CN1780589A - Energy based devices and methods for treatment of patent foramen ovale - Google Patents

Energy based devices and methods for treatment of patent foramen ovale Download PDF

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CN1780589A
CN1780589A CN 200480011731 CN200480011731A CN1780589A CN 1780589 A CN1780589 A CN 1780589A CN 200480011731 CN200480011731 CN 200480011731 CN 200480011731 A CN200480011731 A CN 200480011731A CN 1780589 A CN1780589 A CN 1780589A
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tissue
member
energy
closed
catheter device
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CN 200480011731
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CN100584286C (en )
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W·麦勒奇
D·弗朗西斯
K·霍尼
M·E·迪姆
H·S·吉福德三世
J·阿兰格德洛
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赛热股份有限公司
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Abstract

治疗未闭椭圆孔(PFO)的方法、装置和系统,包括前进一导管装置到达心脏内的一位置,以便治疗一PFO,至少部分地将邻近PFO的组织集合在一起,并对组织施加能量,从而基本上急剧地关闭PFO。 A method of treating oblong hole Ovale (PFO), the apparatus and system, including a conduit means reaches a forward position within the heart, to treat a PFO, at least partially adjacent the PFO tissues together, and energy applied to tissue, thereby substantially abruptly closed PFO. 导管装置一般地包括一细长的导管体,位于远端处或远端附近的至少一个组织附着部件用来将组织集合在一起,位于远端处或远端附近的至少一个能量传输部件用来对组织施加能量。 Conduit means generally comprises an elongated catheter body, a distal end located at or near the distal end of a tissue attachment member for at least the tissue together, located at or near the distal end of the distal end of the at least one energy transmission member for applying energy to tissue. 在某些实施例中,组织附着部件还用作为能量传输部件。 In certain embodiments, the tissue attachment member also as an energy transfer unit. 施加的能量可以是单极或双极的射频能,或诸如激光、微波、超声波、电阻加热等的任何其它合适的能量。 The energy application may be any other suitable energy radiofrequency energy, such as laser or microwave, ultrasound, resistive heating of unipolar or bipolar, and the like.

Description

治疗未闭椭圆孔的基于能量的装置及方法 Treating energy-based apparatus and method for an elliptical hole is not closed

相关申请本申请要求对以下美国临时专利申请的优先权:2003年3月27日提交的Nos.60/458,854(代理人文档号No.022128-000100US);2003年6月11日提交的Nos.60/478,035(代理人文档号No.022128-000110US);2003年7月24日提交的Nos.60/490082(代理人文档号No.022128-000120US);本文援引它们的全部内容以供参考。 RELATED APPLICATIONS This application claims priority to US Provisional Patent Application: Nos.60 / 458,854 (Attorney Docket No. No.022128-000100US) March 27, 2003 filed; Nos 2003 June 11 submission. 60 / 478,035 (Attorney docket No. No.022128-000110US); Nos.60 / 490082 (Attorney docket No. No.022128-000120US) July 24, 2003 filed; cited herein in their entirety by reference. 本申请涉及到以下美国专利申请:2003年9月16日提交的Nos.10/665974(代理人文档号No.022128-000300US);2003年10月2日提交的Nos.10/679245(代理人文档号No.022128-000200US);2004年2月25日提交的Nos.10/787532(代理人文档号No.022128-000130US);以及与本申请同时提交的Nos.10/_______(代理人文档号No.022128-000400US),本文援引它们的全部内容以供参考。 This application is related to the following US Patent Applications: Nos.10 / 665974 (Attorney Docket No. No.022128-000300US) September 16, 2003 filed; Nos.10 / 679245 (Attorney October 2, 2003 filed document No. No.022128-000200US); Nos.10 / _______ (Attorney docket and filed simultaneously with this submission; Nos.10 / 787532 (Attorney docket No. No.022128-000130US) February 25, 2004 filed No. No.022128-000400US), cited herein in their entirety by reference.

技术领域 FIELD

本发明一般地涉及医疗装置和方法。 The present invention relates generally to medical devices and methods. 具体来说,本发明涉及用于治疗未闭椭圆孔的基于能量的装置、系统和方法。 In particular, the present invention relates to energy-based apparatuses, systems and methods for treating an elliptical hole is not closed.

背景技术 Background technique

胎儿的血液循环与成人血液循环有很大不同。 Fetal and adult blood circulation blood circulation is very different. 因为胎儿血液依靠胎盘供氧,而不是由胎儿的肺供氧,所以,血液一般地远离肺通过多个血管和在胎儿生命过程中保持开口(即,打开)的诸孔分流到周围的组织,通常未闭的孔在出生后不久就可关闭。 Because the fetal blood oxygen rely placenta, fetal lung rather than oxygen, so that the blood is generally away from the lung through a plurality of vessels during fetal life and in the retaining opening (i.e., opening) of the holes to the tissue surrounding the shunt, usually not closed aperture can be closed shortly after birth. 例如,胎儿血液从右心房通过椭圆孔直接流入左心房,循环通过肺动脉大血管的一部分血液通过动脉导管流到大动脉。 For example, fetal blood directly from the right atrium into the left atrium through the oblong hole, circulation flows through the aorta pulmonary artery catheter through a portion of the large blood vessels. 胎儿的这种循环示于附图1中。 Fetal This cycle are shown in Fig. 1.

胎儿出生时一新生命开始呼吸,左心房内的血压高于右心房内的血压。 If the baby begins to breathe a new life, the left atrium blood pressure higher than the blood pressure of the right atrium. 在大多数婴儿中,组织皮片关闭椭圆孔并痊愈在一起。 In most infants, the tissue flap closed oblong hole and heal together. 在美国每年大约有20,000个出生的婴儿缺乏这种组织皮片,因此,孔仍保持打开,称其为房间隔缺损(ASD)。 In the United States there are about 20,000 babies born every year lack of such a skin graft tissue, and therefore, the hole remains open, called atrial septal defect (ASD). 在更高的百分比人口中(估计范围在全人口的5%至20%),存在有皮片但没有痊愈在一起。 At higher percentage of the population (estimates range from 5 to 20% of the whole population), but there is not healed skin sheets together. 这种病例称之为椭圆孔未闭(PFO)。 This case is called elliptical hole ovale (PFO). 每次右心房内的血压高于左心房内的血压,血压会推开该未闭的椭圆孔,从而允许血从右心房流到左心房。 Every time the blood pressure is higher than the right atrium of the left atrium blood pressure, blood pressure will not open the closed oblong hole, thereby allowing the blood flow to the left atrium from the right atrium.

由于椭圆孔未闭对于全身的血液循环通常影响很小,所以一直被认为是一种相对良性的病例。 Since the oblong hole is not closed to the blood circulation is generally little influence, it has been considered a relatively benign cases. 然而,最近以来,发现至少部分地起因于PFO而可导致相当多人大脑功能突然丧失。 However, recently, we found at least partly due to the PFO and may lead to a sudden loss of brain function rather than. 在某些病例中,因为PFO允许含有小血栓的血液从静脉循环直接流到动脉循环并流入脑中,而不是流入血栓可在其中被截留和逐渐溶解的肺内,所以,可造成大脑功能突然丧失。 In some cases, because the blood contains small PFO allows the thrombus directly flowing from the venous circulation and into the arterial circulation in the brain, not the lungs flows into the thrombi can be trapped and gradually dissolved therein, so that the brain can cause sudden function loss. 在另外一些病例中,血栓可形成在PFO本身的敞开通道内,并当血压造成血从右心房流到左心房时,形成的血栓可被逐走。 In other cases, the thrombus may be formed within the open channel PFO itself and the blood pressure caused when blood flow to the left atrium from the right atrium, may be Zhuzou thrombosis. 据估计,已经发生过病因不明的大脑功能突然丧失的PFO病人每年有4%发生另外大脑功能突然丧失的风险。 It is estimated that already happened PFO patients of unknown cause sudden loss of brain function 4% additional risk of sudden loss of brain function every year.

目前进一步的研究正将PFO和大脑功能突然丧失联系起来。 Further studies are currently being PFO and the sudden loss of brain function linked. 目前,如果某一患有PFO的人发生两次或多次大脑功能突然丧失,则美国的保健系统会可偿付外科的或其它干预的手术费用以确定地关闭PFO。 Currently, if a person suffers from PFO occurs two or more times a sudden loss of brain function, the American health care system can pay the cost of surgery or other surgical intervention to determine the closed PFO. 然而,很可能获得更加预防性的方法来关闭PFO以防止将来发生大脑功能突然丧失。 However, it is possible to obtain a more preventive approach to close the PFO to prevent future occurrence of sudden loss of brain function. 然而,由于因PFO引起的发病率相对较低,所以,这样一手术的费用和可能的副作用和复杂性必须低。 However, due to the relatively low incidence caused by PFO, therefore, the cost of such a procedure and possible side effects and have low complexity. 例如,在年轻的病人中,PFO经过一段时间有时会自行关闭而对健康没有任何不利影响。 For example, in younger patients, PFO after a period of time can sometimes shut itself down without any adverse health effects.

其它普遍流行和虚弱的病例-慢性偏头疼-也与PFO有关。 Other prevalent cases and weak - Chronic migraine - also related with PFO. 尽管准确的原因还未作出解释,但PFO的关闭已经显示出在许多病人中已经消除或显著地减小了偏头疼。 Although the exact cause is not yet explain, but PFO closure has been shown in a number of patients have been eliminated or significantly reduced migraine. 再者,如果可提供相对非侵入性的手术,则可准许预防性的PFO关闭来治疗慢性偏头疼。 Further, if the available relatively noninvasive surgery, may be permitted to close PFO prophylactic treatment of chronic migraine.

目前,对于PFO可提供的干预性治疗通常是相对侵入性的治疗和/或具有潜在的缺点。 Currently, intervention therapy may provide PFO is typically relatively invasive treatment and / or disadvantages potential. 一种策略是在为其它目的(诸如心瓣膜外科手术)实施的打开心脏手术过程中简单地关闭PFO。 One strategy is to open heart surgery for other purposes (such as heart valve surgery) embodiment of the process of simply closing the PFO. 这通常通过一简单的手术就可实现,例如,用脉管缝合线在PFO上缝合一针或两针。 This can usually be achieved by a simple operation, for example, with a vascular sutures or needles on the two needle PFO. 然而,纯粹为了关闭一无症状的PFO或甚至一非常小的ASD而实施心脏打开手术,很难判断其合理性。 However, in order to close a purely asymptomatic PFO or even a very small ASD and implementation of open heart surgery, it is difficult to determine its legitimacy.

人们已经提出和研究出许多用于关闭PFO的经由皮肤的干预性装置。 It has been proposed and developed a number of interventional devices for closing the PFO through the skin. 大部分这些装置与ASD关闭装置相同或相似。 Most of these devices with the same or similar closing device ASD. 它们通常呈“蛤壳”或“双伞”形状的装置,它们在房隔膜的各侧上展开一生物相容的金属网或织物(例如,ePTFE或Dacron)的面积,连同一中心轴向元件固定住,以此关闭PFO。 They generally "clam-shell" or "double umbrella" shape of the device, they expand a biocompatible metallic mesh or fabric (e.g., Dacron® or the ePTFE) on each side of the separator housing area, together with a central axial member fixed, in order to close the PFO. 然后,该伞愈合到房隔膜内,利用痊愈的响应,在该装置上形成一均匀的组织层或“血管翳”。 Then, the umbrella diaphragm healing into the room by the response recovered to form a uniform layer of tissue or "pannus" on the device. 例如,这样的装置已经由诸如Nitinol Medical Technologies,Inc.(Boston,马萨诸塞州)和AGA Medical,Inc.(White Bear Lake,明尼苏达州)两家公司研制出品。 For example, such devices have (White Bear Lake, Minn.) Was developed by the two companies, such as Nitinol Medical Technologies, Inc. (Boston, Massachusetts) and AGA Medical, Inc. Produced. 美国专利No.6,401,720描述了一用于胸腔镜心脏内手术的方法和装置,其可用于PFO的治疗。 U.S. Patent No.6,401,720 describes a method and an apparatus for the thoracoscopic cardiac surgery, which can be used for the treatment of a PFO.

尽管所提供的装置在某些病例中可很好地得到使用,但它们也面临许多挑战。 Although the device provided in some cases may well get to use, but they also face many challenges. 例如,复杂性相当频繁地造成的结果包括:不合适地展开、装置栓塞到循环中,以及装置断裂等。 For example, due to the complexity of the results quite frequently comprising: improperly deployed, the plug means into the circulation, and means for breaking the like. 在某些情形中,一部署的装置没有完全地愈合到隔膜壁内,留下一本身可成为血栓形成的病灶的暴露组织。 In some cases, a deployment means not completely heal into the septal wall, leaving a lesion itself may be exposed tissue thrombosis. 此外,目前可供的装置通常复杂且制造昂贵,这使得它们用于PFO的预防性治疗不可行。 In addition, currently available apparatus is often complex and expensive to manufacture, which makes them impractical for the prophylactic treatment of a PFO. 另外,目前提供的装置通常这样地关闭一PFO:在PFO隧道的任一侧上放置材料,压迫和尖锐地打开隧道,直到血液凝结在装置上并致使流动停止为止。 Further, such devices are currently typically provided close a PFO: placing the material on either side of the PFO tunnel, the tunnel open and sharp compression until the blood clots on the device and causes the flow stops.

对用于组织焊接的方法和复合物的研究已经进行了多年。 Research methods and complex for tissue welding has been carried out for many years. 例如,Kennedy等人在Surg.Endosc.(1998)12:876-878中的“高爆裂强度的反馈控制的双极容器密封”一文中描述了这样的研究。 For example, Kennedy et al., 12 Surg.Endosc (1998): 876-878 in "bipolar feedback control container sealing high burst strength" is described in an article such studies. 其中特别有意义的是由McNally等人(如美国专利No.6,391,049所示)和Fusion Medical(如美国专利Nos.5,156,613、5,669,934、5,824,015和5,931,165)所开发的技术。 Of particular interest are the techniques developed by McNally et al., (As shown in U.S. Pat. No.6,391,049) and Fusion Medical (as described in U.S. Patent No. 5,931,165 and Nos.5,156,613,5,669,934,5,824,015). 这些技术都揭示传输到组织结合物和补缀的能量,以便连接组织并在动脉、肠子、神经等之间形成愈合。 These techniques are disclosed and transmitted to the tissue patch combination of energy, and is formed so as to connect tissue healing between arteries, intestines, nerve. 还有意义的是,由发明人Sinofsky提出的多个专利涉及到激光缝合生物材料(例如,美国专利Nos.5,725,522、5,569,239、5,540,677和5,071,417)。 Meaning there is a plurality of proposed by the patent invention relates to a laser suture Sinofsky biological material (e.g., U.S. Patent No. 5,071,417 and Nos.5,725,522,5,569,239,5,540,677). 然而,这些揭示的发明中没有一技术显示适于定位PFO组织以便焊接或将能量传输到待焊接的PFO的方法或装置。 However, the disclosed invention is not a technique suitable for displaying PFO tissue positioned to transmit energy to weld or PFO device or method to be welded.

在由Stambaugh等人提出的两篇专利申请(PCT出版物Nos.WO99/18870和WO99/18871)中,描述了对未闭椭圆孔造成热烧伤。 In two patent applications (PCT Publication Nos.WO99 / ​​18870 and WO99 / ​​18871) proposed by Stambaugh et al., It is described of the elliptical hole ovale cause thermal burns. 然而,所述装置和方法对PFO组织造成烧伤,希望最终形成结痂组织而关闭PFO。 However, the apparatus and method of causing burns PFO tissue, scar tissue and eventually want to close PFO. 使用这样的装置和方法,就在手术之后PFO实际上仍保持未闭,仅在以后的一定时间才关闭(如果它全然关闭的话)。 The use of such devices and methods, in fact, remain after surgery PFO is not closed off until only after a certain time (if it is completely off it). 因此,外科医生直到治疗手术做了很长时间之后才知道治疗是否生效。 Thus, the surgeon until a cure surgery done to know whether the treatment is effective after a long time. 经常地,结痂组织可能未形成,或可能不完全形成导致一仍未闭的PFO。 Frequently, scar tissue formation may not, or may not result in a form not yet fully closed PFO.

因此,有利地是需有改进的方法和装置用来治疗PFO。 Thus, advantageously the need for an improved method and apparatus for the treatment of PFO. 理想地是,这样的方法和装置将在实施治疗手术过程中、立即或实施治疗手术后不久之后,帮助密封PFO。 Ideally, such a method and apparatus in the embodiment of the treatment procedure, immediately or shortly after treatment embodiment after surgery, to help seal the PFO. 还为理想的是,这样的装置和方法将在病人心脏内不留下异物(或非常少材料)。 Also desirable that such apparatus and method will not leave foreign matter (or very little material) within the patient's heart. 此外,这样的方法和装置较佳地制造和使用相对简单,因此,给予预防性治疗PFO,例如,防止大脑突然丧失功能,一种可行的选择。 In addition, such methods and apparatus are preferably manufactured using a relatively simple and, therefore, prophylactic treatment of PFO, e.g., to prevent sudden loss of brain function, a viable option. 本发明将满足至少上述某些目的。 The present invention satisfies at least some of the above-described object.

发明内容 SUMMARY

本发明一般地提供用来治疗未闭椭圆孔(PFO)的方法、装置和系统。 The present invention generally provides a method for treating oblong hole ovale (PFO), the apparatus and system. 如在各种实施例中所描述的,通过使用一导管装置至少部分地将邻近未闭椭圆孔的组织集合在一起并对组织施加能量,从而可基本上急剧地关闭一PFO。 As described in the various embodiments, the use of a catheter device through the tissue adjacent to the oblong hole is not closed at least partially together and tissue energy application, thereby substantially abruptly closing a PFO. 所谓“基本上”是指横贯PFO形成一稳定的能承受生理压力的组织搭桥。 By "substantially" refers to a stable traverses PFO formed can withstand the physical stress of tissue bypass. 然而,一基本上关闭的PFO仍可具有一个或多个小的间隙或开口,至少在某些情形下它们经过一定时间后通过痊愈过程而关闭。 However, a substantially closed PFO may still have one or more small gaps or openings, at least in some cases after a predetermined time has elapsed which is closed by the healing process. 所谓“急剧地”是指当关闭手术完成时,PFO基本上关闭。 By "rapidly" it means that when the closing operation is completed, PFO substantially closed. 因此,急剧地关闭使以下所述的实施例不同于现有的技术,现有的技术立足于通过组织痊愈和结痂延滞地关闭PFO。 Thus, embodiments enable off sharply below differs from the prior art, based on prior art by scar tissue healing and delay closing PFO. “急剧地”对于本申请中的用途并不指暂时的含义,因为各种实施例通常提供永久性(或至少长期的)的PFO关闭。 "Rapidly" for use in the present application does not refer to a temporary meaning, for various embodiments generally provide a permanent (or at least long-term) to close the PFO.

词组“邻近一PFO的组织”,或简单地称“PFO组织”,对于本申请中的用途来说,意指可以用来或操纵而帮助关闭PFO的位于PFO内、围绕PFO或PFO附近的任何组织。 The phrase "adjacent to a tissue of PFO", or simply called "PFO organization", for use in the present application, the manipulation means may be used to help or to close PFO located within the PFO, PFO, or any surrounding near PFO organization. 例如,邻近一PFO的组织包括第一房间隔组织、第二房间隔组织、侧向于第一房间隔或第二房间隔的心房隔膜组织、PFO隧道内的组织、心房隔膜的右心房表面或左心房表面上的组织等。 For example, a PFO tissue adjacent the atrial septal tissue comprising a first, a second atrial septal tissue, atrial septal tissue laterally spaced from the first housing or the second housing spaced apart, tissue within the PFO tunnel, the atrial septum or the surface of the right atrium organizations on the surface of the left atrium. 所谓“施加能量”是指能量可传输到PFO组织或从PFO组织传输出。 By "applying energy" means energy may be transmitted to the transmission from the PFO PFO tissue or tissue. 例如,如果施加低温能,则可以说热能传输出组织。 For example, if the application of hypothermia, it can be said that the heat transfer out of the organization. 在各种实施例中,任何多数的能量传输装置和能量形式可被用来提供这样的能量传输。 In various embodiments, any form of energy and the energy transmission device may be used to provide the majority of such energy transfer. 例如,采用的能量类型可包括射频能、低温能、激光能、超声波能、电阻加热能、微波能等。 For example, the type of energy used may include radio frequency energy, cryogenic energy, laser energy, ultrasonic energy, resistive heating energy, microwave energy and the like.

对组织施加能量从而基本上急剧地PFO,有时也可称之为“组织焊接”。 Applying energy to the tissue thereby substantially abruptly PFO, also sometimes referred to as "tissue welding." 较佳地,实施本发明的组织焊接方法,而不使用组织结合物或其它外来材料。 Preferably, embodiments of the present invention, tissue welding method without using a tissue binding, or other foreign material. 然而,在某些实施例中,有利地可使用一个或多个焊接材料。 However, in certain embodiments, may advantageously be used one or more solder material. 各种结合物和其它的组织焊接材料较完整地描述在美国专利申请Nos.10/665974中,它先前已被援引以供参考。 Conjugates and various other tissue welding material more fully described in U.S. Patent Application Nos.10 / 665974, which has previously been incorporated by reference herein. 可被采用的组织结合物或粘结剂的实例包括但不限于:本体血、白蛋白、胶原质、纤维蛋白、氰基丙烯酸盐粘合剂、蛤贝足丝粘结剂、聚合物热熔粘结剂等。 Examples which may be bound or tissue adhesive employed include, but are not limited to: a body blood, albumin, collagen, fibrin, cyanoacrylate, mussels byssus adhesives, hot melt polymer binder and so on.

以下描述的某些实施例提供将邻近一PFO的组织集合在一起(或“附着”组织)。 Certain embodiments described below provide a tissue adjacent a PFO together (or "attached" organization). 在各种实施例中,可在对组织施加或移去能量之前、之中和/或之后,实施组织的附着。 In various embodiments, the tissue may be applied prior to or removal of energy, during and / or after, embodiments of adhering tissue. 一般来说,能量的施加或移去将用来使PFO组织内的胶原质改性。 In general, the application of energy used to remove or modified collagen tissue within PFO. 如果在改性之前和/或之中附着组织,同时,使组织内的胶原质再次改性,则一旦分离的组织内的胶原质将粘结在一起而集合组织。 If and / or in tissue adhesion, while the collagen in the tissue modified again, once the collagen in the tissue to bond separated tissues together to set prior to modification. 因此,某些实施例包括一个或多个在施加或移去能量之前、之中和/或之后集合(并可能保持)组织的装置。 Accordingly, some embodiments includes one or more collections during and / or before or after application of the energy removed (and possibly holding) means tissue. 通过提供基本上急剧地关闭一PFO,装置、系统和方法可以有利地防止大脑突然失去功能、治疗偏头痛和/或防止或治疗由PFO造成或加剧的其它医学上的病情。 By providing a substantially closed sharply PFO, devices, systems and methods may advantageously prevent sudden loss of brain function, treatment of migraine and / or medical condition in the prevention or treatment of exacerbated or caused by other PFO.

在本发明的一个方面,一治疗PFO的方法包括前进一导管装置到心脏内的一位置,以便治疗未闭椭圆孔,和用导管装置至少部分地将邻近PFO的组织集合在一起,并用导管装置对组织施加能量,从而基本上急剧地关闭PFO。 In one aspect of the present invention, a method of treating PFO comprises advancing a catheter device to a location within the heart, to treat ovale elliptical hole, and duct means to a collection of adjacent PFO tissue at least partially together, and by conduit means applying energy to tissue, thereby substantially abruptly closed PFO. 在某些实施例中,在施加能量之前将组织集合在一起。 In certain embodiments, prior to application of energy to tissue together. 可供选择的是,组织可保持在一起,同时施加能量。 Alternatively the tissue may be held together while applying energy. 在某些实施例中,也可在施加能量之后将组织保持在一起,以允许组织冷却、再改性、关闭PFO和/或诸如此类操作。 In certain embodiments, after the application of energy may hold the tissue together, to allow the tissue to cool, and then modified, close the PFO and / or the like operations. 可供选择的是,该方法还包括在能量施加之后有效地冷却组织。 Alternative, the method further comprising, after the application of energy to effectively cool the tissue.

在某些实施例中,在施加能量之后,导管装置可以相对于PFO移动到不同的位置,组织可以再次集合在一起,且可再次施加能量。 In certain embodiments, after the energy application, the conduit means may be moved to different relative positions PFO, tissue may be together again, and the energy may be applied again. 某些实施例包括多次重复移动、集合和能量施加的步骤。 Certain embodiments include repeating the step of moving the collection and application of multiple energy. 在这样的实施例中,PFO可用导管装置通过沿FPO移动而基本上关闭,通常从PFO的一侧移动到另一侧,将组织集合在一起,和多次施加能量。 In such an embodiment, the catheter apparatus can be used PFO substantially closed by moving along the FPO, typically moves from one side to the other side of the PFO, tissue together, and energy applied repeatedly. 这样的一方法可称之为PFO组织的“点焊”。 Such a method may be referred to as PFO organization "spot." 在某些实施例中,导管上的一个或多个偏置部件可用来偏置导管朝向PFO的一侧。 In certain embodiments, one or more biasing members may be used to bias the catheter in the catheter toward one side of the PFO. 例如,导管体的形状、一可膨胀的部件、一偏置的丝线等可帮助推压导管到一侧。 For example, the shape of the catheter body, an expandable member, a wire and the like can help offset the catheter is pushed to one side. 通常地,导管可横贯PFO移动,沿此路径在多个位置处将组织集合在一起并施加能量。 Typically, the catheter can traverse PFO moved along the path at a plurality of positions tissues together and energy application. 在一实施例中,例如,组织附着部件(它也可构造来对组织施加能量)挤压部件之间的组织。 In one embodiment, for example, tissue attachment member (which may also be configured to apply energy to tissue) tissue between the pressing member. 当它们这样操作时,它们也可在组织之间挤压一形状的导管,当组织向下挤压时,导管体的横截面形状可使它被推压到一新的位置。 When they are doing so, they may be a shape extruded conduit between the tissue, when the tissue pressed down, the cross-sectional shape of the catheter body allows it pushed to a new location. 例如,导管体可以具有一三角形、卵形、钻石形或其它的形状。 For example, the catheter body may have a triangular, oval, diamond-shaped, or other shape. 在第一位置处施加能量之后,组织附着部件移动到第二位置,并再次向下挤压在组织和导管体上,因此,推压导管体到一第三位置等等。 After the application of energy at a first position, tissue attachment member to the second position, and once again pressed down in the catheter body tissue and, therefore, the catheter body is pressed to a third position and so on.

还可构思多种其它合适的技术来横贯PFO移动和“点焊”组织。 It may also be contemplated a variety of other suitable techniques to move and traverses PFO "spot" organization. 在另一实施例中,例如,一大的静止的电极定位在右或左心房内,而一较小的移动电极沿着PFO在另一心房内移动而形成点焊。 In another embodiment, for example, a large stationary electrode positioned in the right or left atrium, and a smaller mobile electrode moving along the PFO spot formed on the other atrium. 在其它的实施例中,一个或多个电极可以围绕PFO的圆周转动。 In other embodiments, one or more electrodes may be rotated around the circumference of the PFO.

前进导管装置到心脏内的一位置以便治疗PFO可以采用任何合适的技术来实现。 Conduit means advances to a position within the heart to treat a PFO may employ any suitable technique. 在某些实施例中,例如,导管的一第一远端部分前进到右心房内的一部位,而该第一远端部分用来将组织集合在一起。 In certain embodiments, for example, a first distal portion of the catheter is advanced to a portion of the right atrium, the distal portion for the first tissue together. 在某些实施例中,一第二远端部分可以前进到PFO内或通过PFO,然后,第一和第二远端部分用来附着组织。 In certain embodiments, a second distal portion may be advanced into or through the PFO PFO, and then, the first and second distal portion is attached to tissue. 在某些实施例中,第二部分延伸通过PFO并进入左心房内,这样,第一部分从右心房侧接触组织,而第二部分从左心房侧接触组织。 In certain embodiments, the second portion extends through the PFO and into the left atrium such that the first portion of tissue from the right atrium side contact, and the second portion contacts the tissue from the left atrial side. 在各种实施例中,然后可以操纵一个或两个部分而在它们之间将组织集合在一起。 In various embodiments, it may then be manipulated in one or two portions between which the tissue together. 例如,一个或两个部分可沿轴向朝向彼此移动。 For example, one or two portions movable towards each other in the axial direction. 在某些实施例中,一部分沿轴向朝向另一部分移动,后者部分保持相对静止而用作一抵靠的“回挡”或表面以将组织集合在一起。 In certain embodiments, a portion of the axial direction moving towards the other part, the latter portion remains stationary relative to the abutment used as a "back stop" to the surface of the tissue or together. 许多这样的回挡装置描述在专利申请中,其编号为60/458,854、60/478,035和60/490082,它们已在上文中援引以供参考。 Many such back stop means described in the patent application, which number 60 / 458,854,60 / 478,035 and 60/490082, which are cited in the above reference. 可供选择的是,无论一个还是两个部分也可用来对组织施加能量。 Alternatively, it is, regardless of whether one or two parts can also be used to apply energy to tissue.

至少部分地将组织集合在一起可以采用任何多种合适的方法予以实现。 At least in part the tissue together in any variety of suitable methods can be employed to achieve. 例如,就如刚才所述,导管装置的第一和/或第二远端部分可以朝向彼此移动而捕获、夹紧、夹住、抓住或其它方式附着两个部件之间的组织。 For example, as just described, a first conduit means and / or the second distal portion may be moved toward each other to capture, grip, grip, grasp, or otherwise attached tissue between the two components. 在另一实施例中,通过膨胀一个或多个可膨胀的部件而可以将组织集合在一起。 In another embodiment, one or more by expanding the expandable member may be organized together. 例如,一个可膨胀的部件可在右或左心房内膨胀而推靠组织并因此将它们集合在一起。 For example, an inflatable member may be expanded and pushed against the tissue are thus brought together in the right or left atrium. 在另一实施例中,一个可膨胀的部件可以在右心房内膨胀,而一第二可膨胀部件在左心房内膨胀,该膨胀导致组织在两个部件之间挤压在一起。 Embodiment, an inflatable member may be expanded in a further embodiment of the right atrium, and a second expandable member may be expandable within the left atrium, resulting in the expansion of tissue squeezed between the two components together. 如上所述,通过使用一个可膨胀的部件和一“回挡”部件可以达到类似的结果。 As described above, by use of an expandable member and a "back block" member can achieve similar results. 某些实施例还包括移动一个可膨胀部件朝向另一个以便进一步将组织集合在一起。 Certain embodiments also includes an expandable member moves toward the other to further tissue together. 例如,一可膨胀的部件可以沿导管装置轴向地滑动朝向另一个可膨胀的部件。 For example, an expandable member can be slid axially toward the other inflatable member along the conduit means. 再者,可以使用任何合适的技术。 Furthermore, you can use any suitable technique.

在其它变化的实施例中,使组织集合在一起可以包括在PFO内展开一膨胀部件。 In an embodiment in other variations, the tissue together may comprise an expansion member to expand within the PFO. 诸如两叉的“鱼嘴”形部件那样的膨胀部件,通常地设置在一护套内,同时前进到PFO内。 Expandable member such as a bifurcated "fish mouth" shaped member such as, typically disposed in a sheath, while proceeds to the PFO. 然后,缩回该护套以允许两叉彼此张开。 Then, the sheath is retracted to allow the two to each other to open the fork. 这样的膨胀“鱼嘴”,两叉部件可用形状记忆材料、弹簧加载材料等构造。 Such expanded configuration "fish mouth", available bifurcated shape memory material member, a spring loaded material. 通过在两个叉之间侧向地散开PFO,组织在两个叉之间的区域内集合在一起。 By laterally spread between the two prongs PFO, tissue together in the region between the two prongs. 在某些实施例中,一个或多个可膨胀的部件可与叉或导管装置偶联以便进一步帮助将组织接合在一起。 In certain embodiments, the one or more expandable member may be coupled with a fork or the conduit means so as to further assist the tissue together. 可供选择的是,该方法还可包括使用膨胀部件的一远端部分接触第一房间隔和第二房间隔中的至少一个的左心房表面,以及缩回膨胀部件而将邻近PFO的组织集合在一起。 Alternative, the method may further comprise at least one surface of a distal end portion of the left atrium for use in contact expandable member primum and septum secundum, as well as the expansion member is retracted to a collection of adjacent tissue PFO together. 例如,远端部分可接触第一房间隔并拉它朝向心脏的右侧而接触第二房间隔。 For example, the distal portion may contact and pull it primum atrial septal second contact toward the right side of the heart. 膨胀部件用来附着邻近PFO的组织之后的某些时刻,可有利地将膨胀部件缩回到导管装置内的一位置。 Some time after the expandable member is attached to the tissue adjacent the PFO, the expandable member may advantageously be retracted to a position within the conduit means. 在某些实施例中,例如,膨胀部件可在移去导管装置之前缩回。 In certain embodiments, for example, the expansion member can be retracted prior to removal of the catheter apparatus.

在其它的实施例中,导管装置的第一远端部分和/或第二远端部分可以前进到邻近PFO的组织内。 In other embodiments, the distal end portion of the first conduit means and / or the second distal portion may be advanced to the tissue adjacent the PFO. 换句话说,可致使导管装置的一个或多个部分穿入邻近组织的PFO内。 In other words, cause one or more portions of the penetrating catheter device within the tissue adjacent the PFO. 例如,这样一实施例可包括使用一钳夹状的装置,使第一和第二组织附着部件包括相对的钳夹。 For example, such an embodiment may include the use of a jaw-like means, attached to the first member and the second tissue includes opposing jaw. 在一实施例中,例如,第一远端部分前进到第二房间隔组织内。 In one embodiment, for example, a first distal end portion proceeds into the second atrial septal tissue. 可供选择的是,第二远端部分可前进到第一房间隔组织内。 Alternatively, the second distal end portion may be advanced into the tissue primum. 然后,第一和第二组织附着部件可以一起移动而将组织集合在一起。 The first and second tissue attachment member can be moved together the tissue together. 在还有的另一实施例中,可使用一夹具状的装置,可以穿刺组织也可不穿刺组织。 In yet another embodiment, a clamp-like device may be used, may or may not penetrate tissue piercing tissue. 采用夹具的话,夹具的一部分可以从右心房接触组织,而另一部分可从左心房接触组织。 Then using the jig, the jig may be a portion of tissue contacting the right atrium, the left atrium and another portion may be in contact with tissue. 再者,可以使用多个其它合适的技术中的任何技术,其中有一些技术更加完整地描述在美国专利申请Nos.60/458,854、60/478,035、60/490082、10/665974,以及10/679245中,它们全都在以上被援引以供参考。 Further, any other suitable technique plurality of techniques, some of which are more fully described in the art U.S. Patent Application Nos.60 / 458,854,60 / 478,035,60 / 490082,10 / 665974, and 10/679245 in all of them above are incorporated by reference herein.

在某些实施例中,导管装置可在一导向丝上前进。 In certain embodiments, the catheter device can be advanced over a guidewire. 导向丝通常延伸通过PFO并可包括一沿其长度的延伸部分,以便在PFO内延伸。 Guidewire typically extends through the PFO and may comprise a portion extending along its length so as to extend in the PFO. 可供选择的是,导向丝可延伸入左心房内,该方法可选择地包括:用导向丝的一远端部分接触第一房间隔和第二房间隔中的至少一个的左心房表面,以及缩回导向丝而将邻近PFO的组织集合在一起。 Alternatively that guide wire can extend into the left atrium, the method optionally comprises: a distal end portion of the left atrial surface contacting the guide wire primum and septum secundum at least one, and retracting the guide wire and PFO together the adjacent tissue.

任何合适类型的能量可施加到PFO组织以提供急剧地关闭PFO。 Any suitable type of energy may be applied to the tissue to provide sharply PFO closing PFO. 在某些实施例中,例如,可施加单极或双极的射频能,而在其它变化的实施例中,可施加低温、电阻加热、超声波、微波或激光能、呈诸如盐水那样的加热流体形式的热能等。 In certain embodiments, for example, may be applied to unipolar or bipolar RF energy, while in other variations of the embodiment may be applied to low-temperature, resistive heating, ultrasonic, microwave or laser energy, such as a heating fluid such as saline and other forms of energy. 在各种实施例中,通过对导管装置的单一传导部件或多个传导部件通电来施加能量。 In various embodiments, energy is applied by means of a single conductive member or catheter plurality of conductive components energized. 一般来说,可考虑任何合适的装置来供应能量。 In general, any suitable means can be considered to supply energy. 在一实施例中,对组织施加能量包括将能量施加到一传导的流体,并从导管装置中释放传导的流体以接触组织。 In one embodiment, the fluid, the energy applied to tissue comprising applying energy to a conductive fluid, and released from the catheter conducting means to contact the tissue. 例如,诸如盐水的传导流体可引入到导管装置的一个或多个可膨胀的部件内,诸如射频能的能量可以施加到流体上,然后,该流体从可膨胀的部件中通过可膨胀部件上的至少一个(最好是多个)小孔释放。 For example, such as a conductive fluid can be introduced into the brine within one or more inflatable catheter device components, such as RF energy can be applied to the fluid, then the fluid from the expandable member through the expandable member at least one (preferably more) apertures released. 通电的传导流体然后可接触组织而关闭PFO。 Transfer fluid may then be energized to close contact with the tissue PFO.

该方法的某些实施例还可包括监视施加到组织的能量。 Certain embodiments of the method may further include monitoring the energy applied to the tissue. 例如,监视能量可包括监视组织的温度、组织的阻抗和/或诸如此类的值。 For example, monitoring the energy value of the impedance may comprise monitoring tissue temperature, tissue and / or the like. 这样一方法还可包括确定何时已经对组织供应了足够的能量而急剧地关闭PFO。 Such a method may comprise determining when the tissue has been supplied with sufficient energy to rapidly close PFO. 可供选择的是,该方法还可包括当已经施加了足够的能量时停止能量的施加。 Alternative, the method may further comprise stopping the energy when enough energy has been applied is applied.

任何上述的方法还可包括:利用与导管装置偶联的至少一个可视装置直接地观看PFO和邻近的组织。 Any of the above method may further comprises: using at least a visual device coupled to the catheter device is directly viewed PFO and adjacent tissues. 这样一可视装置可包括一光纤装置、一超声波装置或任何其它合适的可视装置。 Such a device may comprise a fiber optic visualization device, an ultrasonic device, or any other suitable visual means.

在本发明的另一方面,治疗心脏中的一未闭椭圆孔的方法包括:前进一导管装置到心脏内的一位置,以便治疗未闭椭圆孔;使用导管装置至少部分地将邻近未闭椭圆孔的组织集合在一起;用导管装置对组织施加能量,同时,至少部分地将组织保持在一起;以及在施加能量之后至少部分地将组织保持在一起持续一足够的时间,从而基本上关闭未闭椭圆孔。 In another aspect of the present invention, a method of treatment is not closed oblong hole of the heart comprising: advancing a catheter device to a location within the heart, to treat ovale oval aperture; catheter device adjacent the at least partially elliptical ovale well tissue together; applying energy to tissue with the catheter device, while the tissue remains at least partially together; and after the application of energy at least partially holding the tissue together a sufficient duration of time, not to substantially close closed oblong hole. 这样一方法可包括上述诸实施例的任何特征。 Such a method may include any of the features of the embodiments described above.

在本发明的另一方面,治疗心脏中的一未闭椭圆孔的一导管装置包括一细长的导管体,其具有一近端和一远端,位于导管体远端处或其附近用来至少部分地将邻近未闭椭圆孔的组织集合在一起的至少一个组织附着部件,以及至少一个位于远端处或邻近远端的能量传输部件,以便对组织施加能量,从而基本上急剧地关闭PFO。 In another aspect of the present invention, a catheter device for treating a heart ovale oblong hole comprises an elongated catheter body having a proximal end and a distal end located at or near the distal end of the catheter body to at least partially elliptical hole is not closed adjacent the tissue together in at least one tissue adhesion member, and at least one distal end positioned at or adjacent the distal end of energy transfer member to apply energy to tissue to substantially close the PFO abruptly . 在某些实施例中,至少一个组织附着部件包括一第一组织附着部件,用来从心脏的右心房接触组织。 In certain embodiments, a tissue attachment member comprises at least a first tissue attachment member for contacting tissue from the right atrium of the heart. 可供选择的是,在各种实施例中,可以包括一第二组织附着部件,用来从右心房或左心房接触组织。 Alternatively, in various embodiments, it may comprise a second tissue attachment member for contacting the right or left atrium tissue. 例如,在一实施例中,第一和第二部件可以包括一组相对的钳夹,它们可用来从右心房内将组织集合在一起,可供选择的是,前进通过一个或多个邻近PFO的组织。 For example, in one embodiment, the first and second member may comprise a set of opposing jaws, they can be used from the right atrium tissues together, to choose that one or more neighboring advanced through PFO organization. 在某些实施例中,第二部分可以前进通过PFO而从左心房接触组织。 In certain embodiments, the second portion may be advanced through tissue in contact with the left atrium and PFO. 可以包括任何数量不同的组织附着表面。 It may include any number of different tissue attachment surface.

如上所述,例如,第一和第二组织附着部件中的一个或两个可以包括可膨胀的部件,任何一个(或两个)可沿轴向朝向彼此滑动而将组织集合在它们之间。 As described above, for example, one or both of the first and second attachment members may include tissue expandable member, any one (or two) slidably set in the tissue to each other toward the axial direction therebetween. 在其它实施例中,可使用一可膨胀的部件和一个形状可展开的“回挡”部件。 In other embodiments, use the "back block" means an expandable member and a shape expandable. 例如,可展开的部件可包括一形状记忆装置,它可前进到左心房内并展开而接触组织。 For example, the expandable member may comprise a shape memory device which may be advanced into the left atrium and expand to contact tissue. 一可膨胀的气囊可以展开并可沿着导管轴向地移动,以使组织集合在它和展开的回挡之间。 An inflatable bladder can be deployed and movable axially along the catheter, the tissue collection so that between it and the back stopper deployed. 任何一个或多个这样的可膨胀部件还可包括至少一个小孔,以便允许传导流体从可膨胀的部件中跑逸而接触组织。 Any one or more such further comprising an expandable member at least one aperture to allow escape of fluid from the conductive member in the expandable tissue contact. 某些实施例包括多个小孔,而某些实施例包括带有小孔的两个可膨胀的部件。 Some embodiments include a plurality of apertures, and some embodiments include two apertures with the expandable member.

在其它实施例中,第一和第二组织附着部件构造为一夹具的两个臂,其中一个臂设置在右心房内,而另一个臂设置在左心房内,以便将组织夹紧在一起。 In other embodiments, the first and second tissue attachment member configured to clamp a two arms, wherein one arm disposed within the right atrium, while the other arm is disposed within the left atrium, so that the tissue clamped together. 还有其它的实施例包括一组相对的钳夹以及一钩或夹具部件,以使组织朝向夹具。 Still other embodiments include a set of opposing jaws and a hook or clamp member to clamp the tissue orientation. 在其它的实施例中,第一和第二部分构造为一夹子、“发夹”等,其中,第一和第二附着部件的相对形状将组织推压在一起。 In other embodiments, the first and second portions configured as a clip, a "hairpin" and the like, wherein the relative shapes of the first and the second attachment member is pushed together tissue. 例如,在一实施例中,诸部件之一可以成形为一钩或类似的弧形部件,以便钩住在PFO上而从左心房接触组织,而另一部件可以是相对直的以便从右心房接触组织。 For example, in one embodiment, one such component may be shaped as a hook or the like member curved to hooked on contact with the tissue from the left atrium and PFO, and the other member may be relatively straight to the right atrium contact with the tissue. 因此,组织可在两个部件之间抓住在一起,将它们集合在一起,其并不像一物品放置在一发夹的两个夹片之间或在纸张夹的弧形内的情形。 Accordingly, tissue may be caught between the two parts together, and together they are, not as an article which is placed between the two clip or a hairpin in the case of the paper clip is arcuate.

装置的某些实施例还包括一用来前进通过PFO的导向部件,导管装置可滑动地设置在该导向部件上。 Certain embodiments of the apparatus further comprises a guide member to be advanced through the PFO, the catheter device is slidably disposed on the guide member. 例如,导向部件可包括一导向导管和设置在导向导管内的至少一个可膨胀的部件,其中,导向导管可缩回而暴露出可膨胀的部件,从而允许其在PFO内膨胀。 For example, the guide member may include a guide catheter and provided at least one inflatable member of the catheter guide, wherein the guide catheter may be retracted to expose the expandable member, thereby allowing it to expand within the PFO. 该可膨胀的部件又可具有任何合适的构造,但在某些实施例中,它包括至少两个可膨胀开的部件以对邻近PFO的组织提供侧向力,例如,一“鱼嘴”形或双叉的可膨胀部件。 The expandable member can have any suitable configuration but also, in some embodiments, it comprises at least two inflatable member to organize apart adjacent the PFO for providing lateral force, for example, a "fish mouth" shape or bifurcated expandable member. 当暴露时,该可膨胀的部件还可对邻近PFO的组织提供拖拉力。 When exposed, the expandable member may also provide drag force to tissue adjacent the PFO. 为了提供可膨胀的能力,可膨胀的部件可由形状记忆材料制成,其可以是弹簧加载的和/或诸如此类状态的材料。 In order to provide the ability to expandable, inflatable member may be made of a shape memory material, which material may be spring loaded and / or the like state.

在其它变化的实施例中,导向部件可包括一具有沿其长度可膨胀的部分的导向丝。 In other variations of the embodiment, the guide member may comprise a length along its expandable portion of the wire. 例如,可膨胀的部分可以是划分的部分,该划分的部分包括可膨胀的形状记忆材料。 For example, the expandable portion may be divided into portions, the divided portions of the shape memory material comprises expandable. 可供选择的是,导向部件可包括至少一个末端,其用来接触邻近PFO的组织的左心房表面。 Alternatively the guide member may comprise at least one end, which is used in contact with the surface of the left atrial tissue adjacent the PFO. 这样一末端可以与左心房表面适应。 Such a tip may be adapted to the surface of the left atrium. 导向部件可以缩回而接合至少一个末端与左心房表面。 Retracting the guide member may engage at least one end surface of the left atrium. 在上述的任何一个实施例中,一个或多个导向部件,或导向部件的零部件可以用作一个或多个能量传输部件。 In any of the above embodiment, the one or more parts of the guide member, the guide member may be used, or one or more energy transfer member. 例如,在某些实施例中,一膨胀部件可以用作为一单极或双极的射频电极。 For example, in some embodiments, an expandable member can be used as a monopolar or bipolar radiofrequency electrode of.

导管装置的至少一个能量传输部件可包括任何合适的能量传输装置或各种装置的组合。 At least one energy transmission means may comprise conduit means any suitable combination of various energy transmission device or devices. 例如,传输部件可以传输射频能、低温能、电阻加热能、超声波能、微波能、激光能或用于治疗PFO组织的任何其它形式的能。 For example, the transmission means may transmit radiofrequency energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy, laser energy or any other forms of treatment can PFO tissue. 在优选的实施例中,能量传输部件包括一单极或两个双极的射频传输部件。 In a preferred embodiment, the energy transfer member comprises a two bipolar or monopolar RF transmission member. 例如,这样一传输部件可以弯曲成近似于PFO的曲率。 For example, such a transmission member may be bent to approximate the curvature of the PFO. 在其它的实施例中,可使用直的传输部件、网或编结的传输部件、多个销-点传输部件等。 In other embodiments, the transmission member may be used directly, or network transmission component braided, a plurality of pins - point transmission member and the like.

在某些实施例中,一个或多个能量传输部件与一个或多个组织附着部件偶联。 In certain embodiments, the one or more energy transfer member attached to the one or more coupling members tissue. 在某些实施例中,例如,一个或多个能量传输部件就用作为组织附着部件。 In certain embodiments, for example, one or more energy transmission means to use as a tissue attachment member. 在某些实施例中,能量传输部件可沿至少一个组织附着部件的至少圆周部分移动。 In certain embodiments, the energy transmitting member may be attached along at least one tissue movement at least partially circumferential member. 在变化的实施例中,能量传输部件包括一用于前进通过PFO的导向部件,其中,导管装置可滑动地设置在导向部件上。 In a variant embodiment, the energy transfer means comprises a guide member to be advanced through the PFO, wherein the conduit means is slidably disposed on the guide member. 再者,导向部件通常包括至少一个可膨胀部分,以便在PFO内膨胀而至少部分地将邻近PFO的组织集合在一起,在某些实施例中,可膨胀部件用作为能量传输部件。 Further, the guide member generally comprises at least one inflatable portion, so as to at least partially together adjacent the tissue expander in the PFO PFO, in some embodiments, the expandable member may be used as the energy transmission means. 在还有一些其它的实施例中,能量传输部件可与组织附着部件和导向部件/可膨胀部件偶联。 In still other embodiments, the energy transmitting member may be attached to the tissue member and a guide member / coupling the expandable member.

如上所述,在一实施例中,至少一个能量传输部件包括设置在可膨胀部件内的一种或多种能量传输部件,以便对一传导的流体施加能量。 As described above, in one embodiment, the at least one energy transmission means comprises one or more energy transmission member within an expandable member to apply energy to a fluid conduction. 能量传输部件还包括一个或多个传导的流体,它们引入到可膨胀的部件内,然后,允许从可膨胀的部件中跑逸,通常通过多个孔跑逸。 Energy transmission means further comprises one or more conductive fluid, which is introduced into the expandable member, and then, allowing the expandable member from the escape of, typically through escape of a plurality of holes. 在各种实施例中,可以包括带有多孔的一个、两个或多个可膨胀的部件、传导的流体和能量传输部分。 In various embodiments, it may comprise porous with one, two or more of the expandable member, the fluid conducting and energy transmission portion. 在一实施例中,射频能传输到作为传导流体的盐水溶液,但在其它变化的实施例中,可以使用其它形式的能量和/或传导流体。 In one embodiment, the RF energy is transferred to the transfer fluid as a saline solution, but in other variations of the embodiment, other forms of energy and / or transfer fluid.

导管装置的某些实施例还可包括与导管装置偶联的至少一个传感器,用来检测由至少一个能量传输部件供应到组织的能量大小。 Certain embodiments of the catheter device may further comprise at least one sensor coupled to the conduit means for detecting at least one energy supply member to the transfer of energy to tissue. 例如,传感器可以是红外线传感器、热敏电阻和热电偶等,但也可使用任何的传感器。 For example, the sensor may be an infrared sensor, a thermocouple and a thermistor, but any sensor may be used. 可供选择的是,一微处理器可与至少一个传感器偶联,以便处理检测到的数据来确定供应的能量何时已经达到所要求的能量大小。 Alternatively, it is, a microprocessor may be coupled with the at least one sensor, to process the data detected to determine when the energy supply has reached the required amount of energy.

在本发明的另一方面,治疗心脏中的一未闭椭圆孔的系统包括一导管装置和用来将导管装置引导到一位置以便治疗未闭椭圆孔的至少一个导向部件。 Another aspect of the present invention, a treatment system of the heart is not closed oblong hole and the conduit means comprises a means for guiding the catheter to a position so that treatment is not closed oblong hole at least one guide member. 导管装置包括一细长导管体,其具有一近端和一远端,位于导管体远端处或其附近用来至少部分地将邻近未闭椭圆孔的组织集合在一起的至少一个组织附着部件,以及至少一个位于或邻近远端的能量传输部件,以便对组织施加能量,从而基本上关闭未闭椭圆孔。 Conduit means comprises an elongated catheter body having a proximal end and a distal end located at or near the distal end of the catheter body for at least partially closing the tissue adjacent the non-oval holes together at least a tissue attachment member and at least one energy transfer member at or adjacent the distal end in order to apply energy to tissue to substantially close the oblong hole is not closed. 导管装置可包括上述任何的特征或变体。 Conduit means may comprise any of the features described above or a variant thereof.

在下文的描述中将参照附图,详细地描述这些的和其它的实施例。 Referring to the drawings in the following description, these and other embodiments are described in detail.

附图的简要说明图1是胎儿血液循环的示意图;图2是根据本发明的一实施例的导管装置的示意图,导管通过内部腔静脉和右心房,并通过PFO;图3是根据本发明一实施例的具有两个可膨胀部件的导管装置的一远端部分的立体图;图4是根据本发明的另一实施例的具有两个可膨胀部件的导管装置的一远端部分的立体图;图5是根据本发明的另一实施例的具有一个可膨胀部件的导管装置的一远端部分的立体图;图6是根据本发明的另一实施例的具有一个可膨胀部件和一形状记忆部件的导管装置的一远端部分的立体图;图7是根据本发明的另一实施例的具有两个与两个叉偶联的可膨胀部件的导管装置的一远端部分的立体图;图8是根据本发明的另一实施例的具有一个可膨胀部件和两个叉的导管装置的一远端部分的立体图;图9是根据本发明的另一实施例的具有两个 BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic diagram of the fetal circulation; FIG. 2 is a schematic view of a catheter device according to an embodiment of the present invention, the internal catheter through the vena cava and right atrium, and through the PFO; FIG. 3 according to the present invention is a a perspective view of a distal portion of the catheter device having two expandable member of the embodiments; FIG. 4 is a perspective view of a distal end portion according to another embodiment of the present invention having two conduit means of the expandable member; FIG. 5 is a perspective view of a distal portion of the catheter device having an expandable member according to another embodiment of the present invention; FIG. 6 is another embodiment of the invention having an expandable member and an embodiment of a shape memory member a perspective view of a distal portion of the catheter device; FIG. 7 is a perspective view of a distal portion of the catheter device having an expandable member with two prongs two coupling according to another embodiment of the present invention; FIG. 8 is a a perspective view of a distal portion of the expandable member having a fork and two catheter apparatus according to another embodiment of the present invention; FIG. 9 is a two according to another embodiment of the present invention. 织附着部件和一成形的导管体的导管装置的一远端部分的截面图;图10是根据本发明的另一实施例的具有两个组织附着部件和一成形的导管体的导管装置的一远端部分的立体图;图11A-11C是一导管装置的一远端部分的立体图,示出根据本发明的另一实施例的将组织集合在一起的一方法;图12A和12B是根据本发明的另一实施例的具有两个相对钳夹的导管装置的一远端部分的立体图;图13A和13B是根据本发明的另一实施例的具有两个相对钳夹的导管装置的一远端部分的立体图;图14是根据本发明的另一实施例的具有一带有真空的两个叉的组织附着部件的导管装置的一远端部分的立体图;图15A和15B是根据本发明的另一实施例的具有两个相对钳夹和一弧形部件的导管装置的一远端部分的立体图;图16A和16B是根据本发明的另一实施例的具有磁性组织附着部件的导管 A sectional view of the distal end portion of the knitting of the attachment means and conduit means forming a catheter body; FIG. 10 is a catheter body of the catheter device according to another embodiment of the present invention has two tissue attachment members and a shaped a perspective view of the distal portion; FIGS. 11A-11C is a perspective view of a distal portion of a catheter device, according to a further illustrating the present invention a method of tissue together embodiment; FIGS. 12A and 12B are in accordance with the present invention a perspective view of a distal portion of another embodiment of a catheter having two opposing jaw apparatus; FIG 13A the distal end of a catheter having two opposing jaws and 13B are embodiments of the apparatus according to another embodiment of the present invention. a perspective view of the portion; FIG. 14 is a perspective view of a distal portion of the catheter apparatus having a vacuum member having two prongs attached to tissue according to another embodiment of the present invention; FIGS. 15A and 15B according to another embodiment of the invention. a perspective view of a distal end portion has two opposing jaws and a conduit means of the arcuate member of the embodiment; FIGS. 16A and 16B is a catheter having a tissue attachment magnetic member according to another embodiment of the present invention. 装置的一远端部分的立体图;图17是根据本发明的另一实施例的具有夹紧的组织附着部件的导管装置的一远端部分的立体图;图18是一PFO的右心房图,其中,一静止的能量传输部件位于右心房内,以及一根据本发明的另一实施例的多个组织焊接;图19是根据本发明的另一实施例的具有两个可膨胀部件和一个延伸通过心脏的右和左心房的导向丝的导管装置的一远端部分的立体图;以及图20A-20C是根据本发明的另一实施例的具有两个分离的组织附着部件的导管装置的一远端部分的立体图。 A perspective view of a distal portion of the device; FIG. 17 is a perspective view of a distal portion of the catheter device having a tissue clamping member is attached according to another embodiment of the present invention; FIG. 18 is a right atrial FIG PFO, wherein a stationary energy transmission means located in the right atrium, and a plurality of welding a tissue embodiment in accordance with another embodiment of the present invention; FIG. 19 is a further embodiment of the present invention has two expandable member and extending through a a distal end, and FIGS. 20A-20C is a catheter device having two separate tissue attachment member according to another embodiment of the present invention; a perspective view of a distal portion of the catheter guide wire apparatus of the right and left atrium of the heart a perspective view of a portion.

具体实施方式 Detailed ways

本发明的装置和方法通常通过施加能量来医治未闭的椭圆孔(PFO)。 Apparatus and method of the present invention is typically by applying energy to cure the elliptical hole Ovale (PFO). 该方法包括前进一导管装置到心脏内的一位置,以便使用导管至少部分地将组织集合在一起,对邻近一PFO的组织施加能量,从而基本上急剧地关闭PFO。 The method comprises advancing a catheter device to a location within the heart, at least in part to use of the catheter the tissue together, applying energy to tissue adjacent a PFO, PFO thereby substantially abruptly closed. 本发明的装置通常包括一导管装置,其具有一近端和一远端,至少一个组织附着部件,以及邻近远端的至少一个能量传输部件。 Apparatus of the present invention generally comprises a conduit means having a proximal end and a distal end, the at least one energy transfer member attached to at least one tissue section, and adjacent the distal end.

图1是胎儿血液循环的示意图。 FIG 1 is a schematic diagram of the fetal circulation. 图中示出椭圆孔,其中,一箭头表明血液从胎儿的右心房流到左心房。 Oval hole is shown, wherein the arrow indicates a flow of blood from the left atrium to the right atrium fetus. 婴儿出生之后,如果椭圆孔未能关闭(因此,成为一PFO),则血液可从右心房流入左心房,反之亦然,如上所述,导致大脑功能突然丧失、偏头疼以及其它可能对健康不利的病情的风险增加。 After the baby is born, if the oval hole fails to close (and therefore, become a PFO), the blood from right atrium into the left atrium, and vice versa, as described above, resulting in a sudden loss of brain function, migraine headaches and other possible adverse health risk of disease increases.

参照图2,治疗PFO的导管装置10的一实施例合适地包括一导管体12和一个或多个组织附着部件14。 A catheter device embodiment with reference to FIG. 2, the treatment of PFO 10 suitably comprises one or more tissue 12 and a member 14 attached to the catheter body. 导管装置10可以通过一病人的脉管系统前进到心脏内的一位置以便治疗一PFO。 The catheter device 10 can be advanced through a patient's vasculature to a location within the heart in order to treat a PFO. 例如,如图所示,导管装置10通过内腔静脉前进到心脏的右心房内。 For example, as shown, the catheter apparatus 10 proceeds to the right atrium of the heart through the lumen of the vein. 在变化的实施例中,导管装置可前进通过大动脉到左心室,然后,进入到心脏的左心房内以治疗PFO。 In an embodiment variation, the catheter device can be advanced through the aorta to the left ventricle, and then into the left atrium of the heart for the treatment of PFO. 在某些实施例中,一导管装置的两个分离部分可以前进到右心房和左心房,在另一实施例中,导管装置的一导向丝或其它部件可从病人体外延伸,通过脉管系统到右心房,通过PFO到左心房,并通过大动脉到脉管系统而从一第二侧退出病人身体。 In certain embodiments, two separate portions of a catheter device may be advanced to the right and left atria, in another embodiment, a guidewire or other components of the conduit means may extend from outside the patient, through the vasculature into the right atrium through the PFO into the left atrium, and exit from a second side of the patient's body through the aorta to the vasculature. 因此,各种实施例可利用任何合适的进入技术来将一导管装置设置在一部位内以便治疗PFO。 Thus, various embodiments may use any suitable technique to enter in order to treat a portion of a catheter device is provided PFO.

导管体12通常包括一具有至少一个内腔的细长的柔性体。 12 generally comprises a catheter body having at least one lumen of the elongate flexible body. 导管体12可由任何合适的材料或导管技术领域内熟知的材料组合进行制造,这将在下文中予以揭示,例如,PTFE、其它的聚合物等。 12 by a combination of any suitable material known in the technical field or catheter materials for producing the catheter body, which will be hereinafter disclosed, e.g., PTFE, other polymers and the like. 导管体12还可具有任何合适的尺寸、外形、直径、形状等。 The catheter body 12 may have any suitable size, shape, diameter, shape and the like. 可供选择的是,导管体12可以滑动地设置在一导向部件(未示出)上,例如,一导向导管、导向丝等。 Alternatively the catheter body 12 is slidably disposed on a guide member (not shown), e.g., a guide catheter, a guide wire. 在某些实施例中,这样一导向部件可包括一个或多个膨胀部件或用来在PFO内展开的其它类似的装置以帮助附着相邻的组织。 In certain embodiments, such a guide member may include one or more expandable member or the like to aid in adhering adjacent tissue within the PFO device for deployment. 为了进一步描述这样的可膨胀导向部件,可参照美国专利申请No.10/679245,上文中已援引该专利以供参考。 For further description of such an expandable guide member, reference U.S. Patent Application No.10 / 679245, already cited hereinabove by reference in this patent.

组织附着部件14通常可包括任意的一个、两个或多个装置来帮助将邻近PFO的组织集合在一起。 Tissue attachment member 14 generally may include any one, two or more devices together to help the tissue adjacent the PFO. 如图2所示,一部件14可以设置在右心房内以从右心房侧接触组织(诸如第二房间隔组织),而另一部件14可前进通过PFO从左心房接触组织。 2, a member 14 may be disposed within the right atrium to the right atrium side contact tissue (such as the second atrial septal tissue), and the other member may be advanced through the PFO 14 contacts the tissue from the left atrium. 在某些实施例中,组织附着部件14可以预成形并由形状记忆材料、弹簧不锈钢等制造,这样,当它们从导管体12中释放时,它们呈一形状,该形状允许它们将组织集合在一起。 In certain embodiments, the tissue attachment member 14 may be preformed by a shape memory material, such as stainless steel spring manufacture, such that when they are released from the catheter body 12, which form a shape which allows them to tissue collection together.

导管装置10还包括至少一个能量传输部件。 Catheter device 10 further comprises at least one energy transmission member. 在所示实施例中,一个或两个组织附着部件14也可用作能量传输部件。 Embodiment, one or both of the tissue attachment members also serve as energy transfer member 14 in the illustrated embodiment. 在各种实施例中,能量传输部件能将组织集合在一起,能量传输部件可以与组织附着部件偶联,或能量传输部件可以与组织附着部件分离且不与其偶联。 In various embodiments, the energy transfer member capable of tissue together, energy transmission member coupled thereto can be separated from the tissue without tissue attachment member attached to the coupling member, or energy transmission member. 还在各种实施例中,可使用一能量传输部件,以便提供单极的射频能(RF),可以使用两个传输部件,以便提供双极的RF能,或可使用多于两个的传输部件。 Embodiment, a power transmission member may be used to provide a monopolar radiofrequency energy (RF), two transmission members may be used to provide a bipolar RF energy, or more than two may be also various transmission embodiments component.

现参照图3,治疗PFO的导管装置20的另一实施例合适地包括一导管体22、一具有一第一能量传输部件23的第一可膨胀的部件27,以及一具有一第二能量传输部件25的第二可膨胀的部件28,使各个可膨胀部件27、28包括多个允许传导流体26通过的孔24。 Another embodiment of the catheter device 20 Referring now to Figure 3, suitably comprises treating the PFO 27, and a second energy transfer having a catheter body 22, a first inflatable member having a first energy transfer member 23 the second inflatable member 25 of member 28, so that each inflatable member 27, 28 comprises a plurality of holes 24 to allow conductive fluid 26 therethrough. 可膨胀的部件27、28可定位用于在右心房(第一部件27)和左心房(第二部件28)内进行治疗,然后,膨胀而将第二房间隔SS和第一房间隔SP的组织和/或其它邻近PFO的组织集合在一起。 Expandable member 27, 28 may be positioned in the right atrium for treatment (first member 27) and left atrium (second member 28) inside, and then, the second expansion of the atrial septum primum SS and the SP tissue and / or other tissue adjacent the PFO together. 在某些实施例中,一个或两个可膨胀的部件27、28也可沿导管体22轴向地移动,例如,通过滑动以使组织一起集合在两个可膨胀的部件27、28之间。 In certain embodiments, one or both of the expandable members 27, 28 may also be moved axially along the catheter body 22, e.g., by sliding in order to set the tissue between the two members 27 and 28 together with the expandable . 例如,第二可膨胀部件28可以设置在一设置在导管体22上或导管体内的单独的导管体上,以允许第二部件28轴向地沿着导管体22前后地滑动。 For example, the second expandable member 28 may be provided in a separate arranged on the catheter or catheter 22 catheter body to allow the second member 28 to slide axially back and forth along the catheter body 22.

可膨胀的部件27、28可包括任何合适的材料或现已知的材料的组合,或将来开发的材料。 Expandable member 27, 28 may comprise any suitable material or materials now known or later developed material. 用于导管上的可膨胀的气囊部件是众所周知的,在本发明的各种实施例中,可以使用任何合适的变体。 A balloon expandable member on the catheter are well known in various embodiments of the present invention, any suitable variant. 可膨胀的部件27、28可以由顺从的弹性体材料、聚合物等制成,并在膨胀后可具有任何合适的形状。 The expandable member 27, 28 may be made from a compliant elastomeric material, polymer, after expansion and may have any suitable shape.

通过引入诸如盐水溶液等的一个或多个传导流体到可膨胀的部件27、28内,可将能量施加到组织上,通过能量传输部件25、23将能量(诸如RF能)施加到传导的流体26,然后,允许流体26从孔24中通过而接触组织。 The 27, 28 may be applied by one or more energy transfer fluid such as a saline solution or the like is introduced into the expandable member to the tissue, 25.23 energy (such as RF energy) applied to the conductive fluid through an energy transfer member 26, then, allows fluid 26 from the bore 24 through the contact tissue. 因此,流体26可对组织提供需要的能量以致使PFO关闭。 Therefore, the fluid 26 can provide the energy needed to cause the tissue to close the PFO. 在将能量传输到PFO附近的组织之后,传导的流体26无害地在体内耗散。 After the energy to the tissue adjacent the PFO, the conductive fluid 26 is harmlessly dissipated in the body.

在各种实施例中,能量传输部件可包括多个装置中的任何一种,并可传输任何合适类型的能量来关闭一PFO。 In various embodiments, the energy transmission means may comprise any of a plurality of devices, and may be any suitable type of energy transmission to close a PFO. 例如,可采用的某些类型的能量包括射频、低温、电阻加热、超声波、微波和激光能。 For example, certain types of energy may be employed include radio frequency, cryogenic, resistive heating, ultrasonic, microwave, and laser energy. 射频能传输部件可以是单极的或双极的,单极的导管装置也可包括一接地部件。 RF energy transmitting member may be unipolar or bipolar, monopolar catheter device also includes a ground member. 能量传输部件也可具有任何合适的构造,其中许多构造将在下面参照特定的实施例予以描述。 Energy transmission means may be of any suitable construction, many of which configuration will be described with reference to specific embodiments below. 在某些实施例中,能量传输部件与组织附着部件固定地偶联,而在其它的实施例中,能量传输部件可在组织附着部件内移动,例如,可围绕PFO组织的圆周移动而在多个部位处焊接PFO组织。 In certain embodiments, the energy transfer member and the tissue attachment member fixedly coupled, the energy transfer member attached to the movable member within the tissue in other embodiments, for example, may be moved around the circumference of the tissue in multiple PFO a PFO tissue at the weld site. 在某些实施例中,通过在可膨胀的部件27、28内循环冷却的或加热的流体,而不允许这样的流体传出可膨胀的部件27和28,这样可达到能量的供应。 In certain embodiments, by heating the fluid or in the expandable member 27, 28 of the cooling cycle, without allowing such fluid outgoing expandable member 27 and 28, so that the energy supply can be achieved. 在这些实施例中,孔24可从设计中去除。 In these embodiments, apertures 24 may be removed from the design.

能量传输部件23、25在足够的时间内提供足够的能量传输以便焊接组织。 Energy transmission means 23 and 25 provide sufficient energy transfer to weld tissue for a sufficient time. 例如,能量传输的时间跨度可以是从约0.5秒至约15分钟,较佳地是,从约30秒至约5分钟。 For example, the energy transfer time span may be from about 0.5 seconds to about 15 minutes, preferably it is from about 30 seconds to about 5 minutes. 在某些实施例中,能量传输可以是从约0.5瓦至约100瓦,且较佳的是,从约5瓦至约50瓦。 In certain embodiments, the energy transfer may be from about 0.5 watts to about 100 watts, and preferably is from about 5 watts to about 50 watts. 在各种实施例中,也可采用任何其它合适的能量和时间的组合。 In various embodiments, it may also be employed any other suitable combination of energy and time. 在一实验性的实例中,取自猪体内的心脏组织一部分内的一PFO在一流动的盐水中试验,通过施加抽吸力使PFO组织附着并施加RF能量约25瓦持续7分钟,则固定被关闭。 , A portion of the heart tissue within the PFO from test pigs in the experimental example of a flow of a brine by applying a suction force and tissue attachment PFO about 25 watts of RF energy is applied for 7 minutes, the fixed is closed. 然后,停止RF能量施加,但组织附着再继续1分钟以保持组织处于附着,同时,冷却组织以使组织内的胶原质重新进行组织并连接在一起而形成一稳定的组织搭桥。 Then, RF energy application is stopped, but the tissue attachment was continued for 1 minute to hold the tissue is attached, while cooling so that the collagen tissue within the tissue reorganize and connected together to form a stable organization bridge. 在变化的实施例中,也可采用其它的能量施加量、能量施加时间、组织附着时间等。 In a variant embodiment, the application of energy may take other amounts, energy application time, time tissue attachment.

尽管在各种实施例中通过能量传输部件可以传输任何合适类型的能量,但某些实施例将利用单极或双极的射频(RF)能。 While the energy can be transferred embodiment by any suitable type of energy transmission means in various embodiments, certain embodiments will utilize a monopolar or bipolar radio frequency (RF) energy. 例如,装置可以使用单极射频能,其中,能量同时地施加到所有传导元件,通过附连到病人皮肤的外部接地垫完成循环。 For example, the device may use a monopolar radiofrequency energy, wherein the energy is applied simultaneously to all of the conductive elements, to an external ground pad of the patient's skin to complete the cycle by attachment. 或者,双极能量可以同时地施加到所有传导元件,通过一容纳在导管装置任何地方上的接地元件完成循环。 Alternatively, bipolar energy may be simultaneously applied to all the conductive elements, completing the cycle by a ground element housed anywhere on the catheter device. 其它的实施例可包括在两个或多个能量传输部件之间施加双极能量,能量传输部件在导管装置内彼此电气地绝缘。 Other embodiments may include applying bipolar energy in the energy transfer between two or more members, the energy transfer member electrically insulated from each other within the conduit means.

与能量传输部件或组织附着部件偶联的或以其它方式设置在导管装置内的控制系统,可以检测供应到PFO组织的能量大小,且可供选择地,一旦检测到能量供应条件的变化,则可以自动地停止能量供应,例如,如果PFO组织或导管装置内的电阻或阻抗增加,则从导管装置和/或诸如此类的装置中获得的能量也增加。 And attachment means coupled energy transfer means or tissue or otherwise control system disposed within the conduit means, can be supplied to the detection of energy PFO tissues, and alternatively, upon detection of a change to the energy supply conditions, the may automatically stop the supply of energy, e.g., if the resistance or impedance of the tissue of PFO or conduit means increases, the energy from the conduit means and / or the like obtained in the apparatus is also increased. 在某些实施例中,当供应的能量达到一要求的水平,诸如足以基本上关闭PFO的一能量时,能量供应则可自动地停止。 In certain embodiments, when the power supply reaches a level requirements, such as energy sufficient to substantially close a PFO, the energy supply can be automatically stopped. 可用任何合适的方法来监视供应的能量,例如,监视PFO组织内的温度或阻抗等。 Any suitable method can be used to monitor the supply of energy, and the like, for example, to monitor temperature or impedance in the tissue PFO. 在某些实施例中,可以使用一个或多个传感器,它们偶联于组织附着部件、能量传输部件,或导管装置的任何其它部分,以便监视这样的标记。 In certain embodiments, one or more sensors may be used, which attachment member coupled to the tissue, the energy transfer member, or any other portion of the catheter means to monitor such markers. 传感器装置的实例包括但不限于红外线传感器、热敏电阻和热电偶。 Examples of sensor devices include, but are not limited to the infrared sensor, thermistor, and thermocouple. 可供选择的是,一控制系统也可包括与传感器连接的一微处理器,以确定何时已经供应要求的能量和/或何时自动地停止能量传输。 Alternatively, it is, a control system may also include a microprocessor connected to the sensor, to determine when the energy required to have been supplied and / or when energy transmission is automatically stopped. 在变化的实施例中,一微处理器可以附连到导管装置内,它可检测、监视和控制能量供应,因此,不要求单独的传感器。 In a variant embodiment, the microprocessor can be attached to a catheter device that can detect, monitor and control energy supply, and therefore, does not require a separate sensor.

图4示出一导管装置30的略为不同实施例,其具有一导管体32、一第一可膨胀的部件37和一第二可膨胀的部件38,其具有一能量传输部件35和多个允许一传导流体36通过的孔34。 Slightly different embodiment of Figure 4 shows a catheter device 30 having a catheter body 32, a first inflatable member 37 and a second expandable member 38 having a plurality of energy transfer member 35 and allowed a conductive fluid 36 through holes 34. 在此实施例中,第一可膨胀的部件37可用作为一组织附着部件而不需提供附加的能量传输。 Embodiment, the first expandable member 37 may be used as a tissue attachment member without providing additional energy transfer in this embodiment.

参照图5,治疗PFO的导管装置40的另一实施例包括一导管体42、一具有多个孔44允许流体46通过的可膨胀的部件48,以及一能量传输部件45。 Referring to FIG. 5, the treatment of PFO conduit means 40 further includes a catheter embodiment 42, having a plurality of apertures 44 allow fluid 46 through the expandable member 48, and an energy transfer member 45. 在此实施例中,可膨胀部件48的膨胀可足以使组织集合在一起,或朝向近端的力可施加到可膨胀的部件48,例如,通过拉回到导管体42上而使组织集合在一起。 In this embodiment, the expansion of the expandable member 48 may be sufficient to allow tissue together, or towards the proximal end of the force may be applied to expandable member 48, e.g., by pulling back on the catheter body 42 in the tissue collection together.

现参照图6,导管装置50的一实施例包括一导管体52、一可膨胀的部件57,其具有一设置在其中的能量传输部件53和位于其表面上用来使传导流体56通过的诸孔54,以及一成形的远端部分59。 Referring now to Figure 6, a catheter apparatus 50 according to embodiment 52 comprising a catheter, an expandable member 57, which has an energy transmission member 53 disposed therein and positioned such that the conductive fluid 56 which is used by the upper surface hole 54, and a distal end portion 59 shaped. 成形的远端部分59驻留在左心房内并用作为一表面或“回挡”,这样,组织可集合在成形的远端部分59和可膨胀的部件57之间。 Shaped distal portion 59 residing in the left atrium and used as a surface or "back block", so, the organization may be set between the distal end portion 59 and expandable member 57 is formed. 在所示的实施例中,成形的远端部分59是一螺旋的盘圈,它可由形状记忆材料、弹簧不锈钢等制成,这样,当它设置在导管体52内时它具有一相对直的构造,但当它释放时却呈现为盘圈的构造。 In the illustrated embodiment, the distal portion 59 is formed a spiral rim, it may be made of shape memory material, the spring is made of stainless steel, so that, when it is disposed within the catheter body 52 having a relatively straight construction, but when it is released Shique appears as the rim of the constitution. 在其它的实施例中,可以使用其它的回挡装置,诸如在美国专利申请No.60/478,035中较完整地描述的装置,该专利已在上文中援引以供参考。 In other embodiments, other back stop means, means No.60 / 478,035, such as more fully described in U.S. patent application, which patent cited hereinbefore by reference.

图7示出导管装置60的另一实施例,其包括一导管体62、一双叉的组织附着部件64,以及偶联到两个叉64上用来提供进一步组织附着的两个可膨胀的部件66。 FIG 7 illustrates a catheter 60 according to another embodiment of the apparatus, which includes a catheter body 62, one pair of fork tissue attachment member 64, and coupled to the two prongs 64 are used to provide two further inflatable member attached tissue 66. 组织附着部件64的叉可包括镍钛诺、某些其它的形状记忆材料等,组织附着部件64通常从在一PFO内的导管体62中释放而允许叉64张开。 Fork tissue attachment member 64 may include nitinol, shape memory of some other material, typically tissue attachment member 64 is released to allow the fork 64 from the opening 62 in the catheter body in a PFO. 诸叉之间的组织因此集合在一起,基本上弄平或呈“鱼嘴”。 Thus all tissue between the prongs together, form a substantially flattened or "fish mouth." 为了进一步附着组织,可膨胀的部件66可以膨胀,可供选择的是,可以施加近端力,例如通过拉回到导管体62上,用可膨胀的部件66将组织推压在一起。 To further attached tissue, the expandable member 66 can expand, alternative, the proximal force may be applied, for example by pulling back on the catheter body 62, with the expandable member 66 may be pushed together tissue. 诸叉64然后用作能量传输部件以便对组织施加能量。 Zhu then prongs 64 is used as energy transfer member to apply energy to tissue. 通常地,诸叉64是双极RF能量传输部件,但也可考虑变化的实施例。 Generally, all the fork 64 is a bipolar RF energy transfer member, but may be considered a variant embodiment.

在一变化的实施例中,现参照图8,一导管装置70可包括一导管体72、一双叉的组织附着部件74,以及一分离的用于提高组织附着的可膨胀的部件76。 In a variation of the embodiment, Referring now to Figure 8, a catheter means 70 may comprise a catheter body 72, one pair of fork tissue attachment means 74, and means 76 for increasing a separate expandable tissue attachment. 再者,组织附着部件74也可用作为能量传输部件。 Furthermore, tissue attachment member 74 may also be used as an energy transmitting member. 附加地或变化地,多个孔可设置在可膨胀的部件76内以便引入作为能量供应系统一部分的传导的流体。 Additionally or variably, a plurality of holes may be provided for introducing fluid conducting part of an energy supply system within the expandable member 76.

现参照图9,在另一实施例中,一导管装置80合适地包括一导管体86、一第一组织附着部件82和一第二组织附着部件84。 Referring now to Figure 9, in another embodiment, a conduit means 80 suitably comprises a catheter body 86, is attached a first tissue member 82 and a second tissue attachment member 84. 如上所述,一个或两个组织附着部件82、84可以与能量传输部件偶联或可用作为能量传输部件。 As described above, one or both of the tissue attachment members 82, 84 may be coupled to the energy transfer member, or can be used as energy transfer member. 在此实施例中,第一组织附着部件82构造成从右心房(诸如第二房间隔SS)接触组织,而第二组织附着部件84构造成从左心房(诸如第一房间隔SP)接触组织。 In this embodiment, the contact tissue, the first tissue attachment member 82 is configured to the right atrium (such as a septum secundum SS) contact with the tissue, the attachment member 84 is configured as a second tissue from the left atrium (such as primum SP) . 在接触和将组织集合在一起(末端中空的箭头)的过程中,组织附着部件82、84也抵靠导管体86将组织接合在一起(或挤压组织)。 In the process of contacting and tissues together (end of the hollow arrow), the tissue attachment members 82, 84 against the catheter body 86 can be joined together tissue (tissue or extruding). 当力施加到导管体86上时,由于它的横截面形状,它被推压到一侧(实心末端的箭头)。 When a force is applied to the catheter body 86, due to its cross-sectional shape, which is pushed to one side (the end of the solid arrow). 在所示的实施例中,导管体86具有三角形截面,但在一变化的实施例中,它可具有其它的形状,例如,卵形、椭圆体、钻石形等。 In the embodiment shown, the catheter body 86 has a triangular cross-section, in a variation of the embodiment, it may have other shapes, e.g., oval, ellipsoidal, diamond-shaped and so on. 当导管体86被推向侧边时,组织附着/能量传输部件82、84用来对第一部位处的组织施加能量。 When the catheter body 86 is pushed to the side, adhering tissue / energy transmission means 82, 84 for applying energy to the first tissue site. 组织附着部件82、84然后可移动到侧边朝向导管体86而将邻近组织集合在一起,因此,进一步沿着PFO推压导管体86。 Tissue attachment members 82, 84 may then be moved to the side toward the catheter body 86 and the adjacent tissues together, thereby further urging the catheter body along the PFO 86. 然后,可再对第二部位处的组织施加能量。 Then, re-applying energy to the second tissue site. 使用这样一技术,可以横贯一PFO从一侧到另一侧移动导管装置80,当装置80移动时施加能量和关闭PFO。 Using such a technique, a PFO may traverse move from side to side conduit means 80, and energy is applied to close the PFO when the device 80 moves. 换句话说,导管装置沿着PFO“行走”,随之进行组织点焊。 In other words, conduit means along the PFO "walking", followed organized spot.

图10是一导管装置90的实施例,其可用于类似于刚才所描述的方法中。 FIG 10 is an embodiment of a catheter device 90, which can be used in a method similar to that just described in. 装置90包括一导管体92、一第一组织附着部件94,以及一第二组织附着部件96,并显示为设置在一导向丝98上。 Device 90 includes a catheter body 92, 94, and a second member attached to a first tissue tissue attachment member 96, and is displayed on a guidewire 98 is disposed. 在此实施例中,组织附着部件94、96也用作能量传输部件。 In this embodiment, the tissue attachment members 94, 96 also serves as a power transmission member. 第一组织附着部件94是一弹簧加载的钳夹,而第二组织附着部件96是一形状记忆的能量传输部件,例如,一电极。 First tissue attachment member 94 is a spring-loaded jaw, and the second tissue attachment member 96 is a shape memory energy transfer member, such as an electrode. 如上所述,当组织附着部件94、96将邻近PFO的组织集合在一起时,它们使组织抵靠导管体92集合在一起,因此,将导管体92挤压到一边。 As described above, when the tissue attachment members 94, 96 adjacent the PFO tissues together, the tissue against which the catheter body 92 together, therefore, the catheter body 92 pressed to the side. 在对组织施加能量之后,组织附着部件94、96然后可再次朝向导管体92移动,并用来再次将组织集合在一起,因此,再次将导管体92挤压到一边。 After the application of energy to tissue, tissue attachment members 94, 96 may then be moved toward the catheter body 92 again, and is used to organize together again, therefore, the catheter body 92 is again pressed to the side. 为了提高这样一技术,导管体92可包括一个或多个光滑的表面,以允许它较容易地滑动到侧边。 In order to improve such a technique, the catheter body 92 may include one or more smooth surfaces, to allow it to more easily slide to the side. 导管体92还可包括一组织焊接物质的涂层、结合物等,诸如每次部分地擦去导管体的白蛋白被挤压到侧边,因此,提高对组织的施加能量而关闭PFO。 The catheter body 92 may further include a solder material coating tissue, binding, etc., as an albumin per wipe the catheter body part is pressed to the side, thus improving the energy applied to tissue to close PFO. 导管体92还可包括一个或多个用来引导位于能量施加部位处的流体的孔,以用作为一焊接流体,或其它方式提高组织的焊接。 The catheter body 92 may further include one or more holes for guiding the fluid is located at the site of energy application, for use as a welding fluid, tissue, or otherwise improve the welding.

在如图9和10所述的实施例以及其它的实施例中,一导管装置也可包括一偏置部件,其用来偏置导管装置朝向PFO的一侧而开始一PFO的关闭手术。 In an embodiment, and other embodiments and 9 in Figure 10, a catheter device may also include a biasing member for biasing the side facing the PFO conduit means starts a surgical PFO closure. 例如,一可膨胀的部件可以与一导管体偶联,通常在导管体的一侧上,这样,当导管装置定位在PFO内且可膨胀的部件膨胀时,导管装置被推压到PFO的一侧。 For example, an expandable member can be coupled with a catheter body, usually on one side of the catheter body, so that, when the catheter device is positioned within the PFO and expanding the expandable member, the catheter device is pressed against a PFO side. 然后,可将组织集合在一起并在该侧上进行焊接,可膨胀的部件可以逐渐地缩小而允许导管装置朝向PFO的另一侧移动,随着它的移动,将组织集合在一起并施加能量。 Then, the tissue can be welded together and on this side, the expandable member may be gradually reduced to allow movement of the other side of the conduit means towards the PFO, as it moves, the tissue together and applying energy . 利用一偏置的丝线、一具有一偏置形状的导管体等可以达到一类似的结果。 Using a biasing thread, a catheter body having a shape like may be biased to achieve a similar result.

现参照图11A-11C,在另一实施例中,一用于治疗PFO的导管装置100包括一导管体106、一第一组织附着部件104和一第二组织附着部件102。 Referring now to Figures 11A-11C, in another embodiment, an apparatus for the treatment of PFO catheter 100 includes a catheter body 106, a first tissue and a second attachment member 104 tissue attachment member 102. 组织附着部件102、104包括形状记忆材料的能量传输部件,其由镍钛诺或任何其它合适形状记忆材料制成。 Tissue attachment members 102, 104 comprises a power transmission member of a shape memory material, which is made of nitinol, or any other suitable shape memory material. 为了展开组织附着部件102、104,导管体106首先前进通过PFO(如图11A所示)。 To deploy the tissue attachment members 102, 104, the catheter body 106 is first advanced through PFO (FIG. 11A). 导管体106然后抽出/撤回,而第二组织附着部件102前进(实心末端的箭头),以使第二组织附着部件102从导管体106的远端释放。 The catheter body 106 is then withdrawn / withdrawn, and the second tissue attachment member 102 forward (solid arrow tip), such that the second tissue attachment member 102 is released from the distal end 106 of the catheter body. 如图11B所示,导管体106然后可再次前进推压第二组织附着部件102的一表面,因此,打开附着部件(实心末端的箭头)而配合在邻近PFO的组织(诸如第一房间隔)上。 11B, the catheter body 106 is then pushed forward again be attached to a surface member 102 of the second tissue pressure, thus, open the attachment member (solid arrow tip) and fitted in tissue adjacent a PFO (such primum) on. 该技术类似于扩开一发夹的两叉。 This technique is similar flared bifurcated a hairpin. 如图11C所示,在放置第二组织附着部件102而与第一房间隔接触之后,可再次缩回导管体106,而第一组织附着部件104可前进而暴露第一部件104。 11C, after the second tissue is placed in contact with 102 spaced from the first attachment member housing, the catheter body 106 may be retracted once again, while the first tissue attachment member 104 may be advanced to expose the first member 104. 然后,诸组织一起集合在两个组织附着部件102、104之间,且组织附着部件102、104用来对组织施加能量而关闭PFO。 Then, a set of various tissue together between two tissue attachment member 102, 102, 104 and tissue attachment member for applying energy to the tissue to close PFO.

图12A和12B示出用来治疗PFO的一导管装置110的另一实施例,其包括一导管体和一对相对的钳夹114。 A conduit means 12A and 12B show a PFO used to treat another 110 embodiment, which includes a catheter body and a pair of opposed jaws 114. 钳夹114可用来抓住邻近PFO的组织,诸如第二房间隔SS和第一房间隔SP的组织,以将它们集合在一起进行能量施加和组织焊接。 Jaw 114 may be used to grasp the tissue adjacent the PFO, tissue such as the second atrial septum primum SS and SP in order to use them together, and energy applied to tissue welding. 钳夹114也可包括能量传输部件,例如,一双极RF装置的两个电极、一单极RF装置的一个电极和一个能量返回部件等。 Jaw 114 may also include an energy transmission means, e.g., a pair of two pole RF electrode device, one electrode of a monopolar RF energy return means and a like member. 在某些实施例中,一个或两个钳夹114可以前进通过(或换句话说,刺入)PFO组织。 In certain embodiments, one or both jaws may be advanced by 114 (or in other words, piercing) PFO tissue. 这里,如虚线所指示的,一个钳夹前进到第一房间隔SP内。 Here, as indicated by a broken line, a jaw primum proceeds to the SP. 图12A示出张开的钳夹114,而图12B示出抽回到一起而将组织拉在一起的钳夹114。 12A shows the jaw 114 open, and FIG. 12B shows the tissue drawn back together to pull the jaw 114 together.

参照图13A和13B,导管装置110显示为两个钳夹114刺入邻近PFO的组织。 Referring to FIGS. 13A and 13B, conduit means 110 displays puncturing tissue adjacent the PFO for the two jaws 114. 再者,图13A中钳夹114张开,而在图13B中拉回在一起而将组织拉到一起。 Further, FIG. 13A open jaw 114, while in FIG 13B is pulled back together the tissue drawn together.

现参照图14,在一实施例中,用于治疗PFO的一导管装置120合适地包括一导管体122和一双叉的“鱼嘴”形组织附着部件124,其具有多个真空孔126用来施加真空力以提高组织的附着。 Referring now to Figure 14, in one embodiment, a catheter device for treating a PFO 120 suitably includes a catheter body 122 and attachment member "fish mouth" shaped tissue one pair of fork 124 having a plurality of vacuum holes 126 for applying a vacuum force to improve the adhesion of the tissue. 如上所述,组织附着叉124可在PFO内展开而将组织集合在一起,然后,真空孔126可用来进一步附着组织。 As described above, tissue attachment fork 124 may be grouped together within the PFO expand tissue, then the vacuum hole 126 may be further attached to tissue. 能量然后可通过组织附着叉124进行施加,在一实施例中,诸组织附着叉可包括双极RF能量传输部件。 Energy may then be applied to tissue attachment fork 124, in one embodiment, the fork may comprise various tissue attachment bipolar RF energy transfer means.

参照图15A和15B,导管装置130的另一实施例合适地包括一导管体132、一抓持组织附着部件134,以及一形状记忆的组织附着部件136。 Referring to FIGS. 15A and 15B, another embodiment of catheter apparatus 130 suitably includes a catheter body 132, a grip 134, and a tissue attachment member of shape memory holding tissue attachment member 136. 这些组织附着部件134、136可以用来从PFO的右和左心房侧接触组织(如图15A所示),然后,用来将组织集合在一起(如图15B所示)。 These tissue attachment members 134, 136 may be used from the right and left atrial tissue of PFO-side contact (FIG. 15A), and then, used to organize together (FIG. 15B). 一个或两个组织附着部件134、136也可用作能量传输部件。 One or two tissue attachment members 134, 136 may be used as energy transfer member.

在图16A和16B中,一导管装置140包括一导管体142、一正极充磁磁体144和一负极充磁磁体146。 In FIGS. 16A and 16B, a conduit means 140 comprises a catheter body 142, a positive charged magnet 144 and a negative charged magnet 146. 磁体144、146用作组织附着部件和能量传输部件的双重作用,如图16B所示,由于磁体的相对的极性,将组织集合在它们之间。 Dual role of energy transfer member and the attachment member is a magnet 144, 146 as tissue, as shown FIG. 16B, since the opposite polarity of the magnets, the set of the tissue therebetween.

在另一实施例中,如图17所示,从右心房内的立体图可见,用来治疗PFO的一导管装置的组织附着部件150可包括一夹具,其包括一用来定位在右心房内的第一夹具臂152和一用来定位在左心房内的第二夹具臂154。 In another embodiment, shown in Figure 17, a perspective view seen from the right atrium for the treatment of a tissue attachment member PFO catheter device 150 may comprise a jig for positioning comprising a right atrium a first clamp arm 152 and positioned within the left atrium for a second clamp arm 154. 然后,两个臂152、154集合在一起而将组织集合在一起。 Then, two sets of arms 152, 154 together the tissue together.

在图18中,再从右心房内的立体图可见,仅示出一个电极162。 In Figure 18, a perspective view of yet seen from the right atrium, only one electrode 162 is shown. 在装置的一实施例中,一相对大的电极162可定位在右心房内并在整个手术过程中大致地保持在同一位置内。 In one embodiment of the device in a relatively large electrode 162 may be positioned within the right atrium and maintained throughout the procedure in substantially the same position. 一较小的电极然后可设置在左心房内并沿着PFO的组织移动而形成组织的点焊164以关闭PFO。 A smaller electrode may then be disposed within the left atrium and the tissue formed spot 164 moves along the tissue to close a PFO PFO. 压力和双极RF能量朝向较小的电极和较大的电极162之间,以将组织集合在一起和施加能量而关闭PFO。 Bipolar RF energy between the pressure and the direction of the smaller and larger electrodes 162 electrodes to the tissue and the application of energy together to close PFO.

现参照图19,在另一实施例中,一用来治疗PFO的导管系统170可包括一具有一第一可膨胀的部件176的第一导管体172、一具有一第二可膨胀的部件178的第二导管体174,以及一导向丝179。 Referring now to Figure 19 members 178, in another embodiment, a catheter system 170 for treatment of a PFO may comprise a first having a first expandable member 176 of the catheter body 172, having a second inflatable a second catheter body 174, and a guidewire 179. 在一实施例中,导向丝从病人身上的一入口点(诸如一股静脉),延伸通过内腔静脉IVC、右心房RA、PFO和左心房LA,然后,通过左心室、大动脉和最终穿出股动脉。 In one embodiment, the guide wire from a point of entry on the patient (such as an intravenous), extending through the lumen of the IVC vein, the right atrium RA, PFO and the left atrium LA, and then, through the left ventricle, the aorta and the final piercing femoral artery. 导管体172、174可沿着该导向丝分别前进到右和左心房内的部位。 172, 174, respectively, the catheter body may be advanced to the right and the left atrium portion along the guide wire. 在一变化的实施例中,可采用两个导向丝,它们可偶联在PFO内或心脏内的某个地方。 In a variant embodiment, the two guide wires may be employed, they may be conjugated or somewhere within the PFO within the heart.

在另一实施例中,如图20A-20C所示,一导管装置180包括一导管体182、一左心房组织附着部件184和一分离的右心房组织附着部件186。 In another embodiment, as shown in FIG. 20A-20C, a conduit means 180 comprises a conduit 182, a left atrial tissue attachment members 184 and a separate right atrial tissue attachment member 186. 图20A从右心房视图中示出导管体182和左心房部件184,使左心房部件184钩住在PFO上而进入左心房内。 View of the right atrium 20A shows the catheter body member 182 and the left atrium 184, the left atrial member 184 is hooked on a PFO and into the left atrium. 图20B是一从钩住到左心房内的左心房部件184的远端的立体图中取出的详图。 20B is a perspective view from the distal end is hooked to the left atrium of the left atrium member 184 taken in detail. 图20C示出就位的左心房部件184和右心房部件186,用来附着PFO的组织。 20C shows member 184 in place of the left atrium and right atrium member 186, attached to PFO tissue. 在一实施例中,左心房部件184可以转动(弧形箭头)而沿PFO的左心房移动钩住的部分,以在多个部位处施加能量。 In one embodiment, the member 184 may be rotated left atrium (curved arrow) along the hooked portion PFO move the left atrium, the energy is applied at multiple sites.

尽管以上的描述是完整和精确的,但它只描述了本发明的几个示范的实施例。 Although the above description is complete and accurate, but it is only a few exemplary embodiments described embodiments of the present invention. 在不脱离本发明范围的前提下,可以对本发明的一个或多个实施例作出各种变化、添加、省略等。 Without departing from the scope of the present invention, may be made to one or more embodiments of the present invention embodiments various modifications, additions, and the like will be omitted. 此外,本发明的不同元件可以组合来达到任何上述的效果。 Furthermore, the different elements of the present invention can be combined to achieve any of the above effects. 因此,提供以上的描述只是为了示范的目的,不应解释为其限制由附后的权利要求书所阐述的本发明的范围。 Accordingly, the foregoing description is for exemplary purposes only and should not be construed as limiting the scope of the present invention as set forth the appended claims set forth herein.

Claims (136)

  1. 1.一治疗心脏内未闭椭圆孔的方法,该方法包括:将一导管装置前进到心脏内的一位置,以便治疗未闭的椭圆孔;使用导管装置,至少部分地将邻近未闭椭圆孔的组织集合在一起;以及用导管装置施加能量到组织,基本上急剧地关闭未闭椭圆孔。 1. The method of oblong hole is not closed within the heart of a treatment, the method comprising: advancing a catheter device to a location within the heart, for the treatment of non-elliptic hole closed; catheter means, at least partially non-adjacent the closed oblong hole tissue together; and applying energy to the tissue with conduit means, substantially abruptly closed oblong hole is not closed.
  2. 2.如权利要求1所述的方法,其特征在于,在施加能量之前将组织集合在一起。 2. The method according to claim 1, characterized in that, prior to application of energy to tissue together.
  3. 3.如权利要求2所述的方法,其特征在于,还包括将组织保持在一起,同时施加能量。 The method according to claim 2, characterized by further comprising holding the tissue together while applying energy.
  4. 4.如权利要求3所述的方法,其特征在于,还包括在施加能量之后将组织保持在一起而允许它们冷却。 4. The method according to claim 3, wherein, further comprising, after application of energy to hold the tissue together while allowing them to cool.
  5. 5.如权利要求4所述的方法,其特征在于,还包括:将导管装置的至少部分移动到相对于组织的不同位置;再次至少部分地将组织集合在一起;以及再次对组织施加能量。 5. The method according to claim 4, characterized in that, further comprising: at least a portion of the conduit means moving to different positions relative to the tissue; at least partially re-organize together; and again applying energy to tissue.
  6. 6.如权利要求5所述的方法,其特征在于,还包括在沿着未闭椭圆孔的多个部位处重复移动,将组织集合在一起,以及施加能量诸步骤。 6. The method according to claim 5, characterized in further comprising a plurality of mobile repeated along elliptical hole is not closed at the site of the tissue together, and the step of applying various energy.
  7. 7.如权利要求6所述的方法,其特征在于,重复移动、将组织集合在一起、以及施加能量诸步骤在未闭椭圆孔的第一侧开始,并横贯未闭椭圆孔继续到第二侧。 7. The method according to claim 6, characterized in that the movement is repeated, the tissue together, and the step of applying energy at a first side of such elliptical hole is not closed start, and not closed oblong hole traversing proceeds to the second side.
  8. 8.如权利要求7所述的方法,其特征在于,还包括在首先将组织集合在一起之前,使用导管上的一偏置装置,偏置导管装置的至少部分朝向第一侧。 8. The method according to claim 7, characterized in further comprising a first tissue together prior to using a catheter biasing means, the biasing means at least a portion of the conduit toward the first side.
  9. 9.如权利要求7所述的方法,其特征在于,移动导管体的至少部分包括:将组织集合在两个能量传输部件之间,其中,组织抵靠导管装置的一导管体而集合在一起,其中,使组织抵靠导管体集合在一起可将导管体推到不同的位置。 9. The method according to claim 7, wherein moving at least part of the catheter body comprising: a set of tissue between two energy transfer member, wherein the tissue against a conduit and fluid conduit means together wherein the catheter body tissue together against the catheter body may be pushed to a different position.
  10. 10.如权利要求7所述的方法,其特征在于,移动导管装置的至少部分包括:将至少一个能量传输部件移动到不同位置。 10. The method according to claim 7, characterized in that at least part of the movement of the catheter apparatus comprising: at least one energy transmission member moves to a different location.
  11. 11.如权利要求10所述的方法,其特征在于,移动导管装置的至少部分包括:将两个能量传输部件移动到不同位置。 11. The method according to claim 10, wherein moving at least part of the conduit means comprises: a moving energy transfer member to the two different positions.
  12. 12.如权利要求11所述的方法,其特征在于,移动导管装置的至少部分还包括:将一导管体移动到不同位置。 12. The method according to claim 11, characterized in that at least part of movement of the catheter device further comprising: a catheter body will move to a different location.
  13. 13.如权利要求4所述的方法,其特征在于,还包括在施加能量之后有效地冷却组织。 13. The method according to claim 4, characterized in that, further comprising effectively cooled after energy application tissue.
  14. 14.如权利要求1所述的方法,其特征在于,前进导管包括:将导管的第一远端部分定位在心脏的右心房内。 14. The method according to claim 1, characterized in that the advancing catheter comprising: a first distal portion of the catheter is positioned within the right atrium of the heart.
  15. 15.如权利要求14所述的方法,其特征在于,前进导管还包括:前进导管的一第二远端部分至少部分地通过未闭椭圆孔。 15. The method according to claim 14, wherein advancing the catheter further comprising: advancing a second catheter distal end portion at least partially through the oblong hole is not closed.
  16. 16.如权利要求15所述的方法,其特征在于,还包括前进第二远端部分通过未闭椭圆孔进入左心室内。 16. The method according to claim 15, characterized in that, further comprising a second distal portion proceeds through the oblong hole ovale into the left ventricle.
  17. 17.如权利要求15所述的方法,其特征在于,还包括缩回一导管体或护套,以至少暴露第二远端部分。 17. The method according to claim 15, characterized in that, further comprising a catheter body or sheath is retracted to expose at least a second distal portion.
  18. 18.如权利要求15所述的方法,其特征在于,至少部分地将组织集合在一起包括:通过操纵第一和第二远端部分中的至少一个来对组织施加力。 18. The method according to claim 15, characterized in that, at least in part the tissue together comprising: manipulating the first and second distal portions of the at least one force is applied to the tissue.
  19. 19.如权利要求18所述的方法,其特征在于,将组织集合在一起包括:操纵第一和第二远端部分中的一个来对组织施加力;以及将第一和第二远端部分中的另一个保持在一相对稳定的位置内,以用作为一可抵靠而将组织集合在一起的表面。 And combining the first and second distal end portion; actuating a first and second distal portion to apply force to the tissue: 19. The method according to claim 18, wherein the tissue together comprising the other holding in a relatively stable position, for use as a surface abut together and against the tissue.
  20. 20.如权利要求18所述的方法,其特征在于,将组织集合在一起包括:朝向彼此地移动第一和第二远端部分,以将组织集合在它们之间。 20. The method according to claim 18, wherein the tissue together comprising: first and second distal ends are moved towards each other part, in order to set the tissue therebetween.
  21. 21.如权利要求18所述的方法,其特征在于,将组织集合在一起包括:膨胀在第一和第二远端部分的至少一个上的至少一个可膨胀的部件。 21. The method according to claim 18, wherein the tissue together comprising: expanding at least one of the at least one inflatable member on the distal end of the first and second portions.
  22. 22.如权利要求21所述的方法,其特征在于,将组织集合在一起包括:膨胀在第一远端部分上的一第一可膨胀的部件;以及膨胀在第二远端部分上的一第二可膨胀的部件。 22. The method according to claim 21, wherein the tissue together comprising: a first expanded in a distal end portion of the first inflatable member; and an expansion portion on a distal end of the second the second expandable member.
  23. 23.如权利要求22所述的方法,其特征在于,还包括沿导管装置朝向另一可膨胀的部件轴向地移动第一和第二可膨胀的部件中的至少一个,以将组织集合在它们之间。 23. The method according to claim 22, characterized in that, along the catheter device further comprising an expandable member toward the other moves the first and second axially expandable member at least one to tissue collection between them.
  24. 24.如权利要求18所述的方法,其特征在于,操纵第一和第二远端部分中的至少一个包括:前进至少一个部分进入邻近未闭椭圆孔的组织之一内。 24. The method according to claim 18, wherein actuating the first and second distal portion comprises at least one of: at least a forward portion adjacent the tissue into one elliptical hole is not closed.
  25. 25.如权利要求24所述的方法,其特征在于,第一远端部分前进到第二房间隔组织内。 25. The method according to claim 24, wherein the first distal end portion proceeds into the second atrial septal tissue.
  26. 26.如权利要求25所述的方法,其特征在于,第二远端部分前进到第一房间隔组织内,其中,第一和第二远端部分集合在一起而将组织集合在一起。 26. The method according to claim 25, wherein the second distal portion proceeds into the first atrial septal tissue, wherein the first and second distal portion together while the tissue together.
  27. 27.如权利要求16所述的方法,其特征在于,将组织集合在一起包括:在第一和第二远端部分之间施加磁性吸力。 27. The method according to claim 16, wherein the tissue together comprising: applying a magnetic attraction between the first and second distal portion.
  28. 28.如权利要求1所述的方法,其特征在于,前进导管包括:前进导管的可膨胀的远端部分至少部分地通过未闭椭圆孔,该可膨胀的远端部分设置在一护套内。 28. The method according to claim 1, characterized in that the advancing catheter comprising: advancing an expandable catheter distal portion at least partially by an elliptical hole is not closed, the expandable distal portion is disposed within a sheath .
  29. 29.如权利要求28所述的方法,其特征在于,将组织集合在一起包括:缩回护套而暴露可膨胀的远端部分,因此,允许其膨胀而将组织在可膨胀部件的诸部分之间集合在一起。 29. The method according to claim 28, wherein the tissue together comprising: a retractable sheath to expose the distal portion of expandable, thus allowing it to various portions of the tissue expansion of the expandable member together between.
  30. 30.如权利要求1所述的方法,其特征在于,施加能量包括:施加以下至少一种能量:射频能、低温能、电阻加热能、超声波能、微波能和激光能。 30. The method according to claim 1, wherein applying energy comprises: at least one of applying energy: RF energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy and laser energy.
  31. 31.如权利要求30所述的方法,其特征在于,施加单极射频能和双极射频能中的至少一个。 31. The method according to claim 30, wherein the RF energy is applied monopolar and bipolar radiofrequency energy to at least one.
  32. 32.如权利要求30所述的方法,其特征在于,施加能量包括对导管装置的一单一传导部件通电 32. The method according to claim 30, wherein applying energy comprises a single conductive member for power conduit means
  33. 33.如权利要求30所述的方法,其特征在于,施加能量包括对导管装置的多个传导部件通电。 33. The method according to claim 30, wherein the energy is applied to the plurality of conductive members comprising a catheter device is energized.
  34. 34.如权利要求30所述的方法,其特征在于,施加能量包括:对导管装置内的至少一种传导流体通电;以及从导管装置内释放传导的流体以接触组织。 34. The method according to claim 30, wherein applying energy comprises: at least one power-transfer fluid in the conduit means; and releasing from the conductive fluid within the conduit means to contact the tissue.
  35. 35.如权利要求34所述的方法,其特征在于,对传导流体通电包括:对设置在导管装置的至少一个可膨胀的部件内的流体施加射频能。 35. The method according to claim 34, wherein the power transfer fluid comprising: applying RF energy to the fluid is disposed within the at least one inflatable member of the catheter device.
  36. 36.如权利要求35所述的方法,其特征在于,流体包括盐水溶液。 36. The method according to claim 35, wherein the fluid comprises a saline solution.
  37. 37.如权利要求35所述的方法,其特征在于,释放传导的流体包括:允许流体流出位于至少一个可膨胀的部件内的至少一个孔。 37. The method according to claim 35, wherein the conductive fluid comprises release: allow fluid to flow at least one aperture located in at least one expandable member.
  38. 38.如权利要求37所述的方法,其特征在于,还包括引导流体进入可膨胀的部件内。 38. The method according to claim 37, wherein further comprising guiding the fluid into the inflatable member.
  39. 39.如权利要求1所述的方法,其特征在于,施加能量包括使组织内的胶原质改性。 39. The method according to claim 1, wherein applying energy comprises collagen modified within the tissue.
  40. 40.如权利要求1所述的方法,其特征在于,还包括监视施加到组织的能量大小。 40. The method according to claim 1, characterized by further comprising monitoring the amount of energy applied to the tissue.
  41. 41.如权利要求40所述的方法,其特征在于,监视能量大小包括:监视组织的温度。 41. The method according to claim 40, characterized in that, the monitoring of energy comprising: monitoring the temperature of tissue.
  42. 42.如权利要求40所述的方法,其特征在于,监视能量大小包括监视组织的阻抗。 42. The method according to claim 40, wherein the size of the energy monitoring comprises monitoring tissue impedance.
  43. 43.如权利要求40所述的方法,其特征在于,还包括确定何时已经对组织施加了足够的能量而基本上急剧地关闭未闭椭圆孔。 43. The method according to claim 40, wherein further comprising determining when the tissue has sufficient energy is applied to rapidly substantially elliptical hole is not closed off.
  44. 44.如权利要求43所述的方法,其特征在于,还包括当已经施加了足够的能量时停止能量的施加。 44. The method according to claim 43, wherein further comprising stopping energy when enough energy has been applied is applied.
  45. 45.如权利要求1所述的方法,其特征在于,还包括利用与导管装置偶联的至少一个可视装置直接地观看未闭椭圆孔和组织。 45. The method according to claim 1, characterized in that the apparatus further comprises at least one visual device using the coupling of the catheter directly viewing uncompleted closed oblong hole and tissue.
  46. 46.一治疗心脏内未闭椭圆孔的方法,该方法包括:将一导管装置前进到心脏内的一位置,以便治疗未闭的椭圆孔;使用导管装置,将邻近未闭椭圆孔的组织至少部分地集合在一起;用导管装置对组织施加能量,同时,至少部分地将组织保持在一起;以及在施加能量之后至少部分地将组织保持在一起并持续一足够的时间,从而基本上关闭未闭椭圆孔。 The method is not closed within a heart 46. The oblong hole treatment, the method comprising: advancing a catheter device to a location within the heart, for the treatment of non-elliptic hole closed; catheter device, tissue adjacent to the oblong hole is at least not closed partially together; applying energy to tissue with the catheter device, while the tissue remains at least partially together; and at least partially hold the tissue together and a sufficient duration of time after the application of energy, thereby not substantially close closed oblong hole.
  47. 47.一治疗心脏内未闭椭圆孔的导管装置,该导管装置包括:一细长的导管体,具有一近端和一远端;至少一个组织附着部件,位于导管体远端或其附近,以便至少部分地将邻近未闭椭圆孔的组织集合在一起;以及至少一个能量传输部件,位于远端或其附近,以便对组织施加能量,从而基本上急剧地关闭未闭椭圆孔。 Means a treatment catheter 47. elliptical hole ovale in the heart, the catheter comprising: an elongated catheter body having a proximal end and a distal end; at least one tissue attachment member, located at or near the distal end of the catheter body, to at least partially the tissue adjacent the oblong hole is not closed together; and at least one energy transmission means, located at or near the distal end, to apply energy to tissue, thereby substantially abruptly closed oblong hole is not closed.
  48. 48.如权利要求47所述的导管装置,其特征在于,至少一个组织附着部件至少包括第一组织附着部件,以便从心脏的右心房接触邻近未闭椭圆孔的组织。 48. The catheter device according to claim 47, wherein the at least one tissue attachment means comprises at least a first tissue attachment member so as to contact tissue adjacent the oblong hole is not closed from the right atrium of the heart.
  49. 49.如权利要求48所述的导管装置,其特征在于,至少一个组织附着部件还至少包括第二组织附着部件,以便从右心房接触邻近未闭椭圆孔的组织。 49. The catheter device according to claim 48, wherein the at least one tissue attachment means further comprises at least a second tissue attachment member for contacting the adjacent tissue from the right atrium is not closed elliptical hole.
  50. 50.如权利要求49所述的导管装置,其特征在于,第一和第二组织附着部件包括相对的钳夹,其中,第一和第二部件中的至少一个可前进通过邻近未闭椭圆孔的组织。 50. The catheter device according to claim 49, characterized in that the first attachment member and the second tissue includes opposing jaw, wherein the first and second components may proceed through at least one oblong hole adjacent ovale organization.
  51. 51.如权利要求50所述的导管装置,其特征在于,第一附着部件前进通过第二房间隔组织,而第二附着部件前进通过第一房间隔组织。 51. The catheter device according to claim 50, characterized in that the first attachment member advanced through septum secundum tissue, and the second attachment member primum advanced through tissue.
  52. 52.如权利要求48所述的导管装置,其特征在于,至少一个组织附着部件还至少包括第二组织附着部分,用来前进通过未闭椭圆孔以从心脏的左心房接触组织。 52. The catheter device according to claim 48, wherein the at least one tissue attachment means further comprises at least a second tissue portion is attached, by advancing to the left atrium from the heart tissue in contact with oval holes are not closed.
  53. 53.如权利要求52所述的导管装置,其特征在于,第一和第二组织附着部件中的至少一个包括一可膨胀部件。 53. The catheter device according to claim 52, characterized in that the first attachment member and the second tissue includes at least one inflatable member.
  54. 54.如权利要求53所述的导管装置,其特征在于,第一和第二组织附着部件两者包括可膨胀部件,其中,至少一个可膨胀部分沿导管体可滑动地设置,以便可沿轴向朝向另一可膨胀部件移动。 54. The catheter device according to claim 53, wherein both the first and second tissue attachment member comprises an expandable member, wherein the at least one inflatable portion along the catheter body is slidably disposed so as to be along the shaft another expandable member is moved toward.
  55. 55.如权利要求53所述的导管装置,其特征在于,至少一个可膨胀的部件包括至少一个孔,用来释放传导流体以接触组织。 55. The catheter device according to claim 53, wherein the at least one expandable member comprises at least one aperture for releasing transfer fluid to contact the tissue.
  56. 56.如权利要求55所述的导管装置,其特征在于,至少一个可膨胀的部件包括多个小孔,用来释放传导流体。 56. The catheter device according to claim 55, wherein the at least one expandable member comprises a plurality of holes for releasing transfer fluid.
  57. 57.如权利要求55所述的导管装置,其特征在于,第一和第二部件中的一个包括一可膨胀部件,而第一和第二部件中的另一个包括一可展开的成形部分,其中,可膨胀部件和成形部分集合在一起以将组织集合在一起。 57. The catheter device according to claim 55, wherein the first and second components comprises an expandable member, and the other of the first and the second member comprises a shaped expandable portion, wherein the expandable member together forming portion and to the tissue together.
  58. 58.如权利要求57所述的导管装置,其特征在于,可展开的成形部分包括一形状记忆材料,当从导管体中释放时,其从一未展开的形状变化到一展开的形状。 58. The catheter device according to claim 57, wherein the expandable portion comprises forming a shape memory material, when released from the catheter body, which is a change from an undeployed to a deployed shape shape.
  59. 59.如权利要求52所述的导管装置,其特征在于,第一和第二组织附着部件包括一用于将组织夹紧在一起的夹具。 59. The catheter device according to claim 52, characterized in that the first and second tissue attachment means comprises a means for clamping together the clamp tissue.
  60. 60.如权利要求52所述的导管装置,其特征在于,第一组织附着部件具有一第一展开形状,而第二组织附着部件具有一第二展开形状,其中,当展开而接触组织时,第一和第二部件致使组织集合在一起。 60. The catheter device according to claim 52, wherein the first tissue attachment member having a first deployment shape and a second member having a second tissue attachment deployed shape, wherein, when deployed to contact tissue, The first and second member together causing tissue.
  61. 61.如权利要求60所述的导管装置,其特征在于,第一形状大致包括弧形的钩,用来在未闭椭圆孔的边缘上弯曲,以便从左心房对组织施加力,其中,第二形状大致包括直线形的形状,以便从右心房对组织施加压力。 61. The catheter device according to claim 60, wherein the first shape comprises a substantially arcuate hook used to bend the upper edge of the oblong hole is not closed, a force is applied to the left atrial tissue, wherein the first shape comprising two substantially rectilinear shape, so as to exert pressure on the right atrial tissue.
  62. 62.如权利要求52所述的导管装置,其特征在于,第一和第二组织附着部件包括具有相对极性的磁体。 62. The catheter device according to claim 52, characterized in that the first and second tissue attachment member comprises a magnet having opposite polarity.
  63. 63.如权利要求52所述的导管装置,其特征在于,第一组织附着部件包括一对相对的钳夹,以便从右心房接触第二房间隔,以及第二组织附着部件包括一弧形部件,以便前进通过未闭椭圆孔而从左心房接触第一房间隔。 63. The catheter device according to claim 52, wherein the first tissue attachment member comprises a pair of opposed jaws for contacting a second housing spaced from the right atrium, and the second member comprises an arcuate tissue attachment member , progresses to the left atrium via atrial septal contact with the first oblong hole is not closed.
  64. 64.如权利要求47所述的导管装置,其特征在于,至少一个组织附着部件包括:至少两个组织附着部件用来相对于彼此移动而将组织集合在它们之间;以及至少一个偏置部件,用来偏置组织附着部件朝向未闭椭圆孔的第一侧。 64. The catheter device according to claim 47, wherein the at least one tissue attachment means comprises: at least two tissue attachment member to move relative to each other in the collection of tissue therebetween; and at least one biasing member for tissue adhesion member biased toward the first elliptical hole is not closed side.
  65. 65.如权利要求64所述的导管装置,其特征在于,组织附着部件可沿未闭椭圆孔从未闭椭圆孔的第一侧移动到相对的第二侧。 65. The catheter device according to claim 64, wherein the tissue attachment members may be moved along the first side of the elliptical hole ovale never closed oblong hole to an opposite second side.
  66. 66.如权利要求65所述的导管装置,其特征在于,导管体具有这样一截面形状,当将组织集合在两个组织附着部件之间时,组织将导管体推到相对于未闭椭圆孔的不同位置。 66. The catheter device according to claim 65, wherein the catheter body has a cross-sectional shape, when the tissue between the attachment member set of two organizations, organizations will push the catheter body is not closed with respect to the oblong hole different locations.
  67. 67.如权利要求66所述的导管装置,其特征在于,形状选自于以下的组群:三角形、卵形、椭圆形和钻石形。 67. The catheter device according to claim 66, wherein a shape selected from the following group: triangular, oval, elliptical and diamond shaped.
  68. 68.如权利要求66所述的导管装置,其特征在于,两个组织附着部件包括:一个形状记忆组织附着部件;以及一个钳夹部件。 68. The catheter device according to claim 66, characterized in that the two tissue attachment means comprising: a shape memory member is attached tissue; and a jaw member.
  69. 69.如权利要求66所述的导管装置,其特征在于,还包括至少一个位于导管体上用来释放一种或多种流体的孔,以提高对组织施加能量,从而关闭未闭椭圆孔。 69. The catheter device according to claim 66, characterized in that further comprises at least one aperture for release of one or more fluids from the catheter body to increase the energy applied to the tissue, thereby closing the oblong hole is not closed.
  70. 70.如权利要求66所述的导管装置,其特征在于,还包括导管体上的一涂层,当组织接触导管体时,该涂层提高对组织施加能量。 70. The catheter device according to claim 66, characterized in that, further comprising a coating on the catheter body, the catheter body when the tissue-contacting, the coating is applied to increase the energy to the tissue.
  71. 71.如权利要求47所述的导管装置,其特征在于,至少一个组织附着部件包括可释放地设置在导管体内的可膨胀的部件,其中,前进可膨胀部件突出导管体的远端,或相对于可膨胀部件缩回导管体,以允许可膨胀部件在未闭椭圆孔内膨胀。 71. The catheter device according to claim 47, wherein the attachment means comprises at least one tissue releasably disposed in the catheter body expandable member, wherein the distal end of the expandable member projecting forward of the catheter body, or relative the expandable member on the catheter body is retracted to allow the expandable member is not expanded closed elliptical hole.
  72. 72.如权利要求71所述的导管装置,其特征在于,可膨胀部件包括两个叉,它们张开而对邻近未闭椭圆孔的组织提供侧向力。 72. The catheter device according to claim 71, wherein the expandable member comprises two prongs which provide lateral force to spread the tissue adjacent the elliptical hole is not closed.
  73. 73.如权利要求72所述的导管装置,其特征在于,诸叉不延伸入心脏的左心房内。 73. The catheter device according to claim 72, wherein all prongs do not extend into the left atrium of the heart.
  74. 74.如权利要求72所述的导管装置,其特征在于,诸叉是弹簧加载的。 74. The catheter device according to claim 72, wherein the various fork is spring loaded.
  75. 75.如权利要求72所述的导管装置,其特征在于,诸叉包括一形状记忆材料。 75. The catheter device according to claim 72, wherein all prongs comprising a shape memory material.
  76. 76.如权利要求72所述的导管装置,其特征在于,诸叉包括至少一个真空孔,用来施加真空力以进一步将组织集合在一起。 76. The catheter device according to claim 72, wherein all prongs comprises at least one vacuum orifice for applying a vacuum force to further secure the tissue together.
  77. 77.如权利要求47所述的导管装置,其特征在于,还包括一导向部件,以便前进通过未闭椭圆孔,其中,导管装置可滑动地设置在导向部件上。 77. The catheter device according to claim 47, characterized in that, further comprising a guide member to be advanced through the oblong hole is not closed, wherein the conduit means is slidably disposed on the guide member.
  78. 78.如权利要求77所述的导管装置,其特征在于,导向部件包括一沿着其长度的一部分划分的导向丝,该划分的部分包括可膨胀的形状记忆材料。 78. The catheter device according to claim 77, wherein the guide member comprises a portion of partitioning a guidewire along its length, the partitioned portion comprises a shape memory material may be expandable.
  79. 79.如权利要求77所述的导管装置,其特征在于,导向部件包括至少一个末端,用来接触邻近未闭椭圆孔的组织的左心房表面。 79. The catheter device according to claim 77, wherein the guide member comprises at least one end surface of the left atrium, adjacent to the contact hole is not closed oval tissue.
  80. 80.如权利要求79所述的导管装置,其特征在于,至少一个末端可与左心房表面相一致。 80. The catheter device according to claim 79, characterized in that at least one end may coincide with the surface of the left atrium.
  81. 81.如权利要求79所述的导管装置,其特征在于,导向部件可缩回而接合至少一个末端与左心房表面。 81. The catheter device according to claim 79, wherein the guide member may be retracted to engage at least one end surface of the left atrium.
  82. 82.如权利要求77所述的导管装置,其特征在于,导向部件包括至少一个能量传输部件。 82. The catheter device according to claim 77, wherein the guide member comprises at least one energy transmission member.
  83. 83.如权利要求82所述的导管装置,其特征在于,导向部件包括一可膨胀部件以便在未闭椭圆孔内膨胀,其中,可膨胀部件包括至少一个射频能传输部件。 83. The catheter device according to claim 82, wherein the guide member comprises an expandable member to expand in an elliptical hole is not closed, wherein the expandable member comprises at least one radio frequency power transmission member.
  84. 84.如权利要求47所述的导管装置,其特征在于,至少一个能量传输部件传输以下能量中的至少一个能量:射频能、低温能、电阻加热能、超声波能、微波能和激光能。 84. The catheter device according to claim 47, wherein the at least one energy transmission means transmitting the at least one energy in the energy: RF energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy and laser energy.
  85. 85.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件可相对于至少一个组织附着部件移动。 85. The catheter device according to claim 84, wherein the at least one energy transmission member is movable relative to the at least one mobile tissue attachment member.
  86. 86.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件与至少一个组织附着部件偶联。 86. The catheter device according to claim 84, wherein the at least one energy transmission member and the coupling member attached to at least one tissue.
  87. 87.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件包括该至少一个组织附着部件。 87. The catheter device according to claim 84, wherein the at least one energy transmission member comprises at least one tissue of the attachment member.
  88. 88.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件包括至少一个单极射频传输部件。 88. The catheter device according to claim 84, wherein the at least one energy transmission member comprises at least one monopolar RF transmission member.
  89. 89.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件包括至少两个双极射频传输部件。 89. The catheter device according to claim 84, wherein the at least one energy transmission member comprises at least two bipolar RF transfer member.
  90. 90.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件包括:至少一个射频传输部件,设置在一可膨胀部件内,该可膨胀部件包括至少一个孔用来释放流体而接触组织;以及至少一种传导流体设置在可膨胀部件内,并暴露于射频传输部件。 90. The catheter device according to claim 84, wherein the at least one energy transmission member comprising: at least one radio frequency transmission means, disposed within an expandable member, the expandable member includes at least one aperture for releasing fluid contacting tissue; transfer fluid and at least one expandable member disposed within, and exposed to RF transmission member.
  91. 91.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件包括至少一个弧形的射频传输部件。 91. The catheter device according to claim 84, wherein the at least one energy transmission member comprises at least one arcuate member of the RF transmission.
  92. 92.如权利要求84所述的导管装置,其特征在于,至少一个能量传输部件包括网材料和编结材料中的至少一个。 92. The catheter device according to claim 84, wherein the at least one energy transmission member comprises a braided mesh material and at least one material.
  93. 93.如权利要求47所述的导管装置,其特征在于,至少一个能量传输部件包括一导向部件,用来前进通过未闭椭圆孔。 93. The catheter device according to claim 47, wherein the at least one energy transmission means comprises a guide member for advancing through the oblong hole is not closed.
  94. 94.如权利要求93所述的导管装置,其特征在于,导向部件包括至少一个可膨胀的部分,以便在未闭椭圆孔内膨胀,从而至少部分地将邻近未闭椭圆孔的组织集合在一起。 94. The catheter device according to claim 93, wherein the guide member comprises at least one inflatable portion, so as not closed oval hole expansion, thereby at least partially non-adjacent tissue elliptical hole closed together .
  95. 95.如权利要求47所述的导管装置,其特征在于,还包括至少一个与导管装置偶联的传感器,以便检测由至少一个能量传输部件供应给组织的能量。 95. The catheter device according to claim 47, characterized in that, further comprising at least one sensor coupled to the conduit means to detect the energy supplied by the energy transmission means to the at least one tissue.
  96. 96.如权利要求95所述的导管装置,其特征在于,从以下组群中选择至少一个传感器:红外线传感器、热敏电阻和热电偶。 96. The catheter device according to claim 95, wherein the at least one sensor selected from the group comprising: an infrared sensor, a thermistor and a thermocouple.
  97. 97.如权利要求95所述的导管装置,其特征在于,还包括一与至少一个传感器偶联的微处理器,以便处理检测到的数据来确定供应的能量何时已经达到所要求的能量。 97. The catheter device according to claim 95, characterized in that, further comprising a sensor coupled with at least one microprocessor, to process the data detected to determine when the energy supply has reached the required energy.
  98. 98.如权利要求47所述的导管装置,其特征在于,还包括一与导管装置偶联的微处理器,以便检测和控制由能量传输部件传输的能量。 98. The catheter device according to claim 47, characterized in that, further comprising a microprocessor coupled to the conduit means to detect and control the energy transmitted by the energy transmission means.
  99. 99.一用来治疗心脏内未闭椭圆孔的系统,该系统包括:一导管装置,包括:一细长的导管体,具有一近端和一远端;至少一个组织附着部件,位于导管体远端处或其附近,以便至少部分地将邻近未闭椭圆孔的组织集合在一起;以及至少一个能量传输部件,位于远端处或其附近,以便对组织施加能量,从而基本上关闭未闭椭圆孔;以及至少一个导向部件,用来导向导管装置到一位置以便治疗未闭椭圆孔。 99. A system for treating a heart is not closed within the elliptical hole, the system comprising: a catheter device, comprising: an elongated catheter body having a proximal end and a distal end; at least one tissue attachment member, located in the catheter body or near the distal end, so as to at least partially non-adjacent tissue elliptical hole closed together; and at least one energy transmission means, located at or near the distal end, to apply energy to tissue to substantially close the ductus elliptical hole; and at least one guide member, means for guiding the catheter to a treatment position for an elliptical hole is not closed.
  100. 100.如权利要求99所述的系统,其特征在于,至少一个组织附着部件至少包括第一组织附着部件,用来从心脏的右心房接触邻近未闭椭圆孔的组织。 100. The system according to claim 99, wherein the at least one tissue attachment means comprises at least a first tissue attachment member for contacting the right atrium of the heart tissue adjacent the elliptical hole is not closed.
  101. 101.如权利要求100所述的系统,其特征在于,至少一个组织附着部件还至少包括第二组织附着部分,用来从右心房接触邻近未闭椭圆孔的组织。 101. The system according to claim 100, wherein the at least one tissue attachment means further comprises at least a second tissue attachment portion for contacting tissue adjacent the right atrium elliptical hole is not closed.
  102. 102.如权利要求101所述的系统,其特征在于,第一和第二组织附着部件包括相对的钳夹,其中,第一和第二部件中的至少一个可前进通过邻近未闭椭圆孔的组织。 102. The system according to claim 101, wherein the first attachment member and the second tissue includes opposing jaw, wherein the first and second components may proceed through at least one elliptical hole adjacent ovale organization.
  103. 103.如权利要求102所述的系统,其特征在于,第一附着部件前进通过第二房间隔组织,而第二附着部件前进通过第一房间隔组织。 103. The system according to claim 102, wherein the first attachment member advanced through septum secundum tissue, and the second attachment member primum advanced through tissue.
  104. 104.如权利要求100所述的系统,其特征在于,至少一个组织附着部件还至少包括第二组织附着部分,用来从心脏的左心房接触邻近未闭椭圆孔的组织。 104. The system according to claim 100, wherein the at least one tissue attachment means further comprises at least a second tissue attachment portion for contact with the tissues of the heart from the left atrium adjacent the elliptical hole is not closed.
  105. 105.如权利要求104所述的系统,其特征在于,第二组织附着部件可前进通过未闭椭圆孔进入左心房内以接触组织。 105. The system according to claim 104, wherein the second attachment member may be advanced through the tissue ovale into the left atrium oblong hole to contact the tissue.
  106. 106.如权利要求105所述的系统,其特征在于,第一和第二组织附着部件中的至少一个包括一可膨胀的部件。 106. The system according to claim 105, wherein the first attachment member and the second tissue includes at least one inflatable member.
  107. 107.如权利要求106所述的系统,其特征在于,第一和第二组织附着部件两者包括可膨胀的部件,其中,可膨胀部件中的至少一个沿着导管体可滑动地设置,以便可轴向地朝向另一可膨胀部件移动。 107. The system according to claim 106, wherein the first attachment member and the second tissue includes both the expandable member, wherein the at least one slidably disposed along the catheter body may be expandable member in order to It is axially moved toward the other expandable member.
  108. 108.如权利要求106所述的系统,其特征在于,至少一个可膨胀部件包括至少一个孔,用来释放传导的流体而接触组织。 108. The system according to claim 106, wherein the at least one inflatable member comprises at least one aperture for the release of fluid conducting contact tissue.
  109. 109.如权利要求108所述的系统,其特征在于,至少一个可膨胀部件包括多个小孔,用来释放传导的流体。 109. The system according to claim 108, wherein the at least one expandable member comprises a plurality of apertures for conducting fluid release.
  110. 110.如权利要求108所述的系统,其特征在于,第一和第二部件中的一个包括一可膨胀部件,而第一和第二部件中的另一个包括一可展开成形部分,其中,可膨胀部件和成形部分集合在一起而将组织集合在一起。 110. The system according to claim 108, wherein the first and second components comprises an expandable member, and the other of the first and the second member comprises a shaped expandable portion, and the expandable member together forming part of the tissue together.
  111. 111.如权利要求110所述的系统,其特征在于,可展开的成形部分包括一形状记忆材料,当从导管体释放时,该材料从一未展开的形状变化到一展开的形状。 111. The system of claim 110, wherein the expandable shaped portion comprises a shape memory material, when released from the catheter body, the material is changed from a non-deployed shape to a deployed shape.
  112. 112.如权利要求104所述的系统,其特征在于,第一和第二组织附着部件包括一用来将组织夹紧在一起的夹具。 112. The system of claim 104, wherein the first and second tissue comprises a member for attaching the tissue clip clamped together.
  113. 113.如权利要求99所述的系统,其特征在于,至少一个组织附着部件包括:至少两个组织附着部件,用来相对于彼此移动,以将组织集合在它们之间;以及至少一个偏置部件,用来偏置组织附着部件朝向未闭椭圆孔的第一侧。 113. The system according to claim 99, wherein the at least one tissue attachment means comprising: at least two tissue attachment member for movement relative to each other to set the tissue therebetween; and at least one biasing means for biasing the member toward the first side of the tissue attachment is not closed elliptical hole.
  114. 114.如权利要求113所述的系统,其特征在于,组织附着部件可沿着未闭椭圆孔从未闭椭圆孔的第一侧移动到相对侧。 114. The system of claim 113, wherein the first side of the tissue apposition member may never move close along the elliptical hole ovale oblong hole to the opposite side.
  115. 115.如权利要求99所述的系统,其特征在于,至少一个组织附着部件包括一可释放地设置在导管体内的可膨胀的部件,其中,前进可膨胀部件突出导管体的远端,以允许可膨胀部件在未闭椭圆孔内膨胀。 115. The system according to claim 99, wherein the at least one tissue attachment member comprises a releasably disposed in the catheter body expandable member, wherein the expandable member projecting forward distal end of catheter body to allow the expandable member is not expanded closed elliptical hole.
  116. 116.如权利要求115所述的系统,其特征在于,可膨胀的部件包括至少两个部件,它们张开而对邻近未闭椭圆孔的组织提供侧向力。 116. The system of claim 115, wherein the expandable member comprises at least two parts, they provide lateral force to spread the tissue adjacent the elliptical hole is not closed.
  117. 117.如权利要求116所述的系统,其特征在于,暴露的膨胀部件提供侧向力,而不延伸入心脏的左心房内。 117. The system according to claim 116, wherein the expandable member to provide exposed lateral force, without extending into the left atrium of the heart.
  118. 118.如权利要求116所述的系统,其特征在于,可膨胀部件包括一弹簧加载的部件。 118. The system of claim 116, wherein the expandable member comprises a spring-loaded member.
  119. 119.如权利要求116所述的系统,其特征在于,可膨胀部件包括一形状记忆材料。 119. The system of claim 116, wherein the expandable member comprises a shape memory material.
  120. 120.如权利要求99所述的系统,其特征在于,导向部件前进通过未闭椭圆孔,其中,导管装置可滑动地设置在导向部件上。 120. The system of claim 99, wherein the guide member is advanced through the oblong hole is not closed, wherein the conduit means is slidably disposed on the guide member.
  121. 121.如权利要求120所述的系统,其特征在于,导向部件包括一沿其长度的一部分划分的导向丝,该划分的部分包括可膨胀的形状记忆材料。 121. The system of claim 120, wherein the guide member comprises a guide wire along a portion of partitioning of its length, the partitioned portion comprises a shape memory material may be expandable.
  122. 122.如权利要求121所述的系统,其特征在于,导向部件包括至少一个末端,用来接触邻近未闭椭圆孔的组织的左心房表面。 122. The system of claim 121, wherein the guide member comprises at least one end, for contacting the surface of the left atrium is not closed oblong hole adjacent tissue.
  123. 123.如权利要求122所述的系统,其特征在于,至少一末端与左心房表面相一致。 123. The system of claim 122, wherein the at least one end surface coincides with the left atrium.
  124. 124.如权利要求122所述的系统,其特征在于,导向部件可缩回而接合至少一个末端与左心房表面。 124. The system according to claim 122, wherein the guide member may be retracted to engage at least one end surface of the left atrium.
  125. 125.如权利要求99所述的系统,其特征在于,至少一个能量传输部件传输以下能量中的至少一个能量:射频能、低温能、电阻加热能、超声波能、微波能和激光能。 125. The system according to claim 99, wherein the at least one energy transmission means transmitting the at least one energy in the energy: RF energy, cryogenic energy, resistive heating energy, ultrasonic energy, microwave energy and laser energy.
  126. 126.如权利要求125所述的系统,其特征在于,至少一个能量传输部件可相对于至少一个组织附着部件移动。 126. The system of claim 125, wherein the at least one energy transmission member is movable relative to the at least one mobile tissue attachment member.
  127. 127.如权利要求125所述的系统,其特征在于,至少一个能量传输部件与至少一个组织附着部件偶联。 127. The system according to claim 125, wherein the at least one energy transmission member and the coupling member attached to at least one tissue.
  128. 128.如权利要求127所述的系统,其特征在于,至少一个能量传输部件包括至少一个单极射频传输部件。 128. The system according to claim 127, wherein the at least one energy transmission member comprises at least one monopolar RF transmission member.
  129. 129.如权利要求127所述的系统,其特征在于,至少一个能量传输部件包括至少两个双极射频传输部件。 129. The system of claim 127, wherein the at least one energy transmission member comprises at least two bipolar RF transfer member.
  130. 130.如权利要求127所述的系统,其特征在于,至少一个能量传输部件包括:至少一个射频传输部件,设置在一可膨胀部件内,该可膨胀部件包括至少一个孔用来释放流体而接触组织;以及至少一种传导流体,设置在可膨胀部件内,并暴露于射频传输部件。 130. The system of claim 127, wherein the at least one energy transmission member comprising: at least one radio frequency transmission means, disposed within an expandable member, the expandable member includes at least one aperture for releasing fluid contact tissue; and at least one conductive fluid disposed in the expandable member, and exposed to RF transmission member.
  131. 131.如权利要求127所述的系统,其特征在于,至少一个能量传输部件包括至少一个弧形的射频传输部件。 131. The system of claim 127, wherein the at least one energy transmission member comprises at least one arcuate member of the RF transmission.
  132. 132.如权利要求127所述的系统,其特征在于,至少一个能量传输部件包括网材料和编结材料中的至少一个。 132. The system of claim 127, wherein the at least one energy transmission member comprises a braided mesh material and at least one material.
  133. 133.如权利要求99所述的系统,其特征在于,还包括至少一个与导管装置偶联的传感器,以便检测由至少一个能量传输部件供应给组织的能量。 133. The system according to claim 99, characterized in that, further comprising at least one sensor coupled to the conduit means to detect the energy supplied by the energy transmission means to the at least one tissue.
  134. 134.如权利要求133所述的系统,其特征在于,从以下组群中选择至少一个传感器:红外线传感器、热敏电阻和热电偶。 134. The system of claim 133, wherein the at least one sensor selected from the group comprising: an infrared sensor, a thermistor and a thermocouple.
  135. 135.如权利要求133所述的系统,其特征在于,还包括一与至少一个传感器偶联的微处理器,以便处理检测到的数据来确定供应的能量何时已经达到所要求的能量。 135. The system of claim 133, wherein further comprising a sensor coupled with at least one microprocessor, to process the data detected to determine when the energy supply has reached the required energy.
  136. 136.如权利要求99所述的系统,其特征在于,还包括一与导管装置偶联的微处理器,以便检测和控制由能量传输部件传输的能量。 136. The system according to claim 99, characterized in that, further comprising a microprocessor coupled to the conduit means to detect and control the energy transmitted by the energy transmission means.
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US9232997B2 (en) 2006-11-07 2016-01-12 Corvia Medical, Inc. Devices and methods for retrievable intra-atrial implants
US9937036B2 (en) 2006-11-07 2018-04-10 Corvia Medical, Inc. Devices and methods for retrievable intra-atrial implants
US9358371B2 (en) 2006-11-07 2016-06-07 Corvia Medical, Inc. Intra-atrial implants made of non-braided material
US9456812B2 (en) 2006-11-07 2016-10-04 Corvia Medical, Inc. Devices for retrieving a prosthesis
US10045766B2 (en) 2006-11-07 2018-08-14 Corvia Medical, Inc. Intra-atrial implants to directionally shunt blood
US9757107B2 (en) 2009-09-04 2017-09-12 Corvia Medical, Inc. Methods and devices for intra-atrial shunts having adjustable sizes
US9277995B2 (en) 2010-01-29 2016-03-08 Corvia Medical, Inc. Devices and methods for reducing venous pressure
CN103635226A (en) * 2011-02-10 2014-03-12 Dc设备公司 Apparatus and methods to create and maintain an intra-atrial pressure relief opening
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US9642993B2 (en) 2011-12-22 2017-05-09 Corvia Medical, Inc. Methods and devices for intra-atrial shunts having selectable flow rates
US9205236B2 (en) 2011-12-22 2015-12-08 Corvia Medical, Inc. Methods, systems, and devices for resizable intra-atrial shunts

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CN1780591A (en) 2006-05-31 application
CN1780590A (en) 2006-05-31 application

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