CN108366828B - 用于人体粘膜组织的美容治疗的装置和方法 - Google Patents
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Abstract
用于提供身体孔口的分数处理的装置,包括分数能量源和肌肉电刺激(EMS)能量源。可编程控制器控制分数能量和/或EMS能量的施加。探针通过其远端插入身体孔口中。分数能量源被定位用于将来自分数能量源的分数能量通过探针传递到身体孔口周围附近的组织;并且EMS能量源被定位用于将来自EMS能量源的EMS能量通过探针传递到身体孔口周围附近的组织。可编程控制器配置为同时或顺序地控制分数能量和EMS能量的激活。
Description
相关申请
本申请要求了于2012年5月16日递交的美国申请号为13/510,062的优先权并为该申请的继续申请,而上述美国申请是于2010年11月16日递交的PCT/IL10/00947的371国家阶段,其要求了于2009年11月16日递交的美国临时申请号为61/261,381的优先权,其全部内容在此通过引证并入本文。
发明领域
本发明涉及的是在人体粘膜组织的美容治疗中的一种或多种治疗方式的应用,以提供尤其是阴道和肛门紧缩和尿失禁治疗。
背景技术
阴道松弛综合症(VRS)通常称为“阴道松弛”,是一种相当常见的医疗疾病,被描述为最佳阴道结构的丧失,其通常与阴道分娩和自然衰老有关。
多次怀孕和分娩导致VSR情况恶化,以及更年期开始,导致激素水平下降和阴道萎缩。
大多数女性及其丈夫或伴侣认为VSR是“阴道松弛”,抱怨阴道紧致性丧失,这与性交过程中摩擦的减少直接相关,从而导致性满足减少或丧失。
市场上有各种各样的VRS治疗选择,从行为(凯格尔运动)到药物治疗(荷尔蒙,紧肤膏和喷雾剂)到各种更多或更少侵入性外科手术。
尽管行为和药物治疗是无创和安全的,但其疗效有限。
另一方面,各种外科手术以较高的相关风险为代价,可以获得更好的最终结果。
外科手术需要切割阴道和外周组织以重新排列阴道,从而减小阴道的尺寸。
在敏感的阴道组织上或附近进行手术本质上是有风险的,并且可能导致瘢痕形成、神经损伤和感觉减弱。此外,患者需要延长的恢复期。
外科手术过程中最受欢迎的是使用激光进行手术,其中使用激光代替手术刀。
因此,对于阴道复原有效的无创性解决方案显然是需要的。
多种用于组织复原,主要用于皮肤治疗的技术已经描述过了。例如,美国专利第6,387,089号描述了一种被称为光子嫩肤的过程,其中使用脉冲光来加热和收缩胶原蛋白并由此恢复皮肤的弹性。由于胶原蛋白位于真皮层,靶向胶原蛋白的激光必须穿过表皮并穿过真皮表皮交界处。由于比尔吸收定律(Bier’s Law of absorption),激光束通常在皮肤表面最强烈。这导致皮肤上层的不可接受的加热。已经描述了各种方法用于冷却皮肤的上层,同时将下层保持在期望的温度。一种方法是在表面上喷洒制冷剂材料,使得表面保持冷却,同时下层(以及因此胶原蛋白)被加热。这样的方法在美国专利第6,514,244号中描述。另一种方法在美国专利第6,387,089号中描述,是使用冷却的透明物质,例如冰、凝胶或晶体与皮肤表面接触。冷却剂的透明特性允许激光束穿透不同的皮肤层,同时保持皮肤表面上可接受的温度水平。
非消融性光子嫩肤的目的是在乳头状和上层网状真皮室(皮肤表面下约100-400微米)诱导热伤口修复反应,同时保留表皮室。
为了克服与上述不希望的皮肤上层(表皮和真皮)加热有关的一些问题,美国专利第6,311,090号描述了使用RF能量和包括搁置在皮肤表面上的RF电极的装置。产生的反向热梯度显然不会实质上影响黑色素细胞和其他上皮细胞。然而,即使这样的非侵入性方法也存在明显的局限性,即能量不能有效地集中在感兴趣的特定区域,例如真皮。
加热真皮而不加热更多的表面层的其他方法已经被描述了。这些方法涉及使用穿透皮肤表面进入组织并提供加热的导电针。美国专利第6,277,116和6,920,883号描述了这样的系统。不幸的是,这种方法导致皮下层的广泛加热并且潜在地熔化皮下层中的脂肪。这导致了不希望的组织疤痕。
正如美国专利申请公开号为2005/0049582中所述的,已经描述了用于限制组织的一般均匀加热的一种方法是组织的分数处理。该申请描述了使用激光能量在皮肤中形成具有期望形状的处理区,其中未处理的健康组织位于被处理组织的区域之间。这使得未处理的组织能够承受愈合和恢复过程。
与传统的激光换肤术不同,它可以治疗目标组织的整个表面,分数激光皮肤换肤法使用分数光热作用。它针对的是具有分散斑点图案的组织。这导致组织凝固的微观区域的图案在几周内愈合,同时皮肤保持正常的外观。该方法不是在目标组织的表面或仅在真皮中产生全局组织效应,而是在经过处理的一小部分皮肤上产生损伤,凝结多列直径通常为70-100微米的组织,表皮深入真皮达1毫米深。这些激光柱产生被健康组织包围的组织凝血的微热区。健康的组织提供了乳头状真皮中的丰富的干细胞和黑色素细胞库,这些细胞免受创伤和加速愈合过程。来自备用组织的角质形成细胞的小尺寸伤口和短的迁移路径导致快速上皮再生和快速表皮修复。真皮中胶原变性的区域引起炎症级联的上调,这导致胶原重塑至通常400-700微米的深度,引起皮肤收紧。患者没有开放式伤口的事实导致了停机时间最小化。因此,分数激光换肤术是非消融手术。它提供改善的皮肤质地、色调、色素沉着、细纹和紧致肌肤。与需要单次治疗的烧蚀激光器相比,分数换肤需要一系列3-5次治疗。
市场上存在的分数阴道复原系统使用CO2或Er:YAG激光器。这些包括,例如,Fotona的IntimaLase-一种微创,非消融性Er:YAG激光阴道紧缩手术,利用光热激光-粘膜组织相互作用。另一种设备是Alma Laser的FemiLift。这是一种无创激光阴道紧缩装置,使用CO2激光通过对阴道组织内层进行热加热,随着时间推移,诱导胶原蛋白和弹性蛋白的收缩和再生。
这种已知的分数激光换肤系统的缺点包括:它们笨重且昂贵。同样,为了获得显着的结果,组织的加热达到大约70℃的坏死区域的温度,并且组织(无论其是否分别由细胞、角质细胞及其衍生物或胶原蛋白组成)坏死或变性。高于100℃的组织中的温度可能会在组织中形成蒸汽,这可能会造成破坏性影响。这样的温度可能会导致不良的副作用,例如疼痛、红斑、肿胀、偶尔形成疤痕、延长愈合时间和感染。
因此,需要对阴道进行简单、廉价的分数治疗,导致组织损伤并触发组织愈合过程,但没有由组织加热造成的风险和并发症造成组织变性和凝固。虽然本发明可以在医师或其他操作员办公室环境的范围内进行施用,但其操作足够简单,因此可以在用户的家中隐私使用。例如,本发明可以具有开关或其他装置,使得EMS功能可以与RF功能分开,使得用户可以激活本装置的EMS部分而不激活用于训练和/或阴道紧缩目的的RF功能。
发明内容
一方面,提供身体孔口的分数处理的装置包括分数能量源;肌肉电刺激(EMS)能量源;可编程控制器,用于控制分数和/或EMS能量的应用;探针,用于将其远端插入身体孔口的探针。分数能量源被定位用于将分数能量源的分数能量通过探针传递到身体孔口周围附近的组织;并且EMS源被定位用于将EMS能量源的EMS能量通过探针传递到身体孔口附近的组织;可编程控制器被配置为同时或顺序地控制分数能量和EMS能量的激活。
在另一方面,身体孔口可以选自以下其中之一:阴道腔;肛门腔,口腔或耳腔,并且所述处理提供阴道或肛门紧缩之一。
在另一方面,分数能量是射频(RF)能量或超声(US)能量,或者其可以是光能量。
在又一个方面中,控制器可以被配置为首先激活EMS能量,随后激活RF能量,由此首先将身体孔口附近的组织拉动成与探针接触,随后激活RF能量。控制器可以激活EMS能量的施加,然后激活选定次数的RF能量。
另一方面,分数能量源可以包括安装在探针的外部表面上的电极,并且可以沿着探针的另一个表面以一个或多个螺旋的形式安装。该设备可用于家庭使用。
在另一方面,提供一种用于身体孔口的分数处理的方法,其包括:将来自分数能量源的分数能量通过插入身体孔口中的探针传递至围绕身体孔口附近的组织;以及将EMS能量源的EMS能量通过探针传递到身体孔口附近的组织。
在进一步的方面,可编程控制器被配置用于同时或顺序地控制分数能量和EMS能量的一个或多个的传递。所述控制器可以首先激活EMS能量,随后激活RF能量,由此首先将身体孔口附近的组织拉动成与探针接触,随后激活RF能量。控制器可以激活EMS能量的施加,然后激活选定次数的RF能量。所述方法可在办公室或家庭使用的其中之一实施。
在另一方面,可编程控制器可被配置为控制分数能量和/或EMS能量的激活。EMS能量可能被激活,并且为了收紧身体孔口,包括阴道或肛门紧缩,分数能量源不会被激活。
附图说明
图1示出了本发明的系统的总体示意图。
图2A和2B示出了现有技术探针和可以结合本发明的系统使用的本发明的探针。
图2C至2D示出用于原位保持/安装本发明的探针的保持器/贴片机系统。
图3图解说明了本发明的系统在提供RF和EMS能量中的操作。
具体实施方式
本发明的一个方面是提供阴道紧缩治疗的系统和方法。如图1所示,该系统的附图标记为10,其包括阴道探针12,其可被插入阴道并且被配置为向阴道壁(未示出)提供两种类型的电信号的组合。系统10还包括电源单元14,具有图形用户界面(GUI)18的可编程控制器16。连接到控制器的是肌肉电刺激(EMS)单元20和射频(RF)单元22,两者都可以被选择性地启动以在控制器16的控制下向探针12提供它们各自的能量输入。除此之外,可提供压力传感器24和温度传感器26,以在控制器16的控制下激活EMS单元和/或RF单元中的一个或两个之前和/或期间和/或之后从探针12提供反馈。仅作为示例,反馈可以包括作为治疗的时间和程度的治疗效率的量度。如上所述,所施加的第一电信号是肌肉电刺激信号(EMS),其被设计为当被激活时使阴道探针12周围的阴道平滑肌收缩。同样如上所述,第二电信号是射频(RF)信号,其在控制器的控制下被激活时被设计为照射阴道组织。美国申请号为13/510,062的全部内容在此通过引证并入本文,其进一步描述了用于将信号提供给目标组织的可能组合。
现在参图3,其示出了随后是RF脉冲的一系列EMS脉冲。EMS脉冲用于使阴道探针周围的阴道收缩以在内部阴道组织和电极之间产生适当的电耦合。除此之外,压力传感器24可以结合在阴道探针上以测量由阴道在探针12上产生的压力的反馈。感测到的压力量可以提供电极的耦合充足或不足的指示。施加的EMS脉冲激活肌肉并使粘膜组织变平,使肌肉更接近电极表面。例如,可以禁止控制器启动RF单元22直到检测到选定的压力读数。可替换地,如本领域技术人员已知的,通过一组专用电极由治疗电极进行的组织阻抗测量也可以用于为组织电极耦合提供反馈。此外,温度传感器26可以在探头/阴道壁界面处提供温度读数以确保不会发生过度加热。阴道组织的过度加热可能导致控制器停止EMS和/或RF单元的激活。
回到图3中的脉冲序列,在EMS信号之后开始的是治疗RF脉冲。EMS信号可能相对较短,可能在50-350微秒的范围内。该信号可以以大约5-25Hz的频率重复。温度传感器26可以反馈到被配置用于控制RF脉冲宽度的控制器16。
RF可以是双极或单极的。在单极配置中,可以使用耻骨或腰背上的外部电极。EMS信号可以使用专用电极或与用于所述RF单元的相同的电极。在这种情况下,可以提供本领域技术人员已知的二极管桥来“切断”AC RF信号以产生1至30毫秒范围内的有效DC信号。这种配置使得整个系统作为家用设备变得更简单和更容易实现。DC EMS信号可能导致肌肉变得平滑,进而可能引起收缩。
根据本发明的一个方面,该系统被配置用于在EMS和RF信号之间切换。EMS信号后跟RF治疗信号可能会对相邻阴道组织造成热损伤并导致其紧缩。根据本发明的另一个实施方案,可以使用仅RF或仅EMS信号以分别加热或训练(exercise)阴道。根据本发明的另一个实施方案,RF和EMS脉冲的施加顺序可以是任何期望的顺序或次序以实现期望的治疗结果。
阴道是一个中空的器官,由平滑肌组成。平滑肌的特点是高弹性,使他们能够伸展,同时仍保持强大的收缩能力。平滑肌细胞细胞质富含肌球蛋白和肌动蛋白分子,为平滑肌细胞提供收缩能力。平滑肌细胞之间的拉伸结构含有肌动蛋白细丝,其收缩单元附着于致密体上,形成收缩纤维网络。这个网络既不是沿阴道平滑肌的平行线方向,也不是沿着阴道平滑肌的方向。其结果是,平滑肌容易以螺旋状收缩。因此,诱导平滑肌刺激的最有效方式可能不是通过沿着或穿过图2A所示的现有技术阴道探针100提供平行电极102,其中所述现有技术为来自意大利的NovaClinical的VDR技术。如图所示。如图2B所示,一个或多个螺旋电极104安装或以其他方式固定在阴道探针1016上并沿着阴道探针1016。考虑到阴道平滑肌中收缩纤维的解剖和排列,螺旋取向的电极被认为更适合于在接触点产生有效的刺激矢量。
现在转到图2C和2D,这些附图示出了护套的布置,其中图1的阴道探针12可能被插入其中。图2D示出了具有测量标记202的探针200,其可以是每5至10毫米。如图2C所示,探针200可以装配在套筒204内。组合单元的设计包括将套管204插入阴道内。然后可以将探针200插入套筒中,并因此插入患者的阴道。套筒204的一部分将保持在患者身体的外部,医生或其他操作者可以通过读取位置202处的测量标记来读取插入程度。这种布置允许医生或其他操作者选择性地和/或顺序地处理患者的阴道中的各种深度。
如上所述,提供基于光的阴道再生治疗是已知的。然而,将EM治疗与EMS治疗相结合却并非已知的,使得插入的探针周围的组织将被吸引与探针接触,由于与探针的紧密接触,能够提供更有效和高效的阴道壁治疗,从而获得能量来源。
Claims (4)
1.一种提供用于阴道紧致的阴道治疗的装置,所述阴道具有内壁,所述装置包括:
射频(RF)能量源;
肌肉电刺激(EMS)能量源;
可编程控制器,其用于控制RF能量和EMS能量的应用;
探针,其具有远端,所述远端配置用于插入到所述阴道,所述探针具有外部细长探针表面,其形状和尺寸适于与阴道的内壁接触,所述外部细长探针表面具有至少一个RF电极和至少一个EMS电极,所述电极配置用于将RF能量和EMS能量传输到所述阴道的内壁;其中所述可编程控制器配置用于顺序地控制RF能量和EMS能量的应用;
其中所述可编程控制器配置用于首先激活EMS能量源,然后激活所述RF能量源,由此所述阴道内壁被拉动成首先通过EMS能量与探针接触,随后为RF能量的激活。
2.根据权利要求1所述的装置,其中所述控制器配置用于激活所述EMS能量的施加,随后激活选定次数的所述RF能量。
3.根据权利要求1所述的装置,其中所述电极沿着所述外部细长探针表面以一个或多个螺旋的形式安装。
4.根据权利要求1所述的装置,其中所述装置是家庭使用的。
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- 2016-12-13 EP EP16875059.4A patent/EP3389532A4/en active Pending
- 2016-12-13 CN CN202210311640.9A patent/CN114796856A/zh active Pending
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IL295965B1 (en) | 2024-04-01 |
WO2017103923A1 (en) | 2017-06-22 |
CN114796856A (zh) | 2022-07-29 |
IL259809A (en) | 2018-07-31 |
EP3389532A1 (en) | 2018-10-24 |
EP3389532A4 (en) | 2019-01-02 |
CN108366828A (zh) | 2018-08-03 |
IL259809B (en) | 2022-09-01 |
IL295965A (en) | 2022-10-01 |
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