CN102188296A - Devices, systems, and methods for prosthesis delivery and implantation - Google Patents

Devices, systems, and methods for prosthesis delivery and implantation Download PDF

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Publication number
CN102188296A
CN102188296A CN 201110035203 CN201110035203A CN102188296A CN 102188296 A CN102188296 A CN 102188296A CN 201110035203 CN201110035203 CN 201110035203 CN 201110035203 A CN201110035203 A CN 201110035203A CN 102188296 A CN102188296 A CN 102188296A
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China
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prosthesis
lumen
release
proximal end
means
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CN 201110035203
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Chinese (zh)
Inventor
李·博尔达克
吉尔伯特·S·拉罗亚
乔舒亚·斯塔福德
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阿普特斯内系统公司
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Priority to US11/254,619 priority Critical patent/US9320503B2/en
Priority to US11/254,619 priority
Priority to US11/255,116 priority
Priority to US11/255,116 priority patent/US7637932B2/en
Application filed by 阿普特斯内系统公司 filed Critical 阿普特斯内系统公司
Priority to CN200680046854.72006.08.29 priority
Publication of CN102188296A publication Critical patent/CN102188296A/en

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Abstract

Devices, systems, and methods use a catheter device sized and configured for introduction to a targeted site in a hollow body organ or blood vessel. The catheter device includes a first release mechanisms coupled to the prosthesis to secure at least one region of the prosthesis to the catheter shaft, and a second release mechanism coupled to the prosthesis in cooperation with the first release mechanism to prevent full release of the at least one region of the at least one region of the prosthesis from the catheter shaft after actuation of the first release mechanism.; A fastening device sized and configured is for introduction to the targeted site in the hollow body organ or blood vessel occupied by the catheter device, includes an actuator to deploy a fastener in the at least one region of the prosthesis after actuation of the first release mechanism and before actuation of the second release mechanism.

Description

用于假体递送和植入的装置、系统和方法 And means for delivering a prosthesis implantation systems and methods

[0001] 本申请为申请日为2006年8月四日,申请号为2006800468M. 7,发明名称为“用于假体递送和植入的装置、系统和方法”的发明专利申请的分案申请。 Division of the Application [0001] This application is filed on August 4, 2006, Application No. 2006800468M. 7, entitled "Apparatus, systems and methods for delivering a prosthesis for implantation and" patent application of the present invention .

[0002] 相关申请 [0002] RELATED APPLICATIONS

[0003]本申请是 2005 年10 月20 日提交的题名《Devices,Systems, and Methods for Guiding an Operative Tool Into an Interior Body Region》的共同未决的美国专禾Ij串请序列号第11/2M,619号的部分继续再申请,该申请被结合于此作为参考。 [0003] This application is a Title October 20, 2005 filed "Devices, Systems, and Methods for Guiding an Operative Tool Into an Interior Body Region" in co-pending US patent Wo Ij string please Serial No. 11 / 2M , then a continuation of application No. 619, which application is incorporated herein by reference. 本申请还是2003 年10 月23 日提交的题名《Prosthesis Delivery Systems and Methods》的共同未决的美国专利申请序列号第10/692,283号的部分继续再申请,其要求2003年7月21号提交的题名《Endoprosthesis Delivery Systems and Methods》的美国临时专利申请序列号第60/488,753号的权益。 This application is also a title October 23, 2003 filed "Prosthesis Delivery Systems and Methods" in co-pending US Patent Application Serial No. continue to apply part of No. 10 / 692,283, which claims July 21, 2003 US provisional Patent Title filed "Endoprosthesis Delivery Systems and Methods" in the interests of application No. 60 / 488,753 serial number. 本申请还是2004年2月25日提交的题名《Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ》的共同未决的美国专利申请序列号第10/786,465号的部分继续再申请。 This application is also Title February 25, 2004 filed "Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ" co-pending US Patent Application No. 10 / 786,465 serial numbers continue to apply . 本申请还是2005年6月24日提交的题名《Multi-Lumen Prosthesis Systems and Methods》的共同未决的美国专利申请第11/693,255号的部分继续再申请,后者为2003年10月M日提交的美国专利申请系列号第10/693,255号(现为美国专利第6,9¾,661号)的分案申请,其要求2003 年7 月21 日提交的题名《Bifurcated Prosthesis Systems and Methods》的美国临时专利申请系列号第60/489,011号的权益。 This application is also a title June 24, 2005 filed "Multi-Lumen Prosthesis Systems and Methods" in co-pending US Patent Application No. 11 / 693,255 continue to apply, which is October 2003 M United States Patent application Serial number / number (now US Patent No. 6,9¾ 661) of the divisional application, which requires Title July 21, 2003 filed "bifurcated Prosthesis Systems and Methods, filed 10 693,255 rights and interests "of US provisional Patent application Serial No. 60 / 489,011. 本申请还是2002年11月四日提交的题名((Intraluminal Prosthesis Attachment Systems and Methods))的共同未决的美国专利申请第10/307,2¾的部分继续再申请。 This application is also a title Nov. 4, 2002, filed ((Intraluminal Prosthesis Attachment Systems and Methods)) is part of US Patent Application No. 10 / 307,2¾ co-pending continue to apply. 本申请还是题名《Catheter-Based Fastener Implantation Apparatus and Methods with Implantation Force Resolution》的美国专利申请系列号第10/669,881号的部分继续再申请。 This application is also part of Title No. US Patent Application Serial No. 10 / 669,881 "Catheter-Based Fastener Implantation Apparatus and Methods with Implantation Force Resolution" continues to apply. 本申请还是2005年6月M日提交的题名《Endovascular Aneurysm Repair System》的同时待审的美国专利申请第11/166,411 号的部分继续再申请,后者为2002年10月15日提交的美国临时专利申请系列号第10/271,334(现在为美国专利第6,960,217号)的分案申请,其要求2001年11月观日提交的题名《Endovascular Aneurysm Repair System》的美国专利申请系列号第60/333,937 号的权益。 This application is also a title in June 2005 M filed "Endovascular Aneurysm Repair System" of pending US Patent Application No. 11 / 166,411 continue to apply, which is October 15, 2002 filed US provisional Patent application Serial No. 10 / 271,334 (now US Patent No. 6,960,217) of the divisional application, which requires a title in November 2001 filed the concept of "Endovascular Aneurysm Repair System" US Patent equity application Serial No. 60 / No. 333,937. 每一个前述申请都结合于此作为参考。 Each of the foregoing applications are incorporated herein by reference.

技术领域 FIELD

[0004] 本发明主要涉及用于将假体递送和植入到体内靶位的装置、系统和方法,举例来说,用于修复中空身体器官和/或血管的患病和/或损伤部位。 [0004] The present invention relates generally to prostheses for implantation and delivery devices, systems and methods for in vivo target site, for example, for repairing a hollow body organ and / or diseased blood vessel and / or the site of injury.

背景技术 Background technique

[0005] 由损伤或者疾病造成的管壁脆弱可以导致血管扩张和动脉瘤的形成。 [0005] wall caused by injury or disease vulnerability can lead to the formation of blood vessels to dilate and aneurysm. 不进行治疗的话,动脉瘤会生长变大并且可能最终破裂。 Without treatment, then the aneurysm will grow larger and may eventually rupture.

[0006] 例如,主动脉的动脉瘤主要出现在腹部区域,通常在肾动脉与主动脉分叉之间的肾下区。 [0006] For example, aortic aneurysm occurred mainly in the abdominal area, usually infrarenal area between the renal arteries and the aortic bifurcation. 动脉瘤也可出现在主动脉弓与肾动脉之间的胸部区。 Aneurysms can also occur in the thoracic region between the aortic arch and renal arteries. 主动脉瘤的破裂导致大量出 Ruptured aortic aneurysm resulted in a large number of

4血并且具有高致命性。 4 and has a high lethal blood.

[0007] 开放性手术置换血管的患病部位或者损伤部位可以消除血管破裂的风险。 [0007] open surgical replacement of the diseased part of the blood vessel or the site of injury can eliminate the risk of vascular rupture. 在这个方法中,血管的患病部位或者损伤部位被移除并且安装被制成直的或者分叉结构的修复用假体(prosthetic prosthesis),然后通过缝合线永久地附着于并封闭于原血管的末端。 In this method, the damaged or diseased portion of a blood vessel portion is removed and mounted straight or repair is made to the structure of a bifurcated prosthesis (prosthetic prosthesis), and then attached to the suture through and permanently closing vessels in the original end. 用于这些方法的修复用假体通常为无支持纺织管(woven tube)并且一般由聚酯、ePTFE或者其它合适的材料制成。 These methods for repairing endoprosthesis usually unsupported woven tubes (woven tube) and is generally made of polyester, ePTFE or other suitable materials. 假体是纵向无支持的,所以它们可以适应于动脉瘤和原血管的形态变化。 The prosthesis is longitudinally unsupported so they can be adapted to the morphology of the aneurysm and the original vessel. 但是,这些方法需要大的手术切口并且具有高发病率和高死亡率。 However, these methods require a large surgical incision and have a high morbidity and mortality. 另外,许多患者由于其它同病(同患多病,co-morbidity)而不适合这种类型的大手术。 Further, since many patients with other diseases (comorbidity, co-morbidity) not suitable for this type of major surgery.

[0008] 已经引入腔内修复术(endovascular aneurysm repair)来克服与开放性手术修复术相关的问题。 [0008] have been introduced endovascular repair (endovascular aneurysm repair) to overcome the problems associated with open surgical repair surgery. 将动脉瘤桥接于腔内放置的人造血管。 The aneurysm is placed in the cavity of the bridge vascular prostheses. 一般这些用于主动脉瘤的修复用假体折叠(collapse)在导管上通过股动脉递送。 Typically, these repair for aortic aneurysms fold (Collapse) delivering the catheter through the femoral artery in the endoprosthesis. 通常这些假体被设计为具有附着于金属台架(支架)结构的纺织材料,该金属支架扩张或者被扩张以达到血管的内径。 These prostheses are usually designed for the textile material (scaffold) attached to the metal structure having a carriage, which is expanded or expandable metal stent to achieve an inner diameter of the blood vessel. 不同于开放性手术动脉瘤修复术,腔内开伞的假体不是缝合到原血管,但是依靠从支架延伸出的倒钩, 其在开伞(展开,deployment)过程中刺入到原血管中,或者利用支架本身的放射状扩张力使得假体保持在适当的位置。 Unlike open surgical aneurysm repair, endovascular prosthesis parachute is not sutured to the original vessel, but rely on barbs extending from the stent, which parachute (developing, Deployment) during the penetration into the original vessel , or by the stent itself is radially expanded so that the force holding the prosthesis in place. 这些假体附着方式与缝合相比不能产生同样的附着程度并且在展开时会损害原血管。 These prosthesis attachment means can not be generated as compared with the suture attached to the same extent and in the original blood vessel damage when deployed.

[0009] 因此,需要改良递送假体植入物到身体内腔的假体递送装置、系统和方法,并且需要可以适应动脉瘤形态变化并且可以被安全展开而不损害原血管的假体。 [0009] Accordingly, a need for improved delivery of a prosthetic implant to a body lumen prosthesis delivery devices, systems and methods, and may need to adapt to changes in aneurysm morphology and can be safely deployed prosthesis without damaging the original vessel.

发明内容 SUMMARY

[0010] 本发明描述了用于将可放射状扩张的假体递送和植入身体内腔的装置、系统和方法。 [0010] The present invention describes a means for the prosthesis will radially expandable delivery and implanted in the body lumen, the system and method. 特别地,本发明提供了用于将血管假体植入血管(包括动脉和静脉系统)的改良装置、 系统和方法。 In particular, the present invention provides systems and methods for improving vascular prosthesis implantation apparatus vessel (including arterial and venous systems). 在示例性实施方式中,假体被放置在脉管系统中以修补(reinforce)动脉瘤, 尤其是腹主动脉瘤。 In an exemplary embodiment, the prosthesis is placed in the vasculature to patch (Reinforce) aneurysms, particularly abdominal aortic aneurysm.

[0011] 根据本发明的一个方面,装置、系统和方法将开伞导管(employment catheter)定位到中空身体器官或血管中的靶位。 [0011] In accordance with one aspect of the present invention, apparatus, system and method parachute catheter (employment catheter) is positioned into a hollow body organ or a blood vessel target site. 该开伞导管携带可扩张的血管腔内(endovascular) 假体。 The parachute carries intravascular catheter (Endovascular) expandable prosthesis. 该装置、系统和方法启动开伞导管上的第一释放机构以使位于靶位的假体的至少一个区域至少部分扩张而不是从开伞导管完全释放假体的该一个区域。 The apparatus, system and method for initiating parachute release mechanism on the first conduit so that the prosthesis is located at least one target region of the at least partially expanded but not completely released from the catheter unfolding a region of the prosthesis. 在启动了第一释放机构后,该装置、系统和方法使用固定器将假体的至少一个区域固定到靶位上。 After starting the first release mechanism, the apparatus, system and method using the at least one region of the holder of the prosthesis is fixed to the target site. 在使用固定器之后,该装置、系统和方法启动开伞导管上的第二释放机构以使该假体的至少一个区域从开伞导管完全释放。 After the use of the holder, the apparatus, system and method for initiating parachute release mechanism on the second conduit such that at least one region of the prosthesis is completely released from the catheter parachute.

[0012] 根据本发明的另一个方面,装置、系统和方法将开伞导管定位到中空身体器官或血管中的靶位。 [0012] According to another aspect of the invention, an apparatus, a system and method for unfolding a hollow body organ to position the catheter in a blood vessel or target site. 该开伞导管携带可扩张的血管腔内假体。 The parachute endovascular catheter carries an expandable prosthesis. 该装置、系统和方法启动开伞导管上的第一释放机构以使位于靶位的假体的近端区域至少部分扩张而不是从开伞导管完全释放假体的近端。 The apparatus, system and method for initiating a first parachute release mechanism on the proximal end of the catheter to the target region of the prosthesis at least partially but not completely release the expansion of the proximal end of the prosthesis from the catheter parachute. 在启动第一释放机构后,该装置、系统和方法使用固定器将假体的近端固定到靶位。 After starting the first release mechanism, the apparatus, system and method used to anchor the proximal end of the prosthesis is fixed to the target site. 在使用了固定器之后,该装置、系统和方法启动开伞导管上的第二释放机构以将假体的近端从开伞导管完全释放。 After using the fixture, the apparatus, system, and method for initiating a second parachute release mechanism on the proximal end of the catheter to the complete release of the prosthesis from the catheter parachute. 在使用了固定器之后,该装置、系统和方法启动开伞导管上的第三释放机构以将假体的远端从开伞导管完全释放。 After using the fixture, the apparatus, system and method for initiating parachute release mechanism on the third catheter to the distal end of the prosthesis is completely released from the catheter parachute.

[0013] 该装置、系统和方法使得在固定器使用之前,假体的位置和方向的纵向和/或旋转的调整成为可能。 [0013] The devices, systems and methods that use before the fixation, the longitudinal adjustment of the position and direction of the prosthesis and / or rotation becomes possible. 该装置、系统和方法还使得在使用固定器时,保持对假体的控制(远端地和近端地)成为可能。 The devices, systems and methods are also in use such that the holder, to maintain control over the prosthesis (proximally and distally) becomes possible.

[0014] 在所附的说明、图示和权利要求的基础上,本发明的其它特征和优点将显而易见。 [0014] On the basis of the following description, illustrations and claims, the other features and advantages of the invention will be apparent.

附图说明 BRIEF DESCRIPTION

[0015] 图1为示出位于腹主动脉瘤内的假体开伞导管的一种实施方式的透视图。 [0015] FIG. 1 is a perspective view showing an embodiment of an abdominal aortic aneurysm is located within the prosthetic conduit parachute.

[0016] 图2为图1的动脉瘤内的假体开伞的一种实施方式的透视图,其套管被部分收回。 [0016] FIG. 2 is a perspective view of an embodiment of the prosthesis in the aneurysm of FIG. 1 parachute which the sleeve is partially retracted.

[0017] 图3为图1的动脉瘤内的假体开伞的一种实施方式的透视图,其套管完全被收回并且示出近端的放射状扩张。 [0017] FIG. 3 is a perspective view of an embodiment of the prosthesis in the aneurysm of the parachute of FIG. 1, which sleeve is completely retracted and showing the radial expansion of the proximal end.

[0018] 图4为图1的动脉瘤内的多腔假体完全开伞的一种实施方式的透视图。 [0018] FIG. 4 is a perspective view of the arteries of FIG. 1 illustrating one embodiment of a multi-lumen prosthesis within the tumor completely parachute.

[0019] 图5为图1的动脉瘤内的单腔假体完全开伞的一种可选实施方式的透视图。 [0019] FIG. 5 is a single chamber arterial prosthesis within the tumor completely unfolding perspective view of an alternative embodiment of the embodiment.

[0020] 图6为体现本发明特征的多腔假体组件的侧视图,该多腔假体显示具有内腔延伸物(extension)。 A side view of the multi-lumen prosthesis assembly [0020] FIG. 6 embodying features of the invention, the multi-lumen prosthesis having a lumen extending display thereof (extension).

[0021] 图7A为多腔假体组件的主体部件的侧视图。 [0021] FIG. 7A is a main component of the multi-lumen prosthesis assembly in a side view.

[0022] 图7B为示出图7A所示的多腔假体的远端支架弯曲顶端的细节的放大图。 [0022] FIG 7B is an enlarged view of the distal end of the multi-lumen prosthesis shown in FIG. 7A details curved tip of the stent.

[0023] 图7C为假体隔膜的一种实施方式的侧视图,示出了以缝合和编织来形成隔膜。 [0023] FIG 7C is a side view of an embodiment of the prosthesis of the separator, is shown to be formed and the braided suture diaphragm.

[0024] 图7D为图7A的多腔假体组件的主体部件的可选实施方式的侧视图,示出了具有延伸超过第一内腔的第二内腔的假体主体。 [0024] FIG 7D is a side view of the alternative embodiment of the body member of the multi-lumen prosthesis assembly of FIG. 7A embodiment, illustrating a prosthesis body having a second lumen extends beyond the first lumen.

[0025] 图8A为主要沿图6的线8A-8A所截取的多腔假体的主体部件的远端的剖视图。 Cross-sectional view of the distal end of the body member [0025] FIG. 8A is primarily along the line of FIG. 6 taken 8A-8A multi-lumen prosthesis.

[0026] 图8B为主要沿图6的线8B-8B所截取的多腔假体的主体部件的近端的剖视图。 Cross-sectional view of the proximal end of the body member [0026] FIG 8B is primarily along the line 8B-8B 6 taken multi-lumen prosthesis.

[0027] 图9A为假体内腔延伸物的侧视图。 [0027] FIG. 9A is an elevation view of the extension prostheses.

[0028] 图9B为示出图9A所示的为稳固内腔延伸物的支架的弯曲顶端的细节的放大图。 [0028] FIG 9B is an enlarged view of a detail of the curved tip extending stent material shown in FIG. 9A is a solid lumen.

[0029] 图9C为耦接到多腔假体的主体部件的一个延伸内腔的侧视图。 [0029] FIG. 9C is a multi-lumen member coupled to the main body of the prosthesis extending side view of a lumen.

[0030] 图9D为示出如图9C所示耦接到假体主体的远端支架的内腔延伸物的两个稳固性支架的弯曲顶端的细节的放大图。 [0030] FIG 9D is an enlarged view of FIG. FIG. 9C is coupled to the distal end of the lumen of the stent prosthesis body extending curved tip details of two physical stability of the stent.

[0031] 图IOA为图9A的假体内腔延伸物的可选实施方式的侧视图,并且示出了不具有弯曲顶端的稳固性支架。 [0031] FIG IOA side view of an alternative embodiment of the extension product of prostheses FIG. 9A, and shows the stability of the holder does not have a bent tip.

[0032] 图IOB为图IOA所示的稳固内腔延伸物的支架的细节的放大图。 [0032] FIG IOB extending an enlarged view of a detail of the stent lumen thereof is shown in FIG solid IOA.

[0033] 图IOC为示出连接到多腔假体的主体部件的图IOA的假体内腔延伸物的可选实施方式的侧视图。 [0033] FIG. IOC extending side view of an alternative embodiment thereof is shown in FIG prostheses IOA multi-lumen member coupled to the body of the prosthesis.

[0034] 图IOD为示出如图IOC所示连接到假体主体的远端支架的内腔延伸物的可选实施方式的稳固化支架的细节的放大图。 [0034] FIG IOD is an enlarged view of a detail of the robust alternative embodiment stent lumen of the distal end of the stent as shown in Figure IOC shows the prosthesis is connected to the body of the extensions.

[0035] 图11为体现了本发明特征的假体开伞导管的透视图。 [0035] FIG. 11 is a perspective view of the prosthesis embodies features of the invention parachute catheter.

[0036] 图12为图11的开伞导管的近端的一种实施方式的侧视图。 [0036] FIG. 12 is a side view of one embodiment of the proximal end 11 of the catheter of FIG parachute.

[0037] 图13为图11的开伞导管的近端的侧视图,并且示出了覆盖开伞导管部件的套管。 [0037] FIG. 13 is a side view of the proximal end of the catheter of FIG parachute 11, and illustrates the cover member of the catheter cannula parachute.

[0038] 图14A为图11的开伞导管的近端的侧视图,并且示出了在开伞之前覆盖多腔假体的主体部件的套管。 [0038] FIG. 14A is a side view of the proximal end of the catheter of the parachute of FIG. 11, and shows the multi-lumen member covers the body of the prosthesis sleeve before parachute.

[0039] 图14B为示出结构加固的图11的开伞导管套管的可选实施方式的透视图。 [0039] FIG. 14B is a perspective view showing an alternative embodiment of the catheter of FIG parachute reinforced structure 11 of the sleeve.

[0040] 图15为主要沿图12的线15-15截取的开伞导管中轴的内腔的剖视图。 Wire lumen cross-sectional view [0040] FIG. 15 is primarily along 15-15 of FIG. 12 central axis of the catheter parachute.

6 6

[0041] 图16为示出了导管顶端内腔和中轴内腔的开伞导管的导管顶端和中轴的侧视图。 [0041] FIG. 16 is a side view showing the catheter tip and the axis of the parachute lumen catheter tip and catheter lumen axis.

[0042] 图17为在开伞之前位于开伞导管近端的多腔假体的主体部件的透视图,并且示出了在压缩情形下第一近端的阻挡装置。 [0042] FIG. 17 is a perspective view of the body member is located proximal of the multi-lumen catheter parachute prosthesis before the parachute, and showing the blocking device in the case of the first proximal end of the compression.

[0043] 图18A为围绕多腔假体的主体部件的缝合环路径的一种实施方式的侧视图。 [0043] FIG 18A is an embodiment of a suture ring around the path of the body member of the multi-lumen prosthesis side view.

[0044] 图18B为图18A的围绕多腔假体的缝合环路径的可选实施方式的侧视图,示出了多个缝合环。 [0044] FIG. 18B is a side view of FIG. 18A around the ring path of the alternative multi-lumen prosthesis sutured embodiment, illustrating a plurality of the sewing ring.

[0045] 图19为位于开伞导管的近端的多腔假体的主体部件的透视图,示出了释放了的第一近端阻挡装置和扩张了的主体部件的近端。 [0045] FIG. 19 is located at the proximal end of the catheter parachute a perspective view of the body member of the multi-lumen prosthesis, shows a first proximal end of the proximal release the blocking means and the expansion of the body member.

[0046] 图20为开伞导管的远端的一部分的侧视图,示出了第一近端释放装置和第一近端释放线的一种实施方式。 [0046] FIG. 20 is a side view of a portion of the distal end of the parachute of the catheter, illustrating an embodiment of the first proximal end of the proximal releasing means and a first release line.

[0047] 图21为开伞导管的近端的一部分的侧视图,示出了第一近端释放中心套筒(hub) 和中轴内腔的细节。 A side view of a portion of [0047] FIG 21 is a proximal end of the catheter parachute, showing details of the proximal end of the first release central sleeve (Hub) and the central axis of the lumen.

[0048] 图22为开伞导管的远端的一部分的侧视图,示出了第二近端释放装置的一种实施方式的细节。 [0048] FIG. 22 is a side view of a portion of the distal end of the catheter parachute, showing details of one embodiment of a proximal end of a second release device.

[0049] 图23为示出开伞前构造中的稳定臂细节的侧视图,稳定臂的近端通常背向第一近端释放套筒中心而形成拱形。 [0049] FIG. 23 is a side view showing details of the stabilizing arm unfolding in front of the construction, the proximal end of the stabilizing arm generally facing away from the first proximal end of the release sleeve is formed arcuate center.

[0050] 图M为图23稳定臂的开伞前构造以及位于降主动脉中的开伞导管和多腔假体的侧视图,并且示出了耦连于假体主体的近端的稳定臂的近端。 [0050] The map M is configured before unfolding stabilizing arms 23 and FIG catheter in the descending aorta side and unfolding the multi-lumen prosthesis, and shows the proximal end is coupled to the main body of the prosthesis stabilizer arm the proximal end.

[0051] 图25为耦连于假体主体的近端的稳定臂的细节的侧视图,示出了第二近端释放线缝到或者以其它方式延伸穿过稳定臂孔并且穿过假体材料,可释放地将稳定臂稳固在假体主体上。 [0051] FIG. 25 is a side view of a detail of the stabilizing arm is coupled to the proximal end of the prosthesis body, illustrating a second stitching thread to the proximal end of release or otherwise stabilizing arm extending through the hole and through the prosthesis materials, stabilizing arm releasably secure the prosthesis in the body.

[0052] 图沈为图23稳定臂的开伞后构造以及位于降主动脉中的开伞导管和多腔假体的侧视图,并且示出了从假体主体的近端释放了的稳定臂的近端。 [0052] FIG Shen stabilized after the parachute 23 and side arm configuration of FIG catheter in the descending aorta and unfolding the multi-lumen prosthesis, and shows the release of the prosthesis from the proximal end of stabilizer arm body the proximal end.

[0053] 图27为主要沿图23的线27_27所截取的开伞导管轴的近端的剖视图。 Line cross-sectional view of the proximal [0053] FIG 27 is a main direction in FIG. 23 27_27 taken parachute catheter shaft.

[0054] 图观为远端阻挡装置开伞之前位于开伞导管中轴上的假体主体的远端的侧视图。 [0054] FIG side view of the distal end of the distal end of the concept of the prosthesis body is located before the parachute catheter shaft blocking means parachute.

[0055] 图^A为围绕多腔假体的远端的缝合环路径的一种实施方式的侧视图。 [0055] FIG. ^ A surround one embodiment, the distal end of the suture ring of the multi-lumen path prosthesis side.

[0056] 图^B为图^A的围绕多腔假体的远端的缝合环路径的可选实施方式的侧视图, 示出了多个缝合环。 [0056] FIG ^ B ^ is a diagram of a side view of the suture ring around the path A distal end of the multi-lumen prosthesis alternative embodiment, illustrates a plurality of the sewing ring.

[0057] 图30为图观的位于开伞导管轴之上的多腔假体的主体部件的远端的侧视图,示出了释放的远端阻挡装置和扩张的主体部件的远端。 Side view of the distal end of the body member is located [0057] FIG. 30 is a diagram of the parachute concept on multi-lumen catheter shaft prosthesis, shows the distal end of the distal body member to release the blocking means and expansion.

[0058] 图31为开伞导管的近端的一部分的侧视图,示出了远端释放装置和中轴内腔的细节。 [0058] FIG. 31 is a side view of a portion of the proximal end of the catheter parachute, it shows details of the distal end of the release means and the central axis of the lumen.

[0059] 图32为远端阻挡装置开伞之前位于开伞导管中轴之上的假体主体的远端的可选实施方式的侧视图。 [0059] FIG. 32 is a side view of the alternative embodiment of the distal end of the prosthesis on the catheter body axis is located before the parachute ripcord embodiment the distal end of the barrier means.

[0060] 图33为图32的位于开伞导管轴之上的多腔假体的主体部件的远端的侧视图,示出了可选释放的远端阻挡装置和扩张的主体部件的远端。 A side view of the distal end of the body member [0060] FIG. 33 is located on the catheter shaft 32, unfolding the multi-lumen prosthesis, shows the distal end of the distal body optional releasable blocking member and expansion means .

[0061] 图34为体现了本发明特征的开伞导管手柄组件的第一侧的透视图。 [0061] FIG. 34 is a perspective view of a first reflecting side of the unfolding of the catheter handle assembly features of the invention.

[0062] 图35为体现了本发明特征的开伞导管手柄组件的第二侧的透视图。 [0062] FIG. 35 is a catheter handle assembly reflects the unfolding feature of the present invention, a perspective view of a second side.

[0063] 图36为图34的开伞导管手柄组件的上视图。 [0063] FIG. 36 is a top view of the unfolding of the catheter handle assembly 34 of FIG.

[0064] 图37为主要沿图36的线37_37所截取的图34的开伞导管手柄组件的剖视图。 Cross-sectional view of the catheter handle assembly of the parachute of FIG. 34 [0064] FIG. 37 is primarily along a line of FIG. 36 taken 37_37.

[0065] 图38为主要沿图36的线38_38所截取的图34的开伞导管手柄组件的剖视图。 Cross-sectional view of the catheter handle assembly of the parachute of FIG. 34 [0065] FIG. 38 is primarily along a line of FIG. 36 taken 38_38.

[0066] 图39为图34的开伞导管手柄组件的一部分的上视图,示出了在套管收回之前的套管收回装置。 [0066] FIG. 39 is a top view of a portion of the catheter handle assembly of the parachute of FIG. 34 shows the sleeve before recovery of the sleeve retraction device.

[0067] 图40为图39的开伞导管手柄组件的一部分的上视图,显示了在套管收回之后的套管收回装置。 [0067] FIG. 40 is a top view of a portion of the catheter handle assembly of the parachute of FIG. 39 shows the sleeve after recovery means to recover the sleeve.

[0068] 图41为齿条-齿轮机构和位于开伞导管手柄组件内的释放系统的一种实施方式的第二侧的透视图。 [0068] FIG. 41 is a rack - and a gear mechanism located on a second side perspective view of an embodiment of a catheter delivery system in the handle assembly parachute.

[0069] 图42为齿条-齿轮机构和位于开伞导管手柄组件内的释放系统的一种实施方式的第二侧的透视图。 [0069] FIG. 42 is a rack - a gear mechanism and a perspective view of a second side of the one embodiment of the parachute release system in the catheter handle assembly.

[0070] 图43为示出了位于开伞导管手柄组件内的释放系统的细节的透视图。 [0070] FIG. 43 is a perspective view illustrating a parachute release system is located within the catheter handle assembly detail.

[0071] 图44A为体现了本发明特征的内腔延伸开伞导管的透视图。 [0071] FIG. 44A is a perspective view embodies features of the invention the lumen of the catheter extending parachute.

[0072] 图44B为图44A所示的内腔延伸开伞导管的透视图,并且示出了固定外套管和止血阀。 [0072] FIG 44B a perspective view shown in FIG. 44A extending parachute lumen catheter, and shows the outer sleeve and secured hemostasis valve.

[0073] 图45A为图44的内腔延伸开伞导管的近端的一种实施方式的侧视图。 [0073] FIG. 45A is a lumen 44 extending parachute side view of one embodiment of the proximal end of the catheter.

[0074] 图45B为图45A的内腔延伸开伞导管的近端的可选实施方式的侧视图,并且示出了可选的远端阻挡和释放装置。 [0074] FIG lumen 45B is a side view of FIG. 45A extending proximal end of the catheter parachute alternative embodiment, and shows the distal end of an alternative barrier and release means.

[0075] 图46A为图45A的内腔延伸开伞导管的近端部分的侧视图,并且示出了在开伞之前覆盖位于导管轴之上的内腔延伸物的套管。 [0075] FIG lumen 46A is a side view of FIG. 45A extending parachute proximal end portion of the catheter, and shows the cover before the parachute located in the lumen of the catheter shaft over the sleeve extensions.

[0076] 图46B为图45B的内腔延伸开伞导管的近端部分的可选实施方式的侧视图,示出了在开伞之前覆盖位于导管轴之上的内腔延伸物的套管并且包括远端阻挡装置。 [0076] FIG lumen 46B is a side view of FIG. 45B extending parachute alternative embodiment of the proximal portion of the catheter, the sleeve is shown before the parachute cover located over the catheter shaft lumen and extensions including a distal end barrier means.

[0077] 图46C为图44的内腔延伸开伞导管套管的可选具体实施方式的透视图,示出了结构加固。 [0077] FIG 46C is a lumen 44 extending unfolding a perspective view of an alternative embodiment of a catheter DETAILED cannula showing the structural reinforcement.

[0078] 图47A为主要沿图45A的线47A-47A所截取的图45A的内腔延伸开伞导管轴的剖视图。 [0078] FIG. 47A is a line along the main parachute 45A sectional view of the catheter shaft 47A-47A of FIG. 45A taken lumen extends.

[0079] 图47B为主要沿图45A的线47B-47B所截取的图45B的内腔延伸开伞导管轴的可选实施方式的剖视图。 [0079] FIG. 47B is a line along the main cross-sectional view of FIG. 45A parachute alternative embodiment of the catheter shaft taken 47B-47B in FIG. 45B extending lumen.

[0080] 图48A为围绕内腔延伸的近端的缝合环路的一种实施方式的侧视图。 [0080] FIG 48A is an embodiment of the suture loop around the proximal end of the lumen extending in side view.

[0081] 图48B为围绕内腔延伸的远端的缝合环路的一种实施方式的侧视图。 [0081] FIG. 48B is one embodiment of a lumen extending around the distal end of the suture loop side view.

[0082] 图48C为图48A和48B所示的围绕内腔延伸的近端或远端的缝合环路径的可选实施方式的侧视图,并且示出了多个缝合环。 [0082] 48C FIGS. 48A and 48B is a side view of alternative embodiment of the proximal or distal lumen extending around the sewing ring path shown in FIG embodiment, and shows a plurality of the sewing ring.

[0083] 图49A为图44的内腔延伸开伞导管手柄组件的侧视图。 [0083] FIG. 49A is a lumen 44 extending in a side view of the catheter handle assembly of the parachute.

[0084] 图49B为图44的内腔延伸开伞导管手柄组件的可选实施方式的侧视图,并且示出了用于可选的远端释放装置的附加的滑动旋钮。 [0084] FIG. 49B is a lumen 44 extending the parachute side view of alternative embodiment of the catheter handle assembly, and shows an additional alternative for the distal end of the slide knob release device.

[0085] 图50为图44的内腔延伸开伞导管手柄组件的上视图。 [0085] FIG. 50 is a lumen 44 extending the catheter handle assembly view of a parachute.

[0086] 图51为位于内腔延伸开伞导管手柄组件内的释放系统的一种实施方式的透视图。 [0086] FIG. 51 is a perspective view of the parachute located at a lumen extending to an embodiment of the delivery system within the catheter handle assembly.

[0087] 图52为可用于与图53所示的固定器器具或者装置相关的螺旋固定器的一种实施方式的放大透视图。 [0087] The tool holder 52 or means may be used as shown in FIG. 53, associated with an enlarged perspective view of one embodiment of a helical fastener of FIG.

[0088] 图53为体现了本发明的特征的固定器器具的透视图。 A perspective view [0088] FIG 53 embodying features of the invention is a holder of the appliance.

[0089] 图M为图53的固定器器具的手柄组件的透视图。 [0089] M is a perspective view of the handle assembly of the tool holder 53 of FIG.

[0090] 图55为体现了本发明特征的可控导向装置的透视图。 [0090] FIG. 55 is a perspective view of the controlled deflection embodies features of the invention apparatus.

[0091] 图56为图55的可控导向装置的手柄组件的透视图。 [0091] FIG. 56 is a perspective view of the handle assembly 55 of the controlled deflection device of FIG.

[0092] 图57为可以与图55的可控导向装置联合使用的闭塞物(密闭装置,obturator) 或者扩张器的透视图。 [0092] FIG. 57 is closed may be used in conjunction with a controllable guide 55 is a perspective view of FIG. (Obturator, obturator) or dilator.

[0093] 图58为示出位于腹主动脉瘤内的假体开伞导管的一种实施方式的透视图。 [0093] FIG. 58 is a perspective view showing an embodiment of an abdominal aortic aneurysm is located within the prosthetic conduit parachute.

[0094] 图59为在图58的动脉瘤内多腔假体的主体部件开伞的透视图,套管被部分收回。 [0094] FIG. 59 is a perspective view of a multi-chamber body member parachute prosthesis within the aneurysm 58, the cannula is partially retracted.

[0095] 图60为图58的动脉瘤内的多腔假体的主体部件开伞的透视图,但在释放近端或远端阻挡装置之前套管被完全撤回。 A perspective view of the body member of the multi-lumen prosthesis parachute within the aneurysm [0095] FIG 60 FIG 58, but the cannula is completely withdrawn before the device is released proximal or distal end barrier.

[0096] 图61为图58的动脉瘤内的多腔假体的主体部件开伞的透视图,但在释放近端或远端阻挡装置之前套管被完全撤出并且示出了远端阻挡装置的可选实施方式。 [0096] FIG. 61 is a perspective view of the body member of the multi-lumen prosthesis parachute within the aneurysm 58, but blocking the release of the proximal or distal sleeve is fully withdrawn before the device and shows the distal end of the barrier alternative embodiment of the apparatus.

[0097] 图62为图58的动脉瘤内的多腔假体的主体部件开伞的透视图,并且示出了释放的第一近端阻挡装置和扩张了的主体部件的近端。 [0097] FIG. 62 is a perspective view of the body member of the multi-lumen prosthesis parachute within the aneurysm of FIG. 58, and shows a first proximal end of the proximal release the blocking means and the expansion of the body member.

[0098] 图63为图58的动脉瘤内的多腔假体的主体部件开伞的透视图,并且示出了被放置并穿过假体主体内腔的第二导线(或导丝,guide wire)。 [0098] FIG. 63 is a perspective view of the body member of the multi-lumen prosthesis parachute within the aneurysm of FIG. 58, and shows the second wire is placed and through the lumen of the prosthesis body (or guidewire, Guide wire).

[0099] 图64为图58的动脉瘤内的多腔假体的主体部件开伞的透视图,并且示出了可控导向装置和位于第二导线之上并且穿过假体主体内腔的闭塞物。 [0099] FIG. 64 is a perspective view of the body member of the multi-lumen prosthesis parachute within the aneurysm 58, and shows a controlled deflection means and positioned above the second wire and through the lumen of the prosthesis body occlusion.

[0100] 图65为降主动脉内的多腔假体的主体部件开伞的放大透视图,并且示出了在将螺旋固定器穿过假体材料固定到组织中之前的可控导向装置和固定器器具。 [0100] FIG. 65 is an enlarged perspective view of the multi-lumen prosthesis body member within the aorta parachute drop, and shows a controlled deflection means before passing through the helical fastener material is secured to the prosthesis and tissue holder apparatus.

[0101] 图66为降主动脉内的多腔假体的主体部件开伞的放大透视图,并且示出了在将螺旋固定器穿过假体材料固定到组织中之后的可控导向装置和固定器器具。 [0101] FIG. 66 is an enlarged perspective view of the body member down parachute multi-lumen prosthesis in the aorta, and shows a controlled deflection device after passing through the helical fastener material is secured to the prosthesis and tissue holder apparatus.

[0102] 图67为图58的动脉瘤中的多腔假体的主体部件开伞的透视图,并且示出了可控导向装置的弯曲末端和被重置之后用于附加的螺旋固定器配置的固定器装置。 A perspective view of the body member parachute aneurysm [0102] FIG 67 FIG 58 is a multi-lumen prosthesis, and shows the curved guide means and the controlled terminal is reset after an additional fixing screw configuration fixing means.

[0103] 图68为在降主动脉内的多腔假体的主体部件开伞的放大透视图,并且示出了固定器配置模式的一种实施方式。 [0103] FIG. 68 is an enlarged perspective view of the parachute of the multi-cavity in the body member of the prosthesis within the descending aorta, and shows an embodiment of the fixture configuration mode.

[0104] 图69为图58的动脉瘤中的多腔假体的内腔延伸部件开伞的透视图,并且示出了部分位于假体内腔中的内腔延伸导管。 The lumen of the aneurysm [0104] FIG 69 FIG 58 is a multi-lumen prosthesis member extends a perspective view of the parachute, and shows a portion located in prostheses extension catheter lumen.

[0105] 图70为图58的动脉瘤中的多腔假体的内腔延伸部件开伞的透视图,并且示出了从内腔延伸开伞导管收回的并在近端阻挡装置释放之前的套管。 [0105] FIG. 70 is a perspective view of the parachute of FIG aneurysm lumen extending member 58 in the multi-lumen prosthesis, and shows a retracted before the catheter and extending parachute release the blocking device from the lumen at the proximal end casing.

[0106] 图71为图58的动脉瘤中的多腔假体的内腔延伸部件开伞的透视图,并且示出了在近端阻挡装置释放之后耦连到主体部件内腔并且在主体部件内腔完全扩张的内腔延伸物。 [0106] Figure 71 a perspective view of the extension member for the unfolding of the lumen of the aneurysm of FIG. 58 in the multi-lumen prosthesis, and showing the device after release of the proximal end of the blocking member coupled to the body and a lumen in the body member a lumen extending fully expanded lumen thereof.

[0107] 图72为图58的动脉瘤中的多腔假体的主体部件开伞的透视图,并且示出了被移去的内腔延伸开伞导管和释放了的主体开伞导管的稳定臂。 A perspective view of the body member of the aneurysm [0107] FIG 72 FIG 58 is a multi-lumen prosthesis parachute, and shows the body is removed and the catheter lumen extending release of the parachute of the parachute stabilize the catheter arm.

[0108] 图73为图58的动脉瘤中的多腔假体的主体部件开伞的透视图,并且示出了释放了的远端阻挡装置和扩张了的假体主体的远端。 [0108] FIG. 73 is a perspective view of the main parachute aneurysm member 58 in the multi-lumen prosthesis, and shows the distal end of the release of the blocking means and the distal end of the expandable prosthesis body.

[0109] 图74为图58的动脉瘤中的多腔假体的主体部件开伞的透视图,并且示出了第一导线之上的重新覆盖的主体开伞导管的撤出。 [0109] FIG. 74 is a perspective view of the main parachute aneurysm member 58 in the multi-lumen prosthesis, and shows the body to re-cover the first wire above the withdrawal conduit parachute.

[0110] 图75为图58的动脉瘤中的多腔假体的第二内腔延伸部件开伞的透视图,并且示出了部分位于假体内腔中的内腔延伸导管。 The second lumen of the aneurysm [0110] FIG 75 FIG 58 is a multi-lumen prosthesis member extends a perspective view of the parachute, and shows a portion located in prostheses extension catheter lumen.

[0111] 图76为图58的动脉瘤中的多腔假体的第二内腔延伸部件开伞的透视图,并且示出了从内腔延伸开伞导管收回并且在近端阻挡装置释放之前的套管。 Before [0111] FIG. 76 is a second lumen extending aneurysm of FIG. 58 in the multi-lumen prosthesis perspective view of components of the parachute, and shows a lumen extending from the proximal end of the parachute and the catheter retracted to release the blocking means casing.

[0112] 图77为图58的动脉瘤中的多腔假体的第二内腔延伸部件开伞的透视图,并且示出了在近端阻挡装置释放之后连接到主体部件内腔并且在主体部件的内腔完全扩张的第二内腔延伸物。 [0112] FIG. 77 is a perspective view of a second lumen extending member 58 of FIG parachute aneurysm in the multi-lumen prosthesis, and shows the apparatus after releasing the proximal end of the blocking member is connected to the body and the body lumen the second lumen lumen extending member was fully expanded.

[0113] 图78为图58的动脉瘤中的多腔假体的完全开伞的一种实施方式的透视图。 [0113] FIG. 78 is a perspective view of one embodiment of the parachute completely aneurysm of FIG. 58 in the multi-lumen prosthesis.

[0114] 图79A为可以与图53中所示的固定器器具或装置相联合使用的螺旋固定器的可选实施方式的放大透视图。 [0114] FIG 79A is an enlarged perspective view of the helical fastener may be used in combination with the fixture or fixture apparatus shown in FIG. 53, an alternative embodiment.

[0115] 图79B为呈“D”型的图79A的可选固定器的放大的上视图。 [0115] FIG. 79B is a form of "D" enlarged alternative type holder 79A is a top view.

[0116] 图80为降主动脉中的多腔假体的主体部件开伞的放大透视图,并且示出了在将图79A的螺旋固定器穿过假体材料并固定到组织中之前的可控导向装置和具有可选性固定器驱动装置的固定器器具。 [0116] FIG. 80 is an enlarged perspective view of the body member of the multi-lumen aortic prosthesis parachute drop, and shows a can prior to the helical fastener of FIG. 79A through the prosthetic material and secured to the tissue and the control means having a guide holder fixing tool optional driving means.

[0117] 图81为图80的固定器驱动装置和固定器的放大透视图,并且示出了从固定器支座上旋下的固定器。 [0117] FIG. 81 and the driving means enlarged perspective view of the fixture of the fixture of FIG. 80, and shows the holder from the holder in a spin holder.

[0118] 图82A为图80的固定器驱动装置的放大的侧视图,并且示出了位于固定器支座上并且在带螺纹固定器外壳内的固定器,并且还示出了固定器插销(latch)的特征。 [0118] FIG. 82A is a driver retainer 80 is an enlarged side view of FIG apparatus, and shows the support fixture and positioned in the fixture with the fixture screw in the housing, and also shows a retainer pin ( characterized latch) a.

[0119] 图82B为图80的固定器驱动装置的放大的侧视图,并且示出了支座上的并且从承载器上旋下的固定器,并且示出了固定器插销的绕轴旋转。 [0119] FIG. 82B is a driver of the fixture of FIG. 80 is an enlarged side view, and shows and the holder from the carrier under screwed on the support, and shows the fixture pivoting latch.

[0120] 图82C为图80的固定器驱动装置的放大的侧视图,并且示出了位于固定器支座之上并且在带螺纹(threaded)固定器外壳内的固定器,并且还示出了可选的固定器插销特征。 [0120] FIG 82C is a driver retainer 80 is an enlarged side view of FIG device, and shows a support located above the holder and a threaded (threaded) fixed within the fixed housing, and also shows the optional features of the latch holder.

[0121] 图83为具有可释放地放置在固定器插孔(receptacle)的固定器的固定器盒的一种实施方式的透视图。 [0121] FIG. 83 is releasably disposed with a perspective view of one embodiment of cassette holder is fixed jack (RECEPTACLE) of the fixture.

[0122] 图84为图82的固定器盒的可选具体实施方式的透视图。 [0122] FIG. 84 is a perspective view of the alternative embodiment DETAILED cassette holder 82 of FIG.

[0123] 图85为示出了位于固定器盒之上用于从盒移走固定器并将固定器放置于固定器驱动装置中的固定器器具的透视图。 [0123] FIG. 85 is a diagram illustrating the cassette holder located above the cassette is removed from the fixture for the fixture and the fixture is placed in a perspective view of the tool holder driving means.

[0124] 图86为示出了具有位于固定器驱动装置中的固定器并且准备开始开伞的固定器器具的透视图。 [0124] FIG. 86 is a diagram illustrating a perspective view of a tool holder in a fixed drive means and the fixture is ready to begin unfolding.

具体实施方式 Detailed ways

[0125] 本发明的详细介绍 [0125] Detailed Description of the invention

[0126] 本详细介绍披露了用于将放射状可扩张假体递送并且植入到身体内腔中的多种基于导管的装置、系统和方法。 [0126] This detailed description discloses a radially expandable means for delivering a prosthesis and implanting the device in a variety of body lumen, catheter-based systems and methods. 例如,本发明的多个方面应用于需要修复中空身体器官和/ 或血管的患病和/或损伤部位的过程中。 For example, aspects of the present invention is applied to the hollow body organ in need of repair and / or vascular diseased and / or damaged parts of the process. 体现了本发明特征的装置、系统和方法也适合于与不必须基于导管的系统和外科技术一起使用。 Embodies features of the invention apparatus, system and method is not necessarily suitable for use with systems and surgical catheter-based technology.

[0127] 本装置、系统和方法尤其非常适合于治疗主要出现在腹部区域,通常在肾动脉与主动脉分叉之间的肾下区域的主动脉瘤,以及还出现在主动脉弓和肾动脉之间的胸部区域的动脉瘤。 [0127] The present devices, systems and methods particularly well suited for the treatment mainly in the abdominal region, the lower region of the renal aortic aneurysms typically between the renal arteries and the aortic bifurcation, and also appeared between the aortic arch and renal arteries aneurysm in the chest area. 基于这种原因,本装置、系统和方法会在本文中进行介绍。 The present apparatus, systems and methods described herein will be based on this reason. 但是,还是应该了解, 所披露的装置、系统和方法也适合用于治疗身体的其它区域的并非必须与动脉相关的机能障碍。 However, it should still understand, devices, systems and methods disclosed must also not suitable for other areas of dysfunction associated with the treatment of the body's arteries.

[0128] I.概述 [0128] I. Overview

[0129] 图1描述了降主动脉的一部分并且示出了腹主动脉瘤20。 [0129] Figure 1 depicts a portion of the descending aorta and shows abdominal aortic aneurysm 20. 出于示例性说明的目的,图1示出了如位于腹主动脉瘤20内的假体递送和植入的靶位。 For purposes of exemplary illustration, FIG. 1 shows a target such as in abdominal aortic aneurysm 20 within the prosthesis delivery and implantation. 应该了解,靶位也可以在身体的其它区域。 It should be understood that the target may also be in other areas of the body. 在本示例性安排中,假体为腔内植入物的形式。 In the present exemplary arrangement, the prosthesis is in the form of the implant lumen thereof.

[0130] 为了为本发明所述的装置、系统和方法提供统一的方向定位,术语“近端的”或“头向的”用来描述朝向头部或者心脏的关系或方向定位,术语“远端的”或“尾部的”用来描述朝向脚部或者远离心脏的位置或方向定位。 [0130] For devices, systems and methods according to the present invention is to provide a unified direction positioning, the term "proximal" or "first direction" is used to describe the relationship or orientation direction of the head, or positioning of the heart, the term "distal "or" "is used to describe a position or direction toward or away from the heart of the leg portion positioning the tail end. 因此,本装置、系统和方法可以被描述为具有近端的或者头向的部件以及远端的或尾部的部件。 Accordingly, the present apparatus, systems and methods may be described as having a proximal end or the head member and a distal member or the tail. 这些术语的使用也可以应用于在所述植入过程中所使用的植入器,也就是,当开伞导管手柄被定位朝向脚并且远离心脏时,开伞导管手柄是远端的或者尾部的。 Use of these terms may be applied to the implant in the implant process used, i.e., when the ripcord is positioned toward the catheter handle and feet away from the heart, the distal end of a catheter handle parachute or tail .

[0131] 图1中可以看到假体开伞导管200的近端或者头向端202位于第一导线30 (导线在之前已被放置)之上并且延伸穿过腹主动脉瘤20的至少一部分。 In [0131] Figure 1 can be seen that the proximal end of the prosthesis or parachute catheter 200 to the head 202 at the first end of the wire 30 (wire has been placed before) over the abdominal aortic aneurysm and extends through at least a portion 20 . 开伞导管200携带假体的主体120(见图2),其被放置于靶位,例如通过放射状扩张假体主体120(见图幻。在假体主体120扩张后,可以通过固定器装置400引入一个或多个固定器402(见图4)从而将假体主体的近端108固定在合适的位置上。 Carrying parachute catheter body 200 of the prosthesis 120 (see FIG. 2), which is placed at the target, for example, expansion 120 (see phantom prosthesis body by a radially. Expandable prosthesis in the body 120, 400 through the retainer means may be introducing one or more holders 402 (see FIG. 4) so ​​that the proximal end of the prosthesis body 108 fixed in position.

[0132] 图2描绘了假体主体120在靶位开伞的初始阶段。 [0132] FIG 2 depicts the initial stage of the prosthesis at the target body 120 of the parachute. 虽然开伞方法可以改变,但在该示例性具体实施方式中,递送导管200具有可移动的套管或者外鞘210,其覆盖了假体主体120。 While the parachute method may vary, but in the exemplary embodiment, the delivery catheter 200 having a movable outer sleeve or sheath 210 which covers the main body 120 of the prosthesis. 当外套管210被向远端或向尾部方向拉动,假体主体120被暴露但是可以保持未开伞的构造,直到启动释放装置。 When outer sleeve 210 is pulled aft direction or distally, the prosthetic body 120 is not exposed but may remain configured parachute until the activation of the release device. 一旦释放装置被启动,假体主体或者假体主体120的一部分(或多个部分)则自由地放射状扩张,从而扩大以接触到血管内壁的至少一部分。 Once the release device is activated, the prosthesis or the prosthesis body portion of the body 120 (or portions) is freely radially expanded, thereby expanding at least a portion in contact with the blood vessel wall. 假体开伞过程继续进行,包括一个或多个内腔延伸物的开伞,直到多腔或者分叉假体100在血管内完全开伞,如在图4中可以看到,并且在后面会进行更详细地描述。 Unfolding process continues prosthesis, comprising one or more lumens parachute extensions until the multi-lumen prosthesis or bifurcated parachute 100 is fully within the vessel, as can be seen in Figure 4, and will later It is described in more detail below.

[0133] 应该理解术语“假体”和“多个假体”都可以表示独立的部件,或者多个耦连在一起的部件,或者并非必须耦连在一起的多个部件。 [0133] It should be understood that the term "prosthesis" and "a plurality of prostheses" may represent a separate component, or a plurality of parts coupled together, or a plurality of coupling members need not be joined together. 假体可以在靶位上或临近靶位,或者在体外,或者以两者的组合耦连在一起。 Prosthesis may or adjacent the target site on the target, or in vitro, or in a combination of the two coupled together.

[0134] 在一种优选的实施方式中,假体为多腔假体。 [0134] In one preferred embodiment, the prosthesis is a multi-lumen prosthesis. 在一种可选的实施方式中,假体为直的假体。 In an alternative embodiment, the prosthesis is straight prosthesis. 假体100可以为自扩张,或者,假体100可以利用扩张器件,例如气囊或者机械扩张器。 Prosthesis 100 may be self-expandable, or expandable prosthesis device 100 may be utilized, such as a balloon or mechanical expander. 图4描绘了完全开伞了的多腔或者分叉假体100,其被确定了尺寸并且被设置放置于主动脉内以及延伸穿过动脉瘤并且进入对侧髂动脉和同侧髂动脉。 4 depicts a multi-cavity parachute completely or bifurcated prosthesis 100, it is determined in size and placed within the aorta are provided extending through the aneurysm and into the contralateral iliac artery and the ipsilateral iliac artery. 图5描绘了完全开伞了的直假体50。 5 depicts the parachute completely straight prosthesis 50.

[0135] 应该了解,在该过程中的不同时间或者同一时间可以引入一个或多个固定器402 到多腔假体100中从而使主体120和/或内腔延伸物140固定在合适的位置上。 [0135] It should be appreciated that in the process at different times or at the same time can be introduced into one or more fixed 402 to the multi-lumen prosthesis 100 so that the 120 and / or the body lumen 140 extending fixed in place on .

[0136] II.腔内植入的一般方法 [0136] II. General Procedure implantation chamber

[0137] 前述的一个假体或多个假体100以各种方式将其自身植入到中空器官中。 [0137] the one or more prosthetic prosthesis 100 implanted in various ways into the hollow organ itself. 假体可 Prosthesis

11以经由外周血管内穿刺部位,如股动脉,利用基于导管的技术,可选地在成像制导的协助下植入。 11 via the inner peripheral vascular puncture site, such as the femoral artery, using catheter-based technology, optionally with the assistance of the implant imaging guidance. 成像制导包括但是不限于荧光透视法、超声波、磁共振、电脑断层扫描或者它们的组合。 Including but not limited to imaging guidance fluoroscopy, ultrasound, magnetic resonance, computed tomography, or combinations thereof. 可代替地,假体可以在例如开胸手术过程中植入。 May instead, for example, the prosthesis may be implanted during open heart surgery.

[0138] 图58至78示出了通过经皮的,基于导管的过程使得图4所示类型的假体开伞的代表性实施方式。 [0138] FIGS 58-78 illustrate by percutaneous, catheter-based procedure of the type shown in Figure 4 such that the prosthesis parachute representative embodiment. 经皮血管途径可通过,例如进入股动脉的传统方法而实现。 Percutaneous vascular pathway by, for example, conventional methods into the femoral artery is achieved.

[0139] 在这里,多腔假体100的植入首先被描述为多个概括性步骤。 [0139] Here, the multi-chamber implantable prosthesis 100 is first described as a plurality of general steps. 多腔假体和用于植入假体的多个器具中的每一个都通过以后的其他详述而被描述。 Each of the plurality of appliances is described, and the multi-lumen prosthesis for implantation of the prosthesis by other detailed later. 多腔假体100在第III部分进行描述,各种植入装置在第IV部分进行描述。 Multi-lumen prosthesis 100 are described in part III, a variety of implantable devices are described in Section IV. 另外,概括性植入步骤通过以后第V节的其他详述被再次进行描述。 Further, implantation steps are described in general by other again after DETAILED Section V.

[0140] 第一个植入步骤可被描述为假体的主体120的开伞。 [0140] The first implant step may be described as the main parachute 120 of the prosthesis. 开伞导管200被放置于主动脉动脉瘤20中,假体的主体可以被开伞。 Parachute catheter 200 is placed in the aortic aneurysm 20, the prosthesis may be the main parachute. 近端的和远端的阻挡装置将假体主体保持在与开伞导管的近端202预定的关系中。 Proximal and distal barrier means holding the prosthesis body at the proximal end of the catheter 202 parachute predetermined relationship. 通过启动近端释放装置,假体主体120的近端108可以从开伞导管轴被部分或者完全地释放,从而使近端支架130扩张接触到主动脉或者主动脉的一部分。 Release means by activating the proximal end, the proximal end 108 of prosthesis body 120 may be partially or completely released from the unfolding of the catheter shaft so that the proximal end of the stent 130 expanded into contact with a portion of the aorta or the aorta. 在这一步骤中,假体可未从开伞导管完全释放。 In this step, the prosthesis may not completely released from the catheter parachute. 假体主体120可以通过第二近端阻挡装置连接到开伞导管200。 The prosthesis body 120 may be connected to the barrier unfolding through the second catheter 200 proximally. 近端108或者假体主体120的其它区域被固定到血管壁上以抵抗假体的轴向移动。 Proximal end 108 of the prosthesis or other area of ​​the body 120 is fixed to the vessel wall to resist axial movement of the prosthesis.

[0141] 接下来,携带第一假体内腔延伸物140的延伸导管350被引导穿过血管并且到达假体主体120。 [0141] Next, a first carrying extension prostheses 350 of the extension catheter 140 is directed through the blood vessel 120 and reaches the prosthesis body. 第一内腔延伸物套叠地(伸缩性地,telescopically)安装(fit)在假体主体120的第二内腔128内部并且可进行放射状扩张。 A first lumen extending telescopically thereof (telescopically, telescopically) Installation (Fit) at a second inner lumen 128 of the prosthesis 120 and the body may be radially expanded. 然后延伸导管被移开,使得内腔延伸物140耦连到假体主体120上并且延伸进入对侧髂动脉中。 Then extends catheter is removed, such that the lumen 140 is coupled to the extension prosthesis body 120 and extends into the contralateral iliac artery.

[0142] 如果假体主体I20通过第二近端阻挡装置连接到开伞导管200,则第二释放装置被启动从而使得假体主体120的近端108从开伞导管轴216上释放。 [0142] If the prosthetic device is connected to the main parachute I20 conduit 200, the second barrier release means is activated by the proximal end of the second prosthetic body such that the proximal end 120 of the catheter 108 is released from the unfolding axis 216. 然后,启动远端释放装置,使得假体主体120的远端110从开伞导管轴216上释放并且放射状扩张。 Then, to enable remote release means, such that the distal end 120 of the prosthesis body 110 is released from the unfolding of the catheter shaft 216 and radially expanded. 然后开伞导管200移出身体。 Then the catheter 200 parachute out of the body.

[0143] 最后,携带第二假体内腔延伸物140的延伸导管350被引导穿过血管并且到达假体主体120。 [0143] Finally, carrying the second extension prostheses 350 of the extension catheter 140 is directed through the blood vessel 120 and reaches the prosthesis body. 第二内腔延伸物140套叠地安装在假体主体的第一内腔126内部并且可进行放射状扩张。 The second lumen 140 extends telescopically mounted inside the first lumen prosthesis body 126 and may be radially expanded. 然后,延伸导管350被移开,使得内腔延伸物140耦连到假体主体120并且延伸进入同侧髂动脉内。 Then, the extension catheter 350 is removed, such that the lumen 140 is coupled to the extension prosthesis that extends into the body 120 and the ipsilateral iliac artery. 此时,多腔假体100穿过主动脉瘤被完全开伞。 At this time, the multi-lumen prosthesis 100 through the aortic aneurysm is completely unfolding.

[0144] III多腔假体组件 [0144] Multi-lumen prosthesis assembly III

[0145] 图6示出了体现本发明特征的多腔假体组件100。 [0145] FIG. 6 illustrates a multi-lumen prosthesis assembly 100 embodying features of the present invention. 在该示例性实施方式中,多腔假体组件100包含主体部件120和至少一个内腔延伸物140,理想的是两个内腔延伸物。 In the exemplary embodiment, the multi-lumen prosthesis assembly 100 comprises a body member 120 and a lumen extending at least 140, preferably a two lumen extending thereof.

[0146] 主体部件120被确定尺寸并且设置成安装于中空身体器官和/或血管内部。 [0146] body member 120 is sized and arranged to be mounted on the hollow body organ and / or interior of the vessel. 如本说明书中所描述的,开伞靶位是在临近肾动脉的主动脉内,这将在后面作更详细的描述。 As described in the present specification, the target parachute within the aorta adjacent the renal arteries, as will be described in more detail later. 然而,该开伞靶位是以示例性说明假体100的特征为目的而被选择的,而并非用于限制。 However, this target is characterized in parachute illustrative prosthesis 100 is selected for the purpose, and not for limitation.

[0147] 关于图7A,主体部件120具有近端108和远端110,并且包括与近端开口122相通的用于液体流入或者流出假体的内部结构(interior)。 [0147] With regard to Figure 7A, the body member 120 having a proximal end 108 and a distal end 110, and includes a proximal opening 122 for communicating the liquid flowing into or out of the interior of the prosthesis (interior). 主体部件120包括在其内部结构中的隔膜124。 A diaphragm member 120 includes a body 124 in its internal structure. 假体120内的隔膜IM的长度可以变化。 IM length of the separator 120 in the prosthesis can vary. 在示例性实施方式中,隔膜IM没有沿着主体部件120的整个长度延伸,而是与近端开口122以一定距离隔离开来。 In an exemplary embodiment, the separator extends along the entire length of the IM no body member 120, but with a distance from the proximal opening 122 to isolate. 在示例性的安排中,隔膜1¾包括纵向缝合物。 In an exemplary arrangement, the separator comprising a longitudinal 1¾ suture. 该缝合物可以通过将假体材料112(其通常为纺织物)的相对表面(例如前面和后面)连接在一起而形成,例如通过缝合、热结合、缝线或者编织,或者任何组合。 The suture 112 can be connected together (which is typically woven fabric) opposite surface of the prosthesis material (e.g. front and rear) is formed, for example by stitching, thermal bonding, stitching or weaving, or any combination thereof. 因此相对的表面连接到一起在两个腔,第一腔1¾和第二腔1¾之间产生了隔膜或者共用的壁(见图8A和8B)。 So that the surface opposite to the connecting together the two chambers, resulting in a membrane or a common wall (see FIGS. 8A and 8B) between the first chamber and a second chamber 1¾ 1¾. 通常,隔膜IM被定位于沿着主体的中线以产生两个相同大小的内腔126和128。 Typically, the diaphragm is positioned along the center line IM of the body to produce two equal 126 and lumen 128. 然而,如果需要不同尺寸的内腔,隔膜124的位置可以被移动。 However, if the lumen of different sizes, the position of the diaphragm 124 may be moved. 在图7C所示的一种实施方式中,通过在隔膜近端121的缝线131、隔膜远端123的缝线133、和在隔膜近端121的缝线131与隔膜远端123的缝线133之间的编织物135形成隔膜124。 In one embodiment shown in FIG. 7C, the proximal end of the suture 131 through the diaphragm 121, the diaphragm 123 of the distal end 133 of the suture, and the suture 131 and the proximal end of the membrane separator 121 in the distal end 123 of the suture the braid is formed between the diaphragm 124 133135. 例如,缝线和编织的组合为隔膜IM提供了附加的稳定性。 For example, a combination of braided sutures and provide additional stability to the membrane IM.

[0148] 隔膜IM将至少一部分的主体部件120的内部结构改变成多腔流动通道的构造。 [0148] The internal structure of the separator IM least a portion of the body member 120 is changed to the multi-lumen flow channel configuration. 在示例性实施方式中,多腔流动通道构造包含双重的第一内腔1¾和第二内腔128。 In an exemplary embodiment, the multi-lumen flow channel configuration comprises dual first lumen and a second lumen 128 1¾. 由于隔膜124,多腔流动通道构造的双重第一和第二内腔1¾和1¾不会形成分叉的或者分支的内腔。 Since the first and second lumens dual 1¾ 1¾ and do not form a bifurcated or branched lumen of the diaphragm 124, the multi-lumen flow channel configuration. 共用壁或者缝合(隔膜124)防止了分叉并且维持内腔1¾和1¾处于不分叉,通常为平行流动的关系(如图8A和8B所示)。 Or stapling common wall (diaphragm 124) is prevented and the bifurcated lumen to maintain and 1¾ 1¾ is not bifurcated, generally parallel flow relationship (as shown in FIG. 8A and 8B).

[0149] 在示例性的安排中,隔膜IM —般沿着主体部件120的中线分布,使主体部件120 内的多腔流动通道构造是大体均衡的。 [0149] In an exemplary arrangement, the separator IM - like distributed along the centerline of the body member 120, the inner body member 120 of the multi-lumen flow channel configuration is substantially balanced. 但是,应该了解隔膜1¾可形成非均衡的多腔流动通道构造。 However, it should be appreciated that the diaphragm may be formed 1¾ Unbalanced multi-lumen flow channel configuration. 还应该了解可以在内部结构存在多个隔膜,将主体部件120改变成多个流动内腔。 It should also be understood there may be a plurality of the internal structure of the separator, the plurality of body member 120 is changed to the flow of urine. 隔膜的长度可以变化。 The length of the septum can vary. 在代表性实施方式中,隔膜124的长度一般大于IOmm并且不小于5mm。 In a representative embodiment, the length of the separator 124 is generally greater than IOmm and not less than 5mm.

[0150] 在示例性实施方式中,第一内腔126限定了流动通道,其被确定了尺寸并且被设定为接触到与近端开口122有一限定距离的靶向目标或源(source),而被缩短了的第二内腔1¾通常与和主体部件120本身的近端开口122相同的靶向目标相通。 [0150] In an exemplary embodiment, the first lumen 126 defines a flow path, the size of which is determined and is set in contact with a targeted 122 to a target or source of the defined distance (source) and a proximal opening, It is shortened 1¾ second lumen 122 is generally the same targeted to a proximal end in communication with the body itself and the opening member 120. 另外,隔膜124 被确定了尺寸并且被设置成适应于流动通道延伸物140与第一内腔1¾耦连以及与缩短了的第二内腔1¾耦连,如果需要的话,还将它们的接触范围延伸到与近端开口122隔离开的另一个靶向源或者目标。 Further, the size of the diaphragm 124 is determined and is arranged to accommodate the first lumen and a coupling 1¾ shortened 1¾ second lumen coupled, if desired, in the range of their contact with the flow passage 140 also extends 122 extends into the proximal opening of the isolation apart from another targeted source or target.

[0151] 第二内腔1¾沿着隔膜124的至少一部分被缩短。 [0151] 1¾ second lumen along at least a portion of the membrane is shortened 124. 结果,第一内腔126的远端开口127可被认为延伸超过第二内腔128的远端开口129。 As a result, the distal end of the first lumen 126 of the opening 127 may be considered to extend beyond the second lumen 128 of the distal opening 129. 但是,共用壁(隔膜124)防止了分叉并且维持内腔1¾和1¾处于不分叉,通常为平行流动的关系。 However, the common wall (diaphragm 124) is prevented and the bifurcated lumen to maintain and 1¾ 1¾ is not bifurcated, generally parallel flow relationship. 应该了解第一和第二内腔1¾和1¾可以互换,也就是,第二内腔1¾可以延伸超过第一内腔126(见图7D)。 The first and second lumens to be understood and 1¾ 1¾ interchangeable, i.e., 1¾ second lumen may extend beyond the first lumen 126 (see FIG. 7D).

[0152] 在该安排中,理想的是多腔假体组件100包括第一和第二流动通道内腔延伸物140(见图6)。 [0152] In this arrangement, it is desirable that the multi-lumen prosthesis assembly 100 includes a first and a second flow passage extending lumen 140 (see FIG. 6). 理想的是第一和第二内腔延伸物140包含相同的结构,也就是它们是彼此的复制。 Desirable that the first and second lumen extending 140 comprise the same configuration, that is, they are copied to each other. 参考图9A,内腔延伸物140包括近端142,其被确定尺寸并且设置成套叠地安装在主体部件120的第一内腔126和/或缩短了的第二内腔128内。 9A, the lumen extension 140 includes a proximal end 142 that is dimensioned and arranged in sets telescopically mounted within the body member of the first lumen 126 120 and / or shorten the second lumen 128. 内腔延伸物140的远端144 被确定了尺寸并且被设置为将第一内腔126和缩短了的第二内腔1¾的接触范围延伸到与主体部件近端开口122以一定距离隔离的另外一个靶向目标或源。 Extending the distal end 140 of lumen 144 is determined and the size is set to the first lumen 126 and second lumen shortened 1¾ contact range extends to the proximal end of the body member at a distance from the opening 122 of further isolation targeting a target or source. 结果,通过隔膜124,延伸的第二内腔128的一部分与第一内腔1¾接合,并且延伸的第二内腔128的一部分未通过隔膜124与第一内腔126的内腔延伸物140接合。 As a result, through the diaphragm 124, the second lumen extending portion 128 engages the first lumen 1¾, and a second lumen extending portion 128 is not engaging the lumen 140 through the diaphragm 124 and the first lumen 126 of the extensions .

[0153] 主体部件120的第一内腔1¾和通过隔膜1¾接合到第一内腔126的缩短的第二内腔1¾都提供了界面区域或者窝穴(socket),其完全被封入主体部件120自身的体内。 [0153] The first lumen 1¾ body member 120 through the septum and engaging the first lumen to the second lumen 1¾ 1¾ shortened 126 provides an interface region or pocket (socket), it is completely enclosed in the body member 120 own body. 因此,第一内腔1¾和缩短的第二内腔1¾不会倾向于扭结或者翘曲或者其他类型的独立于主体部件120的移动。 Thus, a first lumen and a second lumen 1¾ 1¾ not tend to kink or shortened warp or other type of moving independently of the body member 120. 导线穿过第一内腔1¾或者第二内腔128的通路可以不受阻碍。 1¾ wire lumen through the first passageway or the second lumen 128 can be unobstructed.

[0154] 被套叠安装在界面区域或者穴窝内并且被包裹在主体部件120里面,内腔延伸物140的机械性能通过结构支持和主体部件120自身的完整性得到加强,反之亦然。 [0154] invaginated mounted within the interface region or socket cavity and are wrapped inside the body member 120, a lumen 140 extending in the mechanical properties obtained by reinforcing its structural integrity and support member body 120, and vice versa. 耦连在一起的主体部件120和内腔延伸物140提供了更强的针对内腔延伸物140从主体部件120上移动和/或分离的抵抗力。 Coupled together of the body member 120 and a lumen 140 extending provides a stronger member 140 moves from the body 120 and the resistance or separation / lumen for extending thereof. 固定在封闭的界面区域内,内腔延伸物140被从外围封在主体部件120中从而阻止内腔延伸物140周围液体的泄漏或渗流。 Is fixed within the enclosed interface region, a lumen extending from the periphery 140 is sealed in the body member 120 to prevent leakage or seepage lumen extensions 140 around the liquid. 隔膜IM可以为锥形、弯曲的、波浪形的或者其它非线性的,从而增强内腔延伸物140和主体部件120之间的连结。 IM separator may be tapered, curved, wavy, or other non-linear, thereby enhancing lumen extending between the coupling 140 and the body member 120.

[0155] 在一个示例性的应用中(见图3),主体部件120可以在第一和第二髂骨的,或者同侧和对侧髂骨的动脉的分叉区域的主动脉中进行开伞。 [0155] (see FIG. 3), the body member 120 can be opened in the aorta, or the crotch region of the ipsilateral and contralateral iliac arteries first and second iliac In one exemplary application umbrella. 当主体部件120开伞时,第一内腔1¾和第二内腔1¾保持与主动脉相通。 When unfolding the body member 120, a first lumen and a second lumen 1¾ 1¾ held in communication with the aorta. 在主体部件120开伞后,第一内腔延伸物140 可以安装在第一内腔126的远端开口127中,并且第二内腔延伸物140可以安装在第二内腔128的远端开口1¾中,这样可以确定第一延伸物140的远端144的尺寸以延伸进入第一髂骨的分叉,而第二延伸140的远端144可以延伸进入第二髂骨的分叉(见图4)。 After the parachute body member 120, a first lumen extending at the distal end 140 may be mounted in an opening 126 in the first lumen 127 and second lumen 140 may extend mounted at the distal end of the second lumen 128 of the opening 1¾, the distal end may be sized so that the first extension 140 to 144 extend into the first iliac of the bifurcation, the distal end 144 of second extension 140 may extend into the second iliac of the bifurcation (see FIG. 4). 在这种安排中,内腔126的第一内腔延伸物140作为假体100的第一内腔或者同侧内腔,并且第二内腔128的内腔延伸140作为第二内腔或者对侧内腔。 In this arrangement, the first lumen 126 extending lumen 140 lumen as the prosthesis or the same side of the first lumen 100 and second lumen 128 lumen or second lumen 140 extends a pair of side lumen.

[0156] 主体部件120可以包括在其近端108的近端密封支架130,其可以延伸越过假体材料112(见图7A)。 [0156] body member 120 may include a sealing stent at the proximal end 130 of its proximal end 108, which may extend beyond the prosthetic material 112 (see FIG. 7A). 近端支架130将假体主体120定位于内腔中并且帮助保持假体主体120 处于主动脉中的位置而不阻碍正常血流进入肾动脉。 The proximal end of the stent body 120 of the prosthesis 130 is positioned in the interior of the prosthesis and help keep the body 120 in position in the aorta without obstructing the normal blood flow into the renal arteries. 近端密封支架130还可以用于限制假体边缘的长度,假体边缘暴露于流动的液体并且可能形成扇形边。 Length of the proximal sealing stent 130 may also be used to limit the prosthesis edge, the prosthesis edge is exposed to a flowing liquid and may form scalloping. 例如,近端密封支架130 可以为自扩张的Z字形或者菱形支架,例如,虽然支架可能在外部,或者可能被包围在假体材料112的两层之间,理想的是被缝合在假体材料112的内部。 For example, the stent 130 proximal seal may be self-expanding Z-shaped or diamond-shaped bracket, for example, while stents may be external, or may be enclosed between two layers of prosthetic material 112, it is desirable that the prosthetic material is sewn 112 inside.

[0157] 通常,这个主动脉区域(正好在肾动脉之下的血管瘤的近颈端)也是通过固定器装置400引入一个或多个固定器402从而将假体100固定到合适位置的一个范围(见图4)。 A range of [0157] Generally, the aortic region (just below the renal arteries near the neck end hemangiomas) also introducing one or more fixed by fixing means 400,402 so that the prosthesis 100 is fixed to an appropriate position (see FIG. 4). 但是,应该注意到主体120和内腔延伸物140的其它区域也可以被固定到合适的位置。 However, it should be noted that the body region 120 and a lumen 140 extending the other may be fixed to a suitable position. 理想的是主体部件120的这个区域被确定尺寸并且被设置用于接受并且保持固定器,例如,使菱形或者Z字形支架的尺寸和间距形成特别适合于固定器放置的模式;和/或使用带有“X 式样”或者“正弦曲线式样”的编织纤维(woven fiber)以特别适合固定器的放置;和/或翻折假体材料112以形成多层,以加固固定器402放置的区域中的假体;和/或在放置固定器的区域使用更密的编织方式或者更强固的纤维,举例来说仅由Kevlar™材料或者Vectran™ 材料或者金属线制成或者与典型的聚酯纤维交织而制成。 This area is preferably the body member 120 is sized and disposed for receiving and holding fixture, for example, that the size and spacing of diamond-shaped or Z-shaped bracket adapted to be secured in a particularly placed mode; and / or with an "X Shape" or a "sinusoidal pattern" woven fibers (woven fiber) is particularly suited to placement fixture; and / or prosthetic material 112 folded to form multiple layers, to reinforce the area of ​​the fixture 402 is placed in prosthesis; and / or disposed in the region of the fixture using a denser weave of fibers or more solid, for example made of only Vectran ™ or Kevlar ™ material or metal or a wire with a typical polyester fibers interwoven production. 同样理想的是用假体材料112或者近端密封支架130上的不透射线的标记132荧光地显示该假体区域从而帮助定位固定器直ο It is also desirable prosthetic material mark 112 or the proximal radiopaque stent on the sealing 130132 fluorescent display area to help the prosthesis positioning fixture straight ο

[0158] 可以在整个主体部件120中使用附加的支架。 [0158] Additional stents may be used throughout the body member 120. 理想的是,在主体部件120中使用最少量的支架。 Ideally, the stent with a minimum of 120 in the body member.

[0159] 主体部件120中的多个内腔1¾和1¾通常被缝合到或者以其它方式连接到假体材料112内部或者外部的远端支架环134所支持。 [0159] The plurality of lumens 1¾ 1¾ distal body member 120 and is sewn to generally or otherwise attached to the prosthetic material 112 inside or outside the stent ring 134 are supported. 理想的是,支架环134的近端顶点136 向内成角或者弯曲(见图7B)。 Desirably, the proximal end of the stent ring 134 of the apex 136 inwardly angled or curved (see FIG. 7B). 当内腔延伸物140被放置于第一或者第二内腔中时,向内的角提供了一种具有保持力的特性(见图10B)。 When extending lumen 140 is placed in the first or second lumen, it is provided an inner corner having a retention characteristics (see FIG. 10B). 例如,也可以使用可选的具有保持力的零件,如,钩、倒钩、织物的环或者植入材料的环/折叠或者植入材料的袋状物(pockets)。 For example, the optional components may be used having a holding force, such as a ring or implant material hooks, barbs, fabric loop / folded pouch or implant material (pockets). 理想的是,一个内腔126中的多个远端支架环134与其它内腔128中的多个支架环134轴向交错排列,使得当主体部件120在开伞之前被放射状压缩时它们彼此不会交迭。 Ideally, a plurality of distal lumen 126 of carrier ring 134 with a plurality of lumens 128 in the other holder ring 134 axially staggered, such that when the body member 120 is radially compressed before the parachute from each other when they are not It will overlap.

[0160] 血管内腔或者中空身体器官中的主体部件120的转动的定位是用连接到假体主体120的在荧光透视下可视的附加不透射线标记137和138来完成的。 Rotatably positioning [0160] the vessel lumen or hollow body organ in the body member 120 is connected to the prosthesis body 120 is visible under fluoroscopy additional radiopaque markers 137 and 138 to complete. 通常,这些标记可以连接到假体材料112上。 Typically, these markers can be attached to the prosthetic material 112. 但是,标记137和138可以连接到近端密封支架130或远端支架环134上来代替连接到假体材料112上,或者除了连接到假体材料112上之外还连接到近端密封支架130或远端支架环134上,从而在荧光透视的帮助下确定所有假体开口的位置。 However, markers 137 and 138 may be connected to the proximal end 130 or distal sealing stent onto the stent ring 134 in place of connection to the prosthetic material 112, or in addition to being connected to the prosthetic material 112 is also connected to the proximal sealing stent 130 or distal stent ring 134 to determine the location of all prosthesis openings under fluoroscopy help. 例如,不透射线标记一般是由辐射透不过的材料,如,钼、钼/铱、钽或者金制成的标记带、紧绕线圈、或者线的形式。 For example, radiopaque markers are in general, but by a radiopaque material, such as molybdenum, molybdenum / iridium, tantalum or gold marker band made, tight wound coils, or in the form of lines.

[0161] 理想的是,一个或多个标记137、138比其中的另外一个长,并且连接到主体部件120的相对的侧面,例如,较长的标记137排列在第一内腔1¾的侧面上,而较短的标记138 排列在第二内腔128的侧面上。 [0161] Desirably, the one or more markers than 137,138 wherein another long, and is connected to the opposite side of the body member 120, e.g., a long mark 137 arranged on the side of the first lumen 1¾ and the shorter marks 138 arranged on the side of the second lumen 128. 在可选实施方式中,标记可以沿隔膜排列。 In an alternative embodiment, the marks may be arranged along the membranes. 标记137和138 使临床医生能够确定递送系统中的假体主体120的所需转动方向,这样通过开伞第一远端开口127和第二远端开口1¾沿着所需髂骨动脉排列。 Numerals 137 and 138 enable the clinician to determine the desired direction of rotation of the prosthesis delivery system body 120, so that the first distal end 127 and a second distal opening parachute 1¾ openings arranged along a desired iliac arteries. 也可以包括近端标记132从而使临床医生能够确定主体部件120的近端108相对于主动脉的固定位点的位置。 May also include a proximal marker 132 so that the clinician to ascertain the proximal body member 120 relative to the position 108 to the fixed site of the aorta. 另外,也可以包括远端标记139来帮助定位远端开口127、129以及内腔延伸物140的插入。 Further, marker 139 may comprise a distal end to assist in positioning the distal insert lumen 127, 129 and 140 thereof extending opening. 例如,插入深度标记(多个)125可以连接(attached)到邻近隔膜124,或者可以连接到隔膜上,或者可以连接假体材料112上,从而显示内腔延伸物140的位置和插入的深度。 For example, the insertion depth marking (s) 125 may be connected (attached) to adjacent the diaphragm 124, or may be connected to the diaphragm, or may be connected to the prosthetic material 112, thereby displaying the position and depth lumen extending the insert 140.

[0162] 如上所述,理想的是主体120(以及内腔延伸140)使用假体材料112。 [0162] As described above, it is desirable that the body 120 (and a lumen extending 140) 112 prosthetic material. 主体120的材料112可以携带独立的自扩张、例如Z字形或者菱形支架环。 Material of the body 120, 112 may carry a separate self-expanding, for example, Z-shaped or diamond-shaped carrier ring. 支架环不需要遍及假体主体120而彼此连接。 Throughout the carrier ring prosthesis body 120 need not be connected to each other. 但是,理想的是在假体结构内的某些区域中个体支架环之间具有连接从而提供稳定性和/或附加的放射状支持。 However, it is desirable in certain areas of the prosthesis having a connecting structure to provide stability and / or additional radial support between the individual stent rings.

[0163] 如上所述,将主体部件120的假体材料112的相对的表面(也就是前面和后面) 通过缝合、热结合、缝线或者编织到一起从而形成隔膜124。 [0163] As described above, the opposing surfaces (i.e., front and rear) body member 120 prosthetic material 112 by stitching, thermal bonding, stitching or woven together to form a diaphragm 124. 在隔膜IM区域,支架环134从隔膜124向形成的内腔周围延伸,但是不进入或者干扰隔膜IM本身。 IM in the diaphragm region, extending around the lumen of the stent ring 134 to the diaphragm 124 formed from, but not enter or IM interference membrane itself. 隔膜IM是连续的并且以与支架环134的支持结构分离而形成。 IM membrane is continuous and separated from the support structure to the carrier ring 134 is formed.

[0164] 独立的远端支架环134在保持假体内腔的径向支持的同时考虑到假体主体120的纵向顺应性。 While [0164] Isolated distal stent retaining ring 134 in a radially supporting the prosthesis into the longitudinal cavity consideration compliant body 120 of the prosthesis. 这种技术特征使假体更易于适应血管/动脉瘤形态的变化。 This technique wherein the prosthesis is easier to adapt to changes in vessel / aneurysm morphology artery.

[0165] 支架可以由,例如Nitinol®制成。 [0165] stent may be made, for example, made of Nitinol®. 但是,可以使用其它材料、制造方法和设计。 However, other materials, manufacturing methods and designs. 每个支架可以被缝合到假体材料112上。 Each bracket may be sewn onto prosthetic material 112. 在某些位置,理想的是支架连接到假体材料112的外径。 In certain locations, the stent is preferably connected to the outer diameter of the prosthetic material 112. 但是,也可以考虑将支架连接到假体材料112的内径。 However, it is also conceivable to connect the bracket to the inner diameter of the prosthetic material 112.

[0166] 在示例性的实施方式中,假体材料112为聚脂纤维织物,支架的连接由聚酯纤维缝合物形成。 [0166] In an exemplary embodiment, the prosthesis 112 is a polyester fabric material, the connection bracket formed of a polyester fiber sutures. 然而,也可以考虑使用其它连接方法将支架固定到假体材料112上。 However, it is also conceivable to secure the bracket 112 to the prosthetic material using other connection methods. 这些方法包括结合;抓取假体材料112两层之间的支架;以及直接将支架整合进入编织的假体材料112中。 Such methods include binding; gripping prosthetic material holder 112 between the two layers; and a stent directly integrated into the woven prosthetic material 112.

[0167] 如图9A中所示,内腔延伸物140具有至少一个沿着延伸的长度的至少一部分定位并且连接到假体材料112上的外部螺旋支架146来提供稳定性和/或附加的径向支持。 [0167] As shown in FIG. 9A, 140 having a lumen extending at least a portion located along at least one longitudinal extending prosthetic material and connected to the bracket 146 on outer screw 112 to provide additional stability and radial or / to support. 然而,因为在主体部件120中,可考虑支架146也可以被放置到假体材料112的内部,或者螺旋支架146在假体材料的两层之间被抓取(未显示)。 However, since the body member 120, the bracket 146 may be considered to be placed in the interior 112 of the prosthetic material, or a spiral stent 146 is captured between two layers of prosthetic material (not shown). 假体层112可以为连续管状或者非管状的。 The prosthesis 112 may be a continuous tubular layer or a non-tubular. 假体材料112可以覆盖整个内腔延伸物140或者假体材料112只覆盖内腔延伸的一部分。 Prosthetic material 112 may cover the entire lumen extending portion 140 or cover 112 extending lumen prosthetic material. 另外,如前面所谈论过的,螺旋支架146不必是一个沿着延伸长度的连续支架。 Further, as previously talked, the helical stent 146 need not extend continuously along a length of the stent. 内腔延伸物140的螺旋支架146的附加帮助了内腔延伸物的开伞并且在保持内腔延伸物140 中的内腔径向支持时考虑到纵向顺应性。 Lumen 146 extending helical stent 140 a lumen extending additional help the unfolding thereof and extending in the lumen to maintain lumen 140 radially into consideration when the longitudinal support compliance. 通常,在延伸物140的每一个末端上使用不透射线延伸标记148来帮助内腔延伸物140在主体部件120的第一远端开口127和第二远端开口129的内腔中的安置的可视化。 Typically, at each end of extensions 140 extending radiopaque marker lumen 148 to assist in extending the distal end 140 of the first body member 120 of the opening 129 is disposed in lumen 127 and a second distal opening visualization.

[0168] 如图9A至9D所示,内腔延伸物140中的一个或多个接合支架150可以被确定尺寸,被设置并且被安排用来接合主体120的第一内腔1¾和第二内腔1¾的支架环134。 [0168] As shown, in one or more lumens 140 extensions joined to the arms 9A 9D 150 may be dimensioned, disposed and arranged to engage the first body and the second inner lumen 120 1¾ 1¾ lumen stent ring 134. 至少一个接合支架150的远端顶点147向外形成角度以接合主体部件120上的相配的远端支架134(尤其见图9B和9D中)。 At least a distal stent 150 engages angled apex 147 outwardly to engage the body member 120 on the distal end of the mating bracket 134 (in particular see Fig. 9B and 9D). 这样的接合防止了在内腔延伸物140开伞之后内腔延伸物140相对于第一内腔1¾和第二内腔128的轴向移动或迁移。 After such engagement prevents unfolding lumen 140 extending lumen extending axially thereof relative to the first lumen 140 and second lumen 128 1¾ movement or migration. 在图IOA至IOD所示的可选实施方式中,连接到内腔延伸物140外部的螺旋支架146在不被向外成角的情况下与主体120的远端支架134接合。 In an alternative embodiment shown in FIG IOD to IOA, 140 connected to the external lumen extending helical stent 146 without being outwardly angled body 120 and the distal end 134 of stent engagement. 在这些实施方式中的任意一个中,主体120或内腔延伸物140可以包括其他零件从而帮助防止内腔延伸物140相对于主体120的轴向移动或迁移,例如钩、 倒钩、织物环或者植入材料的环或者折叠、或植入材料的袋装物(pocket)。 In any of these embodiments, the body lumen 120, or extensions 140 may include other components to help protect a lumen 140 extending axially with respect to the movement or migration of the body 120, such as hooks, barbs, or fabric loop ring or folded implant material or implant material Sacks (pocket).

[0169] 在使用过程中(见图58),操纵开伞导管200越过导线30穿过髂骨到达邻近肾动脉的主动脉内的所需位置。 [0169] In use (see FIG. 58), the manipulation wires 30 cross the parachute through the catheter 200 reaches the desired position within the iliac crest adjacent the renal arteries of the aorta. 导管200携带处于放射状紧缩构造的多腔假体系统100的主体部件120。 Carrying conduit 200 in the multi-lumen prosthesis body member radially compact configuration system 100 120. 在如图60所示的靶位,阻挡套管210被收回,这使得第二内腔128的远端支架可以放射状扩张进入合适的位置。 In the target shown in FIG. 60, the barrier sleeve 210 is retracted, the distal end of the stent which makes the second lumen 128 may be radially expanded into a suitable position. 第一内腔126的远端支架134和近端支架130不能扩张, 直到释放机构被启动。 The distal end of the stent 134 and the proximal end of the first lumen 126 of the stent 130 can not expand until the release mechanism is activated.

[0170] 如图69和70所示,例如第一内腔延伸物140以放射状压缩状态被来自对侧髂骨的在导线之上的延伸导管350所携带。 [0170] As shown in FIG. 69 and 70, for example, a first lumen 140 extending radially compressed state is carried by conduit 350 extending from opposite sides of the wire above the iliac. 如图71所示,导管350开伞第一内腔延伸物140,这样内腔延伸物140的近端142套叠地容纳于主体部件120的第二内腔128内并且远端144 延伸进入对侧髂骨。 As shown, a first lumen 71 of the catheter 350 extending parachute 140, so that the proximal end of a lumen 140 extending within the second lumen 142 of sleeve 128 telescopically received in the body member 120 and extends into the distal end 144 of iliac side. 然后,例如第二内腔延伸物140以放射状压缩状态被来自同侧髂骨的延伸导管350所携带。 Then, for example, the second lumen 140 extending radially compressed state is carried by conduit 350 extending from the ipsilateral iliac. 如图77所示。 77 shown in FIG. 延伸导管350开伞第二内腔延伸物140,这样内腔延伸物140的近端142套叠地容纳于主体部件120的第一内腔126内并且远端144延伸进入同侧髂骨。 A second conduit 350 extending lumen extending parachute 140, so that the proximal end of a lumen 140 extending within the first lumen 142 of sleeve 126 telescopically received in the body member 120 and the distal end 144 extends into the ipsilateral iliac. 如图78所示,只有当每个内腔延伸物140套叠地容纳于主体部件120的第一内腔1¾和第二内腔128内,才能形成具有分叉内腔的分叉假体100。 78, only when the inner sleeve 140 of the first lumen and a second lumen 128 1¾ telescopically received within the body lumen extending member 120 each object, to form a bifurcated prosthesis 100 having a bifurcated lumen .

[0171] IV植入装置 [0171] IV implantable device

[0172] A.假体开伞导管 [0172] A. prosthesis parachute conduit

[0173] 图11示出了具有本发明特征的假体开伞导管200。 [0173] FIG. 11 shows a prosthesis having the features of the invention catheter 200 parachute. 导管200的用途是(i)在假体主体120开伞之前包含和/或约束假体主体120(见图14A),(ii)通过脉管系统将假体主体120递送到体内的所需位置,例如中空身体器官或者血管(见图1),和(iii)在所需位置中可控制地开伞假体主体120 (见图2和幻,包括当假体主体120被固定到血管壁时使得处于部分开伞状态的假体主体120保持在稳定的位置。在示例性实施方式中,导管200的近端202示出位于体内腔中的导线30之上(见图1)。导管200将放射状紧缩构造的假体主体120携带到靶位。在靶位,导管200释放放射状紧缩的假体120,其放射状地扩张(见图2和幻。在假体主体120部分或完全扩张或者开伞之后,理想的是通过固定器装置400引入一个或多个固定器402从而将假体材料112固定在合适的位置。固定器402还可以用于将假体材料112与中空身体器官或者血管壁并列并且密封和/或修复液体 The use of catheter 200 is (i) comprises and / or constrained prosthesis body 120 before unfolding of the prosthesis body 120 (see FIG. 14A), (ii) through the vasculature to deliver the prosthesis body 120 to a desired location in the body , for example a hollow body organ or a blood vessel (see FIG. 1), and (iii) in the desired position can be controlled unfolding of the prosthesis body 120 (see FIG. 2 and phantom, comprising a main body 120 when the prosthesis is secured to the vessel wall such that the prosthesis body portion is in a state of parachute 120 remains in a stable position. in the exemplary embodiment, the proximal end 202 of catheter 200 is shown positioned above the lead lumen 30 (see Figure 1). the catheter 200 the prosthesis body radially compact configuration 120 carried to the target site in the target site, the catheter 200 is released radially tightening the prosthesis 120, which is radially expanded (see FIG. 2 and phantom. prosthesis body 120, or partially or fully expanded unfolding Thereafter, 400 preferably by introducing one or more fixed holder means 402 so that the prosthetic material 112 is fixed. fixture 402 may be used to further prosthetic material 112 in parallel with the hollow body organ or vessel wall in place and the sealing and / or repair liquid 漏。可以在下面的部分(3)中找到固定器装置和固定器的其它详细描述。 Drain. Other fixing means and the detailed description of the fixture can be found in the following part (3).

[0174] 如上所述,假体100可以被确定尺寸并且被设置为直的或者分叉形式。 [0174] As described above, prosthesis 100 may be dimensioned and arranged to straight or bifurcated form. 图4描绘了完全开伞的分叉假体100。 Figure 4 depicts a complete parachute furcation prosthesis 100. 图5描绘了完全开伞的直的假体50。 Figure 5 depicts a complete unfolding of the straight prosthesis 50.

[0175] 基于说明的目的,图1示出了位于腹主动脉瘤中的靶位。 [0175] For purposes of illustration, FIG. 1 shows an abdominal aortic aneurysm located in the target site. 当然,靶位点可以为身体的其它地方。 Of course, the target site may be elsewhere in the body.

[0176] 如图11至14B所示,导管200包含内部组件208、套管210和手柄组件212。 [0176] As shown in FIG. 11 to 14B, an internal assembly 208 comprises catheter 200, sleeve 210 and handle assembly 212. 这些组件将会被更详细地进行单独描述。 These components will be described individually in more detail.

[0177] 1.内部组件 [0177] 1. internal components

[0178] 在示例性实施方式中(见图12至14B),内部组件208包含中轴216(其作为假体主体120的支座)、近端和远端阻挡装置218、220,和导管顶端部件222。 [0178] In the exemplary embodiment (see FIGS. 12 to 14B), an internal assembly 208 comprises bottom bracket 216 (which serves as the seat of the prosthesis body 120), the blocking means 218, 220, proximal and distal ends, and a catheter tip member 222. 理想的是近端阻挡装置218包含第一近端阻挡装置2M和第二近端阻挡装置226。 The blocking means is preferably a proximal end barrier means 218 comprises a first proximal end and second proximal 2M barrier means 226. 理想的是在开伞之前和在将假体主体120固定到血管壁之前,第一近端阻挡装置224限制假体主体120的一部分处于放射状压缩和/或部分放射状扩张的状态。 Desirable and before the parachute prior to the prosthesis body 120 is fixed to the vessel wall, the prosthetic device 224 limiting the portion of the body 120 in radial compression and / or radially expanded state the proximal end portion of the first barrier. 理想的是第二近端阻挡装置2¾通过防止轴向移动和有限程度的旋转移动而被用于稳定被开伞的近端密封支架130。 Desirable by 2¾ second proximal stopper means against axial movement and rotational movement of limited extent is used for stabilizing the proximal end of the seal support 130 parachute. 理想的是第一和第二近端阻挡装置还包括共同作用的释放装置或机构228、230,用于在启动之前将第一或第二近端阻挡装置224、2沈保持在与假体主体120理想的关系中。 Over the proximal end of the first and second barrier means or mechanism also comprises release means 228, 230 co-acting, for before starting the first or second proximal end barrier means 224,2 sink maintained in the prosthesis body 120 ideal relationship. 理想的是远端阻挡装置或机构220也包括释放装置或者机构232用于启动/释放远端阻挡装置或机构220。 Preferably distal barrier means or mechanism also comprises release means 220 or means 232 for activating / releasing the distal end of the blocking device or mechanism 220. 释放装置可包含多种装置,如线或多条线、缝合物、磁性元件,或流体,并且可以包括,例如滑动、 牵引或者推动。 The release means may comprise a variety of devices, such as a line or lines, suture, magnetic elements, or fluid, and may include, for example, sliding, pushing or pulling.

[0179] a.中轴 [0179] a. Axis

[0180] 在图13和14A所示的实施方式中,中轴216和近端以及远端阻挡装置218、220位于外套管210的范围内。 [0180] In the embodiment shown in FIGS. 13 and 14A, the axis 216 and a proximal end and a distal barrier means in the range of 210 to 218, 220 located in the outer casing. 在此方面,外套管210作为支座上的假体主体120的封套(见图14A)。 In this regard, the outer sleeve 210 as the prosthesis on the support body 120 of the envelope (see FIG. 14A). 在这个安排中,导管顶端部件222连接到中轴216的近端,并且外套管210的近端在导管顶端部件222的附近终止。 In this arrangement, the catheter tip member 222 is connected to the proximal end of the axis 216, and the proximal end 210 of the outer sleeve member terminates in the vicinity of the catheter tip 222. 这样,导管顶端部件222在外套管210之上向外延伸。 Thus, the catheter tip 222 of the outer sleeve member 210 extends outwardly over. 中轴216、近端和远端释放装置2观、230、232和外套管210可以在导管手柄组件212的近端耦连至手柄组件212(见图11)。 Axis 216, a proximal end and a distal end concept release device 2, 230, 232 and outer sleeve 210 may be coupled to the handle assembly 212 (see FIG. 11) at the proximal end 212 of the catheter handle assembly. 如图14A所见,假体主体120包含在中轴216和开伞导管200的近端部分的外套管210之间所限定的腔234中。 As seen in Figure 14A, the body 120 comprises prosthesis 210 defined between the proximal portion of the outer sleeve 216 and the central axis 200 of the catheter lumen parachute 234.

[0181] 中轴216从手柄组件212延伸到导管顶端部件222。 [0181] axis 216 extending from the handle assembly 212 to the tip 222 of the catheter member. 中轴216可以例如由不锈钢或者包括其它金属或者聚合物的其它合适的医用材料制成。 Axis 216 may be made of stainless steel or other suitable medical materials including other metals or polymers. 中轴216包含至少一个内腔, 理想的是多于一个内腔,并且更理想的是四个内腔。 Comprising at least one lumen axis 216, is preferably more than one lumen, and more preferably four lumen.

[0182] 一个内腔可以被描述为中心内腔236(见图15),其具有0.010至0. 120英寸之间的内径,理想的是在0. 020至0. 060英寸之间并且最理想的是在0. 030至0. 050英寸之间。 [0182] lumen may be described as a central lumen 236 (see FIG. 15), which has an inner diameter between .010 to 0.120 inches, preferably between 0.020 to .060 inches and most desirably It is between from 0.030 to 0.050 inches. 如上所述,中心内腔236允许达到0. 038”直径的导线30插入。理想的是导管顶端部件222 也具有至少一个内腔238(见图16),其被设置为与中轴216内的至少一个内腔排列成行。 该内腔238使得导线30插入穿过中轴216并且穿过导管顶部部件222。通常,该内腔238 具有的内径在0. 010至0. 120英寸之间,理想的是在0. 020至0. 060英寸之间并且最理想的是0. 030至0. 050英寸之间。 As described above, the central lumen 236 is allowed to reach 0.038 "diameter wire 30 inserted Desirably the catheter tip member 222 also has at least one lumen 238 (see FIG. 16), which is arranged to the inner axis 216 at least one lumen arranged in rows. the lumen 238 such that the wire 30 is inserted through the central axis of the top member 216 and through the conduit 222. typically, the lumen 238 has an inner diameter between 0.010 to 0.120 inches, over It is between from 0.020 to 0.060 inches and most desirably between .030 to .050 inches.

[0183] b.导管顶端 [0183] b. The catheter tip

[0184] 理想的是,导管顶端部件222是柔韧性的并且具有长的锥形近端240和短的锥形 [0184] Desirably, the catheter tip 222 is a flexible member and a tapered proximal end 240 has a long and a short tapered

17远端M2。 17 distal M2. 导管顶端部件222的最大直径大约与外套管210近端的外径相同。 The maximum diameter of the tip of the catheter member 222 is approximately the same outer diameter as the outer sleeve 210 of the proximal end. 导管顶端部件222的近端240提供了从含有导线30的内腔238到外套管210的近边的平滑的锥形过渡。 The proximal end of the catheter tip 240 of member 222 provides a smooth transition from the proximal edge of the tapered wire lumen 30 containing the overtube 238 to 210. 这个特征有助于导管的插入和穿过导线30之上的弯曲的解剖结构的导向。 This feature helps insertion of the catheter and through tortuous anatomy over the guide wire 30. 导管顶部部件222的远端242上的锥形部分防止导管顶端部件222在从身体移出开伞导管200的过程中不小心地嵌入到假体主体120、周围解剖结构部分或者导入器套管等。 A tapered portion on the distal end of the catheter 242 the top member 222 of the catheter tip member 222 to prevent removal of the parachute during catheter 200 from the body inadvertently inserted into the body 120 of the prosthesis, or a portion of the surrounding anatomy introducer cannula and the like.

[0185] 2.近端阻挡装置 [0185] 2. The proximal end barrier means

[0186] a.第一近端阻挡装置 [0186] a. A first proximal end barrier means

[0187] 如图17至图19所示,在示例性实施方式中,第一近端阻挡装置2M包含至少一个缝合物或者多个缝合物252和/或相当的结构,其被耦连于假体材料112,或者一个或多个位于假体主体120上的支架130。 [0187] As shown in FIG. 17 to FIG. 19, in an exemplary embodiment, the proximal end of the first blocking means comprise at least 2M or a suture and / or equivalent structures plurality of suture 252, which is coupled to a fake material 112, or one or more of the prosthesis is located on the main body 120 of the bracket 130. 举例来说,释放线250,当释放线250在其最近端位置时, 如图17和18A所示,缝合物252依次环绕着释放装置228。 For example, the release wire 250, when the release wire 250 is in its proximal-most position, as shown in FIG. 18A and 17, the suture 252 around the release means 228 sequentially. 线250的远端收回使得线250 从缝合环252撤出,并且使假体主体120的近端108可以放射状扩张,如图19所示。 Line 250 such that the distal end of the retraction wire 250 is withdrawn from the suture ring 252, and the proximal end of the body 120 of the prosthesis 108 can be radially expanded, as shown in Fig. 在一个可选实施方式中,缝合物252可以包含不止一个缝合物,也就是两个或多个缝合环。 In an alternative embodiment, the suture 252 may comprise more than one suture, i.e. two or more suture rings. 图18B 示出了环绕释放线250的两个缝合环252的路径。 FIG 18B shows the release wire 250 around the sewing ring 252 of the two paths.

[0188] 可以在假体主体120和/或内腔延伸物140上提供带环(belt loop)或者类似物来引导或者支持缝合环沿着缝合环路径(例如,见图17和46B)。 [0188] 120 may extend and / or endoluminal prosthesis body 140 provided on the belt loop (belt loop) or the like guided along a suture or sewing ring support ring path (e.g., see FIG. 17 and 46B). 带环可以以所需的圆周间隔隔开,例如以每90度。 Belt loops may be spaced apart circumferentially at a desired, for example, every 90 degrees.

[0189] 在示例性实施方式中,缝合环252的一端耦连于假体材料112或者一个或多个位于或临近于假体主体120近端108的支架130。 [0189] In an exemplary embodiment, one end of the suture ring 252 is coupled to the prosthesis or one or more material 112 at or adjacent to the prosthesis proximal end of the body frame 130 120 108. 然后缝合环252环绕假体主体120和处于预定模式的释放装置,如图18A所示,用来压缩并且保持假体120的近端108。 Then the suture ring 252 surrounds body 120 and releasing a prosthetic device in a predetermined pattern, as shown in FIG. 18A, for compressing and holding the proximal end 120 of the prosthesis 108. 然后缝合环252的自由末端耦连于假体材料112或者位于或者临近于假体主体120近端108的一个或者多个支架130。 Then the free end of the suture ring 252 is coupled to the prosthetic material 112 or 120 located at or adjacent to one or more of the proximal end 108 of the stent main body 130 of the prosthesis. 图18B示出了两个独立的环绕假体主体120的缝合环252以及释放线250。 FIG 18B illustrates two separate suture around the main body 120 of the prosthesis 252 and a release wire ring 250. 但是,应该了解,缝合环252也可以耦连于假体主体120中的其它位置的支架,和/或假体主体120的其它部件。 However, it should be appreciated that the suture ring 252 may be coupled to other locations in the stent of the prosthesis body 120, and / or other components of the body 120 of the prosthesis.

[0190] 刚刚所描述的实施方式的缝合环252和释放装置228,例如释放线250,将假体120 保持在与中轴理想的关系中(见图17)。 Suture [0190] The embodiment just described embodiment the ring 252 and release means 228, such as the release cable 250, the prosthesis 120 is maintained at an ideal relationship with the axis (see FIG. 17). 当外套管210被收回时,缝合环252和释放装置228防止假体主体120向远端移动。 When outer sleeve 210 is retracted, the suture ring 252 and release means 228 prevents the prosthesis body 120 moves distally. 当外套管210被收回时,缝合环252还保持被缝合环252约束的支架130处于放射状压缩状态。 When outer sleeve 210 is retracted, the suture ring 252 further sewing ring 252 remains constrained stent 130 is radially compressed state. 缝合环252和释放装置228防止假体主体120 的近端108自扩张直到释放装置2¾被撤回。 Release means 252 and suture ring 228 prevents proximal end 120 of prosthesis body 108 from expanding until the releasing means 2¾ is withdrawn. 在示例性实施方式中,通过操纵控制旋钮来向远端移动释放装置228,从缝合环252撤回释放装置2¾来完成释放装置2¾的撤回。 In an exemplary embodiment, by manipulating the control knob to move the release means 228 to the distal end, the suture ring 252 to withdraw the releasing means 2¾ 2¾ complete withdrawal of the release device. 一旦释放装置2¾被撤回,假体主体120被约束的部件就可以自由地自扩张,如图19所示,。 Upon release means 2¾ is withdrawn, member 120 is constrained prosthesis body is free to self-expand, as shown in Fig.

[0191] 如图20和21所示,第一近端释放装置2¾包含放置于中轴216之上的第一近端释放套筒244和释放线250。 [0191], the first releasing the proximal end 20 and 21 placed in the first means comprises a 2¾ on the proximal end 216 of the release sleeve 244 and the central axis of release line 250. 第一近端释放套筒244可以包括套筒244近端中的一个小孔或者内腔对6,其与中轴216中的第一近端释放内腔248是流通的。 The first proximal end of the release sleeve 244 may include a proximal end 244 of the sleeve in an aperture or lumen to 6, the first release lumen 248 proximal the central axis 216 is in circulation. 理想的是每个内腔M6、 248具有适合于第一近端释放线250从手柄组件212延伸到第一近端释放套筒244上的足够大的直径。 Preferably each lumen M6, 248 having a proximal end adapted to first release wire handle assembly 250 to the first proximal end 212 extends sufficiently large diameter on the release sleeve 244 from. 应该了解释放线250也可以在中轴216外部延伸。 It should be understood release line 250 extends in the central axis 216 may also be external.

[0192] 在开伞之前,第一近端阻挡装置2M保持假体主体120处于所需构造(见图17和18A)并且第一近端释放装置2¾选择性地释放假体主体120用于第一阶段的开伞(见图19)。 [0192] Before parachute, the first barrier means 2M proximal prosthesis holder body 120 in the desired configuration (see FIGS. 17 and 18A) and the proximal end of a first release means for selectively releasing the prosthesis 2¾ body 120 for the first a stage parachute (see Figure 19). 在示例性实施方式中,第一近端释放线250的远端连接到手柄组件212中的启动器或者控制钮或旋钮上,这将在后面作进一步描述。 In an exemplary embodiment, the proximal end of the distal end of the first release wire 250 is connected to the handle assembly 212 or a start control button or knob, which will be further described later.

[0193] 假体主体120至少被沿着腔234中的中轴216的第一近端阻挡装置2M所保持, 其在导管顶端部件222的远端242与间隔装置(spacer) 206近端之间延伸(见图14A)。 [0193] The prosthesis body 120 at least a first blocking means along the central axis of the proximal end chamber 234 maintained 2M 216, 206 between the proximal and distal spacer 242 (spacer) 222 in which the catheter tip member extending (see FIG. 14A). 在示例性实施方式中,释放装置2¾包括释放线250,其可以延伸穿过中轴216的至少一部分。 In an exemplary embodiment, the release means comprises a release 2¾ line 250, which may extend through at least a portion of the central axis 216. 线250的近端经过第一近端释放套筒M4的内腔M6。 The proximal end of line 250 through the first lumen proximal release sleeve M4, M6. 这样,第一近端释放线250被保持在处于中轴216中或者沿着中轴的理想关系中。 Thus, the first proximal end of release wire 250 is held at or in the central axis 216 along a central axis of an ideal relationship. 第一近端释放线250的远端耦连到控制旋钮,这样旋钮的向前和向后运动使得释放线250分别向近端和远端移动。 Releasing the proximal end of the distal end of the first line 250 is coupled to the control knob, the knob so that the forward and backward movement of the release wire 250 is moved proximally and distally.

[0194] 如示出的和所描述的,第一近端释放装置2¾耦连到假体主体120的一个受约束的部件,也就是,缝合环252。 [0194] As shown and described, the first release means 2¾ proximal end coupled to a member 120 of the constrained prosthesis body, i.e., the suture ring 252. 然而,应该了解,释放装置2¾可以在两个或多个被约束的区域耦连到假体主体120上,这样释放装置228的收回使得假体在两个或多个被约束区域释放。 However, it should be understood, 2¾ release means may be constrained in two or more regions coupled to the prosthesis body 120, so that the retracting means 228 is released constrained prosthesis is released in two or more regions. 还应该了解释放装置2¾可以包含不止一个的释放器件。 It should also be understood 2¾ release means may comprise more than one release device. 例如,多个单独的释放线250 可以在不同的区域耦连至假体主体120,这样可以独立地控制假体主体120的独立区域的释放。 For example, a plurality of individual release line 250 may be connected in different regions coupled to the prosthesis body 120, so that the prosthesis can be controlled independently of the main body 120 of the release of separate regions.

[0195] b.第二近端阻挡装置 [0195] b. The second proximal end barrier means

[0196] 参考图12,近端阻挡装置218也可以整合第二阻挡装置226,第二阻挡装置2¾可以与第一近端阻挡装置2M协作或者与第一近端阻挡装置分离开来起作用。 [0196] Referring to FIG 12, the proximal end of the blocking device 218 can also be integrated second barrier means 226, a second barrier means cooperating 2M 2¾ means can block the first or proximal end of the proximal end of the first blocking means acts separated. 第二近端阻挡装置2¾可以通过第二近端释放装置230被保持在合适的位置上,以与中轴216保持预定的间隔开的关系。 Second proximal means 2¾ barrier means may be released by a second proximal end 230 is held in position on the axis 216 to maintain a predetermined spaced-apart relationship.

[0197] 参考图22至图27,第二近端阻挡装置2¾可以包含至少一个稳定臂256,和/或相当的结构,并且理想的是不止一个稳定臂,如所示的三个稳定臂。 [0197] Referring to FIG. 22 to FIG. 27, a second proximal end barrier means may comprise at least 2¾ a stabilizer arm 256, and / or equivalent structures, and ideally more than one stabilizer arm, three stabilizing arm as shown. 第二近端释放装置2¾ 可以包含第二近端释放套筒266和第二近端释放线(或多个释放线)268。 2¾ second release means may comprise a proximal end of the proximal end of the release sleeve 266 and the second proximal end of the second release wire (or more release wires) 268.

[0198] 稳定臂256的远端258耦连到第二近端释放套筒沈6。 [0198] 256 distal end 258 of the stabilizing arm coupled to the proximal end of the release sleeve a second sink 6. 在开伞前的结构中,稳定臂256的近端262 —般向后背向第一近端释放套筒244成拱形(见图23和24)并且可释放地连接到位于或者临近于假体主体120近端108的假体材料112上(见图M和25)。 In the structure of the front of the parachute, the proximal end 262 of the stabilization arm 256 - as rearwardly away from the proximal end of the release sleeve 244 into a first arcuate (see FIG. 23 and 24) and can be releasably connected to or positioned adjacent to the prosthesis (see Fig. 25 and M) the proximal end 120 of the main body 108 of the prosthesis material 112. 在开伞后的构造中,如图26中所示,稳定臂256朝向最近的导管顶端222延伸。 In the configuration of the parachute, as shown in FIG. 26, the arm 256 toward the nearest stable catheter tip 222 extends.

[0199] 稳定臂256的近端262包括稳定臂孔沈4。 [0199] proximal end 256 of the stabilization arm 262 includes a stabilizing arm-bore 4. 在开伞前的结构中,稳定臂256位于假体主体120的近端开口122中并且第二近端释放线268被缝线或者以其它方式延伸穿过稳定臂孔264并且延伸穿过假体材料112,可释放地将稳定臂256固定到假体主体120上(见图25)。 In the structure of the front of the parachute, the stabilizer arm 256 is located in the proximal end 120 of the prosthesis body and the second opening 122 in the proximal end of the suture release line 268 is or otherwise stabilizing arm extending through apertures 264 and extend through the prosthesis material 112, may be releasably secured to the stabilizing arms 256 on the prosthesis body 120 (see FIG. 25). 第二近端释放线268的远端收回(使用第二控制旋钮,随后会被描述)使得第二近端释放线268从假体材料112上撤回并释放稳定臂沈4。 The second distal end 268 of the proximal release wire retracted (using the second control knob will then be described) so that the second release wire 268 is retracted from the proximal end of the prosthetic material and the release of the stabilizing arm 112 sink 4. 如图沈所示,此时假体主体120 不受稳定臂256的保持性特性的约束,并且稳定臂回到开伞后构造。 As shown in FIG Shen, case body 120 from the prosthesis retention property stably bound arm 256, and arm back to the stable configuration after the parachute. 应该了解第二近端释放线268可以包含多条释放线,包括对于每个稳定臂256具有一条释放线。 It should be understood second proximal release wire 268 may comprise a plurality of release line, comprising for each line having a stable release arm 256. 第二近端释放线268可以包含延伸穿过中轴的单独的线,然后分成多个线从而分别连接到稳定臂,或者释放线268可以包含多条延伸穿过中轴216从而分别连接到每个稳定臂256的多条线。 Second proximal release wire 268 may comprise a single line extending through the central axis, and then divided into a plurality of lines so that the arms are connected to the stable, or release wire 268 may comprise a plurality of extending through the central axis 216 are connected to each of such a stabilizer arm 256 of a plurality of lines. 在可选实施方式中,稳定臂256可位于导管中轴216上的相反方向。 In an alternative embodiment, the stabilizing arm 256 may be positioned in the opposite direction on the central axis of the conduit 216. 这种构造的稳定臂可以为离开中轴216而被偏离打开并且需要第二装置来保持它们接近中轴216从而在导管移出前被重新包裹。 Such stabilizing arm may be configured to open away from the central axis 216 offset from and requires a second holding means 216 so as to be re-wrapped catheter is removed prior to their proximity to the central axis.

[0200] 在图对至27所示的实施方式中,第二近端阻挡装置2¾包括位于中轴216之上的第二近端释放套筒沈6。 [0200] In the embodiment of FIG embodiment shown to 27, the proximal end of the second barrier means comprises a 2¾ located above the central axis 216 of the proximal end of the release sleeve a second sink 6. 第二近端释放套筒266可以包括在套筒266近端的小孔或者内腔270,其与中轴内的第二近端释放内腔272流通(见图对和27)。 The second release sleeve 266 may include a proximal end 270, a proximal end of the second release lumen 266 within the proximal end of the central axis of the sleeve aperture or flow lumen 272 (see FIG. 27 and on). 理想的是内腔270和272 具有适合至少一个第二近端释放线268从手柄部分212延伸越过第二近端释放套筒266的足够大的直径。 Preferably 270 and 272 is a lumen having a proximal end adapted to release at least a second line 268 across a second proximal end extending from the handle portion 212 is released sufficiently large diameter of the sleeve 266. 应该理解释放线沈8也可以在轴216外部延伸。 It should be appreciated that release line 8 can also extend in the sink shaft 216 outside.

[0201] 在开伞之前,第二近端阻挡装置2¾保持假体主体120处于所需的构造(见图19 和24)并且选择性地释放假体主体120用于开伞的第二阶段(见图26)。 [0201] before the parachute, the proximal end of the second blocking means 2¾ prosthesis holder body 120 in the desired configuration (see FIGS. 19 and 24) and selectively releasing the prosthesis body 120 for the second stage of the unfolding ( see Figure 26). 在示例性实施方式中,第二近端释放线268的远端连接到手柄组件212中的启动器或者控制钮或者旋钮,这个随后将会被进一步讨论。 In an exemplary embodiment, the proximal end of the distal end of the second release wire 268 is connected to the handle assembly 212 or a start control button or knob, this will be further discussed subsequently.

[0202] 假体主体120被第二近端阻挡装置2¾保持处于与中轴隔离开的关系(见图24)。 [0202] The second prosthetic body 120 is maintained at a proximal end barrier means 2¾ isolated relationship with the axis (see FIG. 24). 在示例性实施方式中,第二近端释放装置230包括第二近端释放线沈8,其可以延伸穿过中轴216的至少一部分。 In an exemplary embodiment, the second release means 230 includes a second proximal end of the proximal end of release wire sink 8, which may extend through at least a portion of the central axis 216. 释放线268的近端穿过第二近端释放套筒的内腔270。 The proximal release wire 268 passes through the proximal end of the second lumen 270 of the release sleeve. 这样,第二近端释放线268以理想的关系保持在中轴216中或者沿着中轴216。 Thus, the second proximal release wire 268 held in relation to an ideal axis along the central axis 216 or 216. 第二近端释放线沈8的远端耦连到第二控制旋钮,这样第二控制旋钮的向前或向后运动分别使得第二近端释放线268向近端和远端地移动。 The second distal end of the proximal end of the release wire 8 sink is coupled to the second control knob, so that the second control knob forward or backward, respectively, such that the proximal end of the second release wire 268 is moved proximally and distally.

[0203] 3.远端阻挡装置 [0203] 3. The distal end of the blocking device

[0204] 如图观至33中所示,在示例性实施方式中,远端释放装置220包含至少一个缝合物,或者多个缝合物274和/或相当的结构,其被耦连到假体材料112上,或者假体主体120 上的一个或者多个支架Π4上。 [0204] As shown in FIG concept to 33, in an exemplary embodiment, the distal end 220 includes at least one release means and / or equivalent structures suture, or a plurality of suture 274, which is coupled to the prosthesis the material 112, or on the prosthesis body or a plurality of brackets 120 on Π4. 理想的是,缝合物274耦连到邻近主体120的远端110,更理想的是临近第一内腔126的远端开口127的假体材料112。 Ideally, the suture 274 is coupled to the body adjacent the distal end of 110 120, more preferably adjacent the distal opening of the first lumen 126 127 112 prosthetic material. 当释放线282在其最近端的位置时,如图28和29A所示,缝合物274依次环绕释放装置232,例如释放线观2。 When the release line 282 at its most proximal position, as shown in FIG. 28 and 29A, the suture 274 in turn surrounded by release means 232, such as the release line Concept 2. 线282 的远端收回使得线282从缝合环274上收回,并且使得假体主体120的远端110可以放射状扩张,如图30所示。 Line 282 such that the distal end of the retraction wire 282 is withdrawn from the suture ring 274, and the main body such that the distal end 120 of the prosthesis 110 can be radially expanded, as shown in FIG. 30. 在可选实施方式中,缝合物274可以包含不止一个缝合物,也就是两个或者多个缝合环。 In an alternative embodiment, the suture 274 may comprise more than one suture, i.e. two or more suture rings. 图29B示出了两个缝合环252环绕释放线四2的路径。 FIG 29B shows the path of two suture ring 252 surrounding the four release line 2.

[0205] 如对于第一近端阻挡装置的描述,可以在假体主体120和/或内腔延伸物140上提供带环或者类似物来引导和支持沿着缝合环路径的缝合环。 [0205] As described with respect to the first proximal end barrier means may be provided extending on the belt loops 140 or the like at 120 and / or lumen prosthesis body to guide and support the sewing ring sewing ring along the path. 例如,带环可以以所需的圆周间隔而被隔开,如每90度。 For example, the belt loop can be spaced at desired circumferential spacing, such as every 90 degrees.

[0206] 在示例性实施方式中,缝合环274的一端耦连到位于或邻近假体主体120的远端110的假体材料112或者一个或者多个支架134。 [0206] In an exemplary embodiment, the sewing ring 274 is coupled to one end of the prosthesis material at or adjacent the distal end of the body 110 of the prosthesis 120 or a plurality of brackets 112 or 134. 然后,缝合环274环绕假体主体120和在预定模式中的远端释放装置232,如图29A所示,用来压缩并且保持假体主体120的远端110。 Then, the sewing ring 274 surrounds body 120 and the distal end of the prosthesis in a predetermined pattern of release means 232, shown in Figure 29A, for compressing and holding the prosthesis the distal end 120 of body 110. 然后,缝合环274的自由端耦连于位于或临近于假体主体120的近端110的假体材料112或者一个或者多个支架134。 Then, the free end of the suture ring 274 is coupled to the proximal end of the prosthesis at or adjacent to the main body 120 of the prosthesis material 110 or 112 or a plurality of brackets 134. 图29B示出了两个环绕假体主体120的独立的环252和释放线250。 29B shows two independent release line 250 and a ring 252 surrounding the body 120 of the prosthesis. 然而,应该理解缝合环274也可以耦连到假体主体120其它部位的支架,和/ 或假体主体120的其它部件上。 However, it should be understood that the suture ring 274 may be coupled to other parts of the other components of stent 120 and / or prosthesis of the main body 120 of the prosthesis.

[0207] 如刚刚所描述的实施方式的缝合环274和释放装置232,例如释放线观2,将假体主体120的远端保持在中轴216(见图28)。 [0207] The sewing ring of the embodiment just described embodiment of release means 274 and 232, such as the release line concept 2, the distal end of the prosthesis body 120 is maintained at the central axis 216 (see FIG. 28). 当外套管210被收回时,缝合环274和释放装置232防止假体主体120向远端移动。 When outer sleeve 210 is retracted, the suture ring 274 and release means 232 prevents the prosthesis body 120 moves distally. 当外套管210被收回时,释放装置232还保持被缝合环274约束的一个或多个支架134处于放射状压缩状态。 When outer sleeve 210 is retracted, releasing means 232 further sewing ring 274 remains constrained in one or more brackets 134 radially compressed state. 缝合环274和释放装置232防止假体主体120的远端110进行自扩张,直到释放装置232被收回。 Release means 274 and suture ring 232 prevents the distal end of the body of the prosthesis is self-expanding 110 120, until the release means 232 is retracted. 在示例性实施方式中, 释放装置232的收回是通过操纵控制旋钮使得释放装置232向远距离移动,收回释放装置232并且离开缝合环252来实现的。 In an exemplary embodiment, the retracting means 232 is released by manipulating the control knob 232 such that the releasing means moves further away, the release means 232 and withdrawn leaving the suture ring 252 to achieve. 一旦释放装置232被收回,假体主体120的被约束的部扩张,如图30所示。 Upon release means 232 is retracted, the prosthesis body portion 120 is restrained expansion, shown in Figure 30.

[0208] 在图观至31所示的实施方式中,远端释放装置232包括位于中轴216之上的远端释放套筒276和释放线观2。 [0208] In the embodiment shown in FIGS concept to embodiment 31, the distal end of the release means 232 includes a distal end positioned above the central axis 216 of the release sleeve 276 and release wire Concept 2. 远端释放套筒可以包括在套筒近端的一个小孔或者内腔278, 其与中轴216中的远端释放内腔280流通(见图31)。 The distal end may include a release sleeve 278, which releases the flow lumen 280 (see FIG. 31) and the central axis of the distal end of the sleeve 216 in the proximal end of a lumen or aperture. 理想的是每个内腔278、280具有适合远端释放线282从手柄组件212延伸越过远端释放套筒的足够大的直径。 Each lumen 278, 280 is desirable to have a sufficiently large diameter wire 282 extends beyond the distal end of the handle assembly 212 is released from the distal end of the sleeve for release. 应该了解释放线282也可以在轴216外部延伸。 Release line 282 should be appreciated that the shaft 216 can also extend outside.

[0209] 在远端开伞之前,远端阻挡装置220保持假体主体120的远端110在所需的构造中(见图观),并且远端释放装置232选择性地释放假体主体120的远端110用于开伞的最后一个步骤(见图30)。 [0209] Before parachute distal end, the distal end of the blocking device body 220 holding the distal end 120 of prosthesis 110 (see FIG view), and selectively releasing the distal end device 232 in the desired configuration of the prosthesis body 120 is released the distal end 110 of the parachute for the final step (see FIG. 30). 在示例性实施方式中,远端释放装置232的远端连接到手柄组件212中的启动器或者控制钮或旋钮,这个随后将会作进一步地描述。 In an exemplary embodiment, the distal end of the distal end of the release device 232 is connected to the handle assembly 212 or a start control button or knob, this will then be further described.

[0210] 在示例性实施方式中,远端释放装置232包括远端释放线观2,其可以延伸穿过中轴216的至少一部分。 [0210] In an exemplary embodiment, the distal end of the distal end of the release means comprises a release line 232 Concept 2, which may extend through at least a portion of the central axis 216. 线282的近端穿过远端释放套筒276的内腔278。 The proximal end of the distal release wire 282 passes through lumen 276 of sleeve 278. 然后,远端释放线282的近端可以向后延伸进入中轴216穿过与远端释放套筒276间隔开放置的第二远端释放孔或者内腔观4。 Then, the distal end of the proximal release wire 282 may extend rearwardly into the axis 216 and through the open distal end of the release sleeve 276 spaced opposite second distal aperture or lumen Concept 4 release. 这样释放线观2的近端被保持在处于在中轴216内或者沿着中轴216 的理想的关系中。 Such concept release line 2 is maintained at a proximal end at the central axis 216 or along the ideal relationship axis 216. 远端释放线观2的远端耦连到远端控制旋钮,这样远端控制旋钮的向前和向后运动分别使得远端释放线282向远端地或者向近端地移动。 Concept distal release line coupled to the distal end 2 of the distal end of the control knob, the control knob so that the distal end of forward and backward motions, respectively, such that the distal end of the release wire 282 to move distally or proximally.

[0211] 如示出的和所述的,远端释放装置232耦连到假体主体120或者假体主体的一个部件上,也就是,缝合环274上。 [0211] As shown and described, the distal end of the release device 232 is coupled to a main body member 120 of the prosthesis or prosthetic body, i.e., the suture ring 274. 然而应该了解,远端释放装置232可以在两个或者多个被约束的区域耦连到假体主体120上,这样远端释放装置232的收回释放了假体上的两个或者多个被约束区域。 It should be understood, however, releasing the distal region of the device 232 may be constrained in two or more coupling the prosthesis to the body 120, the distal end of retraction device 232 is released so that the release of two or more of the prosthesis is constrained region. 还应了解远端释放装置232可以包含不止一个单独的释放器件。 It is also understood that the distal end of the release device 232 may comprise more than a single dispensing device. 例如,多个独立的释放线282可以在不同的区域耦连到假体主体120,这样就可以单独控制假体主体120的远端的单独区域的释放。 For example, a plurality of independent release line 282 may be connected in different regions coupled to the prosthesis body 120, so that the prosthesis can be individually controlled release of separate regions of the body distal end 120.

[0212] 在可选实施方式中,远端释放装置220可以包含假体材料112。 [0212] In an alternative embodiment, the distal end of the release device 220 may comprise a prosthetic material 112. 如图32中所示, 远端释放线282可以经临近假体主体120的远端110的假体材料112穿入,例如,第一内腔126。 As shown in FIG. 32, the distal end of the distal end of the release wire 282 may prosthesis 120 112 penetrates through the material 110 located near the prosthesis body, e.g., a first lumen 126. 然后,理想的是远端释放线282延伸进入第二远端内腔观4中。 Then, it is desirable that the distal end of release wire 282 extend into the distal end of the second lumen 4 View. 这样,释放线观2的近端保持处于在中轴216内或沿着中轴216的理想关系中从而保持线观2。 Thus, the concept of the proximal end of release wire 2 is maintained in the axis line 216 so as to maintain or 2 View along the central axis 216 over relationship. 在这种构造中, 远端支架134不是被放射状约束的。 In this configuration, the distal end of the stent 134 is not radially constrained. 当外套管被收回,假体主体120的远端110就可以自由地放射状扩张。 When the outer sleeve is retracted, the distal end of the prosthesis 110 120 of the body can freely radially expand. 远端释放线282用作保持远端110相对于导管轴216的位置。 Holding the distal end of release wire 282 serves as the distal end 110 relative to the shaft 216 of the catheter. 这一特征使假体主体的内腔可以通过更强的液体流动,而仍能在开伞的过程中保持假体主体120的纵向或者轴向的控制。 This feature makes the lumen of the prosthesis body by a stronger liquid flow, while still maintaining control of the body 120 of the prosthesis longitudinal axis or during the parachute. 在示例性实施方式中,如图33所示,释放线观2的收回是通过操纵控制旋钮使释放线观2向远端移动,从假体材料112收回释放线282并且从导管中轴216 释放假体主体120的被约束的部件来实现的。 In the exemplary embodiment shown in Figure 33, the release wire 2 is retracted concept by manipulating the control knob 2 is moved so that the release wire distally View, release wire 282 to recover from the prosthetic material released from the catheter 112 and the axis 216 constrained prosthesis body member 120 is achieved.

[0213] B.外套管 [0213] B. overtube

[0214] 如上所述,外套管210用于约束假体主体120上的支架130、134,防止其扩张并且考虑到假体主体120在体内的可控制性开伞(见图14A)。 [0214] As described above, the outer tube 210 for confining the prosthesis 130, 134 on the body frame 120, preventing its expansion and taking into account the prosthesis body 120 may be controlled unfolding in vivo (see FIG. 14A). 在示例性的安排中,外套管210 耦连于手柄组件212上的启动器或者旋钮302,这将会在随后作更详细地描述。 In an exemplary arrangement, the outer sleeve 210 is coupled to a promoter or a knob on the handle assembly 212 302, which will be described subsequently in greater detail. 如图14A 所示,外套管210向近端延伸越过间隔装置206和假体主体120并且在接近导管顶端组件222的远端242处终止。 14A, the outer sleeve 210 extends proximally beyond the spacer body 206 of the prosthesis 120 and terminates near the distal end of the catheter tip assembly 222 at 242. 通常,外套管210可以由聚合物管或者所属领域中已知的相似材料制成。 Typically, the outer sleeve 210 may be made of tubes made of polymer known in the art or similar material. 在一个实施方式中,套管210可以没有结构的加固。 In one embodiment, the sleeve 210 can no structural reinforcement. 在一个可选实施方式中(如图 In an alternative embodiment (FIG.

2114B所示),套管210可以包括结构的加固,例如,但是不限制于,纵向地沿着外套管长度的线或者杆211,和/或螺旋围绕套管的长度的线或杆213。 2114 b shown), sleeve 210 may comprise a reinforcement structure, for example, but not limited to, the outer sleeve longitudinally along the length of the line or bar 211, and / or spirals around the length of the sleeve or rod 213. 结构的加固也可以为,例如盘绕或者编线的形式。 The reinforcement structure may be, for example, in the form of a coiled or braided wire of. 结构加固的可塑性可以改变,从而根据所选择的应用来影响套管210的弹性。 Plasticity structural reinforcement may be varied to affect the elastic sleeve 210 according to the selected application. 另外,结构的加固可以沿着套管210的整个长度延伸,或者只沿着外套管长度的一部分或者多个部分定位。 Further, the reinforcing structure may extend along the entire length of the sleeve 210, or only a portion of the outer sleeve portion is positioned along a length or more. 结构的加固可以被植入套管210的内部,或者可以耦连到套管的内表面或外表面。 The reinforcement structure may be implanted into the interior of the sleeve 210, or may be coupled to the inner or outer surface connected to the sleeve.

[0215] 在示例性实施方式中,外套管210被设计为沿着其整个长度都保持一致的直径(见图11)。 [0215] In an exemplary embodiment, the outer sleeve 210 is designed to have a diameter along its entire length consistent (see FIG. 11). 由于导管顶端部件222的外径的差异,外套管也可以为锥形。 Due to the difference of the outer diameter of the catheter tip member 222, the outer sleeve may be tapered. 外套管210的直径应该是能容纳假体主体120的,以及可选的假体主体120的延伸部分140或者多个部分(如果存在的话)。 The prosthesis body outer diameter of tube 210 should be able to receive the prosthetic body 120, and optionally a portion 120 extending portions 140 or more (if present). 外径向远端延伸直到手柄组件212。 Extends up to the outer diameter of the handle assembly 212 distally. 外套管外径的相对小的尺寸也考虑到了使血液循环更好地经过开伞导管200。 The relatively small size of the outer diameter of the outer sleeve is also conceivable to better blood circulation through the conduit 200 parachute.

[0216] 回到图14A,间隔装置206为外套管210提供了支持,并且通过占据外套管210内的空间,减少了进入开伞导管200中的空气量。 [0216] Back to Figure 14A, the spacer 206 provides support to the outer sleeve 210, and by occupying space within the outer sleeve 210, reducing the amount of air entering the conduit 200 parachute. 理想的是间隔装置206的近端在临近假体主体120的远端110处终止。 The spacer is preferably terminates adjacent to the proximal end 206 of the prosthesis at the distal end 120 of body 110. 在这种安排中,包含假体主体120的腔234从导管顶端部件222的远端242延伸到间隔装置206的近端。 In this arrangement, the prosthesis comprising a main body 234 of the chamber 120 extends to the distal end 242,222 of the proximal end 206 of the spacer member from the catheter tip. 如图14A所示,间隔装置206位于中轴216之上并且间隔装置206的远端连接到手柄组件212。 14A, the spacer 206 and the spacer 216 located above the central axis of the distal end of apparatus 206 is connected to the handle assembly 212. 通常,间隔装置206可以具有小于外套管210内径的外径。 Typically, the spacer 206 may have an outer diameter smaller than the outer diameter of the tube 210. 间隔装置206可以包含一个内腔或者一排多个内腔用于各种部件经过间隔装置206。 Spacer means 206 may comprise a plurality of lumen or a lumen for discharging various components of apparatus 206 through the spacer.

[0217] C.手柄组件 [0217] C. handle assembly

[0218] 手柄组件212为操作者提供了开伞导管200在体内的的纵向或轴向控制以及旋转控制并且为用于开伞假体主体120的启动器和控制装置提供了通道(access)。 Providing parachute conduit [0218] 212 for the operator to handle assembly 200 provides access (Access) in the longitudinal or axial control and rotation control of the body and the prosthesis body for unfolding and starting control device 120.

[0219] 参考图34至36,手柄组件212包含手柄体四0、套管收回装置四2,其连接到外套管210的远端、滑动旋钮四4,其也可以连接到外套管210的远端,和至少一个连接到近端释放装置和远端释放装置的远端的启动器或者旋钮。 [0219] with reference to FIGS. 34-36, the handle assembly 212 includes a handle body 40, four sleeve retraction device 2, which is connected to the distal end 210 of the outer sleeve, the slide knob four (4), which may also be connected to the distal outer tube 210 end, and at least one release means connected to the proximal and distal ends of the distal releasing means or a starter knob. 理想的是,手柄212包含用于每一个第一近端释放装置228、第二近端释放装置230和远端释放装置232的独立的旋钮。 Desirably, the handle 212 includes a first proximal end for each release means 228, second means 230 and the proximal end of the distal end of the release device 232 independent release knob.

[0220] 在示例性实施方式中,中轴216被抓取(capture)到手柄212内并且具有接收鲁尔接头(Iuer)四6以及连接到其远端的注入阀四7的导线,导线位于手柄212的远端(见图37和38)。 [0220] In an exemplary embodiment, the axis 216 is crawled (Capture) into the handle 212 and having a wire receiving luer (Iuer) 6, and four of its distal end connected to the injection valve 7 is four, the wire is located the distal end of the handle 212 (see FIGS. 37 and 38). 当外套管210被收回时,本特性防止了假体主体120的位置相对于手柄体212 的移动,并且可以使导管轴216受到灌注或者冲洗,如采用盐溶液。 When outer sleeve 210 is retracted, this feature prevents the body position of the prosthesis 120 is moved relative to the handle body 212, the catheter shaft 216 and may be flushed or perfused, such as using a salt solution.

[0221] 为了从导管顶端222收回外套管210并且暴露假体主体120的近端(见图37至40),使用了外套管收回装置四2。 [0221] In order to recover from the outer tip of the catheter 222 proximal end 210 is exposed and the prosthesis body 120 (see FIGS. 37 to 40) was used to recover the overtube apparatus 2 four. 外套管收回装置292可以包括多个不同的机构从而选择性地控制外套管210从导管顶端222的收回。 Overtube retrieval device 292 may comprise a plurality of different mechanisms to selectively control the outer sleeve 210 is withdrawn from the catheter tip 222. 在示例性实施方式中,外套管收回装置292 包含齿条式控制装置从而提供足够从导管顶端222收回外套管210的机械优势。 In an exemplary embodiment, the overtube 292 comprises a rack-type retrieval device control means to provide a mechanical advantage sufficient to recover the outer sleeve 210 from the catheter tip 222. 齿轮298 通过齿轮轴300传动,并且通过位于齿轮轴300的至少一端之上的起始旋钮302使其旋转, 在图41中最好的示出。 Gear drive shaft 300 via a gear 298, a knob and at least a starting gear located on one end of the shaft 300 to rotate 302, best shown in FIG. 41. 可以存在单个起始旋钮,或者如图39和40所示,临床医生可以利用两个共同作用的起始旋钮302,一个位于手柄212的第一侧304,一个位于手柄212的第二侧306。 There may be a single starting knob, or, as shown in FIG. 39 and 40, the clinician may start interacting with two knob 302, a first side 304 of the handle 212, a second side 212 of the handle 306. 附属的齿条308被套管滑动部件(slide) 310传动。 The rack 308 is attached a sliding sleeve member (slide) 310 transmission. 齿轮298控制齿条308沿着套管滑动部件310在图39所示的第一(延伸的套管)位置312和图40所示的第二(收回的套管)位置314之间运动。 A second control rack gear 298 (cannula retracted) position shown in the first (sleeve extending) position of the sliding sleeve member 310 shown in FIGS. 39 312 and 40 308 314 moving between.

[0222] 套管滑动部件310耦连到套管210并且通过装有弹簧的连接销316暂时连接到齿轮条308上。 [0222] the sliding sleeve member 310 is coupled to the sleeve 210 and the spring pin 316 is temporarily connected to the connector 308 with the gear rack. 连接销316通过弹簧或者其他方式缩回到手柄体290中的凹槽318中从而在手柄体四0中的预定位置脱离套管滑动部件310。 The connecting pin 316 is retracted into the recess 318 in the handle body 290 by a spring or other means to disengage the sliding sleeve member 310 at a predetermined position in the handle body 40. 当连接销316脱离时,套管滑动部件310 则自由地以向近端和远端的方向行进而不会重新连接齿条308。 When the connecting pin 316 is disengaged, the sleeve member 310 is free to slide in the direction of travel of the proximal and distal ends and a rack 308 does not reconnect. 理想的是齿条308保持在收回的位置314。 It is desirable to keep the rack 308 in the retracted position 314. 棘轮爪,如回弹棘轮爪320可以耦连到齿条308从而使得齿条向远端方向行进,但限制齿条308向近端行进。 Ratchet pawl, the ratchet pawl 320 such resilience may be coupled to the rack so that the rack 308 travels in the distal direction, but limiting the travel of the rack 308 proximally. 手柄体290可以具有棘齿322从而连接棘轮爪320。 The handle body 290 may have ratchet teeth 322 so that the connection pawl 320.

[0223] 一旦套管滑动部件310向远端行进并且齿条308已经脱落,套管滑动旋钮294则可以被继续用于套管210从假体主体120的收回。 [0223] Once the sliding sleeve member 310 and the rack 308 travels distally has fallen off, the slide knob sleeve 294 can continue to be used to recover the sleeve 210 from the body 120 of the prosthesis. 套管滑动部件310向远端移动直到外套管210脱离假体主体120(例如见图60)。 The sliding sleeve member 310 is moved distally until the outer sleeve 210 from the body 120 of the prosthesis (e.g., see FIG. 60). 没有耦连到假体主体120的近端和远端阻挡装置218、220的一个部分或者多个部分可以自由地自扩张,如图60所示。 Is not coupled to the proximal and distal ends of the prosthesis body 120 of the blocking portion of the device 218 or a plurality of portions may be freely self-expanding, shown in Figure 60. 然而,尽管收回了外套管210,连接到假体主体120的近端和远端阻挡装置218、220的部分仍然被约束而不能自扩张,也如图60所示。 However, although the recovery of the outer sleeve 210, is connected to the proximal and distal ends of the prosthesis body portion 120 of the blocking device 218, 220 is still restrained from self-expansion, it is also shown in Figure 60. 因此,在外套管210收回时,假体主体120的支架结构被保持约束在与中轴216相对的紧密的关系。 Thus, when the outer sleeve 210 retracted, the stent of the prosthesis body 120 is held in a constrained axis 216 opposite to the close relationship. 近端和远端阻挡装置218、220防止假体主体120在外套管210的收回过程中相对于中轴216移动,这可能减少在开伞过程中通过假体主体120的血流。 Proximal and distal ends 218, 220 to prevent the blocking device body 120 of the prosthesis 210 of the outer sleeve retraction with respect to the central axis 216 moves, which may reduce the blood flow through the prosthesis 120 in the body during the parachute. 此外,正如所描述的,假体主体120不是从导管被“推出去”的。 Further, as described, the prosthesis from the catheter body 120 is not "push-out". 因此,假体主体120 不需要纵向的硬度或者具有“突刺(spine),,的支架结构。 Thus, the hardness of the prosthesis body 120 need not have longitudinal or "spurs (spine) ,, stent structure.

[0224] 为了应用第一近端阻挡装置224,如前所述,第一近端滑动旋钮322 (见图34)朝向远端移动直到第一近端释放装置228的近端从第一近端阻挡装置2M收回。 [0224] In order to apply a first proximal end of the blocking device 224, as described above, the first proximal end of the slide knob 322 (see FIG. 34) moves distally from a first proximal end of the proximal end of the device until the proximal end 228 of the first release 2M blocking means retracted. 在示出的实施方式中,第一近端释放线250位于缝合环252的环中,如图17和18A所示。 In the embodiment illustrated, the first release wire 250 is located proximal sewing ring 252 of the ring, as shown in Figures 17 and 18A. 当第一近端释放线250从缝合环252收回,缝合环252释放了其保持性特性,但是仍可保持耦连至假体材料112。 When the first release wire 250 is retracted from the proximal end of the suture ring 252, the sewing ring 252 to release their retention properties, but may remain coupled to the prosthetic material 112. 这样假体主体120的近端108就可以自由地自扩张到其第一阶段的开伞构造,如图1 9所示。 So that the proximal end 120 of prosthesis body 108 is free to self-expand into the configuration of the first phase of unfolding, as shown in Fig.

[0225] 对第二近端阻挡装置2¾和远端阻挡装置220重复同样的步骤。 [0225] and a distal end barrier means 2¾ proximal end of the second blocking means 220 to repeat the same steps. 为了使用第二近端阻挡装置226,如前所述,第二近端滑动旋钮324(见图3¾朝向远端移动直到第二近端释放装置230的近端从第二近端阻挡装置2¾收回。因此如图沈所示,假体主体120的近端108最终从导管轴216释放。为了使用远端阻挡装置220,远端滑动旋钮326(见图35) 向远端移动直到远端释放装置232的近端从远端阻挡装置220收回。这样如图30所示,假体主体120的远端110可以自由地自扩张到其最终的开伞结构。这些步骤中的每一个将会在第V节中被更详细地描述。应该理解,如所示,滑动钮或者旋钮都可以被放置于手柄的第一侧304上,或者全部被放置于手柄的第二侧306,或者以一个或多个放置在第一侧304上和一个或多个放置在第二侧306上。还应该理解旋钮322、3对、3沈可以包含不是手柄组件212的一部分,即在外套管210上的独立的部件。 In order to use the second proximal stopper means 226, as described above, the second proximal end of the slide knob 324 (see FIG 3¾ moves distally until the proximal end of the proximal end of the second device 230 is released from the proximal end of the second blocking means retracted 2¾ Thus Shen As shown, the proximal end 120 of the body 108 of the prosthesis ultimately released from the catheter shaft 216. in order to use the distal end of the blocking device 220, the distal end of the slide knob 326 (see FIG. 35) move distally until the distal end of the release device the proximal end of the blocking device 232 from the distal end 220 retracted. Thus, the distal end 110 120 can be freely self expand to its final unfolding of the prosthesis body shown in FIG. 30. each of these steps will be first section V is described in greater detail. It should be appreciated that, as shown, slide button or knob may be disposed on the first side 304 of the handle, the handle is placed in all or a second side 306, or in one or more disposed on a first side 304 and one or more 306 disposed on the second side. It should also be appreciated that the knob 322,3 pairs sink may comprise 3 not part of the handle assembly 212, i.e., on the outer sleeve 210 separate component.

[0226] 理想的是近端和远端阻挡装置218、220与位于手柄外壳四0中的释放系统3¾协作(见图37和38)。 [0226] desirable to proximal and distal ends 218,220 3¾ blocking means cooperating with the release system is located in the handle housing 40 (see FIGS. 37 and 38). 每个滑动旋钮322、324、3沈分别耦连至分别位于释放系统3¾之中或之上的轨道336、338、340中的释放滑动部件(slide) 330、332、334 (见图41到43)。 Each slide knob 322,324,3 sink are coupled to each sliding member is in the released (Slide) tracks 336,338,340 in or on the delivery system of 3¾ 330,332,334 (see FIG. 41-43 ). 每个释放滑动部件耦连到释放装置的远端,如释放线。 Each release slide member coupled to the distal end of the release device, such as a release line. 应该理解释放系统3¾还可以包括互锁(interlock)系统,如用于控制滑动部件移动次序的机械连接。 It should be appreciated that release system may further include an interlock 3¾ (Interlock) systems, such as the member for controlling the sliding movement of the order of a mechanical connection. 另外,互锁系统还可以包括与套管撤回滑动部件310的机械连接。 Further, the interlock system may also include a withdrawal sliding sleeve member 310 is mechanically connected. 该特性会防止释放滑动部件的启动,直到外套管被收回到预定的位置。 This feature prevents activation of the release of the slide member until the outer sleeve is retracted to a predetermined position. 还应该理解滑动旋钮可以包括一个给临床医生显示出开伞的合适次序的标志。 It should also be appreciated that the slide knob may include a mark is displayed to the clinician parachute suitable order.

[0227] 如所描述的,当套管210被撤回时,假体主体120不是立即从近端释放到远端。 [0227] As described, when the sleeve 210 is withdrawn, the prosthesis body 120 is not released immediately from distal end to proximal end. 一个或多个近端和远端支架130、134在外套管210收回后的第二操作中被释放。 One or more of the stent proximal and distal ends 130, 134 of the outer sleeve 210 to recover after the second operation is released. 因此,假体延伸物140的放置可以包含开伞步骤中的下一步。 Thus, the prosthesis is placed extending parachute 140 may comprise the next step.

[0228] 1.内腔延伸开伞导管 [0228] 1 catheter lumen extending parachute

[0229] 在假体120的主体已经被部分或者完全开伞后,接下来植入内腔延伸物140或者多个内腔延伸物。 [0229] After the main body prosthesis 120 has been partially or completely unfolding, the next implant lumen extending lumen extending 140 or more thereof. 在图44中示出了延伸开伞导管350。 In FIG 44 shows the catheter 350 extending parachute. 应该理解延伸开伞导管350可以整合开伞导管200的描述中所公开的所有特征。 It should be appreciated that the catheter 350 extends parachute ripcord can integrate all of the features described in the conduit 200 as disclosed. 延伸导管用于将内腔延伸物140递送并在靶位开伞。 Extension catheter 140 for delivery lumen extending at the target site and parachute.

[0230] 在示出的实施方式中,延伸导管350携带放射状紧缩构造的内腔延伸物140到靶位。 [0230] In the illustrated embodiment, the extension catheter 350 carries radially compact configuration to the target lumen 140 extends. 在靶位,延伸导管350释放放射状紧缩的内腔延伸物140,其放射状扩张并且耦连到假体主体120的内腔,这个将会在第V节中被进一步描述。 At the target site, the catheter 350 extending release lumen extending radially tight 140, which is radially expandable and coupled to the body lumen 120 of the prosthesis, this will be further described in Section V.

[0231] 如图44至45B所示,延伸导管350包含内部组件358、外套管360和手柄组件362。 [0231] FIG. 44 to 45B, the extension catheter 350 includes an internal assembly 358, the outer sleeve 360 ​​and the handle assembly 362. 这些组件将会在这里进行单独地更详细地描述。 These components will be described in more detail herein individually.

[0232] a.内部组件 [0232] a. Internal components

[0233] 在示例性实施方式中(见图45A),内部组件358包含中轴364,其用作内腔延伸的支座,近端阻挡装置366和延伸导管顶端部件368。 [0233] In the exemplary embodiment (see FIG. 45A), the internal assembly 358 comprises bottom bracket 364, which serves as a lumen extending abutment, a proximal end 366 and a barrier means extending member 368 of the catheter tip. 理想的是在开伞之前以及在耦连到假体主体120之前,近端阻挡装置366使得内腔延伸物的至少一部分保持在放射状压缩或者部分放射状扩张的状态。 Preferably before 120 before the parachute and coupled to the body of the prosthesis, the proximal end 366 such that the blocking device holding portion in the radially compressed or radially expanded state at least a portion thereof extending in the lumen. 理想的是近端阻挡装置366还包括共同作用的释放装置或机构370 用于在启动之前维持近端阻挡装置366与内腔延伸物140处于理想的关系中。 The blocking means is preferably a proximal end 366 further includes a release mechanism or means 370 cooperating blocking means for maintaining the proximal end 366 and a lumen 140 extending in the ideal relationship before starting.

[0234] 在可选实施方式中(见图45B),内部组件还可以包括远端阻挡装置367。 [0234] In an alternative embodiment (see FIG. 45B), the internal assembly further may include a distal barrier means 367. 理想的是,在开伞之前以及在耦连到假体主体120之前,远端阻挡装置367保持内腔延伸物140的至少远端部分处于放射状压缩或者部分放射状扩张状态。 Desirably, before the body of the prosthesis 120 prior to the parachute, and coupled to the distal end of the blocking means 367 holding at least the distal end portion 140 of the lumen extending in the radially compressed or radially expanded state portion. 理想的是远端阻挡装置367还可以包括共同起作用的释放装置或机构371用于在启动之前维持远端阻挡装置367与内腔延伸物140处于理想的关系中。 The distal end of the barrier means preferably is 367 or may further include a release mechanism means 371 co-acting blocking means for maintaining the distal end of the extension 140 with the lumen 367 in the ideal relationship before starting.

[0235] b.中轴 [0235] b. Axis

[0236] 在图45A和45B所示的实施方式中,中轴364和近端以及远端阻挡装置366、367 位于外套管360的范围之内。 [0236] In the embodiment shown in FIGS. 45A and 45B, the axis 364 and a proximal end and a distal end located within the blocking means 366, 367, 360 of the outer sleeve. 在此方面,外套管360用作轴364之上的内腔延伸物140的封闭物或者套管(见图46A和B)。 In this regard, the lumen of the outer sleeve over 364,360 as shaft 140 extending closure or cannula (see FIG. 46A and B). 在这种安排中,导管顶端部件368连接到中轴364的近端,并且外套管360的近端在临近导管顶端部件368处终止。 In this arrangement, the catheter tip member 368 connected to the proximal axis 364 and the proximal end 360 of the outer sleeve member 368 at the tip of the catheter near the termination. 这样,延伸导管顶端部件368 向外延伸越过外套管360。 Thus, the catheter tip extension member 368 extends outwardly beyond the outer sleeve 360. 中轴364、近端释放装置366、远端释放装置367 (图45B所示) 和外套管360在导管手柄组件362的近端处耦连于手柄组件362 (见图44)。 Axis 364, a proximal release means 366, the distal end of the release device 367 (FIG. 45B) and the outer sleeve 360 ​​at the proximal end of the catheter handle assembly 362 is coupled to the handle assembly 362 (see FIG. 44). 如图46A和46B所示,内腔延伸物140包含在由中轴364与在延伸导管350近端部分中的外套管360之间所限定的腔372中。 Shown in FIGS. 46A and 46B, 140 comprises a lumen extending between the outer sleeve 364 and the central axis of proximal portion 350 extending in the conduit 360 defining a cavity 372.

[0237] 中轴364从手柄组件362延伸到导管顶端部件368。 [0237] axis 364 extending from the handle assembly 362 to the tip 368 of the catheter member. 中轴364可以由例如不锈钢或者包括其他金属或者聚合物的其它合适的医用材料制成。 Axis 364 may be made of, for example, stainless steel or other suitable medical materials including other metals or polymers. 中轴364包含至少一个内腔, 并且可以包含不止一个内腔。 Comprising at least one lumen axis 364, and may comprise more than one lumen.

[0238] 一个内腔延伸可以被描述为中心内腔374(见图47A和47B),具有的内径在0. 010 至0. 120英寸之间,理想的是在0. 020至0. 060英寸之间,最理想的是在0. 030至0. 050英寸之间。 [0238] a lumen may be described as extending the central lumen 374 (see FIGS. 47A and 47B), having an inner diameter between .010 to .120 inches, preferably at 0.020 to 0.060 inches between, the ideal is between .030 to 0.050 inches. 如所描述的,中心内腔374可以使得例如0. 038”的导线,也就是第一导向线30 或第二导向线40插入。导管顶端部件368,具有与开伞导管200的导管顶端222所描述的相同的特征,理想的是也具有至少一个被设置为与中轴364里的至少一个内腔并列的内腔376(见图45A)。这个内腔376可以使导线穿过中轴364并且穿过延伸导管顶端部件368 而插入。通常,这个内腔376具有在0. 010至0. 120英寸之间,理想的是在0. 020至0. 060 英寸之间,最理想的是在0. 030到0. 050英寸之间的内径。 As described, the central lumen such that the wire 374 can, for example, 0.038 ", that is, a first guide wire 30 or the second guide wire 40 inserted into the catheter tip member 368, the conduit having a top end 222 of the catheter 200 parachute the same features described, desirable to have at least one axis is provided with the at least one lumen 364 in parallel lumen 376 (see FIG. 45A). this can make the wire through lumen 376 and central axis 364 member 368 extends through the catheter tip is inserted. typically this lumen 376 between having from .010 to 0.120 inches, preferably between 0.020 to 0.060 inches, and most preferably 0 the inner diameter of between 030 to 0.050 inches.

[0239] c.近端阻挡装置 [0239] c. A proximal end barrier means

[0240] 近端阻挡装置366和近端释放装置370可以通过与在前面示出和描述的开伞导管200中包含的阻挡装置224、2沈和释放装置2观、230相同或者相似的方式进行工作。 [0240] proximal end 366 and a proximal end barrier means 370 may release the blocking means 2 by the concept illustrated and described in the foregoing parachute contained in conduit 200 224,2 sink and release means, the same or similar manner as 230 jobs. 如图46A和46B所示,在示例性实施方式中,近端阻挡装置366包含至少一个缝合物,或者多个缝合物378和/或相当的结构,其耦连至内腔延伸假体材料112,或者耦连至内腔延伸物140 上的一个或者多个支架150。 And FIG. 46A, in the exemplary embodiment, the proximal end of the stopper 46B comprises at least one means 366 and / or equivalent structures suture, or a plurality of suture 378, which is coupled to a lumen 112 extending prosthetic material or coupled to a lumen extensions 140 on the bracket 150 or more. 如图46A和48A所示,当释放线380在其最近端的位置时,缝合物378依次环绕近端释放装置370,如释放线380。 As shown in FIG. 46A and 48A, when the release line 380 at its most proximal position, the proximal end of suture 378 in turn surrounded by release means 370, such as the release line 380. 位于释放线内腔381中的线380远端的收回(见图45A和47A)使得线380从缝合环378上收回,并且使得内腔延伸物140的近端142放射状扩张,如图70和71中所见。 Release line 381 is located in the lumen of the distal end of the recovery line 380 (see FIG. 47A and 45A) such that the line 380 is withdrawn from the suture ring 378, and the proximal end thereof such that a lumen 142 extending radially expanded 140, 70 and 71 in FIG. seen. 在可选实施方式中,缝合物378可以包含不止一个缝合物,即两个或者更多个缝合物环。 In an alternative embodiment, the suture 378 may comprise more than one suture, i.e., two or more suture rings. 图48示出了两个缝合环378环绕释放线380的路径。 48 shows a ring 378 surrounding the two suture release line path 380.

[0241] 如对假体主体120所作的描述,可以在内腔延伸物140上提供带环或者类似物从而引导和支持缝合环沿着缝合环的路径。 [0241] The description made prosthesis body 120 may extend lumen 140 provided with a ring or the like to guide and support paths along the sewing ring of the sewing ring. 带环以所需的圆周间隔而被隔开,例如每90度。 With a desired ring is circumferentially spaced apart, for example, every 90 degrees.

[0242] 如图45A中所示,近端释放装置370包含位于中轴364之上的近端释放套筒397, 和释放线380。 [0242] As shown in FIG. 45A, the proximal end of release means 370 comprises a proximal end positioned above the central axis 364 of the release sleeve 397, and release line 380. 近端释放套筒397可以包括套筒397近端中的小孔或者内腔398,其与中轴364内的近端释放线内腔381是流通的。 The proximal end of the release sleeve 397 may include a proximal end 397 of the sleeve aperture or lumen 398, which is the central axis of the inner lumen 364 of the proximal end of the release line 381 is flowing. 理想的是每个内腔381、398具有适合释放线380 从手柄362延伸越过释放套筒397的足够大的直径。 381,398 each preferably having a lumen for release wires 380 extending from the handle 362 over the release of a sufficiently large diameter of the sleeve 397. 应该理解释放线380也可以在中轴364外部延伸。 It should be appreciated that release line 380 may extend outside the central axis 364.

[0243] d.远端阻挡装置 [0243] d. The distal end of the blocking device

[0244] 在可选实施方式中,远端阻挡装置367和远端释放装置371可以通过与前面已示出和描述的开伞导管200中所包含的阻挡装置220和释放装置232相同或者相似的方式进行工作。 [0244] In an alternative embodiment, the distal end barrier and the distal end 367 may be the same device release means 220 and 371 through the blocking means and release means parachute catheter 200 described previously contained 232 have been shown or similar way to work. 如图46B和48B中所示,远端阻挡装置367包含至少一个缝合物,或者多个缝合物379和/或相当的结构,其耦连至内腔延伸假体材料112,或者耦连至内腔延伸物140上的一个或者多个支架150。 As shown in FIG. 46B and 48B, the distal end of the blocking device 367 comprises at least one suture, the suture 379 or more and / or equivalent structures, which is coupled to the prosthetic material extending lumen 112, or coupled to the a plurality of extensions or cavity on the bracket 150 140. 如图46B和48B所示,当释放线383在其最近端的位置时,缝合物379依次环绕远端释放装置371,如释放线383。 FIG. 46B and 48B, when the release wire 383 at its most proximal position, the distal end of suture 379 around the release means 371 successively, such as the release line 383. 位于释放线内腔385中的线383的远端收回(见图45B、47B)使得线383从缝合环379上收回,并且使得内腔延伸物140的远端144 放射状扩张。 Release line 385 at the distal end of the wire lumen 383 retracted (see FIG. 45B, 47B) such that the wire 383 is retracted from the suture ring 379, and so that the distal end 140 of the lumen 144 extending radially expanded. 如对近端阻挡装置366的描述,缝合物379也可以包含不止一个缝合物,即两个或者多个缝合环。 As described on the proximal end of the stopper means 366, suture 379 may also comprise more than one suture, i.e., two or more suture rings. 图48示出了两个缝合环378环绕释放线380的路径。 48 shows a ring 378 surrounding the two suture release line path 380. 该路径也可以用于缝合环379环绕释放线383。 The path can also be used for the sewing ring 379 surrounds a release wire 383.

[0245] 如图45B中所示,远端释放装置371包含位于中轴364之上的远端释放套筒399, 和释放线383。 [0245] As shown in FIG 45B, the distal end of the release device 371 comprises a distal end positioned above the central axis 364 of the release sleeve 399, and release line 383. 远端释放套筒399可以包括在套筒399的近端上的小孔或者内腔395,其与中轴364中的释放线内腔385是流通的。 The distal end of the release sleeve 399 may include a lumen or aperture 395 on the proximal end of the sleeve 399, which is the central axis 364 of the release line 385 is flowing through the lumen. 理想的是每个内腔385、395具有适合释放线383 从手柄组件362延伸越过释放套筒399的足够大的内径。 385,395 each preferably having a lumen for release wires 383 extending across the inner diameter sufficiently large release sleeve 399 from the handle assembly 362. 应该了解释放线383也可以在轴364外部延伸。 Release should be understood in line 383 may extend outside of the shaft 364.

[0246] B.外套管 [0246] B. overtube

[0247] 外套管360可以与所述开伞导管200中包含的外套管210相同或者相似的方式进行工作。 [0247] overtube 360 ​​may operate the same or similar manner as the tube 210 and the outer conduit 200 parachute contained. 外套管360还用于阻止内腔延伸物140上的支架146和150扩张并且可以用于假体主体120的内腔中的内腔延伸物140控制性地开伞。 Overtube lumen 360 to prevent further extension 146 on the bracket 140 and the lumen 150 may be used to expand and body prosthesis 120 in a lumen extending 140 controllably parachute. 在示例性安排中,外套管360耦连到手柄组件362上的启动器或者旋钮382,这将会在后面更详细地描述。 In an exemplary arrangement, the outer sleeve 360 ​​is coupled to the handle assembly 362 or the starter knob 382, ​​which will be described later in more detail.

[0248] 如图46A和46B所示,外套管360向近端延伸越过间隔装置384和内腔延伸物140 并且在临近导管顶端部件368的远端终止。 [0248] and shown in FIG. 46A, the outer sleeve 46B 360 extends proximally beyond the spacer means 384 and 140 and a lumen extending in the distal tip of the catheter 368 near the termination member. 通常,外套管360可以由聚合物管或者所属领域中已知的相似材料制成。 Typically, the outer sleeve 360 ​​may be made from a polymer tube known in the art or similar material. 在一个实施方式中,套管360可以没有结构的加固。 In one embodiment, the cannula 360 may no structural reinforcement. 在可选实施方式中(图46C中所示),套管360可以包括结构的加固,例如,但不限制于,纵向沿着套管的长度的线或者杆361,和/或螺旋围绕套管长度的线或者杆363。 In an alternative embodiment (shown in FIG. 46C), the sleeve 360 ​​may include reinforcing structures, such as, but not limited to, along the longitudinal length of the sleeve or lever 361, and / or spiral around the sleeve the length of the wire or rod 363. 结构的加固也可以为,例如,盘绕或者编线的形式。 The reinforcement structure may be, for example, in the form of a coiled or braided wire of. 结构加固的可塑性可以改变,从而根据所选择的应用来影响外套管360的弹性。 Plasticity structural reinforcement may be varied to affect the elastic overtube 360 ​​according to the selected application. 另外,结构的加固可以沿着套管的整个长度延伸,或者可以只沿着套管长度的一部分或者几部分延伸。 Further, the reinforcing structure may extend along the entire length of the sleeve, or may extend along only a part or parts of the length of the sleeve. 结构加固可以植入套管360内,或者可以耦连到外套管360的内表面或外表面。 Structural reinforcement may be implanted within the sleeve 360, or may be coupled to the inner surface or the outer surface of the outer tube 360.

[0249] 如果需要,如图44B所示,可以具有从手柄组件362的近端延伸的固定套管365。 [0249] If desired, as shown in FIG 44B, it may have a fixed sleeve 365 extending from the proximal end 362 of the handle assembly. 套管360在固定套管365的内部滑动。 Sleeve 360 ​​slides inside a fixed sleeve 365. 固定套管365与止血阀在穿刺位点提供了密封分界面。 Fixing sleeve 365 provides a seal with the hemostatic valve at the puncture site of interface. 固定套管365可以由合适的医疗级塑料,如作为非限定性例子的氟化乙丙烯聚合物(FEP)。 Fixing sleeve 365 may be formed of a suitable medical grade plastic, such as fluorinated ethylene propylene polymers by way of non-limiting example (FEP). 固定外套管365提供了裂断强度和光滑性以减少套管360的滑动刺激中的摩擦力。 Fixing the outer sleeve 365 provides column strength and smoothness to reduce the sliding sleeve 360. stimulate friction. 基于同一个目的,假体开伞导管200也可以具有外套管365。 Based on the same object, the prosthetic conduit 200 may have a parachute overtube 365.

[0250] C.手柄组件 [0250] C. handle assembly

[0251] 手柄组件362可以与所述开伞导管200中所包含的手柄组件212相同或者相似的方式来工作。 [0251] The handle assembly 362 may be associated with the catheter assembly of the parachute handle 200 contains the same or similar manner as 212 to operate. 手柄组件362为操作者提供了纵向或轴向控制以及旋转控制体内延伸开伞导管350,并且提供用于开伞内腔延伸物140的启动器或者控制装置的通路。 Handle assembly 362 provides the operator with a longitudinal or axially extending body control and rotation control parachute conduit 350, and provides a path for unfolding lumen extending initiator composition 140 or the control device.

[0252] 参考图49和50,手柄组件362包括手柄体386,套管收回装置382,其连接到外套管360的远端,和至少一个连接到近端释放装置370的远端的旋钮或者钮392。 [0252] with reference to FIGS. 49 and 50, handle assembly 362 includes a handle body 386, sleeve retraction device 382, ​​which is connected to the distal end of the outer sleeve 360, and at least one proximal end connected to the distal end 370 of the release knob or button 392. 应该了解手柄组件362还可以包括至少一个连接到可选的远端释放装置371的旋钮或者钮393(见图49B),并且旋钮或钮以如下所述近端释放装置370相同或者相似的方式进行工作。 It should be understood handle assembly 362 may further comprise at least one embodiment the distal end 371 connected to the optional device releases a knob or button 393 (see FIG. 49B), and a knob or button 370 to release the same or similar means to the proximal end is as follows jobs.

[0253] 在示例性实施方式中,中轴364被捕获在手柄362中并且具有接收鲁尔接头388 以及连接到其远端的注入阀390的导线,导线位于手柄362的远端(见图50和51)。 [0253] In an exemplary embodiment, the axis 364 is captured in the handle 362 and having a luer receiver 388 and its distal end connected to the injection valve 390 of the wire, the wire located at the distal end of the handle 362 (see FIG. 50 and 51). . 这种特性防止当外套管360被收回时内腔延伸140的位置相对于手柄体362发生移动,并且可以使导管轴364进行灌注或者冲洗,如用盐溶液。 This feature prevents the extended position when the inner chamber 140 when the outer sleeve 360 ​​is retracted relative to the handle body 362 moves, the catheter shaft 364 and may be flushed or perfused, such as a salt solution.

[0254] 为了从导管顶端368收回外套管360并且暴露内腔延伸物140,可以使用套管收回装置,如套管收回旋钮382。 [0254] In order to recover the outer sleeve 368 of the catheter 360 from the tip 140 and a lumen extending exposed, the cannula retraction device may be used, such as knob 382 to recover the sleeve. 套管收回装置382可以包括多个不同的机构以选择性地控制套管360从导管顶端368收回。 Cannula retrieval device 382 may include a plurality of different mechanisms to selectively control sleeve 360 ​​is withdrawn from the catheter tip 368. 在示例性实施方式中,套管收回装置包括可被临床医师利用的两个共同作用的收回旋钮382,在手柄362的每一侧设置一个。 In an exemplary embodiment, the sleeve comprises two interacting retrieval device may be utilized to recover the clinician knob 382 disposed one on each side of the handle 362.

[0255] 套管收回旋钮382用于从内腔延伸物140收回套管360。 [0255] knob 382 is used to recover the sleeve lumen 140 extending from the cannula 360 withdrawn. 套管收回旋钮382向远端移动直到外套管360脱离内腔延伸物140 (见图70)。 To recover the sleeve 382 moves distally until the knob 360 extending from lumen 140 (see FIG. 70) of the outer sleeve. 如图70所示,未连接到近端阻挡装置366的内腔延伸物140的一个部分或者多个部分可以自由地自扩张。 70, a lumen device is not connected to the proximal end 366 thereof a portion of the barrier extension 140 or more portions of self-expanding freely. 但是尽管撤回了外套管360,连接到近端阻挡装置366的内腔延伸物140的部分仍然被约束不能自扩张。 However, despite the withdrawal of the outer sleeve 360, connected to the proximal portion of the device lumen 366 extending barrier 140 is still restrained from self-expansion. 当外套管360被收回时,内腔延伸物140的支架结构被保持约束在与中轴364相对的紧密的关系中。 When outer sleeve 360 ​​is retracted, the stent lumen extending structure 140 is held in a constrained opposite the axis 364 in a close relationship. 近端阻挡装置366防止在外套管360的收回过程中内腔延伸物140相对于中轴364 移动,其可能在开伞过程中将通过内腔延伸物140的血流减到最小。 Blocking means to prevent the proximal end 366 of the outer sleeve 360 ​​of the retraction lumen extending axis 140 relative to the movement 364, which may extend to minimize the blood flow through the lumen 140 in the unfolding process. 另外,如所述,内腔延伸物140不是被“推出”延伸导管350。 Further, as described, the lumen 140 extending not "push" the catheter 350 extends. 因此,内腔延伸物140不需要具有纵向硬度或者具有“突刺(spine)”的支架结构。 Thus, 140 need not have a lumen extending longitudinal stiffness or a "spurs (Spine)" stent structure.

[0256] 为了应用近端阻挡装置366,如前所述,近端释放滑动旋钮392 (见图49A和50)向远端移动直到近端释放装置370的近端从近端阻挡装置366收回。 [0256] In order to apply a proximal blocking means 366, as described above, the proximal end of the slide knob 392 is released (see FIG. 49A and 50) move distally until the proximal end 370 of the proximal end of the blocking device is released from the proximal end 366 retracted. 在示例性实施方式中,近端释放线380位于缝合环378的环中,如图46A和48A中所示。 In an exemplary embodiment, the proximal end of release wire 380 located around the sewing ring 378, as shown in FIG. 46A and 48A. 当近端释放线380从缝合环378收回,缝合环378解除了它的保持力特性,但是仍可以保持耦连到假体材料112。 When the proximal end of release wire 380 retracted from the sewing ring 378, the sewing ring 378 to lift its retention characteristics, but still may remain coupled to the prosthetic material 112. 这样,如图70和71所示,内腔延伸物140的近端142自由地自扩张到其开伞构造并且将其自身耦连到假体主体120的内腔中。 Thus, as shown in FIG. 70 and 71, the proximal end 140 of the lumen extending 142 from expanding to its free configuration and unfolding itself coupled to the lumen of the prosthesis body 120. 经过新的延伸物140的液体的自然流动提供了足够的力量以引起内腔延伸物140的限制性机构与假体主体120的共同作用的限制性机构接合。 Natural flow of the liquid through the new extension 140 provides sufficient force to cause the limiting means limiting means extending lumen 140 of the prosthesis body 120 engages interaction. 内腔延伸支架和/或内腔延伸支架150向外延伸的顶点147接合假体主体支架134的匹配的向外延伸的顶点136(见图10B)。 Matching lumen extending support and / or lumen extending bracket 150 outwardly extending apex 147 engaging the bracket body 134 of the prosthesis 136 extends outwardly of the apex (see FIG. 10B). 这些步骤的每一步将会在第V节中更详细地描述。 Each of these steps will be described in more detail in Section V to. 应该了解滑动钮或者旋钮都可以位于手柄的一侧,或者都可以在手柄的对侧,或者可位于两侧, 如图所示。 It should be understood slide button or knob may be located on one side of the handle, or may be on the opposite side of the handle, or may be located on both sides, as shown in FIG. 还应该了解旋钮382和392可以包含不是手柄组件362的部分,即在外套管360 上的独立部件。 It should also be understood knobs 382 and 392 may not contain a portion of the handle assembly 362, i.e., independent of the outer sleeve member 360.

[0257] 理想的是,近端阻挡装置366与位于手柄外壳386中的释放系统394合作。 [0257] Desirably, the proximal end stopper 366 394 cooperate with the housing delivery system 386 located in the handle of the device. 近端释放滑动旋钮392耦连到位于释放系统394之中或者之上的轨道398中的释放滑动部件396(见图51)。 Release slide rail member proximal end 398 to release the slide knob 392 is coupled into the delivery system 394 is located in or on the 396 (see FIG. 51). 释放滑动部件396耦连到释放装置370的远端,如释放线380。 Release slide member 396 is coupled to the distal end 370 of the release means, such as the release line 380. 应该了解释放系统394也可以包括互锁系统,如用于控制滑动移动顺序的机械连接。 Release should be appreciated that the system 394 may also include an interlock system, such as the sliding movement sequence for controlling the mechanical connection. 另外,互锁系统还可以包括与套管收回滑动382的机械连接。 Further, the interlock system may further comprise a mechanical connection with the sliding sleeve 382 retracted. 这个特性防止了在外套管被收回到预定的位置之前释放滑动部件的启动。 This feature prevents the activation of the release of the slide member before the outer sleeve is retracted to a predetermined position. 还应该了解滑动旋钮可以包括给临床医生显示出开伞的合适顺序的标记。 It should also be understood to include a slide knob clinician can exhibit appropriate marker sequence of the parachute.

[0258] 如所述的,当套管360被收回时,内腔延伸物140不是立刻从近端到远端释放。 [0258] As described, when the sleeve 360 ​​is retracted, the lumen extension 140 is not immediately released from the proximal end to the distal end. 一个或多个内腔延伸支架146和150可以在外套管360收回之后的第二操作中被释放。 One or more lumens extending brackets 146 and 150 of the second outer sleeve 360 ​​may operate to recover after being released. 因此, 假体延伸物140的放置可以包含开伞过程中的最后一个步骤。 Thus, the extension prosthesis 140 is placed may comprise a final step in the process of unfolding.

[0259] D.固定器装置和固定器 [0259] D. holder and retainer means

[0260] 如前所述,可以通过固定器装置400弓丨入一个或者多个固定器402 (见图5¾从而将假体100固定在合适的位置。通常,固定器402会被引入到假体主体120的近端;但是, 应该了解固定器可以被引入到假体100中的任何部分,包括内腔延伸物140,从而将其固定在合适的位置。另外,固定器402还可以用于将假体材料112与中空身体器官或者血管排列成行。固定器还可以用于密封和/或修复液体的泄露或者渗流(例如,围绕假体100的近端支架和/或远端支架)。在操作中,一个或者多个固定器402可以在不同的时间或者同一时间引入到假体100中。 [0260] As described above, can be fixed into the one or more bow Shu 402 by fixing means 400 (see FIG 5¾ whereby the prosthesis 100 is fixed in place. Typically, the holder 402 may be introduced into the prosthesis proximal body 120; however, be appreciated that the holder may be incorporated into any portion of the prosthesis 100, including a lumen 140 that extends, so as to be fixed in position further, the fixture 402 also may be used. prosthetic material 112 and the hollow body organ or vessel arranged in a line. the fixture may also be used to seal and / or repair the leak or seepage of the liquid (e.g., around the proximal end of stent 100 and / or distal stent prosthesis). at operation , one or more holders 402 may be incorporated into the prosthesis 100 at the same time or different times.

[0261] 如图53和M中所示,理想的是固定器器具400包含包括控制组件406和显示组件408的手柄组件404。 [0261] shown in Figure 53 and M, it is desirable that the tool holder 400 includes a control assembly 406 comprises a display assembly 408 and the handle assembly 404. 固定器递送轴409(在其近端410具有固定器驱动装置411)耦连到手柄组件404的近端用于固定器402的递送。 Fixture delivery shaft 409 (at its proximal end 410 having a fixed driving means 411) coupled to the proximal end 404 of the handle assembly 402 for delivering the fixture. 耦连到手柄组件远端的可以是灌注口或者 A handle assembly coupled to a distal perfusion port, or may be

27注入阀422。 27 422 injection valve.

[0262] 手柄组件404给临床医生提供了固定性控制特性。 [0262] The handle assembly 404 is provided to a clinician fixability control characteristics. 位于手柄组件404中的是控制组件406。 Located in the handle assembly 404 is a control component 406. 控制组件提供了运动控制,如向前或者后退的驱动特征,用于将固定器402以回转或者其它方式移动到固定位置或从固定位置移开。 Providing a control assembly motion control, such as forward or backward driving characteristics for the fixture 402 to swivel or otherwise move to a fixed position and away from the fixed position. 理想的是控制组件包括向前控制钮412和后退控制钮414。 Desirably includes a control assembly 412 controls the forward and reverse control knob 414. 向前和后退控制钮412、414为临床医生提供了符合人机工程学的并且单指控制的固定器装置400。 Previous provides the clinician and ergonomic control of a single finger and fixing device 400 controls 412, 414 is retracted.

[0263] 理想的是手柄组件包括显示组件408从而给临床医生提供控制信息。 [0263] desirable to handle assembly includes a display control component 408 to provide information to the clinician. 显示组件可以包括显示灯,也就是发光二极管(LED),和/或产生可听信号(音调)来提供固定器402 向前或者后退移动的视觉和/或听觉显示的能力,例如,通过各种音调和/或向前灯416 和后退灯418。 The display assembly may include a display lamp, which is a light emitting diode (the LED), and / or produce an audible signal (tone) to provide the holder 402 forward or backward movement of the visual and / or audible display capabilities, e.g., by various tone and / or forward and backward light lamp 416 418. 另外,显示组件可以包括状态音调(status tone)和/或状态灯(status light)402从而反馈给临床医生各种信息。 Further, the display assembly may include a tone status (status tone) and / or a status light (status light) 402 so that various information feedback to the clinician. 音调可以使用,例如,各种音调或者脉冲,状态灯420可以使用,例如,各种闪烁信号和发光次数,从而为临床医生提供不同的指示,如,例如故障指示、位置指示和定时指示。 Tones can be used, for example, various tones or pulses, status light 420 may be used, for example, various light-emitting and blinking signal frequency to provide an indication of different clinicians, such as, for example, a fault indication, indicating the location and the timing indication.

[0264] 固定器装置400和固定器402的进一步详细描述可以在2002年11月四日提交的名力《Intraluminal Prosthesis Attachment Systems and Methods》禾I」Ef3i青第10/307,226 号和2004 年2 月四号提交的名为《Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ》的美国专利申请第10/786,465号中找到,这两个专利都结合于此作为参考。 [0264] fixing device 400 and the name of the holder described in further detail force 402 can be submitted on 4 November 2002 "Intraluminal Prosthesis Attachment Systems and Methods" Wo I "Ef3i green No. 10 / 307,226 and 2004 U.S. Patent application entitled "Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ" is found, filed February 4 No. 10 / 786,465, both of these patents are incorporated herein by reference.

[0265] 在这个实施方式中,形成固定器402的近端盘管422从而产生斜构件424,其横穿螺旋固定器的直径。 [0265] In this embodiment, the fixture 402 is formed in the proximal end of the coil 422 to produce a ramp member 424, the diameter of which traverses the coil holder. 固定器402的远端包含尖的顶端426,例如锥尖或者凿出的尖端, 从而帮助容易进行组织穿透。 The distal end of the holder 402 comprises a pointed tip 426, e.g. carved tip or tip of the cone, it helps easy tissue penetration. 相似的螺旋固定器在美国专利第5,964,772 ;5, 824, 008 ; 5,582,616 ;和6,296, 656号中进行了描述,其全部内容结合于此作为参考。 It described and 6,296, No. 656, which is incorporated herein by reference; similar helical fastener in U.S. Patent Nos. 5,964,772; 5, 824, 008; 5,582,616.

[0266] 在可选实施方式中,固定器装置400和固定器430可以包含使固定器430被可释放地固定到固定器驱动装置432上的特征。 [0266] In an alternative embodiment, the fixing device 400 and the fixture 430 may comprise the fixing device 430 is releasably secured to the fixture features on the drive apparatus 432. 如图79A和79B中所示,理想的是螺旋固定器430的近端盘管434包括斜构件436,其横穿固定器430的直径。 As shown in FIG. 79A and 79B, it is desirable that the proximal end 430 of the helical fastener 434 comprises a helical coil member 436, which traverses the fixed diameter of 430. 斜构件436可以将固定器430的横截面(diameter)分成两截,或者如图所示可以被弯曲,形成D字型的近端盘管434。 Helical member 436 may be fixed to a cross-section 430 (Diameter) is divided into two parts, or may be curved as shown, is formed D-shaped proximal end 434 of the coil. 理想的是斜构件436完全穿过横截面从而防止固定器430成为开放的盘管并且控制穿透组织的深度。 Member 436 is preferably inclined so as to prevent complete cross-section through the depth of the holder 430 becomes open and the control coil penetrate tissue. 另外,斜构件436可以被连接到前一个盘管,如图所示,从而加强整个结构并且为固定器驱动装置432提供固位(retentive)的形状。 Further, the oblique member 436 may be connected to the previous coil, as shown, to strengthen the overall structure and to provide a shape retention (of Retentive) drive means 432 is fixed. 这种连接可以通过焊接、粘结或者其它合适的方法形成。 This connection may be formed by welding, adhesive or other suitable methods.

[0267] 位于固定器递送轴的近端410的是固定器驱动装置432。 [0267] proximal end of the delivery shaft holder 410 is fixed to drive means 432. 在示例性实施方式中(见图80和81),固定器驱动装置432包括位于螺纹状的固定器外壳439中的固定器支座438。 In the exemplary embodiment (see FIGS. 80 and 81), the holder driving means 432 comprises a screw-shaped fixture housing 439 support the holder 438. 螺纹状的固定器外壳439可以包括接头(tab)437或者其它耦连装置从而卡扣装接或者耦连到固定器支座438以方便归位。 The threaded fastener 439 may include a connector housing (tab) 437 or other coupling means such snap fitting or fixture is coupled to the support 438 to facilitate homing. 驱动装置432和支座438之间的耦连可以采取不同的形式-例如磁体、抓紧器或者其他合适的机械连接。 Coupling between the drive means 432 and the support 438 may take various forms - for example, a magnet, a grasper or other suitable mechanical connections. 在图80和81所示的实施方式中,驱动装置432和支座438是作为单独一个个体完整地连接在一起的。 In the embodiment shown in FIG. 80 and 81, the driving device 432 and the support 438 is an individual as a single integrally connected together.

[0268] 支座438被确定了尺寸并且被设定为与选择出的固定器430接合。 [0268] seat 438 is determined and the size is set to be engaged with the holder 430 selected. 斜构件436用于确定形状,如“D”型,从而接合到支座438上,其使位于支座438之上的固定器430旋转从而将假体固定到组织。 Ramp member 436 is used to determine the shape, such as "D" type, joined to the support 438 so that the fixing device 430 positioned above the abutment 438 is fixed so that the rotation of the prosthesis to the tissue. 斜构件436还可以作为障碍来防止螺旋结构430在组织中穿透过深。 Helical member 436 may also act as barriers to prevent too deep penetration of the coil structure 430 in the tissue.

[0269] 如图80和81中所示,固定器430位于固定器外壳439之中并且在支座438之上。 [0269] As shown in FIG. 80 and 81, the fixture 430 is located within holder 439 and the housing 438 above the abutment. 支座438包括释放掣子440。 Holder 438 comprises a release pawl 440. 释放掣子(latCh)440可以为,例如装有弹簧,磁性或者具有杠杆作用。 Release pawl (latCh) 440 may be, for example, with a spring, magnetic or a lever action. 掣子440防止固定器430过早的释放。 Latch 440 to prevent premature release of the fixture 430. 理想的是释放掣子440需要一种力来克服掣子的保护力。 Desirable release pawl 440 a need for a force to overcome the detent force of the protection. 例如,可以通过牵引力克服释放掣子440,举例来说,固定器430穿过假体被固定在组织内并且进入或者螺旋进入组织的固定器的牵引力可以克服释放掣子的保护力。 For example, it can be overcome by the traction release pawl 440, for example, the fixture 430 is fixed to the prosthesis through a traction force in the tissue and into the tissue or threaded into the fixture may be protected against the force of the release pawl. 选择地,可以通过临床医生按手柄组件404上的释放钮444启动磁力来克服释放掣子440 (如图86所示)。 Alternatively, it is possible to overcome the release pawl 440 (shown in FIG. 86) by the clinician pressing the release button on the handle assembly to start magnetic 404,444. 在图82A和82B中所示的一种实施方式中,释放掣子440包括杠杆臂442从而提供闭锁力(latching force)。 In one embodiment and the embodiment 82A shown in FIG. 82B, the release pawl 440 includes a lever arm 442 to provide a latching force (latching force). 当支座438被旋转从而配置固定器430时,固定器430旋转进入组织的力可以足够克服释放掣子440的力。 When the seat 438 is arranged such that rotation of the fixture 430, the fixture 430 is rotated a force into the tissue can be sufficient to overcome the force of the release pawl 440. 如图82A中所示,通过固定器释放掣子440的方式将固定器430保持固定在支座438上。 As shown in FIG 82A, the release pawl 440 by way of the holder 430 is fixed to the holder 438 remains stationary. 如图82B所示,固定器430进一步螺旋进入组织会导致固定器的每一个盘管去克服释放掣子440的力并且使固定器430 可以从支座438上脱离。 As shown in FIG. 82B, the fixture 430 is further threaded into tissue will cause each coil holder to overcome the force of the release pawl 440 and the fixture 430 may be disengaged from the abutment 438.

[0270] 在可选的实施方式中,释放掣子440可以包括释放弹簧445,如图82C中所示。 [0270] In an alternative embodiment, the release pawl 440 may include a release spring 445, as shown in FIG 82C. 释放弹簧445被确定尺寸并且被设定为提供足够的将固定器430保持在支座438上的力,当固定器旋转进入组织时,仍使固定器430可以克服释放弹簧445和释放掣子440的力。 Release springs 445 are dimensioned and is set to provide adequate holding force on the retainer 438 in the seat 430, when the rotation of the fixture into the tissue, the fixing device 430 can still overcome the spring 445 and release the release pawl 440 of force.

[0271] 理想的是固定器外壳439包括预定数量的内螺纹441 (例如两条或者3条螺纹)。 [0271] preferably is a fixed housing 439 includes internal threads 441 of a predetermined number (e.g., two or three threads). 在这种设计中,外壳439的螺纹部分可以为不连续的贯穿外壳的长度。 In this design, the threaded portion of the housing 439 may be discontinuous throughout the length of the housing. 当固定器被装载到固定器驱动装置432之上时(如下所述),螺纹441接合固定器430,并且还部分地驱动螺旋固定器430从固定器驱动装置432出来并且进入组织。 When (as described below) is loaded into the fixture secured on the drive means 432, 441 engage the threaded fastener 430, and is also partially driven helical fastener 430 from the fastener driving device 432 out of and into the tissue. 理想的是,螺纹外壳的螺纹部分在与外壳顶端443预定的距离处终止。 Ideally, the threaded portion of the housing to the top housing 443 and terminates at a predetermined distance. 螺纹外壳439没有螺纹的部分提供了固定器439可以被旋转但是不会被从固定器驱动装置432驱动出去的区域。 Unthreaded portion 439 provides a fixed threaded shell 439 may be rotated but not be driven out of the region of the drive means 432 from the fixture. 当被驱动装置旋转的时候, 只有在固定器430之前已经与假体120和组织接合的情况下,外壳439的非螺旋特征可以使固定器430将其自身从固定器驱动装置432中拔出。 When the apparatus is driven to rotate, only in the case before the holder 430 has engaged with the tissue and the prosthesis 120, the housing 439 a non-helical feature may enable the holder 430 itself from the holder driving means 432 removed. 这种特征保证了固定器430穿透深度的统一。 This feature ensures that the holder of 430 penetration depth of unity.

[0272] 螺旋固定器,例如402和430,可以位于固定器盒446中,如图83和84中所示。 [0272] helical fastener such as 402 and 430, may be located in the cassette holder 446, FIG. 83 and 84 in FIG. 固定器盒446可以采取任何方便的形式,如长方形或者圆形,如图所示,并且包括任何合适数量的固定器塞孔448,如6个,虽然可以使用任何数量。 Cassette holder 446 may take any convenient form, such as rectangular or circular, as shown, and comprising 448, such as six, although any number may be any suitable number of holder plug hole. 在装运过程中,盒446可以被用来储存和保持固定器,并且还可以提供在医疗过程中将固定器430传到,例如固定器装置400的简易装置。 During shipment, the cartridge 446 can be used to store and hold the fixture, and the fixture 430 may also be provided in the transmitted medical procedure, such as a fixed device 400 of a simple apparatus.

[0273] 如图83和84所示,固定器塞孔448被确定尺寸并且被设计为可以使固定器装置400的近端410和固定器驱动装置432接近固定的固定器430。 [0273] shown in FIGS. 83 and 84, the holder plug hole 448 is sized and designed to make the proximal end 400 of the fixing device 410 and retainer 432 close to the fixed drive means 430 is fixed. 固定器430可以位于塞孔柱449上,从而将固定器430保持在塞孔448之中。 Holder 430 may be located on the jack post 449, so that the holder 430 held in the plug hole 448. 或者可选地,固定器430可以通过固定器430和塞孔448之间的过盈(interference),或者通过将固定器顶端426穿透进入塞孔448基部的材料,而被保持在塞孔448中。 Or alternatively, the holder 430 may be fixed by an interference between the plug 430 and aperture 448 (Interference), or by fixing the tip 426 to penetrate into the plug hole 448 of the base material, it is held in a plug hole 448 in. 当固定器驱动装置432被插入到塞孔448中从而将固定器430定位到支座438上时,塞孔柱449可以包括塞孔柱弹簧447,,使得塞孔柱449 收回进入塞孔448中。 When the holder driving means 432 is inserted into the plug hole 448 is positioned so that the fixture 430 to the abutment 438, the plug 449 may include a peg jack 447 ,, such that the spring for the plug hole into the plug hole column 449 to recover 448 .

[0274] 图85和86示出了位于固定器驱动装置432中的固定器430的实施方式。 [0274] FIGS. 85 and 86 illustrate an embodiment of the fixed drive means 432 of the fixture 430. 可以看到,固定器驱动装置432被定位于塞孔448之上并且被轻轻地插入到塞孔中。 It can be seen, the holder driving means 432 is positioned above the plug hole 448 and is gently inserted into the plug hole. 插入的力使得固定器430克服支座438上的释放掣子440的力并且被定位于支座438之上。 Insertion force such that retainer 430 against the force of the release pawl 440 on the support 438 and 438 is positioned above the abutment. 然后,使用固定器驱动装置手柄404上装有的控制组件406来后退固定器驱动装置。 Then, using a fixed drive assembly with the control means of the handle 406 to the fixture backward driving means 404. 螺纹外壳439 的内螺纹441将固定器430带入到固定器驱动装置432中和用于配置的位置中。 Internal thread 439 of the housing 441 of the fixture 430 into the position 432 and the fixed drive means for configuration. 图86示出了从盒446移出的并且位于固定器驱动装置432之上的固定器430。 FIG 86 shows the fixture 446 is removed from the cartridge holder and drive means positioned above 432 430. 应该了解,盒446可以被用于容纳各种形状和尺寸的固定器,并不限定于,如所披露的固定器430。 It should be appreciated that the cartridge 446 can be used to accommodate various shapes and sizes of the holder is not limited to, as disclosed in the holder 430.

[0275] E.可控导向装置 [0275] E. controlled deflection means

[0276] 可控导向装置450可以被用于建立开放通道,通过其根据需要而配置的操控性器具,如固定器装置400。 [0276] A controlled deflection means 450 may be used to establish an open channel, by its handling appliance configured as required, fixing device 400. 图55和56示出了可控导向装置450的实施方式。 55 and 56 illustrate an embodiment of a controllable guide device 450. 可控导向装置包含手柄妨4所携带的弹性导向管452。 A controlled deflection means comprise a handle hinder the elastic guide tube 452 carried by four. 手柄被确定了尺寸并且被设计为由临床医生符合人机工程学地持有从而将导向管452引入到靶位。 And the size of the handle is determined by the clinician designed ergonomically holder 452 so that the guide tube is introduced to the target site.

[0277] 为了建立固定器装置400的开放通道,可控导向装置450包括内部导路456,其延伸并且连续地经过手柄454的内部并且进入和穿过导向管452。 [0277] In order to establish a fixed open channel means 400, guide means 450 includes a controllable internal guide passage 456 which extends continuously through the interior of the handle and 454 and into and through the guide tube 452. 手柄454的远端还可以包括封口物457从而限制经过导向管452的液体流动。 The distal end of the handle 454 may further comprise a liquid sealing material 457 so as to limit the flow through the guide tube 452. 在将导向管引入穿过血管到达靶位的过程中,具有顶端部件459的闭塞物或者扩张器458(见图57)被放置于导向管452中从而密封导向管并且限制经过导向管452的液体流动,以提供用于引导穿过脉管系统的无创顶端,并且提供了导线内腔470。 Reaching the target site in the blood vessel during introduction through the guide tube, the member having a tip 459 of the dilator, or obturator 458 (see FIG. 57) is placed in the guide tube 452 to seal the liquid through the guide tube and the guide tube 452 to limit the flow, to provide an atraumatic tip for the guide through the vasculature, and provides a guidewire lumen 470.

[0278] 理想的是手柄组件包括可旋转的可控组件460和注入口462。 [0278] preferably includes a handle assembly is controllably rotatable assembly 460 and inlet port 462. 可控组件460可以用于使导向管452的近端464偏离形成弯曲或者偏离的构造,这将在后面描述。 Controllable assembly 460 may be used to guide proximal end 464 of the tube 452 is bent or formed to be offset from offset, which will be described later. 可控组件460以所需方向进行旋转,造成近端464弯曲或者偏离成预定的构造。 Controllable assembly 460 in the desired direction of rotation, resulting in bent or offset from the proximal end 464 to a predetermined configuration. 射线不透标记466可以被放置于导向管452的近端区域464从而可以进行荧光可视化定位偏离端区域。 Radiopaque markers 466 may be positioned in the proximal region 464 of the guide tube 452 can be positioned offset from the fluorescence visualized end region. 在弯曲或者偏离的构造中,近端464可以以与靶位具有理想关系而被定向。 The curved or offset configuration, proximal end 464 may be oriented to have a desired relationship with the target site.

[0279] 可控导向装置450的进一步详细描述可以在2005年10月20号提交的名为《Devices, Systems, and Methods for Guiding an Operative Tool Into an Interior Body Region》(序列号待提供)中找到,其结合于此作为参考。 [0279] Further details of the controllable guide device 450 may be named October 20, 2005, filed "Devices, Systems, and Methods for Guiding an Operative Tool Into an Interior Body Region" (serial number pending) found , which is incorporated herein by reference.

[0280] V.植入方法详述 [0280] V. DETAILED DESCRIPTION implantation method

[0281] 在这里将会更详细地描述第II节中总体上描述的假体100植入的步骤。 [0281] In a step 100 where the implanted prosthesis Section II generally described will be described in more detail. 在示例性实施方式中,分叉假体100的开伞基本可以通过,例如十二个步骤获得,并且基本在图58 至78中示出。 In an exemplary embodiment, the bifurcated prosthesis 100 is substantially parachute can be, for example, twelve steps is obtained, and substantially shown in Figures 58 to 78. 示例性实施方式会披露用于植入假体100的系统、方法和使用的器具。 Exemplary embodiments disclose system for implantation of prosthesis 100, and the method of use of the appliance. 应该理解这些相同或者相似系统、方法和器具也可以用于植入身体的其它区域的其它假体构造。 It should be understood that these same or similar systems, instruments and methods may also be used with other prosthetic implant configurations other regions of the body. 在整个植入过程中,可以使用成像制导并联合位于假体100和开伞器具上的射线不透标记。 In the entire implantation process, and it can be combined using an imaging-guided radiation positioned on the prosthetic appliance 100 and parachute opaque marker.

[0282] 通过使用所述领域已知的导引器可以产生进入脉管系统的通路。 [0282] The vascular access system may be generated by using the passage of the introducer known in the art. 止血导引器护套(未示出),例如,可以首先被放置在左股动脉中,为植入器具提供了通路。 Hemostatic introducer sheath (not shown), for example, may first be placed in the left femoral artery, providing access to the implantable device. 第二导引器护套(未示出)也可以被放置在右股动脉中,为植入器具提供了通路。 The second introducer sheath (not shown) may also be placed in the right femoral artery, providing access to the implantable device. 应该理解也可以使用可选的穿刺点。 It should be understood can also use the optional puncture site. 例如,左股动脉和右股动脉上的通路都可以使多个植入器具同时位于脉管系统中,使植入程序可以被有效地实施。 For example, the left femoral artery and the right femoral artery access may be located in a plurality of implantable devices at the same time in the vasculature, the implant procedure can be implemented efficiently.

[0283] A.定位假体主体 [0283] A. positioning the prosthesis body

[0284] 第一步包括将假体主体120定位到所需位置。 [0284] The first step comprises positioning a prosthesis body 120 to a desired position. 从左边或者右边动脉,在成像制导下,第一导线30进入到同侧髂骨动脉并且到降主动脉。 Artery from the left or right, under imaging guidance, the first wire 30 into the ipsilateral iliac artery and the descending aorta. 然后,操纵开伞导管200越过第一导线30到达体内所需位置(例如主动脉瘤),用于假体主体120的开伞(如图58所示)。 Then, manipulation of the catheter 200 beyond the first parachute wire 30 reaches a desired position (e.g., aortic aneurysm) in vivo, for the main parachute prosthesis 120 (FIG. 58). 可以在穿刺位点使用传统的止血阀安排(在图44B中以示例性说明的目的示出)。 Using conventional hemostasis valve arrangements (for purposes of illustration of exemplary shown in FIG. 44B) at the site of the puncture.

[0285] B.收回外套管 [0285] B. recover the outer sleeve

[0286] 接下来,外套管210被以远端或者尾端的方向收回从而暴露假体主体120。 [0286] Next, in the direction of the outer sleeve 210 is retracted the distal end or trailing end of the body 120 to expose the prosthesis. 首先通过旋转手柄组件212上的起始旋钮302,外套管210最先从它在导管顶端222上的稳固位置上收回。 First, by starting knob on the handle assembly 212,302, the outer sleeve 210 is retracted from its first stable position on the catheter tip 222. 在通过起始旋钮302的旋转产生的机械优势使得外套管210从导管顶端222收回之后,手柄212上的套管滑动旋钮294可以被用于进一步收回外套管210并且完全暴露假体主体120 (如图59和60所示)。 In the mechanical advantage generated by the initial rotation of the knob 302 such that outer sleeve 210 after the catheter tip 222 retracted, the slide knob on the handle of the cannula 212 294 may be used for further recovery of the outer sleeve 210 is fully exposed and the prosthesis body 120 (e.g. As shown in FIGS. 59 and 60). 假体主体120的未约束的一部分或者多个部分自扩张, 如图60中所示。 Prosthesis part or a plurality of portions of the body 120 is not constrained self-expanding, as shown in FIG. 60. 可选地,第一内腔1¾可以未被放射状地约束,但是仍然相对于中轴216被约束(见图32),只要外套管210被收回,第一内腔126也可以自扩张,如图61中所示。 Alternatively, the first lumen may be unsubstituted 1¾ radially constrained, but still with respect to the central axis 216 is constrained (see FIG. 32), as long as the outer sleeve 210 is retracted, the first lumen 126 may be self-expanding, as shown in 61 shown in FIG. 如图59至61所示,在外套管210的收回过程中和其后,由于近端和远端阻挡装置218、220耦连到假体主体120,假体主体120保持其相对于中轴216的位置。 As shown in FIG. 59 to 61, retraction of the outer sleeve 210 and subsequently, due to the proximal and distal ends 218, 220 of the blocking device is coupled to the body 120 of the prosthesis, the prosthesis holder body 120 with respect to the central axis 216 s position.

[0287] 应该了解外套管210的收回和近端以及远端释放装置228、230、232的收回,或者它们的组合,可以在单独一个步骤或者过程或者多个步骤中实现。 [0287] should be appreciated that the outer sleeve and a proximal end and a distal end 210 retracted to release the retrieval device 228, 230, or a combination thereof, may be implemented in a single step or multiple steps or processes. 在这种安排中,一个单独的启动机构可以共同耦连到外套管210和任何一个或所有释放装置228、230、232,这样外套管210和释放装置2观、230、232在一个步骤,或者多个步骤中被收回。 In this arrangement, a single activation mechanism may be co-coupled to the outer sleeve 210 and any or all of a release means 228, 230, 210 so that the outer sleeve 2 and the release device concept, in a step 230, 232, or the plurality of steps is retracted.

[0288] C.释放第一近端阻挡装置 [0288] C. to release the proximal end of the first barrier means

[0289] 在开伞过程中的第三个一般步骤中,在外套管210收回之后,手柄组件212上的第一近端滑动旋钮322向远端移动,其导致第一近端释放装置2¾的近端,也就是第一近端释放线250,从第一近端阻挡装置224,也就是缝合环252收回,并且使被约束的一个或多个支架130以及假体主体120的近端108作为一个整体进行放射状自扩张到第一阶段开伞构造,如图62中所示。 [0289] A third general process step the parachute, after recovery of the outer sleeve 210, a first proximal end of the slide knob on the handle assembly 212,322 moves distally, which causes the first proximal end of the release means 2¾ a proximal end, the proximal end is a first release wire 250, the blocking means from the first proximal end 224, the suture ring 252 is retracted, and the prosthesis and the proximal end of the body 120, one or more stent is constrained as 130,108 a whole radially expanding from a first stage to a parachute configuration, as shown in Figure 62. 理想的是假体主体120的近端108朝向血管或者中空身体器官的内壁部分地或者完全地放射状扩张。 Desirable that the proximal end 120 of prosthesis body 108 toward the inner wall part of the blood vessel or hollow body organ or fully radially expanded.

[0290] 在开伞过程中的这个点上,假体主体120的近端和远端分别通过第二近端阻挡装置2¾和远端阻挡装置232被保持和控制。 [0290] On this point in the process of unfolding, proximal and distal ends of the prosthesis body 120, respectively, and a distal barrier means 2¾ maintaining and controlling means 232 is blocked by the second proximal end. 这使操作者可以在下一个步骤之前(固定近端)纵向地或者旋转地调整假体主体120的位置,以及在下一个阶段(固定近端装置)中维持或者保持控制假体主体120。 This allows the operator prior to a step (a fixed proximal end) or longitudinally adjust the position of the rotation 120 of the lower prosthesis body may be, and to maintain or control the prosthesis holder body 120 in the next stage (proximal fixing means). 另外,因为在开伞和固定过程中假体主体120可以选择性地从近端和远端被保持和控制,所以假体120本身不需要自支持,但是可以取而代之为顺应纵向和/或旋转的方向,从而可以顺从和适应可能在植入之后产生的解剖学结构的变化(例如动脉瘤的收缩)。 Further, since the prosthesis body 120 may be held and selectively controlled from the proximal end and the distal end of the parachute and the fixing process, the prosthesis 120 itself need not self-supporting, but instead can adapt to the longitudinal and / or rotational direction, which can adapt to changes and compliant (e.g., aneurysm shrinkage) of the anatomy may be generated after implantation.

[0291] D.固定近端 [0291] D. proximal end secured

[0292] 第四个一般步骤包括将假体主体120的近端108固定到血管或者中空身体器官的内壁。 [0292] The fourth step typically comprises a proximal end 120 of prosthesis body 108 is fixed to an inner wall of a blood vessel or hollow body organ. 从右股动脉,在成像制导下,使用传统的血管内途径将第二导线40带到对侧髂骨动脉中并且到降主动脉。 The right femoral artery, under imaging guidance using conventional intravascular route to the second wire 40 into the contralateral iliac artery and the descending aorta. 但是,也可以使用其它穿刺位点和方法。 However, also other puncture sites and methods. 理想的是导线40延伸穿过第二扩张了的内腔128并且穿过假体主体120的近端开口122(见图63)。 Preferably a wire 40 extending through the second lumen 128 of the expandable prosthesis body and through the proximal end 120 of the opening 122 (see FIG. 63). 接下来,然后可控导向装置450,具有位于内部导向通道456中的闭塞物458,被控制越过第二导线40到假体主体120的所需位置(见图64)。 Subsequently, the guide means 450 is then controlled with the occlusion 458 is located inside the guide channel 456, is controlled to a desired position beyond the second lead 40 to the prosthesis body 120 (see FIG. 64). 一旦可控导向装置450位于合适的位置,闭塞物458和第二导线40都从内部导向通道458和身体上移开。 Once a controllable guide means 450 located in suitable positions, the occlusion 458 and the second conductor 40 are removed from the body 458 and the inner guide channel.

[0293] 通过旋转可控组件460 (见图5¾,并且继续使用荧光透视可视化,临床医生偏转近端区域464从而将通道456的近端开口468定向到与其中需要引入固定器402的位点处于所需的相对关系,如果必要的话,旋转手柄妨4从而旋转弹性导向管452。然后,操作器具,如固定器装置400被插入穿过可控导向装置450的导向通道456,并且继续前进直到固定器,如固定器402,被定位用于与此时被定向的近端开口468相关的开伞,如图65所示。当固定器装置400被向前离开可控导向装置450并且接触到假体主体120的壁,合力被施加于以与固定器装置近端410相反的方向移动的可控导向装置450的近端464。该合力造成可控导向装置450的近端464偏离直到它接触内腔或者中空身体器官中的假体主体的相对的壁。这样,作用于假体主体120以及来自于固定器装置400近端410的血管的力,通过位于血 [0293] is controlled by the rotation assembly 460 (see FIG 5¾, and continues to use fluoroscopic visualization, the clinician deflecting area 464 so that the proximal end of the proximal end of the passage 456 with an opening 468 which is directed to the need to introduce a fixed site 402 desired relative relationship, if necessary, rotation of the handle 4 so as to hinder rotation of the elastic guide tube 452. then, the operation tool, such as a fixing device 400 is inserted through the guide passage 450 controlled deflection means 456, and continues until the fixed forward , such as fixture 402 is positioned to the proximal end 468 associated with the unfolding of the opening at this time is oriented, shown in Figure 65. when the guide 400 is controlled to leave the forward anchor means 450 and contacts the prosthesis wall body 120, a controlled force is applied to move the guide means in a direction opposite the proximal end of the proximal end 450 of the holder 410 464. the resulting force until it contacts the proximal end 450 of the controlled device 464 deviates from the guide the opposing walls of the cavity of the prosthesis body or a hollow body organ in this manner, and the force acting on the prosthesis body 120 from the proximal end to the fixing device 400 of the vessel 410, through the blood located 或者中空身体器官内的可控导向装置450被部分地分解了。腔内装置的代表性实施方式,其在使用中应用了2004年2月25号提交的名为《Systems and Methods for Attaching a Prosthesis Within a Body Lumen or Hollow Organ》的美国专利申请第10/786,465号所披露的螺旋固定器,其结合与此作为参考。 Guide means or controllable within a hollow body organ 450 is partially decomposed. Representative embodiments of the cavity means, the application 2004 filed on February 25, entitled "Systems and Methods for Attaching a Prosthesis, in use, Within a Body Lumen or Hollow Organ "U.S. Patent application No. 10 / 786,465 disclosed a helical fastener, which is incorporated herein by reference.

[0294] 然后固定器装置400被启动从而将固定器402应用到假体主体120的近端108和周围组织中(见图66)。 [0294] and fixing device 400 is activated so that the holder 402 is applied to the proximal end 108 of the prosthesis and surrounding tissue of the body 120 (see FIG. 66). 如果固定器装置400是单独装载装置(fire device),也就是它只携带一个固定器402,固定器装置400穿过内部导向通道456被收出并且装上新的固定器402。 If the fixing device 400 is a separate loading device (fire device), that is, it only carries a retainer 402, fixing device 400 through an internal guide channel 456 is closed off and install a new fixture 402. 见图85和86,装载到固定器装置400的固定器430的一种实施方式。 Figure 85 and 86, an embodiment of the load fixing device 400 of the fixture 430. 可控装置450 的近端区域464被重新调整方向到与新的固定器位点处于相对的关系。 Controllable proximal region 464 of device 450 is reoriented to a new site is in a relatively fixed relationship. 固定器装置400穿过内部导向通道456被插回从而将第二固定器402应用到新的固定器位点(见图67)。 Fixing means 400 through the inner guide channel 456 is inserted back into the second fixture 402 so as to apply to the new anchor site (see Fig. 67). 以这种次序重复直到所需数量和排列的固定器402应用到假体主体120上,如图68中所见。 This order is repeated until the desired number and arrangement of the holders 402 is applied to the prosthesis body 120, as seen in Figure 68.

[0295] 此时,固定器装置400被撤回,留下可控导向装置450在合适的位置。 [0295] At this time, the fixing device 400 is withdrawn, leaving the guide means 450 controllably suitable location. 充填器458 被重新定位于内部导向通道456中,并且第二导线40被控制穿过充填器内腔470到达相对于假体主体120的所需位置。 Obturator 458 is repositioned inside the guide channel 456, and the second wire 40 is controlled through the lumen of the obturator 470 relative to the prosthesis body reaches the desired location 120. 一旦第二导线40位于合适的位置,可控导向装置450和充填器458都从内部导向通道456和身体移开留下第二导线40在血管内合适的位置。 Once the second wire 40 is located right position, the guide means 450 and the controllable packer 458 from the 45640 are appropriate position of the inner body is removed leaving the guide passage and a second wire within the vessel.

[0296] 经过开伞过程的这一阶段,当进行固定的时候,假体主体120的近端和远端都分别被第二近端阻挡装置2¾和远端阻挡装置232保持和控制。 [0296] After this stage of the unfolding process, when fixing the proximal and distal ends of the prosthesis body 120 are respectively blocked by the second means 2¾ proximal and distal ends 232 to maintain and control the blocking means.

[0297] E.放置第一内腔延伸物 [0297] E. thereof disposed a first lumen extending

[0298] 开伞过程的第五个常规步骤中,在假体主体120的近端108固定后,延伸开伞导管350被用于定位在假体主体120的内腔中开伞的内腔延伸物140。 [0298] The fifth step parachute conventional process, after the proximal end 120 of the prosthesis 108 is fixed to the body, extending parachute catheter 350 is positioned in the lumen of the prosthesis to the body lumen 120 extending parachute 140. 从左或右股动脉,在成像制导下,延伸导管350被控制越过第二导线40到合适的位置,也就是,套叠地部分位于假体主体120的第二内腔128中,如图69所示。 Left or right femoral artery, under imaging guidance, over the extension catheter 350 is controlled to the appropriate position of the second wire 40, i.e., telescopically positioned in the second lumen portion 128 of prosthesis body 120, FIG. 69 Fig. 可以在穿刺位点使用传统的止血阀设计(在图44B出于示例性说明的目的示出)。 Using conventional hemostasis valve designs (for purposes of exemplary illustration shown in FIG. 44B) at the site of the puncture.

[0299] F.收回延伸导管外套管 [0299] F. withdrawn extension catheter overtube

[0300] 接下来,延伸导管的外套管360必须向远端或者尾端方向收回从而暴露内腔延伸物140。 [0300] Next, the extension catheter 360 to be retracted to the outer sleeve or the distal direction to expose a lumen extending trailing end 140 thereof. 延伸导管手柄362上的套管滑动旋钮382向远端推进从而收回套管360并且完全暴露内腔延伸物140。 Extending the slide knob on the sleeve catheter handle 362,382 cannula retracted thereby advancing distally extending lumen 360 and 140 is completely exposed. 内腔延伸物140的未约束的一个部分或者多个部分自扩张(见图70)。 A part or a plurality of lumen extending portion 140 is not constrained self-expanding (see FIG. 70). 在收回外套管360的过程中和过程后,因为近端阻挡装置366耦连到内腔延伸物140,所以内腔延伸物140保持其相对于中轴356的位置。 In the process of recovery of the outer sleeve 360 ​​and the post-process, because the proximal end of the blocking device 366 is coupled to the lumen extension 140, it was held lumen extending its position relative to the central axis 356 140.

[0301] G.释放内腔延伸近端阻挡装置 [0301] G. release lumen extending proximal end barrier means

[0302] 在开伞程序的第七个常规步骤中,在撤回延伸导管外套管360之后,延伸导管手柄组件362上的近端滑动旋钮382向远端移动,这造成近端释放装置370的近端,即近端释放线380,从近端阻挡装置366,即缝合环378上收回并且使被约束的一个或多个支架150 和内腔延伸物140的近端142可以放射状的自扩张到开伞构造,如图70和71所示。 [0302] In a seventh step of a conventional parachute procedure, after the withdrawal of the catheter extending outer sleeve 360, extending over the proximal end of the catheter handle assembly 362 moves the slide knob 382 distally, which causes the release device near the proximal end 370 end, i.e., the proximal release wire 380, the blocking device 366 from the proximal end, i.e. retracted and the one or more stents are constrained proximal end 150 and a lumen 140 extending composition 142 may self-expand radially to open a suture ring 378 umbrella configuration, as shown in FIG. 70 and 71. 理想的是内腔延伸物140的近端142扩大到接触假体主体140的第二内腔1¾的内壁。 Desirable lumen extending proximal end 140 of the second lumen 142 to expand the inner wall 140 of the contact 1¾ prosthesis body. 经过内腔延伸物140的液体自然流动提供了足够的力以引起内腔延伸物140的限制性机构与共同作用的假体主体120的限制性机构的接合。 A lumen extending through the natural flow of the liquid 140 provides sufficient force to cause engagement of the limiting means limiting the prosthesis body lumen extending mechanism 140 cooperates with the 120. 内腔延伸支架和/或内腔延伸支架150向外延伸的顶点147与位于假体主体120的第二内腔1¾中的远端支架134相匹配的向外延伸的顶点136接合,从而将内腔延伸物140耦连到假体主体120。 And a lumen extending brace engaging / vertex or apex 147 extending outward and distal stent 134 is located in the second lumen 1¾ prosthesis body 120 matches a lumen extending outwardly extending bracket 150 136, whereby the inner extending cavity 140 is coupled to the body 120 of the prosthesis.

[0303] 在撤回延伸导管350之前,理想的是外套管360被重新放置于与导管顶端368处于相邻的关系。 [0303] Prior to withdrawal of the catheter extension 350, the outer sleeve 360 ​​is desirable to be repositioned in the catheter tip 368 and is in contiguous relationship. 延伸导管手柄362上的套管滑动旋钮382向近端的方向推进从而将套管360 重新置于开伞前的构造。 Extending the sleeve slide knob 382 on catheter handle 362 so as to advance the sleeve 360 ​​placed back structure before unfolding the proximal direction. 此时,延伸导管350可以被收回并且从身体移走。 At this time, the extension catheter 350 may be withdrawn and removed from the body. 第二导线40可以被移走,或者被保留直到开伞程序结束。 The second wire 40 may be removed, or is retained until the end of the unfolding procedure.

[0304] H.释放第二近端阻挡装置 [0304] H. second proximal stopper release means

[0305] 在开伞程序中的第八个常规步骤中,在第一内腔延伸物140开伞之后,第二近端阻挡装置2¾被释放。 [0305] In an eighth step of a conventional parachute program, after a first lumen extending parachute 140, a second proximal end barrier means 2¾ is released. 为了释放假体主体120的近端108,手柄212上的第二近端释放滑动旋钮3M向远端移动,这造成第二近端释放装置230,即第二近端释放线268的近端,从假体材料112和稳定臂孔沈4撤回,并且使稳定臂256从假体主体120的近端108释放,并且向近端弹开,如图72中所示。 To release the proximal end 120 of prosthesis body 108, a handle 212 on the proximal end of the second slide knob release 3M moved distally, which causes the proximal end of the second release means 230, i.e. the proximal end 268 of the proximal end of the second release line, 112 from the prosthetic material and the withdrawal of the stabilizing arm-bore 4, and the stabilizing arm 256 is released from the proximal end 120 of prosthesis body 108, proximally and bounce, 72 as shown in FIG. 假体主体120的近端108不再是与中轴216为被约束的关系。 The proximal end 108 of prosthesis body 120 with axis 216 is no longer constrained relationship.

[0306] I.释放远端阻挡装置 [0306] I. releasing the distal end of the blocking device

[0307] 在开伞程序的第九个常规步骤中,在释放第二近端阻挡装置2¾之后,远端阻挡装置220被释放。 After [0307] In a ninth step of a conventional parachute program, the release of the second barrier means 2¾ proximal, the distal end of the blocking device 220 is released. 为了释放假体主体140的远端110,手柄212上的远端释放滑动旋钮3¾ 被向远端移动,这造成远端释放装置232,即远端释放线282的远端从远端阻挡装置220,即缝合环274收回,并且被约束的支架134可以放射状的自扩张到第二阶段开伞构造,如图73 中所见。 To release the prosthesis the distal end 110 of the body 140, the distal end of the handle 212 to release the slide knob 3¾ moved distally, which causes the distal end of release means 232, i.e. the distal end of the distal end of line 282 is released from the distal end of the blocking device 220 , i.e. retracted sewing ring 274, and 134 may be constrained stent radially self-expanding parachute configuration to the second stage, as seen in Figure 73. 如前面所提到的,可选择地,一个或多个支架140不是必须被远端阻挡装置2¾约束。 As previously mentioned, optionally, one or more brackets 140 are not necessarily be the distal end of the blocking device 2¾ constraints. 假体主体120不再是与中轴216为被约束的关系。 The prosthesis body 120 with axis 216 is no longer constrained relationship.

[0308] 在收回开伞导管200之前,理想的是外套管210被重新放置到与导管顶端222处于相邻的关系中。 [0308] Prior to recovery parachute catheter 200, it is desirable that the outer sleeve 210 is repositioned to a catheter tip 222 is in an adjacent relationship. 导管手柄212上的套管滑动旋钮四4向近端的方向推动从而重新将套管210置于开伞前的构造。 Sleeve slide knob 212 on catheter handle four (4) proximal direction thereby pushing back the sleeve 210 is placed before the parachute configuration. 此时,开伞导管200可以被从身体撤回,留下第一导线30在脉管系统中(见图74)。 At this time, parachute catheter 200 may be withdrawn from the body, leaving the first wire 30 in the vasculature (see FIG. 74).

[0309] J.放置第二内腔延伸物 [0309] J. placing a second lumen extending thereof

[0310] 在开伞过程的第十个常规步骤中,在释放远端阻挡装置220和撤回开伞导管200 之后,放置第二内腔延伸物140用于开伞。 [0310] In a tenth step of parachute conventional process, the release device 220, and the distal end of catheter 200 parachute after withdrawal, placement of the second lumen 140 extending barrier for unfolding. 与用于第一内腔延伸物140的开伞的常规步骤是相同的或相似的,但是在这里为了清楚起见还是进行了重复。 Conventional steps for a first lumen extending the parachute 140 is the same or similar, but for clarity here, or were repeated. 延伸开伞导管350再次被用于放置第二内腔延伸物140,用于在假体主体120的内腔中开伞。 Catheter 350 extending parachute is again used to place a second lumen 140 extending, for luminal prosthesis body 120 parachute. 从左或右股动脉,例如, 在成像制导下,延伸导管350被控制越过第一导线30到所需的位置,也就是,套叠部分放置于假体主体120的第一内腔126中,如图75所示。 Left or right femoral artery, for example, under imaging guidance, the catheter 350 is controlled to extend beyond the first position 30 to a desired conductor, i.e., telescoping portion placed in the first lumen 126 of prosthesis body 120, 75 shown in FIG. 如前所述,传统止血阀设计再次被用于穿刺位点(在图44B中以示例性说明的目的而示出)。 As described above, the conventional hemostasis valve is designed for piercing site again (for purposes of an exemplary illustration shown in FIG. 44B).

[0311] K.收回延伸导管外套管 [0311] K. withdrawn extension catheter overtube

[0312] 接下来,延伸导管的外套管360必须以远端或者尾端的方向被收回,从而暴露内腔延伸物140。 [0312] Next, the extension catheter 360 of the outer sleeve must be retracted in the direction of the distal end or trailing end, to expose a lumen 140 extends. 延伸导管手柄362上的套管滑动旋钮382向远端的方向推进从而收回套管360并且完全暴露内腔延伸物140。 Extending the sleeve slide knob 382 on the handle 362 of the catheter is advanced so that the distal direction of the sleeve 360 ​​and retracted fully exposed lumen 140 extends. 内腔延伸物140的未约束的一个部分或者多个部分自扩张(见图75和76)。 A part or a plurality of lumen extending portion 140 is not constrained self-expanding (see FIG. 75 and 76). 如图76所示,在收回外套管360的过程中和过程后,因为近端阻挡装置366耦连到内腔延伸物140,所以内腔延伸物140保持其相对于中轴356的位置。 As shown in FIG 76, after the process of recovery of the outer sleeve 360 ​​and in the process, because the proximal end of the blocking device 366 is coupled to the lumen extension 140, 140 so the lumen extending holding position with respect to the central axis 356.

[0313] L.释放内腔延伸近端阻挡装置 [0313] L. release lumen extending proximal end barrier means

[0314] 在开伞过程中的第十二个常规步骤中,在收回延伸导管外套管360之后,延伸导管手柄组件362上的近端滑动旋钮382向远端移动,这造成近端释放装置370,即近端释放线380的近端从近端阻挡装置366,即缝合环378收回,并且使被约束的一个或多个支架150和内腔延伸物140的近端142放射状的自扩张到开伞构造,如图77中所示。 [0314] In a twelfth step parachute conventional process, after recovery of the outer sleeve extension catheter 360 extends over the proximal end of the catheter handle assembly 362 moves the slide knob 382 distally, which causes the proximal end of release means 370 , i.e., the proximal ends of release wire 380 from the proximal end of the blocking device 366, i.e., the suture ring 378 retracted, and the one or more stents are constrained proximal end 150 and a lumen 142 thereof extending radially self-expanding to an open 140 umbrella configuration, as shown in Figure 77. 理想的是内腔延伸物140的近端142扩大到接触假体主体140的第一内腔126的内壁。 Desirable lumen extending enlarged proximal end 140 to the inner wall 142 of the first lumen 126 of the body 140 contact the prosthesis. 通过内腔延伸物140的液体自然流动产生了足够的力以引起内腔延伸140限制性机构与共同作用的假体主体120的限制性机构接合。 The natural flow of the liquid produces a sufficient force 140 to cause a lumen extending through the body of the prosthesis lumen extending limiting mechanism 140 cooperates with the limiting mechanism 120 engages. 内腔延伸支架和/或内腔延伸支架150的向外延伸顶点147与位于假体主体120的第一内腔126中的远端支架134相匹配向外延伸顶点136接合(见图10B),从而将内腔延伸物140耦连到假体主体120。 A lumen extending support and / or lumen of the stent 150 extends outwardly extending apex 147 and distal stent 134 is located in the first lumen 126 of prosthesis body 120 matches 136 engaging outwardly extending apex (see FIG. 10B), thereby extending lumen 140 is coupled to the body 120 of the prosthesis.

[0315] 在撤回延伸导管350之前,理想的是外套管360被重新放置为与导管顶端368处于相邻的关系。 [0315] Prior to withdrawal of the catheter extension 350, the outer sleeve 360 ​​is desirable to be re-placed at the tip of the catheter 368 adjacent relationship. 延伸导管手柄362上的套管滑动旋钮382向近端的方向推进从而重新将外套管360置于开伞前的构造。 Extending the sleeve 382 slide knob 362 advancing on the catheter handle 360 ​​is placed so as to re-configuration of the overtube before the parachute proximal direction. 此时延伸导管350可以被收回并且从身体移走。 At this time, the extension catheter 350 may be withdrawn and removed from the body. 此时,第一导线30和第二导线40都可以被移走从而完成分叉假体的开伞过程,如图78中所示。 At this time, the first wire 30 and second wire 40 may be removed to complete the unfolding process bifurcated prosthesis 78 as shown in FIG.

[0316] 应该理解刚才所披露的一般步骤不是必须按着它们被披露的顺序。 [0316] It should be appreciated that the general procedure just disclosed is not necessarily the order they were disclosed by pressing. 例如,在第一内腔延伸物140的开伞之前可以释放第二近端阻挡装置,并且在完成开伞过程之前可以移走第二导线。 For example, before a first lumen extending parachute 140 may release the proximal end of the second barrier means, and may be removed before completion of the process of the second wire parachute. 应该了解固定器可以应用于内腔延伸物,也可以将内腔延伸物连接到髂骨动脉。 Should be appreciated that the fixture may be applied to a lumen extensions, extensions may be connected to a lumen iliac arteries.

[0317] 还应该了解这里所披露的优选具体实施方式的部件和/或特征可以一起使用或者单独使用,而描述的方法和装置可以进行组合或者整体地或者部分地改动。 [0317] It should also be understood member and / or features of the preferred embodiment herein disclosed embodiments may be used together or separately, while the methods and apparatus described herein may be combined or wholly or partially altered. 应该考虑到导向装置、固定器装置和螺旋固定器的部件可以相对于彼此被交替地定向,例如分叉、二轴等等。 It should be considered a guide means, fixing means and the helical fastener member may be alternately oriented with respect to one another, e.g. bifurcated second shafts and the like. 另外,应该理解各种具体实施方式可以应用于这里没有披露的其它程序中,如血管损伤、动脉剥离、人造心脏阀附件和在血管系统和主要在体内的其它假体装置的附件。 Further, it should be understood that various embodiments may be applied to other applications not disclosed herein, as vascular injury, the release arteries, artificial heart valves and vascular systems and the main accessory attachments other prosthetic device to the body.

[0318] 前面所述的被认为是本发明原则上的说明。 [0318] The foregoing is considered illustrative of the principles of the invention. 另外,由于所属领域的普通技术人员会想到很多的改动和变化,不希望把本发明限定为示出和描述的确定的结构和操作。 Further, since the ordinary skill in the art would think of many modifications and variations, without wishing to limit the invention as described and defined structure and operation shown. 同时披露了优选的具体实施方式,其细节可以改变而不背离已在权利要求中确定的本发明的精神。 While the preferred embodiment disclosed embodiments, the details may be changed without departing from the spirit of the present invention have been defined in the appended claims.

[0319] 基于建立一个完整的披露目的并且为了解释清楚,本发明的优选实施方式在上面进行了详细地介绍。 [0319] Based on a complete disclosure purposes to establish and clarity of explanation, the preferred embodiment of the present invention were described in detail above. 所属领域的普通技术人员会想到在本说明书的范围和精神内的其它改动。 Those of ordinary skill in the art will envision other modifications within the scope and spirit of the present specification.

Claims (13)

1. 一种用于将假体递送到靶位的系统,包括:导管装置,所述导管装置被确定了尺寸并且被设置为引入到中空身体器官或者血管中的靶位,所述导管装置包括:轴,所述轴被确定了尺寸并且被设置为在所述导管装置的引入过程中携带所述假体, 第一释放机构,所述第一释放机构被耦接到所述假体从而将所述假体的至少一个区域固定到所述导管轴上,以及用于操控所述第一释放机构的第一致动器,以及第二释放机构,所述第二释放机构被耦接到所述假体,与所述第一释放机构协作以防止在所述第一致动器启动之后所述假体的所述至少一个区域中的所述至少一个区域从所述导管轴完全释放,由此所述第一致动器的启动使得在靶位的所述假体的所述至少一个区域从所述导管轴部分释放,而不是从所述导管轴完全释放所述至少一个区域,以及用于操控第二 1. A method for delivering a prosthesis to a target system, comprising: conduit means, said conduit means being dimensioned and determines the set into a hollow body organ or a blood vessel target site, said catheter means comprising : a shaft are determined in size and is arranged to carry the prosthesis during introduction of the catheter device, the first release mechanism, the first release means is coupled to the prosthesis so that the at least one region of the prosthesis is secured to said catheter shaft, and the first actuator for actuating the first release mechanism, and a second release mechanism, the second release mechanism is coupled to the said prosthesis cooperating with said first mechanism to prevent the release of the prosthesis the at least one region of at least one region is completely released from the catheter shaft after the start of the first actuator by this is the first actuator so that the start of the prosthesis at least one region of the target is released from the catheter shaft portion, but not completely released from the catheter shaft at least one region, and with to control the second 释放机构使得所述假体的所述至少一个区域从所述导管轴完全释放的第二致动器, 以及固定装置,所述固定装置被确定了尺寸并且被设置为引入到被所述导管装置占据的所述中空身体器官或者血管中的靶位,所述固定装置包括致动器,用于在所述第一释放机构启动之后和所述第二释放机构启动之前在所述假体的所述至少一个区域中配置固定器。 The release mechanism of the prosthesis such that at least one region of the catheter shaft is fully released from the second actuator, and a fixing means, said fixing means is determined and the size is arranged to be introduced into said conduit means occupied by the hollow body organ or a blood vessel target site, said fixing means comprises an actuator for releasing and before said second means is actuated in said first release mechanism after the start of the prosthesis said at least one region configured holder.
2.根据权利要求1所述的系统,其中所述第二释放机构包括至少一个从所述导管轴悬垂的稳定臂。 2. The system according to claim 1, wherein the release mechanism comprises at least a second stabilizing arm from the catheter shaft depending.
3.根据权利要求1所述的系统,其中所述第一释放机构包含缝合物或者细丝或者线。 3. The system of claim 1, wherein said first release mechanism comprises a suture or a filament or wire.
4.根据权利要求1所述的系统,还包括用于引导所述固定装置引入的导向管。 4. The system of claim 1, further comprising guide means for guiding the introduction of the fixed tube.
5.根据权利要求4所述的系统,其中所述导向管包括用于遥控偏转所述导向管的机构。 5. The system according to claim 4, wherein the guide tube comprises means for remotely controlling the deflection of the guide tube.
6.根据权利要求1所述的系统,还包括互锁机构,用于防止在没有预先启动所述第一释放机构之前所述第二释放机构启动。 6. The system according to claim 1, further comprising an interlock mechanism for preventing the second release mechanism is not activated prior to activating the first pre-release mechanism.
7.根据权利要求1所述的系统,还包括被耦接到所述假体从而将所述假体的第二区域从所述导管轴释放的第三释放机构以及操控所述第三释放机构的第三致动器。 7. The system according to claim 1, further comprising a body coupled to the prosthesis such that the third region of the second release mechanism releasing the prosthesis from the catheter shaft and said third control releasing mechanism the third actuator.
8. 一种系统,包括纵向顺应假体,所述纵向顺应假体具有一个近端和一个远端,导管装置,所述导管装置被确定了尺寸并且被设置为用于引入到中空身体器官或者血管中的靶位,所述第一导管装置包括:轴,所述轴被确定了尺寸并且被设置为在所述导管装置引入的过程中携带所述假体, 第一释放机构,所述第一释放机构耦接到所述假体的近端从而将所述假体的所述近端固定到所述导管轴,以及操控所述第一释放机构的第一致动器,第二释放机构,所述第二释放机构耦接到所述假体的所述近端,与所述第一释放机构协作以防止在所述第一致动器启动之后所述假体的所述近端从所述导管轴完全释放,由此所述第一致动器的启动使得位于所述靶位的所述假体近端从所述导管轴被部分释放,而不是从所述导管轴完全释放所述假体的所述近端,以及操控所述 8. A system, comprising a longitudinally compliant prosthesis, the longitudinal compliant prosthesis having a proximal end and a distal end, the catheter device, the catheter device is determined and set as a dimension for introduction into the hollow body organ or a target blood vessel, said first conduit means comprises: a shaft are determined in size and is arranged to carry the prosthesis during introduction of said catheter means, a first releasing mechanism, the first a release mechanism coupled to the proximal end of the prosthesis so that the proximal end of the prosthesis is secured to said catheter shaft, and control the first actuator means releasing said first, second release mechanism , the second release mechanism coupled to the proximal end of the prosthesis, cooperating with the first release mechanism to prevent after the start of the first actuator from the proximal end of the prosthesis the catheter shaft is fully released, whereby the start of the first actuator such that the prosthesis proximal end portion of the target is released from the catheter shaft, the catheter shaft and not completely released from the said proximal end of the prosthesis, and the control 第二释放机构将所述假体的所述近端从所述导管轴完全释放的第二致动器,以及第三释放机构,所述第三释放机构独立于所述第一和第二释放机构耦接到所述假体的所述远端,以及操控所述第三释放机构将所述假体的所述远端从所述导管轴完全释放的第2/2页三致动器,以及固定装置,所述固定装置被确定了尺寸并且被设置为引入到被所述导管装置所占据的所述中空身体器官或者血管中的所述靶位,所述固定装置包括致动器,用于在启动所述第一释放机构之后并且在启动所述第二和第三释放机构之前,在所述假体的所述近端配置固定器。 The second release mechanism to the proximal end of the prosthesis is completely released from the catheter shaft of the second actuator, and a third release mechanism, said third release mechanism independent of the first and second release means coupled to the distal end of the prosthesis, and the third control means to release the distal end of the prosthesis is completely released from the catheter shaft, page 2/2 three actuators, and a fixing means, said fixing means is determined and the size of the disposed hollow body organ or the target vessel is introduced into said conduit means is occupied, the fixing means comprises an actuator, with and prior to starting said second and third release mechanism, the proximal end of the prosthesis fixture arranged after starting the first release mechanism.
9.根据权利要求8所述的系统,其中所述第二释放机构包括至少一个从所述导管轴悬垂的稳定臂。 9. The system of claim 8, wherein the release mechanism comprises at least a second stabilizing arm from the catheter shaft depending.
10.根据权利要求8所述的系统,其中所述第一释放机构包括缝合物或者细丝或者线。 10. The system according to claim 8, wherein said first release mechanism comprises a suture or a filament or wire.
11.根据权利要求8所述的系统,还包括引导所述固定装置引入的导向管。 11. The system of claim 8, further comprising a guide tube guiding the fixing means introduced.
12.根据权利要求11所述的系统,其中所述导向管包括遥控偏转所述导向管的机构。 12. The system according to claim 11, wherein said remote control means comprises a deflection guide tube of the guide tube.
13.根据权利要求8所述的系统,还包括互锁机构,用于防止在没有预先启动所述第一释放机构之前所述第二释放机构启动。 13. The system according to claim 8, further comprising an interlock mechanism for preventing the second release mechanism is not activated prior to activating the first pre-release mechanism.
CN 201110035203 2001-11-28 2006-08-29 Devices, systems, and methods for prosthesis delivery and implantation CN102188296A (en)

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US11/255,116 US7637932B2 (en) 2001-11-28 2005-10-20 Devices, systems, and methods for prosthesis delivery and implantation
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