CN101287414A - 使用超声能量和低温能量的组合选择性去除组织的设备和方法 - Google Patents
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Abstract
公开了用于选择性和有目标地去除无用组织的超声设备和方法。所述设备和方法可利用超声能量和低温能量的组合来选择性地去除组织。所述设备产生低温能量和超声能量,并以组合方式或顺序地将低温能量和超声能量传递给组织,而且提供对无用组织部分的大小可调整的切除,并可用于其他身体组织,包括内脏。
Description
发明背景
发明领域
本发明涉及患者组织的去除,且更具体地,涉及使用超声能量和低温能量的组合来去除组织的设备和方法。
相关技术描述
人类的皮肤是身体的最大器官,并作为反应各种内部和外部有关健康的疾病的指示物。皮肤保护身体免遭人类在他们每天生活环境中自然暴露到的常见的物理、化学及微生物的入侵。
皮肤病通常被定义为影响皮肤的疾病。皮肤病常常影响多层皮肤。一些常见的皮肤病包括皱纹、疤痕、疣、非转移黑素瘤病、基底细胞癌和人类乳头瘤病毒,以及各种癌前和癌变皮肤生长。一些皮肤病是由病毒感染引起的皮肤局部生长,其通常不会传染。
治疗皮肤病的通常方法包括外科手术去除、化学去皮、低温和电子治疗。这些方法通常具有破坏周围健康组织的缺点,从而增加感染率、高复发率、和/或手术后的大量疼痛或不适。此外,许多现有方法复杂且不精确。在瞄准不健康组织时缺少精确性,可导致不能完全去除必要的有害组织,而且还可导致对周围健康皮肤组织的损害。任何未被去除的不健康组织能够很快成为病症复发的基础。另外,由于对周围组织的损害或破坏,已治疗的组织可能成为感染或污染物的引入点。因此,需要瞄准并完全地或有效地完全去除患病组织而不破坏周围组织的设备和方法。
发明内容
本发明涉及用于选择性切除无用(unwanted)皮肤层的设备和方法。根据本发明的设备和方法可满足上述需要,并且还提供本领域的技术人员在审阅本公开内容时将会认可的额外优点和改进。
根据本公开内容的设备以组合方式或顺序地将超声能量和低温能量传递给皮肤组织。通过超声能量和低温能量的这种组合或顺序应用,可破环并去除无用组织层。该设备可用于治疗位于人体和动物体表层或内部的患病组织或无用组织层/生长。该设备可用来有目标地和选择性地切除软组织和硬组织。
根据本发明的设备的实施方式可以是具有近端和远端的手持设备。近端可包括手柄,以使所述设备可由外科医生抓取和操纵。超声尖端可设置在设备的远端上。超声尖端可包括主体,且该主体可界定一个或更多腔。通过将来自贮存器的低温流体传递至由超声尖端界定的一个或更多腔内,可对超声尖端进行低温冷却。超声换能器可用来激发超声尖端。因此,超声尖端可同时进行低温冷却以及由超声换能器激发,或者可顺序地冷却并由换能器激发,以便可以在超声尖端处形成低温能量和超声能量的同时和顺序的组合。然后,超声尖端可被置于待去除的目标组织上,以便将低温能量和超声能量以组合方式或顺序地传递至待去除的目标组织。
低温流体通常是气相或液相。可以使用本领域的技术人员认可的低温气体或液体,例如液氮。低温流体可传递至由超声尖端的主体所界定的一个或更多腔。低温流体可通过一个或更多连接管或设计成引导低温流体在腔中流动的其他部件来传递。一方面,一个或更多入口管设置成与腔相连通以将低温流体引入腔内,且一个或更多出口管设置成允许低温流体从腔中移除或流经腔。另一方面,内部腔可设计为接近超声尖端的末端,以便更有效地冷却该末端。
超声尖端具有用于将超声传递至目标组织的超声活动末端(ultrasonically active distal end)。这可与低温能量的应用相结合、在低温能量的应用之后、或在低温能量的应用之前应用于组织。可通过直接接触、通过形成在超声尖端上的冰球、或通过从超声尖端射出的低温喷射,来应用该低温能量。此处所使用的“冰球”,通常指冰粒或块的产生,因为该术语的使用通常与低温治疗有关。尽管此处被标作“冰球”的冰粒或块可具有圆形几何形式,但是组成“冰球”的冰粒或块并非必需具有球的几何形式,这将由本领域的技术人员认可。
超声尖端通常由金属例如钛组成,尽管超声尖端也可由塑料或金属和塑料的组合组成,这将会被本领域的技术人员认可。超声换能器可用来激发超声尖端。超声尖端可通过超声操纵杆(horn)连接到超声换能器。超声尖端可从超声操纵杆拆卸或永久连接到超声操纵杆。可拆卸的超声尖端可以是一次性的。
在其他方面,超声尖端的末端可具有各种几何形状,例如边缘尖锐的(sharp edged)、圆锥形的、锯齿状的、波浪形的、扁平的、圆形的或各形状的组合。可以针对在组织上执行的各种手术选择合适的各种形状。可拆卸的超声尖端能够允许外科医生在手术过程中将末端的几何形状改变成合适的几何形状。
另一方面,连接到腔的孔可设置在该末端上,使得可从末端形成冰球或喷射低温流体。
本公开内容的设备可用于运用超声能量和低温能量同时和/或顺序切除组织。可通过将低温流体供应至末端、激发超声换能器、且然后将末端放置成与组织接触直到组织被切除,来实现低温能量和超声能量的同时应用。
可替代地,低温能量和超声能量可通过该设备顺序地应用于将被切除的组织。例如,可通过激发超声换能器、将末端放置成与组织接触、且然后将低温流体供应至末端,开始顺序应用。该顺序可以反向,使得通过将低温流体供应至末端、将末端放置成与组织接触、且然后激发超声换能器,开始该顺序。正如本领域的技术人员所认可的,可以在切除手术中使用低温能量和超声能量的顺序和同时应用的各种组合。
低温能量可按不同方式传递至组织,例如通过将低温流体供应至超声尖端,并且然后将末端放置成与组织直接接触。可替代地,末端上的冰球可放置成与组织接触,或从末端中的孔发射的低温喷射可用于将低温能量传递至组织。
将低温能量与超声能量组合能够为选择性组织去除过程提供多个益处。结合本发明各方面的设备的一个优点是避免了超声尖端粘附到患者组织。结合本发明各方面的设备的另一优点是超声振动使待去除的组织从健康组织分离。结合本发明各方面的设备的另一优点是高强度超声能量可独自破坏目标组织且仅仅由低温效果补充。结合本发明各方面的设备的另一优点是由于应用超声能量获得疼痛减轻效果使得该过程中的疼痛更少。结合本发明各方面的设备的另一优点是对于处理过的组织和周围组织来说,超声能量和低温能量的应用可具有抗菌效果。从下面的论述和附图,本发明的这些和其它新颖方面将会变得更加明显。
附图说明
图1是用于去除组织的系统的实施方式的整体图解总览,其可提供超声能量和低温能量的组合;
图2展示了根据本发明的超声尖端的实施方式,设置成将低温流体从外部直接传递至尖端末端部分内部,并通过内部的一个圆头孔(bluntorifice);
图3展示了根据本发明的超声尖端的实施方式,设置成将低温流体传递通过内部的两个圆头孔;
图4展示了超声尖端的实施方式,具有用于将低温介质传递进入和传递出来的两个单独的外部管和两个内部孔;
图5(a)展示了超声尖端的实施方式的横截面前视图,具有用于将低温介质传递进入和传递出来的两个单独的外部管和两个内部孔;
图5(b)展示了具有两个孔的超声尖端的实施方式的水平横截面;
图6(a)至6(i)展示了不同形状的超声尖端末端部分的实施方式的横截面视图;
图7展示了将低温介质传递通过换能器和超声尖端的孔的实施方式;
图8展示了超声尖端的实施方式的横截面视图,内部腔与到辐射表面的孔相连通;
图9展示了通过设置在辐射表面和组织之间的冰球将低温和超声能量传递至组织的实施方式;
图10展示了通过从辐射表面射向组织的低温喷射将超声能量传递至组织的实施方式;
图11展示了超声尖端末端部分的实施方式的透视图,界定了位于径向表面上的多个孔,用于从周围和侧壁上去除身体内腔(例如脉管、腔等)的组织;
图12展示了具有用于将超声能量聚集到组织的反向锥形辐射表面的超声尖端的实施方式;及
图13展示了具有用于将超声能量聚集到组织的凹形辐射表面的超声尖端的实施方式。
发明的详细描述
本发明涉及用于通过超声能量和低温能量的组合来切除组织的设备,并涉及这种设备的使用方法。超声能量和低温能量同时或按不同顺序的高度可控的、精确的传递,允许破坏无用组织而不损伤周围组织。
图1显示了本设备10的实施方式的全视图。本发明的设备10可以是具有远端超声尖端1的手持设备,该远端超声尖端1以组合方式或顺序地将超声能量和低温能量传递至选择治疗的皮肤组织区9。超声尖端1包括主体,该主体界定用于低温流体20的一个或更多内部腔7。低温流体20可以是本领域的技术人员将会认可的气体或液体,例如液氮。可通过低温流体传递管4将低温流体20从源5传递至内部腔7,低温流体传递管4在低温流体入口管16处连接到超声尖端7。低温流体入口管16界定将低温流体传递管4连接到一个或更多内部腔7的内部通道17。超声换能器3可通过电缆(cable)11连接到超声发生器6。超声尖端1提供超声活动末端14,以用于通过直接接触、通过显示在图9中的冰球22、或通过显示在图10中的低温喷射24,将超声能量和低温能量传递至组织9。
超声尖端1通常由金属例如钛制成。超声尖端1也可由塑料制成且可一次性使用。超声尖端1可由超声换能器3激发。超声尖端1可通过超声操纵杆2连接到超声换能器3。本领域的技术人员应认识到,超声尖端1可以是可连接到超声操纵杆2的分离部件,或者超声尖端1和超声操纵杆2可组合为单一部件。超声换能器3通常通过电缆11连接到超声发生器6。超声换能器根据由超声发生器11产生并通过电缆11传递至超声换能器3的驱动信号产生脉冲。作为时间函数的驱动信号可以是矩形、梯形、正弦曲线、或本领域的技术人员所认可的其他信号类型。超声频率可以在18KHz和20MHz之间,或更多。优选频率是20KHz-60KHz,且推荐频率是35KHz。超声波的振幅可以在1微米和200微米之间,或更多。
图2是超声换能器3的图示,其中由低温流体入口管16界定的内部通道17连接到由超声尖端1界定的内部腔7。图2还显示了超声操纵杆2和超声尖端1的机械振动的振幅图。传递管16在机械谐振节点28处连接到超声操纵杆2或超声尖端1,机械谐振节点28就是超声操纵杆2或超声尖端1的振动振幅为零的点。如果管4没有在谐振节点28处连接到超声操纵杆2或超声尖端1,那么末端14处的超声能量的强度就会衰减。
图3显示了超声尖端1的构造,其中低温流体通过具有朝尖端14延伸的狭窄细长部分的腔7传递。腔7的数量必须是至少一个。在一些实施方式中,更多腔7可通过增加表面积,提供高功效的低温切除。在其他实施方式中,腔7的狭窄细长部分可将低温流体引导至末端辐射表面(图8、9、10)上或径向表面(图11)上的一个或更多孔12。
图4展示了具有低温流体入口管16和低温流体出口管8的超声尖端1的实施方式,低温流体入口管16界定内部通道17,其将低温流体传递管4连接到一个或更多内部腔7,低温流体出口管8界定到一个或更多内部腔7的内部通道19。于是,低温流体可通过低温流体入口管16添加到一个或更多内部腔7中,并且可通过低温流体出口管8从一个或更多内部腔7中移除,使得低温介质通过超声尖端的一个或更多腔7循环。
图5(a)是由超声尖端1的主体30界定的腔7的侧视图。图5(a)还显示了通过超声尖端1的末端部分延伸并与腔7流体连通的通路32,这可增加超声尖端1和低温介质之间的热传递效率。主体30还界定多个管状通道34。管状通道34从腔7向末端14发散,以允许低温流体接近末端14,同时保持主体30的结构完整性。
图5(b)显示了具有用于改善低温流体循环的两个腔7的超声尖端的实施方式的横截面。
图6(a)至6(i)是不同形状的末端14的横截面图。图6(a)展示了可用于切除较大区域的组织9的圆形或椭圆形末端14。图6(b)展示了尖锥形末端14,其可用于精确切除较小区域的组织9。图6(c)、6(d)、6(e)及6(f)展示了用于切除局部组织9的各种扁平的末端14。图6(g)显示了锯齿状末端14。与末端14的几何形状匹配的一次性塑料罩盖26可用于罩住末端,如图6(e)所示。
图6(h)和6(i)所示的各种超声尖端1的几何构造,特别设计用于切除身体内腔例如脉管、腔等中的无用组织层。超声尖端被设计用于插进身体内腔内而不伤害周围组织。
图7展示了低温流体20通过内腔34的传递,内腔34经过超声换能器3的中心、超声操纵杆2,并连接到一个或更多腔7。此特定实施方式可提供本领域的技术人员在评阅本公开内容时会认可的制造优势。
图8展示了在腔7和末端14之间具有孔12的超声尖端1的横截面视图,使得低温流体20可从腔7流经孔12,从而从末端14流出。这个类型的实施方式允许如图9所示的在末端14上形成冰球22,和/或如图10所示的低温喷射。然后,低温能量和超声能量能够通过末端14和组织9之间的冰球22和/或低温喷射传递至组织9。
图11给出了超声尖端1的三维视图,其中多个孔12设置在末端14上,以用于从周围切除身体内腔的壁和侧壁(例如脉管、腔等)。
图12显示了将超声能量聚集在焦点44上的末端14的向后锥形,而图13显示了将超声能量聚集在焦点44上的末端14的凹形。
根据本发明的设备可用于选择性地切除无用皮肤组织,例如疣、胎块、癌前期皮肤生长、瘤、黑素瘤及疤痕。在使用本设备的一个示范性技术中,低温能量和超声能量同时应用于将被切除的组织。这个技术包括将低温流体20供应至末端14、激发超声换能器3、以及然后将末端14放置成接近和/或接触组织9直到组织被切除。
可替代地,低温能量和超声能量可通过该设备顺序地应用至将要切除的组织。例如,可通过激发超声换能器3、将末端14放置成接近和/或接触组织9、以及然后将低温流体供应至末端14,来开始顺序应用。该顺序也可以反向,在这种情况下,将通过将低温流体20供应至末端14、将末端14放置成接近和/或接触组织9、以及然后激发超声换能器,开始该顺序。在切除组织9的过程中,可使用低温能量和超声能量顺序应用以及低温能量和超声能量同时应用的组合,如本领域的技术人员所认可的。
通过将低温流体20供应至末端14,并且将该末端放置成接近组织和/或将该末端放置成与组织9接触,可将低温能量传递至该组织。可替代地,末端14上的冰球22可放置成与组织接触,或者来自末端14中的孔12的低温喷射24可用于将低温能量传递至组织。
尽管已经在此展示和描述了具体实施方式和使用方法,但是本领域的普通技术人员应认识到,旨在实现相同目的的任何布置可代替所显示的具体实施方式和方法。应理解,上面的描述旨在说明性的且不是限定性的。对于那些本领域的技术人员来说,在评阅本公开内容时,上面的实施方式和其它实施方式的组合以及上面的使用方法和其它使用方法的组合将会显而易见。应参考附加权利要求来确定本发明的范围以及与此权利要求所授权的等同的全部范围。
Claims (18)
1.一种设备,其包括:
超声尖端,其包括主体,所述主体界定腔和内部通道并具有末端,所述末端设置成在所述主体和患者组织之间传递能量,所述内部通道在所述主体的外表面和所述腔之间延伸,所述内部通道设置成使低温流体流通至所述腔,所述腔设置成冷却所述主体的所述末端;以及
超声换能器,其与所述超声尖端相连通,以激发所述超声尖端。
2.如权利要求1所述的设备,其中所述超声换能器在18KHz和60MHz之间的频率下运行。
3.如权利要求1所述的设备,其中所述超声换能器在20KHz和100KHz之间的频率下运行。
4.如权利要求1所述的设备,其中所述超声换能器在约35KHz频率下运行。
5.如权利要求1所述的设备,其中所述末端振幅在1微米和300微米之间。
6.如权利要求1所述的设备,其中所述末端振幅约50微米。
7.如权利要求1所述的设备,其中所述末端是圆形的。
8.如权利要求1所述的设备,其中所述末端是矩形的。
9.如权利要求1所述的设备,其中所述末端是尖头的。
10.如权利要求1所述的设备,其中所述超声尖端的末端具有尖锐边缘。
11.如权利要求1所述的设备,其中所述超声尖端的末端具有锯齿状边缘。
12.如权利要求1所述的设备,其中所述超声的末端是凹形的。
13.如权利要求1所述的设备,其中所述超声尖端的所述主体界定一个或更多孔,所述一个或更多孔中的每一个连接到所述腔。
14.一种用于去除患者组织的方法,其包括:
提供具有超声尖端的超声换能器,所述超声尖端包括主体,所述主体界定腔和内部通道并具有末端,所述末端设置成在所述主体和患者组织之间传递能量,所述内部通道在所述主体的外表面和所述腔之间延伸,所述内部通道设置成使低温流体流通至所述腔内,所述腔设置成冷却所述主体的所述末端;
通过所述内部通道将低温材料流通至所述超声尖端的所述腔内;
使所述超声尖端超声振动;以及
接触患者组织,以低温治疗并将超声能量传递至组织。
15.如权利要求14所述的方法,其还包括:首先使所述超声尖端超声振动,然后使组织与所述超声尖端的所述末端接触,并在所述末端接触组织之后激发低温能量。
16.如权利要求14所述的方法,其还包括:首先使低温材料流通至所述超声尖端的所述腔,然后使组织与所述超声尖端的所述末端接触,并使所述超声尖端超声振动。
17.如权利要求16所述的方法,其还包括:所述超声尖端的所述末端通过设置在所述超声尖端的所述末端和组织之间的冰球,将用于切除的超声低温能量传递至组织。
18.如权利要求16所述的方法,其还包括:所述超声尖端的所述末端通过设置在所述超声尖端的所述末端和组织之间的低温喷射,将用于切除的超声低温能量传递至组织。
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US6413263B1 (en) * | 2000-04-24 | 2002-07-02 | Axon Instruments, Inc. | Stereotactic probe holder and method of use |
US6551309B1 (en) * | 2000-09-14 | 2003-04-22 | Cryoflex, Inc. | Dual action cryoprobe and methods of using the same |
US6527765B2 (en) * | 2000-10-06 | 2003-03-04 | Charles D. Kelman | Cryogenic surgical system and method of use in removal of tissue |
US6648880B2 (en) * | 2001-02-16 | 2003-11-18 | Cryocath Technologies Inc. | Method of using cryotreatment to treat brain tissue |
US6478754B1 (en) * | 2001-04-23 | 2002-11-12 | Advanced Medical Applications, Inc. | Ultrasonic method and device for wound treatment |
US6936045B2 (en) * | 2001-09-20 | 2005-08-30 | Endocare, Inc. | Malleable cryosurgical probe |
US6858025B2 (en) * | 2002-08-06 | 2005-02-22 | Medically Advanced Designs, Llc | Cryo-surgical apparatus and method of use |
-
2005
- 2005-10-13 US US11/250,870 patent/US7572268B2/en not_active Expired - Fee Related
-
2006
- 2006-09-15 CN CNA2006800379100A patent/CN101287414A/zh active Pending
- 2006-09-15 EP EP06803615A patent/EP1933713A4/en not_active Withdrawn
- 2006-09-15 WO PCT/US2006/035864 patent/WO2007046989A2/en active Application Filing
- 2006-09-15 JP JP2008535538A patent/JP2009511168A/ja active Pending
- 2006-09-15 KR KR1020087011147A patent/KR20080057338A/ko not_active Application Discontinuation
Also Published As
Publication number | Publication date |
---|---|
EP1933713A4 (en) | 2009-10-21 |
WO2007046989A2 (en) | 2007-04-26 |
KR20080057338A (ko) | 2008-06-24 |
US7572268B2 (en) | 2009-08-11 |
WO2007046989A3 (en) | 2007-07-12 |
US20070088217A1 (en) | 2007-04-19 |
JP2009511168A (ja) | 2009-03-19 |
EP1933713A2 (en) | 2008-06-25 |
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