chamber is provided in the vicinity of a branch vessel and the main vessel at the intersection; and a second wire driven forward by a second chamber, its distal end through the distal lumen adjacent the distal end of the second hole and into the branch vessel.
  2. 2.权利要求1的方法,其特征在于第一导线被定位在超过主血管和分支血管相交处。 The method of claim 1, wherein the first conductor is positioned over the main vessel and the branch vessel intersection.
  3. 3.权利要求1的方法,其特征在于所说导线引入器的定位使第一腔的远端设置在超过主血管和分支血管相交处,还包括:观看定位在第一腔远端邻近的不透射线的标记。 Watch is not positioned in the first chamber adjacent the distal end: The method of claim 1, wherein said positioning the distal end of the lead introducer disposed in the first chamber exceeds the main vessel and the branch vessel intersection, further comprising radiopaque marker.
  4. 4.权利要求1的方法,其中所说导线引入器的定位为将第二腔的远端开口定位在主血管和分支血管相交处的领近,还包括:观看定位在第二腔远端邻近的不透射线的标记。 The method of claim 1, wherein the positioning of said introducer wire to the distal end of the second chamber opening is positioned in the main vessel and the branch vessel collar near the intersection, further comprising: viewer positioned in the second chamber adjacent the distal end the radiopaque marker is.
  5. 5.权利要求1的方法,其特征在于还包括:撤走套在第一和第二导线上的导线引入器,从而从主血管内拿掉导线引入器,同时将主导线的远端留在主血管内,而将分支导线的远端留在分支血管内。 The method of claim 1, characterized by further comprising: a withdrawal sleeve on the first and second lead wires introducer, the introducer wire thus removed from the main vessel, while the distal end of the main wire to remain in within the main vessel, and the distal end of branch wires remain in the branch vessel.
  6. 6.权利要求5的方法,其特征在于还包括:将导线引入器分隔成多个沿纵向延伸的部分。 The method according to claim 5, characterized by further comprising: a wire introduced into the vessel into a plurality of portions extending longitudinally along.
  7. 7.权利要求6的方法,其特征在于分隔导线引入器的步骤包括将双腔导线引入器沿一条或多条撕开接缝分开。 The method of claim 6, wherein the step of introducing the wire separator device comprises a double lumen introducer wire along one or more seams torn apart.
  8. 8.权利要求5的方法,其特征在于还包括将主支架和分支支架定位在相交处附近,所说定位步骤包括:驱使主支架沿第一导线前进;和驱使分支支架沿第二导线前进;其中第二导线至少部分移过主支架的内部并经主支架内的侧边孔出来。 The method of claim 5, characterized by further comprising a branch stent and the main stent is positioned in the vicinity of the intersection, said positioning step comprises: a first driving wire forward along the main bracket; and a second drive branch stent advanced along the wire; wherein the second wire is at least partially moved through and out the interior of the main stent through the side hole in the main stent.
  9. 9.权利要求8的方法,其特征在于,由第一导管驱使主支架沿第一导线前进;及由第二导管驱使分支支架沿第二导线前进。 9. The method as claimed in claim 8, characterized in that, driven by a first conduit along a main stand of the first wire forward; and driven by a second conduit branch stent advanced in the second conductor.
  10. 10.权利要求9的方法,其特征在于主支架至少部分被设在第一导管远端的第一气囊展开,其中第二导管的远端然而被驱前进至少部分通过至少部分已被展开的主支架。 10. The method as claimed in claim 9, characterized in that the first airbag main stent is at least partially disposed at the distal end of the catheter to expand the first, wherein the distal end of the second conduit is however driven at least in part by at least the forward portion has been expanded in the main bracket.
  11. 11.一种用来将分支导线引入到主支架和分支支架相交处的分支血管内的系统,所说系统包括:一个具有第一和第二腔的导线引入器,所说第一和第二腔各有一个远端开口,其中第一腔的远端开口设在沿导线引入器比第二腔的远端开口更远的位置上,其中第一腔和第二腔都各适于接纳一根通过其内的导线。 11. A method for branch wires introduced into the system in the main branch vessel stent and the branch stent intersection, said system comprising: a lead introducer having a first and a second chamber, said first and second a distal opening of each cavity, wherein the distal end opening of the first chamber is provided at a position farther than the distal opening of the second chamber of the introducer along the wire, wherein the first and second chambers are each adapted to receive a roots through the wire therein.
  12. 12.权利要求11的系统,其特征在于第一腔的远端设在导线引入器的远端上。 12. The system of claim 11, wherein the distal end of the first chamber is provided on the distal end of the lead introducer.
  13. 13.权利要求11的系统,其特征在于还包括:一个设在第二腔远端开口邻近的不透射线的标记。 13. The system as claimed in claim 11, characterized by further comprising: a second chamber disposed distal radiopaque markers adjacent to an opening.
  14. 14.权利要求11的系统,其特征在于还包括:一个设在第一腔远端开口邻近的不透射线的标记。 14. The system as claimed in claim 11, characterized by further comprising: a first chamber provided in the distal end of the radiopaque markers adjacent the opening.
  15. 15.权利要求11的系统,其特征在于还包括:一根可被第一腔接纳的第一导线;和一根可被第二腔接纳的第二导线。 15. The system as claimed in claim 11, characterized by further comprising: a first conductor with a first chamber can be admitted; and a second conductor of the second chamber may be admitted.
  16. 16.权利要求11的系统,其特征在于所说导线引入器具有多个沿纵向延伸的部分,这些部分适于沿着纵向延伸的撕开接缝分离。 16. The system of claim 11, wherein said conductor insertion portion having a plurality of longitudinally extending along these portions is adapted to tear along a seam extending longitudinally separated.
  17. 17.权利要求11的系统,其特征在于还包括:一个套在第一导线上的主支架;和一个套在第二导线上的分支支架。 17. The system as claimed in claim 11, characterized by further comprising: a conductor set on the first main bracket; on the sleeve and a second lead branch stent.
  18. 18.权利要求17的系统,其特征在于还包括:一个用来沿第一导线引入主支架的第一导管;和一个用来沿第二导线引入分支支架的第二导管。 18. The system as claimed in claim 17, characterized by further comprising: a first conduit for introducing a first main stent along the wire; and a second conduit for introducing a second branch stent along the wire.
  19. 19.一套器件,包括:一个按权利要求11规定的系统;和按权利要求1方法规定的使用指示。 19. A set device, comprising: a predetermined system as claimed in claim 11; and instructions for use according to claim 1 in a predetermined method.
  20. 20.权利要求1的方法,其特征在于所说导线引入器的定位使第二腔的远端设在主血管和分支血管相交处的附近,还包括:观看一对设在该引入器相反两侧的不透射线的标记,该对不透射线的标记处在第一腔远端附近。 20. The method of claim 1, wherein said positioning the lead introducer in the vicinity of the distal end of the second chamber provided in the branch vessel and the main vessel at the intersection, further comprising: viewing one pair of the two opposite introducer provided radiopaque marker side, the first chamber in the vicinity of the distal end of the radiopaque marker.
  21. 21.权利要求11的系统,其特征在于还包括:一对设在该引入器相反两侧的不透射线的标记,该对不透射线的标记设在第一腔远端开口附近。 21. The system as claimed in claim 11, characterized by further comprising: a pair of radiopaque markers provided on the opposite sides of the introducer, the pair of radiopaque marker disposed near the distal opening of the first chamber.
  22. 22.权利要求11的系统,其特征在于该引入器的直径处在约6弗伦奇到约8弗伦奇的范围内。 22. The system as claimed in claim 11, characterized in that the introducer diameter in the range of about 8 French to about 6 French.
  23. 23.权利要求15的系统,其特征在于第一和第二导线的直径处在约0.014英寸到约0.035英寸的范围内。 23. The system as claimed in claim 15, characterized in that the diameter of the first and second conductors is in the range from about 0.014 inches to about 0.035 inches.
  24. 24.权利要求11的系统,其特征在于第一腔和第二腔的远端开口之间的距离处在约0.039到约2.5英寸的范围内。 24. The system as claimed in claim 11, characterized in that the distance between the distal end of the first and second chambers an opening in the range from about 0.039 to about 2.5 inches.
  25. 25.权利要求11的系统,其特征在于第一和第二腔的直径处在约0.016英寸到约0.038英寸的范围内。 25. The system as claimed in claim 11, characterized in that the diameter of the first and second chambers is in the range from about 0.016 inches to about 0.038 inches in.
  26. 26.权利要求1的方法,其特征在于还包括:使一个设在该导线引入器远端的导线引入器第一腔周围的气囊膨胀。 26. The method of claim 1, characterized by further comprising: a wire provided in the distal end of the lead introducer introduced into a first chamber surrounding the airbag is inflated.
  27. 27.权利要求11的系统,其特征在于还包括:一个设在该导线引入器远端的导线引入器第一腔周围的气囊。 27. The system as claimed in claim 11, characterized by further comprising: a wire provided in the distal end of the lead introducer introduced into the first chamber surrounding the balloon.
  28. 28.一种将导线引入到分支血管内的系统,所说系统包括:一个具有第一腔和第二腔的导线引入器,所说第一和第二腔各有一个远端开口;其中所说第二腔包括一个设在所说第二腔远端开口附近的偏转件,所说偏转件的形状被设计得能使导线端头经所说第二腔远端开口偏转。 28. A lead introduced into the system in the branch vessel, said system comprising: a chamber having a first chamber and a second wire is introduced, said first and second chambers each have a distal opening; wherein said second chamber comprises a second chamber disposed in said distal opening near the deflector, the shape of said deflecting member is designed to be the wire from the tip through the distal opening of said second chamber deflection.
  29. 29.权利要求28的系统,其特征在于所说第二腔包括一条纵轴线,并且所说偏转件以不平行于所说纵轴线的角度定位。 29. The system as claimed in claim 28, wherein said second chamber comprises a longitudinal axis, and said deflector to an angle not parallel to the longitudinal axis of said positioning.
  30. 30.权利要求29的系统,其特征在于所说不相平行纵轴线的角度约为45度。 30. The system of claim 29, wherein said angle is not parallel to the longitudinal axis of about 45 degrees.
  31. 31.权利要求28的系统,其特征在于还包括一个第一导管,一气囊设在该第一导管远端附近,所说第一导管适于可滑动地被插入到所说第一腔内。 31. The system as claimed in claim 28, characterized by further comprising a first conduit, a balloon disposed near the distal end of the first conduit, said first conduit is adapted to be slidably inserted into said first chamber.
  32. 32.权利要求28的系统,其特征在于还包括一个第二导管,一气囊设在该第二导管远端附近,所说第二导管适于可滑动地被插入到所说第二腔内。 32. The system as claimed in claim 28, characterized by further comprising a second conduit, a balloon disposed near the distal end of the second conduit, said second conduit is adapted to be slidably inserted into said second cavity.
  33. 33.权利要求28的系统,其特征在于还包括至少一个设在所说远端开口中至少一个开口的邻近的不透射线的标记。 33. The system as claimed in claim 28, characterized by further comprising at least one marker disposed adjacent the distal opening of said at least one opening is radiopaque.
  34. 34.权利要求28的系统,其特征在于还包括一根适于沿所说第一腔安置的第一导线和一根适于可滑动地被安置在所说第二腔内的第二导线。 34. The system as claimed in claim 28, characterized by further comprising a first one of said wires adapted to move along a first and a lumen disposed adapted to be slidably disposed in a second chamber of said second conductor.
  35. 35.权利要求28的系统,其特征在于第一腔的远端开口沿该导线引入器设在比第二腔远端开口更远的位置上。 35. The system as claimed in claim 28, wherein the distal end opening of the first chamber along the lead introducer disposed at a position farther than the distal opening of the second chamber.
  36. 36.权利要求29的系统,其特征在于所说第二腔远端开口以不平行于所说纵轴线的角度定位。 36. The system as claimed in claim 29, wherein said second lumen distal opening angle non-parallel to said longitudinal axis positioning.
  37. 37.一种将导线引入到分支血管内的方法,所说方法包括:将第一导线插入到主血管内;驱使导线引入器沿所说第一导线通过所说主血管,所说导线引入器具有可滑动地接合所说第一导线的第一腔;将导线引入器定位,使第一腔的远端设在主血管和分支血管分叉点之后;驱使第二导线通过第二导线引入腔,所说第二腔在其远端附近有一偏转件和一开口;其中所说驱使第二导线前进的步骤包括用所说偏转件偏转第二导线,使其端头进入到所说分支血管内。 37. A method of wire into the branch vessel, said method comprising: a first wire is inserted into the main vessel; driving said first wire along a wire is introduced through said main vessel, said introducer wire slidably engaging with a first chamber of said first conductor; the introduction of the wire positioning, the distal end of the first chamber provided in the main vessel and the branch vessel after the bifurcation point; a second wire introduced into the drive chamber through the second wire said second chamber in the vicinity of its distal end having a deflection member and an opening; wherein said driving step comprises advancing the second lead wire with said second deflecting deflecting member so tip into the branch vessel of said .
  38. 38.权利要求37的方法,其特征在于还包括将第一导管插入到所说第一腔内,并且当所说气囊在所说分叉点附近时,使气囊在所说第一导管上膨胀。 38. The method as claimed in claim 37, characterized by further comprising a first catheter into said first cavity and said air bag when in the vicinity of said point of bifurcation, the balloon is inflated in said first conduit.
  39. 39.权利要求37的方法,其特征在于还包括将第二导管插入到所说第二腔内,并且当所说气囊在所说分叉点附近时,使气囊在所说第二导管上膨胀。 39. The method as claimed in claim 37, characterized by further comprising a second catheter into said second cavity and when said bifurcation vicinity of said balloon, said balloon inflated in the second conduit.
  40. 40.权利要求39的方法,其特征在于所说膨胀步骤包括当所说第二导管气囊至少部分被设在所说分支血管内时,使该气囊膨胀。 40. The method of claim 39, wherein said expanding step includes a second conduit when said balloon is at least partially disposed within said branch vessel so that the balloon is inflated.
  41. 41.权利要求38的方法,其特征在于还包括将第二导管插入到所说第二腔内,并且当所说气囊在所说分叉点附近时,使气囊在所说第二导管上膨胀。 41. The method as claimed in claim 38, characterized by further comprising a second catheter into said second cavity and when said bifurcation vicinity of said balloon, said balloon inflated in the second conduit.
  42. 42.权利要求41的方法,其特征在于所说使所说第一和第二气囊膨胀的步骤包含一种轻触气囊的技术。 42. The method of claim 41, wherein said step of causing said first and second bladders inflated airbag comprises one touch technology.
  43. 43.权利要求41的方法,其特征在于所说使所说第一和第二气囊膨胀的步骤包括在所说主血管内使所说第一气囊膨胀而在所说分支血管内使所说第二气囊膨胀。 43. The method of claim 41, wherein said making comprises a first of said balloon is inflated in the main vessel of said first and said second step being such that said balloon is inflated in said first branch vessel two balloon is inflated.
  44. 44.权利要求37的方法,其特征在于还包括当所说导线引入器上的不透射线标记到达所说分叉点附近时,中断所说导线引入器的定位。 44. The method of claim 37, wherein when said further comprising a radiopaque marker on the introducer wire reaches the vicinity of the point of said forked, interruption of said introducer wire positioning.
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US9855158B2 (en) 2008-09-25 2018-01-02 Advanced Bifurcation Systems, Inc. Stent alignment during treatment of a bifurcation
US9737424B2 (en) 2008-09-25 2017-08-22 Advanced Bifurcation Systems, Inc. Partially crimped stent
US9730821B2 (en) 2008-09-25 2017-08-15 Advanced Bifurcation Systems, Inc. Methods and systems for treating a bifurcation with provisional side branch stenting
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US9254210B2 (en) 2011-02-08 2016-02-09 Advanced Bifurcation Systems, Inc. Multi-stent and multi-balloon apparatus for treating bifurcations and methods of use
US9364356B2 (en) 2011-02-08 2016-06-14 Advanced Bifurcation System, Inc. System and methods for treating a bifurcation with a fully crimped stent
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JP2004501675A (en) 2004-01-22 application
EP1267751A2 (en) 2003-01-02 application

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