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Method and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures

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CN1204242A
CN1204242A CN 96199063 CN96199063A CN1204242A CN 1204242 A CN1204242 A CN 1204242A CN 96199063 CN96199063 CN 96199063 CN 96199063 A CN96199063 A CN 96199063A CN 1204242 A CN1204242 A CN 1204242A
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method
apparatus
bypassing
arterial
obstructions
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CN 96199063
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Chinese (zh)
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P·C·埃瓦特
J·C·弗拉赫蒂
J·T·加里博托
P·E·麦考利
T·R·麦克霍尔德
J·马科韦
J·B·惠特
C·A·维达尔
R·J·雷德蒙
T·班克斯
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血管转换公司
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Abstract

本发明是用于在哺乳类体内血管的或非血管的体内位置处血管再造,和/或施行其它医学操作的方法、部件、和系统。 The present invention is a non-vessel revascularization at a location within the body for in vivo mammalian blood vessel, and / or other medical procedures performed methods, components, and systems. 该方法一般包含从一条血管至一个血管的或非血管的目标位置的至少一条血管外通路的形成。 The method generally comprises forming a blood vessel from a blood vessel or to a target position of the at least one vessel extravascular passageway. 在该血管再造方法中,血管外通路被用作供接近或在血管的或非血管的目标位置施行操作的导管。 In the revascularization process, it is used as an extravascular passageway for the purposes of the catheter close to or in the non-operating position of the target blood vessel the blood vessel. 公开的还有可用于形成本发明的血管外通路的导管部件(100,103)和系统(138),以及供修正,维持和/或关闭这种血管外通路的装置。 Also disclosed may be used to form the conduit means (100,103) and system (138) of the present invention extravascular passageway, and correcting for, maintain and / or devices such extravascular passageway closed.

Description

为动脉阻塞物加设旁路和/或其他经血管操作的方法和装置 Method and apparatus for the arterial occlusion was added bypassed and / or other operations transvascular

相关申请本申请要求1995年10月13日提交的美国临时申请60/005,164号和1996年2月2日提交的60/010,614号申请的优选权。 RELATED APPLICATIONS This application claims the United States October 13, 1995 Provisional Application No. 010,614 application 60/60 / 005,164, and February 2, 1996 filed a preferred right. 临时申请第60/005,164号和60/010,614号的全部公开内容在此并入本文作为参考。 Provisional Application No. 60 / 005,164 and 60 / 010,614 the entire contents of which disclosure is incorporated herein by reference.

发明领域本发明主要涉及医疗方法,部件,系统,尤其涉及在a)血管再造和/或b)哺乳动物体内施行血管或非血管的医疗操作的方法,设备,系统。 Field of the Invention The present invention generally relates to medical methods, components, systems and more particularly relates to a method of a) revascularization and / or b) in a mammal purposes of vascular or vascular medical procedures, devices, systems.

发明背景A. A. Background of the Invention 涉及到血管再造操作的背景在现代医学实践中,常常需要为被阻塞的患病的及损伤的动脉的部分加设旁路。 Background related to the operation of revascularization in modern medical practice, it is often required to install a bypass as part of the diseased and damaged artery is blocked. 用于为这些阻塞的,患病的,损伤的血管加设旁路的典型手术操作需要动脉的开放手术暴露,将管状移植物连接(例如:缝合)到受损的动脉(例如:自体移值,异体移植,同族异体移植,修复或生物修复移植)以使移植物的一端连接于阻塞,患病,损伤部位的上游,移植物的另一端,在其下游连接于该动脉。 Open surgery for obstructive, diseased, vascular bypassing add these lesions typical surgical procedure requires exposure of the artery, connected to the tubular graft (e.g.: stitching) to the damaged artery (e.g.: shift value from body , allograft cognate allograft, graft repair or bioremediation) so that one end is connected to the graft occlusion, illness, injury site upstream, the other end of the graft, downstream thereof connected to the artery. 在这种方法中动脉血通过旁路移植物开通道,因而恢复被阻塞的,患病的或损伤动脉远端部位的血流,以预防组织缺血,梗塞和其他由于经过患病动脉的受损血流造成的后果。 In this method, by arterial bypass grafts open channel, thereby restoring the blocked, diseased or damaged blood flow in the artery distal sites to prevent tissue ischemia, infarction and the other due to the diseased artery through loss of blood flow consequences.

虽然外科动脉旁路移植已经在体内各个部位施行,但其最典型的动脉加设旁路操作是用于进行以下的治疗:ⅰ. Although arterial bypass graft surgery has been practiced in various parts of the body, but most typical artery and bypass operation is provided for the following treatments: ⅰ. 冠状动脉疾病或ⅱ. Coronary artery disease, or ii. 影响下肢的周围血管疾病。 Peripheral vascular disease affecting the lower extremities.

ⅰ. Ⅰ. 冠状动脉病冠状动脉病一直是全世界发病率和死亡率的主要原因之一。 Coronary artery disease, coronary artery disease has been one of leading causes of morbidity and mortality worldwide. 冠状动脉病的典型病因是在冠状动脉内形成动脉粥样硬化斑,这种动脉硬化斑的堆积易于导致冠状动脉血流的全部或部分阻塞,如果不治疗可导致心肌局部缺血、梗塞和死亡。 Typical causes of coronary artery disease is the formation of atherosclerotic plaques in the coronary arteries, which tends to cause arteriosclerotic plaque accumulation all or partially blocked coronary flow, if left untreated can cause myocardial ischemia, infarction and death .

许多年以来,传统的冠状动脉病的外科治疗一直是采用冠状动脉加设旁路手术。 For many years, the traditional surgical treatment of coronary artery disease has been established plus coronary artery bypass surgery. 其中病人通常被麻醉,放置心肺旁路(体外循环),并且病人的心脏暂时停止工作。 Which the patient is usually anesthetized, placed cardiopulmonary bypass (CPB), and the patient's heart temporarily stopped working. 进行开胸(例如:正中胸骨切开)用外科解剖的方式暴露阻塞的冠状动脉,用一条或更多的病人的人隐静脉或乳内动脉做旁路移植。 Open chest (e.g.: median sternotomy) with blocked coronary anatomy surgically exposed, with one or more human patients with saphenous vein or internal mammary artery bypass grafts do. 将收集的动脉或静脉部分吻合到阻塞的冠状动脉,以围绕动脉的阻塞形成旁路导管。 The collected portion of an artery or vein obstruction to coronary artery anastomosis, is formed around the artery to block the bypass duct. 这种传统的冠状动脉加设旁路的外科治疗方法是昂贵的,极度具有创伤性的,这种手术与术中的术前的合并症有明显的关系。 This conventional surgical treatment of coronary artery plus bypassing expensive, having extreme traumatic, this operation has a significant relationship with complications preoperative surgery.

对传统的冠状动脉加设旁路的外科治疗的一种替代方式是球囊血管成形术。 An alternative to the traditional coronary bypass surgical treatment plus provided is balloon angioplasty. 在球囊血管成形术中,一个柔韧的引导导管,经皮插进周围动脉(如:股动脉),且通过管腔推进穿过血管,直到导管的远端抵达被阻塞的冠状动脉的开口处为止。 In balloon angioplasty, a flexible guide catheter, is inserted percutaneously peripheral arteries (eg: femoral artery) and advanced through the blood vessel through the lumen until the distal end of the catheter is blocked coronary arteries arrival opening until. 此后,一个球囊导管穿过引导导管并进入阻塞的损伤部位。 Thereafter, a balloon catheter through the guide catheter and into the injury site blocked. 将球囊导管的球囊一次或更多次地充盈,以扩张阻塞损伤区域的冠状动脉。 The balloon catheter balloon filling one or more times, to dilate the blocked artery damaged area. 这些球囊血管成形术比传统的冠状动脉加设旁路的外科治疗方法,花费少且损伤少。 Surgical treatment of these balloon angioplasty than conventional bypassing coronary, less costly and less damage. 然而,这种球囊血管成形术的方法有相当比率的血管形成部位发生再狭窄的病例。 However, this method has a balloon angioplasty angiogenesis considerable portion of the restenosis rate cases. 这种再狭窄的原因和机制一直是不断在研究的题目。 This causes and mechanisms of restenosis has been the subject of continued research. 但是,这种再狭窄通常被归因于:a)动脉壁上的团块增大(例如:新内膜形成),b)动脉壁的增厚,而团块中基本没有改变。 However, this is generally attributed to restenosis: agglomerate a) an increase in the arterial wall (e.g.: neointima formation), b) thickening of the arterial wall, and substantially no change in the agglomerates. (如:血管重塑)和/或c)经球囊扩张操作产生的动脉壁裂痕和裂隙在恢复时经球囊扩张的动脉壁呈辅射状收缩。 (Such as: vessel remodeling) and / or c) of the arterial wall as a balloon-shaped secondary emission systolic arterial wall cracks and fissures produced by the recovery operation by the balloon.

另一种传统的冠状动脉加设旁路手术治疗方法是冠状动脉内阻塞物质的血管腔内去除术(例如:动脉切开术)或削磨术(例如:超声,激光)。 Another conventional coronary artery bypass surgery plus provided treatment substances within an endovascular occlusion of coronary ablation (e.g.: arteriotomy) or atherectomy cutting (e.g.: ultrasonic, laser). 这些血管腔内去除或削磨操作是通过导管放置去除或削磨装置穿过血管系统到达冠状动脉的阻塞部位。 The endovascular skiving or removing operation is to remove or skiving apparatus through the vascular system to the obstruction site through a catheter placed in the coronary artery. 这种导管放置的去除或削磨装置是利用切,刮,声波,粉碎或气化或另外方式从冠状动脉腔内消磨阻塞物质。 This catheter placement or removal of the device is the use of sharpened cutting, scraping, sound waves, grinding, or otherwise kill or vaporized material from the blocked coronary angioplasty. 这种操作过程必须小心谨慎以避免对动脉壁造成穿孔或损害,因为这种穿孔或损害能够引起出血或过多的疤痕和继发的动脉腔的再闭塞。 This operation care must be taken to avoid damage to the arterial wall or perforations, such as perforation or damage can cause excessive bleeding or reocclusion scars and secondary lumen of the artery. 此外,这些削磨操作,至少在一些情况下,由于需要小心地控制和去除被从阻塞物上除掉或分离出的碎片,以预防这种阻塞物的碎片避免进入病人的循环系统,使这个过程显得混乱。 Further, the sharpening operation, at least in some cases, the need to be carefully controlled and remove debris are removed or separated from the stopper, such debris to prevent obstruction of the circulatory system into the patient's avoided, so that the process appears confusing.

动脉切开术的导管和其他导管放置的切除装置的实例已经被描述于美国专利第3,433,226号(Boyel),3,823,717号(Pohlman,等),4,808,153号(Parisi),4,936,281号(Stasz),3,565,062号(Kuris),4,924,863号(Stener),4,370,953号(Don Michael,等),5,069,664号(Suess,等),4,920,954号(Alliger,等)和5,100,423k号(Fearnot),以及外国专利/专利公开文献EP0347098A2(Shiber),WO87-05739(Cooper),WO89-06515(Bernstein,等),WO90-0130(Sonic Needle Corp.),EP316789(DonMicheal,等),DE3,821,836(Schubert),DE2438648 (Pohlman),和EP0443256A1(Barush)。 Examples of the cutting device arteriotomy placement of catheters and other catheters have been described in U.S. Patent No. 3,433,226 (Boyel), No. 3,823,717 (Pohlman, et al), 4,808,153 (Parisi), number (Stasz) 4,936,281, No. 3,565,062 (Kuris), No. 4,924,863 (Stener), No. 4,370,953 (Don Michael, etc.), 5,069 , No. 664 (Suess, et al), 4,920,954 (Alliger, etc.), and number (Fearnot) 5,100,423k, and foreign patents / patent publications EP0347098A2 (Shiber), WO87-05739 (Cooper), WO89-06515 (Bernstein, etc.), WO90-0130 (Sonic Needle Corp.), EP316789 (DonMicheal, etc.), DE3,821,836 (Schubert), DE2438648 (Pohlman), and EP0443256A1 (Barush).

其他替代传统的冠状动脉旁路的外科治疗方法还包括:最小创伤性的内窥镜操作,至少是直接地,在病人胸壁上的切一个小切口(如:1-3cm)将胸腔镜和相关的手术器械穿过这个切口进行手术。 Other alternative to traditional coronary artery bypass surgical treatment method further comprising: minimal invasive endoscopic procedures, at least directly, to the patient's chest wall cut a small incision (eg: 1-3cm) and the associated thoracoscopic the surgical instrument through the incision surgery. 这种最小创伤性冠状动脉加设旁路操作已在美国专利第5,452,733号(Sterman等)中描述。 This addition provided a minimally invasive coronary bypass operation is described in U.S. Patent No. 5,452,733 (Sterman, etc.). 假如这些最小创伤性的冠状动脉旁路操作是完美的,进行这种最小创伤操作的病人相对于进行传统动脉旁路手术治疗者可以减少不舒服感和缩短恢复时间。 If these minimally-invasive coronary artery bypass operation is perfect, for such a patient in a minimally invasive operation is performed with respect to a conventional arterial bypass surgery can reduce the sense of discomfort and recovery time. 然而,这种典型的内窥镜外科手术操作需要大量的操作者技术和训练。 However, such a typical endoscopic surgical procedure requires a lot of operator skill and training. 而且,与用传统的冠状动脉加设旁路的手术方法一样,这些胸腔镜的操作过程一般是在全身麻醉下进行的,一般需要一个或多个胸管在手术后的一段时间里被留在固定的位置以引流从移植吻合口漏出的任何血液,并减少气胸的发生。 Further, with the conventional surgical methods bypassing coronary added as the thoracoscopic operation is generally carried out under general anesthesia, or more typically a chest tube is required to remain in a period of time after surgery from a fixed position to drain any leaked graft anastomosis blood, and reduce the incidence of pneumothorax. 这种气胸是由于在胸壁上全层切口的形成而引起的。 This is due to the formation of pneumothorax full thickness incision in the chest wall caused. 此外这种胸腔镜的冠状动脉旁路的一些操作需要病人被放置心脏旁路且病人的心脏暂停止工作。 In addition, some operations such coronary artery bypass patient in need thoracoscopic cardiac bypass is placed and the patient's heart is stopped temporarily. 另外一些这种胸腔镜操作意在不放置病人的心肺旁路且不停止心脏工作时能够被使用。 Others can be used when such a thoracoscopic procedure a cardiopulmonary bypass is not placed in the intended patient work without stopping the heart. 然而,这种意在没有心肺旁路和心脏停止跳动的能够被使用的胸腔镜的操作是相对复杂的操作,并且一般需临时挟闭或结扎将被加设旁路的冠状动脉。 However, this is not intended to operate in cardiac arrest and cardiopulmonary bypass thoracoscopic can be used is a relatively complex operation, and generally will be temporarily closed nip coronary ligation or bypassing is added. 因此,甚至这种没有心肺旁路/心脏停止工作下可以被使用的胸腔镜操作也由于操作的复杂性和需要暂停止挟住或结扎被加设旁路的冠状动脉而易有独特的和显著的危险性和困难。 Thus, even without such a cardiopulmonary bypass / heart stops working thoracoscopic procedure may also be used due to the complexity and the need to temporarily stop or ligature is applied to clamp the coronary artery bypass operation provided a unique and apparent significant risks and difficulties. 这样,与传统的冠状动脉手术有关的许多弊端,以及附加的潜在的弊端,可以与这些最小创伤的胸腔镜操作相关联。 Thus, many drawbacks associated with conventional coronary surgery, as well as additional potential drawbacks, the operation may be associated with these minimally invasive thoracoscopic.

另一种上文提到过的实际上没有为冠状动脉阻塞加设旁路但是仍然可以被用于改善心肌缺血区域的血流的操作过程,是被称为经心肌血管再造术(TMR)的操作。 Another, previously mentioned is virtually no increase coronary artery occlusion bypassed but may still be used to improve blood flow during myocardial ischemia operation region, is known by the myocardial revascularization procedures (TMR) operation. 在TMR操作中利用一根能穿透组织的探针,如激光探针形成许多全层穿过缺血心脏壁的穿透通道进入左心室腔。 Penetrate tissue with a probe in a TMR operation, as many laser probe is formed through the full thickness of ischemic heart wall into the ventricular cavity through passages. 来自左心室的氧合血液隙后向外流,通过这个穿透通道,以便灌注缺血的心肌。 After oxygenated blood from the left ventricle to drain gap, through which through passages, so that perfusion of myocardial ischemia. 这种经心肌血管再造术操作的实例被描述于美国专利第5,554,152号(Aita等),5,380,316号(Aita等),和5,125,926号(Linbares等)。 This is described in U.S. Patent, Nos. No. 5,554,152 (Aita et) No. 5,380,316 (Aita et) 5,125,926 (Linbares etc.) Examples of myocardial revascularization procedures by operation.

一种改进的TMR操作需要从左心室到阻塞的冠状动脉,阻塞的下游处形成一种加瓣膜的和/或内部加斯坦特固定膜的经心肌道路(例如:在心肌壁形成的一种组织间隙隧道)。 An improved TMR operation requires from the left ventricle to the coronary artery occlusion, myocardial path formed by an addition valve and / or fixed inside Vegas Tante downstream blocking film (e.g.: myocardial wall formed in an organizational gap tunnel). 这种改进的TMR的操作被描述于美国专利第5,287,861号(Wilk),5,409,019号(Wilk),和5,429,114号(Wilk)。 Operation of such an improved TMR is described in U.S. Patent No. 5,287,861 (Wilk), (Wilk), and number (Wilk) 5,429,114 Number 5,409,019.

ⅱ. Ⅱ. 周围血管病周围血管病通常是由动脉粥样硬化斑的形成和/或血栓物质在周围动脉内导致。 Peripheral vascular disease peripheral vascular disease is usually caused by formation of atherosclerotic plaques and / or thrombi in peripheral arteries substance. 在许多情况下,当下肢动脉由于周围血管病形成阻塞时,即产生称为一种间歇跛行的现象。 In many cases, when the lower extremity arterial occlusion due forming peripheral vascular disease, which produce the phenomenon known as an intermittent claudication. 间歇跛行是以用力(即走路或跑步)时,患腿出现疼痛和进行性乏力为特点的。 Intermittent claudication is forced (i.e., walking or running), suffering from leg pain and characterized by progressive weakness.

对周围血管病治疗的一般外手术方法,特别是对表现出间歇跛行症状的病人中,是用经手术暴露患病的动脉并吻合一种管道的旁路移植物(例如,一种编织的聚酯或膨胀的聚四氟乙烯(ePTFE)形成的管)到患病的动脉,以使这种移植物的一端被连结于阻塞物的上游,移植物的另一端连结于阻塞物的下游。 General surgical treatment of the outer peripheral vascular disease, especially for exhibiting symptoms of intermittent claudication in a patient, the diseased artery is exposed and with surgically stapling A pipe bypass grafts (e.g., a woven poly tube) to the diseased artery, so that this end of the graft is connected to the upstream of the obstruction, and the other end connected to graft obstruction downstream ester or expanded polytetrafluoroethylene (ePTFE) is formed. 用这种方式,动脉血将流给管状旁路移植物并绕过动脉阻塞,从而恢复血流到动脉阻塞的下游。 In this way, the arterial blood flow to the tubular bypass grafts to bypass blocked arteries and to restore blood flow to the artery downstream of the blockage.

治疗下肢周围血管病的传统的动脉旁路移植手术的一种替代方法,是称为原位静脉旁路加设的方法。 An alternative to conventional vascular disease is peripheral arterial bypass graft treatment for lower extremity surgery, vein bypass is called in situ addition of the set. 这种原位静脉加设旁路操作的施行是通过在腿部至少形成两个(2)开放的切口以在阻塞的上游和下游位置暴露患病动脉。 Such in-situ vein bypasses addition operation is performed (2) an open incision to expose the diseased position blocking upstream and downstream in the artery by formation of at least two legs. 伸展经过腿部大体平行于患病的动脉的一条周围静脉,随后通过将一种器械插入静脉去溶解或破坏位于这根静脉的静脉瓣进行准备。 After extending leg portion substantially parallel to the diseased artery in a peripheral vein followed by venous valve located in the root of the vein is prepared by dissolving one kind of instrument is inserted into the vein or to destroy. 此后从该静脉延伸的任何侧枝被切断、结扎或通过栓塞阻塞。 Thereafter any collateral vein that extends from the cut, by ligation or embolization occlusion. 这根经准备的静脉被嫁接于动脉阻塞之上和之下的位置,这根被嫁接的静脉末端被放置使接触并直接缝合于动脉于阻塞的上游和下游位置。 This warp was prepared veins grafted artery occlusion position above and below the root end of the vein graft is placed and sutured directly contacting the arterial occlusion in the upstream and downstream positions. 用这种方法,动脉血流流过经准备的静脉节段,这个经准备的静脉节的将作为旁路管道绕过动脉阻塞物。 In this way, arterial blood flows through the venous segments prepared by preparing the vein section will bypass arterial blockage as a bypass conduit. 最新的原位静脉旁路操作的实例被描述于White,R. Examples of the latest in-situ vein bypass operation is described in White, R. A和Fogarty,T. A and Fogarty, T. J. J. ,周围血管内介入法Pgs,166-169,Mosby&CO. , Interventional perivascular Pgs, 166-169, Mosby & amp; CO. (1996)。 (1996).

ⅲ. Ⅲ. 损害动脉血流的创伤和其它疾病身体的各种动脉可以被创伤损害(例如:撒裂伤,挤压损伤,钝性胶部创伤)或被血管外病症(例如:相邻的肿瘤的增生和向内生长)侵裂或挤压。 Traumatic damage to the various arterial blood flow and other physical trauma disorders may be arterial damage (e.g.: Caesar laceration, compression injury, blunt trauma adhesive portion) or extravascular disorders (e.g.: proliferation and tumor adjacent ingrowth) invasion crack or extrusion. 治疗被这种创伤或疾病影响的动脉的典型手术方法是手术暴露和分离患病的动脉节段,并随后a)切除并且重新连结或b)为患病的动脉节段加设旁路,以恢复动脉血流流经或绕过患病的动脉节段。 Treatment is typically surgical methods such arterial trauma or disease is affected artery surgically exposed and isolated segments diseased, and then a) removal and re-link or b) is added to the diseased artery section bypassed to restore blood flow through the artery segmental artery or bypass illness. 在许多情况下,被损伤和疾病影响的动脉节段可以是很大以致手术不可能进行单纯切除,患病段的除去和邻近动脉断端的端-端吻合。 In many cases, the affected arterial segment disease and damage may be so large that the simple excision surgery impossible, to remove diseased sections of the artery adjacent to the stump and the end - to - end anastomosis. 因此在这种切除的和端-端吻合是不合适的选择的情况下,在患病的动脉上连接一种管状旁道移植物,(如由编织聚乙烯,orePTET形成的管状移植物)对患病的动脉节段加设旁路可能是合乎需要的。 Therefore, in such a cutting and end - to - end anastomosis where it would not be selected in the diseased artery bypass graft A tubular connection, (e.g., a woven tubular graft polyethylene, orePTET formation) of diseased arterial segments plus bypassed may be desirable.

虽然上述许多手术操作代表相对最新的进展,与传统手术方法相关的侵裂性和危险已经被缓和,本领域仍需求,即为被阻塞的损伤的和患病的动脉节段加设通路而发展新的、安全的、可靠的、最小创伤和/或透过管膜的操作。 Although many of these surgical procedures represent a relatively recent advances invasion crack and hazards associated with traditional surgical methods have been eased, the art is still demand, that is blocked damaged and diseased arterial segments plus design and development path new, safe, reliable, minimum and / or operation of wound permeable membrane tube.

B. B. 涉及到其他血管外手术/介入操作的背景手术和介入操作的许多类型已经在身体的器官,组织或体腔范围内预先形成。 Vascular surgery involving other outer / surgical and interventional procedures BACKGROUND Many types of interventional procedures have been previously formed in the organ, tissue or body cavity of the body range. 传统地,进入到这种器官,组织或体腔是通过一个或更多身体的开放外科切口来完成的,从而使患病的器官,组织或体腔被外科地暴露。 Conventionally, into which organ, tissue or body cavity through a body opening or more surgical incisions to complete, so that the diseased organ, tissue or body cavity is surgically exposed.

近些年,已进行实质性的努力去发展“最小创伤”的手术技术,因而一个或更多的内窥镜被利用于观察患病的器官,组织或体腔,手术器械或其它装置被插入体内以通过相对小的“最小通路”(例如:小于3cm)切口完成要求的手术或介入操作。 In recent years, substantial efforts have been made to develop "minimally invasive" surgical techniques, and thus one or more of the endoscope is used for observation of a diseased organ, tissue or body cavity, the surgical instrument or other device inserted into the body through a relatively small "minimum path" (eg: less than 3cm) incision or surgical intervention to complete the requested operation.

虽然这些内窥镜“最小通路”手术方法的出现,其优越性超过传统的开放式的手术技术,即它们可以使手术切口缩到最小的范围内,因此可以导致最小的手术后不适,但这种内窥镜方法常被限制于通过身体的管腔和体腔可接近的操作,这种管腔或体腔可以被清亮的体液充满或用气体吹入以提供一个开放的区域放置手术内窥镜和器械于其中。 The "minimum path" Although these surgical endoscope, its advantages over conventional open surgical techniques, i.e., they may be reduced to the surgical incision within a minimum range, and therefore can result in minimal post-operative discomfort, but the method is often limited to the kinds of the endoscope through body lumens and body cavities accessible operation, such a lumen or body cavity may be filled with a clear fluid or gas is blown to provide an open area of ​​the endoscope and the surgical placement equipment in it.

鉴于与即使是最现代的“最小通道”手术和介入操作相关的限制,在本领域中仍然需要发展用于接近肿瘤,器官,组织和其他身体内血管外位置的新方法和装置,以不必在体内形成任何开放式手术切口而施行手术和/或介入性操作。 In view of the limitations associated with even the most modern "minimum channel" surgical and interventional procedures, there remains a need in the art for the development of new methods and apparatus for organs, tissues and other body extravascular location close to the tumor, in order to not have to vivo formation of any open surgical incision and the surgical repair and / or invasive procedures.

发明概要一般来说,本发明提供应用哺乳动物体内的血管系统作为一种管道以施行各种类型的医学操作的方法。 SUMMARY Generally, the present invention provides the use of the vascular system of a mammal as a conduit for the purposes of the method of various types of medical procedures. 由于遍布全身的导管管道的广泛分布,血管系统提供一种通路,通过这个通道,部件能够被移动到达选择的治疗部位,否则这些部位只可以通过一个直接切口到达。 Since the catheter tube throughout the body are widely distributed, there is provided a vascular system passageway, through this channel, the mobile member reaches the treatment site can be selected, or these parts can only reach a direct incision. 本发明的特殊方法包括a)血管再造方法,和b)在体内血管外位置进行各种类型的医疗操作的方法。 The particular method of the present invention comprises a) a method of revascularization, and b) perform various types of medical procedures in vivo method of extravascular location.

本发明的血管再造方法一般包括在血管之间,在相同血管的不同位置间,或一条血管和另一种容纳血的形态学结构(例如:心脏的腔)间,一个或更多的血管外通路的形成,以使血液流经这些通路。 Revascularization method of the present invention is generally comprised between blood vessels, between different positions in the same vessel, or a vessel and another morphological structure receiving blood (e.g.: heart chamber) between one or more outer vessel passage is formed so that blood flow through these passages. 在本发明的许多应用中,氧合血(即:pO2大于50的血)被携带通过血管外通路,以达到提供或增加组织灌注的目的是所期望的。 In many applications of the present invention, the oxygenated blood (ie: pO2 blood greater than 50) is carried through the extravascular passageway, in order to achieve or increase tissue perfusion purposes is desirable. 按照本发明的血管再造方法形成的血管外通路可用经皮,经管腔方法形成,这种方法避免了在哺乳动物体内形成开放手术切口。 Extravascular passageway formed according revascularization method of the present invention can transdermally, administered cavity forming method, this method avoids the formation of an open surgical incision in mammals. 本发明的这种血管再造方法可以适用于周围血管和/或冠状血管。 This revascularization method of the present invention can be applied to a perivascular and / or coronary vessels.

按照本发明的血管再造方法,提供了为提供动脉血流到达由于在动脉节段中存在阻塞,损伤或疾病而丧失了血流的组织的方法。 Revascularization according to the method of the present invention, there is provided a method of blocking due to damage or disease in the artery segments lost tissue blood flow reached to provide arterial flow. 这种方法通常包含:在容纳动脉血的形态学通道(例如:一个动脉或左心腔)和一个将灌注血流丧失组织的血管之间形成第一血管外通路的步骤这样动脉血将通过该血管外血流道路并且进入该血管,以通过此血管去灌注血流丧失的组织。 This method generally comprising: receiving in the arterial blood morphological channel (e.g.: an artery or the left heart chamber) and a loss of blood between the vascular tissue perfusion step of forming a first such extravascular passageway through the arterial extravascular blood flow path and into the blood vessels, blood vessels go through this loss of blood flow perfusion of tissue. 在本方法的一些应用中,第一血流通路将在一种动脉和一种邻近的静脉间被形成,这样血液将从动脉流进邻近的静脉,并随后逆行通过这条静脉以通过静脉血管系统逆向灌注组织。 In some applications of the present method, the first flow path to be formed inter arteries and one vein adjacent, so that the arterial blood will flow into the adjacent vein and then through this retrograde through the venous vein reverse tissue perfusion system. 此外,第二血流通路可以在静脉和阻塞,损伤或疾病所存在的动脉间被形成,这样已经进入静脉的动脉血将再进入该动脉,于其阻塞,创伤或被疾病影响的节段的下游,从而通过阻塞,损伤或疾病影响的节段所在的内源动脉灌注血流丧失的组织。 Further, the second flow path may be formed between the vein and the occlusion, the presence of injury or disease of the arteries, so that the arterial blood has entered the vein will reenter the artery, obstruction thereon, segments impact trauma or disease downstream, so by blocking the segments affected by disease or injury where blood loss endogenous arterial infusion of tissue. 本发明的医学操作方法主要包括,从一条血管到另一种体内位置(例如:血管组织,器官,体腔,肿瘤等)的至少一种血管外通路的形成步骤,和随后经血管外通路传递一种物质或装置,以在所选择的体内位置上进行所期望的医疗操作。 Medical operating method of the present invention mainly comprises, from one vessel to another location in the body (for example: vascular tissues, organs, body cavities, cancer, etc.) the step of forming at least one of the extravascular passageway, and subsequently a path transfer extravascular substances or apparatus to perform a desired medical procedure at a selected position on the body.

进一步按照本发明,提供一种部件,这种部件能够插进血管并能用于形成血管外通路,这种血管外通路从导管部件所插入的血管延伸至一个目标位点,(例如:a)另外的血管,b)另外的容纳血液的形态学结构(例如:心脏的腔),c)同一血管的另一个位置或d)一个血管外的位置(例如:器官,肿瘤,体腔等)。 In further accordance with the present invention, there is provided a member, such a member can be inserted into a blood vessel and an outer vessel can be used to form a passage, which passage extends from the extravascular catheter member is inserted into a blood vessel target site, (example: a) Further blood vessel, b) receiving additional blood morphological structures (e.g.: d or another location of the heart chamber), c) the same blood vessel) of a position of the outer vessel (eg: an organ, a tumor, a body cavity, etc.). 通过这个导管部件形成的血管外通路可用于施行本发明的方法,如上文所概述。 Extravascular passageway formed by this method can be used in the implementation of the conduit member of the present invention, as outlined above. 这种通路形成导管部件可以包括一种具有一个组织穿通元件(例如,一种元件,部件或能量流)的延伸的,易弯的导管体,这种元件能从导管体穿出,以通过导管所在的血管管壁,并通过位于血管和期望该通路延伸至的目标位置(例如:其他血管,解剖结构,血管外的位置,或同一血管上的其他位置)之间的任何其他组织形成通路。 Such passage forming member may include one catheter having a tissue penetrating element extending (e.g., an element or component of energy flow), the pliable catheter body, the piercing element from the catheter body, through the conduit where the vessel wall, and extending through the passageway positioned to the desired target position and the blood vessel: passage formed between any other organization (e.g. other vascular anatomical structure, the position of the outer vessel, or another location on the same blood vessel). 这种组织穿通元件可包含:一种适当类型的组织穿通元件,部件或能量流,包括但不必限于中空和/或实体的针,套管针(带或不带一种包绕的柔韧的鞘),激光束,激光发射元件,电烙器的探头,热尖探针,旋转组织穿通装置,或超声消磨探针。 This may include tissue penetrating elements: a suitable type of tissue penetrating element, component, or the energy flow, including but not necessarily limited to the hollow and / or entity needle cannula needle (with or without one wrapped flexible sheath ), laser beam, probe laser emitting element, the electrocautery, hot tip probes, rotary feedthrough tissue, or an ultrasonic probe kill. 任选地,导管部件可装备上吸引腔,可膨胀的球囊或其他结构特征或能用于易化或辅助组织穿通元件(例如元件,装置,能量流)从血管至所选择的目标位置的通过的装置。 Optionally, the conduit member may be equipped with suction chamber, or balloon expandable, or other structural features can be used easily through tissue or the auxiliary element (e.g., element, apparatus, power flow) from the vessel to the selected target position by means of. 也可以任选,导管部件的组织穿通元件可以结合一种导丝腔,或供通过由组织穿通元件形成的血管外通路传递导丝的其它工具。 May also optionally, tissue member through the conduit member may bind one guidewire lumen, or other means for passing the guidewire through the vascular tissue through the outer passage forming member.

进一步按照本发明,这种具有上述特性的通路形成导管部件可结合一种或多种供使组织穿通元件定向,以保证血管外通路在它预期的位置被形成的元件。 In further accordance with the present invention, such a passage having the above properties may be formed in the catheter member in conjunction with one or more elements for orientation through the tissue, to ensure that the element in its extravascular passageway is formed in a desired position. 这种定向装置可以安装在通路形成导管上或结合在其中,或可以与通路形成导管分离地形成,并与来自任何适合的体内的和/或体外位置的导管结合使用。 This orientation means may be mounted on a passage formed in the catheter or incorporated therein, or may be formed separately from the conduit passage is formed, and used in conjunction with catheters and / or in vitro from any suitable position of the body. 这种定向装置可以包含各种类型的主动和/被动装置,包括,但不限于,体外或体内的超声装置,体外或体内的多普勒装置,体内或体外放射显像装置,磁共振成像装置,X线断层照像装置,感应线圈,电磁部件,和各种具有导管的标记,这种标记能够通过放射显像,声,超声,照像术,MRI或其他方法辩认。 This orientation means may include various types of active and / or passive devices, including, but not limited to, in vitro or in vivo ultrasound device, a Doppler device vitro or in vivo, in vitro or in vivo radioimaging device, a magnetic resonance imaging apparatus , X-ray radiographic tomography apparatus, an induction coil, an electromagnetic component, various flags and a catheter, which can be labeled, acoustic, ultrasonic, photographic technique, MRI or other methods recognizable by radioimaging.

仍然进一步按照本发明,为去除组织,加衬,斯坦特固定模化,纵向压迫和/或通过本发明形成的血管外通路的其它修正提供通路修正部件。 Still further in accordance with the present invention, to remove tissue, lining, of stents, and other modifications longitudinal compression / or extravascular passageway formed by the present invention provides a path correcting means.

本发明的进一步目的和优点对本领域的技术人员,在阅读下文详细描述的优选实施方案后是显而易见的,其中某些本发明的优选实施方案和实例被详细提出。 Further objects and advantages of the present invention to those skilled in the art, upon reading the following detailed description of the preferred embodiments will be apparent, certain preferred embodiments and examples of the present invention are set forth in detail.

附图简述图1a是一种人类心脏的前面透视图,显示冠状动脉和其上的静脉的典型位置。 DRAWINGS Figure 1a is a perspective front view of a human heart, showing typical locations of the coronary arteries and the venous.

图1b是一种人类心脏的后面透视图,显示动脉和其上的静脉的典型的位置。 1b is a perspective view of the human heart of the latter, shows a typical arterial and venous locations on.

图1c是通过位于图1a的1c节段中相邻的冠状动脉和冠状静脉的纵剖图,其中按照本发明的血流通路已经形成,以为冠状动脉内的阻塞加设旁路。 Figure 1c is a longitudinal sectional view through section 1c in FIG. 1a positioned adjacent coronary artery and coronary vein, wherein the flow path in accordance with the present invention have been formed, that within the coronary artery occlusion plus bypassed.

图1d是一种通过图1c的1d-1d线的横剖图。 Figure 1d is a cross-sectional view through line 1d-1d of Figure 1c.

图1e是一种Brouck-Moscheau三角的简图,该三角为一种通过人类心脏的某些冠状动脉和冠状静脉限定的解剖学界标。 Figure 1e is a schematic view of one kind of Brouck-Moscheau triangle, the triangle defined by some as a coronary artery and coronary vein of the human heart anatomical landmarks. 可在右前斜位X光片上看到。 It can be seen in the right anterior oblique X-ray film.

图1f是本发明的另一种血管再造方法透视图,其中血管外组织间隙通路从血管上的第一位置(阻塞的上游)向同一血管上的第二位置(阻塞的下游)形成。 FIG. 1f is another perspective view of revascularization method of the present invention, wherein the extravascular tissue (downstream occlusion) via a gap from a first position (upstream occlusion) of a blood vessel to a second location on the same blood vessel formation.

图1f′是图1f中所示血管的一种透视图,本发明的血管再造方法的已完全运用以形成绕过阻塞的旁路通道。 FIG. 1f 'shown in FIG. 1f is a perspective view of one of the vessels, the use of completely revascularization method of the invention to form a bypass passage bypassing the obstruction.

图2是一种人体的透视图结合按照本发明用于在体内一个血管外位置上施行医学操作的经血管的方法的一种图解说明。 FIG 2 is a perspective view illustrating the body of a binding for performing a medical operation in the blood vessel within the outer vessel position by a method according to the invention.

图2a是一种图2的目标组织的放大的透视图,显示组织穿通元件从通路形成导管穿入目标组织的方式。 2a is an enlarged perspective view of a target tissue FIG. 2, showing a catheter penetrate the target tissue through tissue is formed from the passage member.

图2a′是一种图2的目标组织的放大图,显示一种接近管道,这种管道已经被推进通过和/或被交换进入血管外通路进入目标组织。 FIG. 2a 'of the target tissue is an enlarged view of FIG. 2 A, A proximity display pipeline, which has been advanced through the duct and / or exchanged into extravascular passageway into the target tissue.

图2b是一种具有皮下注射开口内在传递/取样套管的示意图,这种套管用于重复输注/抽出物质,或监测目标区域中的条件。 FIG 2b is a schematic view of the internal opening subcutaneous delivery / sampling cannula having a cannula which is repeated infusion / extraction material, or monitoring the condition of the target region.

图2c是经血管外通路插入的导管的示意图,该导管被用于临时展开一种部件进入目标区域,监测目标区域中的条件,或向目标区域输注/或从中抽出物质。 2c is a schematic view of vascular access catheter inserted through the outside of the catheter is used to temporarily expand the A component into the target area, the target area of ​​the monitoring condition, the target area or infusion / withdrawal therefrom or substance.

图2d是利用本发明的血管外通路永久放置的部件(如,流体引流分流器)的示意图。 Figure 2d is a schematic diagram of the present invention is the use of the extravascular passageway is permanently placed member (e.g., fluid feed splitter) is.

图2e是一种导管的示意图,该导管经过本发明的血管外通路插入并进入另一条管状形态学通路的管腔,用于取样,接近或在管状形态学通路中施行手术或介入操作。 Figure 2e is a schematic view of a catheter, and the catheter inserted into the lumen via another tubular passage through the outer vessel morphology of the present invention, for sampling, or surgical intervention performed near or operate in a tubular passage morphology.

图2f是按照本发明施行血管外微手术的经血管操作的示意图。 Figure 2f is a schematic diagram of extravascular vascular microsurgery operations performed by the present invention according to.

图3a是显示按照本发明形成的未修正血流通路的纵剖图。 FIG 3a is a longitudinal sectional view of the uncorrected flow path formed in accordance with the present invention.

图3b是显示按照本发明形成的内部加衬血流通路的纵剖图。 Figure 3b is a longitudinal sectional view of the flow path formed inside of the lining according to the present invention.

图3c是显示按照本发明形成的纵行压迫血流通路的纵剖图。 Figure 3c is a longitudinal sectional view of the longitudinal compression flow path formed in accordance with the present invention.

图3d是具有非突出的斯坦特固定膜或斯坦特固定膜性移植物置于其中的本发明的血流通路纵剖图。 FIG 3d is a non-protruding film or stents Stent graft membrane longitudinal sectional view of the blood flow passage in which the present invention is placed.

图3d′是一种透视图,显示任意选择的凸缘和/或任意选择的凸出物,它们可以被结合入可置于按照图2d的本发明的血流通路中的非突出斯坦特固定膜或斯坦特固定膜性移植物。 FIG. 3d 'is a perspective view showing a flange arbitrarily selected and / or projections arbitrarily selected, they can be incorporated into the flow path may be placed in accordance with the present invention secured to FIG. 2d in a non-protruding Stent film or membrane graft stents.

图3e是通过本发明的血流通路的剖面图,在该血流通路中具有半突出的或突出的斯坦特固定膜或斯坦特固定膜性移植物的第一实施方案。 Figure 3e is a sectional view of the present invention, the blood flow through the passage, a first embodiment having a projecting or protruding half stents Stent film or membrane graft in the blood passage.

图3f是通过本发明的第一和第二血流通路的剖面图,在该血流通路中具有突出的斯坦特固定膜或斯坦特固定膜性移植物的第二实施方案。 Figure 3f is a cross-sectional view through the first and second flow path of the present invention having a second embodiment of the projection of a film or stents Stent graft membrane of the blood passage.

图4a是按照本发明形成动静脉血流通路的第一方法的图示。 4a is illustrating a first method for forming the flow passage of the arterial and venous blood in accordance with the present invention.

图4b是按照本发明形成动静脉血流通路的第二方法的图示。 4b is a form illustrating a second method of the arterial and venous blood flow path in accordance with the present invention.

图4c是按照本发明形成动静脉血流通路的第三方法的图示。 Figure 4c illustrates a third method is to form the flow passage of the arterial and venous blood in accordance with the present invention.

图4d是按照本发明形成动静脉血流通路的第四方法的图示。 4d is a form illustrating a fourth method of the arterial and venous blood flow path in accordance with the present invention.

图4e是按照本发明形成动静脉血流通路的第五方法的图示。 FIG 4e is formed arteriovenous illustrating a fifth method according to the present invention, the flow passage.

图5a是一种两个(2)相邻血管的纵剖图,阐明了为定向,瞄准并引导一种组织穿通元件以形成按照本发明的动静脉血通路的第一方法。 Figure 5a is a two (2) adjacent a longitudinal sectional view of the blood vessel, to clarify the orientation and aiming one tissue through the guide member to form a first passage arteriovenous method according to the invention.

图5b是一种邻近动脉和静脉的纵剖图,阐明了为定向,瞄准,并引导一种组织穿通元件以形成按照本发明的动静脉血流通路的第二方法。 FIG 5b is a longitudinal cross-sectional view of an adjacent artery and vein, to illustrate the orientation, aiming, and one tissue through the guide member to form a second method according to the present invention, arterial and venous blood flow passage.

图5c是一种邻近动脉和静脉的纵剖图,阐明了为定向,瞄准,并引导一种组织穿通元件以形成按照本发明的动静脉血流通路的第三方法。 FIG. 5c is a longitudinal cross-sectional view of an adjacent artery and vein, to illustrate the orientation, aiming, and one tissue through the guide member to form a third method according to the present invention, arterial and venous blood flow passage.

图5d是一种邻近动脉和静脉的纵剖图,阐明了为定向,瞄准,并引导一种组织穿通元件以形成按照本发明的动静脉血通路的第四方法。 FIG. 5d adjacent arteries and veins is a longitudinal sectional view of a clarified directional, aiming, and one tissue through the guide member to form a fourth passage of the arterial and venous blood method according to the invention.

图5e是一种图示,阐明一种为利用被动的放射显像可见的标记物去定向,瞄准和/或引导一种组织穿通元件去形成按照本发明的血管血管外通路的方法。 Figure 5e is an illustration, as explained a radioimaging using passive markers visible to the orientation of targeting and / or guide elements through one tissue to blood vessel formation method according to the present invention the extravascular passageway.

图5e′说明一种按照图5e可以被利用的放射显像标记的第一类型。 Figure 5e 'in Figure 5e illustrates a first type may be utilized radioimaging labeled.

图5e″说明一种按照图5e可以被利用的放射显像标记的第二类型。 FIG. 5e "illustrates a second type may be utilized in accordance with FIG. 5e radiation imaging marker.

图5e说明一种按照图5e可以被利用的放射显像标记的第三类型。 FIG 5e a type described in FIG third 5e may be utilized radioimaging labeled.

图5f是一种图示,说明一种利用超声可见标记去瞄准,校直和/或引导一种组织穿通元件以形成按照本发明的血管外通路的方法。 Figure 5f is an illustration, using an ultrasonic illustrates a visible mark to aim, alignment, and / or one tissue through the guide member to form a passage according to the method of the present invention the extravascular.

图5f′是图5f中所示超声可见标记的透视图。 FIG. 5f 'shown in FIG. 5f is a perspective view of ultrasonically visible marker.

图5g是一种用MRI去定向,瞄准或引导一种组织穿通元件,以形成按照本发明的血管外通路的方法的示意图。 Figure 5g is a directed to use MRI, aiming or guiding one tissue penetrating member, to form a schematic diagram of a method according to the present invention extravascular passageway.

图5g′是一种用磁共振成像(MRI)可见标记易化定向,瞄准和/或引导组织穿通元件形成按照本发明的一种血管外通路的第一实施方案的透视图。 FIG. 5g 'is a perspective view of a magnetic resonance imaging (MRI) is oriented visible indicia facilitated, aiming and / or guide element formed tissue through a first embodiment according to the present invention an intravascular outer passage.

图5g″是一种用磁共振成像(MRI)可见标记易化定向,瞄准和/或引导组织穿通元件形成按照本发明的一种血管外通路的第二实施方案的透视图。 FIG. 5g "is a visible mark facilitated orientation, a perspective view and / or guide element formed tissue through a second embodiment according to the present invention an intravascular outer passage aim with a magnetic resonance imaging (MRI).

图5h是一种图示,说明利用多普勒装置易化定向,瞄准和/或引导组织穿通元件以形成按照本发明的一种血管外通路的方法。 Figure 5h is an illustration, the device described Doppler facilitated orientation, aiming and / or tissue through the guide member to form an intravascular method according to the present invention the outer passage.

图5i是一种图示,说明压力感受装置易化组织穿通元件的定向,瞄准和/或引导以按照本发明形成血管外通路的方法。 Fig 5i is a illustration, a pressure sensing means easily directed through tissue elements, aiming and / or guide a method of forming an extravascular passageway in accordance with the present invention.

图5j是一种图示,说明利用发射器和接受器装置来定向,瞄准和/或引导组织穿通元件以按照本发明形成一种动静脉血流通路的方法。 FIG. 5j is an illustration, described with reference emitter and receiver means directed to a method of arterial and venous blood flow passage is formed according to the present invention aiming and / or tissue through the guide element.

图5k是一种图示,说明利用发射和感应线圈装置来定向,瞄准和/或引导一种组织穿通元件以按照本发明形成动静脉血流通路的方法。 Fig 5k is an illustration, using the described transmitting means and the induction coil is oriented, aimed, and / or the guide means of organization arteriovenous flow passage is formed in accordance with the present invention through elements.

图5l是一种图示,说明利用磁性装置定向,瞄准和/或引导一种组织穿通元件以按照本发明形成一种动静脉血流通路的方法。 FIG. 5l is an illustration, using a magnetic device orientation described, aiming and / or guide method of one tissue in arterial and venous blood flow passage forming member according to the present invention, through.

图6a是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第一方法。 Figure 6a is a longitudinal sectional view of a portion of the catheter through the vascular tissue through the present invention, illustrating a first method of tissue through exit element from the catheter.

图6b是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第二方法。 FIG 6b is a longitudinal cross-sectional view of a portion of the catheter through the vascular tissue through the present invention, a second method of tissue penetrating element from the catheter exit.

图6c是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第三方法。 FIG 6c is a longitudinal cross-sectional view of a portion of the catheter through the vascular tissue through the present invention, a third method of tissue penetrating element from the catheter exit.

图6d是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第四方法。 Figure 6d is a longitudinal cross-sectional view of a portion of the catheter through the vascular tissue through the present invention, a fourth method of tissue penetrating element from the catheter exit.

图6d′是通过图6d所示导管部件的远端末端的透视图。 FIG. 6d 'is a perspective view of the distal tip of the catheter through the member shown in FIG. 6d.

图6e是本发明的穿血管的组织穿通导管的一部分的纵剖图。 Figure 6e is a longitudinal sectional view of a portion of the catheter through the vascular tissue through the present invention. 说明组织穿通元件从导管中退出的第五方法。 Description of organizations fifth method element exits from the catheter through.

图6f是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第六方法。 Figure 6f is a longitudinal sectional view of a portion of the catheter through the vascular tissue through the present invention, a sixth element through a tissue to exit from the catheter.

图6g是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第七方法。 FIG. 6g is a longitudinal sectional view of a portion of the catheter through the vascular tissue through the present invention, a tissue through a seventh element exit from the catheter.

图6h是本发明的穿血管的组织穿通导管的一部分的纵剖图,说明组织穿通元件从导管中退出的第八方法。 FIG. 6h is a longitudinal sectional view of a portion of the catheter through the vascular tissue through the present invention, a tissue through an eighth element exit from the catheter.

图6i是本发明的穿血管的组织穿通导管的一部分纵剖图,说明组织穿通元件从导管中退出的第九方法。 FIG 6i is a longitudinal sectional view through a portion of the catheter through the blood vessel tissue of the present invention, a tissue through a ninth member exit from the catheter.

图7a是按照本发明的组织穿通元件的第一实施方案的远端部分纵剖图。 Figure 7a is a longitudinal sectional view of the distal portion of the element through a first embodiment according to the present invention is organized.

图7a′是一种沿图7a的7a′-7a′连线的横剖图。 FIG 7a 'in FIG. 7a is a 7a'-7a' cross-sectional view of the connection.

图7b是按照本发明的组织穿通元件的第二实施方案的远端部分纵剖图。 Figure 7b is a partial longitudinal sectional view of the distal end through a second embodiment of the device according to the embodiment of the present tissue.

图7c是按照本发明的组织穿通元件的第三实施方案的远端部分纵剖图。 FIG 7c is a longitudinal cross-sectional view of the distal portion of the element through the tissue according to a third embodiment of the present invention.

图7d是按照本发明的组织穿通元件的第四实施方案的远端部分纵剖图。 Figure 7d is a longitudinal cross-sectional view of the distal portion of the element through a fourth embodiment according to the present tissue.

图7d′是图7d沿7d′-7d′连线的横剖图。 FIG 7d '7d 7d'-7d is a view along a cross-sectional view of the connection.

图7e是按照本发明的组织穿通元件的第五实施方案的远端部分的纵剖图。 Figure 7e is a longitudinal sectional view of the distal portion of the tissue according to the fifth embodiment of the present invention through the elements.

图7e′是图7e沿7e′-7e′连线的横剖图。 FIG. 7E '7e 7e'-7e is a view along a cross-sectional view of the connection.

图7e″是通过图7e中所示部件的替换实施方案的横剖图,它包含有一种实性的管心针位于其中的一种中空管。 Figure 7e "is a cross-sectional view of an alternate embodiment of the embodiment shown in FIG. 7e member, there is a solid comprising stylet located therein a hollow tube.

图7f是按照本发明的组织穿通元件的第六实施方案的远端部分的纵剖图。 Figure 7f is a longitudinal sectional view of the distal portion of the tissue according to the present invention through the elements of the sixth embodiment.

图7f′是形成图7f中所示组织穿通元件一部分的尖端带套管的延伸元件的透视图。 Figure 7f 'is a perspective view of a portion of the extension member tip element with the sleeve is formed as shown in FIG tissue through 7f.

图7g是按照本发明的组织穿通元件的第七实施方案的远端部分的纵剖图。 FIG. 7g is a longitudinal sectional view of the distal portion of the seventh embodiment of the element according to the present invention through tissue.

图7h是按照本发明的组织穿通元件的第八实施方案的远端部分的纵剖图。 FIG. 7h is a longitudinal sectional view of the distal portion of the tissue according to the present invention through the elements of the eighth embodiment.

图7i是按照本发明的组织穿通元件的第九实施方案的远端部分的纵剖图。 FIG 7i is a longitudinal sectional view of the distal portion of the tissue according to the present invention through the elements of the ninth embodiment.

图7j是按照本发明的组织穿通元件的第十实施方案的远端部分的纵剖图。 FIG. 7j is a longitudinal sectional view of the distal portion of the tissue according to the tenth embodiment of the present invention through the elements.

图7k是按照本发明的组织穿通元件的第十一实施方案的远端部分的纵剖图。 FIG 7k is a longitudinal sectional view of the distal portion of the tissue according to the eleventh embodiment of the present invention through the elements.

图7l是按照本发明的组织穿通元件的第十二实施方案的远端部分纵剖图。 FIG 7l is a longitudinal sectional view of the distal portion of the tissue according to a twelfth embodiment of the present invention through the elements.

图7m是按照本发明的组织穿通元件的第十三实施方案的远端部分纵剖图。 FIG 7m is a partial longitudinal sectional view of the distal tissue according to a thirteenth embodiment of the present invention through the elements.

图8a是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第一实施方案。 Figure 8a is a longitudinal sectional view which shows a first embodiment of an apparatus for correcting a tissue gap formed in accordance with the present invention passage.

图8b是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第二实施方案。 FIG 8b is a longitudinal sectional view which shows a second embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8c是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第三实施方案。 Figure 8c is a longitudinal sectional view which shows a third embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8d是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第四实施方案。 Figure 8d is a longitudinal sectional view which shows a fourth embodiment of an apparatus for correcting a tissue gap formed in accordance with the present invention passage.

图8e是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第五实施方案。 FIG. 8e is a longitudinal sectional view which shows a fifth embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8f是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第六实施方案。 FIG. 8f is a longitudinal sectional view which shows a sixth embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8g是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第七实施方案。 FIG. 8g is a longitudinal sectional view which shows a seventh embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8h是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第八实施方案。 FIG. 8h is a longitudinal sectional view which shows an eighth embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8h′是图8h部件的正视图,该部件被用于修正按照本发明形成的动静脉血流通路。 FIG. 8h 'is a front view of FIG. 8h member, the movable member is used for correcting venous flow passage formed in accordance with the present invention.

图8i是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第九实施方案。 Fig 8i is a longitudinal sectional view which shows a ninth embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图8j是一种纵剖图,该图显示用于修正按照本发明形成的组织间隙通路的装置的第十实施方案。 FIG. 8j is a longitudinal sectional view which shows a tenth embodiment of an apparatus for modifying tissue according to the present invention, a gap is formed passage.

图9a是一种部件的第一实施方案的正视图,该部件能够用于纵行压缩按照本发明形成的动静脉通路。 9a is a front view of a first embodiment of a member, the compression member can be used for arteriovenous access wale formed in accordance with the present invention.

图9a′图9a中所示的部件的部件分解透视图。 FIG. 9a 'component member shown in Figure 9a an exploded perspective view of FIG.

图9b是一种部件的第二实施方案的正视图,该部件能够用于纵行压缩按照本发明形成的动静脉血流通路。 9b is a front view of a second embodiment of a member, which member can be compressed to form a wale according to the present invention, arteriovenous flow path.

图9b′是安装于一种传递导管内的图9b部件的部分纵剖图。 FIG. 9b 'is attached to a partial longitudinal sectional view of the inner member of Figure 9b delivery catheter.

图9b″是部分地弹出其运送导管的图9b部件的一种透视图。 Figure 9b "which is a perspective view of the catheter of FIG conveying member 9b is partially ejected.

图9b是完全地弹出其运送导管的图9b部件的一种透视图。 FIG 9b is a perspective view of one kind of pop-up completely its conveying member 9b of the catheter of FIG.

图9c是一种部件的第三实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通路。 9c is a front view of a third embodiment of a member, the member can be used to compress the wale blood flow according to the present invention, the movable path.

图9d是一种部件的第四实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通路。 Figure 9d is a front view of a fourth embodiment of a member, the member can be used to compress the wale arteriovenous flow passage according to the invention.

图9e是一种部件的第五实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通道。 Figure 9e is a front view of a fifth embodiment of a member, which member can be compressed in the wale for arterial and venous blood flow channel of the present invention.

图9f是一种部件的第六实施方案的正视图,该部件能够用于纵行压缩按照本发明的动静脉血流通路。 FIG. 9f is a front view of a sixth embodiment of a member, the member can be used to compress the wale blood flow according to the present invention, the movable path.

图9f′是安装于一种运送导管内的图9f部件的部分纵剖图。 FIG. 9f 'is attached to a partial longitudinal sectional view of the inner member of FIG. 9f conveying conduit.

图9f″是一种图9f部件在其被安装于其运送导管内时的透视图。 FIG. 9f "FIG. 9f is a perspective view of a member when they are conveyed within the catheter mounted thereon.

图9f是部分地展开至其运送导管外的图9f部件的纵剖图。 FIG 9f is a longitudinal sectional view of FIG conveying member 9f outer catheter to partially deployed.

图9f″″是充分展开至其运送导管外的图9f部件的横剖图。 FIG. 9f "" is fully expanded to its cross-sectional view of the catheter of FIG. 9f outer conveying member.

图10a是一种本发明的经血管组织穿通导管部件的第一实施方案的透视图。 10a is a perspective view of a first embodiment according to the present embodiment of the catheter member through the vascular tissue by the invention.

图10b是通过图10a的10b-10b连线的纵剖图。 Figure 10b is a longitudinal sectional view through the connection 10a of FIG. 10b-10b.

图10c是通过图10a的10c线的纵剖图。 Figure 10c is a longitudinal sectional view through the line 10c of FIG. 10a.

图10d是通过图10a的10d-10d连线的横剖图。 Figure 10d is a cross sectional view through the connection 10a of FIG. 10d-10d.

图10c′是一种可任选的导丝/鞘推进装置的示意图,这种装置可以被结合进本发明的经血管组织穿通导管的任何实施方案。 FIG. 10c 'is a schematic view of an optional guide wire / sheath propulsion device, such a device may be incorporated into the present invention through the vascular tissue through any of the embodiments of the catheter.

图10c″是导管部件的组织穿通元件正在穿通组织时图10c′的装置的示意图。 FIG. 10c "is a schematic diagram of the apparatus of FIG. 10c 'of the tissue penetrating element of the catheter member is through tissue.

图10c是这种组织穿通元件已经穿通组织和进入一种血管管腔或开放腔之后图10c部件的示意图。 FIG 10c is a schematic diagram of this element through tissue after the tissue has been through and enter into a vessel lumen or cavity opening member 10c in FIG.

图11a是通过本发明的经血管组织穿通导管部件的第二实施方案的手持组成部位的纵剖图。 Consisting of a longitudinal sectional view of the handheld portion of the second embodiment of FIG 11a through the vascular tissue through the present invention through the catheter member.

图11b是通过本发明的经血管组织穿通导管部件的第二实施方案的远端部分的部分纵剖图。 Vertical cross-sectional view of the distal portion of the second embodiment of FIG. 11b through vascular tissue by the present invention through the catheter member.

图11c是显示组织穿通操作第一阶段期间图11b部件的纵剖图。 Figure 11c is a longitudinal cross-sectional view of FIG. 11b during tissue member through the first stage of the operation display.

图11c是显示组织穿通操作第二阶段期间图11b部件的纵剖图。 Figure 11c is a longitudinal cross-sectional view of FIG. 11b during tissue member through the second stage of the operation display.

图11d是图11c的节段11d的放大纵剖图。 Figure 11d is an enlarged longitudinal sectional view of the section 11d of Figure 11c.

优选实施方案的详细描述下列详细描述和其所提及的附图仅仅是为描述本发明的某种当前优选的实施方案的目的而提供,并不意在以任何方式限制本发明的范围。 Detailed Description of the Preferred Embodiments The following detailed description and the accompanying drawings to which it refers only for the purpose of describing certain presently preferred embodiments of the present invention is provided, not intended to limit the invention in any way. 事实上,应理解到下面所提出的详细描述和实例仅仅是作为本发明可以被利用或实践的某些方法的实例或说明。 In fact, it should be understood that the detailed description set forth below are merely examples and may be utilized or in some instance, or illustration of the practice of the method of the present invention. 这些实例和说明并不意在穷尽描述本发明所有可能的实施方案和实例,而是意在阐述本发明可被应用于的一些但不是所有应用。 These examples and illustrations are not intended to be exhaustive description of all possible embodiments and examples of the present invention, but is intended to illustrate some, but not all applications of the present invention can be applied. A. A. 本发明的方法ⅰ. The method of the present invention i. 血管再造方法广义地说,本发明的血管再造方法提供了一种建立一或多条通路10的方法,通过该通路血液可流出或流出至少一条血管。 The method of revascularization Broadly speaking, revascularization method of the invention provides a method for establishing a pathway 10 one or more, may flow in or out of the passageway through at least one blood vessel. 在多数情况下,流经该通路的血液将优选含有大于约50的pO2。 In most cases, blood flowing through the passage will preferably contain greater than about 50 of pO2.

在某些情况下,该血管外通路10将被用于为动脉的阻塞,受损或患病节段加设旁路。 In some cases, the extravascular passageway 10 will be used to block the artery, diseased or damaged segment plus bypassed. 在本发明的某些实施方案中,只有一条第一血流通路(例如,从阻塞上游的动脉开始的通路)会形成于一条阻塞的、受损的或患病的动脉(或另一条未受损动脉或一种充满血液的形态学结构如心腔),和一条静脉之间,从而允许动脉血经该静脉逆向流动,以便通过静脉血管系统逆向灌注组织。 In certain embodiments of the invention, only a first flow path (e.g., starting from the blocked artery upstream passage) formed in an obstruction, the damaged or diseased artery (or another unprotected loss morphological structure or one filled with arterial blood, such as the heart chamber), and between a vein, the vein to allow reverse flow through the arterial blood to reverse perfused tissue by venous vasculature. 在本发明的其它实施方案中,一或多条第二血流通路也会形成于阻塞的动脉与该静脉间,阻塞的下游处,以使通过第一血流通路进入静腔管腔的动脉血能随后在阻塞的下游处进入或重新进入该动脉的管腔,从而通过被阻塞动脉的剩余(即,未阻塞的)部分灌注组织。 In other embodiments of the present invention, one or more of the second flow path is also formed between the blocked artery and vein, downstream of the blocking in the artery through the first flow path into the static chamber lumen downstream of the blood can then blocked or re-entering into the lumen of the artery, so that by the remaining (i.e., not blocked) are blocked portion of the artery perfused tissue.

虽然图1a和1b中提供的解剖图是冠状血管系统特有的,但应理解到本发明方法可应用于全身的血管而不必限于阻塞的冠状动脉的治疗(例如,股区域,主动脉髂动脉区域,等)。 While the anatomy Figures 1a and 1b are provided in the coronary vascular system-specific, it is to be understood that the method of the present invention may be applied to the body without having to be limited to treatment of coronary vascular occlusion (e.g., femoral region, aortoiliac region ,Wait).

参照附图,图1a和1b提供了人类心脏正常血管解剖学的详细图示,其中冠状动脉基本平行并邻近于冠状静脉。 Referring to the drawings, Figures 1a and 1b provides a detailed illustration of the vascular anatomy of the normal human heart, wherein the coronary substantially parallel and adjacent to the coronary veins. 图1a,1b和1e中显示的特殊解剖学结构按照下列图例标记: FIG. 1a, 1b and 1e special anatomical structure displayed in accordance with the following legend marker:

A 主动脉AIV 前室间静脉CA 冠状动脉CV 冠状静脉CS 冠状窦CIR 旋转动脉IVC 下腔静脉LAD 左前降动脉SVC 上腔静脉PA 肺动脉PV 肺静脉TA 外膜TM 中膜TI 内膜GCV 心脏大静脉图1c-1d阐述本发明的一项特殊应用,其中阻塞OB位于心脏左前部分的一条冠状动脉内。 A front chamber between the vein AIV aortic artery CA coronary sinus CS coronary vein CV rotation CIR inferior vena cava IVC artery LAD left anterior descending artery PA Pulmonary Artery SVC superior vena cava pulmonary vein PV TA TI intima tunica adventitia TM cardiac vein GCV FIG. 1c-1d describes a particular application of the invention, wherein the obstruction OB is located within a portion of the left anterior coronary heart. 如图所示,阻塞的冠状动脉CA位于邻近于,并通常平行于,一条冠状静脉CV处。 As shown, the blocking of the coronary artery CA is located adjacent to, and generally parallel to, at a coronary vein CV. 第一血流通路10a形成于冠状动脉CA和临近冠状静脉CV之间,位于动脉阻塞OB的上游处。 The first flow path 10a is formed between the coronary artery CA and the adjacent coronary vein CV, located upstream artery occlusion OB. 而且,在图1C的显示中,一条可任选的第二血流通路10b形成于冠状静脉CV的管腔与冠状动脉CA的管腔之间,位于阻塞OB的下游处。 Further, in the display of FIG. 1C, optionally a second flow path 10b is formed between the lumen and the lumen of the coronary artery CA of the coronary vein CV, located downstream of the obstruction OB. 而且,在这些图中,显示了可选择的栓塞元件12a,12b被置于冠状静脉CV的管腔中第一血流通路10a近端和可选择的第二血流通路10b的远端处的位点。 Further, in these figures, it shows an alternative plug element 12a, 12b is disposed a second distal blood flow lumen of the coronary vein CV proximal end of the first flow path 10a and path 10b selectable at site. 这些可选择的栓塞元件被用于引导进入冠状动脉CA的动脉血流通过第一血流通路10a,通过邻近冠状静脉CV的一个节段,并通过第二血流通路10b,以使动脉血在阻塞OB的下游重新进入冠状动脉CA的管腔。 These optional artery embolization element is used to guide through the coronary artery CA into the first flow path 10a, through a segment of the adjacent coronary vein CV, and through a second flow path 10b, so that the arterial blood OB downstream blocking the coronary artery CA to re-enter the lumen. 可选择的栓塞元件12a,12b可为足以阻断或阻止流动的部件之任何一种或组合,这些部件如线圈;止血材料如胶原,凝胶泡沫TM或纤维蛋白,被包被的斯坦特固定膜或框架,可拆开的球囊,瓣结构如夹,扣件或栓,等。 Alternatively the plug member 12a, 12b may be sufficient to block or prevent any one or combination of components of the flow of these components such as coils; hemostatic material such as collagen, fibrin gel foam or TM, is fixed coated Stent film or frame, detachable balloon valve structures such as clips, fasteners or bolt, and the like. 另外这些元件所起到的功能可通过使用各种方法包括结扎,熔接,凝结,或其它手术方法完成。 In addition, these elements may include features played ligation, fusion, condensation, or other surgical methods accomplished by using various methods.

如图1d的横断面图中所示,本发明的每一条血流通路10基本上是通过一条动脉(如冠状动脉CA)的管壁通过邻近静脉(如冠状静脉CV)的管壁并通过可能位于冠状动脉CA和冠状静脉CV间的任何结缔组织或膜性组织延伸的一条组织间隙隧道。 Cross-sectional view shown in FIG. 1d, the present invention, each of the blood flow passage 10 by a substantially arteries (such as coronary artery CA) through the tube wall adjacent the vein wall (e.g., coronary vein CV) and by possible located in a tunnel of any connective or interstitial tissue membrane between the coronary artery CA and the coronary vein CV extends. 以此方式,各条血流通路10是作为冠状动脉CA和冠状静脉CV的管腔间的一条流导管。 In this manner, the pieces of blood flow passage 10 is a coronary vein CV and the coronary artery CA of a flow conduit between the lumen.

图1e是称为Brouck-Moscheau三角的冠状血管系统的一部分的示意图。 Figure 1e is a schematic of a portion called the coronary vascular system Brouck-Moscheau triangle. 如图所示,Brouck-Moscheau三角由左前降冠状动脉LAD,旋转冠状动脉CIR,前室间静脉AIV和心脏大静脉GCV限定。 As shown in FIG, Brouck-Moscheau by the triangular left anterior descending coronary artery LAD, coronary rotation CIR, the anterior interventricular vein AIV and cardiac vein GCV defined. 动脉粥样硬化斑块形成所导致的阻塞常见于左前降动脉LAD和/或旋转动脉CIR的近端部分中。 Obstructive atherosclerotic plaque formation caused by common in the left anterior descending artery LAD and / or rotation of the proximal portion of the artery CIR. 本发明的血管再造方法可用于通过Bouck-Moscheau三角周围的动脉和静脉间形成适当的血流通路10而治疗左前降动脉LAD和/或旋转动脉CIR的这种阻塞。 Revascularization method of the present invention can be used passages 10 and the left anterior descending artery LAD and / or obstruction of such rotation CIR of the arterial blood flow through the formation of an appropriate cam between arteries and veins surrounding Bouck-Moscheau. 例如,如果阻塞出现在左前降动脉LAD的近端部分中,则可在心脏大静脉GCV和旋转动脉CIR间形成第一血流通路10a并在左前降动脉LAD和前室间动脉AIV间位于阻塞下游处形成第二血流通路10b。 For example, if a blockage in the LAD proximal portion of the left anterior descending artery, a first flow path 10a can be formed in a large vein GCV and rotating the heart and arteries located at the block between the CIR between the left anterior descending artery LAD artery and the anterior chamber AIV a second flow path is formed downstream 10b. 一种管腔阻塞元件12可置于心脏大静脉GCV中,第一血流通路10a近端处和/或置于前室间静脉AIV中第二血流通路10b远端处,以使来自旋转动脉CIR的动脉血通过第一血流通路10a,通过心脏大静脉GCV,通过前室间静脉AIV流动,并进入左前降动脉LAD,阻塞下游处。 A lumen blocking member 12 may be placed in the cardiac vein GCV, a first flow path 10a at the proximal end and / or the second flow path 10b disposed at the distal end of the vein AIV between the front chamber, so that the rotation from the CIR artery through a first arterial blood flow path 10a, through the heart and great vein of GCV, through the anterior vein AIV flow, and into the left anterior descending artery LAD, downstream of the blockage. 另外,在阻塞出现于旋转动脉CIR的情况中,第一血流通路10a和第二血流通路10b可以反过来,以便通过左前降动脉LAD流动的血液将通过前室间静脉AIV,通过心脏大静脉GCV流动并进入旋转动脉CIR中,阻塞的下游处。 Further, the rotation of the arterial obstruction appears in the case where the CIR, a first flow path 10a and the second flow path 10b may be reversed in order to pass the anterior vein AIV, through the heart through a large LAD left anterior descending artery blood flow and into the vein GCV flow rotation CIR artery, the downstream occlusion. 按照这些实例,应理解到本发明的血管再造方法可以以下述方式使用,即从一条动脉或从任何其它来源(例如,左心室)获得动脉血并将这种动脉血送入另一条动脉。 According to these examples, it should be understood that the revascularization method of the invention may be used in such a manner that from an artery and the arterial or obtained from any other source (e.g., the left ventricle) into another such arterial artery. 而且,按照本发明的血管再造方法,应理解第二血流通路10b至少在某些情况下可被取消并且动脉血可通过经前室间静脉AIV或心脏大静脉GCV的逆向灌注而提供给心肌的缺血区域。 Further, according to the method of the present invention revascularization, to be understood that the second flow path 10b may be canceled at least in some cases, and arterial blood may be supplied to the chamber through the myocardium through between the front or reverse vein AIV large cardiac vein GCV perfusion the ischemic area.

应理解到在本发明的血管再造方法的一些应用中,血管外通路10可包含从相同血管上的第一位置延伸至第二位置的一种组织间隙隧道。 It should be understood that in some applications revascularization method of the present invention, the extravascular passageway 10 may extend from a first position comprise on the same blood vessel to a second position a tissue gap tunnel. 如图1f中所示,具有阻塞OB形成于其中的一条血管BV可利用本发明的通路形成导管100加设旁路,这种加设旁路是通过将一种组织穿通元件102穿过阻塞上游处的血管管壁,通过邻近组织,并随后通过阻塞下游处的血管管壁。 As shown in FIG. 1f, obstruction OB having formed therein a passageway blood vessel BV may utilize the present invention catheter 100 is formed bypassing addition, this increase is by bypassing one tissue penetrating member 102 passes through the upstream occlusion at the vessel wall, through the adjacent tissue, and then through the vascular wall downstream of the blockage. 以此方式,图1f′中所示组织间隙通路10在血管BV中阻塞OB周围形成一条旁路导管。 In this manner, around FIG. 1f 'in FIG tissue obstruction OB gap passage 10 formed in the blood vessel BV is a bypass conduit.

ⅱ. Ⅱ. 在血管外位置施行手术或介入操作的方法除上述血管再造方法外,本发明还包括用于在体内血管外位置施行各种手术或介入操作的方法。 The method of surgery performed extravascular location or intervention operations in addition to the above-described method of revascularization, the present invention further comprises a method for performing a variety of surgical or interventional procedures extravascular location in the body. 本发明的这些方法通过从一条血管向一种血管外位置(如器官,组织,体腔,等)形成一或多条血管外通路并随后通过该血管外通路送入用于在血管外位置完成所期望的手术或介入操作的一或多种操作施行装置来完成。 These methods of the present invention, by forming a path from an extravascular or vascular To a extravascular location (e.g., organs, tissues, body cavities, etc.) and then fed through the extravascular passageway for completing the extravascular location one or more desired surgical or interventional devices operating purposes to complete the operation. 可按照本发明的这种方法施行的手术或介入操作的类型包括:运送治疗物质·可流动药物的运送;·一种可植入药物运送装置(例如,微球,等)的植入;·医学治疗流体的运送;·用于继续给药的接近导管的植入;·遗传学材料,细胞,微生物或病毒载体,等的植入。 This type of method may be performed in accordance with the present invention, a surgical or interventional procedure comprising: conveying transport therapeutic substance-flowable medicament; - an implantable drug delivery device (e.g., microspheres, etc.) implant; - transport of medical treatment fluid; - for near continuous administration of implanted catheters; - genetic material, cells, microorganisms, or viral vectors, such as implantation.

部件的临时或永久展开·刺激器(电的或物理的)的植入;·感受器的植入; · Temporarily or permanently deployed stimulator (electrical or physical) of the implant member; - the implant susceptor;

·电极的植入;·发射器,接受器或应答器的植入;·支持元件(如斯坦特固定膜)的植入;·标记物(如放射显像可视标记物,或溶液)的植入。 Electrode implantation; * implanted transmitter, receiver or transponder; - the implant support member (e.g., stents film); · markers (e.g., radioimaging visual marker, or solution) implantation.

组织切除术,切割术或消磨术·组织消磨术或破坏术;·组织(如,神经,纤维)的切割或横切;·肿瘤,患病组织等的切除和去除;·内源组织的扩张,伸张或其它修正以恢复开放,流动,构型,或功能。 Tissue resection, or vitrectomy surgery · kill tissue damage or kill operation procedure; - tissue (e.g., nerve fibers) or transverse cutting; - tumors and other diseased tissue excision and removal; endogenous tissue expansion · , stretching or other modifications to restore an open, flow, configuration, or function.

取样应用·组织的取样(如,活检);·固体物质(如,结石,痛风石,等)的取样;监测应用·测定在目标区域可测的压力,pH,温度,氧饱合度,溶解气体的分压,ECG,EEG,激发电位,或其它变量。 Sample application tissue sample (e.g., biopsy); solid material (e.g., stones, tophi, etc.) of the sample; monitoring application measured in the target area can be measured pressure, pH, temperature, oxygen saturation, dissolved gas partial pressure, ECG, EEG, evoked potentials, or other variables.

提供图2-2f的目的为进一步详述和阐明可按照本发明的这种实施方案实施的一些特殊介入和/或手术操作。 FIG 2-2f object is to provide further detail and illustrated embodiments may be implemented in this embodiment of the present invention, some special intervention and / or surgical procedures. 图2显示人体的示意图,其中一个本发明的通路形成导管装置100已被经皮插入一条血管(例如,股静脉)并已通过腔静脉,颈内静脉和大脑大静脉前进至邻近血管外目标区域(例如,脑室)的所期望位置。 2 shows a schematic view of a human body, wherein the passageway of the present invention forming catheter device 100 has been inserted into a blood vessel (e.g., femoral vein) percutaneously and has through the vena cava, the internal jugular vein, and cerebral vein proceeds to adjacent extravascular target area (e.g., the ventricles) in the desired position. 随后,组织穿通元件102从导管100穿过导管100的远端部分所在的大脑血管管壁并且该组织穿通元件穿过邻近大脑组织前进至脑中的一个血管外目标位置T。 Subsequently, the element 102 through the tissue of the brain through the blood vessel wall where the distal portion of the catheter from the catheter 100 and the tissue 100 through a member through the extravascular target location adjacent brain tissue proceeds to brain T. 以此方式,一条血管外通路10在大脑血管到血管外目标位置T间形成。 In this manner, an extravascular passageway 10 into the blood vessel in the brain between the extravascular target location T is formed. 在需要时,最初通过组织穿通元件102形成的通路10可按照显示于图8a-8h并在下文中详述的通路修正装置和方法进行组织切除,扩张或修正。 If desired, the first passage 102 formed by the tissue penetrating element 10 may follow via a display correcting apparatus and method, and described in detail in FIGS. 8a-8h Hereinafter tissue resection, or fix expansion.

图2a是目标区域T和通路形成导管部件100所进入的邻近血管BV的放大图。 2a is an enlarged view of 100 into the blood vessel BV adjacent the target region T and the passage forming member conduit. 最初通路形成导管部件100的组织穿通元件102被推进至导管100外,通过血管BV的管壁,并通过位于血管BV和目标区域T之间的组织。 Initially tissue passage forming member 100 through the conduit member 102 is advanced into the outer catheter 100, through the wall of the blood vessel BV and BV through tissue located between the vessel and the target area T. 此种应用中使用的组织穿通元件102优选结合一个管腔114,第二导丝GW2可通过该管腔前进至目标区域T。 Such tissue used in the application member 102 is preferably bonded through a lumen 114, a second guidewire GW2 can be advanced through the lumen to the target area T. 随后,组织穿通元件102可与通路形成导管100一起退出和去除,而将第二导丝GW2留在适当位置。 Consequently, the group member 102 may be formed through the exit passage 100 and removed together with the catheter, while the second guidewire GW2 left in place.

如图2a中所述,一种接近套管103可随后沿预置的第二导丝GW2前进,以使套针103通过血管系统延伸,通过由组织穿通元件102形成的血管外通路10而进入目标区域T。 In the FIG. 2a, A proximity sleeve 103 may then advanced along guidewire second preset the GW2, so that the trocar 103 extending through the vascular system, the vascular tissue through the outer member 102 through the passage 10 formed into the target area T. 此接近套管可随后被用作导管用于药物的导入,部件的植入,取样,监测,手术装置的展开或按照上述在血管外位置施行手术或介入操作的方法的其它应用。 This sleeve can then be used as a close a conduit for introducing an implantable drug, member, sampling, monitoring, deployment of the surgical device or other application method according to the purposes of surgical intervention or extravascular operation of the above-described position.

图2b-2f阐述可按照本发明的这一方面施行的血管外手术或介入操作的几类特定实例。 FIGS. 2b-2f types set forth specific examples of extravascular surgical or interventional procedures may be performed in accordance with this aspect of the present invention.

参照图2b,一种皮下开口装置105可安置于接近套管103的近端,并可用于经该接近套管103注射或抽出可流动物质(例如,药物,医学治疗流体,放射显像对比溶液,细胞,遗传学材料,微生物或病毒载体等),进入目标区域T。 Referring to Figure 2b, one subcutaneously opening device 105 may be disposed near the proximal end of the sleeve 103 and may be used through the cannula 103 near the injection or withdrawal of flowable material (e.g., a drug, medical fluid treatment, radioimaging comparative solution , cellular, genetic material, microorganisms or viral vectors, etc.), into the target area T. 另外,开口装置105和套管103可用来在目标区域T完成压力或其它条件的定期监测(例如,通过用流体填充套管103并将一根连接至压力传感器的针插入开口装置105,可获得目标区域T处的压力读数)。 In addition, opening means 105 and the sleeve 103 may be used to complete the regular monitoring of pressure or other conditions in the target area T (e.g., a pressure sensor connected to the needle through the cannula 103 filled with a fluid and inserted into the opening device 105, obtained pressure readings at the target region T). 因此,图2b阐明了具有位于皮下的注射开口105的内在接近套管103可被用于连续地将可流动物质注入/抽出目标区域T的方法。 Thus, Figure 2b illustrates an injection under the skin having an opening 105 near the inner sleeve 103 may be used to continuously inject the flowable material / extraction method of the target region T. 可通过将药物反复输注至体内特定目标区域T治疗的疾病类型的特殊实例包括帕金氏病,癫痫,高血压,肿瘤,抑郁症,阿采默病,睡眠疾患,行为疾患,运动障碍,等。 By repeated infusion of the drug to a particular instance of a particular body type of targeted disease areas, including the treatment of T Pa's disease, epilepsy, high blood pressure, cancer, depression, Ah mining silent disease, sleep disorders, behavioral disorders, movement disorders, Wait. 另外,接近套管103和注射开口105可用作一种用于定期输注替代流体或溶液以实现各种类型替代治疗的工具。 Further, the sleeve 103 and close the injection opening 105 can be used as an alternative method for periodic infusion solution or fluid replacement therapy implement various types of tools. 这些应用也可用图2c中所示部件施行。 These applications may also be implemented as shown in FIG member 2c.

图2c显示另一种安排,其中该接近套管103被从腹中取出并被用作将临时部件106送入目标区域T的导管。 Figure 2c shows another arrangement, in which the sleeve 103 is removed from near the belly and used as a temporary member 106 into the target region T catheter. 该部件106可被连接至能发送某些形式的能量至部件106或从部件106接受信息的体外装置107。 The member 106 may be connected to some form of energy can be transmitted to the extracorporeal device 106 or receiving member information from member 106,107. 可使用的体外装置107的类型的实例包括,但不必限于,电信号产生器,电烙器装置,放射频率信号产生器,低温装置,超声产生器,示波器的类型,监视器,图表记录器,电流计,激光,观察仪器,其它仪器,等。 Examples of types of extracorporeal device 107 that may be used include, but are not necessarily limited to, electrical generator, electrocautery apparatus, the radiation frequency of the signal generator, a low temperature device, an ultrasonic generator, the type of the oscilloscope, a monitor, a chart recorder, galvanometer laser, observation equipment, other equipment, and the like. 可通过临时放置的部件106被送至目标区域T的治疗类型的特殊实例包括组织的无线电频率切割(例如,心脏内的神经束或致心律不齐传导束)低温组织破坏(例如,肿瘤的),电烧灼术(例如,为止血或消磨组织),等。 106 can be sent to specific examples of the type of treatment of the target region T by the temporary placement member comprises a radio frequency tissue cutting (e.g., nerve bundles within the heart rhythm, or arrhythmias induced tracts) cryogenic tissue destruction (e.g., a tumor) electric cautery (for example, to stop bleeding or kill tissue), and so on. 几类可与临时放置的部件106一起使用的监测或信息回收操作的实例包括局部EEG测定法,局部ECG测定法,电流计反应记录,氧饱和度测定,溶于流体中的气体分压测定,pH测定,特殊电解质或其它化学物质浓度的电极测定,等。 Examples of monitoring information or the recovery operations can be used with several types of the temporary placement member 106 includes a local EEG assay, local ECG assay, a recording galvanometer reaction, oxygen saturation measurement, fluid dissolved gas partial pressure measurement, pH measurement, special measuring electrode electrolyte concentration or other chemicals, and the like.

图2d显示本发明的一种应用,其中接近套管103被用于从目标区域T持续地引流流体。 FIG 2d shows an application of the present invention, wherein the cannula 103 is used to close the drainage of fluid from the target area T continuously. 在此方式中,接近套管103的近端上设有许多出口小孔109,以使在目标区域T中收集的过量流体通过接近套管103的管腔向近端引流并引流到出口小孔109外。 In this manner, the sleeve is provided with a plurality of exit near the proximal end 103 of the aperture 109, so that excess fluid was collected in the target region T near the drainage through the lumen 103 of the cannula proximally and drainage to the outlet aperture 109 outside. 在其中有出口小孔109形成的接近套管103的近端部分可从腹中取出以使过量流体被引流至一种在体外放置的容器或器皿,或者替代地被植入体内(如腹膜腔)的另一个位置以使过量的流体会流入这种身体的其它区域,在那里通过自然的生理功能被吸收而不对身体引起损伤或危害。 In which the outlet aperture 109 is formed near the proximal portion of the cannula 103 can be removed from the belly so that excess fluid is drained into the container or vessel A placed vitro, or alternatively be implanted in the body (e.g., the peritoneal cavity ) at another location so that excess fluid will flow into other areas of the body, where it is absorbed without causing damage or harm to the body through the natural physiological functions. 这种应用的一个实例是使用套管103作为一种内部分流或从脑室引流过量脑脊液至体内的第二位置(如,腹膜腔)。 One example of such an application is the use of split sleeve 103 as an internal or draining excess CSF from the ventricle to a second position (e.g., the peritoneal cavity) in vivo. 由于套管103是通过血管系统和通过按照本发明产生的血管外通路10植入的,植入套管103使用的技术可经皮实施,而不象利用植入用于治疗脑积水和其它疾病的流体引流分流部件的其它方法那样典型地需要大的手术切口。 Because the sleeve 103 through the vascular system and extravascular by following the path 10 of the present invention produced implantation, implantation technique sleeve 103 may be implemented using the skin, unlike the use of implants for the treatment of hydrocephalus, and other other methods of draining the fluid diverter member as a disease typically require a large surgical incision.

图2e显示本发明的另一种特殊应用,其中接近套管103从血管BV延伸,通过本发明的血管外通路10并进入第二管状形态学通路或导管的管腔111,即本应用中的目标T。 Figure 2e shows another particular application of the invention in which the sleeve 103 extends from near the vessel BV, according to the present invention by extravascular passageway 10 and into the second tubular morphology passage 111 or lumen of the catheter, i.e. the present application target T. 几类可形成本发明的这项应用中的目标T的管状通路或导管包括血管,生殖泌尿管道,外分泌管道,内分泌管道和淋巴管道。 Form a tubular passage of several types of target T the application of the present invention include a catheter or a blood vessel, genito-urinary duct, pipe exocrine, endocrine, lymphatic ducts and pipes. 在接近套管103被置于目标管道或通路T的腔111中后,此方法学的任何上述所述应用均可使用,包括样本的抽出或药物的输注,部件的展开,等。 After the cavity 111 in the target duct or passage T in the sleeve 103 is placed in proximity, any of the above-described application of this methodology may be used, including expand sample withdrawal or drug infusion, member and the like.

图2f阐明本发明的应用的另一种特殊实例,其中接近套管103通过血管系统,通过本发明的血管外通路10延伸,并进入一个目标区域T,以使一或多种手术器械113可被送至目标区域T以实现在目标区域T中施行手术(例如,微手术)操作。 FIG. 2f illustrate another specific example of the application of the present invention, wherein the sleeve close 10310 extending through the vascular system, according to the present invention by extravascular passageway, and into a target area with T, so that one or more of the surgical instrument 113 may T is sent to the target area in order to achieve the purposes of surgery (e.g., micro-surgery) in the target area T operation. 以此方式,被从腹中取出的控制系统115可被连接至手术器械113并可用于在目标区域T中行使手术器械113的所期望操作和处理。 In this manner, been removed from the belly of the control system 115 may be connected to the surgical instrument surgical instrument 113 can be used to exercise in a target region T 113 and the processing operation desired.

ⅲ. Ⅲ. 通路的类型图3a-3f和以下提出的详细描述,描述了按照本发明形成的血管外通路10的某些类型。 Passage of the type described in detail in FIG. 3a-3f, and set forth below, describes certain types of passage 10 according to the present invention is formed in an outer vessel. 图3a-3f所示以及以下的详细描述,只仅仅是被做为可以形成的通路的类型的实例而提出,并不意在穷尽描述按照本发明可以应用的通路10的所有可能的类型。 The following detailed description and illustrated in FIG. 3a-3f, and is only just, and are not intended to all possible types of exhaustive description of passage 10 according to the present invention can be applied as examples of the type of path that may be formed. 此外,应当认识到,尽管图3a-3f所示标明通路10形成于一条静脉和动脉之间,图3a-3f阐明的通路的多种修正可以被广泛应用于按照本发明形成的任何或全部类型的血管外通路10,只要这种修正合适的话。 Further, it should be appreciated that, although FIG indicated between a path as shown in 3a-3f 10 is formed in an artery and vein, 3a-3f illustrate various modifications of the path map may be widely applied to any or all of the type formed in accordance with the present invention extravascular passageway 10, as long as such modifications if appropriate. 实际上,图3a-3f所示以及以下详细描述的通路10并不局限于动脉和静脉之间,而且可以广泛应用于本发明的所有通路10中。 In fact, the path described in detail below and shown in FIGS. 3a-3f 10 between arteries and veins are not limited, and can be widely applied to all channels 10 of the present invention.

如图3a所示,通路10包括非斯坦特固定膜性,无衬里的组织间隙的隧道(图3a)。 As shown in FIG. 3a 10 passages comprising a non-membrane stents, unlined tunnels tissue gap (FIG. 3a). 另外,如图3b-3f所示,这种通路10可以配备有各种类型的表面修正或辅助装置,例如管状衬里(图3b)、纵行约束夹子(图3c)、或局限于通路10之内的斯坦特固定膜或斯坦特固定膜性移植片(图3d),或自起超出通路10的斯坦特固定膜或斯坦特固定膜性移植片(图3e-3f)。 Further, as shown in FIG, 10 may be provided with such openings 3b-3f various types of surface correction or the auxiliary means, such as a tubular liner (FIG. 3B), the clip wales constraints (FIG. 3C), or the restricted passage 10 stents or stents membranes within membrane graft (FIG. 3d), or from the film passage 10 exceeds stents or stents graft membrane (FIGS. 3e-3f).

特别参照图3a,显示了在两条血参间延伸的通路10,它没有任何斯坦特固定膜、衬里、管材、包被、瓣膜、表面修正、布置于通路10内的物质或装置。 With particular reference to Figure 3a, shows a passage extending between the two blood parameters 10, it has no stents film, liners, tubing, coating, valves, correction surface, substance or device disposed within the passage 10. 在这点上,这种非斯坦特固定膜性、无衬里的、未修正的通路10仅仅是一条延伸于二条血管间的组织间隙的隧道(例如,一条穿刺通道或隧道),从而血液可以由一条血管的管腔流进另一条血管的管腔。 In this regard, stents such non-membrane, unlined, uncorrected passage 10 is only a tunnel extending between the two vascular tissue gap (e.g., a puncture channel or tunnel), so that blood may be made flows into the lumen of a blood vessel lumen of another blood vessel.

图3b显示了一条形成于二条血管之间的通路10,有一个管状内衬20置于其中。 Figure 3b shows a passage is formed between the two vessels 10, a tubular liner 20 disposed therein. 这种内部衬里20可以包括一段刚性的或易弯的塑料管,一层生物可容性聚合物包被,一层不同于周围组织类型的细胞(例如,内皮细胞层生物组织移植片等),一层可以通过激光处理、电烙术等条形成修正厚度的组织,或任何与非斯坦特固定膜性且未加衬里的通路10本身内表面类型不同的物质。 This inner liner 20 may comprise a length of rigid or pliable plastic tube, a layer of bio-compatibility polymer coating, a layer of tissue types different from the surrounding cells (e.g., endothelial cell layer biological tissue graft, etc.), tissue modification layer may be formed by laser treatment thickness, electrocautery like strip, or with any of various non stents membrane lining the passage itself and not the inner surface 10 types of substances. 通路10内的这种衬里20可以被用来:a)易化血流以层流而非端流通过通路10,或b)避免缘于周围肌肉自然收缩的不必要通路关闭或组织向通路10内生长。 This passage 10 within the liner 20 may be used to: a) facilitated blood flow rather than laminar flow through the end passage 10, or b) to avoid unnecessary due to natural shrinkage passage surrounding muscle or tissue of the closing passage 10 internal growth. 在衬里20是通过对通路10的壁应用可流动物质或能量(例如,产生可控制的组织化学灼伤或生物相容性聚合物包被的化学物质,内皮细胞悬浮液,等等)而形成的情况中,参照本发明的部件,可以通过应用诸如图8h-8h″所示以及以下更全面描述的部件来完成应用这些可流动物质于通路10的壁。 In the liner 20 is formed by the wall of passage 10 on the flowable substance or application of energy (e.g., generating a controlled burn histochemical or biocompatible polymer coating chemicals, endothelial cell suspension, etc.) case, with reference to components of the invention can be accomplished by the use of these substances and the flowable components shown and described more fully below, such as those illustrated 8h-8h "to the passage wall 10.

图3c显示通路10,其中安置了纵行约束装置22以便纵行压迫通路10的相对端互相接近,从而使位于血管间的任何组织(例如,疏松结缔组织)变紧密。 Figure 3c shows the passage 10, which is disposed opposite the end 22 of the passage 10 so that longitudinal compression wales restraint device close to each other, such that any organization (e.g., loose connective tissue) is located between the compacted vessel. 这种纵行约束装置22也可以被安置,来为通路10提供幅射状支持,和/或维持开口状态。 This longitudinal restraint apparatus 22 may also be positioned to provide support for the radiation-shaped passage 10, and / or maintaining an open state. 在通路10所连接的血管位于器官表面(例如,位于心脏表面的冠状动脉和静脉)、或位于海绵状或疏松组织(例如,疏松结缔组织)、或动脉和静脉间存在开放空隙时,在本发明的这些应用中,约束装置22纵行压迫通路10的应用可能特别重要。 When vascular access connector 10 located on the organ surface (e.g., surface of the heart's coronary arteries and veins), or in the spongy tissue or loose (e.g., loose connective tissue), or the presence of open voids between arteries and veins, in the present these applications of the invention, the restraining means 22 wales compression passage 10 is applied may be particularly important. 这些海棉状或疏松组织的存在可以允许流动于通路10中的血液渗进动脉和静脉之间的这些组织或空隙,因而可能导致血肿形成。 The presence of these spongy tissue or loose passage may allow blood flowing in these tissues infiltrated or voids 10 between the artery and vein, which may lead to hematoma formation. 可以被用于纵行压迫如图2c所示的血流通路10或易化通过向侧吻合连接二条血管的约束装置22的特定类型的实例,图示于图9a-9f,并参照9a-9f更全面地描述于下文。 Blood may be illustrated in FIG. 2c for compression longitudinal passage 10 or facilitated by instances of a particular type of constraint means laterally connecting two vascular anastomosis 22, illustrated in FIGS. 9a-9f, 9a-9f and reference described more fully below.

图3d显示本发明的通路10,有一个非凸出的斯坦特固定膜或斯坦特固定膜性移植片24置于通路10之内。 3d shows a passage 10 according to the present invention, there is a non-protruding film or stents Stent graft membrane 24 disposed within the passageway 10. 这种斯坦特固定膜或斯坦特固定膜性移植片24可以包括一个压力可扩张或自行扩张的栓状斯坦特固定膜或框架,并且可选择地,可以被诸如由编织聚酯或扩张的聚四氟乙烯(ePTFE)的柔韧节段的连续管状元件所覆盖。 Such film or stents Stent graft membrane 24 may include a bolt-shaped frame or a film stents pressure expandable or self-expandable, and optionally, can be woven polyester, such as polyethylene or expanded by the tetrafluoroethylene (ePTFE) is a continuous tubular element covered with a flexible segment. 安置这种斯坦特固定膜或斯坦特固定膜性移植片24于通路10内,可以用以维持通路10处于基本上开放的形状,以易化非湍流血流流过通路10。 Such stents disposed film or membrane graft stents 24 in passage 10, can be used to maintain the shape of the passage 10 is substantially open, to facilitated through the non-turbulent blood flow passage 10. 斯坦特固定膜或斯坦特固定膜性移植片24可以由任何合适的材料形成,包括,但并不限于,各种类型的压力可扩张或自行扩张的丝网或互相编织的聚合材料条带。 Stent Stent film or membrane graft 24 may be formed of any suitable material, including, but not limited to, various types of pressure expandable or self-expandable wire mesh or woven polymeric material strip with one another. 在斯坦特固定膜性移植片24被应用的情况下,斯坦特固定膜性移植片24上的管状移植片覆盖可以是连续的或部分的,从而斯坦特固定膜只有一部分被覆盖。 In the case of film-Stent graft 24 is applied, stents graft tubular graft membrane sheet 24 of the covering can be continuous or portion so stents film only partially covered.

应当理解,当应用一个凸出的斯坦特固定膜性移植片(例如,被覆盖的斯坦特固定膜26或28)时,可以不必要再安置可选的栓塞元件12于斯坦特固定膜性移植片26、28延伸其内的血管管腔之内,因为斯坦特固定膜性移植片上的管状外覆盖将被用来限定一个通过血管管腔的闭合流动导管,并将基本上阻断通过那部分血管内部的血流,因此不需要单独的栓塞元件12。 It should be understood that, when applied to a convex membrane graft stents (e.g., stents covered with the film 26 or 28), the plug member may not necessarily be re-arranged alternative stents 12 to graft membrane sheets 26, 28 within the vessel lumen extending therein, the outer cover because the tubular membrane graft stents would be used to define a closed conduit to flow through a blood vessel lumen, and that portion is substantially blocked by inside the blood vessel, and therefore it does not require a separate plug element 12.

图3d′显示斯坦特固定膜或斯坦特固定膜性移植片24a的修正,包括一个凸缘25和/或自斯坦特固定膜或斯坦特固定膜性移植片24a的一端或二端延伸的垂直凸起27,以保持斯坦特固定膜性移植片24a在通路10中处于基本上固定的纵行位置。 FIG. 3d 'show stents correction film or a film of graft stents 24a includes a flange 25 and / or vertically from one end of the film or stents Stent graft membrane 24a extending ends or protrusion 27 to maintain a film of graft stents 24a in a substantially fixed position in the longitudinal passage 10.

图3e显示半凸起或凸起的斯坦特固定膜或斯坦特固定膜性移植片26,它可以按照如图3d所示的非凸起的斯坦特固定膜或斯坦特固定膜性移植片24的同样方式被设置,但与图3d所示不同的是它在通路10末端之外凸出或延伸,进入动脉A和静脉的毗邻部分。 Figure 3e show stents film projection or projections or semi stents graft membrane 26, which can be in a non-convex film as shown in FIG. 3d stents or stents graft membrane 24 it is arranged in the same manner, but it is shown in FIG different projection or extends beyond the end of the passage 10, into the next portion of the arterial and venous a 3d. 如图3e所示,当如此展开时,这个斯坦特固定膜或斯坦特固定膜性移植片26将基本上采取“S”形状,以易化层状、非湍流的血流沿所期望的方向通过通路10。 As shown in FIG. 3e, when so deployed, the stents Stent film or membrane graft 26 taken substantially "S" shape to facilitated layered, non-turbulent blood flow in the desired direction through the passage 10. 图3e的点状线阐明了斯坦特固定膜或斯坦特固定膜性移植片26的一个“半凸起的”实施方案,其中,其一端与通路10的一端对齐,同时其另一端延伸进入邻近通路10解剖结构(例如,静脉)。 The dotted line in Figure 3e illustrates a film or stents Stent graft membrane 26 "half raised" an embodiment, wherein one end thereof is aligned with an end of passage 10 while the other end extends into the adjacent anatomy passage 10 (e.g., intravenous). 斯坦特固定膜或斯坦特固定膜性移植片26的这种“半凸起的”实施方案,可以被应用,从而不阻塞任何可能穿过动脉A的血流,并且,对于那些阻塞OB是不完全的患者和仍有些动脉血流通过动脉A的患者而言,将特别有可用性。 Such film or stents Stent graft membrane 26 "half raised" an embodiment, may be applied so as not to block any blood flow through the artery A is possible, and, for those who are not blocking OB some patients are still full and arterial blood flow through the patient's arteries a, will be particularly availability. 对于阻塞OB是完全性的其它患者,应用斯坦特固定膜或斯坦特固定膜性移植片26的完全“凸起的”方案可能比较合适,如图3e中的点状线所示,其中,这些斯坦移固定膜或斯坦特固定膜性移植片26从通路10的二端延伸而出,进入邻近的解剖结构(即,静脉和动脉)。 For complete obstruction OB is "convex" scheme may be appropriate in other patients with complete application or a film stents Stent graft membrane sheet 26, as shown in FIG. 3e dotted lines, wherein these Stein fixed shift film or membrane Stent graft 26 extends out from the two ends of the passage 10, into the adjacent anatomical structure (i.e., venous and arterial).

图3f显示另外一种凸起的斯坦特固定膜或斯坦特固定膜性移植片28,它延伸贯穿第一条血流通路10a,并且它另外凸起穿过动脉A和静脉V邻近部分的可选的第二条血流通路10b,由此形成一条连续“U”形导管,通过它的官腔,层状非端流血流可以通过通路10a和10b。 FIG. 3f Show stents film which projection or stents graft membrane 28, which extends through the first flow path 10a, and it is further raised through the artery and vein A portion may be adjacent to V selected second flow path 10b, thereby forming a continuous "U" shaped conduit through which bureaucratic, non-laminar blood flow through side passages 10a and 10b.

应当理解,一个或多个瓣膜也可以形成于斯坦特固定膜或斯坦特固定膜性移植片24、26、28的任何一个实施方案,或管状衬里20中,或纵向约束装置22中,或通路10中,以易化血流以所期望的方向通过通路10,同时减少或避免血液沿与所期望方向的反方向通过通路10返流。 It should be understood that one or more of the valves may be formed in a film or stents Stent graft membrane any of the embodiments 24, 26, or tubular liner 20, or 22 in the longitudinal constraint, or passage means 10, the flow of blood to the facilitatory desired direction through the passage 10, while reducing the risk of blood or reverse direction along a desired direction through the passageway 10 reflux.

ⅳ. Ⅳ. 用于在二条血管间形成通路的穿血管方法图4a-4e和随后的详细描述,是为阐明某些方法而提出的,这些方法可被用来在二条血管间形成血管外通路10,以完成本发明的某些血管再造方法。 Vessel through the following detailed description method of FIG. 4a-4e and passages formed between the two vessels is used, is to clarify some of the methods proposed, these methods can be used to extravascular passageway 10 is formed between the two vessels to complete some revascularization method of the present invention. 图4a-4e所示以及随后的详细描述并不意在穷尽阐明可以用来形成通路10的所有可能的方法,而只是提供了用于这些操作的目前已知的方法的实例。 As well as the following detailed description are not shown in FIGS. 4a-4e illustrate intended to be exhaustive of all possible methods may be used for forming passage 10, but as merely providing examples of the presently known methods of these operations. 此外,尽管在图4a-4e所示阐明的应用中,阻塞OB存在于一条血管内,这些图中所阐明的基本方法可以应用于多种血管再造方法中,这些方法中,通路10的形成并非用于绕过阻塞的目的,或者其中阻塞OB位于远离通路10形成地点的位置。 Further, although in the application shown in FIGS. 4a-4e illustrate in blocking OB present in a blood vessel, the basic method set forth in these figures may be applied to various revascularization methods, these methods, passage 10 is not formed for the purpose of bypassing the obstruction, wherein the obstruction OB or passage 10 is formed at a position remote from the location. 此外,应当理解,图4a-4c阐明的方法不必形成于二条血管之间或一条动脉与静脉之间。 Further, it should be understood that the method set forth in Figures 4a-4c need not be formed between the two vessels or between a vein and an artery. 实际上,这些方法可以应用于任何血管和任何其它中空解剖结构之间,并可用作静脉到静脉、动脉到动脉或静脉到动脉通路10。 In fact, these methods may be applied between any of the blood vessels and any other hollow anatomical structure, and can be used as an artery or vein to vein into the artery 10 via veins, arteries to.

图4a显示一种方法,其中,导管100通过管腔向前进入一条动脉A,组织穿通元件102从导管100穿过,通过动脉A管壁,通过动脉A和静脉V之间的组织,通过静脉的管壁,形成第一通路10a。 Figure 4a shows a method, wherein the catheter 100 into the artery through the lumen of a forward A, tissue penetrating element from the catheter 102 through 100, A through an artery wall, through the tissue between the artery and vein A V, through a vein wall, forming a first passage 10a. 用这种方式形成第一血流通路10a后,一条导丝可以通过组织穿通元件102或通过导管100,并通过新形成的第一通路10a。 After forming a first flow path 10a in this embodiment, a guide wire may pass through the element 102 through tissue or through a conduit 100, through the first passage 10a and the newly formed. 然后,停用组织穿通元件(例如,退回到导管100中),将导管沿导丝向前,通过第一通路10a,进入静脉管腔,越过毗邻动脉A中阻塞OB的位置。 Then, disabling element through tissue (e.g., back to the conduit 100), the catheter along the guide wire forwardly through the first passage 10a, into the lumen of the vein, artery beyond the position A adjacent to the obstruction OB. 然后,在导管远端位于静脉管腔中的情况下,再次将组织穿通元件102向前穿出导管100,形成延伸穿过静脉壁、任何位于静脉和动脉A之间的组织和动脉A壁的第二血流通路102。 Then, in the case where the distal end of the catheter is located in the venous lumen, again through the tissue piercing element 102 forwardly conduit 100 is formed extending through the vein wall, any tissue and arterial wall is positioned between A vein and artery of A The second flow path 102. 然后,可再次将组织穿通元件102退回到导管100内,并可将导管从血管中退出并退出体外。 Then, again through the tissue can be retracted into the catheter 102 element 100, and the catheter withdrawn from the vessel and exit vitro. 用这种方式,如图4a所示的方法,完成了在动脉阻塞OB上游形成第一血流通路10a和在动脉阻塞下游形成第二血流通路10b。 In this manner, the method shown in FIG. 4a, completed the second flow path 10b is formed in a first flow path 10a and the upstream artery obstruction OB is formed downstream of the arterial blockage.

图4b显示了一种可替换的方法,其中,将导管100通过管腔向前进入一条静脉管腔,将导管远端置于将要形成第一血流通路10a的位置附近。 Figure 4b shows an alternative method, wherein the catheter venous lumen 100 enters a forwardly through the lumen, the distal end of the catheter is placed near a position to be a first flow path 10a is formed. 然后,将组织穿通元件102穿出导管100,形成通过静脉V管壁、静脉V和动脉A之间的任何组织以及动脉A管壁的第一血流通路10a。 Then, the tissue piercing element 102 through conduit 100, a first flow path 10a is formed by any tissue between the wall of the vein V, venous and arterial A V A and the arterial wall. 然后,停用组织穿通元件102(例如,退回到导管100中),并将导管通过静脉V进一步向前,直到导管远端达到将要形成的第二血流通路10b的位置附近。 Then, disabling element 102 through tissue (e.g., back to the conduit 100), and further forwards through the venous catheter V, a position near the second flow path 10b until the distal end of the catheter to be formed reached. 然后,再次将组织穿通元件102穿出导管100,通过静脉V管壁、静脉V和动脉A之间的组织以及动脉A管壁,形成所期望的第二通路10b。 Then, again through the tissue piercing element 102 of the catheter 100, through the wall of the vein V, A wall between arterial tissue and venous and arterial V A, to form the desired second passage 10b. 然后,再次停用组织穿通元件102(例如,退回到导管100中)并可以将导管100退出静脉组织并移出。 Then, again disabling element 102 through tissue (e.g., into the return conduit 100) and can exit the catheter 100 and out of the vein tissue. 用这种方式,如图4b描述的方法,仅仅通过静脉V的插管和经管腔导管术,完成了在动脉阻塞OB下游形成第一血流通路10a和在动脉阻塞OB上游形成第二血流通路10b。 In this manner, the method described in Figure 4b, only the vein V through lumen cannula and administered by catheterization, to complete the first flow path 10a is formed in the downstream artery obstruction OB and OB arterial occlusion formed in the upstream of the second blood flow path 10b.

图4c所示为另一种可选的方法,导管100经管腔向前进入一条动脉A,导管100远端置于将要形成第一血流通路10a的位置附近。 Figure 4c shows an alternative method, the catheter 100 advanced into an artery chamber administered A, 100 positioned near the distal end of the catheter to the location to be formed in the first flow path 10a. 然后,组织穿通元件102穿出导管100,通过动脉壁、动脉A和静脉V之间的任何组织以及静脉V管壁,形成第一血流通路10a。 Then, the tissue piercing element 102 through conduit 100, through the artery wall, as well as any tissue between the arterial wall of the vein V A and V vein, forming a first flow path 10a. 然后,停用组织穿通元件102(例如,退回到导管100中),并将导管通过动脉A管腔进一步向前,穿过阻塞OB,直到导管100远端达到将要形成第二血流通路10b的位置附近。 Then, disabling element 102 through tissue (e.g., back to the conduit 100), and the catheter is further advanced through the lumen of the artery A, through the OB blocked, until the catheter reaches the distal end 100 to be formed in the second flow path 10b nearby location. 导管100通过阻塞OB的这种前进,典型地需要先将一根导丝通过阻塞OB,以易化随后将导管100向前穿过阻塞OB。 Through this blocking OB catheter 100 advances, typically requires a first guidewire obstruction OB, facilitated subsequent to catheter 100 forward through the obstruction OB. 在阻塞OB是部分性的,或阻塞物柔软到能允许导丝通过的情况下,这种预先将导丝通过阻塞OB的途径可以完成。 OB is a partial obstruction in or soft obstruction to allow a case where the guidewire, advance the route which the guidewire may be accomplished by blocking OB. 然而,在阻塞OB是完全性的,或形成钙化斑或其它坚硬物质的情况下,图4c所示的方法可能不可行,在这种情况下,操作者典型地选择图4a或4b所示的方法之一。 However, the obstruction OB is complete or when forming calcified plaque or other hard substance, the method shown in Figure 4c may not be possible, in this case, the operator typically selected as shown in FIG. 4a or 4b one way. 然而,在如图4c所示导管100成功地穿过了阻塞OB的情况下,将再次将组织穿通元件102穿出导管100,通过动脉10a管壁、动脉A和静脉V之间的任何组织以及静脉V管壁,形成第二血流通路10b。 However, where the catheter 100 shown in Figure 4c successfully through blocking of OB, again through the tissue piercing element 102 of the catheter 100, through the artery wall 10a, any tissue between the artery and the vein V and A V vein wall to form a second flow path 10b. 然后,停用组织穿通元件102(例如,退回到导管100中),将导管退出动脉组织并移出体外。 Then, disabling element 102 through tissue (e.g., back to the conduit 100), the catheter removed and exit arterial tissue in vitro. 用这种方式,图4c所示的方法,按照本发明,完成了形成第一血流通路10a和第二血流通路10b。 In this manner, the method shown in 4c, the according to the present invention, the completion of the formation of a first flow path 10a and the second flow path 10b.

图4d所示的另一种可选的方法中,其中提供了带有正压泵104的导管100,用来向导管泵入正压流体(如盐水),并通过近导管100远端管体形成的多个正压出口小孔106溢出。 An alternative method shown in Figure 4d, which is provided with a positive pressure pump 104 of the conduit 100, to positive pressure fluid pumped into the catheter (e.g., saline), and through the near the distal end of the catheter tube 100 a plurality of apertures 106 formed positive overflow outlet. 在导管邻近正压出口小孔106处形成一个近端封闭元件108(例如,一个完全阻断血管腔的球囊)。 In forming a proximal end 106 of the catheter adjacent the outlet orifice positive closure element 108 (e.g., a balloon lumen completely blocked). 将一个单独的远端封闭(如,一个球囊)110置于静脉V管腔内将要形成第二血流通路10b的位置的稍上游处。 The distal end of a separate closure (e.g., a balloon) 110 placed slightly upstream lumen intravenous V is to be formed position of the second flow path 10b. 将导管100通过静脉V管腔向前,直到导管远端达将要形成第二血流通路10b的位置附近。 The catheter 100 advanced through the lumen of the vein V until the distal end of the catheter to be formed near the positions of the second flow path 10b. 然后,将近端封闭元件108展开(例如,充气),从而将邻近导管100上正压出口小孔106的静脉V完全封闭。 Then, the proximal end of the closure member 108 to expand (e.g., inflated), so the pressure adjacent the outlet orifice of the vein catheter 100 V 106 is completely closed. 然后,将正压流体(例如,盐水)通过导管管腔并由正压出口小孔106溢出,导致静脉V中压力P1上升,最好基本与动脉A中的平均压力P2相等。 Then, the positive pressure fluid (e.g., saline) through the catheter lumen by the pressure overflow outlet aperture 106, resulting in increased venous pressure P1 and V, A is preferably substantially equal to the average arterial pressure P2. 这种静脉V管腔中压力形成,为辨别各种静脉侧枝SB的存在提供了可行的方法,静脉侧枝可能需要结扎、关闭或栓塞,以避免从新形成的静脉旁路管道内任何显著失血。 Such a pressure lumen of the vein V formation, provides a feasible method to identify the presence of various SB collateral vein, the vein may need collateral ligation, embolization, or off, to avoid any significant loss of blood within the vein bypass duct from the newly formed. 另外,在组织穿通元件102穿出导管100,通过静脉V管壁和动脉A管壁,形成本发明的通路10时,静脉V腔内的压力形成可以维持。 Further, the tissue piercing element 102 through conduit 100, through the wall of the vein and artery V A wall forming passage 10 of the invention, the venous pressure chamber V is formed can be maintained. 静脉V内压力P1和动脉内压力P2的这种相等,还被用来在通路10形成后,避免血液从动脉A管腔向静脉V管腔快速喷涌或流动。 V venous internal pressure P1 and the pressure P2 which is equal intraarterial, also used in the passage 10 is formed, to avoid rapid blood flow to the vein V or spewing from the arterial lumen A lumen.

图4e所示的另一种可选的方法中,将第一导管100推进动脉A,第二导管推进静脉V。 An alternative method shown in Figure 4e, the first propulsion artery catheter 100 A, a second catheter is advanced vein V. 在某些情况下,将第一、第二导管100置于基本上相对的位置,如图4e所示。 In some cases, substantially opposite the position at the first, second conduit 100, shown in Figure 4e. 然后,如图所示,用各个导管100的组织穿通元件102在动脉A和静脉V之间形成第一和第二备血流通路10a、10b。 Then, as shown, with the respective conduits 100 of tissue penetrating member 102 is formed a first and a second flow path 10a between the apparatus A and the arterial vein V, 10b. 然后,停用组织穿通元件102(例如,退回到导管100中),并将导管100退出血管并移出体外。 Then, disabling element 102 through tissue (e.g., back to the conduit 100), and 100 and exit out of the vascular catheter body. 用这种方式,图4e所示的方法,按照本发明,完成了在所期望的血管间第一和第二血流通路10a和10b的形成。 In this manner, the method shown 4e, the according to the present invention, completed the first and second flow path 10a is formed between the desired and the vessel 10b.

Ⅴ. Ⅴ. 控制、瞄准和引导用来形成血管外通路的组织穿通元件和/或辅助部件的方法和装置图5a-5l显示装置的实例,当组织穿通元件102自本发明的导管100向前,形成所期望的血管外通路10时,该装置被用来定向、瞄准、控制和/或引导组织穿通元件102。 Examples of apparatus method of controlling, targeting and guidance for forming extravascular passageway tissue penetrating member and / or the auxiliary member and the apparatus of FIG. 5a-5l show, when the tissue penetrating element 102 from 100 forward of the catheter of the present invention, a desired extravascular passage 10 when the device is used to target, targeting, control, and / or the guide member 102 through tissue. 一般地,这些定向、瞄准、控制和引导装置被用来定位导管100,从而,组织穿通元件102穿出导管100时,将接触到并穿入导管100所位于的血管的管壁。 Generally, these oriented, aimed, and the control means is used to locate the guide catheter 100, such that, when the tissue piercing element 102 through conduit 100, and to penetrate the wall of a blood vessel in contact with the catheter 100 is located. 应当理解,图5a-5l提出的图示,以及随后的详细描述,仅仅是提供了应用本发明的各种定向、瞄准、控制和/或引导装置的实例,并不意味着穷尽显示或描述了可以用于这些目的所有可能的装置。 It should be appreciated that illustrated in FIG. 5a-5l proposed, and the following detailed description merely provides various applications of the present invention is directed, aimed at controlling and / or guiding means examples, and are not intended to be exhaustive or displays described these purposes can be used for all possible devices. 另外,应当理解为,任何或全部如图5a-5l所示和如下描述的装置,可以与这里描述的本发明的其它任何元件结合,形成一个“系统”,由此,本发明的通路形成导管100可被定向、瞄准、控制或引导。 Further, it should be understood that any or all of the apparatus in FIG. 5a-5l shown and described below, any other elements of the invention described herein may be combined to form a "system", whereby the present invention is formed via conduit 100 can be oriented, aiming, guiding or control.

图5a显示一种方法,其中,一个主动成像部件50被安置于本发明的导管100所在的同一条血管中。 Figure 5a shows a process in which a vessel with an active imaging member 50 is disposed is located in the catheter 100 of the present invention. 这种主动成像部件50可以包括任何合适类型的导管容受的成像部件,包括,但不限于,血管内超声装置(IVUS导管),多普勒装置,血管内镜,等等。 Such active imaging member 50 may include a catheter suffer imaging member of any suitable type, including, but not limited to, intravascular ultrasound device (IVUS catheter), a Doppler device, angioscopy, or the like. 在许多情况下,主动成像部件50将有一个感受器(例如,超声传感器,声波传感器,成像-接受镜头,等等)形成于其上的特定位置。 In many cases, the active imaging member 50 has a receptor (e.g., an ultrasonic sensor, a sonic sensor, the imaging - receiving lens, etc.) is formed on a specific position thereon. 典型地期望这种感受器52被安置于紧密邻近组织穿通元件102通过血管壁的位置,以便提供对组织穿通元件102的所期望的观察、瞄准和引导。 Typically this is desirable susceptor 52 is disposed at a position closely adjacent the tissue penetrating element 102 through the vessel wall, in order to provide a desired element 102 as viewed through tissue, targeting and guidance. 应当理解,主动成像装置50可装置于通路形成导管100之上,或形成于通路形成导管100之内,可以载于导管100内的单轨或侧管中(图9-10),或者可以定位于完全独立和分开的管体内,如图5a所示。 It should be understood that the active devices in the imaging device 50 may be formed on the catheter passage 100, passage formed or formed within the catheter 100, or may be contained in the side of the monorail catheter tube 100 (FIG. 9-10), or may be positioned completely independent and separate from the tubular body, shown in Figure 5a. 在通路形成导管100中至少安置主动成像部件50的远端部分,体现这种方法的通路形成导管100的实施方案,特别显示于图9-10,并参照这些图示如下全面描述。 Passage formed in the conduit 100 is disposed in at least a distal portion of the imaging member 50 is active, this method reflects the passageway forming catheter 100 of the embodiment, particularly shown in FIGS. 9-10 and described fully below with reference to these drawings.

用于观察、瞄准和引导组织穿通元件102的一种可替换的方法显示于图5b,其中主动成像部件50被安置于通路形成导管100的组织穿通元件102将要通过的血管内。 For viewing, method A component 102 through alternative organizations aiming guide and shown in Figure 5b, wherein the active imaging member 50 is disposed in passage 100 formed in the vascular tissue through the catheter member 102 to be adopted. 如图5b所示,主动成像部件50的感受器52可以被安置于紧密邻近将要形成的通路10的位置,从而,在组织穿通部件102从导管100向主动成像部件50的的感受器52延伸时,感受器可以瞄准和引导它。 5b, an active imaging member susceptor 5250 may be disposed at a position in close proximity to be formed passage 10, so that, when the tissue penetrating member 102 extending from 100 susceptor 52 of the catheter to an active imaging member 50, the susceptor and guide it can be targeted.

图5c显示另外一种可替换的方法,除原来的主动成像部件50之外,合并应用第二成像装置54(例如,一个被动或协主动装置)。 Further Figure 5c shows an alternative method, in addition to the original active imaging member 50, and the combined application of the second imaging device 54 (e.g., a passive or active device RA). 这个第二成像装置可以形成于通路形成导管100上,或组织穿通元件102本身上,并能够与原来的成像装置50通讯或被其感受。 The second imaging apparatus may be formed in the passage formed on the catheter 100, through the tissue, or element 102 per se, and capable of communication with the original image forming apparatus 50 or its feel. 原来的成像部件50有一个感受器52,被安置于通路形成导管100所在血管的邻近血管中。 Original image forming means 50 has a susceptor 52, is disposed adjacent the passage formed vascular catheter 100 is located in a blood vessel. 主动成像部件50将要与第二成像装置54感受或通讯,从而提供观察、瞄准和引导组织穿通元件102的直接方法。 The imaging member 50 to be active and the second image forming apparatus 54 or communication experience to provide a view of the direct method and the aiming guide member 102 through tissue. 在这个实施方案中,第二成像装置54可以包括能够被主动成像部件50所询问、显像或分辨的任何合适类型的物质或装置。 In this embodiment, the second image forming apparatus 54 may include an active imaging member 50 that can be interrogated, developing or resolved any suitable type of material or device. 例如,主动成像部件50的感受器52可能包括一个无线电频率发射器,通路形成导管100上的第二成像装置54可能包括一个无线电频率应答器,可以被询问,并将对主动成像装置50的无线电频率发射器发出的无线电信号发出应答信号。 For example, an active imaging member susceptor 5250 may include a radio frequency transmitter, a second passage is formed on the image forming apparatus 54 includes a catheter 100 may be a radio frequency transponder can be interrogated, and the radio frequency active imaging device 50 the radio signal transmitter emits an acknowledge signal. 可选择地,在主动成像部件50是荧光镜、血管内超声(IVUS)部件或多普勒的实施方案中,位于通路形成导管100上的第二成像装置54可以包括一个不传导无线电的标志,反射表面或声音小孔,由此,可以将无线电波、声音或超声能量反射回主动成像部件50。 Alternatively, the active member 50 is a fluoroscopic imaging, intravascular embodiment ultrasound (IVUS) or Doppler component, the second imaging device is located in passageway 54 formed on the catheter 100 may include a nonconductive radio flag, or sound reflective surface apertures, thus, it may be a radio wave, sound, or ultrasonic energy reflected back to the active imaging member 50. 形成于导管100体部或组织穿通元件102上,以增强其被主动成像部件50所显现的声音小孔或表面的类型的实例,在美国专利第4,977,897(Hurwitz)号中有描述。 Is formed through the element 102 to enhance the sound holes or instance of the type which is exhibited by the surface of the active imaging member 50, are described in U.S. Patent No. 4,977,897 (Hurwitz) No. 100 of the catheter body or tissue .

图5d显示一个系统,其中,磁体57a、57b被安置于修正的通路形成导管101a中,用来协同具有尖锐远端尖端107的组织穿通导丝103,在所显示的二条血管BV1和BV2之间形成通路10,导管101a、101b的每一条有磁体57a、57b放置于其一侧。 Figure 5d shows a system, wherein the magnets 57a, 57b are disposed in the passage formed corrected conduit 101a, the used sharpened distal tip 107 having a synergistic tissue through the guide wire 103 between the two vessel BV1 and BV2 displayed passage 10 is formed, the conduit 101a, 101b each have a magnet 57a, 57b disposed on one side thereof. 一条中空管腔109延伸通过每一个磁体以及形成于导管体内部的邻近插入物、在这种方式中,磁体57a、57b内的答腔开口可以被安置成彼此直接排成一线,利用磁体57a、57b的吸引力完成这种排成一线的位置。 A hollow lumen 109 extending through the insert and adjacent each magnet in the interior of the catheter body is formed, in this embodiment, the magnets 57a, 57b then spoke within the opening may be disposed in direct line with each other are arranged, using a magnet 57a, 57b this attraction complete line of aligned position. 然后,具有尖锐远端尖端107的组织穿通导丝103可以被推向前,通过第一导管101a的导丝管腔109a,穿出导管101a的磁体57a内的管腔开口,通过第一条血管BV1的管壁,通过第一条血管BV1和第二条血管BV2之间的任何组织,通过第二条血管BV2的管壁,进入另一条通路形成导管101b的磁体57b的管腔开口。 Then, the inner lumen having a sharpened distal tip 57a of the magnet 107 through tissue 103 may be pushed forward guidewire, the guidewire lumen through a first conduit 101a, 109a, 101a of the piercing catheter opening through the first vessel BV1 wall, by any tissue between the first vessel BV1 and BV2 second vessel, through a second wall of the blood vessel BV2, a passage is formed into another magnet 57b lumen catheter opening 101b. 用这种方法,组织穿通导丝103将形成第一条血管BV1和第二条血管BV2之间的通路10。 In this way, tissue through the guide wire passageway 103 is formed between the first vessel 10 and second vessel BV1 BV2. 应当理解,组织穿通导丝103的远端尖端107可以包括能够退回到导丝内的尖锐远端尖端,从而在导管101a、101b退出后,导丝GW可以留在血管内。 It should be appreciated that the distal tissue penetrating tip 107 of guidewire 103 may include a sharpened distal tip can be retracted into the guide wire so that the catheter 101a, 101b after the exit, the guidewire GW may remain within the vessel. 可以替换地,组织穿通导丝103可以是激光丝、热丝或其它任何类型适于形成所期望的通路10的组织穿通元件。 May alternatively, the tissue through the guide wire filament 103 may be a laser, hot wire, or any other type suitable for forming the desired tissue through the element passage 10.

图5e-5e显示方法和装置,通过这些方法和装置,在本发明的通路形成导管100上形成被动放射显像成像可见标志,在每一个血管外通路10形成之前,可以被用来实现导管100的精确旋转定位。 FIG. 5e-5e display method and apparatus by which the method and apparatus of the present invention is formed in the passage forming passive radiological imaging of visible marks on the catheter 100, prior to passage 10 formed in each of the outer vessel, the catheter may be used to implement 100 precise rotational positioning. 图5e显示,在计划的方式中,一条通路形成导管100安置于第一条血管BV1中,打算按照本发明,自第一条血管BV1进入邻近的目标T(例如,一个体腔,一团组织或另一条血管),形成一条通路10。 Figure 5e shows in a planned manner, the duct forming a passage 100 disposed in the first blood vessel BV1, according to the present invention is intended, from the first strip into the adjacent vessel BV1 target T (e.g., a body cavity, tissue, or a group another vessel), a passage 10 is formed. 一个放射成像装置118,如荧光镜或X线部件之类,被用来在屏幕120(例如,一个X线片盒或荧光屏)上,提供第一条血管BV1和第二条血管BV2的放射图像。 A radiation imaging device 118, such as X-ray or fluoroscopy member or the like, is used on the screen 120 (e.g., X-ray film cassette or a screen), providing radiation image first vessel BV1 and BV2 in the second vessel .

图5e′显示一条导管100,在这条导管100有放射成像可见的(例如,不透过射线或放射发亮的)标记122a、122b纵行分开安置于导管100的相对侧。 FIG. 5e 'show a catheter 100, catheter 100 in this visible radioactive imaging (e.g., radiopaque or radiation shiny) markers 122a, 122b disposed on opposite longitudinal sides of the duct 100 separate. 如图所示,这些放射成像可见标记122a和122b优选位于,相对于导管100的高度H而言,相同高度的位置,但却纵行分开。 As shown, the radiographic imaging visible markers 122a and 122b are preferably located with respect to the height H of the catheter 100, the same height, but apart wales. 因此,如图5e′的下部方框所示,通过使这些放射成像可见标记122a、122b在屏幕120上与相应高度刻度直接连成一线的方法,导管100可以被精确地旋转定位。 Thus, FIG. 5e 'of a lower block, by these radiological imaging visible indicia 122a, 122b on the screen 120 connected directly with the line height scale as a method, the catheter 100 may be rotated precisely positioned.

图5e″显示了另一种类型的被动标记系统,它可以被用来获得导管100的精确旋转定位。参照图5e″,在通路形成导管100的一侧有一个环状放射成像可见标记124,且有一个盘状或点状放射成像标记126在另一侧,与环状标记124直接相对。 FIG. 5e "shows another type of passive tag system which may be used to obtain precise rotational positioning of the catheter 100. Referring to Figure 5e", 100 formed in the side of the catheter has an annular passage radioimaging visible mark 124, and it has a disc-shaped or dot radiological imaging marker on the other side 126, 124 directly opposite the annular mark. 用这种方式,通过将盘状或点状标记126变成在屏幕120上显示为位于环状标记124之内的方法获得导管100的精确旋转定位。 In this manner, the disk-shaped or dot-shaped mark 126 into the display method flag 124 is located within an annular obtain precise rotational positioning of the catheter 100 on the screen 120.

还有另外一种可以用于获得导管100精确旋转定位的放射成像可见标志显示于图5e。 There is another radioimaging 100 may be used to obtain precise rotational positioning of the catheter shown in FIG visible marking 5e. 参照图5e,所提供的导管100有两(2)个基本上大小相同的放射透过小孔128a、128b,位于导管100上的相对侧面,互相直接相对。 Referring to FIG 5e, a catheter 100 is provided with a two (2) substantially the same size as the radiation through holes 128a, 128b, located on opposite sides of the duct 100, directly opposite each other. 用这种方式,通过旋转导管100,直至第一个和第二个放射透过小孔128a和128b变成互相直接连成一线,从而如图5e的侧框中所阐明,在屏幕120看到它们好象一个单一开口,从而可以获得导管100的精确旋转定位。 In this way, by rotating the catheter 100 until the first and second orifices 128a and 128b through the radiation into a line directly to each other, so that the side of the box in FIG 5e forth, watching the screen 120 they seem to a single opening, which can obtain precise rotational positioning of the catheter 100.

图5f-5f′显示一种方式,其中,通路形成导管100上形成一个超声可见标记130,它结合应用一个体外放置的超声成像传感器132,实现导管100的精确旋转定位。 FIG. 5f-5f 'show a manner in which a passageway forming catheter 100 visible mark on the ultrasound 130, which combines the application of ultrasonic imaging sensor 132 a disposed in vitro, precise rotational positioning of the catheter 100. 如图所示那样,超声可见标记130形成于导管100的特定位置上,这一特定位置与组织穿通元件102将要穿出导管100的位置和方向有已知的关系。 As shown in FIG ultrasonically visible mark 130 is formed at a specific location on the catheter 100, this particular position of the tissue penetrating element 102 to be piercing position and orientation of catheter 100 has a given relation. 体外超声成像传感器132置于身体上,从而,通路形成导管100所位于的血管BV1和导管100的组织穿通元件102将要穿入的目标(例如第二条血管,组织块,或其它目标位置),都能显像。 In vitro ultrasonic imaging sensor 132 is placed on the body, thereby forming a target tissue via conduit 100 and is positioned vessel BV1 catheter 100 through element 102 to be penetrated (e.g., the second vascular tissue mass, or other target position), You can imaging. 然后,旋转导管100,直到超声可见标记130被传感器132清晰和完全地显像。 Then, the rotation of the catheter 100 until the ultrasonic sensor 132 is visible markers 130 and completely clear imaging. 这种超声可见标记130的定位,被用来确定导管放置于其适当的旋转定向,使组织穿通元件穿入目标T。 Such positioning ultrasonically visible marker 130, is used to determine catheter placed in its proper rotational orientation of the tissue penetrating element through the target T.

图5g-5g″阐明的方式,其中,通路形成导管100上的被动标记被用来与磁共振显像(MRI)系统联合,实现导管100的精确纵行和旋转定位,也用来确定导管100所在的血管与目标T之间的距离,由此提共一种方法,确定组织穿通元件102为在血管BV1和目标T之间形成所需的通路而所需移动的距离。在这个实施方案中,导管100管体由可通过MRI显示的材料形成。另外,在导管100管体的特定位置,形成可辨别的MRI标记134。该标记可能包括一个感应线圈134a或一个小物质块134b,它不同于导管100管体的材料,以便在MRI上特别显示。 5g 5g-"FIG manner set forth, wherein the passage 100 is formed on the passive markers catheter is used in combination with a magnetic resonance imaging (MRI) system, accurate longitudinal and rotational positioning of the catheter 100, the catheter 100 is also used to determine the the distance between the blood vessel and the target T is located, thereby providing a total of a method to determine the required distance while moving element 102 through tissue to form a desired path between T and the target vessel BV1. in this embodiment , the catheter body 100 is formed from a material that can be displayed by MRI. in addition, in a particular location of the catheter body 100, formed discernable MRI marker may comprise a marker 134. the induction coil 134a or a small block of the substance 134b, it is different the material of the catheter body 100, so as particularly shown on MRI.

特别参照图5g′,将感应线圈134a置于导管100上或壁内的特定位置,并与一条延伸通过导管到达一个外在位置的丝135相连,在那里它们可以连接到合适的电源,示波器和/或其它监测系统。 Referring particularly to FIG 5g ', 134a induction coil 100 placed in a particular location on or in the wall of the catheter, and a wire connected with an extension 135 through the external catheter to the location, where they can be connected to a suitable power source, oscilloscope and and / or other monitoring systems. 由此,线圈134a中的电磁场的电流、相位和振幅可以被监测。 Thus, the coil 134a of the electromagnetic field current, phase and amplitude may be monitored. 用这种方式,MRI扫描器135范围内的导管100的移动,将导致线圈134a在MRI系统形成的可变但已知的磁场内改变位置。 In this manner, movement of the catheter 100 within the scope of the MRI scanner 135, a variable coil 134a will result in formation of the MRI system but changing the position of the magnetic field is known. 用这种方式,导管100在MRI场中的每一次移动,将导致电流,相位和振幅的变化。 In this manner, each conduit 100 moves in the MRI field will result in a change in current, phase and amplitude. 然后,自线圈134a接受到的电流相位和振幅信息,被用来确定线圈134a相对于目标T的精确位置。 Then, since the current phase and amplitude information of the received coil 134a, the coil 134a is used to determine the precise position with respect to the target T. 而且,如果线圈134a变成定位于MRI扫描器135所显示的特定平面之外,将表明导管100已经纵向移出了所期望的平面。 Further, if the coil 134a is positioned in a particular plane into the MRI scanner 135 displayed outside, it will show a catheter 100 has been moved out of the longitudinal plane of the desired. 用这种方式,线圈134a可被用于导管100的精确纵向和旋转定向。 In this manner, the coil 134a can be used for accurate longitudinal and rotational orientation of the catheter 100. 而且,从线圈134a获得的信息可被用于确定线圈134a和目标T之间的确切距离,由此提供信息,使操作者能够以适合将要形成的通路10的长度的方法,控制组织穿通元件102。 Furthermore, information obtained from the coil 134a can be used to determine the exact distance between the target T and the coil 134a, thereby providing information, to enable the operator method can be adapted to the length of the passage 10 is formed, the control element 102 through tissue .

特别参照图5g″,一个替代的MRI标记134b包括一块独立的材料,它不同于导管100管体的材料,且能被MRI显示。用这种方式,MRI可显示的标记134b可以精确地显示于MRI显像,并可以被用来可视化地调整导管100相对于目标T之间的纵行或旋转定向和定位。而且,观察到的标志134b和目标T之间的距离,可用被用来使操作者能够控制组织穿通元件102的路径,以在导管100所在的血管BV1和目标T之间,形成期望长度的通路10。 With particular reference to FIG. 5g ", an alternative MRI marker 134b includes a separate material which is different from the material of the catheter body 100, and can be displayed MRI. In this manner, MRI marker 134b may be displayed on the display can be accurately MRI imaging, and it can be used to visualize the catheter 100 relative to the adjustment or longitudinal positioning and rotational orientation between the target T. Furthermore, the distance between the target T and the flag 134b observed, can be used to enable the operation is able to control the device through the tissue path 102 to between the target T and the vessel BV1 catheter 100 is located, a passage 10 formed in the desired length.

图5h-5l显示了“主动”成像装置具体类型的实例,它可以与通路形成导管100相关联、安装于其上或结合于其中,易化导管100在血管中的精确旋转定向。 FIG. 5h-5l show the "active" Examples of specific types of imaging apparatus, it is associated with the conduit 100 may be formed with a passage, mounted thereon or incorporated therein, facilitated accurate rotational orientation of the catheter in a blood vessel 100.

参照图5h,主动成像装置的一种是多普勒装置136,它可以与通路形成导管100相关联、安装于其中或合并于其内,例如合并于一种可以从商业途径获的部件中,名为Smart Needle,CardiovascularDynamics,Inc,Sunnyvale,加利福尼亚。 Referring to FIG. 5h, an active device is a Doppler imaging device 136, which may form a conduit 100 associated with the passage, in which is mounted thereon or incorporated, for example, to one combined can be obtained from commercially member, called Smart Needle, CardiovascularDynamics, Inc, Sunnyvale, California.

参照图5h,多普勒装置136安装于导管100上或置于其中,并被从侧面方向(例如,垂直于导管100的长轴)瞄准或指引。 Referring to FIG. 5h, a Doppler device 136 is mounted on a catheter 100 or disposed therein, and from the side direction (e.g., perpendicular to the long axis of catheter 100) or guidelines aimed. 多普勒装置136在定位和辨别目标T的流体或其它物质的流动时有用。 Doppler device 136 is useful when the flow of fluid or other substance and identify the target T is positioned. 因此,在目标T包括流体或其它物质流动于内的血管或其它解剖结构时,图5h所示的实施方案是有用的。 Thus, when the target T comprises flowing fluid or other substance within a vessel or other anatomical structures, in the embodiment shown in FIG. 5h is useful. 由多普勒装置136提供的信号振幅和其它可辨别的信息,使操作者能够:a)纵向定位导管,从而多普勒装置136显示期望的目标T内的流动特征(例如,一个阻塞的下游和一条动脉);b)旋转定向导管,使多普勒信号振幅达到峰值,从而表明多普勒装置136瞄准目标T内的流动中心(例如,血管腔的中心)。 Flow characteristics (e.g., a downstream occlusion in the target T a) longitudinally positioning the catheter, so that a desired Doppler display apparatus 136: signal amplitude and other discernable Doppler information provided by the means 136, so that the operator can and an artery); b) the rotational orientation of the catheter, so that the peak amplitude of the Doppler signal, thereby indicating a Doppler flow center apparatus 136 (e.g., the center of the vessel lumen) T in the target sighting. 和c)确定多普勒装置136和目标T内的流动中心之间的距离。 And c) determining a Doppler flow means the distance between the center 136 and the target T. 多普勒装置136和目标T内的流动中心(例如,腔道中心)之间距离的这种确定,将使操作者能够控制组织穿通元件102,从而,组织穿通元件102将从导管100只通过或延伸所期望的距离,由此形成一个进入目标的流动中心(例如腔道)的通路10,而不至于移动太远而可能穿刺或穿孔目标T的对侧壁。 Doppler flow device 136 within the target T and the center (e.g., center cavity) determine the distance between this will enable the operator to control the tissue penetrating element 102, and thus, tissue penetrating element from the catheter 100 through 102 or extending a desired distance, thereby forming a flow into the center of the target (e.g., lumen) of the passage 10, and thus will not be moved too far may puncture or perforate side walls to target T.

在导管100安置于第一条血管BV1内后,多普勒装置136将被活化,且导管100将被纵行移动,和/或旋转,直至多普勒信号显示目标T的被显示部分内所期望的流动,而且多普勒信号振幅已达峰值,从而,表明多普勒装置136已直接与目标T排成一线。 After the first blood vessel BV1, a Doppler device 136 is disposed to be activated in the conduit 100 and the conduit 100 is longitudinal moved and / or rotated until the Doppler signal T is a display target of the display portion desired flow, and reached the peak amplitude of the Doppler signal, thereby indicating a Doppler device 136 is directly aligned with the target line T. 然后,多普勒装置136的频率输出可能变化,产生峰振幅反应的频率将表示多普勒装置136与目标T之间的距离。 Then, a Doppler frequency of the output means 136 may change the frequency of peak amplitude response is generated indicating the distance between the device 136 and the target doppler T. 在这个实施方案中,目标T必须是一条血管或其它内有流动物质的解剖结构,从而可被声音(例如,多普勒)装置所辨别。 In this embodiment, the target T must have a blood vessel or other anatomical structures within the flow material, so that the sound can be distinguished (e.g., Doppler) apparatus.

在图5i显示的实施方案中,一个血管内超声成像装置138安置于通路形成导管100的导管100一侧的特定位置。 In the embodiment shown in FIG. 5i, a vascular ultrasound imaging device 138 is disposed in passage 100 formed in a specific position on one side of the catheter 100 the catheter. 超声成像装置100的这种特定位置,优选离组织穿通元件102将要穿出导管100的位置有已知的直线距离和旋转距离。 With this specific position of the ultrasound imaging apparatus 100, preferably through element 102 from the tissue piercing position of the catheter 100 will have a linear distance and a known rotational distance. 在导管100放置于第一条血管BV1内之后,可以旋转导管100,直到目标T(如,血管,搏动组织或其它能被超声成像显示的目标位置)直接形成一线,并被超声装置138直接显示,从而表示导管100被纵向及旋转定向,使得组织穿通元件102如愿地穿过第一条血管BV1管壁,并进入目标T。 After the catheter 100 is placed within the first blood vessel BV1, catheter 100 may be rotated until the (target position, such as a blood vessel, or other tissue pulsation ultrasound imaging can be displayed) of the target line T is formed directly, and the ultrasound device 138 is displayed directly , thus indicating that the catheter 100 is longitudinally and rotationally oriented such that the tissue penetrating element 102 desirably passes through the wall of the first blood vessel BV1, and into the target T.

图5j所示的方式,其中,应用第一个发射器/接受器线路140a和第二个发射器线路140b来完成通路形成导管100的精确旋转定向。 Shown in FIG. 5j, wherein application of a transmitter / receiver circuit 140a and the second transmitter line 140b are formed to complete the precise rotational orientation of the catheter passage 100. 如图所示,在通路形成导管100的一侧的特定位置上,第一个发射器或接受器线路140a被放置于导管上,或置于其壁内。 As shown, the passage forming a specific position on one side of catheter 100, a first transmitter or receiver circuit 140a is placed on the conduit, or placed in its wall. 这个第一发射器或接受器线路140a最好紧密邻近组织穿通元件102将要穿出导管100的位置。 The first transmitter or receiver circuit 140a is preferably in close proximity to the tissue penetrating element 102 to the piercing position of the catheter 100. 第二发射器或接受器线路140b放置于目标T中(例如,第二条血管、目标组织或通路形成导管100的组织穿通元件将要穿入的其它位置)。 Second transmitter or receiver circuit 140b placed in the target T (e.g., the second vessel, the target tissue or tissues other locations passage formed through the catheter member 100 to be penetrated). 在导管100进入第一条血管BV1后,旋转导管,同时发射器或接受器线路140a、140b之一发出信号,从而,这种信号可以被发射器或接受器线路140a、140b的另一个接受。 After the first catheter 100 into the blood vessel BV1, rotating the catheter, while the transmitter or receiver circuit 140a, 140b issue one signal, whereby this signal can be a transmitter or receiver circuit 140a, 140b to accept another. 用这种方式,持续旋转导管,直到发射器/接受器140a、140b接受的信号振幅达到峰值,由此,表示第一发射器/接受器线路140a和第二发射器接受器线路140b处于最接近的点,由此,提示导管100在第一条血管BV1中处于所期望的旋转定向的位置上。 In this manner, continued rotation of the catheter, until the transmitter / receiver 140a, 140b receiving the peak signal amplitude, thereby representing a first transmitter / receiver circuit 140a and the second transmitter receiver circuit 140b is closest point, whereby, in a presentation position of a desired rotational orientation of the first catheter 100 on the blood vessel BV1. 另外,接受器线路140a、140b的一个或全部2个可以放置在不同的血管BV1和/或目标区域T内,当监测到的线路140a、140b之间的信号如此表示时,实现血管BV1内导管100的所期望的纵行定位。 Further, the receptacle lines 140a, 140b, one or all of two or may be placed in different vessel BV1 and / target region T, when the signal between the monitored line 140a, 140b thus represents, to achieve an intravascular catheter BV1 positioning a desired longitudinal row 100.

图5k显示可替换的布置,其中,感应线圈142位于通路形成导管100上或其壁内的特定位置,该位置与组织穿通元件102将要穿出导管100的位置相对应。 FIG. 5k show an alternative arrangement in which the induction coil 142 is located in a specific location on the catheter passageway 100 is formed in the wall thereof, through which the position of the tissue piercing element 102 to be a position corresponding to the conduit 100. 一个发射器线路144放置于目标T之内(例如,第二条血管,目标组织或导管100的组织穿通元件102打算穿过的其它位置)。 A transmitter 144 disposed within the target line T, (e.g., the second vessel, tissue or target tissue 100 of the catheter 102 through element intended to pass through the other positions). 给予发射器线路144以能量,从而发射一个电磁信号,而且感应线圈142也获得了能量。 Administration line 144 to the energy transmitter to emit a magnetic signal, and an induction coil 142 also received energy. 然后,旋转导管100,直到感应线圈142内的信号的相位和振幅提示感应线圈142位于它与发射器线路100的最近点,由此,证实导管100被放置于适当的旋转定向,以引起组织穿通元件102自导管100经过,通过第一条BV1管壁,进入目标T。 Then, the rotation of the catheter 100 until the phase and amplitude tips induction coil 142 signal within the induction coil 142 is in its transmitter nearest point of the line 100, thereby confirming the catheter 100 is placed in an appropriate rotational orientation, to cause tissue through element 102 from the conduit 100 passes through the first wall BV1, into the target T.

图5l阐明的方式中,第一和第二磁体146a-146b被用来实现通路形成导管100的精确旋转定位。 FIG. 5l forth, the first and second magnets 146a-146b are used to achieve precise rotational positioning of the catheter is formed passage 100. 第一磁体146a放置于通路形成导管100上或其壁内的特定位置,该位置与组织穿通元件102将要穿出导管100的位置相对应。 A first magnet disposed in the passage 146a formed in a specific location on or within the wall of the catheter 100, through which the position of the tissue piercing element 102 to be a position corresponding to the conduit 100. 第二磁体146b放置于穿入目标T的另一条导管148上(例如,第二条血管、目标组织或组织穿通元件102将要穿过的其它位置)。 The second magnet 146b is placed (e.g., the second position of the other vessel, the target tissue or through tissue will pass through element 102) on the other conduit 148 penetrates into target T. 通路形成导管100被旋转,或被允许自行旋转,直到第一磁体146a和第二磁体146b连接一线,而且互相尽可能地接近,由此,表明通路形成导管100被放置于正确的旋转定向,使组织穿通元件102穿过第一条血管BV1,进入目标T。 Passage forming catheter 100 is rotated, or allowed to self-rotating, until the first magnet and the second magnet 146a 146b connecting line, and as close as possible to each other, thereby forming passage indicated that catheter 100 is placed in the correct rotational orientation of the tissue penetrating element 102 through the first blood vessel BV1, into the target T. B. B. 本发明的部件图6到12显示本发明的部件,它们可以用于按照本发明形成血管外通路10,或者修正或装备这种通路10。 FIG member of the present invention, the display section 6-12 of the present invention, they can be used extravascular passageway 10, or correct or equipment such passage 10 is formed in accordance with the present invention. 应当理解,图6-12所示以及以下提出的详细描述,只是打算描述和图解某些实例和目前优选的部件的实施方案,并不意在穷尽列举和描述本发明可能采取的有形形式的全部可能的部件或实施方案。 It should be understood that the detailed description set forth below and shown in Figure 6-12, but intended to describe some examples and illustrated embodiments and presently preferred embodiment of the member, it is not intended to be an exhaustive list and describe a tangible form of the present invention may be taken by all possible components or embodiments.

ⅰ. Ⅰ. 易化组织穿通元件退出导管体的退出方案图6a-6i显示了布置和装备的实例,由此,本发明用于开始时形成血管外通路10的组织穿通元件102,可以由位于血管腔内的通路形成导管100内退出,而使组织穿通元件102穿过导管100所在的血管壁,从而建立所期望的血管外通路10。 Easy organization program exits through exit element of the catheter body of FIG. 6a-6i show examples of the arrangement and equipment, whereby the present invention is formed in an outer vessel access member 10 through tissue 102, it may be positioned by the vessel lumen at the beginning of a exit passage 100 is formed within the catheter, the tissue penetrating element 102 where the catheter through the blood vessel wall 100, thereby establishing a desired extravascular passageway 10.

以下提出的对图6a-6i的详细描述,涉及不同类型的组织穿通元件102。 Detailed description of FIGS. 6a-6i is set forth below, it involves different types of tissue penetrating element 102. 本文应用术语“组织穿通元件”意味着包括可以用于穿通组织的延伸元件、部件或装置、能量流(例如,热,激光束等)的全部可能类型。 In this paper, the term "tissue penetrating element" is meant to include all possible types of elements may be used to extend through the tissue, components or devices, energy flow (e.g., thermal, laser beam, etc.). 因此,当描述到组织穿通元件102“穿”出导管100时,这种描述将不必然意味着一个固体元件穿出导管管体,而是也可以包括以能生成所期望的血管外通路10的方式和方向,来自导管管体的组织穿通装置的操作或能量流(例如,热,激光)的穿出。 Thus, when describing the tissue penetrating element 102 "through" the catheter 100, which will be described does not necessarily mean a solid element piercing catheter tube, but may also include an outer can generate a desired vascular path 10 manner and direction, of the tissue from the catheter tube feedthrough operation or energy flow (e.g., heat, laser light) piercing. 另外,应当理解,图6a-6i所显示以及提供的与这些图有关的描述,并不意在描述或阐明本发明可用于使组织穿通元件102穿出通路形成导管100的全部的可能的安排或装置。 Further, it should be appreciated that FIGS. 6a-6i shown and provided herein is associated with these figures is not intended to describe or illustrate all possible arrangements or apparatus of the present invention may be used to tissue through element 102 piercing path forming catheter 100 . 另外,以下的详细描述涉及某些包括“预弯回弹元件”的组织穿通元件102。 In the following detailed description is directed to certain comprising "pre-bent resilient member" element 102 through tissue. 术语“预弯回弹元件”意味着一种元件,当它不被约束时将采取弯曲或曲线的形状,但具有足够的弹性,可以被退回并约束于导管部件100腔内,而不导致元件的塑形变形。 The term "Pre-Bending element" means an element when it is not bound to take a curved or curvilinear shape, but sufficiently resilient, and can be constrained to return lumen of the catheter member 100, without causing element the plastic deformation. 能用于形成本发明的某些组织穿通元件102的预弯回弹元件的材料实例,包括在体温或在这些部件将被应用的温度下有回弹性、弹性或超弹性的材料。 Examples of some materials can be used to form the present tissue penetrating element 102 pre-bent resilient member, comprising a resilient body temperature or at a temperature of the member to be applied, elastic or superelastic material. 这些材料的实例包括某些不锈钢,某些塑料和某些超弹性合金和聚合物,如镍钛合金。 Examples of such materials include certain stainless steel, certain plastics and certain polymers and superelastic alloy, such as Nitinol.

图6a所示的通路形成导管100a的实施方案中,管腔112a通过导管100a纵行延伸,在远端小孔114处停止。 6a embodiment shown in FIG passage 100a formed in the catheter, a lumen extending through the conduit 112a 100a wales, aperture stop 114 at the distal end. 组织穿通元件102包括上述定义过的预弯回弹元件。 Tissue penetrating element 102 includes a pre-bent resilient element as defined above before. 当退回管腔112内时,组织穿通元件102的这一实施方案采取基本上直的、非弯曲或最小弯曲的形状,以适应导管100a的周壁。 When retracted within the lumen 112, through tissue elements 102 of this embodiment taken substantially straight, non-bent or curved shape minimum to accommodate the circumferential wall of the conduit 100a. 然而,当组织穿通元件102向前穿出导管100a远端的出口小孔114a时,组织穿通元件102将采取其预弯形状,从而组织穿通元件102的远端将穿过导管100a所在的血管管壁。 However, when the tissue piercing element 102 through the distal end 100a of the catheter outlet orifice 114a forward, tissue penetrating element 102 to assume its pre-bent shape, so that the tissue penetrating element 102 will pass through the distal end of the catheter tube 100a where the vessel wall. 应当理解,关于这一实施方案,以及本文描述的本发明的全部其它实施方案,组织穿通元件102可以被塑形以形成任何形状或大小的通路10。 It should be appreciated that, with respect to this embodiment, and all other embodiments of the invention described herein, the tissue penetrating element 102 may be shaped to form any shape or size of the passageway 10. 因此,在其中组织穿通元件102包括一个预弯回弹元件的实施方案中,组织穿通元件的预弯形状可以是连续曲线、部分直线、部分曲线,多重曲线,或适于形成所期望的大小和形状的初始血管外通路10的任何其它预弯形状。 Thus, the tissue penetrating element 102 includes a pre-bending embodiment resilient element, the through element is pre-bent shape of the tissue may be a continuous curve, linear portion, part of the curve, multiple curve, or suitable for forming a desired size wherein and the initial shape of the outer vessel of any other pre-bent shape of the passage 10. 而且,如以下将要更详尽描述的那样,可能应用不同种类的通路修正部件,去除组织、扩大、扩张或修正通路的大小和/或形状,从而最终产生的通路10的形状可能基本上不同于组织穿通元件102第一次穿通后形成的初始通路。 Furthermore, as will be more fully described below, may apply different types of path correcting means, removal of tissue, expanded, or expanded size and / or shape correction path, the final shape to the passageway 10 may generate substantially different tissues initial passage through the first member 102 is formed through.

图6b显示的通路形成导管部件100b,有一个纵行延伸并终止于远端侧壁出口小孔114b的管腔112。 Figure 6b shows a forming passage conduit member 100b, and has a longitudinal extending side walls terminating in a distal outlet aperture 112 lumen 114b. 在侧壁小孔114b和管腔112b的对侧表面之间,一个偏导器表面115形成于管道112b内。 Between the pair of side surfaces 114b and the side wall aperture 112b, a lumen, a deflector surface 115 is formed in the duct 112b. 以柔韧材料制成的组织穿通元件102在退回管腔112b时,基本上是直的形状。 Made of flexible material in a tissue penetrating element 102 upon its return lumen 112b, substantially straight shape. 然而,当沿远端方向向前时,该组织穿通元件102的远端将被偏导器表面115偏转,并通过侧壁小孔114b穿出导管100b管腔。 However, when the forward in the distal direction, the distal end of the tissue penetrating element 102 will be deflected deflector surface 115, and side wall aperture 114b through 100b piercing catheter lumen. 用这种方式,组织穿通元件可以以相对于导管100b的纵轴LA的侧方方向穿出导管100b的管体。 In this manner, the tissue penetrating member relative to the catheter 100b may be the direction of the longitudinal axis LA of piercing the side of the tubular body of the catheter 100b.

图6c显示导管部件100c有一个沿纵轴延伸并终止于远端侧壁出口小孔114c的管腔112c。 Figure 6c shows a duct member 100c extending along a longitudinal axis and terminating in a distal outlet orifice side walls of a lumen 112c 114c. 组织穿通元件102可以是一个预弯回弹元件,且在完全退回到导管100c的管腔112c时,基本上是直的形状。 Tissue penetrating element 102 may be a pre-bent resilient member and, when fully retracted into the catheter lumen 112c to 100c, substantially straight shape. 然而,当该组织穿通元件102沿远端方向向前时,由于其寻求它的预弯形状的固有倾向,该预弯回弹元件102的远端将自行定位,并穿出出口小孔114c,而不需要管腔112c壁上的任何表面的提起或偏转。 However, when the forward direction in the distal tissue penetrating element 102, because it seeks to its pre-bent shape inherent tendency, the distal end of the pre-bent resilient member 102 will position itself, and out the outlet aperture 114c, 112c lumen wall without the need for any lifting or deflection surface.

图6d和6d′显示一个导管部件100d,它有一个纵向延伸的管腔112d,终止于远端出口小孔114d。 Figure 6d and 6d 'show a conduit member 100D, which has a longitudinally extending lumen 112d, a distal end terminating in an outlet orifice 114d. 一个砧板元件180安置于导管100d远端前方间隔的距离,并通过整合形成的支柱182而与导管相接触。 An anvil member 180 disposed at a distal end spaced from the front of the catheter 100d, and contact with the conduit 182 through the integration of the pillar is formed. 砧板元件180有一个远端钝面184和偏转表面186形成于其近侧,与导管100d的管腔112d的远端出口小孔114d直接排成一线。 Anvil member 180 has a blunt distal surface 184 and a deflection surface 186 is formed at its proximal, the distal end of the outlet catheter lumen 112d 100d 114d holes arranged in a line directly. 本实施方案中,组织穿通元件102包括一个柔韧元件,或回弹、预弯元件,并如所示那样,采取基本上直的或最小弯曲的形状,以适应和能够退回到导管的腔114d。 The present embodiment, the tissue penetrating element 102 comprises a flexible member, or resilient, pre-bent member, and as shown above, take a minimum or substantially straight curved shape to accommodate and can be retracted into the lumen of the catheter 114d. 然而,当穿通元件102穿出导管的远端开口114d时,组织穿通元件102的远端尖端将拱向砧板元件180的偏转器表面186,并针因而被偏转、被引导或产生弯曲或在侧方向成曲线,从而组织穿通元件将如图示那样穿过血管BV1的管壁。 However, when the piercing distal end 102 of the catheter member through the opening 114d, the distal tip of the tissue penetrating element 102 will arch toward the anvil surface 180 of the deflector member 186, and thus the needle is deflected or guided or bending the side direction of the curve, so that the tissue penetrating element passes through the wall of the vessel BV1 as illustrated.

优选地,砧板元件180的偏转器表面186不与导管100d的管腔112d的内表面相连续。 Preferably, the deflector surface, the anvil member 180 and 186 are not continuous with the inner surface of the lumen of the catheter 100d to 112d.

图6e所示导管部件100e的另一种实施方案,其中导管部件100e包括一个可退回的外导管鞘190,和一个延伸内在元件192,一个预弯回弹管194形成于元件192内或安装于其远端部分内。 As shown in FIG. 6e catheter member 100e another embodiment, wherein the catheter comprises a retractable member 100e of the outer catheter sheath 190, inner member 192 and an extension, a pre-Bending tube 194 is formed in or attached to the inner member 192 the distal end portion thereof. 延伸内在元件192有一个远端钝头196,并在其内形成一个延伸侧开口198,从而当外导管鞘190在近端方向上被退回时,如图所示,预弯回弹管状元件194将向外弹出到其预弯的侧曲形状。 Extending the inner member 192 has a blunt distal end 196, and is formed in a side thereof extending within the opening 198, so that when the outer catheter sheath 190 is retracted in the proximal direction, as shown, the tubular resilient member 194 prebending the curved shape of the side spring outward to their pre-bent. 本实施方案中的组织穿通元件102可以是一个柔韧元件或预弯回弹元件,在它向前穿出内在管状元件194远端上的远端开口114e时,它将采取预弯形状。 When the present embodiment the tissue through a flexible element 102 may be pre-bent resilient element or elements, in which the inner tubular piercing member distal end forward on the distal end 194 opening 114e, it would take a pre-curved shape. 用这种方式,当导管鞘190在近端方向上退回时,预弯管状元件194可以形成第一角A1,当预弯回弹组织穿通元件102向前穿出预弯管状元件194的远端开口114e时,它可以形成第二角A2,从而,在组织穿通元件102远端尖端瞄准的方向和导管100e的纵轴LA之间,第一角A1和第二角A2将联合,结果形成第三角A3。 In this manner, when the catheter sheath 190 retracted in the proximal direction, the pre-bending-like member 194 may be formed of a first angle A1, when the pre-Bending element 102 forwardly through tissue piercing elbow-like member 194 of the pre the distal end opening 114e, it can form a second angle A2, and thus, the distal end of the tissue 102 between the tip member and the direction of longitudinal axis LA of the aiming of the catheter through 100e of the first angle and the second angle A2 to A1 joint, results forming a third angle A3. 如以上所详细解释的那样,组织穿通元件102的远端尖端和导管100e纵轴LA之间的角A3并不必然指定或限定了组织穿通元件102将要形成通路102的确切角度。 As explained in detail above, tissue penetrating distal tip member and the catheter 102 A3 angle between the longitudinal axis LA 100e is not necessarily define or specify the exact angle member 102 through passage 102 will be formed in the tissue. 实际上,组织穿通元件102可以是任何合适的形状,包括将形成连续曲线通路的连续曲线形状。 In effect, the through element 102 may be any suitable shape, including a continuous curved shape continuous curve path.

图6f显示了导管部件100f的另一种实施方案,其中,导管部件100f包括一个可以在近端方向上退回的管状外鞘202,以及一个具有远端钝头206和一个形成于其上的侧面开口208的延伸内在元件204。 Figure 6f shows another embodiment of the catheter member 100f, which comprises an outer catheter member 100f can be retracted in a proximal direction of the tubular sheath 202, and a side on which the blunt distal end 206 and formed to have a inner member 208 extending opening 204. 组织穿通元件102最好是一个安装于延伸元件104内的预弯回弹元件,紧密邻近侧面开口208,从而,当导管外鞘202向前而覆盖侧面开口208时,组织穿通元件102将采取基本上直的或最小弯曲的形状,以便适应导管部件100f的内腔112f,并被约束于其内。 Tissue penetrating element 102 is preferably attached to a resilient member extending within the pre-bending element 104, the side opening 208 in close proximity, so that when the catheter sheath 202 to cover the front side opening 208, element 102 through tissue substantially will take straight or minimal curved shape to accommodate the lumen of the catheter member 100f, 112f, and restrained therein. 然而,当外鞘202在近端方向上退回以暴露侧面开口208时,组织穿通元件102将向外弹回其预弯形状,从而,组织穿通元件的远端指向,或将恰恰接触到,导管部件100f将要插入的血管BV的管壁。 However, when the outer sheath 202 retracted in the proximal direction to expose the side opening 208, the tissue penetrating element 102 outwardly spring back to its pre-bent shape, whereby the distal end of the tissue member through the point, or just in contact with the catheter 100f member to be inserted in a blood vessel BV wall. 至少在某些实施方案中,组织穿通元件可以随后在远端方向上被推向前,从而穿过血管壁和任何期望的血管外组织,按照本发明形成血管外通路10。 In at least some embodiments, the tissue penetrating element may then be pushed forward in the distal direction, through the vessel wall and thus any desired extravascular tissue, extravascular passageway 10 formed in accordance with the present invention.

图6g显示另外一个实施方案,通路形成导管部件100g包括一个管状导管管体,它有一个中空腔112g纵行延伸通过,并开口于远端开口114g。 FIG. 6g show a further embodiment, the conduit passage forming member 100g comprises a tubular catheter body, which has a hollow cavity extending through the wales 112g, and an opening in the distal opening 114g. 导管100g的远端管体可以向侧方弯曲,如图6g的点状线所示。 100g catheter distal tube may be bent sideways, 6g of the dotted line shown in FIG. 导管部件100g在侧方的这种弯曲将引起出口小孔114g变成指向导管部件100g所在血管的管壁,从而,组织穿通元件102随后向前穿出导管部件100g的远端开口114g,导致组织穿通元件102接触并穿过导管部件100g所在血管BV的管壁。 In such a catheter member 100g will cause bending of the side outlet aperture directed into the conduit member 100g 114g where the vessel wall, thereby penetrating tissue piercing element 102 may then forward the catheter component distal end opening 100g 114g, leading to tissue through the contact element 102 and through the wall of the catheter member 100g where the blood vessel BV. 在形状记忆合金、拉丝、反电磁线圈或能引起导管尖端弯曲的任何其它合适的机械、装置或材料的存在下,导管100g的可弯曲远端可以由其直的形状变成其曲线或弯曲的形状。 In the shape memory alloy wire drawing, any other suitable mechanical anti solenoid or bending can cause the catheter tip, the presence of the device or material, 100g catheter distal end may be bent into its curved shape by a straight or curved shape.

图6h显示通路形成导管部件100h的另一个实施方案,它包含一个管状导管100h,它有一个可从其中穿过的组织穿通元件102。 FIG. 6h show another embodiment of the catheter passage forming members 100h and 100h comprising a tubular conduit, which has therethrough a tissue penetrating element 102. 一个可充盈球囊210形成于导管部件100h的一侧,与血管BV管壁上将要形成的血管外通路10的位置相对。 Filling a balloon 210 may be formed on the side of the catheter member 100h, and extravascular blood vessel BV wall will be formed in the passage 10 opposite positions. 在组织穿通元件102向前进之前或向前进期间,球囊210的充盈将:a)当组织穿通元件102向前穿过血管BV的管壁时,阻止或防止导管100h弹回和压向血管BV的对侧壁,和b)用来稳定和保持导管部件100h的远端部分在血管BV的管腔内处于基本固定的位置,从而,在组织穿通元件102向前进或穿过血管BV管壁时,可以应用增强的力量或压力于其上。 In the element 102 through the tissue prior to or during the advancement proceeds, filling the balloon 210 will: a) when the tissue penetrating element 102 through the forward wall of the blood vessel BV, the conduit 100h resist or prevent spring back and pressed against the blood vessel BV the pair of side walls to stabilize, and b) a distal portion of the catheter and the holding member 100h is in a substantially fixed position within the lumen of the blood vessel BV so that, when the tissue penetrating element 102 in the forward or through the blood vessel wall BV It can be applied to enhance the force or pressure on it. 在图6h所示的实施方案中,导管部件有一个远端出口开口114h,组织穿通元件102是一个预弯回弹元件,在穿出远端出口114h时,它采取侧向弯曲或曲线的形状。 In the embodiment shown in FIG. 6h, the catheter member has a distal outlet opening 114h, tissue penetrating member 102 is a pre-bent resilient member, when the outlet piercing distal end 114h, it takes the shape of the curve or bend laterally . 然而,应当理解,图6h所示的侧球囊210可以与图6a-6i所示的任何类型的导管结合或联合使用,包括那些其中组织穿通元件穿出导管部100h侧壁的侧出口小孔。 However, it should be appreciated that the side of the balloon 210 as shown in FIG. 6h may be combined with any type of catheter shown in FIGS. 6a-6i or in combination, include those wherein the tissue piercing element through the catheter side wall portion 100h of the side outlet aperture .

图6i显示另外一种实施方案,通路形成导管部件100i包含一个延伸的、可弯曲的、管状导管管体,它有一个沿纵向延伸的中空管腔114i;和一个旋转安装于管状导管管体远端的钝体尖端元件212。 FIG 6i show another embodiment, the passage forming members 100i comprises a conduit extending, flexible, tubular catheter tube, which has a hollow lumen extending longitudinally along one 114i; and rotatably mounted on a tubular catheter tube distal end of the tip element 212 of the bluff body. 远端尖端元件212有一个弯曲管腔214延伸通过,其近端与导管100i的管腔114i连成一线,其远端终止于远端头部元件112一侧的侧出口小孔114i。 Member 212 has a distal tip 214 extends through a curved lumen, the lumen of the catheter with its proximal end in a line 100i to 114i, which terminates in a distal end side of the outlet orifice 114i distal head element 112 side. 本实施方案中的组织穿通元件102可以包括一个柔韧元件或回弹预弯元件。 The present embodiment the tissue through a flexible element 102 may include a pre-bent resilient element or elements. 在任一情况下,组织穿通元件102可以先前进到中间位置,其中,组织穿通元件的远端尖端置于远端头部元件212的弯曲管腔214内。 In either case, the tissue penetrating element 102 may be first advanced to an intermediate position, wherein the tissue penetrating distal tip member disposed within the distal end 212 of the head element 214 is a curved lumen. 当组织穿通元件102处于这种中间位置时,组织穿通元件102可以被旋转。 When the tissue penetrating element 102 is in this intermediate position, tissue penetrating member 102 may be rotated. 由于其在远端尖端元件121的弯曲管腔214内的摩擦接触,组织穿通元件102的这种旋转将引起远端尖端元件212同时旋转。 Because of its frictional contact with the inner member 121 distal tip 214 of a curved lumen, the tissue penetrating element 102 will cause such a rotation member 212 rotates while the distal end of the tip. 在这种方法中,组织穿通元件102的部分前进和旋转可以用来做为一种方法,旋转移动远端尖端元件212,以适应侧出口小孔114i的旋转定向,从而指引组织穿通元件以期望的侧向方向,在期望的地点,形成本发明的血管外通路10。 In this method, the tissue through the forward portion and the rotary member 102 may be used as a method, the rotational movement of the distal tip member 212, to accommodate the rotational orientation of the side outlet aperture 114i, whereby the guidance element to the desired tissue through in the lateral direction, at a desired location, extravascular passageway 10 is formed according to the present invention. 用这种方式,在达到期望的远端尖端元件212的旋转定向后,组织穿通元件102进一步向前穿出侧出口小孔114i,将使组织穿通元件穿过导管100i所在的血管BV的管壁,形成期望的血管外通路10。 In this way, after the rotational orientation of the distal tip member 212 to achieve the desired tissue through piercing element 102 further forward side outlet orifice 114i, will through the catheter member through a blood vessel BV wall tissue 100i where , extravascular passageway 10 formed in a desired.

ⅱ. Ⅱ. 可以结合于通路形成导管的组织穿通元件的类型下列图7a-7m和下文中提出的相关的详细描述,打算描述和阐明可按照本发明应用的某些类型的组织穿通元件102。 Of the type described in detail through the following elements may be bonded to FIG passage formed tissue conduit 7a-7m and related presented below, intended to be described and illustrated according to some types of tissue through the application of the present invention, element 102. 应当认识并理解到,以下描述和图7a-7m显示的组织穿通元件102的特定类型,并不意在穷尽列举和描述可应用的组织穿通元件102的所有可能的类型,而是意在提供可以应用的组织穿通元件102的类型的实例。 It should be appreciated and understood that, 7a-7m tissue shown in the following description and through a particular type of element 102, and is not intended to be an exhaustive list and describe the applicable tissue elements in all possible types 102 through, but is intended to provide a use examples of the type of element 102 through tissue. 如上解释,术语“组织穿通元件”并不限于固体元件,也可以包括不同的装置、部件、或能量流。 As explained above, the term "tissue penetrating element" is not limited to a solid element, it may comprise different devices, components, or energy flow. 而且,术语“回弹、预弯元件”应当按照以上提出的这一术语的定义来解释。 Also, the term "resilient, pre-bent member" should be interpreted in accordance with the definition of the term set forth above.

参照图7a-7m,显示了可用于本发明的通路形成导管100的组织穿通元件102的不同类型。 Referring to FIGS. 7a-7m, shows the different types can be used according to the present invention, the passage is formed through the tissue tract 100 of member 102. 这些组织穿通元件102被设计成穿出可弯曲导管管体,穿入导管100所在的血管管壁,必要时穿过邻近血管外组织,形成本发明所期望的血管外通路10。 These organizations through piercing element 102 is designed to be flexible catheter tube, penetrate the blood vessel wall where the catheter 100, through the adjacent extravascular tissue, if necessary, according to the present invention, a desired outer passage 10 formed blood vessels.

图7a和7a′显示了组织穿通元件102a的第一个实施方案。 7a and 7a 'shows a first embodiment of the elements 102a through the tissue. 这个组织穿通元件102a包括一个由柔韧材料,例如可从商业途径获得的Microlumen. This organization through Microlumen element 102a comprises a flexible material, e.g. commercially available from. Inc. Inc. ,Tampa,弗洛里达州的聚酰亚胺(Polyimide)管制成的延伸的、柔韧的针,和一个形成于其上的尖锐的、倾斜的远端尖端300。 , Tampa, Florida, polyimide (Polyimide) tubing extending, flexible needles, and formed thereon a sharp distal tip 300 is inclined. 一个可选的管腔302可以沿穿通元件102a纵行延伸。 An optional lumen 302 may extend in the wale 102a through element. 一个预弯、回弹元件304,或者一条拉丝,纵行安置于组织穿通元件102a内。 A pre-bent, resilient member 304, or a drawing, to a longitudinal tissue disposed through the inner member 102a.

当元件102a退回到通路形成导管100管腔之内时,回弹针元件304a将被引致采取基本上直的或最小弯曲的形状,适应导管管腔的形状,允许组织穿通元件102被完全退回进入导管管腔。 When elements 102a back to path 100 formed within the catheter lumen, the needle resilient element 304a will be brought to take a minimum or substantially straight curved shape adapted to the shape of the catheter lumen, allow the tissue penetrating element 102 is fully retracted into the the catheter lumen. 然而,当组织穿通元件露出或向前穿出通路形成导管100时,预弯针元件304的远端部分将在侧方弯曲或呈曲线,由此使整个柔韧的组织穿通元件102a采取如图7a的剖视线所标示的那样的侧向弯曲或曲线的形状。 However, when the tissue penetrating element is exposed forwardly piercing or passage 100 formed in the catheter, the distal end portion of the pre-curved needle element 304 will be bent or curved at the side, whereby the entire flexible member 102a tissue taken through FIG. 7a as the lateral section line marked bend or curve shape. 以此方式,预弯回弹针元件304将引起柔韧或可弯曲的组织穿通元件体部采取期望的侧向弯曲或曲线的形状。 In this manner, the pre-Bending element 304 will cause needle shape pliable or bendable element body tissue through the side portion to take a desired curved or curvilinear. 在某些情况下,这种安置也可以允许组织穿通元件102a的柔韧体部围绕预弯回弹针元件304a旋转或转动,以易化或加强推进组织穿通元件进入血管管壁或邻近组织。 In some cases, this arrangement may allow the tissue portion through the flexible member body 102a about element 304a needles pre Bending rotated or turned in order to enhance the promotion or facilitation element through tissue into a blood vessel wall or the adjacent tissue.

图7b显示组织穿通元件102b的另外一种实施方案它包含一条柔韧的延伸近端长柄306,它有一个刚性、尖锐远端尖端元件308安置于近端长柄306远端上或加入其中。 Figure 7b shows the tissue penetrating element 102b is another embodiment comprising a flexible shank proximal end 306 extends, which has a rigid, sharp distal tip member 308 is disposed at the distal or proximal end of the shank 306 added thereto. 在这个实施方案中,组织穿通元件102b的近端长柄306足够柔韧和可弯曲,以通行于扭曲的解剖曲线或导管管腔内的曲线,同时刚性远端尖端部分308由刚性材料形成,如不锈钢,从而维持基本上尖锐的远端尖端310穿入并穿过血管管壁和期望的血管外组织,按照本发明形成血管外通路10。 In this embodiment, the tissue member through the proximal end 102b of the shank 306 may be curved and sufficiently flexible to pass through the catheter lumen within the anatomical curve in a graph or distorted, while the rigidity of the distal tip portion 308 is formed of a rigid material, such as stainless steel, thereby maintaining the extravascular tissue substantially sharp distal tip 310 and penetrate through the vessel wall and desired extravascular passageway 10 formed in accordance with the present invention.

图7c显示组织穿通元件102c的另外一种实施方案它包含一个延伸的实性或中空的带有尖锐远端尖端312的针,由预弯回弹材料形成,如超级弹性镍钛合金,或在组织穿通元件102c正常使用时可能遇到的温度范围内,表现为有回弹性、弹性或超弹性的其它合金。 7c shows tissue penetrating element 102c is another embodiment which comprises a solid or hollow needle extending with a sharpened distal tip 312 formed by a pre-bent resilient material, such as a superelastic nitinol, or tissue through a temperature range that may be encountered during normal use, element 102c, manifested as a resilient, elastomeric or other superelastic alloys. 由预弯回弹材料形成的组织穿通元件102c的这个实施方案,在退回到通路形成导管100的管腔112内时,将采取基本上直的或最小弯曲的形状,从而整个组织穿通元件102c可以完全退回管腔112。 When the resilient material by the tissue pre-bending element is formed through 102c of this embodiment is formed within the lumen 112 of the catheter 100 back to the path to be taken substantially straight or curved shape of the smallest, so that the whole element organization through 102c may lumen 112 fully retracted. 然而,当组织穿通元件102c向前穿出导管100的出口小孔114c时,组织穿通102c将采取其预弯形状,从而在侧方弯曲或曲折,相对于导管的纵轴LA形成角A,由此,有利于组织穿通元件102c的远端部分向前穿过血管管壁和任向邻近组织,以形成按照本发明所期望的血管外通路10。 However, when the tissue penetrating element outlet aperture 102c piercing catheter 100 forward 114c, 102c through tissue to assume its pre-bent shape, so that the bent or meandering side, with respect to the longitudinal axis LA of the catheter forms an angle A, produced by this is conducive to tissue through the distal end portion 102c of the element through the vessel wall and any adjacent tissue to forward to the desired outer form according to the present invention, vascular access 10.

图7d显示,组织穿通元件102d的另外一种实施方案它包含一个具有尖锐的(例如,斜切过的)远端尖端314和纵向延伸通过的导丝通路管腔316的中空针。 Figure 7d shows the tissue through 102d element comprising another embodiment having a sharp (e.g., over the beveled) distal tip 314 and the guidewire passage lumen extending longitudinally through the hollow needle 316. 应当理解,按照图6a-6i列举和以上详细描述的组织穿通元件穿出方案的不同,中空针可以由预弯、回弹材料或柔韧材料形成。 It will be appreciated, piercing member through the different programs, the hollow needle may be bent by a pre-organized in accordance with FIGS. 6a-6i described in detail above and include, resilient material or flexible material. 图7d显示的穿刺元件102d的实施方案,具有允许导丝GW通过导丝通路管腔316向前进的优势。 Piercing element 102d of the embodiment shown in Figure 7d, it has the advantage of allowing 316 to advance a guidewire passage lumen guidewire GW. 按照本方式,导丝GW可以在远端方向上间歇性向前,或可以被置于持续向远端的压力之下,从而,当组织穿通元件102d的尖锐远端尖端314进入另一条血管的管腔或其它空腔时,导丝GW将在远端方向上很快向前,由此标志着组织穿通元件102d的尖锐远端尖端314已经进入该血管管腔或空腔。 According to the present embodiment, the guidewire GW may intermittently forwardly in the distal direction, or may be placed under constant pressure to the distal end, so that, when the sharp distal tissue penetrating tip 314 of element 102d into another tube of a blood vessel when the cavity or other cavity, the guide wire GW will quickly forward in the distal direction, thereby marking the tissue penetrating element 102d has a sharp distal tip 314 enters the vessel lumen or cavity. 因此,在本发明的血管再造方法中,形成二条血管间的血管外通路10时,或在本发明的另外的血管外步骤中,形成一条血管与一个包括另一条血管或其它中空体腔的目标T之间的血管外通路10时,穿通元件102d的这种实施方案特别有用。 Thus, in the revascularization method of the present invention, the formation of the extravascular passageway between the two vessels 10, or in a separate vessel to the steps of the present invention, the formation of a blood vessel and the target T comprises another blood vessel or other hollow body lumen between extravascular passageway 10, through the element 102d of this embodiment is particularly useful. 施加于导丝GW的指向远端的压力可以手工施加,或应用如图10c′、10c″和10c所示以及如下全面详细描述的压力施加安全装置。 Directed pressure is applied to the distal end of the guidewire GW may be applied manually, or applied in FIG. 10c ', 10c ", and the pressure and fully described in detail below is applied to the security device shown 10c.

图7e还显示了组织穿通元件102e的另外一种实施方案它包含一个有尖锐(例如,斜切过的)远端尖端318的实性针。 Figure 7e shows a further element 102e through tissue of another embodiment comprising a sharp (e.g., chamfered off) the distal tip of the needle 318 of the solid. 如图7e′所示,本实施方案的穿刺元件102e可以由一个连续的实性延伸元件,例如一条丝形成。 'Shown in FIG. 7E, the piercing element 102e of this embodiment may be, for example, a wire formed from a continuous solid member extends. 可以替换地,如图7e″所示,本实施方案的组织穿通元件可以包含一个具有纵行延伸通过的中空管腔114e″的外部管状元件102e″,和一个可同轴插入穿刺元件102e″的中空管腔114e″的可移除实性管心针元件320,从而,管状穿通元件102e″连同实性管心针元件320将基本上形成了一个实性针结构,与图7e'所示的实性延伸穿刺元件102e'结构相似。 May alternatively, as shown in FIG 7E ", the tissue of the present embodiment through member may comprise a longitudinal line extending through the hollow lumen 114e has the" outer tubular member 102e ', and a coaxially inserted piercing element 102e' of hollow lumen 114e "removable solid stylet member 320, so that, through the tubular member 102e" together with the solid stylet tube member 320 formed of a substantially solid pin structure, shown in FIG. 7e ' solid extending piercing element 102e 'structural similarity.

图7f显示组织穿通元件102f的另外一种实施方案它由2个部分联合组成,一个具有形成于其远端的尖锐套管针尖端324的延伸实性或管状元件322,和一个环绕的、可纵向向前进的外鞘326。 Figure 7f show another embodiment of the tissue penetrating element 102f which consists of a joint composed of two parts, a solid or tubular element extending tip 324 of a sharp needle cannula 322 having a distal end thereof, and a circumferential, may longitudinal outer sheath 326 forward. 外鞘326的远端部分可以逐渐变细,未显示,从而它可以覆盖和防护延伸元件322的尖锐套管针尖端324。 An outer sheath distal end portion 326 may be tapered, not shown, so that it can cover and protect the needle cannula extending sharpened tip 324 of element 322. 然而,当沿血管管壁或其它组织向前进时,尖锐套管针尖端324将露出外鞘326远端开口之外,从而通过血管管壁和/或其它组织穿入和前进。 However, when the blood vessel along the wall or other tissue is advanced, the sharp trocar tip 324 is exposed outside the distal opening of the sheath 326, so that by the vascular wall and / or tissue penetration and other proceeds. 当套管针尖端进入另一条血管管腔或其它中空体腔时,外鞘326可以响应施加于外鞘326上的间歇或连续指向远端的压力而向前。 When the trocar tip into the lumen of another blood vessel or other hollow body lumen, the outer sheath 326 may be intermittently applied in response to the continuous outer sheath 326 or distal end of the forwardly directed pressure. 这种指向远端的压力可以手工施加,或用如图10c′、10c″和10所示及如下全面描述的持续压力施加安全部件施加。 This distally directed pressure may be applied manually, or applied to the security element is applied with FIG. 10c ', 10c "and a comprehensive and continuous pressure as described 10 FIG.

图7g显示组织穿通元件102g的另一种实施方案,包括一个具有能量发射远端尖端330形成于其远端的延伸管状元件328。 FIG. 7g show tissue through element 102g another embodiment, comprises an energy-emitting distal tip having a distal end thereof extending in the tubular element 328 330 is formed. 一条或多条能量发射丝或元件332可以自管状元件328发出,并与能量发射远端尖端330相连,从而向远端尖端330释放期望形式的能量。 One or more wires or an energy emitting element 332 may be emitted from the tubular member 328, and is connected to the energy-emitting distal tip 330, the tip 330 so that a desired form of energy release distally. 按照本方式,能量发射远端尖端可以发射任何适当类型的能量,这些能量将切除、切割或易化按照本发明的方法推动元件328通过血管和其它血管外组织。 According to the present embodiment, the energy-emitting distal tip may emit any suitable type of energy, which will be cut, the cutting element 328 or facilitated pushing through the vessel and other extravascular tissue method according to the present invention. 可以从能量发射远端尖端330发射的能量类型的实例包括热(例如,电阻热或激光热形成“热尖部”)、单极电烙器(electrocautery)、双极电烙器、超声,等等。 It may be emitted from the distal tip of the energy emitting type of energy 330 Examples include heat (e.g., heat resistance or laser thermal forming "hot tip"), monopolar electrocautery (electrocautery), bipolar cautery, ultrasonic, etc. Wait.

图7h显示组织穿通元件102h的另一种实施方案它包含一个延伸可弯曲导管100,一个纵行延伸通过的管腔112和一个置于其远端的可旋转的通路形成尖端336。 FIG. 7h show tissue elements 102h through another embodiment comprising a flexible catheter 100 extends, extending through a longitudinal lumen 112 and a distal end which is placed a rotatable tip passage 336 is formed. 一个可旋转驱动元件338通过导管100的管腔112纵行延伸,在期望推进组织穿通元件102h穿过血管管壁或其它组织时,操作此可旋转驱动元件以旋转远端尖端336。 When a rotatable drive member 338 of the catheter 100 lumen 112 extending wales, the desired tissue through advancing member 102h through the vessel wall or other tissue by the operation of this driving member to rotate the rotatable distal tip 336. 旋转的远端尖端336可以是任何合适的形状,以在旋转时形成期望形状的通过组织的隧道或通路。 Rotation of the distal end tip 336 may be any suitable shape to form a desired shape when rotated by a tunnel or passageway tissue. 在这一点上,旋转尖端336的外表面可以装备一个尖锐的螺旋刀片或螺纹元件件337或其它组织切割或扩张的装置,以易化可旋转尖端336所期望的组织旋转钻孔、切割或扩张。 In this regard, rotation of the outer surface of the tip 336 may be equipped with a sharp blade or helical threaded element 337 or other tissue cutting device or expansion, to easily rotatably tip 336 of the desired tissue rotary drilling, cutting or expanded .

图7i显示另外一种组织穿通元件102i的实施方案。 FIG. 7i show another embodiment of the tissue through the element 102i. 在本实施方案中,组织穿通元件102i包括从形成于导管100内的小孔或透镜覆盖口114i发出的一来脉冲或连续激光。 In the present embodiment, the tissue penetrating element to 102i includes a pulsed or continuous laser light emitted from the lens or aperture formed in the conduit 100 within the cover opening 114i. 一个诸如光导纤维之类的激光传导元件340通过导管100的管腔112纵行延伸,终止于靠近一个诸如镜子之类的反射表面341处,并与之排成一线,自激光传导元件340远端发来的激光由此被反射出侧面小孔或开口114i。 A fiber such as a laser or the like of the conductive member 340 of the catheter 100 lumen 112 extending wales, terminates in a near surface 341 of the reflector such as a mirror or the like, and arranged in line therewith by conduction from the laser element 340 distal end sent reflected laser light is thus a side holes or openings 114i. 因此,在这一特定的实施方案中,组织穿通元件120i不是由固体物质或是可展开的组织穿通装置所形成,而是包括能够汽化或切开血管管壁和其它血管外组织,以形成本发明所期望的血管外通路10的脉冲或连续激光束。 Thus, in this particular embodiment, the tissue penetrating element 120i is not a solid material or tissue may be expanded through the forming apparatus, but can be vaporized comprising a vessel wall and cutting or other extravascular tissue, to form the present invention, a desired outer vascular access pulsed or continuous laser beam 10.

应当理解,本实施方案中的组织穿通元件102i可以被以不同方法修正。 It should be understood that the present embodiment of the tissue member through 102i may be modified in different ways. 例如,在反射表面341处,一个连续能量向导(例如,光导纤维)可以通过导管管体延伸,终止于导管侧壁上的出口或透镜内,从而,能量流(例如,激光)将自导管侧方穿出。 For example, the reflective surface 341, a continuous energy guide (e.g., optical fibers) may extend through the catheter tube, terminating in the outlet conduit or a lens on the side wall, whereby the flow of energy (e.g., laser) from the side of the catheter Fang piercing. 可替换地,一个能量发射装置可以安置于导管侧壁上或置于其内,从而可以从导管的侧外方向发射期望的能量流。 Energy Alternatively, one energy emitting device may be disposed on the side walls or catheter placed therein, so that the outer side may be emitted from a desired flow direction of the catheter. 另外,图7i特别显示的实施方案以及以上提到的其变化,将不限于激光能,也可以应用任何合适的能量流,包括热、超声、激光,等等。 Further, FIG. 7i embodiment particularly shown and variations thereof mentioned above, is not limited to the laser energy, may be applied to any suitable energy flow, including heat, ultrasound, laser, and the like.

图7j显示另外一种实施方案,组织穿通元件102j可与本发明的通路形成导管100相结合。 FIG 7j show another embodiment, the tissue penetrating member may be formed with a passage 102j catheter 100 of the present invention in combination. 在本实施方案中,组织穿通元件102j包括一个延伸激光传导元件,激光能可沿此通过,从而,激光能将自延伸激光传导元件102j的远端343发出。 In the present embodiment, the tissue penetrating element 102j includes a conductive member extending laser, laser energy along this passage, so that the laser can extend from the distal end of the conductive element 102j laser 343 emits. 延伸激光传导元件102j可以是预弯的,从而当它自导管100的远端开口114穿出时,它将在侧方自动曲折或弯曲,因而接触导管100所在的血管BV的管壁,以允许发自激光传导元件102j的远端343的激光能量在血管管壁和其它血管外组织内形成期望的血管外通路10。 Laser 102j extending conducting element may be pre-bent so that the distal end of the catheter when it is self-piercing 100 of opening 114, it will automatically lateral bending or curving, thus contacting the wall of the blood vessel BV where catheter 100, to allow extravascular laser energy from the bottom of the distal end of the laser conducting element 343 102j formed in a desired blood vessel wall and other extravascular tissue passage 10. 另外,应当理解,按照所有图示于图6a-6i和如上全面描述的所有组织穿通元件102的适当的出口方案,多种其它的出口方案可应用于激光传导元件102j,例如,形成于导管100的侧壁小孔。 Further, it should be appreciated that, in accordance with all illustrated in FIGS. 6a-6i and all organizations as fully described through suitable outlet program element 102, various other schemes may be applied to the laser outlet 102j conductive element, e.g., the catheter 100 is formed the side walls of the hole.

图7k显示可用于本发明的通路形成导管100的组织穿通元件102k的另一种实施方案。 FIG 7k display can be used according to the present invention is formed via a further embodiment of a tissue penetrating catheter 100 of the element 102k. 图7k所示的组织穿通元件102k,包括一个延伸中空针,它有一个管腔316纵行延伸通过,和一个尖锐远端尖端。 7k structure shown in FIG. 102K through element, comprising a hollow needle extends, which has a lumen 316 extending through the wales, and a sharp distal tip. 一个真空源(例如,吸引器)344附着于组织穿通元件102k的管腔316的近端,从而,在组织穿通元件的远端被推向前穿通血管BV或其它组织以形成本发明的血管外通路10时,将拖或拉组织进入管腔316。 A vacuum source (e.g., suction) 344 is attached to the proximal end of tissue lumen element 316 through 102k, whereby the distal tissue penetrating element is pushed forward through the blood vessel BV or other tissue to form an extravascular invention passage 10, the drag or pull the tissue into the lumen 316. 一个可选的封闭袖口317,它可包括一个安装于组织穿通元件102k外,面与其上的尖锐远端尖端分开一些距离的可充盈环状球囊,可以放置于毗邻血管BV管壁,从而形成封闭,它将避免管腔316应用吸引器而引起从血管BV管腔中漏出或吸出血液。 An optional closed cuff 317, which may include a tissue penetrating element attached to 102k, the sharpened distal end face on which the tip can be separated at some distance from the annular filling balloon may be placed adjacent to the wall of the blood vessel BV, thereby forming closed, the lumen will prevent the application 316 to cause leakage or aspirator aspirates blood from the blood vessel BV lumen. 用这种方式,在组织穿通元件102k向前穿过血管壁组织或其它血管外组织时,可选的封闭袖口317可以易化将血管管壁BV或其它血管外组织拉或吸入管腔316的远端。 In this manner, when the tissue penetrating element 102k through the outer vessel wall or other tissue vascular tissue forward, closing sleeve 317 can optionally facilitated or outside the blood vessel wall BV or other vascular tissue pulling the suction lumen 316 remote.

图7l显示了可用于本发明的通路形成导管100的组织穿通元件102l的另外一种实施方案。 FIG 7l shows another embodiment of the present invention can be used in forming the passage 100 of the catheter through tissue elements of 102l. 参照图7l,提供了一个组织穿通元件102l,与标准组织穿通元件102相结合,例如具有尖锐远端尖端的实性或中空针,和具有回弹、预弯远端部分347和纵行延伸通过的中空管腔349的环绕管状鞘346。 Referring to FIG. 7L, it provided a tissue penetrating member 102L, the standard organization through element 102 in combination, for example, having a sharp distal tip of solid or hollow needle, and having a resilient, pre-bent distal end portion 347 and extending through the wales hollow lumen 349 of tubular sheath 346 surrounding. 内有组织穿通元件102的鞘346沿导管100的管腔112被推向前。 Organized through the sheath member 346 in a lumen 102 of the catheter is pushed forward 112,100. 当鞘346的远端部分347向前穿出导管100的远端开口114时,鞘的预弯远端部分347向侧方自动弯曲或折弯,如图7l的点状线所示。 When the distal end portion 347 of the sheath 346 forwardly piercing distal end 100 of the catheter opening 114, the pre-bent distal end portion of the sheath 347 is automatically laterally curved or bent, 7L dotted line shown in FIG. 然后,柔韧或预弯组织穿通元件102将被沿鞘346的管腔349推向前,穿过血管BV的管壁或其它血管外组织,按照本发明形成所需的血管外通路10。 Then, pre-bent or pliable tissue penetrating element 102 will be in front of the sheath into the lumen 349 346, through the wall of the blood vessel BV or other extravascular tissue, vascular access desired outer form 10 of the invention. 任选地,真空源345可与鞘346的管腔349的近端相连结,以牵拉血管BV管壁与鞘346的远端部分347接触,从而易化组织穿通元件102前进和穿过血管管壁或其它组织。 Optionally, the vacuum source 345 may be coupled to the proximal end 349 of the sheath lumen 346 to pull the blood vessel wall BV and distal end of the contact portion 347 of the sheath 346, thereby easily advancing tissue penetrating element 102 and through a blood vessel wall or other tissue.

图7m显示组织穿通元件102m的另一种实施方案。 FIG 7m Another display element organization through 102m through embodiments. 参照图7m,提供的导管100具有一个侧壁开口114形成于其中和一个中空管腔112纵行延伸通过,并终止于侧壁开口114。 Referring to FIG 7m, the catheter having a side wall 100 provides an opening 114 formed therein and a hollow lumen 112 extending longitudinally through the row, and terminating in the side wall opening 114. 一个诸如尖头的中空或实性针的组织穿通元件102,可以通过导管100的管腔112向前进并穿出侧壁开口114。 Such as a hollow needle or a solid tissue penetrating tip member 102, through the lumen 112 of the catheter 100 and out through the forward sidewall of the opening 114. 一个真空源350(例如,吸引器)放置于管腔112的近端,如图7m所示,吸引器被用来牵拉血管BV管壁向下与侧边小孔114接触。 A vacuum source 350 (e.g. inhalator) is placed in the proximal end of lumen 112, as shown in Fig 7m, suction is used to pull down the wall of the blood vessel BV contact with the side aperture 114. 这种由吸引器引起的血管BV管壁与侧面小孔114的接触,易化组织穿通元件102实现向前并穿过血管BV管壁,形成按照本发明所期望的血管外通路10。 This contact with the side wall of the blood vessel BV caused by suction orifice 114, through tissue easily can realize a forward member 102 and through the blood vessel wall BV, formed in accordance with the present invention, a desired outer vascular access 10. 而且,这种吸收器附着帮助保持被穿入的组织处于紧绷状态,因而易化穿通这些组织。 Moreover, this helps maintain the absorber is attached in a tight state penetrate tissue, thus facilitated through these tissues.

ⅲ. Ⅲ. 通路修正装置图8a-8h和以下提出的详细描述,显示了多种类型的装置,可用于处理、扩大、去除组织、扩张、排列、包被或修正起初由组织穿通元件102形成的血管外通路10。 Detailed Description path correction apparatus of FIG. 8a-8h and presented below, show various types of apparatus available for processing, expanded, remove tissue expansion, arrangement, coated or corrected initially extravascular passageway by the tissue penetrating element 102 is formed 10. 应当认识并理解,图8a-8h所示以及以下的详细描述是意在描述和阐明,根据本发明可用的通路修正装置类型的代表性实例,而不是意在全部列举和描述按照本发明可用的每一种可能的通路修正装置。 It should be appreciated and understood that the detailed description and the following shown in FIGS. 8a-8h are intended to describe and illustrate, according to representative examples of the type of path correction apparatus of the present invention is usable, not intended to list and describe all usable according to the invention every possible path correction means.

图8a显示通路修正装置500a的第一种实施方案,它包含一个延伸管状元件,在其远端有一个环状尖锐远端切割尖端502,和一个中空管腔504a纵行延伸通过。 8a shows the path correction means 500a in the first embodiment, comprising a tubular element extending, at its distal end has an annular sharpened distal cutting tip 502, 504a and a hollow lumen extending through the wales. 本实施方案的通路修正装置500a可以沿着穿过由组织穿通元件102形成的初始通路或通道的导丝GW向前,从而环状远端切割尖端502将切除组织或扩大由组织穿通元件102形成的初始通路或通道,以便提供所期望大小和形状的血管外通路10。 Guidewire GW path correction apparatus 500a of the present embodiment may be made through the tissue penetrating member 102 is formed along an initial path or the forward channel, whereby the annular distal cutting tip 502 will cut tissue or a tissue expansion device 102 is formed through initial passages or channels, in order to provide the desired size and shape of the extravascular passageway 10. 应当理解,吸引器或真空管可用于本实施方案的通路修正装置500a的远端管腔504a,以易化远端切割尖部502挖除组织,从而,环状远端切割尖部502切割的组织将被牵拉以朝向近端的方向进入管腔504a,并可以由一个合适的收集管收集以随后进行病理检查。 It will be appreciated, vacuum suction may be used, or the distal end 500a of passage correcting apparatus according to the present embodiment the lumen 504a, to facilitated excavation distal cutting tip 502 tissue, thereby cutting tissue annular distal tip portion 502 of the cutting It will be pulled in the proximal direction into the lumen 504a, and may be collected by a suitable collection tube for subsequent pathological examination.

图8b显示通路修正装置500b的另外一种实施方案,它包含一个逐渐变细的扩张器,它有一个基本上圆柱形的近端部分506,和一个逐渐变细的远端部分508。 Figure 8b shows another embodiment of the correction means passage 500b, which includes a tapered dilator which has a substantially cylindrical proximal portion 506, and a tapered distal end portion 508. 一个中空管腔504b通过本实施方案的通路修正装置500b纵行延伸,从而,通路修正装置500b可以沿一条插入由通路形成元件102形成的初始通路或通道的导丝GW向前。 A hollow lumen 504b through 500b wale path correction device of this embodiment extends so that the passage 500b correction means along the guide wire GW may initially inserted into a channel or passage is formed by a passage member 102 is formed forwardly. 当该通路修正装置500b向前通过这种初始形成的通路或通道时,逐渐变细的远端部分508将扩张通路或通道达到装置500b的近端部分506的较大直径。 When the forward path correction apparatus 500b passages or channels through which the initially formed, tapered distal portion 508 of the dilator proximal end of the device channel or passage 500b reaches the larger diameter portion 506. 一个可选的能量发射带510可安置于装置500b的近端部分506,从而在装置500b向前穿过时,它发出热或其它能量来进一步修正通路10的表面。 With an optional energy emitting means 510 may be disposed on a proximal portion 500b, 506, 500b so that when the device is advanced across it emits heat or other energy to the surface 10 of the further modified path.

图8c显示通路修正装置500c的第三种实施方案,它包含一个延伸管状元件,它有一个与以上图8a所示的实施方案的远端切割尖端502相似的环状尖锐远端切割尖端512,但更加适合发射能量(例如,热,震动,激光等)。 Figure 8c shows a third embodiment of path 500c correction apparatus, comprising a tubular member extending, which has a distal end with the above embodiment shown in FIG. 8a cut sharpened distal tip 502 similar to the annular cutting tip 512, but more suitable for emitting energy (e.g., heat, vibration, laser, etc.). 在本装置500c的实施方案中,一个能量传导丝或元件514延伸穿过装置500c的管状近端部分,并与环状远端切割尖端512相连,从而,传导电能、超声震动、或任何其它合适的能量形式到远端尖端512,以易化推动远端尖端512到达期望的血管管壁或其它血管外组织。 In an embodiment of the apparatus 500c, a wire or the energy conducting member 514 extends through the tubular portion of the proximal end of the apparatus 500c, and the annular cutting tip 512 is connected to the distal end, thereby conduct electrical energy, ultrasonic vibration, or any other suitable forms of energy to the distal tip 512 to push the distal tip 512 of easily reach a desired blood vessel wall or other extravascular tissue. 贯穿装置500c形成的中空管腔504允许装置500c沿着被置于由组织穿通元件形成的初始通路或通道内的导丝向前。 Hollow lumen 504 through 500c forming apparatus allows the apparatus 500c forward along the guide wire is placed in the initial path or channel through the element formed tissue. 在装置500c前进时,电流或其它能量将通过能量传导丝或元件514,从而,由远端尖端发出热或其它能量会易化装置500c穿过组织的通路和前进。 500c when the device is forward, current or other energy or a conductive wire 514 through the energy element, whereby the forward and sent via heat or other energy is facilitated by the apparatus 500c through the tissue distal tip. 应当理解,一个真空源(例如,吸引器)可以附着于管腔504c的近端,进一步易化装置500c穿过组织的通路和前进,并牵拉任何挖掉的组织通过管腔504c,从而,去除的组织可以被收集到收集管中,被送去做相应的病理研究。 It should be appreciated that a vacuum source (e.g., suction) may be attached to the proximal end of lumen 504c, 500c is further facilitated through the passage means and advancing the tissue, and pulling the tissue dig through any lumen 504c, so that, removed tissue may be collected into a collection tube, sent do the corresponding pathological study.

图8d显示通路修正装置500d的第四种实施方案,它包含一个延伸管状导管516,它有一条中空管腔504d纵行延伸通过,并有一个环状球囊518安置于其外表面。 FIG. 8d show a fourth embodiment 500d of the path correction means, comprising a tubular catheter 516 extends, which has a longitudinal hollow lumen extending through 504d, and has an annular outer surface of a balloon 518 disposed thereon. 一个独立的球囊充盈管腔(未显示)将延伸穿过导管516的近端部分,以允许充盈流体被注入球囊518里面或被抽出。 Filling a separate balloon lumen extending through the proximal portion of the catheter 516, to allow the filling fluid is injected or withdrawn inside the balloon 518 (not shown). 本实施方案的通路修正装置500d,可以沿着置于组织穿通元件造成的初始通路或通道内的导丝GW,被向前推,直到未充盈的球囊518置于这个初始形成的通路或通道内。 Path correcting means 500d of this embodiment, guidewire GW may pass through the element caused by the initial tissue disposed along the passage or passages, it is pushed forward until not filling the balloon 518 disposed passages or channels initially formed Inside. 然后,球囊518可以被充盈,以扩张或伸展初始形成的通路或通道,提供一个具有期望的直径和/或形状的修正的血管外通路10。 Then, the balloon 518 may be filling to expand or stretch passages or channels initially formed, providing an outer vessel having a corrected desired diameter and / or shape of the passage 10.

图8e显示通路修正装置500e的第5种实施方案,它包含一条延伸柔韧导管体,它由互相纵行排成一线的近端部分520′和远端部分520″组成。近端和远端部分520′和520″互相通过两(2)条延伸的、可弯曲的切割丝522连接。 FIG. 8e via a display correction device 500e fifth embodiment, which includes a flexible catheter body extends, which are arranged in the proximal end of each line of the longitudinal portion 520 'and a distal portion 520 "component. Proximal and distal portions 520 'and 520' each two (2) extending, flexible cutting wire 522 is connected through. 一个中空管腔504e延伸通过装置500e的近端520′和远端520″部分,从而,沿着插入在组织穿通元件102初始造成的通路或通道内的导丝GW,装置500e可以被推向前。一条牵拉丝(未显示),或导丝本身,可以被包容于导管体的近端部分520″内,从而,导管体的远端部分可以被拉向近端,由此减小导管体近端部分520′和远端部分520″之间的间隙。这将引起切割丝522向外弓起,如图8e的幻影线所示。在操作中,装置500e将沿着导丝GW并穿过初始形成的通路或通道向前。然后,导管体的远端部分520″被拉向近端方向,缩短了导管体近端部分520′远端和远端部分520″之间的距离,由此引起切割丝522向外弓起。可选地,电流可以通过切割丝以便增强丝的切割作用。然后,装置500e将向近端方向退出由组织穿通元件102初始形成的通路或通道,从而,向外弓起的切割丝522将扩大 504e a hollow lumen extending through the proximal end 520 of device 500e 'and a distal end 520 "section, so that, in the insertion passage 102 or channel caused an initial element organization through guidewire GW, apparatus 500e can be pushed forward . a pull wire (not shown), or the guide wire itself, is contained in the portion 520 'of the proximal end of the catheter body, whereby the distal end portion of the catheter body may be pulled proximally, thereby reducing the catheter body the gap between the proximal end portion 520 'and a distal portion 520. "this will cause the outwardly arched cutting wire 522, as shown phantom lines 8e. in operation, apparatus 500e and the wear along the guide wire GW passages or channels through the initially formed forwardly. then, the distal end of the catheter body portion 520 'is pulled in the proximal direction, the proximal end of the catheter is shortened portion 520' distal end and a distal end portion 520 "between the distance from this causes cutting wire 522 outwardly arched. Alternatively, the current through the wire in order to enhance the cutting action of the cutting wire. then, 500E will exit the apparatus by the tissue in the proximal direction through element 102 of the initial passages or channels formed thereby, the outwardly arched cutting wire 522 will expand 初始形成的通路或通道,由此,按照本发明,将通路或通道变成扩大了的狭缝样的血管外通路10。 Initial passages or channels formed thereby, according to the present invention, the outer passages or channels into the enlarged slot-like passage 10 vessels.

图8f显示通路修正装置500f的第六种实施方案,它包含一个延伸长柄元件530,其远端上安置了一个拉回切割装置532。 FIG. 8f show a sixth embodiment of the path correction means 500f, which includes a shank extending element 530, which is disposed on a distal end of the cutting device 532 is pulled back. 拉回切割装置532包括一个具有钝性远端表面534和环状近端切割边缘536的刚性元件。 The cutting device 532 comprises a back blunt distal surface 534 and a proximal end having a cutting edge of the rigid annular element 536. 一个中空管腔504f纵行延伸通过长柄530和拉回切割元件532,从而,沿着插入在由组织穿通元件102形成的初始通路或通道内的导丝GW,装置500f可以被推向前。 A hollow lumen extending through the shank 504f wale retract the cutting element 530 and 532, thus along the initial insertion path or channel by the tissue penetrating element 102 is formed of a guidewire GW, the device 500f may be pushed forward. 在拉回切割元件532全部进入初始形成的通路或通道内后,它将被向近端方向退回,从而近端切割表面536将切除组织,以便扩大或去除通路的组织。 Pulling back the cutting element 532 entering all the initially formed within the channel or passage, it will be retracted in the proximal direction, thereby cutting the proximal surface of the resected tissue 536, in order to expand the passage or removal of tissue. 可选择地,在拉回元件532退回时,切割表面536可以被旋转,以利于切割组织。 Alternatively, when the back element 532 retracted, the cutting surface 536 may be rotated to facilitate tissue cutting. 而且,可选择地,一地砧板(未显示)可以被放置于通路10的对侧端,以提供相对切割边缘536的对向压力,由此易化拉回切割元件532切割组织。 Further, alternatively, to a cutting board (not shown) may be placed on opposite ends of passageway 10 to provide a cutting edge 536 relative to the pressure, thereby easily cutting member 532 of cutting tissue pulled back. 被近端切割表面536从通路壁上切除的组织,将被收集到拉回切割元件532的内腔538内。 Is cut proximal surface 536 of tissue excised from the passage walls, it is collected back into the lumen of 538,532 of the cutting element.

图8g显示通路修正装置500g的第七种实施方案,它包含一个延伸长柄540,其远端上安置了一个推前切割元件542。 FIG. 8g display correction device 500g via the seventh embodiment, which comprises a shank 540 extending, placed before a push cutting element 542 on its distal end. 一条中空管腔504g纵行延伸通过长柄540和切割元件542,从而,沿着插入由组织穿通元件102形成的初始通路或通道之内的导丝GW,装置500g可被前推。 A hollow lumen extending through the shank 504g wale 540 and cutting element 542, such that, along the guide wire GW is inserted in the tissue by the initial passage or passages formed through the element 102, the device 500g may be pushed forward. 切割元件542包括具有基本上圆柱形外表面的远端部分542′,和具有向外逐渐减少外表面的近端部分542″。一个尖锐环状切割边缘544形成于远端部分542′的远端,从而,当装置500g向远端方向前进时,切割边缘544将切下一块基本上圆柱形的组织,因而扩大了装置500g向前穿过的初始形成的通路或通道。可选择地,在装置500g前进时,尖锐环状切割边缘544可以被旋转。而且。一个可选用的砧板(未显示)可以被放置于通路10的对侧端,以相对切割边缘544提供反向压力,因而有利于装置500g切割组织。 The cutting element 542 includes a distal end having a substantially cylindrical outer surface of the distal end portion 542 ', and a proximal end having a gradually reduced outwardly of the outer surface of the portion 542. "A sharp annular cutting edge 544 is formed at a distal end portion 542' of the so that, when the device 500g to advance distally, the cutting edge 544 to cut a piece of tissue is substantially cylindrical, thus expanding the passages or channels through the initially formed forwardly 500g apparatus. Alternatively, the apparatus when 500g proceeds, the sharp annular cutting edge 544 may be rotated. Further one optional anvil plate (not shown) may be placed on opposite ends of channel 10, opposite to the cutting edge 544 provide reverse pressure, thus facilitating means 500g cutting tissue.

图8h显示通路修正装置500h的第八种实施方案,它包含有一条管腔504h纵行延伸通过的一个延伸管状元件550。 FIG. 8h show an eighth embodiment of the path correction means 500h, 504h that includes a lumen extending longitudinally extending rows 550 through the tubular member. 多个外溢小孔554形成于管状元件550,其范围局限于距管状元件550远端的一段间隔距离。 A plurality of overflow apertures 554 formed in tubular member 550, its scope is limited some distance from the distal end 550 of the tubular member. 而且,一个远端导丝出口小孔形成于元件550的远端,从而,沿着插入到组织穿通元件102形成的初始通路或通道内的导丝GW,装置500h可被推向前。 Further, a distal guidewire outlet aperture 550 formed in the distal end member, whereby, along the guide wire inserted into the inner member 102 through passageways or channels formed in the initial tissue GW, device 500h may be pushed forward. 近端和远端封闭球囊552′、552″形成于管状元件550的外表面,位于外溢小孔554的近侧和远侧。如图8h″所示,管状元件550可以沿导丝GW向前,直到外溢小孔534被置于将被可流动流体物质所处理的通路10之内。 Closing the proximal and distal balloon 552 ', 552 "are formed on the outer surface of the tubular member 550, overflow aperture 554 is located proximal and distal. FIG. 8H", the tubular member 550 can be moved to the guidewire GW before, until the spill holes 534 is disposed within the fluid material to be treated can flow passage 10. 然后,环状封闭球囊552′、552″将被充盈,以封闭通路10的相对端。然后,预期的可流动物质将通过管状元件550的管腔504h,由此,它流出外溢小孔554,并充满仍然被封闭球囊552′、552″所封闭的通路10之内。 Then, ring closure of the balloon 552 ', 552 "will be filling, to close the opposite ends of the passage 10. Then, the intended substance can flow through the lumen of the tubular member 504h 550, whereby it flows overflow orifice 554 , still closed and filled balloon 552 ', 552 "of the passage 10 closed. 在可流动物质对通路10壁实现了所期望的处理后,负压可以被应用于管腔504h,以从通路10之内抽回可流动物质。 After the passage of the flowable material wall 10 achieves the desired processing, the negative pressure may be applied to a lumen 504h, to withdraw from the passage of the flowable material 10. 然后,封闭球囊522′、522″将被去除充盈,且装置500h将被退回并移出通路10。图8h′显示一种可替换的修正,装置500h′,其中管状元件550上不形成流体外溢小孔554,而是一个诸如丝的能量传导元件(未显示)延伸通过管状元件550的元件体,而且在管状元件550上封闭球囊552′、552″之间的区域将安装一个电极、电烙器装置、阻热器、激光或其它能量发射装置,从而,按照上述参照图8h和8h″的方式,当装置500h″变成位于通路之内时,管状元件550上封闭球囊552′、552″之间的外表面将变热或发射能量,此处理通路10的壁。 Then, the closed balloon 522 ', 522 "filling will be removed, and the device 500h will be rejected and removed from the passage 10. FIG. 8H' show an alternative correction means 500h ', wherein the tubular member 550 does not form a fluid spills apertures 554, but a conducting element such as a power wire (not shown) extending through the tubular member body member 550, and the balloon 552 on the tubular closure element 550 ', the region between the 552 "will be installed one electrode, electrically cautery apparatus, heat resistance, laser or other energy transmission means, whereby, as described above with reference to FIG. 8h and 8h "mode, when the apparatus 500h" becomes positioned within the passage of time, closing the tubular member 550 of the balloon 552 ', between the outer surface 552 'or the transmit energy will heat, this processing path wall 10.

ⅳ. Ⅳ. 供形成于两血管间的血管外通路的纵行压迫和/或支持的装置在本发明血管外通路10形成于两(2)血管间的应用中(如在许多上述血管再生步骤中),血管壁间存在海绵状或疏松组织可能引起问题,即通过通路10的血流可能易于渗透入这种海绵状或疏松组织,从而产生血液漏出和/或血肿形成。 Longitudinal compression and / or devices to support supply formed in the extravascular passageway between the two vessels passage extravascular present invention 10 is formed on two (2) applied between the blood vessel (e.g., in a number of the blood vessel regeneration step), vascular intramural presence spongy or loose tissue may cause problems, i.e., through the flow path 10 may easily penetrate into this spongy tissue or loose, resulting in leakage of blood and / or hematoma formation.

阻止血液向组织或附近血管壁间的间隙渗透的方法是在通路10内置入纵行通路压迫装置22,从而防止血液向其中渗入。 Prevent blood or tissue penetration into the gap near the vessel wall of the passage way 10 is built into the compression device 22 wale passage, thereby preventing infiltration of blood thereto. 而且,在通路10中配置这种纵行压迫装置22可额外提供通路内的结构支持,以维持通路的开放并防止由于附近组织的运动而使通路弯曲或关闭。 Further, configuring such longitudinal compression to provide structural support means within the passage 22 in the passage 10 may additionally, in order to maintain an open passageway adjacent tissue and to prevent movement of the curved passage or closed. 然而,应理解到,任何这种纵行压迫装置22将如此构建以提供防止血液渗入附近组织的足够纵行压迫,但这种压迫又不会引起组织的过分压迫而导致内源性缺血和可能的组织坏死。 However, it should be appreciated that any such longitudinal compression means 22 thus constructed to provide sufficient compression to prevent longitudinal nearby tissue infiltration of blood, but this compression without causing excessive compression of tissue ischemia caused by endogenous and possible tissue necrosis. 图9a-9f指向特殊纵行压迫装置22的实例,该装置可被置于本发明的血管外通路中以防止血液的组织渗透和/或提供通路内的结构支持。 FIGS. 9a-9f point wale special compression device 22 of the example, the device may be placed in the extravascular passageway of the present invention to prevent tissue infiltration of blood and / or structural support provided in the passage. 应该理解到,图9a-9f和下列详述并不意在完全列举和描述可按照本发明使用的纵行压迫装置22的所有可能类型。 It should be understood that FIGS. 9a-9f and the following detailed description are not intended to fully enumerate and describe all possible types of apparatus 22 may be in accordance with the longitudinal compression of the present invention. 勿宁说,这些图和下列详细描述仅是可使用的纵行压迫装置22类型的一些实例。 Rather the following detailed description and the drawings are only longitudinal compression can be used in some examples, 22 types of devices.

显示于图9a-9f并在下文中描述的纵行压迫装置22的应用不必限于本发明的血管外通路10,而是也可与其它方法联合使用,用于形成身体的相邻管状形态学通路如血管,输卵管等间的侧侧连接(如,吻合术)。 Shown in FIGS. 9a-9f application and longitudinal compression device 22 is described hereinafter in the present invention is not necessarily limited extravascular passageway 10, but may also be used in combination with other methods for forming the body passage adjacent the tubular morphology the side to side between the blood vessels, fallopian tubes and other connections (e.g., anastomosis).

图9a-9a′显示纵行压迫装置22a的第一实施方案,它包含一个第一环状元件600和一个第二环状元件602,它们可直接互相联合和互相连接以便纵行压迫围绕两血管BV1和BV2间形成的通路10的血管壁和其它组织。 FIGS. 9a-9a 'longitudinal compression device 22a show a first embodiment, comprising a first annular member 600 and a second annular member 602, they may be combined with each other and connected to each other directly to two longitudinal compression about the vessel BV1 and BV2 between the vessel wall formed by the passageway 10 and other tissue. 第一环状元件600具有许多从其一侧伸出的腿状元件604。 A first ring-like member 600 having a plurality of legs 604 extending from its side. 第二元件602具有许多接受小孔606,这些小孔的位置和结构适合接受腿状元件604于其中。 A second member 602 having a plurality of receiving holes 606, the location and configuration of these holes adapted to receive the leg-like member 604 therein. 每一腿状元件604在其中形成一个刺刀状连接器608或其它类型的连接器,以使腿状元件604插入接受小孔606时,连接器608将约束在接受小孔606中形成的相应元件或表面以便锁住并固定第一和第二环状元件600,602,这种固定方式引起对血管BV1和BV2的管壁部分和其它围绕通路10的居中组织的纵行压迫。 When each of the leg-like member 604 which is formed in a bayonet-like connector 608 or other type of connectors, so that the leg-like member 604 is inserted into receiving holes 606, 608 connected to respective constraining element receiving apertures 606 formed in or surface for locked and first and second ring elements 600, 602, this causes a fixed manner vessel BV1 and BV2 and the other wall portion longitudinal compression of the tissue centering around the passage 10.

图9b-9b显示纵行压迫装置22b的第二实施方案,它包含一个已弯曲为图9b中所示的构型的回弹(如超弹的)线圈,该线圈具有两个上部弓形片段610′,610″和两个下部弓形片段612′和612″,如图所示。 FIG. 9b-9b wale show a second embodiment 22b of the compression device, comprising a bent has been illustrated in FIG. 9b rebound configuration (e.g., a superelastic) a coil having two upper arcuate segments 610 ', 610' and a lower two arcuate segments 612 'and 612', as shown in FIG. 装置22b最初被安装在管状导管616的管腔614中。 Device 22b is initially installed in the lumen of a tubular conduit of 614,616. 内部导管元件618远端部分内径减小,该部分被同轴地置于外部导管616的腔614中,以使装置22b的纵行延伸的下部弓形部分612′,612″被捕获并通过摩擦力约束在内部管状导管618的远端减小直径部分的外表面与外部导管616的内腔表面之间,如图9b′所示。外部导管616最初通过通路10插入,装置22b在其中展开,随后将内部导管616向远方推进,以将纵行延伸的上部弓形部分610′,610″推出导管616的远端开口外,以便使上部弓形部分610′,610″向外回弹弯曲从而位于第一血管BV1的腔表面。随后,将内部导管618向后拉以释放纵行延伸的下部弓形部分612、612′、612″,形成摩擦力约束并被捕获于内部导管618和外部导管616间,并且退出外部导管616以使下部弓形部分612′、612″能穿出导管616的开放远端并向外回弹弯曲以便紧靠并约束第二血管BV2的管壁和位于其间的海绵 The inner diameter of the distal end portion of the inner catheter 618 to reduce the element, which part is disposed coaxially within the outer catheter lumen 614 616, the device 22b to the lower arcuate wales extending portion 612 ', 612' and is captured by friction between the luminal surface of the inner tubular catheter at the distal end constraints 618 reduced diameter portion of the outer surface of the outer duct 616, as shown in FIG 9b 'shown in FIG. exterior catheter 616 is initially inserted through the passage 10, in which the deployment means 22b, and then the inner catheter 616 to advance the distance to the upper arcuate portion 610 extending in the wale ', 610 "616 out the distal end opening of the outer catheter so that the arcuate upper portion 610', 610" spring back outwardly so that at the first bend luminal surface of the blood vessel BV1. subsequently, the inner catheter 618 is pulled back to release the lower portion of the arcuate portions 612, 612 extending wale ', 612 ", are formed and trapped inside the frictional constraint conduit 618 and outer conduit 616, and exit the outer catheter 616 to the lower arcuate portion 612 ', 612 "can wear open distal end of catheter 616 and is bent outwardly in order to spring back against the wall of the second blood vessel BV2 and bound therebetween and sponge 状或疏松组织,参见图9b。形成装置22b的环状线形元件可为任何适合的回弹类型材料,优选的材料可包含在装置22b在哺乳动物体内展开和植入期间将会遇到的温度范围内表现超塑性或高度可弯曲特性的镍钛合金或多聚体。 Or like loose tissue, see FIG. 9b. The apparatus 22b is formed an annular linear element can be any suitable type of resilient material, preferably in the temperature of the device may comprise material 22b during deployment and implantation within a mammal that will be encountered superplastic performance or height within the range of bending characteristics of nitinol or multimers.

图9c显示包含一个第一环形球囊620和一个第二环形球囊622的纵行压迫装置22c的第三实施方案。 FIG. 9c shows balloon 620 comprising a first and a second annular ring 622 of the compression balloon wale apparatus 22c of the third embodiment. 第一和第二环形球囊620,622互相纵行排成一线并通过许多纵行连接器元件624相连接。 The first and second annular balloons 620, 622 longitudinal line arranged in line with each other and connected by a number of longitudinal connector elements 624. 装置22c最初被置于通路内而使去充盈的第一环形球囊620紧临第一血管BV1的腔面放置而去充盈的第二环形球囊622紧临第二血管BV2的腔面放置,并且连接器元件624通过通路10纵行延伸。 Means 22c is disposed within the first passage to the filling of the first annular cavity close to the surface of the first balloon 620 is placed away filling vessel BV1 second annular balloon 622 is placed close to the cavity surface of the second blood vessel BV2, and the connector member 624 extends through the passage 10 wales. 随后,第一和第二环形气囊620,622被充盈以便纵行压迫围绕通路10的血管BV1和BV2之管壁部分以及位于其间的组织部分,如图9c所示。 Subsequently, the first and second annular bladder 622 is surrounding the filling to compression vessel BV1 longitudinal passage 10 and the wall portion located BV2 and the tissue portion therebetween, shown in Figure 9c. 环形球囊元件620,622可用胶状或可医用多聚体物质充盈,这些物质在环状球囊元件620,622被充盈后将完全或部分固化,从而避免沿管线的漏出或环形球囊元件620,622去充盈。 Annular balloon member 622 may be used for medical or gum polymer material filling, leakage of these materials or annular balloon member along the pipeline in the annular member 620, the balloon is completely or partially cured after filling, thus avoiding 620, 622 to the filling.

图9d显示纵行压迫装置22d的第四实施方案,它包含一个环状第一磁体626和一个环状第二磁体628,它们通过许多纵行连接元件630连接。 Figure 9d show longitudinal compression device 22d to a fourth embodiment, comprising an annular first magnet 626 and a second annular magnet 628, which are connected by a number of connecting elements 630 wales. 该装置22d最初被展开于通路10中,以便第一环状磁体626被紧临第一血管BV1的腔表面放置并且第二环状磁体628被紧临第二血管BV2的腔表面放置。 The means 22d is initially deployed in passage 10, so that the first ring magnet 626 is close to the surface of the first cavity and the second vessel BV1 placing ring magnet 628 is close to the luminal surface of the second blood vessel BV2 placed. 这些环状磁体626,628通过磁力相向运动从而与纵行连接器元件630接触并纵行地连接磁体,从而压迫环绕通路10的血管BV1,BV2之管壁部分以及位于其间的任何组织。 These magnetic ring magnet 626, 628 move toward each other into contact with the connector elements 630 wales and wales connected to the magnet, so that compression of the blood vessel BV1 10 surrounding the passage, the wall portions of BV2 and through any tissue positioned therebetween.

图9e显示纵行压迫元件22e的第五实施方案,它包含可被向内压迫并通过第一和第二球囊640,642的被充盈而连接的第一环状元件632和第二环状元件634。 Figure 9e show longitudinal compression element 22e of the fifth embodiment, it contains can be forced inwardly by being connected to, and filling the first and second balloons 640, 642 of the first annular member 632 and the second annular element 634. 至少一个连接器元件636从第一环状元件632的内侧伸出。 At least one connector element 636 extends from the inside of the first ring member 632. 在第二环状元件634中形成至少一个对应接受小孔(未显示),并且这种接受小孔的大小和结构适合接受连接器元件636,并与连接器元件636上所形成的锯齿或其它可接合表面进行连接。 With the serration formed on the connector element 636 is formed at least one corresponding receiving orifice (not shown), and this receiving aperture sized and adapted to receive a connector element structure 636, and a second annular member 634 or other engagement surface can be connected. 装置22e在通路10中如此放置,首先在球囊640、642去充盈时插入导管638,通过通路直至上部环状元件632紧靠第一血管BV1的腔表面,并且第二环状元件634紧靠第二血管BV2的腔表面。 Means 22e so placed in the passage 10, the catheter 638 is first inserted into the balloon 640, 642 to the filling, through the passage 632 until it abuts against the cavity surface of the first blood vessel BV1 upper ring member, and a second annular member 634 against the surface of the second blood vessel BV2 chamber. 随后,气囊640、642被同时被充盈以驱使环状元件632、634内向相向运动。 Subsequently, the balloon 642 to be driven simultaneously filling the annular member 634 within the opposite movement. 当环状元件被向内驱动时,第一环状元件632的腿636将进一步向前进入第二环状元件634的接受小孔,并且腿636上的锯齿将通过摩擦力被约束并固定在这种接受小孔(未显示)中。 When the annular member is driven inwardly of the first annular member 632 further leg 636 of the second annular element 634 forward into receiving apertures, and the serrations on the legs 636 will be constrained and secured by friction this acceptance apertures (not shown). 当达到对血管BV1、BV2壁和位于其间并环绕通路10的组织的期望量压迫时,球囊640、642可去充盈,并将带有去充盈的气囊640、642的导管638撤去,将装置22e留在通路10中的适当位置。 Upon reaching vascular BV1, BV2 wall and is positioned therebetween and compressing tissue surrounding the passage 10 a desired amount of balloon 640, 642 to be filling, and the filling with a balloon catheter 638 to 640, 642 removed, the device 22e is left in the passage 10 in place.

图9f-9f″″显示纵行压迫装置22f的第六实施方案,可按照本发明,将它安置在形成于两血管BV1、BV2间的血管外通路10中。 FIG. 9f-9f "" show a sixth embodiment of the longitudinal compression device 22f, in accordance with the present invention, it is formed in two vessels placed in BV1, extravascular path 10 between BV2. 如图所示,该装置22f包含许多基本平行的、延伸的、预弯回弹丝元件646,通常排列为柱形。 As shown, the apparatus 22f comprises a plurality of substantially parallel, resilient wire pre-bent member 646 extending, generally cylindrical arrangement. 任选地,由刚性或柔韧材料形成的柱状连接元件648可被连接于每一个单一丝元件646,以使它们保持所期望的柱状排列。 Optionally, the cylindrical connecting element is formed from a rigid or flexible material 648 may be connected to each single trace element 646, so that they maintain the desired columnar arrangement. 每一丝元件646都是预弯的,从而,当不受压时,每一丝元件646的对端将向外弯曲而使丝元件基本成为“C”形构型,如图9f″中点状线所示。开始时,将装置22f安置在管状运送导管650的腔652中。将一个内部管状导管元件654同轴地置于运送导管650的腔652中。该内部导管654具有外径减小的远端部分656。装置22f被安置在导管656的管腔652中,从而使每个单一丝元件646被限制并以基本垂直的构型被固定。丝元件646的近端被捕获于内部导管654的远端部分656之外表面与外部导管650的内腔壁之间,如图9f′所示。装置22f被如此植入通路10中,首先将导管650放入通路10,以使运送导管远端与第一血管BV1的腔表面平齐,如图9f′所示。随后,将内部管状导管654向远端方向推进以使丝元件646的远端超出外部导管650的远端,从而使丝元件646的远端向外弯曲并紧靠或压迫性地插入 Each trace element 646 is pre-bent so that, when unstressed, a trace of each pair of end elements 646 of the wire element bent outwardly to become substantially "C" shaped configuration, as shown in FIG 9f "by dotted lines FIG. Initially, the tubular conveying apparatus 22f disposed in lumen 652 of the catheter 650. the interior of a tubular member 654 disposed coaxially within the catheter lumen 652 conveying conduit 650. the inner conduit 654 having a reduced outer diameter the distal end portion of apparatus 656. 22f are disposed in the catheter lumen 652 656, so that each single trace element 646 is limited and substantially perpendicular configuration is fixed proximal end of the wire element 646 is trapped in the inner catheter 654 the distal portion of the catheter between the outer surface and the lumen wall 650, as shown in FIG 9f than 656 'shown in FIG. 22f apparatus is so implanted in the passage 10, the conduit 650 into the first passage 10, so far the transport conduit cavity surface of the first end of the vessel BV1 flush FIG 9f 'shown in FIG. subsequently, the inner tubular catheter 654 is advanced in a distal direction so that the distal end 646 of the wire member beyond the distal end of the outer catheter 650, so that the wire the distal end member 646 is bent outwardly and abuts against the insert or pressure 一血管BV1的腔表面,如图9f中所示。随后,将内部导管654向近端方向稍微后退,以使丝元件646的近端透镜从摩擦接触中释放,并捕获于内部导管654的远端部分656和外部管650的内部腔面间。随后,将整个导管650向近端方向退出,从而将整个装置22f从环绕的导管650的限制中释放,并允许丝元件646的近端弯曲并紧靠或压迫性地插入第二血管BV2的腔表面,如图9f所示。以此方式,装置22f可在围绕通路10的区域压迫血管BV1,BV2的管壁和其间任何组织。另外,如图9f中所示,应理解到,在采用柱状连接器元件648的实施方案中,这种柱状连接器元件可包含一段合成的或生物修复移植材料以便在通路10中形成为一层基本为柱状的内衬,如图9f″″中所示。 A luminal surface of the blood vessel BV1, 9f as shown in FIG. Subsequently, the inner catheter 654 is slightly retracted in the proximal direction so that the proximal end of the wire member 646 is released from frictional contact lens, and to capture the inner catheter 654 between the distal end portion 656 of the outer tube and the inner surface of the cavity 650. subsequently, the entire catheter 650 to exit the proximal direction, so that the entire device 22f is released from the restriction in the surrounding conduit 650 and allow the proximal end 646 of the bent wire element and against oppressive inserted into the cavity or surface of the second vessel BV2. in this manner, the passage means may surround the region 22f BV1 10 of pressure vessels, the wall BV2 any tissue therebetween and shown in FIG 9f Further as shown in FIG 9f, it should be understood that in embodiments employing columnar connector element 648, which may comprise a cylindrical section of the connector element, or a synthetic graft material to bioremediation layer is formed in passage 10 a substantially cylindrical liner, FIG. 9f "" in FIG.

应理解到,虽然装置22f在上文中被描述为一预弯回弹结构,但丝元件646也可由韧性金属或其它压力可变形材料形成,并在导入插管650中配备一种适当的变形工具如可扩张球囊以便使线性元件646的末端在穿出插管导管650时按意愿使其压力变形,从而提供所期望的预弯“C”构型。 It should be understood that while the apparatus 22f is described above as a pre-bent resilient structure, the wire member 646 may also be a ductile metal or other pressure deformable material, and with an appropriate modification of the tool introduction cannula 650 the expandable balloon 646 so that the end of the linear element according to the wishes of the catheter when the piercing cannula 650 to a pressure deformed so as to provide the desired pre-bending "C" configuration.

ⅴ. Ⅴ. 一种优选的通路形成导管和系统图10a-11d显示优选通路形成导管的两种基本实施方案,以及相伴的装置,按照本发明,它们结合在一起而形成通路形成系统。 A preferred passages forming ducts and the system of Figure 10a-11d show preferred form two passage conduits basic embodiment, and the accompanying apparatus according to the present invention, they are bonded together to form a passage forming system. 图12a-13b提供了一个优选方法利用图10a-11d所示通路形成导管和系统以在两条邻近血管BV1,BV2间形成血管外通路10的分步图示。 FIGS 12a-13b provides a preferred method for forming the outer conduit and the vascular system is formed between two adjacent blood vessel BV1, BV2 passage 10 illustrated by step passage 10a-11d shown in FIG.

参照图10a-10c,显示了优选通路形成导管装置100p的第一实施方案,它包含一个有一个腔702的延伸的可弯曲导管体700,该腔702纵行穿过该导管体,并在该导管体的远端终止于一个远端出口小孔704。 Forming a first embodiment with reference to FIG 100p conduit means 10a-10c, show the preferred path, comprising a flexible catheter body has a cavity extending 702 700, the chamber 702 through the catheter body wale, and in the the distal end of the catheter body terminates in a distal outlet aperture 704. 一个包括图7a-7k中所示和在上文中描述的任何适当组织穿通元件102被配置于导管体700的腔702中。 FIGS includes any suitable organization and described above in FIG 7a-7k element 102 through 702 are disposed in the cavity 700 of the catheter body. 应认识到,出口小孔704和腔702的构型可被修正以适合将组织穿通元件穿出出口小孔704的任何适当出口方案,包括在图6a-6i中特别显示并在上文中详细描述的那些穿通元件出口方案。 It should be appreciated that the outlet aperture 704 and the cavity 702 of the configuration may be modified to fit the tissue piercing element through the outlet aperture 704 of any suitable outlet program, including particularly shown and described above in detail in FIGS. 6a-6i those programs through the outlet member.

易弯曲导管体700优选由易弯曲多聚体材料如尼龙,pebax,聚乙烯等,或柔软金属管材如薄壁hypotubing形成。 Pliable catheter body 700 is preferably made of flexible polymeric material such as nylon, Pebax, polyethylene, etc., or a soft thin-walled metal pipe as hypotubing formed. 金属编织物或其它加固材料可镶嵌于导管体700的壁上或形成于其壁内,以提供结构上的加固并使导管体700能够被旋转或扭曲而不适当的变形或卷曲。 A metal braid or other reinforcing material may be embedded in the wall of the catheter body 700 or formed in the wall thereof to provide a structural reinforcement and the catheter body 700 can be rotated or twisted or crimped without appropriate modification. 另外,在组织穿通元件102包含一个预弯回弹元件或针的实施方案中,一个刚性的管加固元件701可被设置于导管体700的腔702的远端部分附近,如图10b所示,以便在穿通元件102退入导管体700的腔702时为穿通元件102的预弯远端部分提供刚性约束。 Further, through the tissue member 102 comprises a pre-bent resilient element or embodiment of the needle, a rigid tubular reinforcing member 701 may be disposed in the vicinity of the distal end portion of the catheter body lumen 702 700, shown in Figure 10b, in order to retreat into element 102 through conduit 700 while chamber 702 to provide a rigid constraint through pre-bending the distal end portion 102 of the conductive element. 这种导管加固元件701的存在可防止组织穿通元件102上的任何锐利远端头损伤或穿刺入制成导管体700的相对软的塑料材料。 The presence of such reinforcing member 701 prevents the catheter any sharp distal tissue penetrating head trauma or puncture element 102 formed into the relatively soft plastic material of the catheter body 700.

手持部分706安装在可弯曲导管体700的近端。 A proximal handle portion 706 is mounted deflectable catheter body 700. 手持部分706包含一个刚性外壳,在其中形成一个基本为柱状的,中空内腔712。 Handle portion 706 comprises a rigid housing, which is formed in a substantially cylindrical, hollow interior 712. 组织穿通元件102的近端部分延伸入手持部分706的空腔712。 Tissue penetrating element 102 extends into the proximal portion of the cavity portion 706 hand 712. 一个驱动按钮710与组织穿通元件102相连接,如图10c中所示。 A button 710 with the tissue through the drive member 102 is connected, as shown in Fig 10c. 驱动按钮710可被按下并向远端方向前进以引起组织穿通元件102穿出出口小孔704,达到形成本发明的血管外通路10的目的。 Driving button 710 may be pressed to advance the distal direction to cause tissue piercing through outlet orifice 704 element 102, is formed to achieve the object of the present invention, the extravascular passageway 10. 随后,驱动按钮710可向近端方向后退,以使组织穿通元件退入可弯曲导管体700的腔702中。 Then, actuation of the button 710 may be retracted in the proximal direction, so that the tissue back into the member through the flexible chamber 702 of the catheter body 700.

任选地,一种成像导管侧管720可连接于可弯曲导管体700的远端部分,此成像导管侧管720包含一个延伸管,在该延伸管中有一个腔722沿其纵行延伸。 Optionally, an imaging catheter 720 can be connected to the side tube may be bent in the distal portion of the catheter 700, this side of the imaging catheter tube 720 comprises an extension tube, the extension having a lumen extending along the tube 722 wale. 在紧邻出口小孔704处,有一个窗口724形成于侧管720的上侧壁。 In close proximity to the outlet orifice 704, a window 724 is formed on the side wall 720 of the side tube. 一种成像导管50,例如可商购自BostonScientific/心血管成像公司,马萨诸塞;Endosonics公司pleasonton,加利福尼亚:和Hewlett-Packard,North Andover,马萨诸塞的数种型号的血人超声导管,可插入到侧管720的腔722中,以使感受器部分52(例如,成像超声波发射和接受的部分)被置于窗口724旁。 An imaging catheter 50, e.g., commercially available from BostonScientific / Cardiovascular Imaging, Massachusetts; Endosonics company Pleasonton, California: human blood and Hewlett-Packard, North Andover, Massachusetts several types of ultrasound catheter, may be inserted into the side tube 722,720 in the cavity, so that susceptor portion 52 (e.g., the imaging ultrasonic transmission and receiving portion) 724 is disposed beside the window. 制造侧管720的材料优选一种防止成像导管50所利用的能量类型(如,超声)传递的材料,但是窗口724可以是一个开放孔,或被一种可被成像导管50所利用的能量穿透的材料所覆盖。 Material material side tube 720 for preventing the imaging catheter 50 is preferably utilized type of energy (e.g., ultrasound) delivered, but a window 724 may be open hole, or an imaging energy be utilized through conduit 50 covered by permeable material. 以这种方式,成像导管50的感受器部分52将只接受与窗口724成直线排列的区域的图像。 In this manner, the imaging catheter portion 52 of susceptor 50 will only accept an image region 724 are arranged in line with the window. 另外,窗口724优为直角构型并且被限制于紧邻可弯曲导管体700的出口小孔704的侧管720侧壁。 Further, the window 724 is preferably a right angle configuration and may be limited to the curved side proximate the outlet aperture 700 of the catheter body sidewall 704 of the tube 720. 通过这种方式,这种窗口724的特定大小,结构和位置,可允许使用者按下述方法完成导管装置100p的精确旋转定位,即,通过简单地旋转装置100p直到目标组织(例如,其它血管)可经窗口724,通过成像导管清晰地看到,从而表明出口小孔704定位正确,以使组织穿通元件102经出口小孔740的随后穿出可导致组织穿通元件102穿过导管装置100p所在的血管壁,并进入目标组织(例如,其它血管)。 In this way, this particular window size 724, the structure and location, can allow the user to complete the precise rotational positioning of the catheter apparatus 100p according to the following method, i.e., by simply rotating apparatus 100p until the target tissue (e.g., other vascular ) window 724 may be clearly seen through the imaging catheter, thus indicating correct positioning of the outlet aperture 704, through the tissue to elements 102 through outlet orifice 740 can then lead to tissue through piercing element 102 is located through the catheter apparatus 100p vessel wall, and into the target tissue (e.g., other blood vessels). 而且,窗口724的这种定位将允许管50被用于观察组织穿通元件102的实际运动和穿通,从而保证血管外通路在所期望的位置形成。 Moreover, such positioning window 724 will allow the tube 50 is used to observe tissue penetrating element 102 and the actual movement through, so as to ensure the extravascular passageway is formed in a desired position.

作为可在侧管720内分离的位置形成窗口724的另一选择,侧管720的远端可位于组织穿通元件102穿出导管体700的位置附近,并且成像导管50的感受器部分52可简单地伸出并伸到侧管720的远端以外,从而使它能够清晰地显示组织穿通元件102的展开和运动。 As can be separated in the position of the other side of the tube 720 forming the selection window 724, the distal end side of the tube 720 may be positioned through tissue piercing element 102 near the location of the catheter body 700, and the imaging portion 52 of susceptor 50, the catheter may simply projecting and extending beyond the distal end of the side tube 720, so that it is possible to clearly show the deployed through tissue and moving elements 102. 在这一可选择设置中,成像导管50显示的视野将不再受窗口724的限制或约束,而且成像导管50能够对侧管720的远端周围全方位360°范围成像。 In this alternative arrangement, the field of view imaging catheter 50 will no longer be displayed to limit or restrict the window 724, and the imaging catheter 50 can be around the distal end of side tube 720 forming a full 360 ° range. 因而,任何适当类型的标记装置或标记材料可形成于导管装置100p或组织穿通元件102p上,以便在放置或启动组织穿通元件102前使成像导管550可以用来行使所期望的功能,即确定导管装置100p的正确旋转定位。 Thus, any suitable type of marking devices or marking material may be formed in the catheter device 100p or tissue penetrating element 102p, in order to place or starting tissue through of the imaging catheter 550 element 102 before may be used to exercise the desired function, i.e. determination of the catheter 100p proper rotational positioning of the device.

另外,如上所述,导丝腔726可通过组织穿通元件102纵行延伸并可在远端终止于一个在组织穿通元件102远端形成的导丝出口小孔728。 As described above, the guide wire lumen 726 through tissue penetrating element 102 may extend in the wale terminates in a distal guidewire outlet aperture in the tissue through the distal end of member 102 is formed of 728. 以此方式,导丝GW可通过组织穿通元件102延伸并可前进到导丝出口小孔728外。 In this manner, the guide wire GW by tissue member 102 extends through the guide wire can be advanced to an outer outlet orifice 728.

在远端被提供导丝腔726和导丝出口小孔728的组织穿通元件102的实施方案中,腔726中导丝GW的存在可被用作一种手段以精确测定组织穿通元件102的远端何时已穿入目标血管腔或其它腔或开放区域。 Is provided in the guide wire lumen 726 and a distal guidewire outlet aperture 728 through tissue embodiment element 102, the chamber 726 in the presence of the guidewire GW may be precisely measured to distal tissue penetrating element 102 is used as a means when threaded into the end of the target vessel lumen or cavity, or other open area. 为完成这一点,当组织穿通元件102穿过导管装置100p所在的血管的壁时和穿过通路10所要通过的任何其它血管外组织时,连续的或间断的向远端方向的压力将会被加在导丝GW上。 To accomplish this, any other when the outer vessel 102 through the vascular catheter apparatus 100p located through tissue and through the passage when the wall element 10 through tissue, continuous or intermittent pressure will be in the distal direction applied to the guidewire GW. 只要组织穿通元件102的末端紧靠组织,导丝GW就不会露出或穿出远端导丝出口小孔728,并且,相应地,应用于导丝GW的向远端方向的压力将会遇到由于存在紧靠导丝出口小孔728的组织引起的阻力。 As long as the tip 102 against the tissue member through tissue, the guidewire GW will not be exposed or piercing distal guidewire outlet aperture 728, and, accordingly, the pressure applied to the guide wire GW will encounter the distal direction Because of the resistance against the guidewire outlet aperture 728 of the tissue caused. 然而,当组织穿通元件102进入目标血管腔或其它开放空间时,由于向其施加了向远端方向的压力,导丝出口小孔728将立即打开,并且导丝GW将会快速穿出导丝出口小孔728。 However, when the tissue penetrating element 102 into the target vessel lumen or other open space, since the pressure is applied thereto in the distal direction, and the guide wire exit aperture 728 will immediately open, and the guide wire GW will quickly piercing guidewire outlet orifice 728. 这种导丝GW的快速推进将提示操作者组织穿通元件102的远端实际上已进入目标血管腔或其它开放空间。 This rapid advance guidewire GW will prompt the operator to the distal end of tissue penetrating member 102 into the target vessel lumen actually or other open space. 在此时,组织穿通元件102的推进可有意地停止,以避免组织穿通元件穿透目标血管的对侧壁或通路10在其中延伸的开放区域另一侧其它组织的任何可能性。 At this time, advancing tissue penetrating element 102 may be intentionally stopped to avoid any possibility of the other side of the open area 10 which extends in the other tissues or tissue for passage through the side wall elements penetrate the target vessel.

图10c′-10c提供了可合并入通路形成导管100p以对导丝GW给予连续的或间断的指向远端的压力的装置示意图,如上所述,用于确定组织穿通元件102的远端何时已进入目标血管腔或其它开放空间。 FIG 10c'-10c provides a passage formed in the conduit may be incorporated into the device in schematic 100p continuous or intermittent administration of distally directed pressure to the guidewire GW, as described above, for determining the tissue through the distal end 102 of any element when the vessel has entered the target cavity or other open space. 参阅图10c′-10c,装置800包含一或多个弹簧802(springs),这些弹簧通过连接器元件804连接至突出于导管体700的近端之外的导丝GW的一部分。 Referring to FIG. 10c'-10c, device 800 comprises one or more springs 802 (springs), which spring is connected to a portion of the proximal end of the catheter protrudes outside the body 700 of the guidewire GW 804 through the connector element. 应理解到,装置800可合并入手持部分706的内腔712中,或制成可安装在手持部分706的近端的独立单位。 It should be understood that the device 800 may be incorporated into the handheld portion 706 of the lumen 712, or may be formed in a separate mounting unit 706 of the proximal end of the handle portion.

如图10c中所示,在操作开始前,导丝GW可自由伸出组织穿通元件102的远端的出口小孔728,从而使装置800的弹簧元件802成一种松弛(例如,收紧的)状态。 As shown in FIG 10c, before the operation begins, the guidewire GW may freely projecting distal end of the tissue through the outlet aperture 102 of the element 728, so that the spring member 802 of device 800 into a relaxed (e.g., tightened) status.

图10c″显示,当组织穿通元件102通过组织推进时,导丝GW的远端将与出口小孔728保持平齐,并且装置800的弹簧元件802将由于导丝GW的远端对邻近组织所施加的指向远端的压力而成张紧(例如,被拉长)状态。 FIG. 10c "display, when the tissue penetrating element 102 advancing through the tissue, the distal end of the guidewire GW is held flush with the outlet aperture 728, and a spring element means 800 since the distal end 802 of the guidewire GW to adjacent tissue directed pressure exerted from the distal end of tension (e.g., stretched) state.

图10c显示,当组织穿通元件102的远端尖部出现在血管腔或其它开放区域中时,导丝GW将立即前进到导丝出口小孔728外,从而允许装置800的弹簧元件802再次成松弛的(例如,缩短的)状态。 FIG 10c display, when the tissue penetrating distal tip member 102 is present in the vascular lumen or other open area, the guidewire GW will proceed immediately to the outer guidewire outlet aperture 728, thereby allowing the spring member 802 of the apparatus 800 again into the relaxed (e.g., shortened) state. 导丝的这种突然前进和弹簧元件802的放松将向操作者显示,组织穿通元件102已达到血管腔或其它开放空间内,并且应停止进一步推进组织穿通元件102。 This sudden guidewire advancing member and the spring 802 will relax operator display, tissue penetrating element 102 has been reached within the vessel lumen or other open spaces, and further promote the stop member 102 through tissue.

如上所述,应认识和理解到,图10c′-图10c中描述和显示的压力施加装置是任选的,不必包括在导管部件100p中。 As described above, it should be appreciated and understood that the pressure map 10c'- FIG 10c described and illustrated application device is optional and need not include the catheter member 100p. 而且,应理解和认识到,向远端方向持续地或间断地驱动导丝GW可人工完成(即,手工操作),而不需要使用任何装置。 Further, it should be understood and appreciated that, in the distal direction continuously or intermittently driven guidewire GW may be done manually (i.e., manual), without using any device.

图11a-11d显示优选通路形成导管和系统100p可被修正以适合在图7f中显示并在上文中详述的特殊类型组织穿通元件102f的方法。 FIGS 11a-11d show a preferred method of forming a passage through a catheter and system 102f element 100p may be modified to fit the display and described in detail above in FIG. 7f particular type of tissue. 这种特殊组织穿通元件由一个内部穿透元件322和一个纵行可推进外鞘326组成。 This particular tissue penetrating element is penetrated by an inner member 322 and a longitudinal outer sheath 326 may be advanced composition.

图11a-11d显示一种经修正的优选导管装置100P′,象导管装置100P的上述实施方案一样,该导管装置包含一个可弯曲导管体700(有一个腔702通过该可弯曲管体纵向延伸),一个手持部分706(有一个内部腔712形成于其中),和一个成像导管侧管(有一个腔722和窗口724形成于其中),所有这些已在上文中详述。 FIGS 11a-11d show a preferred conduit device amended 100P ', like the above-described embodiments of the catheter apparatus 100P as the conduit means comprises a flexible catheter body 700 (there is a cavity 702 extending through the flexible tube longitudinally) , a handle portion 706 (712 has an internal cavity formed therein), imaging catheter and a side tube (722 has a cavity formed therein and a window 724), all of which have been described in detail above.

在导管装置100P′的这项实施方案中,手持部分706被修正以结合第一和第二驱动按钮710a,710b。 In the catheter device 100P 'of this embodiment, the handle portion 706 is modified to incorporate a first and second driving button 710a, 710b. 第一驱动按钮710a被连接于在其远端上具有锐利套针尖端324的预弯回弹内部元件322。 The first button 710a is connected to a drive having a pre-bent resilient member 322 inside the sharp trocar tip 324 at its distal end. 第二驱动按扭710b连接于一个逐渐变细的可弯曲鞘326,该鞘以上文中详细描述的方式可在内部元件322上纵向地推进,参阅图7f。 A second button 710b is connected to a driving tapered flexible sheath 326, the sheath of the embodiment described in detail above with advancing longitudinally in the inner element 322, see FIG. 7f. 因此,在导管装置100P′的这项经改变的实施方案中,内部元件322和围绕的鞘326可利用驱动按钮710a,710b独立地推进和后退。 Thus, the catheter device 100P 'of the altered embodiment, the inner member 322 and the sheath 326 may be surrounded by the drive buttons 710a, 710b are independently advanced and retracted.

应理解到,当内部元件326无任何导丝腔时,可任选是否向外部鞘326施加连续的或间断的指向远端的压力以实现相同的管腔穿通信号功能,参阅图10c′-10c。 It should be understood that, when the inner member 326 has no guide wire lumen, whether optionally applying a continuous or intermittent distally directed pressure to the outer sheath lumen 326 to achieve the same function through the signal, see FIG 10c'- 10c. 相应地,恒定或间断压力弹簧装置800可连接于导管部件100p′的这项实施方案中鞘326,以便以图10c′-10c中导丝GW中所述相同方法向远端方向推动鞘326,或者,也可通过手工技术来完成(如果希望的话)。 In this embodiment, the sheath 326 Accordingly, the spring constant or intermittent pressure device 800 may be connected to a conduit member 100p 'so as to push the sheath 326 in the distal direction to guide wire GW in FIG 10c'-10c the same procedure or, alternatively, it may be done (if desired) by manual techniques.

导管部件100和本文所述其它部件和装置可以多种方式结合以形成实施本发明的方法的独特系统。 Catheter member 100 may be bonded to form an unique system of the present embodiment of the invention the method and apparatus described herein, other components and a variety of ways. 本文所述这系统应被理解为所述各种逐条列记的功能性组成部分的一或多种的组合。 This system is described herein to be understood as the combination of one or more of the various components of a functional itemized. 这些系统的组成部分可在相互之间机械的或暂时的关系中被使用,以实现本文描述的新方法,而且也可以在能够实现所述目标的许多组合可能的任意一种中使用。 Component of these systems may be mechanical or temporarily in relation to each other are used to implement the new methods described herein, but may be used in any of a number of possible combinations to achieve the goals. 这种系统可包括一个尺寸上适合放入血管,并且可推进至紧邻血管外目标或邻近血管目标处的导管体。 Such systems may include a size to fit within the blood vessel, and the catheter body may be advanced to a next adjacent vessel or extravascular target at the destination. 该导管还可以某种方式结合一个或多个所述主动或被动定位方法,以帮助导管在血管中相对于目标的正确定位。 The catheter may also incorporate certain active or passive way one or more positioning methods, in order to help correct positioning of the catheter in a blood vessel with respect to the object. 而且,导管可结合至少一种组织穿通元件从而可以形成从血管到目标的通路。 Further, the catheter may incorporate at least one tissue penetrating member can be formed from the vessel to the target path. 该系统还可结合一种被设计好尺寸可插入通路中的导丝,且该导丝能通过导管导入以便其进入通路并提供通向目标的轨道。 The system may also be designed in conjunction with one dimensional guide wire may be inserted into the passage, and the guidewire through the catheter into the passageway so that it enters the track and provides access to target. 本系统也可结合一种或多种可通过导丝放置或插入的部件的安置,例如管道依尺寸制造成维持工具或供完成治疗或诊断终点的其它部件。 The present system may also incorporate one or more may be positioned by placing guide wire or the insertion member, for example, pipe manufacturing sized to maintain a complete tool or other member for therapeutic or diagnostic endpoints. 另外,本系统可包括一或多种的各种血管阻断方法,以使与本发明的血管外通路有效相关的血管可被阻断或关闭而允许血液再定路线。 Further, the present system may include a variety of vascular or more blocking method, such that the effective blood vessel associated with the present invention extravascular passageway may be blocked or closed while allowing blood to re-routed.

ⅵ. Ⅵ. 通路形成导管和系统的优选实施方案的操作图12a-12d提供了使用图10-10c所示组织穿通导管部件和系统100p的第一实施方案的优选方法的逐步图示。 FIG operation of a preferred embodiment of the catheter and the passage forming system 12a-12d is provided using FIG stepwise illustrating a preferred method of tissue through a first embodiment of the catheter components and systems 100p 10-10c FIG.

图13a-13b提供了使用优选通路形成导管部件和系统100p′的第二实施方案的优选方法的逐步图示。 FIGS 13a-13b of stepwise illustrating a preferred method of the second embodiment of the catheter components and systems forming 100p 'using the preferred path.

参照图12a-12d,成像导管50被插入侧管720的腔722以便导管50的成像感受器部分52被置于窗口724附近。 Referring to FIGS. 12a-12d, the imaging catheter 50 is inserted into the side tube lumen 720 of the catheter 722 so that the imaging portion 52 of susceptor 50 is placed adjacent the window 724. 以此方式,成像导管50与通路形成导管部件100′的结合形成了按照本发明的一个“系统”。 In this manner, the imaging catheter 50 and the passage forming member binding catheter 100 'is formed in accordance with the present invention, a "system." 在组织穿通元件102退入可弯曲导管体700的腔704以使组织穿通元件102的远端尖端藏入管状加固元件701中的情况下,包含导管装置100p和成像导管50的系统被插入哺乳类患者的血管,并推进直至导管体700的远端和侧管720的远端被置于邻近第二血管BV2处的第一血管BV1内,目的在于形成第一血管BV1和第二血管BV2间的通路10。 Tissue penetrating element 102 back into the flexible catheter 700 lumen 704 so that tissue penetrating member distal end 102 of tip hidden into the tubular case member 701 in the reinforcement, the containing system conduit means 100p and the imaging catheter 50 is inserted into a mammal patient's blood vessel and advanced until the distal end of the catheter body and the distal end 700 of the tube 720 side is disposed within a first vessel BV1 adjacent the second blood vessel BV2 at aimed formed between the first and second vascular vessel BV1 BV2 passageway 10.

导管部件100p随后被旋转直至通过成像导管50经窗口724看到的成像野IF清晰地看到通路10将会延伸入的第二血管BV2。 100p catheter member 50 is then is rotated until the second blood vessel BV2 clearly see the passage 10 will extend into the field through the imaging window seen IF 724 by the imaging catheter. 这表明导管部件100t已置于正确的旋转定向以允许组织穿通元件102在所期望的位置形成通路10,而使它延伸入第二血管BV2。 This indicates that the catheter member 100t is in the correct rotational orientation to allow the tissue penetrating element 102 is formed passage 10 in the desired position, and it extends into the second blood vessel BV2. 随后,驱动按钮710将向前推进直至组织穿通元件102的远端尖端开始穿过第一血管BV1壁。 Then, actuation of the button 710 forward until the tissue penetrating distal tip member 102 begins through the first wall of the blood vessel BV1. 任选地,在组织穿通元件102继续前进时,间断的或持续的指向远端的压力可通过手(即手动地)或通过压力施加装置800施加于导丝GW。 Optionally, the tissue penetrating element 102 continues to move forward, intermittent or continuous distally directed pressure by a pressure device 800 or may be applied to the guidewire GW is applied by hand (i.e., manually).

参照图12b,一旦组织穿通元件102的远端尖端进入第二血管BV2的管腔,导丝GW将立即向远端方向前进,从而提示操作者组织穿通元件702的推进应该停止。 Referring to FIG. 12b, once the distal end of the member 102 through the tissue into the lumen of the second blood vessel BV2 tip, the guidewire GW will immediately advance distally, thereby prompting the operator to promote tissue penetrating element 702 should be stopped. 在那时,操作者将不再继续驱动按钮710的推进。 At that time, the operator will no longer continue to drive the advance button 710.

随后,驱动按钮710将被退至其最近端,以便将组织穿通元件102退入导管体700的腔702中,而让导丝GW保持延伸于新形成的通路10并进入第二血管BV2的管腔。 Subsequently, the button 710 is driven to retreat its nearest end to the tissue penetrating element 102 back into the cavity 702 of the catheter body 700, so that a guidewire GW while holding the newly formed extending passage 10 and into the second blood vessel BV2 tube cavity.

如图12c中所示,通路形成导管部件100p和相伴的成像导管50可随后从体内抽出并去除,留下导丝GW经第一血管BV1,穿过通路10并进入第二血管BV2放置。 As shown in FIG 12c, the passage forming member 100p conduit and accompanying imaging catheter 50 may then be withdrawn and removed from the body, leaving the guidewire GW through the first blood vessel BV1, through the passage 10 and into the second blood vessel BV2 placement.

如图12d中所示,一种通路修正装置500,例如图8a-8h中所示任何类型的通路修正装置500,可随后沿导丝GB向前推进以修正(例如扩大,组织切除,处理,包被等)通路10。 As shown in FIG. 12 d, one kind of correction apparatus 500 via, for example, via the correction means 500 of any type, can then move forward along the guide wire in GB shown in FIGS. 8a-8h to correct (e.g. enlarged, tissue ablation, treatment, coating, etc.) passage 10.

应理解到,在图12v中所示步骤完成后,导丝GW可留在通路10中原位以允许图9a-9f中所示任何所需斯坦特固定模(stents),斯坦特固定膜性移植物,或通路限制装置22在通路10中展开。 It should be understood that in the step shown in FIG 12v completed, the guidewire GW may be left in place to allow passage 10 shown in FIG. 9a-9f any desired stents (stents), membrane graft stents thereof, or a passage restricting means 22 is deployed in the passageway 10.

图13a-13e阐明了用于利用图11a-11b中所示通路形成导管部件和系统100p的经修正实施方案的逐步优选方法。 FIGS. 13a-13e illustrate a preferred method for using a stepwise path shown in FIG. 11a-11b formed amended embodiment of the catheter components and systems 100p.

最初,所期望的成像导管50被插入侧管720的腔722,以便显像导管50和通路形成导管装置100p′结合在一起而成为一个通路形成“系统”。 Initially, the desired imaging catheter 50 is inserted into the side tube lumen 722 720, the imaging catheter 50 is formed so as catheter device 100p 'become bonded together to form a passage "system" and passage.

通路形成导管100p和相伴的成像导管50被随后推进血管系统至导管体700和侧管720的远端位于第一血管BV1紧邻第二血管BV2处,在这两条血管间将形成一条通路10。 100p passage of ducts and accompanying imaging catheter 50 is then advancing to the distal vasculature 700 and side tube 720 of the catheter body is located adjacent to a first vessel BV1 second blood vessel BV2 at a passage 10 formed between these two blood vessels. 成像导管50然后被加予能量以使成像导管的感受器部分52能通过窗口724在成像野IF内接受影像。 Imaging catheter 50 is then applied to the energy to the susceptor 52 through the imaging catheter portion 724 receiving the window image in the imaging field IF. 成像部件100p′随后被旋转直至通路10要延伸入的第二血管BV2经窗口724通过成像导管50清晰地成像。 The imaging member 100p 'then is rotated until the passageway 10 to extend into the second vessel via the window 72 450 BV2 sharply imaged by the imaging catheter. 这表明导管部件100p′的正确旋转定向和定位已经获得。 This indicates that the catheter member 100p 'correct rotational orientation and positioning has been obtained. 而且,导管装置100p′可纵行移动直至在成像野IF中观察到第二血管BV2中的所期望的流动特征,从而表明导管部件100p是在其正确的纵行位置。 Further, the catheter device 100p 'may be moved until the wale observed a desired flow characteristics in the second blood vessel BV2 IF in the imaging field, thereby indicating that the catheter member 100p is in its correct position wale. 另外,成像导管50可被用来确定第一血管BV1和第二血管BV2间的距离,以便限定组织穿通元件102f形成所期望的从第一血管BV1至第二血管BV2的通路10而应展开的距离。 Further, the imaging catheter 50 can be used to determine the distance between the first and the second blood vessel BV2 vessel BV1, tissue penetrating element so as to define a desired and 102f are formed to be deployed from a first vessel to a second vessel BV1 BV2 passage 10 distance.

如图13a所示,在导管100p′被纵行地和旋转地定位后,组织穿通元件102f被展开到导管体700外,并开始穿过第一血管BV1壁推进。 As shown in FIG. 13a, after the catheter 100p 'and wales are rotatably positioned, tissue penetrating element 102f to be deployed outside the catheter body 700, and starts advancing through the first wall of the blood vessel BV1. 组织穿通元件102f的外鞘326将处于轻微后退的位置以使套管针尖端324延伸出鞘326的远端以完成所期望的经组织穿通。 Tissue penetrating element 102f of the outer sheath 326 is slightly retracted position so that the needle cannula tip 324 extending distal sheath 326 to complete the desired tissue through via.

在图13a中所示组织穿通元件102f的前进中,手动压力或通过装置800施加的压力可被用于向鞘326施加指向远端的压力。 Advancing tissue penetrating element 13a shown in FIG 102f, the manual pressure or pressure applied by the device 800 may be used to apply distally directed pressure to the sheath 326. 以此方式,当组织穿通元件102f的套管针尖端324进入第二血管BV2腔时,鞘326将立即前进进入第二血管BV2腔,从而提示操作者所期望的通路10已经形成并且应停止组织穿通元件102f的进一步前进。 In this manner, when the trocar tip member 324 through tissue into the second blood vessel BV2 102f of the lumen, the sheath 326 is advanced into the second blood vessel BV2 immediately lumen, thereby prompting the operator to a desired passage 10 has been formed and the tissue stop through element 102f is further advanced.

图13b所显示,在鞘326进入第二血管BV2腔后,延伸的带套管针尖元件322可被抽出并去除,从而留下鞘326作为通过通路10的管道。 Figure 13b shows, the sheath lumen 326 into the second blood vessel BV2, with the cannula extending tip member 322 may be withdrawn and removed, leaving the sheath as a conduit 326 through the passage 10.

如图13c所显示,导丝GW可随后穿过鞘326的腔并进入第二血管BV2。 Shown in FIG. 13c, the guidewire GW may then pass through the lumen of the sheath 326 and into the second blood vessel BV2.

然后,如图13d所示,通路形成导管部件100p′和相伴的成像导管50可从导管体抽出和去除,从而使导丝GW留在原位,并且经过第一血管BV1腔,穿过通路10延伸进入第二血管BV2。 Then, as shown in FIG. 13d, conduit passage forming member 100p 'and accompanying imaging catheter 50 can be withdrawn from the catheter body and removed, so that the guidewire GW is left in place, and through a first blood vessel BV1 lumen 10 through the passage extends into the second blood vessel BV2.

之后,如图13e所示,任何适当类型的通路修正装置500可沿预先定位的导丝GW前进以达到所期望的通路10修正效果。 Thereafter, any suitable type of passage 13e shown in FIG correcting apparatus 500 may be advanced to achieve the desired effect of the correction path 10 along pre-positioned guidewire GW.

应理解到本发明已在上文仅通过参考某些特定实施方案和实施例进行详述。 It should be understood that the present invention has been described only by reference to certain specific embodiments and examples described in detail above. 未尽力穷尽描述本发明的所有可能实施方案,或提供本发明可被实践的每一方法。 We did not try to exhaust all possible embodiments of the present invention described embodiment, each of the methods provided, or the invention may be practiced. 事实上,本领域技术人员可认识到,可对上述实施方案和实施例进行各种添加,消减,修正和改变而不离开本发明意指的精神和范围。 Indeed, those skilled in the art may recognize that the above embodiments and various additions embodiments, reduction, modifications and changes without departing from the spirit and intended scope of the present invention. 因而,应意在将所有这种添加,消减,修正和改变包括在下述权利要求书的范围中。 Accordingly, it should be intended that all such additions, reduction, modifications and changes are included in the following claims range.

Claims (94)

1. 1. 一种血管再造的方法,所述方法包含下列步骤:a)在一条血管上的第一位置和一条血管上的第二位置间形成一条血管外通路,以使含PO2至少50的血液流过所述血管外通路。 A method of revascularization, said method comprising the steps of: between a) a first position in a blood vessel and a second location in a blood vessel forming an extravascular passageway to allow blood PO2 containing at least 50 flows through the said extravascular passageway.
2. 2. 权利要求1的方法,其中所述第一位置和第二位置位于至少一条心脏血管上。 The method of claim 1, wherein said first and second positions are located on the at least one cardiovascular.
3. 3. 权利要求1的方法,其中所述第一位置和第二位置位于相同血管上。 The method of claim 1, wherein said first and second positions are located on the same vessel.
4. 4. 权利要求1的方法,其中所述第一位置和所述第二位置位于不同血管上。 The method of claim 1, wherein said first position and said second position are located on different vessels.
5. 5. 权利要求4的方法,其中所述血管是一条动脉和一条静脉。 The method as claimed in claim 4, wherein the blood vessel is an artery and a vein.
6. 6. 权利要求4的方法,其中所述血管是一条静脉和一条静脉。 The method as claimed in claim 4, wherein the blood vessel is a vein and a vein.
7. 7. 权利要求4的方法,其中所述血管是一条动脉和一条动脉。 The method as claimed in claim 4, wherein the blood vessel is an artery and an artery.
8. 8. 权利要求4的方法,其中多数所述血管外通路形成于所述血管间。 The method as claimed in claim 4, wherein said passage is formed in the outer most vessel between the blood vessel.
9. 9. 权利要求1的方法,其中所述血管外通路为给阻塞的,损伤的或患病的血管节段加设旁路而形成。 The method of claim 1, wherein said extravascular passageway is blocked to, damaged or diseased vessel segment is formed bypassing added.
10. 10. 权利要求1的方法,其中所述第一位置位于动脉上而所述第二位置位于静脉上,从而使血液将从所述动脉,通过所述血管外通路而进入所述静脉。 The method of claim 1, wherein said first location is on the second position artery vein, such that blood from the artery, the blood vessel through the outer passage into the vein.
11. 11. 权利要求10的方法,其中已通过所述血管外通路进入所述静脉的血液随后被引致通过所述静脉流动以便通过静脉血管系统逆向灌注组织。 The method as claimed in claim 10 in blood, wherein the vein has been entered by the extravascular passageway is then caused to flow through the venous reverse perfused tissue by venous vasculature.
12. 12. 权利要求11的方法,其中所述血液被引致经该静脉流动以便通过静脉血管系统逆向灌注组织,这种逆向灌注是通过:b)在邻近所述血管外通路的位置阻断所述静脉以引起通过所述血管外通路流入所述静脉的血液经过所述静脉,按照将导致经静脉血管系统的所述组织逆向灌注的方向流动。 The method of claim 11, wherein the blood is caused to flow backward through the vein through the venous vasculature perfused tissue, which is the reverse perfused by: b) block the vein to cause the blood vessel at a position adjacent to an outer passage the extravascular passageway through said venous blood flows through the venous flow in the direction to cause the tissue via the venous vasculature reverse perfusion.
13. 13. 权利要求1的方法,其中在步骤a中形成的血管外通路是形成于第一血管和第二条血管间的第一条血管外通路,以使含PO2至少50的血液从第一血管,通过所述血管外通路流动并进入第二血管。 The method as claimed in claim 1, wherein the extravascular passageway is formed in the first step is a passage formed between the outer vessel the first vessel and second vessel, so that blood PO2 containing at least 50 from a first blood vessel, by the extravascular flow passage and into the second blood vessel.
14. 14. 权利要求13的方法,其中所述方法还包含下述步骤:b)在所述第二血管和心脏的另一条血管间形成至少一条,第二血管外通路以使经过第一血管外通路进入第二血管的血液经过所述第二血管外通路随后流入另一条血管。 The method of claim 13, wherein said method further comprises the steps of: b) forming at least one between said second vessel and the other vessel of the heart, so that the second passage through the extravascular first vessel into the first outer passage two blood vessels through the second passage and then flows into the extravascular another vessel.
15. 15. 权利要求14的方法,其中所述血流被引致经过第二血管外通路流入其它血管,其法为:c)在邻近第二血管外通路处阻断第二血管,以引起所述血液从所述第二血管经过所述第二血管外通路流回所述另一条血管。 The method of claim 14, wherein the blood flow is induced through the second passage flows into the extravascular other angiogenesis, which method is: c) a second block adjacent the second vessel at the extravascular passageway, to cause the blood from the said second vessel via the outer passage of said second vessel back into the another vessel.
16. 16. 权利要求1的方法,其中至少所述第一和第二位置之一位于一条血管上,该血管是其中一条血管存在阻塞、损伤或患病片段的一个血管系统之一部分。 The method of claim 1, wherein the at least one of said first and second positions are located on a vessel, wherein the vessel is a blood vessel occlusion is present, a portion of a damaged or diseased vascular system of the fragment.
17. 17. 权利要求1的方法,其中所述方法的步骤a如下施行:ⅰ)提供包含延伸的可弯曲导管体的通路形成导管部件,该可弯曲导管体具有一个可从那里通过的组织穿通元件,以穿过所述导管体所插入的血管壁;ⅱ)将所述导管体插入血管系统并放置所述导管体以使组织穿通元件位于将形成所述血管外通路的位置附近;ⅲ)将所述组织穿通元件从所述导管体通过以便按照所述方法的步骤a形成所述血管外通路。 The method of claim 1, wherein the step of the method a following purposes: i) providing access comprising extending the flexible catheter body forming a duct member, the flexible catheter body having a tissue a from there through the feedthrough member to wear the catheter body is inserted through the vessel wall; ii) the vascular system and inserted into the catheter body of the catheter body is placed through the tissue forming element located near the position of the extravascular passageway; iii) the tissue through member through an outer passage to form said vascular body from the catheter according to the procedure of the method a.
18. 18. 权利要求17的方法,其中步骤ⅰ还包含:提供一种定位方法,用于定位所述第一和第二位置并确定导管部件的方向以便导管的组织穿通元件从所述第一位置通过而到达所述第二位置,从而在一条血管上的所述第一位置和一条血管上的所述第二位置间形成所述血管外通路。 The method of claim 17, wherein the step of ⅰ further comprising: a direction to provide a positioning method for positioning the first and second positions and to determine the catheter to the catheter member through tissue member from the first position through to the the second position, such that between a blood vessel in the first position and the second position on a blood vessel forming said extravascular passageway.
19. 19. 权利要求17的方法,其中步骤ⅰ中提供的部件的组织穿通元件还结合一个腔,在用所述组织穿通元件产生所述血管外通路时一根导丝可通过该腔,并且其中所述方法还包含下述步骤:使一根导丝通过所述腔并允许所述导丝在所述导管的退出和去除后保留延伸在所述血管外通路中,从而准备好经所述通路,在所述导丝上随后推进一或多种其它装置。 The method of claim 17, wherein the step of ⅰ tissue member through element provided in combination with one further chamber, in the generation of said extravascular passageway by said tissue penetrating element through which a guide wire lumen, and wherein the method further comprising the steps of: a guidewire through the lumen and to allow the guide wire to exit after the catheter is removed and reserved in the extravascular extending passage, through said passage so as to be ready in the subsequently advancing one or more other devices on said guidewire.
20. 20. 在有动脉和静脉形成于其中的哺乳类心脏中冠状血管再造的一种方法,所述方法包含下列步骤:提供用来在两条血管间形成血管外通路的通路形成导管;将所述导管插入外周血管并将所述导管推进入心脏的血管;使用所述导管在导管所在的心脏血管和另一条心脏血管间形成至少一条第一血管外通路,以使血液从一条血管经过血管外通路而流入另一条血管。 In mammals the heart arteries and veins have formed therein in a method for coronary revascularization, said method comprising the steps of: providing a passage for forming the extravascular passageway is formed between the two vascular catheter; the catheter is inserted peripheral vascular conduit and push the blood vessel into the heart; the catheter is formed using the at least one first passage between the outer vessel where the catheter and another cardiovascular cardiovascular, so that blood from the blood vessel through a passage flows into the extravascular another blood vessels.
21. twenty one. 权利要求20的方法,其中所述至少一种通路形成于一条心脏动脉和一条心脏静脉间,以使来自动脉的血液经过至少一条所述血管外通路进入心脏静脉。 The method of claim 20, wherein said at least one passage formed between an artery and a cardiac vein of the heart, the artery so that blood from the blood vessel through the at least one outer passage into the cardiac veins.
22. twenty two. 权利要求21的方法,其中从心脏动脉流入心脏静脉的动脉血随后被促使通过静脉流动从而通过心脏静脉血管系统逆向灌注心脏组织。 The method of claim 21, wherein the vein into the heart from the heart artery is then forced through the arterial blood flow so as to reverse the vein tissue perfused through the heart cardiac venous vasculature.
23. twenty three. 权利要求22的方法,其中所述动脉血被促使经静脉流动,从而通过在邻近血管外通路处阻断相反方向的经静脉流动而通过心脏静脉血管系统逆向灌注心脏组织。 The method of claim 22, wherein the arterial blood is caused to flow through the vein to the heart tissue perfused by blocking reverse direction opposite to the vessel adjacent the outer passage through the heart via the venous flow venous vasculature.
24. twenty four. 权利要求21的方法,其中该方法还包含:使用所述导管以形成从所述心脏静脉至所述心脏动脉的至少一条第二血管外通路,以使进入所述心脏静脉的动脉血会随后流经所述至少一条第二血管外通路并进入一条心脏动脉,从而通过心脏动脉血管系统灌注心脏组织。 The method of claim 21, wherein the method further comprises: using the catheter from the heart to form a cardiac vein to the artery at least one second extravascular passageway, such that cardiac vein into the arterial blood flow will then at least one second vessel via the outer passage and into a heart artery to the heart tissue perfused through the heart artery system.
25. 25. 权利要求20的方法,其中所述方法是为了实现为一段阻塞的,损伤的或患病心脏动脉节段加设旁路的目的。 The method of claim 20, wherein said method is implemented as a period for blocking, damaged or diseased segments of the heart artery and bypassing purposes.
26. 26. 权利要求25的方法,其中所述血管再造在具有旋转动脉,心脏大静脉,前室间静脉和左前降动脉的哺乳类心脏中施行,目的是为阻塞的、损伤的、或患病的旋转动脉节段加设旁路,其中所述方法还包含:ⅰ. Or diseased arteries rotation method as claimed in claim 25, wherein said rotary artery revascularization having a large vein of the heart, the anterior cardiac veins and mammals in the left anterior descending artery purposes, for the purpose of blocking, damage segment plus bypassed, wherein the method further comprises: ⅰ. 在左前降动脉和前室间静脉间形成第一血管外通路;ⅱ. A first passage between the outer vessel left anterior descending artery and vein between the front chamber is formed; ii. 在心脏大静脉和旋转动脉之阻塞、受损或患病节段的下游处一个位置间形成第二血管外通路;和ⅲ. In blocking cardiac veins and large arteries of rotation, damaged or diseased segment downstream of a second path between the extravascular location is formed; and iii. 使血液从左前降动脉经第一血管外通路,经前室间静脉流入心脏大静脉,并经第二血管外通路进入旋转动脉之阻塞,受损或患病节段的下游处。 From the left anterior descending artery blood vessel through a first outer passage, flows into the large vein via the anterior cardiac veins, extravascular and through the second passage enters the blocking rotation of the artery, downstream of the diseased or damaged segment.
27. 27. 权利要求26的方法,其中步骤ⅲ通过在邻近第一血管外通路的位置阻断前室间静脉腔来完成。 The method of claim 26, wherein the step is accomplished by ⅲ between an outer position adjacent the front of the first vascular access blocking chamber venous lumen.
28. 28. 权利要求27的方法,其中步骤ⅲ还通过在邻近第二血管外通路的位置阻断心脏大静脉腔来完成。 The method of claim 27, wherein the step of ⅲ through an outer position adjacent the second vascular access blockade of cardiac venous lumen to complete.
29. 29. 权利要求28的方法,其中所述血管再造在具有旋转动脉,心脏大静脉,前室间静脉和左前降动脉的哺乳类心脏中施行目的是为阻塞的,受损的或患病的左前降动脉节段加设旁路,其中所述方法还包含:ⅰ. The method of claim 28, wherein said rotary artery revascularization having a large vein of the heart, the anterior cardiac veins and mammals in the left anterior descending artery for the purpose of blocking purposes, the left anterior descending artery damaged or diseased segment plus bypassed, wherein the method further comprises: ⅰ. 在旋转动脉和心脏大静脉间形成第一血管外通路;ⅱ. A first passage formed between an outer rotating vascular arteries and vein of the heart; ii. 在前室间静脉和左前降动脉之阻塞,受损或患病节段的下游处一个位置间形成第二血管外通路;ⅲ. Between the antechamber and venous obstruction of the left anterior descending artery, downstream of the diseased or damaged section of a second path between the extravascular location is formed; iii. 促使血液从旋转动脉,经第一血管外通路,经心脏大静脉流入前室间静脉,并经第二血管外通路进入左前降动脉之阻塞,受损或患病节段下游。 Rotation causes blood from the artery, through the first extravascular passageway by a large anterior interventricular vein cardiac vein into the chamber, and through the second passage into the extravascular left anterior descending artery occlusion, the damaged or diseased sections downstream.
30. 30. 权利要求29的方法,其中步骤ⅲ通过在邻近第一血管外通路的位置阻断心脏大静脉腔来完成。 The method of claim 29, wherein the step of blocking the cardiac vein ⅲ chamber through a first position adjacent the outer vessel access to complete.
31. 31. 权利要求30的方法,其中步骤ⅲ还通过在邻近第二血管外通路的位置阻断前室间静脉腔来完成。 The method of claim 30, wherein the step of blocking ⅲ through between the front at a position adjacent to the second compartment extravascular passageway venous lumen to complete.
32. 32. 一种用于在哺乳类体内在一个体内目标位置施行医学操作的方法,所述方法包含下列步骤:a)在血管内安置一个导管部件,该部件包含:ⅰ)具有一个近端末端和一个远端末端的可弯曲导管体;ⅱ)一个组织穿通元件,它可在所述导管体上通过到第一位置外,以形成从导管所在的血管延伸至所述血管外体内目标位置的一条血管外通路;b)使导管体的第一位置相对于体内目标位置定向,以使组织穿通元件可运送到导管体的第一位置外而形成所述血管和所述体内目标位置间的一条血管外通路;c)使组织穿通元件通过到导管体外以形成所述血管和所述体内目标位置间的所述血管外通路;和d)经所述血管外通路运送至少一种操作实施装置,并使用该操作实施装置在所述体内目标位置实施所述医学操作。 A method for the purposes of medical procedures mammalian body in vivo in a target position, said method comprising the steps of: a) a catheter disposed in a blood vessel component, the component comprising: i) having a proximal end and a distal end end of the catheter body may be bent tip; ii) a tissue penetrating element, through which the first position on the outer catheter body to form an outer vessel where the catheter extends from the blood vessel to the target position of the outer vessel body passage; b) the first position of the catheter body relative to the target position within the orientation to the tissue penetrating member may be transported to a first position outside the catheter body and the blood vessel to form an extravascular passageway between the target location in the body ; c) through the tissue member through the conduit in vitro to form the passage between the outer vessel and the target position within the blood vessel; and d) extravascular passageway through said at least one operating embodiment of the transport apparatus, and the use of the medical operation device according to embodiments operating in the presence of the target position.
33. 33. 权利要求32的方法,其中所述医学操作是输送一种可流动物质,并且其中所述操作实施装置包含一个管状套管,通过此套管所述可流动物质可被运送至所至所述血管外位置。 The method of claim 32, wherein said medical procedure is to deliver one flowable substance, and embodiments wherein the operating means comprises a tubular sleeve through which said flowable substance cannula can be conveyed to the vascular actions outside position.
34. 34. 权利要求32的方法,其中所述医学操作是植入一种可植入性药物运送装置,并且其中所述操作实施装置是一种用于将所述药物运送装置通过所述血管外通路传递,并将所述运送装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical implant is an operation of an implantable drug delivery device, and wherein said operating means is an embodiment of means for transmitting said extravascular passageway by said drug delivery, the transport means and implanting the vascular implant device in the outer position.
35. 35. 权利要求32的方法,其中所述医学操作是植入供放射治疗的放射活性物质,并且其中所述操作实施装置是一种用于将该放射活性物质通过所述血管外通路传递,并将所述放射活性物质植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical implant is an operation radioactivity for radiotherapy, and wherein said operating means is an embodiment of the radioactivity through the extravascular passageway for delivery, and the said radioactivity implanting the vascular implant device in the outer position.
36. 36. 权利要求32的方法,其中所述医学操作是植入一种刺激器装置并且其中所述操作实施装置包含一种用于将所述刺激器装置通过所述血管外通路传递并用于将所述刺激器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein said medical procedure is implanting the stimulator apparatus and wherein said operating means comprises said embodiment stimulation means for transmitting through said extravascular passageway and for the stimulation means implanting the vascular implant device in the outer position.
37. 37. 权利要求32的方法,其中所述医学操作是植入一种感受器装置并且其中所述操作实施装置包含用于将所述感受器装置通过所述血管外通路传递并用于将所述感受器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein said medical procedure is implanting the susceptor and wherein the apparatus comprises means for operating embodiment of the susceptor means is transmitted through said extravascular passageway and for the susceptor means implantation said extravascular location of the implantable device.
38. 38. 权利要求32的方法,其中所述医学操作是植入一种电极装置并且其中所述操作实施装置包含用于将所述电极装置通过所述血管外通路传递并用于将所述电极装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical implant operation is an electrode and wherein said apparatus comprises means for operating the embodiment of the electrode device through the transmission path and extravascular electrode device for the implantation said extravascular location of the implantable device.
39. 39. 权利要求32的方法,其中所述医学操作是植入一种发射器装置,并且其中所述操作实施装置包含用于将所述发射器装置通过所述血管外通路传递并用于将所述发射器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the implant is a medical procedure A transmitter apparatus, and wherein said operating means comprises embodiments the transmitter means for transmitting said extravascular passageway by said transmitter and for means implanting the vascular implant device in the outer position.
40. 40. 权利要求32的方法,其中所述医学操作是植入一种接受器装置,并且其中所述操作实施装置包含用于将所述接受器装置通过所述血管外通路传递并且于将所述接受器装置植入所述血管外位置的植入装置。 32 in the method as claimed in claim receptacle, wherein said receptacle implanting the medical device is operating, and wherein the operation of the embodiment of the receptacle means comprises means for transmitting by said passage and extravascular means implanting the vascular implant device in the outer position.
41. 41. 权利要求32的方法,其中所述医学操作是植入一种应答器装置,并且其中所述操作实施装置包含用于将所述应答器装置通过所述血管外通路传递并用于将所述应答器装置植入所述血管外位置的植入装置。 The method of claim 32, wherein said medical procedure is implanting the transponder device, and wherein the operation of the embodiment apparatus comprising means for transmitting the transponder through said extravascular passageway and for the transponder means implanting the vascular implant device in the outer position.
42. 42. 权利要求32的方法,其中所述医学操作是植入一种支持元件装置并且其中所述操作实施装置包含用于将所述支持元件装置通过所述血管外通路传递并用于将所述支持元件装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical implant is a kind of support the operating member and wherein said apparatus comprises means for operating embodiments of the supporting element means to support said element through said transmitting means and for extravascular passageway said extravascular implant device implanted position.
43. 43. 权利要求32的方法,其中所述支持元件是一种斯坦特固定模,它在通过该血管外通路时首先采取一种紧凑构型,以后则展开为一种操作构型以对位于所述血管外位置的至少一种形态学结构产生结构支持。 The method of claim 32, wherein said support member is an stents which, when the extravascular passageway through the first adopt a compact configuration, is located after the vessel is expanded configuration to operate as a pair morphological structure of at least one outer support structure position is generated.
44. 44. 权利要求32的方法,其中所述医学操作是植入一种标记装置并且其中所述操作实施装置包含用于将所述标记装置通过所述血管外通路传递并用于将所述标记装置植入所述血管外位置的植入装置。 The method of claim 32, wherein the medical implant is a markup operation and wherein said apparatus comprises means for operating embodiment the marker means by said extravascular passageway for the delivery and implantation marking means said extravascular location of the implantable device.
45. 45. 权利要求44的方法,其中所述标记由放射显像可视材料形成。 The method of claim 44, wherein said visual marking is formed by a radioimaging material.
46. 46. 权利要求32的方法,其中所述医学操作是组织消磨,并且其中所述操作实施装置是一种组织消磨装置。 The method of claim 32, wherein said medical procedure is to kill tissue, and wherein said operating means is an embodiment of apparatus to kill tissue.
47. 47. 权利要求32的方法,其中所述医学操作是组织破坏,并且其中所述操作实施装置是一种组织破坏装置。 The method of claim 32, wherein said medical procedure is tissue destruction, and wherein said operating means is an embodiment of tissue destruction device.
48. 48. 权利要求32的方法,其中所述医学操作是组织切割,并且其中所述操作实施装置是一种组织切割装置。 The method of claim 32, wherein said medical procedure is a tissue cutting, and wherein said operating means is an embodiment of a tissue cutting device.
49. 49. 权利要求48的方法,其中医学操作是神经的横断,并且其中所述操作实施装置是神经横断装置。 The method of claim 48, wherein the medical procedure is nerve transection, and wherein said operating device is a nerve transection embodiment apparatus.
50. 50. 权利要求32的方法,其中医学操作是生物性流体的取样,并且其中所述操作实施装置是可通过其将生物学流体样本从所述血管外位置吸出的套管。 The method of claim 32, wherein the medical procedure is a biological fluid sample, and wherein said operating means is implemented by which a biological fluid sample is aspirated from the vessel outer position of the sleeve.
51. 51. 权利要求32的方法,其中医学操作是固体物质的取样,并且其中所述操作实施装置是一种用于从所述血管外位置将固体物质样本移去的装置。 The method of claim 32, wherein the medical procedure is the sampling of solid material, and wherein said operating means is means for embodiments the extravascular location from solid matter sample removed.
52. 52. 权利要求51的方法,其中所述医学操作是一种组织活检,并且其中所述操作实施装置是一种用于将组织片段从所述血管外位置切断并获取的一种活检工具。 The method of claim 51, wherein said biopsy is a medical procedure, and wherein said operating means is an embodiment of a biopsy tool for cutting tissue fragments from the extravascular location and acquired.
53. 53. 权利要求32的方法,其中所述方法还包含:在实施所述医学操作后从血管系统中抽出所述导管。 The method of claim 32, wherein said method further comprises: withdrawing the catheter from the vascular system in the embodiment of the medical operation.
54. 54. 权利要求32的方法,还包含:将一个管状套管置于所述血管外通路中并使所述管状套管在所述管状套管抽出和去除后保持存在于所述血管外通路中。 The method of claim 32, further comprising: a tubular sleeve disposed within the outer vessel and the tubular sleeve passage remains present in the extravascular passageway after the extraction and removal of the tubular sleeve.
55. 55. 权利要求54的方法,其中所述存在于内的管状套管从所述血管外位置延伸至一处体内位置,以便从所述血管外位置向所述第二位置引流流体。 The method of claim 54, wherein said tubular sleeve is present in the extravascular extending from said position to a position in vivo, for draining fluid from the extravascular position to the second position.
56. 56. 权利要求54的方法,其中所述存在于内的管状套管可从任何体外位置接近,以允许所期望的物质经过所述套管被运送至所述血管外位置。 The method of claim 54, wherein said tubular sleeve is present in the in vitro may be accessible from any position to allow the desired substance is conveyed through the sleeve to the extravascular location.
57. 57. 权利要求56的方法,其中所述套管经过所述血管外通路,并经过血管系统延伸,并连接至可从体外位置接近的一个皮下注射开口,以允许可流动物质经皮注射入所述注射开口并通过所述存在于内的套管被运送至所述血管外位置。 The method of claim 56, wherein said cannula through said extravascular passageway and extending through the vascular system, and is connected to a position accessible from outside of a hypodermic opening to allow the flowable material percutaneously injected into the injection opening the vessel and is conveyed to the outer position by the presence in the casing.
58. 58. 权利要求53的方法,其中所述方法还包含:在所述医学操作完成后,血管外通路从所形成的血管中的开口的关闭。 The method of claim 53, wherein said method further comprises: after the medical procedure is completed, the extravascular blood vessel path from an opening formed in the closure.
59. 59. 权利要求58的方法,其中血管中所述开口的关闭是通过展开一种血管壁关闭装置进行的,该装置选自由下列组成的一组装置:能量发射部件;烧灼器部件;缝合部件;订合部件(stapling device);血管内移植物;斯坦特固定膜性血管内移植物;球囊;线圈;一条凝血产生材料;微纤维胶原;明胶(collagen sponge);纤维素凝胶;和其组合。 The method of claim 58, wherein the blood vessel to close the opening is closed by unfolding the wall of an intravascular device, which device is selected from the group consisting apparatus consisting of: an energy emitting member; cautery member; suture member; staplers means (stapling device); endovascular grafts; stents within a vascular graft membrane; balloon; coil; a coagulation producing material; microfibrillar collagen; gelatin (collagen sponge); cellulose gel; and combinations thereof.
60. 60. 一种可插入血管并可用于形成血管外通路的导管部件,该通路经过导管部件所插入的血管管壁延伸至一个体内目标位置,所述导管装置包含:具有近端和远端末端的可弯曲导管体;可穿出导管体上的第一位置以形成所述血管外通路的组织穿通元件;和用于至少确定导管体的旋转定向以易化导管体上第一位置的恰当定位的定向工具,以使组织穿通元件从导管体的随后穿出将形成所述血管和所述体内目标位置间的所述血管外通路。 A catheter inserted into the vessel and means for forming the extravascular passageway, the passageway extending through the catheter member is inserted into a blood vessel wall in vivo target location, the catheter apparatus comprising: a tip having a proximal end and a distal bendable catheter body; a first piercing position on the catheter body to form the extravascular tissue through passage member; orientation tool for determining at least the rotational orientation of the catheter body of the catheter body to facilitated proper positioning of the first position , so that tissue penetrating element from the catheter body will then piercing the extravascular passageway is formed between the blood vessel and the target position of the body.
61. 61. 权利要求60的部件,其中所述第一位置是在所述导管体远端中形成的一个出口小孔且所述组织穿通元件可穿出所述出口小孔,而其中所述组织穿通元件适合在其穿出形成于所述导管体远端末端的所述出口小孔时按第一方向弯曲,从而穿通导管所插入的血管管壁。 Member of claim 60, wherein said first location is an outlet aperture formed in the distal end of the catheter body and the tissue piercing element through the outlet orifice, and wherein said tissue penetrating element adapted is bent in a first direction when it is formed piercing the outlet aperture at the distal end of the catheter body so that insertion of the catheter through the blood vessel wall.
62. 62. 权利要求60的部件,其中所述第一位置是在所述导管体侧壁中形成的一个出口小孔;其中所述组织穿通元件,当穿出位于所述导管体侧壁中的所述出口小孔时会穿透导管所插入的血管壁。 When the piercing is located in the sidewall of the catheter body wherein the outlet through the tissue member; member as claimed in claim 60, wherein said first location is an outlet aperture formed in said side wall of the catheter body penetrate the vessel wall of the catheter is inserted when the aperture.
63. 63. 权利要求60的部件,其中所述组织穿通元件包含一个在其中安装有一个具锐远端尖端和一个预弯回弹针元件的延伸的柔韧针头,所述针元件可有效地引起所述柔韧针头按第一方向屈曲。 Member of claim 60, wherein said tissue penetrating member comprising a in which is mounted a flexible needle having a sharp distal tip and a pre-bent resilient member extending needle, the needle element may be effective to cause the flexible needle buckling a first direction.
64. 64. 权利要求60的部件,其中所述组织穿通元件是一种延伸的元件,它包含:ⅰ)具有远端末端的柔韧近端长柄,和ⅱ)由刚性材料形成并安装在所述柔韧近端长柄的远端上的具锐尖端元件。 Member of claim 60, wherein said tissue penetrating element is an extension element, which comprises: i) a proximal shank having a flexible distal end, and ii) are formed and mounted on the proximal end of a rigid flexible material with sharp tip member on the distal end of the shank.
65. 65. 权利要求60的部件,其中所述组织穿通元件包含一个带有具锐远端尖端的弹性预弯元件。 Member of claim 60, wherein said tissue penetrating element comprises a distal end having a tip with sharp pre-bent resilient member.
66. 66. 权利要求65的部件,其中所述针头由一种当插入哺乳类体内时为超弹性的材料形成。 Member of claim 65, wherein the superelastic material forming the needle from a mammal when inserted into the body.
67. 67. 权利要求66的部件,其中所述超弹性材料为一种镍钛合金。 Member of claim 66, wherein the superelastic material is a nickel-titanium alloy.
68. 68. 权利要求66的部件,其中所述预弯回弹元件是在其中纵行延伸有一个空腔的空心针头。 Member of claim 66, wherein said pre-bent resilient member is one in which there is a longitudinal cavity extending hollow needle.
69. 69. 权利要求66的部件,其中所述预弯回弹元件是一种实体针。 Member of claim 66, wherein said pre-bent resilient member is a solid needle.
70. 70. 权利要求60的部件,其中所述组织穿通元件包含在其远端上形成了一个套管尖端的延伸元件,与一个围绕所述针元件配置并可相对于所述针元件纵行移动的管鞘。 Member of claim 60, wherein said tissue penetrating element comprises forming a sleeve member extending tip on its distal end, with a pin element disposed around said tube and said needle sheath member movable relative to the wales .
71. 71. 权利要求60的部件,其中所述组织穿通元件包含一个具有一个能量发射远端尖端形成于其上的延伸元件,所述能量发射远端尖端能有效发射能量而易化所述组织穿通元件的经组织穿通。 Member of claim 60, wherein said tissue penetrating element comprises an energy transmission having a distal tip formed thereon extending member, said energy-emitting distal tip of the apparent effective transmit energy through the tissue penetrating element through the organization.
72. 72. 权利要求60的部件,其中在所述组织穿通元件上的能量发射远端尖端选自一组能量发射装置,包含:电阻加热尖端;单极电烙器尖端;双极电烙器尖端;超声发射尖端元件;和其可能的组合。 Member of claim 60, wherein the tissue through the energy-emitting distal tip of the element selected from the group of energy-emitting apparatus, comprising: a resistive heating tip; monopolar electrocautery tip; bipolar electrocautery tip; ultrasound transmitter a tip member; and the possible combinations thereof.
73. 73. 权利要求60的部件,其中所述组织穿通元件包含一个具有带有一个形成于其上的旋转组织切割装置的远端的延伸元件。 Member of claim 60, wherein said tissue penetrating element comprises a distal end having thereon with a rotary tissue cutting device extends forming member.
74. 74. 权利要求60的部件,其中所述组织穿通元件是能够穿出形成于所述导管体中的所述出口开口的一种能量流。 Member of claim 60, wherein said tissue penetrating element is an energy capable of piercing the outlet conduit formed in the body of the flow opening.
75. 75. 权利要求60的部件,其中所述能量流选自包含下列的一组能量类型;激光;热;超声;和其可能的组合。 Member as claimed in claim 60, wherein the energy flow is selected from a group comprising the type of energy; laser; heat; ultrasound; and possible combinations thereof.
76. 76. 权利要求60的部件,其中所述组织穿通元件包含一个具有一个穿过其中纵行延伸的管腔的延伸元件,所述管腔能与负压源相连接,以通过所述组织穿通元件的远端将组织吸入该管腔。 Member of claim 60, wherein said tissue penetrating member comprising an extending member having a lumen therethrough extending wales of the lumen can be connected to a negative pressure source, through the distal tissue penetrating element the suction end of the tissue lumen.
77. 77. 权利要求60的部件,其中所述组织穿通元件包含:具有开放远端的预弯回弹管鞘;和具有具锐远端尖端的延伸元件,所述延伸元件被安置在所述管鞘内并沿其向前推进,以使尖锐远端尖端暴出到管鞘的开放远端末端外;所述延伸元件由足够柔韧而能适应管鞘的预弯构型的材料所构建。 Member of claim 60, wherein said tissue penetrating member comprising: a distal end having an open pre-Bending tube sheath; and having a distal end with sharp tip extending member, the extending member is disposed in the tube and intrathecal along its forward, so that the sharpened distal tip bursts open distal end of the tube to the outer sheath; said extension element is constructed of a material pre-bent configuration of the flexible enough to adapt to the sheath tube.
78. 78. 权利要求60的部件,还包含:连接于可弯曲导管体的至少一处远端部分的侧管(car)装置,所述侧管装置被构建以在其中能接受一种成像导管以使成像导管能够用来观察组织穿通元件以导管体上的第一位置的穿出。 Member of claim 60, further comprising: a side tube connected to a distal end portion of the at least one flexible catheter body (CAR) device, the apparatus-side pipe is constructed to accept therein an imaging catheter such that the imaging catheter It can be used to observe the tissue through a first member to a position on the catheter body piercing.
79. 79. 权利要求78的部件,其中所述侧管是由一种对成像部件所利用的能量至少部分不可通透的材料形成,并且其中所述侧管还包含:在所述侧管中紧邻导管体上所述第一位置处形成并允许所述成像部件能观察所述组织穿通元件穿出导管体上的所述第一位置并穿过导管所在血管管壁的窗口。 Member of claim 78, wherein said side tube is formed of a pair of energy utilized by the imaging means at least partially non-transparent material, and wherein said side tube further comprises: a catheter body proximate said side tube forming said first position and allowing the imaging means to observe the tissue through said piercing element a first location on the catheter body through the catheter and the blood vessel wall where the window.
80. 80. 权利要求79的部件,其中所述窗口被定位于在产生所述血管外通路时所述组织穿通元件会经过的方向上;所述窗口从而包含所述定向工具的至少一部分,所述导管体第一位置的定向从而可通过旋转导管部件直至位于侧管中的成像装置能够看到拟定要形成通路的目标部位来控制,从而保证在组织穿通元件穿出出口小孔前导管部件处于适当的旋转定向。 Said first conduit member such that the window comprises at least a portion of said tool orientation,; member of claim 79, wherein said window is positioned in a direction at the time of generating the passage of the extravascular tissue penetrating element will pass so as to be directed to a location in the image forming apparatus side tube member by rotating the catheter until the formulation can be seen to be formed is located in a target zone of the channel is controlled to ensure proper rotational orientation of the tissue in the piercing element through the outlet orifice front duct member .
81. 81. 权利要求60的部件,其中导管体由可弯曲塑性材料形成,并且其中在所述导管体管腔的一部分周围,邻近出口小孔处被安置了一种刚性导管加固元件,以防止组织穿通元件退入导管体内时组织穿通元件停留在与导管体的可弯曲塑性材料接触状态。 Member as claimed in claim 60, wherein the catheter body is formed from a bendable plastic material, and wherein a portion around the lumen of the catheter body, adjacent the outlet orifice of the catheter was placed on a rigid reinforcement member, to prevent tissue back through element when the tissue penetrating element into the catheter body to stay in contact with the plastic material of the catheter body bent state.
82. 82. 权利要求60的部件,它还包含:安装在所述导管体近端末端的一个手持部分,所述手持部分具有一个与所述组织穿通元件相连接的驱动按钮,所述驱动按钮可向第一方向前进以推进所述组织穿通元件离开所述出口小孔,并可向第二方向后退以使所述组织穿通元件退入所述导管体的管腔。 Member of claim 60, further comprising: a handle portion mounted on the proximal end of the catheter body, the handle portion having a button element through a drive connected to the drive with the button to the first tissue advancing direction to advance said tissue penetrating element out of the outlet orifice, and a second direction reverse to said tissue back into the member through the lumen of the catheter body.
83. 83. 包含权利要求60通路形成导管部件的一种系统,它还结合:能与所述定向工具共同使用以进一步易化导管体上第一位置的适当定位的成像装置。 As claimed in claim 60 comprising a passage member to form a catheter system, also in combination: the image forming apparatus can be used to further facilitated properly positioned on the catheter body a first position together with the tool orientation.
84. 84. 权利要求83的系统,其中所述成像装置选自下列一组成像装置,包括:超声成像装置;多普勒成像装置;放射显像成像装置;磁共振成像装置;电磁成像装置;和其可能的组合。 Doppler imaging apparatus;; radioimaging image forming apparatus; magnetic resonance imaging apparatus; means electromagnetic imaging; ultrasound imaging apparatus and its possible: The system of claim 83, wherein the imaging means is selected from the image composition means, comprising combination.
85. 85. 权利要求84的系统,其中所述装置是一种成像导管。 The system of claim 84, wherein said apparatus is an imaging catheter.
86. 86. 权利要求85的系统,其中通路形成导管部件还包含连接于可弯曲导管体的至少一处远端部分的侧管装置,所述侧管装置被构建以便在其中接受成像导管,从而使成像导管可以用来观察组织穿通元件从导管体上第一位置的通过;并且,所述成像导管至少部分地被置于所述侧管装置内。 The system of claim 85, wherein the passage forming member further comprising a conduit connected to the distal-side tube portion of the at least one flexible catheter body, said side tube apparatus is constructed so as to accept therein the imaging catheter, so that the imaging catheter may be to observe through the member from the first position through the catheter body tissue; and, said imaging catheter being positioned at least partially within said side tube means.
85. 85. 权利要求84的系统,其中所述侧管装置由一种像导管所使用的能量至少部分可通透的材料形成,并且其中所述侧管装置还包含:在所述侧管装置中紧邻导管体上所述第一位置处形成以允许所述成像导管观察所述组织穿通元件穿出导管体上的第一位置并穿过导管所在的血管管壁的窗口;以及位于所述侧管中邻近所述窗口处以便限制通过所述成像导管观察的视野至通过所述窗口可观察到的视野的所述成像导管。 The system of claim 84, wherein the energy from a side tube apparatus used as a catheter may be formed at least partially permeable material, and further wherein said side tube apparatus comprising: a catheter body proximate the side tube means forming on said first position to permit said imaging catheter to observe the tissue piercing element through a first location on the catheter body and catheter through the vessel wall where the window; and positioned adjacent to the side of the tube said window so as to limit the field of view of said imaging catheter viewed through the field of view to be observed through the window of the imaging catheter.
86. 86. 权利要求85的系统,其中所述通路形成导管部件是可旋转的以使该导管部件可根据意愿旋转直至成像导管能够通过所述窗口看到目标区域,从而保证在组织穿通元件穿出所述导管体上第一位置前导管体上的第一位置是处于正确的旋转位置。 The system of claim 85, wherein said passage forming member is rotatable conduit such that the conduit member may be able to see the target area through said window at will rotate until the imaging catheter, so as to ensure the piercing member through the tissue conduit a first position on a first position before the body is a catheter body is in the correct rotational position.
87. 87. 包含权利要求58的导管部件的系统,其中组织穿通元件包含一个有一个通过其纵行延伸的导丝腔的延伸元件,以使导丝可在所述组织穿通元件形成所述血管外通路时沿所述腔前进,所述系统包含:进一步与延伸的可弯曲导丝结合的所述权利要求58的导管部件,该导丝可通过所述组织穿通元件的所述导丝腔。 Comprising a system of claim 58 of the catheter member, wherein the tissue penetrating element comprises an extending member guidewire lumen which wale extending through to the guide wire along when forming the extravascular passage of the tissue penetrating element advancing said cavity, said system comprising: a catheter member 58 is further claimed in combination with the flexible guide wire extending claims, the guidewire through the guidewire lumen of the tissue penetrating element.
88. 88. 一种纵行压迫装置,它可用于纵行压迫形成于第一和第二有腔管状形态学管道中的开口周围的组织,其中所述第一和第二管状形态学通道互相侧侧并排在一起以使所述开口互相排成一线,所述纵行压迫装置包含:可放置于围绕着其中的开口的第一管状形态学导管的腔表面附近的第一部分;可放置于围着形成于其中的开口的第二管状形态学导管腔表面附近的第二部分;将所述第一和第二部分互相连接,以便纵行压迫围绕排成一线的第一和第二形态学导管开口的组织和居于其间的任何血管外组织的工具。 One kind of longitudinal compression device which can be used for compression are formed in the wale first and second tubular conduit with a cavity in the morphology of tissue around the opening, wherein the first side of each side and the second tubular passage side by side morphology together so that the opening arranged in line with each other, said longitudinal compression apparatus comprising: a first part can be placed in the vicinity of the cavity surface surrounding the opening wherein the first tubular conduit morphology; may be placed around the formed therein the second tubular portion in the vicinity of the second surface of the opening of the catheter lumen morphology; the first and second portions to each other, so arranged in a line about the longitudinal compression of the first and second conduit openings tissue morphology tools and any extravascular tissue intervening.
89. 89. 权利要求88的纵行压迫装置,其中所述第一和第二部分包含可置于所述腔表面附近的环状元件。 Longitudinal compression device as claimed in claim 88, wherein said first and second portions comprises an annular member disposed near the cavity surface.
90. 90. 权利要求88的纵行压迫装置,其中第一和第二部分包含以柱状排列形成并经所述第一和第二开口延伸的延伸丝元件的对侧末端,所述丝元件的所述对侧末端向外弯曲以便紧靠并约束所述第一和第二形态学导管的腔表面。 The contralateral wale compression device as claimed in claim 88, wherein the first and second portions comprises a columnar arrangement and dried to form the opposite side end of the first member and the second opening extending filaments extending said wire element end bent outwardly to abut and constrain the first and second lumen of the catheter surface morphology.
91. 91. 权利要求90的纵行压迫装置,其中所述丝元件为预弯回弹丝元件,当被置于所述第一和第二开口中并去除外部束缚时,该元件将采取所述弯曲构型。 Longitudinal compression device as claimed in claim 90, wherein said element is a filament wire pre Bending element, when placed in said first and second openings and remove the external constraints, which will take the bending element configuration .
92. 92. 权利要求90的纵行压迫装置,其中所述丝元件是塑性可变形的,并且其中所述部件还包含一个压力施加工具,该工具在所述丝元件被置于所述第一和第二开口中后可用来弯曲所述丝元件的对侧端。 Longitudinal compression device as claimed in claim 90, wherein said wire member is plastically deformable, and wherein said pressure applying means further comprises a tool that is disposed in said opening of said first and second wire element after it is used to bend the opposite end of the wire element.
CN 96199063 1996-10-11 1996-10-11 Method and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures CN1204242A (en)

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Cited By (8)

* Cited by examiner, † Cited by third party
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CN100579474C (en) 2008-07-09 2010-01-13 南京航空航天大学 Surgery vascular bypass surgery equipment
CN104013468A (en) * 2013-03-01 2014-09-03 杨西群 Nickel-titanium memory alloy needle cannula for operation
CN104039381A (en) * 2011-11-10 2014-09-10 主动脉医疗公司 System for deploying device to distal location across diseased vessel
CN104411356A (en) * 2012-05-08 2015-03-11 布里奇波因特医学公司 System for treating blood vessels
CN104619272A (en) * 2012-09-13 2015-05-13 冲击波医疗公司 Shockwave catheter system with energy control
CN105616045A (en) * 2016-03-03 2016-06-01 福建省立医院 Interventional therapy device and method realizing steering and positioning fenestration through laser catheter
CN105615999A (en) * 2016-03-03 2016-06-01 福建省立医院 Reversible laser balloon catheter and method for applying same
CN105744913A (en) * 2013-09-19 2016-07-06 曼霍勒公司 Systems and methods for deploying a luminal prostheses over a carina

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100579474C (en) 2008-07-09 2010-01-13 南京航空航天大学 Surgery vascular bypass surgery equipment
CN104039381A (en) * 2011-11-10 2014-09-10 主动脉医疗公司 System for deploying device to distal location across diseased vessel
CN104411356A (en) * 2012-05-08 2015-03-11 布里奇波因特医学公司 System for treating blood vessels
CN104619272A (en) * 2012-09-13 2015-05-13 冲击波医疗公司 Shockwave catheter system with energy control
CN104013468A (en) * 2013-03-01 2014-09-03 杨西群 Nickel-titanium memory alloy needle cannula for operation
CN105744913A (en) * 2013-09-19 2016-07-06 曼霍勒公司 Systems and methods for deploying a luminal prostheses over a carina
CN105616045A (en) * 2016-03-03 2016-06-01 福建省立医院 Interventional therapy device and method realizing steering and positioning fenestration through laser catheter
CN105615999A (en) * 2016-03-03 2016-06-01 福建省立医院 Reversible laser balloon catheter and method for applying same

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