Source: https://patents.google.com/patent/CN1177570C/en
Timestamp: 2019-02-23 07:21:29
Document Index: 507960051

Matched Legal Cases: ['Application No. 2', 'Application No. 2', 'Application No. 2', 'application No. 2', 'application No. 2', 'art 322']

CN1177570C - Endovassular prosthesis for closing aneurysma opening - Google Patents
Endovassular prosthesis for closing aneurysma opening Download PDF
CN1177570C
CN1177570C CNB998028673A CN99802867A CN1177570C CN 1177570 C CN1177570 C CN 1177570C CN B998028673 A CNB998028673 A CN B998028673A CN 99802867 A CN99802867 A CN 99802867A CN 1177570 C CN1177570 C CN 1177570C
CNB998028673A
CN1290153A (en
托马斯・R・马罗塔
托马斯·R·马罗塔
A・舒可夫
乔治·A·舒可夫
・R・里奇
唐纳德·R·里奇
M・佩恩
伊恩·M·佩恩
1999-02-12 Application filed by 托马斯・R・马罗塔, 托马斯·R·马罗塔, 乔治·A·舒可夫, 唐纳德·R·里奇, 伊恩·M·佩恩 filed Critical 托马斯・R・马罗塔
2001-04-04 Publication of CN1290153A publication Critical patent/CN1290153A/en
2004-12-01 Publication of CN1177570C publication Critical patent/CN1177570C/en
本发明提供了一种用于血管内封闭动脉瘤开口的修复物，该修复物包括：一个体部，它具有一个近端、一个远端以及位于这两者之间的至少一个可膨胀的部分，所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态，以使所述至少一个可膨胀的部分紧贴血管管腔，其特征是，一个叶部与该体部连接，该叶部能相对于体部独立移动。 The present invention provides a composition for repairing an aneurysm closing an opening in a blood vessel, the repair material comprising: a body portion having a proximal end, a distal end and positioned between the at least one inflatable portion of both a first state, said at least one expandable portion can be force acting thereon against the radially outward expansion of an unexpanded state into an expanded second, such that the at least one inflatable portion against the blood vessel lumen, characterized in that a leaf portion is connected to the body portion, the blade portions can move independently with respect to the body portion. 因此，该体部的总的作用是将血管内修复物固定在动脉瘤所在附近的靶标机体通道处，叶部起着封闭动脉瘤开口的作用，从而导致动脉瘤闭合。 Thus, the overall effect is to repair the body portion of the body passageway at the target was fixed in the vicinity of the aneurysm where the intravascular, leaves plays the role of the aneurysm opening is closed, resulting in the closure of the aneurysm.
用于血管内封闭动脉瘤开口的修复物 Endovascular aneurysm for closing the opening of restoration
本发明一方面涉及一种血管内修复物。 In one aspect the present invention relates to an endovascular prostheses. 本发明另一个方面涉及一种治疗患者体内动脉瘤的方法。 Another aspect of the present invention relates to a method of treating an aneurysm in a patient.
如本领域所知道的，动脉瘤是动脉壁中的异常的隆起性外表。 As known in the art, arterial aneurysm is an abnormal bulge in the wall of the appearance. 在一些情况下，隆起可能是从动脉全方位向外形成光滑的隆起外表—这称为“梭状动脉瘤”。 In some cases, it may be raised from the artery-round bulge outward to form a smooth appearance - this is called "fusiform aneurysm." 在其它情况下，隆起可能是从动脉分叉点或动脉一侧产生的囊状形式—这称为“囊状动脉瘤”。 In other cases, the capsule may be in the form of ridges produced from an artery or arterial bifurcation point side - this is called "saccular aneurysms."
尽管动脉瘤会发生在身体的任何动脉内，但是发生在脑内的那些会导致产生中风。 Although aneurysms can occur in any artery of the body, but it occurs in the brain that can lead to stroke. 脑内发生的极大多数囊状动脉瘤具有一个颈部，该颈部从脑血管中伸出，并膨胀形成突出于血管的囊泡。 Most saccular aneurysms electrode brain has occurred a neck which extends from the cerebral blood vessels and the expansion vessel are formed projecting in a vesicle.
这些动脉瘤引起的问题能以几种不同的方式发生。 These problems caused by an aneurysm can occur in several different ways. 例如，如果动脉瘤破裂，血液会进入脑或蛛网膜下腔(即紧密围绕脑的腔隙)—后者称为动脉瘤性蛛网膜下出血。 For example, if the aneurysm rupture, blood enters the brain or the subarachnoid space (ie, closely around the cavities of the brain) - the latter known as aneurysmal subarachnoid hemorrhage. 这之后会有下列症状中的一种或几种：恶心、呕吐、复视、颈部僵硬和丧失知觉。 This will be one or more of the following symptoms after: nausea, vomiting, double vision, neck stiffness and loss of consciousness. 动脉瘤性蛛网膜下出血是一种急症医学状况，需要立即治疗。 Under arterial aneurysm subarachnoid hemorrhage is an emergency medical condition that requires immediate treatment. 实际上，10-15％处该状况的患者在到达医院进行治疗前死亡。 In fact, 10-15% of patients with this condition are at death before reaching hospital treatment. 高达50％的处该状况的患者会在出血后最初30天内死亡。 Up to 50% of patients at the condition will die in the first 30 days after hemorrhage. 在存活下来的那些患者中，约有一半将忍受永久性中风的痛苦。 In those patients who survive, about half will suffer a permanent stroke. 通常这种中风会在出血一至二周后由蛛网膜下出血诱导由脑血管痉挛而自行发生。 This stroke will typically one to two weeks after hemorrhage, subarachnoid hemorrhage induced by a cerebrovascular spasm occur on its own. 动脉瘤还会引起与出血无关的问题，但这较少见。 Aneurysms can also cause problems with bleeding unrelated, but this is less common. 例如，动脉瘤会在其自身内形成一个血块，该血块会与动脉瘤脱离，向下游传送，因此有堵塞动脉分支引起中风的可能。 For example, an aneurysm can form a blood clot within itself which will clot from the aneurysm to the downstream transmission, and therefore may block the arterial branch causing a stroke. 而且，动脉瘤还会压迫神经(这可能会导致一只眼睛或脸部麻痹或感觉异常)或压迫邻近的脑(这可能会导致癫痫发作)。 Moreover, the aneurysm will be nerve (which may result in one eye or facial numbness or paresthesia) or compression of adjacent brain (this may cause seizures).
由于动脉瘤尤其是脑动脉瘤潜在的致命后果，本领域提出采用各种方法来治疗动脉瘤。 Because cerebral aneurysms, especially aneurysms potentially fatal consequences, the art proposed various methods to treat aneurysms. 美国专利5609628揭示了一种血管内接枝物，它包括：有远端和近端的伸长的体部，其具有确定管状通道的柔软的壁，所述体部的近端向流动的液体开放；一个帽结构，其具有相对的近端和远端帽表面，所述帽的近端与体部的远端面相连并封闭该远端以防止液体流出所述远端；且帽的近端表面的直径大于体部的直径。 U.S. Patent No. 5,609,628 discloses an endovascular graft, comprising: an elongated body with a proximal end and a distal end, the tubular channel having determined soft wall, the proximal end of the body portion of the liquid flowing open; a cap structure having opposed proximal and distal surfaces of the cap, with the distal face of the proximal end portion of the cap body is connected to and closes the distal end of said distal end to prevent liquid outflow; and near the cap the diameter of the body portion is greater than the diameter of the end surface.
总地来说，动脉瘤可以从血管外部用外科技术来治疗，或从血管内部用血管内技术来治疗(后者在介入(即非外科)技术的宽的标题下)。 Generally, aneurysms may be used to treat surgical techniques vessel from the outside, or from the interior of the vessel with the treating endovascular techniques (the latter intervention (i.e., non-surgical) techniques a wide heading).
外科技术通常涉及颅骨切开术，该方法需要在患者颅骨中产生一个开口，通过这个开口，外科医师能伸入仪器直接在脑上作手术。 Surgical techniques usually involve a craniotomy, the method needs to provide an opening, through this opening, the surgeon for surgical instruments can be inserted into the brain in a patient directly on the skull. 在一个方法中，牵开脑，暴露形成动脉瘤的血管，然后外科医师横过动脉瘤的颈部置入小夹钳，从而阻止动脉血液进入动脉瘤。 In one approach, the retractor brain aneurysm formed is exposed, and then the surgeon across the neck of the aneurysm into small clamps, thereby preventing arterial blood into the aneurysm. 如果动脉瘤内有血块，该夹钳还阻止血块进入动脉，从而避免了中风的发生。 If a blood clot within the aneurysm, the clip also prevents blood clots into the arteries, thus avoiding the occurrence of stroke. 在正确放置了夹钳后，动脉瘤将在数分钟内闭合。 After the clamp is positioned correctly, the aneurysm will be closed within a few minutes. 外科技术是动脉瘤最常用的治疗方法。 Aneurysm surgery is the most common treatment. 不幸的是，治疗这些病状的外科技术被认为是很大的外科手术，其对患者有高度危险性，而且需要患者强壮以至有机会经该手术后存活。 Unfortunately, surgical treatment of these conditions is considered to be a big surgery, which is highly dangerous for patients, and patients need strong even have a chance to survive after the surgery.
如上所述，血管内技术是非外科技术，其通常在血管造影室中用导管输送系统来进行。 As described above, endovascular techniques are non-surgical techniques, generally using angiographic catheter delivery system to the chamber. 具体地说，已知的血管内技术涉及采用导管输送系统，用阻止动脉血液进入动脉瘤的材料来填充动脉瘤—该技术广义上称为栓塞。 Specifically, known endovascular techniques involve using the catheter delivery system, to prevent the material of the arterial blood into the aneurysm to fill the aneurysm - this technique is referred broadly plug. 这种方法的一个例子是Guglielmi Detachable Coil(可分离绕线)，它涉及通过一个系统在动脉瘤内闭塞动脉瘤，该系统采用一个铂绕线与不锈钢输送线和电解分离部分相连接。 An example of this approach is Guglielmi Detachable Coil (separable winding), which relates to a system, the aneurysm occlusion within the aneurysm, the system uses a platinum wire and a stainless steel delivery wire and electrolytic separation section connected. 因此，一旦铂绕线被放入动脉瘤内，它便通过电解质的溶解与不锈钢传输线分开。 Thus, once the platinum wire is placed within the aneurysm, it will separate from the transmission line by dissolving the electrolyte and the stainless steel. 具体地说，患者的血液以及灌输的盐水起着导电溶液的作用。 Specifically, the patient's blood and the infusion of saline solution functions as the conductive. 正极是不锈钢传输线，负极是放在患者腹股沟内的接地针。 The positive electrode is a stainless steel transfer line, the negative electrode is placed within the patient's groin ground pin. 一旦电流传递通过不锈钢传输线，紧靠铂绕线(铂绕线当然不受电解影响)的不锈钢分离区的非绝缘部分就会发生电解溶解。 Once the current passing through a stainless steel transfer line, close to platinum wire (platinum wire is of course not affect electrolysis) non-insulated part of the separation zone electrolytic dissolution of the stainless steel occurs. 其它方法涉及使用诸如醋酸纤维素聚合物的材料来填充动脉瘤的囊。 Other methods involve the use of a material such as cellulose acetate polymer to fill the aneurysm sac. 尽管这些血管内方法是本领域中的一个进步，但它们仍有缺点。 Although these methods is a vascular advance in the art, but they still have drawbacks. 具体地说，这些血管内方法的危险性包括在操作中使动脉瘤破裂或由于装置或动脉瘤血块的远端栓塞而引起中风。 Specifically, the risk of these methods include the vascular aneurysm or manipulation operation since the apparatus aneurysm or blood clot distal embolization caused by stroke. 另外，用这些技术还关系到消除血管内动脉瘤闭合后的远期结局。 In addition, these techniques are also related to the elimination of long-term outcome after endovascular aneurysm closure. 具体地说，存在有填充材料在动脉瘤内重新排列的证据，在随后的血管造影术时动脉瘤再现。 Specifically, there is evidence that the filler material within the aneurysm rearranged aneurysm upon subsequent playback angiography.
一种特定类型的脑动脉瘤已被证实是很难治疗的，尤其是用上述的外科夹钳或血管内栓塞技术来治疗，它发生于远端底部动脉(basilar artery)处。 One particular type of brain aneurysm has proven to be difficult to treat, particularly using the above surgical clamp or endovascular embolization techniques treatment, which occurs at the bottom of the distal end of the artery (basilar artery) at. 此类动脉瘤是一种易破的外突，通常位于基底动脉的末端分叉点处。 Such aneurysm is a frangible outer projecting end usually located at the point of bifurcation of the basilar artery. 要成功治疗此类动脉瘤是非常困难的，至少部分原因是在放置外科用夹钳期间必须不损伤所有脑干穿通血管。 Successful treatment of these aneurysms is very difficult, at least in part because of the placement during the surgical clamp must not damage the brain stem through all the blood vessels.
不幸的是，有时动脉瘤的大小、形状和/或位置会使外科夹钳和血管内栓塞技术不能用于特定的患者。 Unfortunately, sometimes the aneurysm size, shape and / or position and causes endovascular surgical clamp technique can not be used for a particular patient. 一般而言，这些患者的预后是不良的。 In general, the prognosis for these patients is poor.
因此，尽管现有技术在治疗动脉瘤领域中已经取得进展，但是仍然有待改进之处，尤其是血管内栓塞技术，因为它是大手术的一种有吸引力的替换方案。 Thus, while the prior art in the field of treatment of aneurysms has been progress, but still areas for improvement, especially in endovascular technology, because it is major surgery is an attractive alternative. 具体地说，希望有一种血管内修复物，它能用来栓塞用其它方法难以或不能治疗的动脉瘤。 Specifically, desirable to have an endovascular prostheses, it can be used by other methods difficult or plugs can not be treated aneurysms. 还希望这些血管内修复物能用来治疗目前用血管内方法治疗的动脉瘤，同时减少或避免目前的血管内栓塞形成技术所具有的缺点。 These vessels is also desirable restoration can be used to treat aneurysms currently treated using endovascular methods, while reducing or avoiding the formation of current endovascular techniques has drawbacks.
发明揭示本发明的一个目的是提供一种新的血管内修复物，该修复物避免或减少了上述现有技术的至少一个缺点。 Disclosed is an object of the present invention is to provide a restoration of new blood vessels within the at least one disadvantage of the restoration to avoid or reduce the above-described prior art.
本发明的另一个目的是提供一种血管内封闭动脉瘤开口的新方法，该方法避免或减少了上述现有技术的至少一个缺点。 Another object of the present invention is a novel method of closing aneurysm openings provide an intravascular, which avoids or reduces the aforementioned disadvantages of the prior art at least one.
因此，本发明一方面涉及一种用于血管内封闭动脉瘤开口的修复物，该修复物包括：一个体部，它具有一个近端、一个远端以及位于这两者之间的至少一个可膨胀的部分，所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态，以使所述至少一个可膨胀的部分紧贴血管管腔，其特征是，有一个与该体部连接的叶部，该叶部能相对于体部独立移动。 Accordingly, an aspect of the present invention relates to prostheses for closing an opening in a blood vessel aneurysm, the repair material comprising: a body portion having a proximal end, a distal end and positioned between the at least one of the two a first power state the expandable portion, the at least one expandable portion can be against the effect thereof on the radially outward expansion of an unexpanded state into an expanded second, such that the at least one inflatable portion close to the vessel lumen, characterized in that the leaf has a portion connected to the body portion, the leaf portion relative to the body portion to move independently.
本发明另一方面涉及一种用来血管内封闭动脉瘤的修复物，该修复物包括：一个体部，它具有一个近端、一个远端以及位于两者之间的至少一个可膨胀的部分，所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态，以使第一个可膨胀的部分紧贴血管管腔，和一个与该体部连接的叶部，该体部在以下两个状态之间变动：(i)第一个状态是近端、远端和叶部沿体部纵轴对齐，和(ii)第二个状态是叶部只与远端和近端中的一个沿纵轴对齐。 Another aspect of the invention relates to an aneurysm closure endovascular repair, the repair material comprising: a body portion having a proximal end, the at least one inflatable between a distal end portion located therebetween and a first state, said at least one expandable portion can be force acting thereon against the radially outward expansion of unexpanded to a second expanded state, so that the first expandable portion against a vascular lumen chamber, and a leaf portion connected to the body portion, the body portion between the two state changes: (i) a first state is aligned with a proximal end, a distal end and leaf portion along the longitudinal axis of the body portion, and ( ii) the second state is a leaf portion longitudinal axis is aligned with the distal end and a proximal end only one direction.
本发明另一方面涉及一种用来血管内封闭动脉瘤开口的修复物，该修复物包括：一个具有纵轴的体部，它包含至少一个可膨胀的部分，所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态，以使第一个可膨胀的部分紧贴血管管腔，和一个与该体部连接的叶部，该体部在以下两个状态之间变动：(i)第一个状态是至少一个可膨胀部分与叶部沿该纵轴对齐，和(ii)第二个状态是至少一个可膨胀部分与叶部沿该纵轴不对齐。 Another aspect of the invention relates to a closure for an opening of the aneurysm endovascular repair, the repair material comprising: a body portion having a longitudinal axis, comprising at least one expandable portion, the at least one inflatable portion the first state can force acting thereon against the radially outward expansion of unexpanded to a second expanded state, so that the first expandable portion against a vascular lumen, and a portion connected to the body leaf portion, the body portion between the two state changes: (i) a first state is at least one expandable portion and the leaf portion are aligned along the longitudinal axis, and (ii) a second state is at least one expansion portion of the leaf portion along a longitudinal axis not aligned.
本发明另一方面涉及一种用一种修复物来血管内封闭动脉瘤开口的方法，该修复物包括：一个体部，该体部具有一个近端、一个远端和位于它们之间的至少一个可膨胀的部分；以及与该体部相连的一个叶部，该方法包括下列步骤：将修复物放置在一个导管上；通过机体通道的导管插入术将修复物和导管一起插入机体通道内；将修复物和导管移动到动脉瘤开口所在的靶标机体通道；将径向向外膨胀的力作用于至少一个可膨胀部分上，使得至少一个可膨胀的部分紧贴靶标机体通道，迫使叶部紧贴动脉瘤开口，从而封闭动脉瘤开口。 The present invention relates to a method aspect aneurysm opening was closed with a prosthetic endovascular repair which comprises: a body portion, the body portion having a proximal end, a distal end and located therebetween, at least an expandable portion; and a connected to the body portion leaves, the method comprising the steps of: restoration is placed on a catheter; by catheterization of the body passageway will restorations and catheter are inserted together into the body passageway; the catheter is moved to a restoration and the aneurysm opening is located in a target body passageway; the expanded radially outwardly force to the at least one expandable portion, such that the at least one inflatable portion against the target body passageway, forcing the leaves tight attached to the opening of the aneurysm thereby closing the aneurysm opening.
因此，本发明者已经发现了一种新的血管内方法可用来封闭动脉瘤开口，尤其是囊状动脉瘤中的开口，导致动脉瘤闭合。 Accordingly, the present inventors have discovered a new method of the vessel can be used to close the aneurysm opening, especially the opening of a saccular aneurysm, resulting in closing the aneurysm. 该方法是真实的血管内方法，因为通过本发明的血管内修复物，不需要用一种材料(如Guglielmi可拆卸绕线(detachable coil)中所用的材料)来填充动脉瘤囊。 This is true intravascular methods, because the present invention via intravascular prostheses, no one material (e.g., Guglielmi detachable bobbin (detachable coil) used in the material) to fill the aneurysm sac. 相反，本发明的血管内修复物运作的根据是，它起封闭动脉瘤囊开口的作用，从而避免采用填充材料。 In contrast, according to the restoration operation of the present invention is intravascular, it is blocked from the action of the opening of the aneurysm sac, thus avoiding use of the filling material. 因此，发现了一种避免或减少现有技术中许多缺点的新的血管内修复物。 Thus, a method was found to reduce or avoid the restoration of new blood vessels in the prior art a number of disadvantages. 本发明的血管内修复物包含一个叶部，该叶部能紧贴动脉瘤开口，从而闭合动脉瘤。 Endovascular repair of the present invention comprises a leaf, the leaf portion against the aneurysmal opening can thereby closing the aneurysm. 该叶部与包含至少一个可膨胀部分的体部相连接，并且能相对于该体部独立地移动。 The leaf portion comprising at least a portion of the expandable body is connected, and can move relative to the body portion independently. 管状部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态，以迫使第一个可膨胀的部分紧贴血管管腔。 A first state against force acting thereon tubular portion can be radially outwardly on expansion of an unexpanded state to a second expanded, to urge the first expandable portion against a vascular lumen. 因此，体部起的作用大致是将血管内修复物固定在动脉瘤开口所在附近的靶标血管管腔机体通道处，叶部起的作用是密封动脉瘤开口，从而闭合动脉瘤。 Thus, the role of the body portion to substantially fix the target vessel lumen at a body passage was secured near the aneurysm opening is located within the blood vessel, the role leaves the aneurysm opening is sealed, thereby closing the aneurysm. 因此，如下文进一步的展开描述，叶部起作用，并且能独立于血管内修复物的体部移动。 Accordingly, as described further deployment, leaf functions, and independently of the endovascular repair moving body portion thereof.
较佳的，并且如下文进一步展开描述的那样，至少一个可膨胀部分通常的结构呈管状。 Preferably, and as described further expanded as described herein, at least one expandable portion is generally tubular configuration. 实际上，在整篇说明书中，所提及的可膨胀部分通常是管状的结构。 In fact, throughout the specification, mentioned expandable portion generally tubular configuration. 然而，这些引证只起描述的目的，本领域技术人员会认识到，可以用非管状的结构(例如在膨胀时打开的爪形设计)作为至少一个可膨胀的部分。 However, these cited only as descriptive purposes, those skilled in the art will recognize that a non-tubular structure (e.g., opens upon expansion claw design) as at least one inflatable portion.
本发明的血管内修复物的体部具有一个大致的纵轴，该体部是灵活的。 Restoration of the body portion endovascular present invention generally has a longitudinal axis, the body portion is flexible. 叶部可以相对于膨胀或非膨胀的体部在至少第一状态和第二状态之间独立地移动。 Expanded leaf or expanded with respect to the body portion independently movable between at least a first state and a second state. 因此，在第一位置中，体部的远端和近端沿叶部对齐。 Thus, in the first position, the distal and proximal body portions aligned along the blade unit. 在第二个状态中，在固定体部的远端和近端的同时，叶部维持一定程度的独立移动。 In the second state, while the distal and proximal ends of the fixed body portion, the leaf portion to maintain a certain degree of independent movement. 通过这种方式，叶部可相对于体部“独立移动”。 In this manner, the leaf portion relative to the body portion may be "independent movement." 在一个实施例中，较佳的是，该独立移动是通过放置叶部使其相对于血管内修复物的其余部分旋转来实现的。 In one embodiment, it is preferred that this independent movement is the remainder of the endovascular repair was achieved with respect to rotation by placing it leaves. 应当理解，尽管叶部能相对于体部独立移动，但远端、近端和叶部的最终对齐(在封闭动脉瘤开口后的对齐)没有特定的限制，这取决于诸如动脉瘤的大小和位置以及特定患者的解剖学等因素。 It should be appreciated that, although the leaves can be independently movable with respect to the body portion, but the final alignment of the distal end, a proximal end and leaf portion (aligned with the aneurysm after closing the opening) is not particularly limited, depending on the size of the aneurysm and such location and specific patient anatomy and other factors. 关键点在于叶部能相对于体部独立移动。 The key point is that the leaf portion relative to the body portion to move independently.
在一个较佳的实例中，体部呈软管形式，较佳的是柔软的有孔的管。 In a preferred embodiment, the body portion has a form of a hose, preferably a flexible tube with holes. 在该实例中，叶部可能是沿管长度的一个剪开物，管子的至少一端、较佳的是两端可在其上施加了径向向外的力之后膨胀，从而将管子固定在靶标机体通道中。 In this example, may be a leaf was cut along the length of the tube, at least one end, preferably both ends of the tube after expansion may be applied in a radially outward force thereon, thereby fixing the tube at the target body channel. 叶部能在管子弯曲和/或管子膨胀时在径向向外的方向上移出管平面，被迫紧贴动脉瘤的开口，从而封闭动脉瘤的开口。 Leaves the tube portion can be bent in the radially outward direction out of the plane of the tube and / or expansion of the tube forced against the opening of the aneurysm thereby closing the aneurysm opening.
在另一个较佳的实例中，体部的形式成一对相互连接的相对的管状或环状的部分。 In another preferred embodiment, the body portion to form a pair of opposed tubular or annular portion interconnected. 叶部与管状或环状的部分之一或两者相连。 One portion of the tubular or annular leaf portion is connected to or both. 环状的部分能在其上施加了径向向外的力(例如通过导管固定的气囊施加或自身膨胀装置固有的力)时膨胀，以迫使体部固定在靶标机体通道中。 Annular portion can be expanded when a radially outward force is applied on thereof (e.g., the force applied to the device itself or intrinsic expanded by balloon catheter securement) to force the body portion fixed to the target body passageway. 如本领域中所知道的，可以通过将这些部分设计成具有多孔表面(例如含有许多相互连接的支柱)，来赋予环状部分可膨胀性。 As known in the art, these parts can be designed to have a porous surface (e.g., comprising a number of interconnected struts), the annular portion to impart swellability. 对于诸如不锈钢的材料，这使环状结构在到达塑性变形点之前膨胀。 For materials such as stainless steel, which makes the cyclic structure is plastically deformed before reaching the expansion point. 叶部能在管子弯曲和/或管子膨胀时在径向向外方向上移出管平面。 Leaves the tube portion can be bent in a radially outward direction out of the plane of the tube and / or expansion of the tube.
据认为本发明的血管内修复物为上文所述的常规外科技术提供了一种有意义的备选方案。 It is believed that the present invention intravascular prostheses provide a meaningful alternative to conventional surgical techniques described hereinabove. 而且，预计本发明的血管内修复物能用来治疗某些经诊断认为不能进行手术的动脉瘤。 Moreover, the present invention is expected to intravascular prostheses can be used to treat some believe can not be diagnosed aneurysm surgery. 还认为本发明的血管内修复物提供了目前的血管内方法(如上文所述的Guglielmi Detachable Coil)所具有的有意义的优点。 Also considered to be within the vascular prostheses of the present invention provides a method for intravascular current (as described above Guglielmi Detachable Coil) has significant advantages. 具体地说，由于本发明的血管内修复物不用将金属填充材料(例如铂绕线)插入动脉瘤，因此减小了破坏动脉瘤的危险性，从而减小了金属填充材料的动脉瘤间重排以及随后的动脉瘤的再现的危险。 Specifically, since the restoration without filling a metal material (e.g., platinum wire) is inserted into an aneurysm in a blood vessel of the present invention, thus reducing the risk of destruction of the aneurysm, the aneurysm so as to reduce the inter-metallic filler weight dangerous reproduction row and subsequent aneurysm.
附图简述下面将参照附图描述本发明的实例，其中相同的参考数字意味着相同的元件，其中：图1-5描述了基底动脉末端分支点的部分剖面透视图，其中正在输送和植入本发明血管内修复物的第一个实例；图6描述了图1-5所述的本发明血管内修复物第一个实例之改进的放大图；图7描述了图1-5所述的本发明血管内修复物第一个实例之另一改进的放大图；图8-10描述了本发明血管内修复物的叶部形状的各种实例；图11描述了本发明血管内修复物的第二个实例的透视图；图12-15描述了基底动脉末端分支点的部分剖面透视图，其中正在输送和植入图11所示的实例；图16描述了本发明血管内修复物的第三个实例的透视图；图17-18描述了基底动脉末端分支点的部分剖面透视图，其中正在输送和植入图16所示的实例；图19描述了图16-18所示的本发明血管内修复物的实例之改 BRIEF DESCRIPTION will be described below with reference to the accompanying drawings of examples of the present invention, wherein like reference numerals mean the same elements and in which: Figures 1-5 describe the basilar artery cross-sectional perspective view of the end portion of the branch point, and wherein the plant is conveyed the endovascular repair of the present invention a first example thereof; FIG. 6 depicts a modified example of a first endovascular repair of the present invention is an enlarged view of FIG. 1-5; FIG. 7 depicts the FIG 1-5 another example of a first endovascular repair composition of the present invention to improve an enlarged view; FIG. 8-10 depict various examples of the shape fix leaf object of the present invention within the blood vessel; FIG. 11 depicts an intravascular prostheses of the present invention a perspective view of a second example; 12-15 illustrate cross-sectional perspective view of the end portion of the basilar artery branch point, and wherein the implant being conveyed example shown in FIG. 11; FIG. 16 depicts an intravascular present invention restoration a perspective view of a third example; FIG. 17-18 describes the basilar artery cross-sectional perspective view of the end portion of the branch point, and wherein the implant being conveyed example shown in FIG. 16; FIG. 19 is described according to FIGS. 16-18 examples of the invention change endovascular restoration 进的放大图；图20-22示意性地描述了本发明血管内修复物的较佳实例的透视图；图23描述了图20-22所示血管内修复物所包括的一个实例的二维放大透视图；和图24描述了图20-22所示血管内修复物所包括的另一实例的二维放大透视图。 Into an enlarged view; FIG. 20-22 schematically depicts a perspective view of a preferred example of the present invention, endovascular repair thereof; FIG. 23 depicts one example of endovascular prostheses comprised of two-dimensional as shown in FIG 20-22 enlarged perspective view; and Figure 24 depicts another example of a two-dimensional endovascular prostheses 20-22 shown in FIG enlarged perspective view included.
实施发明的最佳方式参看图1-5，下面将具体参照将同一血管内修复物植入基底动脉末端分支点来描述本发明血管内修复物的第一个实例。 BEST MODE FOR CARRYING OUT THE INVENTION Referring to Figures 1-5, will be the same with particular reference to endovascular repair implant basilar artery branch end point will be described a first example of restoration of blood vessels within the present invention.
图中描述了基底动脉10，它末端在接合点15分叉成一对次级动脉20、25。 Depicted basilar artery 10, which split ends 20, 25 into a pair of secondary arteries at the junction 15. 动脉瘤30位于接合点15处。 Aneurysm 30 is located at the joint 15. 动脉瘤30有一个开口35(仅出于描述目的而放大显示)，血液通过该开口进入并维持动脉瘤30。 Aneurysm 30 has an opening 35 (exaggerated for purposes of description only the display), the blood enters through the opening 30 and maintain the aneurysm.
将血管内修复物100固定在导管50上。 The endovascular repair 100 is fixed to the catheter 50.
导管50包括可充气的气囊55和一条导引金属丝60。 Catheter 50 includes an inflatable balloon 55 and a guidewire 60. 导管50、可充气的气囊55和导引金属丝60是常规的的。 Catheter 50, an inflatable balloon 55 and guidewire 60 are conventional. 如本领域所知道的，可充气的气囊55能沿导引金属丝60移动。 As known in the art, inflatable balloon 55 can be moved along the guide wire 60.
血管内修复物100由体部105构成。 Endovascular restoration portion 100 is constituted by the body 105. 体部105包括一个近端110和一个远端115。 A body portion 105 includes a proximal end 110 and distal end 115. 血管内修复物100还包括一个与体部105相连的叶部120。 Endovascular repair 100 further comprises a leaf portion attached to the body portion 105,120. 如图所示，叶部包括颈部125和头部130。 As illustrated, leaf portion comprises a neck 125 and a head 130. 头部130比颈部125宽。 Wider than the head portion 130 of the neck 125. 在所述的实例中，叶部120的头部130背向远端115(叶部120的头部130朝向近端110)。 In the example, the head 120 of leaf portion 130 facing away from the distal end 115 (the head portion 120 of the leaf 130 toward proximal end 110).
体部105是大致成管状的元件，它应制成充分地柔软，使得它能被操纵到达靶标机体通道，并且具有充分的可膨胀性，从而使它能固定在靶标机体通道中的合适位置处。 The body portion 105 is a substantially tubular member, it should be made sufficiently flexible so that it can be manipulated reaches the target body passageway, and having sufficient expandability so that it can be fixed at an appropriate position in the target body passageway .
实现这点的一种方法是构造结构类似于内支架(stent)的结构制造血管内修复物100。 A method to achieve this is a configuration similar to the configuration of the structure of the stent (stent) producing 100 endovascular prostheses. 如本领域所知道的，内支架是一种可膨胀的修复物，它通常用来获得和维持机体通道(例如血管、呼吸道、胃肠道等)的开放。 As is known in the art, is an expandable stent of the restoration, it is usually used to obtain and maintain the body passage (e.g. vascular, respiratory, gastrointestinal tract, etc.) open. 内支架的两个总体设计要求是：(i)它在未膨胀状态下必须足够柔软，从而使其能完整地被操纵导引至靶标机体通道，和(ii)在膨胀的状态下，它必须具有足够的径向刚性，以避免产生再狭窄和/或内支架回弹。 Two general design requirements of a stent are: (i) it is in the unexpanded state must be sufficiently flexible so that it can be manipulated completely guided to the target body passageway, and (ii) in the expanded state, it must It has sufficient radial rigidity to avoid restenosis and / or stent recoil. 本发明的血管内修复物本身不是一种内支架，因为它不需要满足设计要求(ii)—即本发明血管内修复物的目的不是维持被封闭的机体通道的开放。 Endovascular repair of the present invention per se is not a stent, because it does not meet the design requirements (ii) - i.e. object of the present invention is not restoration endovascular body to maintain an open channel is closed. 相反，为了将修复物固定在正确的位置，本发明的血管内修复物包括一个或多个可膨胀的元件。 Conversely, in order to repair was fixed in the correct position, intravascular present invention comprises one or more expandable elements repair.
因此，在该方法中，体部105可能是一个多孔的管，它具有由众多相交的部分来限定的多孔性(为了清楚起见，图1-5中没有示出体部105的多孔性)。 Thus, in this method, the body portion 105 may be a porous tube having a porosity defined by a number of intersecting portions (for clarity, not shown in the figures 1-5 the porous body portion 105). 相交部分的确切方式没有特别的限制，其选择应能使多孔管在未膨胀的状态下具有足够的柔软性，同时具有靠管上径向向外的力来实现至少一定程度膨胀的可能性。 The exact manner in intersection is not particularly limited portion, which enables the porous tube should be selected to have sufficient flexibility in the unexpanded state while having the possibility of a radially outward force against the pipe to achieve a certain degree of expansion of at least. 通常，多个相交部分的排列确定了规则的重复的图案。 Typically, the plurality of intersecting portions arranged in a repeating pattern determination rules. 例如参见，下列待批专利申请中公开了各种重复的图案：加拿大专利申请号2,134,997(1994年11月3日提交)；加拿大专利申请号2,171,047(1996年3月5日提交)；加拿大专利申请号2,175,722(1996年5月3日提交)；加拿大专利申请号2,185,740(1996年9月17日提交)；加拿大专利申请号2,192,520(1996年12月10日提交)；国际专利申请PCT/CA97/00151(1997年3月5日提交)；国际专利申请PCT/CA97/00152(1997年3月5日提交)；和国际专利申请PCT/CA97/00294(1997年5月2日提交)；这些申请每一份的内容以及其中引用的参考文献均纳入本文作参考(后文总称为“Divysio专利申请”)。 See, for example, the following copending patent applications disclose various repeating pattern: Canadian Patent Application No. 2,134,997 (November 1994 filed May 3); Canadian Patent Application No. 2,171,047 (1996, filed March 5); Canadian Patent Application No. 2,175,722 (1996, May 3 filed); Canadian Patent application No. 2,185,740 (1996, September 17 filed); Canadian Patent application No. 2,192,520 (filed 1996, December 10); international Patent application PCT / CA97 / 00151 (1997, March 5 filed); international Patent application PCT / CA97 / 00152 (filed 1997, March 5); and international Patent application PCT / CA97 / 00294 (1997 May 2 submitted); these applications every and wherein a content of the references cited herein are incorporated by reference (hereinafter collectively referred to as "Divysio patent application"). 尽管Divysio专利申请中公开的重复图案适用于内支架的设计，但是也可对它们进行改进，以提高用于本发明血管内修复物的管状结构的弯曲性(例如通过改变Divysio专利申请中提出的多边形设计)，即使得到的管子可能不能用作内支架。 Although the Divysio patent application discloses repeating pattern applicable to the design of the stent, but they may be modified to enhance the repair of the present invention for intravascular flexibility of the tubular structure material (e.g., made by changing the Divysio patent application polygonal design), even though the tube may not be used to give the stent.
体部105可以用任何合适的材料构成。 Body portion 105 may be composed of any suitable material. 在一个较佳的实例中，体部105由塑性可变形的材料(如金属、合金或聚合物)构成。 In a preferred embodiment, the body portion 105 made of a plastically deformable material (e.g., metal, alloy or polymer) configured. 合适的金属和合金的非限制性例子可以选自：不锈钢、钛、钽等。 Non-limiting examples of suitable metals and alloys may be selected from: stainless steel, titanium, and tantalum. 在该实例中，用来膨胀体部105的径向向外的力可以通过导管固定的气囊的膨胀来施加，这在下文有更详细的讨论。 In this example, the force used to radially outward expansion of the body 105 may be applied by a fixed portion of the balloon catheter is inflated, which is discussed in more detail below. 在另一个较佳的实例中，体部105由能在至少约30℃的温度下、较佳的在约30-40℃范围内自身膨胀的“形状记忆”金属合金(如镍钛诺)制成。 In a further preferred embodiment, the body portion 105 can be at a temperature of at least about 30 deg.] C, preferably the "shape memory" metal alloy itself expansion in the range of about 30-40 deg.] C (such as nitinol) Ltd. to make. 在该实例中，可以理解当体部105暴露于处于程控自身膨胀温度的环境下时，体部105固有的径向向外的力使其膨胀。 In this example, the body portion 105 can be understood that when exposed to expansion itself is under programmed temperature environment, the radial force inherent body portion 105 to expand it outwardly. 在还有一个较佳的实例中，体部105可以由生物可降解的材料制成。 In yet a preferred embodiment, the body portion 105 may be made of a biodegradable material. 如本领域所知道的，生物可降解的材料在长期接触体液后会发生降解，因此可用于本发明的血管内修复物，因为动脉瘤会在动脉瘤开口闭合后数分钟内闭合。 As known in the art, a biodegradable material degradation will occur after prolonged contact with body fluids, thus can be used in the present invention intravascular restoration, since the aneurysm would be closed within a few minutes after the opening of the aneurysm is closed.
体部105的生产方式没有特别的限制。 It is not particularly limited production portion 105 of the body. 较佳的，体部105用施加在管状原料上的激光切割技术来生产。 Preferably, the body portion 105 with a laser beam applied on the tubular cutting techniques to produce the raw material. 因此，原料可以是如上所述的金属、合金或聚合物的薄管，然后从其中切去部分，留下所需的上述重复模式。 Thus, the raw material may be a thin tube of metal, alloy or polymer as described above, and then cut away from the section, leaving the repeated pattern desired. 然后，采用这种技术，可用激光加工成叶部120的颈部125和头部130的轮廓，就可简单地产生叶部120。 Then, using this technology, laser processing can be used to contour the neck portion 125 of leaf portion 120 and head portion 130 can easily produce leaf portion 120.
另外，还可以从一条或多条预先成形的金属丝来制造具有所需多孔重复图案的体部105。 Further, body portion 105 can be produced having the desired porous repeating pattern from one or more wire preformed. 在另一个备选实例中，可以用平床激光(flat bed laser)切割技术，任选地与焊接技术组合，来制造具有所需多孔重复图案的体部105。 In another alternative example, it may be a flat bed laser cutting technique (flat bed laser), optionally in combination with a welding technology, having a body portion 105 to manufacture the desired porous repeating pattern.
由于血管内修复物100起封闭朝向动脉瘤30之开口35的作用，因此重要的是要相应地设计叶部120。 Since the restoration of action 30 of the opening 35 toward the closure 100 from an aneurysm in a blood vessel, so it is important to leaf portion 120 be designed accordingly. 具体地说，应这样设计叶部120，使得它能封闭朝向动脉瘤30的开口35。 Specifically, leaf portion 120 should be designed such that it is closed toward the opening 35 of the aneurysm 30. 这可以多种方式来实现。 This can be accomplished in several ways. 在一个实例中，将叶部120的头部130设计成无孔的。 In one example, the head 120 of leaf portion 130 is designed to be non-porous. 在另一个实例中，将叶部120的头部130设计成是多孔的(例如为了便于生产体部105)，然后用合适的无孔涂层材料覆盖。 In another example, the head 120 of leaf portion 130 is designed to be porous (e.g., in order to facilitate the production of the body portion 105), and then covered with a suitable non-porous coating material. 无孔涂层材料可以有活性(例如药剂、胶粘剂等，起无孔表面的作用并具有额外的优点)或没有活性(例如一种惰性的涂层材料，其唯一的目的是提供无孔的表面)。 Nonporous coating material may be active (e.g. pharmaceutical, adhesives, etc., function as non-porous surfaces and has the additional advantage) or no activity (e.g., an inert coating material, whose sole purpose is to provide a non-porous surface ). 在还有一个实例中，叶部120的整个表面(即颈部125和头部130的总和)的最初设计可以是无孔的，或者最初是有孔的，随后用一无孔涂层覆盖。 In yet another example, the entire surface of leaf portion 120 (i.e., the sum of the neck 125 and head 130) may be initially designed to be non-porous, or originally porous and subsequently covered with a non-porous coating.
血管内修复物100上还可包含一种涂层材料。 Endovascular restoration 100 may further comprise one coating material. 该涂层材料可以连续地或不连续地涂布在修复物表面上。 The coating material may be applied discontinuously or continuously on the surface of the restoration. 另外，涂层可以涂布在修复物的内表面和/或外表面上。 Further, the coating may be coated on the inner surface of the restoration and / or outer surface. 涂层材料可以是一种或多种生物惰性材料(例如来减少修复物的形成血栓性)、一种在植入后渗入机体通道壁的药物组合物(例如提供抗凝血作用，向机体通道输送药物等)等。 The coating material may be one or more of a biologically inert material (e.g. to reduce the formation of thrombotic restoration), A pharmaceutical composition after implantation penetrate the walls of the body passageway (e.g., to provide anticoagulant action, to the body passage delivery of drugs, etc.) and the like.
血管内修复物100宜具有一种生物相容的涂层，以便最大程度地减小与机体血管壁和/或通过血管流动的体液(通常是血液)的不利的相互作用。 Restoration 100 preferably has a coating of one biocompatible intravascular body vessel wall in order to reduce and / or adverse interaction with the fluid flowing through the blood vessels (typically blood) to the maximum extent. 该涂层宜为一种聚合物材料，它通常是通过向修复物提供一种溶剂配制的预先形成的聚合物溶液或分散液然后除去该溶剂来提供的。 The coating material is suitably a polymer, which is usually the solvent is then removed by providing a polymer solution or dispersion of a pre-formed formulation into a solvent to provide the restoration. 另外也可采用非聚合物的涂层材料。 In addition the coating material may also be non-polymeric. 合适的涂层材料，例如聚合物，可以是聚四氟乙烯或硅氧烷橡胶、或已知具有生物相容性的聚氨基甲酸酯。 Suitable coating materials, such as polymers, may be polytetrafluoroethylene or silicone rubber, or polyurethane having known biocompatible. 然而，较佳的聚合物宜具有两性离子悬垂基团，它通常是磷酸铵酯基团，例如磷酸胆碱基团或其类似物。 Preferably, however, the polymer preferably has zwitterionic pendant groups, generally ammonium phosphate ester groups which groups, such as choline phosphate group or the like. 合适聚合物的例子在国际申请WO-A-93/16479和WO-A-93/15775中有所描述。 Examples of suitable polymers are described in International Application WO-A-93/16479 and WO-A-93/15775. 那些说明书中描述的聚合物是与血相容的且通常是生物相容的，而且是光滑的。 Those polymers described in the specification is compatible with the blood and is generally biocompatible, and is smooth. 重要的是修复物的表面被完全涂覆，以便最大程度地减小不利的(例如与血的)相互作用(该相互作用可能会在来源血管中导致形成血栓)。 It is important to fully repair the coated surface thereof, in order to reduce undesirable (for example, blood) to maximize the interaction (the interaction may result in vessel thrombosis source).
良好的涂层可以通过适当地选择涂层条件(如涂层溶液的粘度、涂覆技术和/或溶剂除去步骤)来获得。 Good coating can be obtained by appropriately selecting the coating conditions (e.g., viscosity of the coating solution, coating / steps or techniques and the solvent was removed).
参看图1，一旦需要植入血管内修复物100，就将其固定在导管50的气囊55上。 Referring to Figure 1, once the need to implant endovascular prostheses 100, which will be fixed to the catheter balloon 50 to 55. 然后以箭头A的方向将导管50移动通过基底动脉10。 Then the direction of arrow A, the catheter 50 is moved through basilar artery 10.
参看图2，用常规的导引金属丝和X光透视技术，将固定在导管50的气囊55上的血管内修复物100导引至动脉瘤30所在位置。 Endovascular repair Referring to Figure 2, a conventional guide wire and the X-ray technique, the catheter balloon 50 is fixed on the guide 55 to position 100 of the aneurysm 30 is located. 在所描述的实例中，体部105的远端115进入次级动脉20。 In the example described, the distal end 115,105 of the body portion into the secondary artery 20. 在实践中，基底动脉分支处的次级动脉是不对称的，体部105的远端115导引进入两个次级动脉中较大的一个。 In practice, the secondary branch of the basilar artery are asymmetric, the distal end of the body portion 105 of the guide 115 into the two secondary arteries larger one. 另外，在所述的实例中，当体部105在弯折进入次级动脉20时，叶部120上升或移动至与体部105的管状平面不成一直线，从而确定了开口135。 Further, in the example, when the body portion 105 is bent into the secondary artery 20, leaf portion 120 to move up or with the tubular body portion 105 of the plane of alignment, thereby defining the opening 135.
参看图3和4，一旦当血管内修复物100位于正确的位置，气囊55膨胀，从而对体部105施加径向向外的力。 Referring to Figures 3 and 4, once the restoration 100 in the correct position within the blood vessel, the balloon 55 expands, a radially outward force is applied to the body portion 105. 开始时，这导致体部105膨胀从而使其一部分紧贴基底动脉10和次级动脉20的壁。 At the beginning, which results in the body portion 105 such that it expands against the walls of basilar artery 10 and secondary artery 20. 参看图4，随着气囊55继续膨胀，一部分气囊55压迫在叶部120的颈部125和头部130上，从而迫使叶部120紧贴次级动脉20，25的管壁，结果导致封闭动脉瘤30的开口35。 Referring to Figure 4, as the air bag 55 continues to expand, balloon 55 presses against the part of the neck portion 125 of leaf portion 120 and the head 130, thereby forcing leaf portion 120 against the walls of secondary artery 20 and 25, resulting in blocking arteries 30 of 35 tumors opening.
参看图5，气囊55放气，将气囊和导引金属丝60一起沿箭头B的方向从血管内修复物100中抽出。 Referring to Figure 5, the balloon 55 deflated, with the endovascular repair from the direction of arrow B, the airbag 60 and the guide wire 100 was extracted. 在所述的实例中，血管内修复物100通过体部105紧紧压迫在基底动脉10和次级动脉20的壁上而固定在位置上。 In the example, the workpiece 100 is fixed in position by the body portion 105 pressing against the wall of basilar artery 10 and secondary artery 20 of the endovascular repair. 另外，在所述的实例中，叶部120靠箭头C方向上的血液流动对其施加的力以及体部105至导引进入次级动脉20的远端115弯曲开口固有的力的组合来固定。 Also, combinations of the examples, leaf portion 120 against the blood flow in the arrow C direction and its force is applied to the guide portion 105 enters secondary artery distal 11,520 bending forces inherent in the opening of the fixed . 一旦叶部120封闭了开口35，随后动脉瘤就会闭合。 Once leaf portion 120 closes the opening 35, it will then close the aneurysm.
图6描述了图1-5所述血管内修复物之改进方案的放大视图。 6 depicts an enlarged view of the development of intravascular restoration of the 1-5 in FIG. 在图6中，相同的数字用来代表图1-5中相同的元件，图6中的改进的或新的元件用后缀“a”表示。 In FIG. 6, the same numerals used to denote the same elements in FIG. 1-5, FIG. 6 in an improved or new elements are denoted by the suffix "a". 具体地说，叶部120a已经过改进，使得颈部125a由不导电的材料制成，而头部130a由导电材料制成。 Specifically, leaf portion 120a has been improved, so that the neck portion 125a of a non-conductive material, while the head 130a is made of an electrically conductive material. 另外，在头部130a的动脉瘤侧放置了药学上可接受的胶粘剂132a，并且将一根定位金属丝140a固定在头部130a的连接点145a处。 Further, the head portion 130a of arterial aneurysm side placed pharmaceutically acceptable adhesive 132a, and a positioning wire 140a is fixed at a connection point 145a in the head 130a. 在使用时，可用定位金属丝140a来确定叶部120a的方向，从而使头部130a正确地闭合动脉瘤30的开口35。 In use, positioning wire 140a can be used to determine the orientation of the leaf portion 120a so that the head 130a correctly closes opening 35 of aneurysm 30 of the artery. 一旦叶部120a位于正确的位置，就使电流通过定位金属丝140a，从而使其与头部130a在连接点145a上分开。 Once leaf portion 120a is in the correct position, current is passed through positioning wire 140a, so that it separated from the head 130a at a connection point 145a. 另外，根据胶粘剂132a的特征，通过定位金属丝140a的电流可起激活胶粘剂132a的附加的作用。 Further, according to the characteristics of the adhesives 132a, current positioning wire 140a may serve the additional role through the activation of an adhesive 132a. 当然，也可以改进图6所示的具体实例，例如：(i)省略胶粘剂132a，因而电流起着将头部130a密封到开口35周围的作用；(ii)省略定位金属丝140a，从而通过胶粘剂132a实现头部130a与开口周围的封合；或(iii)用相同材料(导电的或不导电的)制造头部130a，因而定位金属丝140a的主要目的是使叶部120a对齐。 Of course, may also improve the specific example shown in FIG. 6, for example: (i) omit adhesive 132a, 130a and thus current serves to seal head 35 around the opening of the role; (ii) omit positioning wire 140a, so that by adhesive 130a and 132a to achieve sealing around the opening of the head portion; or (iii) of the same material (electrically conductive or non-conductive) for producing a head 130a, and thus the main purpose of positioning wire 140a is to align the leaf portion 120a.
图1-6所述实例的一种较佳的改进涉及将定位金属丝140a改进成图1-5所示导引金属丝60的辅助(或第二根)导引金属丝。 A preferred example of the modification of Fig. 1-6 involves the positioning wire 140a modified to guide wire shown in FIG. 60, 1-5 secondary (or second root) guidewire. 具体地说，当导引金属丝60导引进入次级动脉20时，辅助导引金属丝可通过叶部的开口(例如靠近图6中连接点145a的位置)并在血管内修复物植入时进入次级动脉25。 Specifically, when the guide wire 60 into the secondary guide 20 is the artery, the guide wire may be assisted by the opening leaf portion (e.g., close to the connection position of the point 145a in FIG. 6) and implanted in a blood vessel repair when entering the secondary artery 25. 通过以这种方式使辅助导引金属丝通过叶部，将大大促进修复物的输送，重要的是，能加强对叶部封合动脉瘤开口的方向的控制。 By this way the auxiliary guide wire through the leaves, will greatly facilitate the delivery of the restoration, it is important that leaf portion can enhance sealing artery aneurysm opening direction control.
图7中描述了图1-5所述血管内修复物的另一种改进方案。 Figure 7 depicts another improved embodiment of the restoration within the blood vessel of FIG. 1-5. 在图7中，用相同的数字代表图1-5中相同的元件，图7中改进的或新的元件用后缀″b″表示。 In FIG. 7, the same elements 1-5, in FIG. 7 modified or new elements are indicated by the suffix "b" by the same numerals in FIG. 具体地说，对叶部120b进行改进，使头部130b的动脉瘤侧涂覆了药学上可接受的可膨胀的化合物132b。 Specifically, leaf portion 120b is improved, so that the aneurysm coated side of the head 130b Compound 132b pharmaceutically acceptable swellable. 在使用时，一旦当叶部120b的取向使得头部130b正确闭合了动脉瘤30的开口35，可膨胀的化合物132b就与体液发生化学反应，膨胀成膨胀的化合物134b并填充了动脉瘤。 In use, once leaf portion 120b when the orientation such that the head 130b correctly closes opening 30 of aneurysm 35, expandable compound 132b chemically reacts with bodily fluids to occur, expands into the expanded compound 134b and fill the aneurysm. 或者，可膨胀的化合物132b可以用如图6所述的定位金属丝来电激活。 Alternatively, expandable compound 132b may be positioned as shown in FIG 6, the wire incoming call activation.
图8-10描述了叶部之头部形状的各种改进方案。 Figures 8-10 describe various developments shape of the head portion of the leaf. 在图8-10中，相同的数字用来代表图1-5中相同的元件，图8-10中的改进的元件分别用后缀″c″，″d″和″e″来表示。 In Figures 8-10, like numerals are used to denote the same elements in FIG. 1-5, FIG 8-10 elements are modified with the suffix "c", "d" and "e" is represented. 对于本领域技术人员显而易见的是，图8-10中分别描述的头部130c、130d或130e可以从体部105中切出或与其重叠。 The skilled person will be apparent that the head described in Figure 8-10, respectively 130c, 130d, or 130e may be cut out from the body portion 105 or overlaps.
图11描述了血管内修复物200形状的本发明的第二个实例。 11 depicts a second example of the present invention was 200 fixes the shape of the blood vessel. 血管内修复物200由体部205构成。 Endovascular restoration portion 200 is constituted by the body 205. 体部205包括一个近端210和一个远端215。 A body portion 205 includes a proximal end 210 and distal end 215. 血管内修复物200还包括一个与体部205相连的叶部220。 Endovascular repair 200 further comprises a leaf portion connected to the body portion 205,220. 如图所示，叶部220包括一个颈部225和一个头部230。 As illustrated, leaf portion 220 comprises a neck 225 and a head portion 230. 头部230比颈部225宽。 Head 230 is wider than the neck portion 225. 在所述的实例中，叶部220的头部230背向远端215(即，叶部220的头部230朝向近端210)。 In the example, the head 230 of leaf portion 220 facing away from the distal end 215 (i.e., head 220 of leaf portion 230 toward the proximal end 210).
体部205还包括一对环235、240，它们由一对金属丝245、250相互连接。 Body portion 205 further includes a pair of rings 235,240 which are interconnected by a pair of wires 245,250. 在所述的实例中，叶部220与环235相连。 In the example, leaf portion 220 is connected to the ring 235. 金属丝245、250的位置宜赋予修复物200足够的完整性，同时提供最大程度的弯曲性，以提供增强的导引作用。 Positions 245, 250 of the wire 200 should impart sufficient integrity restoration, while providing the greatest degree of flexibility to provide enhanced steering effect. 金属丝245、250的目的是将环235和240相互连接起来，同时使得修复物200具有足够的弯曲性(从而使其能导引至靶标机体通道)，且具有足够的可膨胀性(这样它就能固定在靶标机体通道的合适位置处)。 Object of the wire 245, 250 is connected to each ring 235 and 240 together, so that the restoration 200 while having sufficient flexibility (so that it can be guided to the target body passageway), and has sufficient swellability (so that it It can be fixed at a suitable position of the target body passageway). 在修复物200膨胀期间(即修复物200处于正确位置这一时点之后)，金属丝245、250并非是特别重要的。 (I.e., after the restoration in the correct position of the point 200) during expansion restoration 200, a wire 245, 250 it is not particularly important. 另外，本领域技术人员显然能看出，叶部220能相对于修复物200的近端210和远端215独立移动(在所述的实例中，叶部220能相对于环235、240独立移动)。 Further, those skilled in the art can obviously be seen, the leaf portion 220 is independently movable with respect to the repair of the proximal end 210 and a distal end (200) 215 (in the example, leaf portion 220 is independently movable relative to the ring 235, 240 ).
参看图12-15，将修复物200固定在导管50上，并参照上文图1-5所述方式进行输送和植入。 Referring to FIGS. 12-15, the restoration 200 is fixed to the catheter 50, and the delivery and implantation 1-5 embodiment described above with reference to FIG. 在该实例中，较佳的是以这样的方式植入修复物200：使金属丝245、250毗邻基底动脉10和次级20(在所述实例中)。 In this example, in such a preferred embodiment the implant restoration 200: 245, 250 adjacent to the wire base 10 and the secondary artery 20 (in the example).
本发明的这一实例可用来描述本发明的血管内修复物与常规的内支架之间的差别。 This example of the invention used to describe the present invention within the blood vessel repair was the difference between a conventional stent. 具体地说，在本发明的实例中，可膨胀的元件是环235、240。 Specifically, in the example of the present invention, the expandable member 235, 240 is a ring. 环235、240包括相互连接的支柱的多孔结构，为了清楚起见，在该图中没有描绘出该结构。 Rings 235, 240 comprises a porous structure of interconnecting struts, for clarity, in this figure not depict the structure. 相互连接的支柱的多孔结构的确切特征没有特定限制，这是本领域技术人员力所能及的。 The exact characteristics of the porous structure of interconnecting struts is not particularly limited, as one skilled in the art could. 膨胀环235、240的主要作用是将修复物200固定在位置上，且不必改变通过其中有环发生膨胀的动脉部分的血流—即这是内支架的目的。 The main role of the expansion ring 235, 240 is a restoration 200 is fixed in position, and without changing the blood flow through the artery portion which expands the ring - i.e., it is the object of the stent.
图16描述了血管内修复物300形状的本发明第三个实例。 Figure 16 depicts a third example of the present invention, the shape of the restoration 300 of the blood vessel. 血管内修复物300由体部305构成。 Endovascular repair material portion 300 is constituted by the body 305. 体部305包括一个近端310和一个远端315。 A body portion 305 includes a proximal end 310 and distal end 315. 血管内修复物300还包括一个与体部305相连的叶部320。 Endovascular repair composition further comprises a leaf portion 300 is connected to a body portion 305,320. 体部305包括一对环335和340，它们通过一对金属丝345和350相互连接。 Body portion 305 comprises a pair of rings 335 and 340, which are interconnected by a pair of wires 345 and 350. 同样，环335、340包括一个相互连接的支柱的多孔结构，为了清楚起见，该图中没有描述该结构。 Similarly, a ring 335, 340 comprising struts interconnected porous structure, for the sake of clarity, the figure does not describe the structure. 相互连接的支柱的多孔结构的确切特征没有特别限制，这是本领域技术人员力所能及的。 The exact characteristics of the porous structure of interconnecting struts is not particularly limited, as one skilled in the art could. 如图所示，叶部320通过一对金属丝322和324与环335和340相连。 As illustrated, leaf portion 320 is connected to rings 335 and 340 by a pair of wires 322 and 324. 另外，金属丝345、350的每一个各自含有一对波浪形的部分355，金属丝322和324的每一个各自含有一个波浪形的部分355。 Further, each of the wires 345, 350 each includes a pair of wave-shaped portions 355, each wire 322 and 324 each comprising a wave-shaped portion 355. 波浪形部分355改进了修复物300的弯曲性和导引性。 Wavy portion 355 improves the restoration 300 and bending of the guide.
同样，金属丝322、324、345和350的尺寸宜赋予修复物300足够的完整性，同时最大程度地提高弯曲性以提供增强的导引作用。 Similarly, the size of the wire should impart 322,324,345 and restoration 350 300 sufficient integrity while maximizing flexibility to provide enhanced steering effect. 金属丝345、350的目的是与环335、340相互连接，同时使修复物300具有足够的弯曲性(这样它能导引至靶标机体通道)且具有足够的可膨胀性(这样它能固定在靶标机体通道的合适位置上)。 Objective wire 345, 350 is interconnected with the ring 335, 340, 300 while the restoration having sufficient flexibility (so that it can guide the body passageway to a target) and has sufficient swellability (fixed so that it can suitable target position on the channel body). 在修复物300膨胀期间(即修复物300处于正确位置这一时点后)，金属丝345、350并不是特别重要的。 (Ie after the restoration point 300 is in the correct position) during restoration 300 expansion, wire 345, 350 is not particularly important. 金属丝322、324的目的是使叶部230相对于修复物300的近端310(在所述实例中这将包括环335)和远端315(在所述实例中这将包括环340)更为独立的移动。 Object of the wire 322 is to fix the leaf portion 230 with respect to the proximal end 310 of the object 300 (in the example, this would include ring 335) and a distal end 315 (in the example, this would include ring 340) more as an independent movement. 参看图17-18，将修复物300固定在导管50上，并参照上文图1-5所述方式进行输送和植入。 Referring to FIGS. 17-18, the restoration 300 is fixed and transported implanted on catheter 50, as described above with reference to FIGS. 1-5 embodiment. 进一步参看图18，本领域技术人员会理解，为了获得最优的效果，金属丝322、324、345和350在环335、340上的位置应使得金属丝324在血管内修复物植入后不越过次级动脉25。 With further reference to FIG. 18, one skilled in the art will appreciate that, in order to obtain an optimal effect, wires 322,324,345 and 350 position on the ring 335, 340 of the wire 324 such that restoration is not implanted within the vessel across the secondary artery 25.
图19描述了图16-18所示血管内修复物的一种改进方案。 FIG 19 describes an improved endovascular restoration scheme 16-18 shown in FIG. 在图19中，相同的数字用来表示图16-18中相同的元件，图19中新的元件用后缀″f″表示。 In Figure 19, the same numerals are used to represent the same elements in FIGS. 16-18, in Figure 19 the new elements are indicated with the suffix "f". 在图19中，加入了波浪形金属丝326f来连接叶部320和金属丝345、350。 In Figure 19, the addition of undulating wire 326f connected to leaf portion 320 and wires 345, 350. 另外，叶部320和环340之间没有相互连接的金属丝。 Further, there is no interconnection between the leaf portion 320 and ring 340 wires. 在该实例中，省略了叶部320和环340之间的相互连接的金属丝，从而避免血管内修复物植入后连金属丝越过次级动脉25的管腔，同时，波浪形金属丝326f的加入改善了修复物的物理完整性。 In this example, the wire is omitted between the blade portion 320 and ring 340 are connected to each other so as to avoid the implanted endovascular repair wire connected across the secondary lumen 25 of the artery, while undulating wire 326f It added to improve the physical integrity of the restoration.
图20-22描述了怎样从管状原料中切下血管内修复物400的各个元件(同样，为了清楚起见，图20-22中没有描述修复物400的具体的孔隙以及气囊导管输送系统)。 20-22 describes how the various elements of the repair material from the vessel 400 within the tubular raw material is cut (again, for clarity, described in Figures 20-22 is not repaired and the specific pore balloon catheter delivery system was 400).
血管内修复物400由体部405构成。 Endovascular restoration portion 400 is constituted by the body 405. 体部405包括一个近端410和一个远端415。 A body portion 405 includes a proximal end 410 and distal end 415. 血管内修复物400还包括一个与体部405相连的叶部420。 Endovascular repair was 400 further comprises a leaf portion attached to the body portion 405,420. 如图所示，叶部420包括用来封闭动脉瘤开口35的封闭部425。 As illustrated, leaf portion 420 comprises a closing portion for closing the opening 35 of aneurysm 425. 在所述的实例中，叶部420的自由端背向远端415(即叶部420的自由端朝向近端410)。 In the examples, the free end of leaf portion 420 facing away from the distal end 415 (i.e., the free end 420 of leaf portion 410 toward the proximal end).
体部405还包括一对可膨胀的管状部分435、440，它们通过一根脊450相互连接。 Body portion 405 further includes a pair of inflatable tubular portions 435, 440 are connected to each other by a ridge 450. 在所述的实例中，叶部420与管状部分435相连。 In the example, leaf portion 420 is connected to the tubular portion 435. 脊450的尺寸宜赋予修复物400足够的完整性，同时最大程度地提高弯曲性以增强导引性。 The ridges 450 impart a size appropriate restoration 400 sufficient integrity while maximizing flexibility to enhance the introductory. 脊450的目的是使管状部分435、440相互连接，同时使修复物400具有足够的弯曲性，这样修复物就能导引至靶标机体通道。 Purpose of the ridges 450 of the tubular portion 435, 440 are connected to each other, while the restoration 400 has sufficient flexibility, so that the restoration can be guided to the target body passageway. 对于本领域技术人员显而易见的是，叶部420能相对于修复物400的近端410和远端415独立移动(在所述的实例中，叶部420能相对于管状部分435、440独立移动)。 The skilled person will be apparent that, with respect to leaf portion 420 fixes the proximal end 410 and a distal end 400. The independent movement of 415 (in the example described, the leaf portion 420 with respect to independent movement of the tubular portion 435, 440) .
图23描述了可膨胀的修复物400的一个实例的二维图形。 Figure 23 depicts one example of a two-dimensional pattern 400 may be expandable restoration. 在所述的实例中，封闭部分425包括一系列大致纵向的蜿蜒的支柱426、427、428，它们独立地在一端与管状部分435连接，相反的一端通过一个横向的支柱429来相互连接。 In the example, the closure portion 425 includes a series of generally serpentine longitudinal struts 426,427,428, they are independently connected at one end to the tubular portion 435 and an opposite end via a transverse strut 429 connected to each other.
支柱426、427、428、429产生的多孔结构上覆盖了一种材料，该材料适合(i)抵抗修复物400的膨胀，和(ii)在展开后封闭动脉瘤30的开口35。 The porous structure of struts 426,427,428,429 is covered with a produced material, which material is suitable for (i) resistance to the expansion of the restoration 400, and (ii) closing the opening 35 of aneurysm 30 after deployment. 用于此目的的材料的性质没有特定限制。 Nature of the materials used for this purpose is not particularly limited. 较佳的，该材料包含Cardiothane 51TM(Kontron Instruments，Inc.，Everett，Massachusetts)、一种已知用于血管内器械的医药级聚氨基甲酸酯/硅氧烷聚合物(如用于主动脉内心脏辅助器械的气囊材料)。 Preferably, the material comprises Cardiothane 51TM (Kontron Instruments, Inc., Everett, Massachusetts), for a known endovascular medical grade polyurethane / silicone polymer (e.g., the aorta for the balloon material cardiac assist devices). 因此，“裸露的”封闭部分425最初可用5.7％重量∶体积(w∶v)的有机溶剂(例如2∶1的四氢呋喃：1，4-二噁烷)配制的Cardiothane 51TM溶液来涂覆。 Thus, a "bare" blocking portion 425 initially available 5.7% weight: volume (w:v) an organic solvent (e.g. 2:1 tetrahydrofuran: 1,4-dioxane) was prepared to coat Cardiothane 51TM. 然后可以用溶于相同溶剂的Cardiothane 51TM溶液(11.7％w∶v)再涂覆最初涂覆的封闭部分425。 It can then be dissolved in a solution of Cardiothane 51TM same solvent (11.7% w:v) recoating initially coated blocking portion 425. 聚合物变干后，将封闭部分的支柱基本上包埋在聚氨基甲酸酯-硅氧烷覆盖层内。 After the polymer is dry, the struts of blocking portion are substantially embedded in the polyurethane - silicone inner coating layer. 然后用环氧乙烷对有覆盖层的封闭部分425进行消毒。 Then disinfected with the coated portion 425 is closed with ethylene oxide. 关于该方法的更多信息，参见Okoshi等人的“多孔的对有皮层的聚氨基甲酸酯-聚二甲硅氧烷小直径血管移植物的体内评价”，ASAIO Transactions 1991；37：M480-M481，该文内容纳入本文作参考。 For more information on this method, see Okoshi et al., "To have a porous polyurethane skin layer - In vivo evaluation of simethicone small diameter vascular grafts", ASAIO Transactions 1991; 37: M480- M481, the text of which is incorporated herein by reference.
图24描述了一个可膨胀修复物400例子的二维图象。 FIG 24 depicts an example of an expandable material 400 fix two-dimensional image. 在所述的例子中，封闭部分425包括与管状部分435连接点475相连的翼片470。 In the example described, the closure portion 425 includes a tubular portion 435 is connected to the point 475 is connected to the flap 470. 如图所示，翼片470的一部分含有一系列紧密分布的细微切口480。 As shown, the flap portion 470 comprises a series of closely spaced fine incision 480. 细微切口480的尺寸、数目和位置的选择是本领域技术人员力所能及的，其选择用来优化翼片470的弯曲性，同时限制了体液通过的孔隙度。 480 fine incision size, number and location of choice are those skilled whatever its chosen to optimize flexibility of tab 470 while limiting porosity of body fluid.
不超出本发明范围和精神的上述具体实例的其它变化和改进对于阅读了本说明书的本领域技术人员来说是显而易见的。 Other variations and modifications of the specific examples described above without departing from the scope and spirit of the invention will be apparent upon reading this specification the skilled person. 例如，尽管在各个所述的实例中，显示出叶部在输送时朝向修复物的近端，但这不是必需的，在一些情况下，相反的取向可能是较佳的。 For example, although in each of the examples, the leaves showed towards the proximal restorations during transport, but this is not necessary, in some cases, the opposite orientation may be preferred. 另外，在所述的各种实例中，叶部包括一个头部和一个颈部，但颈部并非在所有情况下都必须存在。 Further, in various examples described, the leaf portion comprises a head and a neck, the neck but does not need to be present in all cases. 还有，在所述的各种实例中，显示了一对可膨胀的环形环，但也可用单个可膨胀的锚固手段(例如环形环等)或3个或多个可膨胀的锚固手段(如环形环等)来构成修复物。 Also, in various examples described, shows a pair of annular expandable ring, but can also be a single expandable anchoring means (e.g., annular ring, etc.) or 3 or more expandable anchoring means (e.g. annular ring, etc.) to form the restoration. 再有，在所述的各种实例中，叶部基本上是细长的，与修复物的纵轴平行放置，但也可以这样放置该叶部：使其与修复物的纵轴垂直。 Further, in various examples described, the leaf portion is substantially elongate, with a longitudinal axis parallel to the placement of the restoration, but it may be disposed such that the leaf: it perpendicular to the longitudinal axis of the restoration. 更有，在所述的各种实例中，体部的可膨胀部分包括一对具有多孔结构的环，但是也可以采用具有无孔结构的环，将环向下折，用可移动的机械约束力维持它们处于该状态，除去该约束后，使环展开成展开状态(在该实例中，选择环尺寸为其最终植入的直径，然后向下折叠—例如参见WO-A-95/26695，其内容纳入本文作参考)。 More, in the various examples, the expandable portion of the body portion comprises a pair of rings having a porous structure, but may be employed with a non-porous structure of the ring, folded down the ring, with a movable mechanical constraints they maintain a force in this state, the constraint is removed after the ring to expand into the deployed state (in this example, select the ring size of its final implanted diameter and then folded down - see for example WO-a-95/26695, which is incorporated herein by reference). 不脱离本发明精神和范围的其它改进对于本领域技术人员来说在阅读了本说明书之后是显而易见的。 Other modifications without departing from the spirit and scope of the present invention the skilled artisan upon reading this specification will be apparent.
1.一种用于血管内封闭动脉瘤开口的修复物，该修复物包括：一个体部，它具有一个近端、一个远端以及位于这两者之间的至少一个可膨胀的部分，所述至少一个可膨胀的部分能靠作用于其上的径向向外的力从未膨胀的第一状态膨胀成膨胀的第二状态，以使所述至少一个可膨胀的部分紧贴血管管腔，其特征是，有一个与该体部连接的叶部，该叶部能相对于体部独立移动。 1. A method for closing an opening of the aneurysm endovascular repair, the repair material comprising: a body portion having a proximal end, a distal end, and at least one inflatable positioned between the two portions, the a first state of said at least one force expandable portion can be against the action thereon in the radial direction outwardly expanded an unexpanded state into an expanded second, such that the at least one inflatable portion against the vessel lumen , characterized in that the leaf has a portion connected to the body portion, the leaf portion relative to the body portion to move independently.
2.根据权利要求1所述的修复物，其中该叶部包括一个无孔的部分。 The restoration of claim 1, wherein the leaf portion comprises a nonporous claim portions.
3.根据权利要求1所述的修复物，其中至少一个可膨胀的部分是有孔的。 3. The restoration according to claim 1, wherein the at least one expandable portion is porous.
4.根据权利要求1所述的修复物，其中该体部包括至少一对相对的可膨胀的部分。 The restoration according to claim 1, wherein the body portion comprises expandable portion opposing at least one pair.
5.根据权利要求4所述的修复物，其中相对的可膨胀的部分通过连接装置相互连接。 The restoration according to claim 4, wherein the opposed expandable portions are interconnected by connecting means.
6.根据权利要求4所述的修复物，其中相对的可膨胀的部分通过至少一根金属丝相互连接。 6. restoration according to claim 4, wherein the opposed expandable portions are interconnected by at least one wire.
7.根据权利要求4所述的修复物，其中该叶部与相对的可膨胀部分中的一个相连接。 7. restoration according to claim 4, wherein the expandable portion and the leaf portion opposite the one connected.
8.根据权利要求4所述的修复物，其中相对的可膨胀部分包括一个有孔的表面。 8. The restoration according to claim 4, wherein the expandable portion includes opposing a foraminous surface.
9.根据权利要求5所述的修复物，其中相对的可膨胀部分、连接装置和叶部是整体形成的。 Restoration according to claim 5, wherein the opposed expandable portions, the connection means and the leaf portion are integrally formed.
10.根据权利要求1至9任一项所述的修复物，其中该体部是管子。 10. The restoration 1-1 according to any one of claim 9, wherein the body portion is a tube.
11.根据权利要求1至9任一项所述的修复物，其中该体部是有孔的管子。 Restoration according to claim 1-1 according to any one of claim 9, wherein the body portion is a porous tube.
12.根据权利要求11所述的修复物，其中管子由塑性可变形的材料制成。 12. The restoration of claim 11, wherein the tube is made of a plastically deformable material.
13.根据权利要求11所述的修复物，其中管子由自身膨胀的材料制成。 13. The restoration of claim 11, wherein the tube is made of a self-expandable material.
14.根据权利要求11所述的修复物，其中叶部是管子的一切出部，以在第二位置中确定体部的开口。 14. The restoration of claim 11, wherein the leaf portion is a portion of all the tubes, determines the opening of the body portion in the second position.
15.根据权利要求1至9任一项所述的修复物，其中该叶部包括一个头部。 15. 1-1 restoration according to any one of claim 9, wherein the leaf portion comprises a head portion.
16.根据权利要求15所述的修复物，其中该叶部包括一个将头部和体部相互连接起来的颈部。 16. The restoration according to claim 15, wherein the leaf portion comprises a neck portion and a body portion connecting the head portion with each other.
17.根据权利要求16所述的修复物，其中该头部比颈部宽。 17. The restoration according to claim 16, wherein the head portion wider than the neck.
18.根据权利要求1至9任一项所述的修复物，其中叶部的表面上还包含药学上可接受的胶粘剂。 18. 1-1 restoration according to any one of claim 9, wherein the upper surface of the leaf portion further comprises a pharmaceutically acceptable adhesive.
19.根据权利要求1至9任一项所述的修复物，其中叶部还包括调节叶部相对于体部之位置的调节装置。 19. 1-1 restoration according to any one of claim 9, wherein the leaf portion further comprises adjusting means adjusting the position of the blade portion of the body portion with respect to.
20.根据权利要求19所述的修复物，其中该调节装置包括与叶部相连接的金属丝。 20. restoration according to claim 19, wherein the adjustment means comprises a wire connected to a leaf portion.
21.根据权利要求20所述的修复物，其中该金属丝与叶部上的一点相连接，该点在叶部与体部相连的点的远端。 21. The restoration according to claim 20, one of which is connected to the leaf portion of the wire, the distal end of the point and the point of attachment of the leaf body portion.
22.根据权利要求1至9任一项所述的修复物，其中叶部还包括能膨胀并进入动脉瘤开口的药学上可接受的化合物。 22. The restoration according to any one of claims 1 to 9, wherein further comprises a leaf portion can be expanded into a pharmaceutically acceptable compound according to the aneurysm opening in claim.
23.根据权利要求22所述的修复物，其中该药学上可接受的化合物在受激活后膨胀。 23. The restoration according to claim 22, wherein the pharmaceutically acceptable compound by expansion after activation.
24.根据权利要求22所述的修复物，其中该药学上可接受的化合物在电激活后膨胀。 24. The restoration according to claim 22, wherein the pharmaceutically acceptable expandable compound after electrically activated.
25.根据权利要求1至9任一项所述的修复物，其中叶部包括一个用来接收将修复物导引至靶标位置的导引装置的孔。 25. The restoration according to any one of claims 1 to 9, wherein the leaf portion comprises a hole for receiving the repair was guided to a target position of the guide device according to claim.
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