CN1646066A - 利用热压缩和药物治疗邻近身体导管的组织的方法和装置 - Google Patents

利用热压缩和药物治疗邻近身体导管的组织的方法和装置 Download PDF

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CN1646066A
CN1646066A CNA038049473A CN03804947A CN1646066A CN 1646066 A CN1646066 A CN 1646066A CN A038049473 A CNA038049473 A CN A038049473A CN 03804947 A CN03804947 A CN 03804947A CN 1646066 A CN1646066 A CN 1646066A
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约翰·蒙
阿兰·J·芬恩
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Imunon Inc
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Abstract

一种利用温热疗法治疗邻近身体导管的组织，同时防止由于浮肿造成身体导管阻塞的方法和装置，包括在待治疗组织区域内注射封装在热敏载体如脂质体内的药物。由能量发射源产生的热将环绕身体导管的部分组织加热到接近43℃的温度达到一段时间，以足够破坏所述组织的加热的部分。此外，由能量发射源产生的热激活热敏载体以激活封装的药物的释放，以及药物以受加热的组织为作用目标。能量发射源的聚集能量与作用在目标区上的压缩都有助于将药物传递到目标区，以便自然支架具有长期的功效。

Description

利用热压缩和药物治疗邻近身体导管的组织的方法和装置
技术领域
本发明总体上涉及一种为了利用温热疗法治疗可见瘤、微细恶性和良性的细胞组织，利用单能量施加器或多微波施加器、温暖的液体以及压缩来控制聚集的能量到身体上的系统和方法。具体地说，本发明涉及一种用于利用尿道邻近前列腺组织的压缩的微波热和温热治疗以产生生物支架(stent)的经尿道的导尿管。
背景技术
为了利用温热疗法治疗前列腺，必须加热前列腺的重要部分，同时保护前列腺的健康组织以及包括病人的尿道和直肠壁的周围组织。前列腺就在膀胱下面环绕尿道。所有内部器官中最容易患病的前列腺是老年人当中的良性前列腺增大(BPH)、急性前列腺炎、以及更严重的痛苦，癌症共同折磨的部位。BPH为主要出现在前列腺过渡区的非恶性、双侧瘤状肿胀。如果不经治疗，BPH将产生通常导致不断增加的尿频、尿急、失禁、遗尿症和缓慢或中断尿流的尿道阻碍。
BPH最新的治疗方法包括经尿道的微波温热疗法，其中使用微波能量以提高前列腺尿道周围组织的温度为大约45℃以上，从而热破坏肿胀的前列腺组织。美国专利号No.5,330,518和5,843,144说明了通过经尿道的温热疗法消除前列腺肿胀组织的方法，其请求保护的主题在此作为参考。然而，此种类型的治疗仍然需要做出改进，以进一步保持或增强温热疗法治疗后尿道的开放。更具体地说，尽管消除了使尿道收缩的肿胀组织，但也不是总能改进尿流，因为通过经尿道的温热疗法的治疗产生的浮肿堵塞了尿道的通道，导致通过上述方法治疗的病人要在温热疗法治疗后配置导尿管达几天或几个星期。
美国专利号No.5,007,437，5,496,271和6,123,083公开了除了锚状或Foley气囊外具有冷却气囊的经尿道的导尿管，并在此作为参考。然而，这些专利循环作为冷却液的液体，用于通过冷却气囊优先消除其邻近的非前列腺组织的热。专利6,123,083还公开了使用大约12℃-15℃之间的寒冷水作为冷却液的美国专利号No.5,413,588说明的温热疗法导尿管系统。寒冷水可以有效地冷却邻近冷却气囊的尿道。同样，专利5,496,271说明了冷却液作为液体保持尿道壁的冷却温度。此种对尿道的冷却无助于当冷却气囊去除后保持加热尿道内的畅通，而且降低了紧邻尿道壁组织中的治疗效果。
对于另外已知的另一热诊疗，如同美国专利号No.5,499,994所述，为在尿道中插入膨胀气囊，以扩张膨胀气囊来压缩阻塞的尿道。然而，要扩张膨胀气囊24小时以上且仍然不能治愈病人患病的前列腺，且可能产生副作用(例如，尿道壁的撕裂)。美国专利号No.6,102,929说明了当外科处理后膨胀前列腺组织，以增大尿道使病人舒服地排泄的后操作程序。此膨胀要求插入另外的装置并要求装置保持在病人体内1天或更多天。
鉴于后处理导尿管或其它装置仍然需要通过医疗机构考虑的实际情况，还需要进一步改进温热疗法以避免浮肿造成的阻塞，并保持和增强尿道的畅通。
发明内容
本发明的目的在于提供一种用于热治疗邻近身体导管如前列腺的组织，同时防止由于浮肿造成身体导管阻塞的装置和方法。为了达到此目的，本发明使用具有能量发射源的导尿管以及环绕能量发射源的压缩气囊，其中温热的液体通过压缩气囊流动以温暖邻近压缩气囊的身体导管壁。
当本发明相对身体导管为尿道的优选实施方式进行说明，通过温热疗法治疗前列腺组织时，温热液体、压缩和微波的组合可以用于实现包括但不局限于其它身体导管，如心脏血管、食管、鼻咽以及直肠的上述目的。也就是说，本发明的目的在于畅通身体导管以便不妨碍导管的正常功能。能量发射源的动力以及压缩气囊的直径和形状以及导尿管都将根据待治疗的组织或身体导管变化。
产生压缩目标面积的系统的最低限度侵入的RF、微波或超声聚集能量综合用于封装药物介质的热敏脂质体，用于最小程度侵入大瘤质量的目标治疗，以及非癌增大前列腺的治疗。根据本发明，聚集的能量加热目标区并激活热敏脂质体，并在目标组织中释放药物。
与循环冷却液以冷却尿道壁的技术不同，本发明循环温热的液体以保持尿道30℃以上的温度。申请人认为，生物支架或模型开口不能由冷却的循环液体形成(即，在25℃-30℃范围内循环进病人体内的液体)。温热流体温度的优选范围在30℃-60℃之间。优选实施例为将35℃的液体循环进病人体内。当在循环之前温热流体外部温度通过病人测量为33℃时，申请人实现了形成生物支架。
根据本发明，将选择环绕尿道的含胶原质组织的体积加热到大于43℃一段时间，以充分地破坏组织的选择区域。在激活能量发射源之前，将预成型压缩气囊充满温热液体，以扩张压缩的前列腺尿道壁，从而减少环绕尿道壁的前列腺中的血流，以便在限制血流供应的的区域更有效地进行能量吸收性加热。结果，尿道壁的蛋白质产生变性或为在从能量发射源发射的热面前松开。膨胀压缩气囊的温热液体协助变性过程，同时防止吸收的能量发射热烧灼尿道壁。此变性使尿道壁与压缩气囊产生的尿道形状一致，并降低了尿道壁的弹性，以便接加热后的支架增强周期自然地凝固导致生物支架的膨胀形状。也就是说，当压缩气囊放气并去除后，膨胀的身体导管壁不能恢复到其先前的形状，从而在身体导管如尿道中实现自然开口。
根据本发明的优选实施方式，在加热步骤后进行接近10分钟或更少时间的支架增强周期。当能量发射源的动力已经关掉后，支架增强周期保持压缩气囊的压力，以便温热疗法几分钟后，形成膨胀的尿道的凝固且不需要导尿管和其它装置。
根据本发明的优选实施方式，压缩气囊通常为在压缩气囊的两侧具有斜面的圆柱形，并沿直径的长度对称。在优选实施方式中可以固定能量发射源的位置。然而，压缩气囊可以为任何形状，以产生所需模型或在身体导管或尿道内支架，并可以沿导尿管的长度为不对称。
压缩气囊需要沿导尿管的长度相对尿道壁保持大约10-25psi的压力，而优选压力的大小大约为15psi。压缩气囊也可以沿导尿管的长度具有变化的直径。另外，压缩气囊也可以为单个气囊或多个气囊。
在一个实施方式中，压缩气囊的直径穿过半径变化，以实现身体导管的不对称成型。压缩气囊的其它形状包括根据所需生物支架，其顶点邻近膀胱颈或直对远离膀胱颈的锥形圆柱体。这些锥形圆柱体可以使能量发射热聚集在环绕身体导管具体区域，并产生对应于此形状的生物支架或开口。
根据本发明，优选温热液体与流出限制一起采用以循环通过压缩气囊，以便气囊中流体的压力保持在大约10-25psi的压力。压缩气囊中入口和出口的位置使得液体在压缩气囊内为层流流动。此外，压缩气囊中的入口和出口设置为以便在气囊中最小化气穴，因为气穴的结果是产生“热点”。
除了压缩气囊的各种形状外，压缩气囊也可以局部地覆盖屏蔽或吸收能量发射射线的接地或未接地的导体材料，以便热量在前列腺组织的一些部分减少并聚集在其它部分。在此实施方式中，能量发射源或微波天线可以移动，以便其能量发射部分的位置可以改变到最佳化加热用于具体治疗的组织。如果可能，能量发射源的优选位置和运动取决于压缩气囊的尺寸、形状和屏蔽。
在另一实施方式中，与压缩气囊的压缩一起进行的聚集辐射可以用于激活携带药物的热敏脂质体。因此，包括设置在治疗病人血流内的热激活药物输送系统的热力治疗系统有效地输送热，以便可以改进在前列腺内的药物输送。药物输送系统响应由聚集的辐射加热的治疗区域在治疗区域释放选择的药物。携带在热敏脂质体或其它热敏药物载体中的更高释放药剂的浓度可以产生长期的治疗功效。
附图说明
参照相应的附图对下面优选实施方式进行具体说明，将使本发明的这些和其它方面和优点变得更加清晰和容易理解，其中：
图1是显示受到良性前列腺增生影响的泌尿器的男性骨盆区，并插入根据本发明具有充气压缩和Foley气囊的导尿管的垂直截面视图；
图2是显示图1的放大部分视图；
图3是显示本发明的尿道导尿管的平面视图；
图3a是显示沿图3中线a-a截取的尿道导尿管的截面视图；
图3b是显示温热液体泵送系统的另一实施方式；
图4是显示用于压缩气囊膨胀的通过导尿管的液体流视图；
图5a和5b是显示在未膨胀和膨胀状态中压缩气囊的尿道截面简图，其分别说明根据本发明的尿道壁和前列腺的膨胀；
图6是显示说明根据本发明的膨胀、不对称压缩气囊的尿道截面简图；以及
图7a-7d是显示用于增加屏蔽操作的另外压缩气囊的形状和技术。
具体实施方式
本发明的目的在于提供一种用于热治疗邻近身体导管组织如尿道的装置和方法，同时防止由于浮肿造成的身体导管阻塞。除了聚集能量和压缩外，药物输送还有助于长期的治疗功效。下面将说明根据本发明的方法、系统以及另外的方法和装置。
下面将参照图1-6说明用于良性前列腺增生的微波温热疗法治疗后，保持或膨胀尿道的直径成选择的尿道形状以恢复尿道畅通的第一方法和装置。图1是显示在泌尿器上良性前列腺增生(BPH)效果的男性骨盆区的垂直截面视图。尿道10为从膀胱11通过前列腺12和阴茎头14的外尿道口13的引导排泄管。在尿道10周围的前列腺12内生长的良性肿瘤组织导致尿道10阻塞，其中断了尿从膀胱11到尿道口13的排出。侵害尿道10并产生压缩(未示出，如同压缩气囊膨胀一样)的前列腺12的肿瘤组织可以通过加热和使侵害的肿瘤组织陷于坏死有效地消除。比较理想的是，采用本发明，加热和使尿道10前面和侧面的前列腺12的尿道周围的肿瘤组织陷于坏死，同时避免不必要和不希望的伤害尿道10以及邻近的健康组织，如外括约肌17、直肠18以及膀胱颈19。
图2是显示说明图1的放大截面视图，其包括尿道10和膀胱11的具体解剖特性以及显示根据本发明具有膨胀压缩气囊112和膨胀的Foley或锚状气囊118的导尿管100。如图1-4所示，本发明使用了具有能量发射源110和环绕发射源110的能量发射部分的压缩气囊112，温热的流体流过以温暖邻近压缩气囊的尿道壁。通过包含能量发射的本发明导尿管100，可以实现前列腺12中良性肿瘤组织的有选择加热(经尿道的温热疗法)。具有多个传感器的直肠探针102插进直肠18并测量在直肠壁处吸收发射的能量产生的热量。
如图2所示，有3个传感器104安装在探针102上。优选传感器为整体安装在探针不同的径向位置并彼此间隔接近1cm。Foley气囊118插进病人的膀胱，以便压缩气囊最接近端位于病人膀胱颈的前列腺紧接末梢。压缩气囊112的长度根据病人的膀胱尺寸变化。典型的压缩气囊长度为大约40mm，且长度范围在25到60mm。
导尿管100为大约18French(French为等于0.333mm或0.013英寸的测量单位)。由于成年男性的尿道平均直径大约为22 French，所以环绕导尿管的抽放气压缩气囊112将增加2 French，以便导尿管100的直径和气囊112小于病人的尿道直径，以减缓病人的痛苦。优选多个内腔轴100和相应的模制部分为优选通过Concept Polymer Incorporated销售的商标为C-FlexTM的医药等级聚合体挤压出。优选压缩气囊由Allied销售的商标为PETTM的医药等级的聚酯材料模制成，其具有基于其初始最大模制形状的拉伸极限。其它的材料包括由Dow Corning有限公司制造的硅树脂材料，商标名称为Silastic RTM，用于轴挤出和多种塑造的型号Q7-4850和Q7-4765，以及用于Elastosil型号LR3003/30Us的锚状气囊118。优选导尿管100的材料具有在50D和80D之间的肖氏硬度。
当完全插入后(即，未膨胀的Foley气囊到达病人的膀胱)，将液体(消过毒的水)泵进Foley膨胀阀113，从而膨胀Foley气囊118并保持病人尿道内的导尿管。膨胀阀113保持Foley气囊中的液体具有所需的压力，以便导尿管固定在病人体内。然而，导尿管仍然能相对尿道做有限的纵向运动。当将Foley气囊膨胀后，将温热的液体，优选低损耗的液体(例如，去离子或消毒水)通过一个或多个导尿管膨胀/循环内腔120(图3a)缓慢地泵进前列腺压缩气囊112，以膨胀同样膨胀的尿道壁并保持尿道壁30℃以上的温度。膨胀压缩气囊的直径接近在25-60French的范围内。优选用于膨胀压缩气囊112的温热液体为更有效传导微波到待加热组织的最小能量吸收溶液。
在图3显示了根据本发明实现的典型导尿管。在此图中Foley气囊未膨胀。如图左侧所示，Foley膨胀阀113、温热消毒液体入口115a和消毒液体出口115b设置成接收液体。消毒液体入口和出口115a、115b可以在温热疗法期间在压缩气囊中循环消毒液体，并保持所需压力以达到规定的液体流型和气囊内液体的分布。中心内腔126容纳能量发射源110，其可以为同轴电缆形式的天线。如图3a所示，凸出部分127在中心通道126中形成，以便保持能量发射源110居中在导尿管100内并产生用于排出液体流的通道。凸出部分127使能量发射源和导尿管外壁之间的距离保持恒定，从而保证在能量发射源110的能量发射部分处一致的加热形式。能量发射源110直接连接到低损耗的液体以使发射功率最大化，并冷却能量发射源的轴。
如图4所示，孔122、124在压缩气囊112两侧上的一个或多个导尿管内腔120中使用，以便温热液体可以在一端和另一端外通过内腔120泵进压缩气囊112。然后，温热的水循环通过容纳能量发射源110如微波天线的中心孔126，并流到病人导尿管100外面。孔122、124的位置和直径可以使压缩气囊112在整个温热疗法治疗中保持充足的液体流和大约10-25psi的压力。在优选实施方式中，输出流体侧的通道配置有限制孔116，以限制用于最大限度地使液体通过压缩气囊112的压缩气囊的压力。在另一实施方式中，限制孔116直接定位于用于将导尿管连接到外温热液体泵送系统的连接管(例如，115a、115b)中的导尿管的外部(图3b)。温热液体的加压循环形成为以便减少膨胀气囊中的气穴。因此，可以避免产生“热点”导致烧灼尿道壁的压缩气囊中的气穴。此形成前列腺尿道组织所需要的压缩，其保持温热疗法治疗中和后不会烧灼尿道壁。
将患病的前列腺组织加热到治疗的温度(高于大约43℃)，同时保持非前列腺组织内层尿道的温度在30℃以上。非前列腺组织包括尿道壁和邻近组织，并设置在能量发射源110和前列腺组织12之间。源110的能量发射部分110a设置在导尿管100中，以便其保持在压缩气囊112内。优选能量发射部分110a发射辐射微波场，其作为能量发射部分110a(例如微波天线)和待加热组织之间距离的反函数(例如，平方倒数)产生变化。结果，比前列腺组织12更靠近能量发射部分110a的尿道壁10的非前列腺组织将加热到比待治疗前列腺组织更高的温度。同样，最近的前列腺组织将加热到比更远端前列腺组织更高的温度。
Sterzer的美国专利号No.5,007,437公开了使用气囊以压缩前列腺组织并移动尿道壁远离产生热的微波天线。此方法通过移动尿道壁远离产生热的天线，降低了微波场的强度和尿道壁处产生的获得热。然而，Sterzer也使用了循环液体以连续冷却尿道壁，同时膨胀尿道壁。申请人认为，此循环冷却液防止了尿道壁和邻近前列腺组织达到使蛋白质变性或重新塑性重构的充分温度。结果，如图5a和5b所示，申请人建立了与温热液体的循环一起使用的膨胀前列腺压缩气囊可以减轻变性问题的理论。
图5a和5b分别显示了未膨胀压缩气囊截面和膨胀压缩气囊截面的视图。当将压缩气囊未膨胀时，从能量发射源或微波天线110到末梢的前列腺组织202和包括尿道壁和邻近非前列腺组织的最接近组织204的径向距离小于当压缩气囊膨胀时的径向距离。如图所示，膨胀的压缩气囊112在尿道导尿管的整个圆周周围形成对称圆凸的延伸。具体地说，从微波天线110到膨胀压缩气囊112最接近组织204内圆周的径向距离R1b明显大于相应未膨胀压缩气囊112的径向距离R1a，同样，到膨胀压缩气囊112前列腺组织202内圆周的径向距离R2b明显大于相应未膨胀压缩气囊112的径向距离R2a。因为前列腺组织是软的并可以压缩，因此，膨胀压缩气囊112前列腺组织的外和内径R3b和R2b之间的差，对应于未膨胀压缩气囊112的径向距离R3a和R2a之间的差充分地降低。
因此，膨胀压缩气囊使前列腺12受到尿道壁的压缩，从而降低压缩的尿道壁和前列腺被膜的边缘之间的组织厚度。更末梢的组织202不受到与更靠近尿道204的组织一样的压缩。由于通过天线110发射能量的实际组织厚度较小，储存的能量更均匀地分布在整个前列腺被膜中。因此可以使前列腺组织更均匀地加热和更高的治疗温度，而不会用超过其最大安全温度加热任何部分的非前列腺组织。
同时，膨胀压缩气囊112限制压缩的前列腺中的血流，以便发射的热量不会通过正常血流运走，因此使此组织更容易通过发射的能量加热。由于整个组织的厚度降低，因此所需有效加热前列腺组织204到治疗温度的能量也降低。结果，在典型的非压缩治疗中，可以邻近直肠壁到最大安全温度41℃的所需提高更远端前列腺组织202温度的能量将明显高于根据本发明需要的能量。因此，可以更均匀地加热前列腺组织并达到更高的温度，而不会超过其最大安全温度加热任何部分的非前列腺组织。
为了在微波温热疗法治疗期间将最近的组织204加热到预定的胶原质转变温度以上，与使用冷却液相反，使用大约31℃-60℃范围的优选30℃以上的温热液体循环通过压缩气囊112。结果，尿道壁和邻近组织充分地变性，从而在温热疗法治疗后可以形成自然的生物支架。
温热尿道壁30℃以上并保持此温度用于变性尿道壁的蛋白质；但不会超出最大加热尿道壁安全温度。此变性使尿道壁与通过压缩气囊112产生的尿道膨胀形状一致，并降低了尿道壁的弹性，以便在温热疗法治疗加热后的支架强化期间使生物支架的膨胀形状自然凝固。即，在压缩气囊不膨胀并去除后，膨胀的尿道壁不会返回到其先前的形状，从而达到身体导管如尿道的自然开口。
在前列腺组织加热终止后的支架强化周期需要压缩气囊在所需的10-25psi压力时保持膨胀少于大约10分钟。在此强化周期期间，只要在压缩气囊中保持用于凝固生物支架的压力，通常不再需要循环通过压缩气囊的液体。即，当已经关闭能量发射源的动力后，支架强化周期保持压缩气囊的压力，以便在温热疗法后达到几分钟后实现凝固的膨胀尿道，就不再需要排泄尿的导尿管或其它装置。
根据本发明的优选实施方式，压缩气囊112通常为在压缩气囊的两侧具有斜面的圆柱形，并沿直径的长度对称。然而，压缩气囊112也可以为任何形状，以便在身体导管或尿道内产生所需模型或支架。如图6所示，导尿管100上的压缩气囊112′设计为以便其环绕导尿管100不对称膨胀。不对称的气囊112′膨胀身体导管，以便邻近身体导管的组织区域根据膨胀压缩气囊112′的宽度接受能量发射源110更多或少的辐射能。膨胀的压缩气囊112′越宽，邻近身体导管的组织就越受到压缩，就越远离热量产生源。
压缩气囊112需要沿导尿管的长度相对尿道壁保持大约10-25psi的压力，优选的压力等级为大约15psi。如图7a-7d所示，压缩气囊沿导尿管的长度可以具有不同的直径。另外，压缩气囊可以为单个气囊或多个气囊。
在一个实施方式中，压缩气囊的直径穿过半径变化以实现身体导管的不对称成型。此形状显示在7a中，其中压缩气囊只在中间膨胀大约27French和在另一端上膨胀46French。压缩气囊的其它形状包括根据所需的生物支架，其顶点邻近膀胱颈或直接远离膀胱颈的锥形圆柱体(图7b-7c)。另外，这些锥形圆柱体可以使选择的能量发射聚集在环绕身体导管的具体区域，并产生对应于此形状的生物支架或开口。另外，在优选方式中，锥形或其它所需形状的气囊可以提供用于非特定疾病的局部治疗。
除了压缩气囊的各种形状外，压缩气囊还可以覆盖有屏蔽能量发射射线的材料，以便可以在前列腺组织的一些部分降低热量并聚集在其它部分。即，屏蔽可以使前列腺组织优先加热。在此实施方式中，导尿管/气囊/天线组合的有效加热区通过沿使用的内部或外部导尿管的轴，有选择的增加远端局部屏蔽材料控制。其它或除了导尿管屏蔽材料外，屏蔽材料可以施加到无论是内部还是外部的压缩气囊表面。
当接地时，施加的屏蔽有选择地吸收能量发射源或天线发射的微波能量，以改进加热形式并控制储存的热量进入周围的目标组织。对于电接地屏蔽，内部连接导线穿过液体循环内腔或包埋在导尿管轴材料中，并连接到导尿管的最远端。然后，这些导线终止在能量发射源的外电表面和/或分别终止用于充分消散吸收发射能量的系统接地点。在导尿管轴和/或在压缩气囊上提供屏蔽的量和位置根据所需的加热形式变化。
在此实施方式中，能量发射源110或微波天线可以移动，以便其能量发射部分110a的位置可以改变以用于具体治疗的组织的加热最佳化。如图3b所示，纵向天线定位器装置128可以移动天线并同样在所需的位置锁紧。如果可能，能量发射源的优选位置和运动取决于压缩气囊的尺寸、形状和屏蔽。
因此，本发明的方法和装置消除了疾病组织在身体导管产生的阻塞，同时形成身体导管的自然或生物支架，以便浮肿或肿胀不会靠近身体导管。结果，在支架强化周期后，形成身体导管如尿道中消除阻塞的开口。
此外，根据本发明，温热液体循环、膨胀和加热有效地重新塑性重构组织周围丰富的胶原质成为具有所需膨胀直径的选择形状。因此，当前的发明可以通过增加尿道直径以增加前列腺尿道和周围组织的开放性。
当使用具有上述聚集能量和压缩温热疗法治疗的组合时，可以实现更有效的药物输送。脂质体可以工程加固在药物中，产生具有增强功效、更安全或包括两者的新药物的微小人造脂质颗粒(有机混合物包括脂肪、脂肪状混合物和类固醇)。具体地说，本发明使用了热敏脂质体。因此，有效药物的毒性可以通过使用脂质体技术治疗癌肿瘤或增大前列腺预期的前列腺炎。选择具体的脂质使具有液晶的脂质体在40℃-50℃的范围中相变，其中脂质体经过突然的物理性质变化。脂质体可以具有一个或多个包括药剂的液态室。这些液态室通过脂质双分子层密闭。当用于激活药物载体或脂质体的优选温度为接近41℃时，可以实现较低的温度激活。
用于热敏脂质体的具体配方设计在美国专利No.5,094,854进行了说明，在此作为本发明的参考。虽然使用比先前技术更高浓度的脂质体，但本发明应该增加在前列腺中释放基因药品或药物药品的量。此增加的单位面积药物为使用具有目标面积压缩的更高浓度和聚集能量的结果。
虽然本发明通过优选实例进行了公开和说明，但是应当认为本领域的熟练技术人员可能在此基础上做出各种形式和细节上变更，而不会脱离由权利要求所限定的保护范围和主题精神。

Claims (6)

1.一种用于治疗邻近身体导管的组织的温热疗法的方法，包括步骤：
将包括导尿管的能量发射源插进身体导管中，以便能量发射源位于邻近待治疗组织的区域，以使来自能量发射源的聚集能量加热待治疗组织的区域；
给设置在导尿管上的压缩气囊膨胀到足够扩张身体导管壁的压力并压缩待治疗的组织；
将封装在热敏载体内的药物注射在待治疗组织区域内；以及
加热身体导管周围的一部分组织到接近43℃的温度达到一段时间，以足够通过能量发射源破坏组织的加热部分，其中热量激活热敏载体以激活封装药物的释放，药物以待加热的组织为作用目标。
2.根据权利要求1所述的方法，其特征在于：
待治疗的组织为前列腺，以及封装在热敏载体内的药物治疗前列腺炎。
3.根据权利要求1所述的方法，其特征在于，载体为热敏脂质体。
4.根据权利要求1所述的方法，其特征在于：
封装在载体内药物的注射步骤发生在病人的血流内，并在目标区加热之前经过充分的时间周期。
5.根据权利要求4所述的方法，其特征在于：
当加热步骤开始时，热敏载体内的药物位于目标组织处。
6.一种利用温热疗法治疗邻近身体导管的组织的设备，包括：
含有用于插入身体导管的导尿管的能量发射源，以便能量发射源位于邻近待治疗组织的区域，以使来自能量发射源的聚集能量加热邻近身体导管的待治疗组织；
设置在导尿管上的压缩气囊；
用于将压缩气囊膨胀到一定的压力以足够扩张身体导管壁并压缩待治疗组织的装置；以及
用于注射封装在热敏载体内的药物于待治疗组织区域内的装置，其中能量发射源将环绕身体导管的部分组织加热到接近43℃的温度达到一段时间，以足够通过能量发射源破坏所述组织的加热部分，其中热量激活热敏载体以激活封装的药物的释放，以及药物以待加热的组织为作用目标。
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US8224455B2 (en) 2012-07-17
US8374702B2 (en) 2013-02-12
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US7833220B2 (en) 2010-11-16
WO2003070298A2 (en) 2003-08-28
AU2003211070A8 (en) 2003-09-09
JP4362373B2 (ja) 2009-11-11
US20110034976A1 (en) 2011-02-10
WO2003070298A3 (en) 2004-02-12
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