CN105873525A - 仪表化伤口闭合装置 - Google Patents

仪表化伤口闭合装置 Download PDF

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Publication number
CN105873525A
CN105873525A CN201580003670.1A CN201580003670A CN105873525A CN 105873525 A CN105873525 A CN 105873525A CN 201580003670 A CN201580003670 A CN 201580003670A CN 105873525 A CN105873525 A CN 105873525A
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CN
China
Prior art keywords
wound
plate
treatment
sensing
layer
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Pending
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CN201580003670.1A
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English (en)
Inventor
埃米尔·贝尔森
小爱德华·C·德里斯科尔
埃里克·斯托内
艾伦·斯切尔
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Qi Pulin Pharmaceuticals
Zipline Medical Inc
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Qi Pulin Pharmaceuticals
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Publication of CN105873525A publication Critical patent/CN105873525A/zh
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Abstract

一种伤口或切口闭合设备包括第一板和第二板。每一个板包括底部粘附层、中间基体层和连接这两个板的上负荷分布层。传感或治疗元件被安置在邻近两个或更多个所述层处、在其内部或在其之间。所述传感或治疗元件可以提供对所述切口的感测和/或治疗并且/或者监测所述切口以使得可以自定义和更新所述治疗。

Description

仪表化伤口闭合装置
交叉引用
本PCT申请要求提交于2014年1月5日的美国临时申请号61/964,477的权益，上述申请通过引用并入于此。
发明背景
本申请涉及医疗系统、装置和方法。具体而言，本申请涉及具有集成的治疗和/或传感器性能的外科切口闭合装置的构建、用法和功能。
发明内容
本文公开了将治疗和/或传感能力并入伤口闭合装置中的医疗装置、系统和方法。
本申请的发明人之前已经公开了涉及外科皮肤闭合的发明。例如，在都提交于2013年7月24日的美国临时申请号61/958,254和61/958,259，以及提交于2014年2月14日的美国专利申请号14/180,524中描述了此类皮肤闭合器械，上述申请的内容通过引用并入于此。如所描述的，可以在患者皮肤上期望形成外科切口的部位处放置粘附贴片。在放置贴片之后，沿着延伸穿过贴片中部的轴线形成切口。在形成切口之后，可以打开所述切口以进行期望的手术操作，并且在所述手术操作完成之后，可以通过用夹子、拉链、齿杆(“ratchet”)、扎带或其他(一个或多个)闭合构件将所述板的内边缘拉在一起而闭合所述切口。此类外科闭合装置是为了改善愈合和减少因切口造成的瘢痕形成。
包括测量运动、加速度、应力/应变、温度、压力、氧气饱和度和张力、CO2张力、水分和其他参数的那些传感器在内的局部传感器在本领域和医疗装置市场中是众所周知的。然而，将这样的传感器和功能并入伤口闭合装置中以及/或者与术后物理治疗结合使用在市场中尚且无法达到。此外，包括热、光(包括红外光、可见光和紫外光)、电信号、运动(例如，振动)和压力的递送在内的治疗能力的递送，在本领域和医疗装置市场中是众所周知的。然而，将这样的性能并入伤口闭合装置中以及/或者与术后物理治疗结合使用在市场中尚且无法达到。本公开内容的各方面提供了并入了至少一些上述提及的能力的伤口或切口闭合器械和使用方法。
本公开内容的各方面提供了伤口或切口闭合设备，所述设备包括用于横向地邻近伤口或切口的第一侧边而放置的第一板、用于横向地邻近所述伤口或切口的第二侧边而放置的第二板以及被安置成邻近或被集成到所述第一板或第二板中的一个或多个中的传感或治疗元件。所述第一板可包括第一底部粘附层、第一中间基体层和第一上负荷分布层。类似地，所述第二板可包括第二底部粘附层、第二中间基体层和可连接到所述第一上负荷分布层的第二上负荷分布层，例如，通过一个或多个扎带和扎带齿杆连接。如下文中进一步描述的，所述板的不同层可以由各种材料构建。
所述传感或治疗元件可以被安置成邻近或被集成到所述第一底部粘附层、所述第二底部粘附层、所述第一中间基体层、所述第二中间基体层、所述第一上负荷分布层或所述第二上负荷分布层中的一个或多个中。所述传感或治疗元件可以被安置于所述第一板或第二板中的一个或多个的层中的两个或更多个层之间的袋内。所述第一面或第二板可以具有穿过一个或多个所述层的通路以允许接近所述袋。
所述传感或治疗元件可以被配置用于与所述伤口或切口闭合设备外部的接收装置通信，诸如无线通信(例如，蓝牙、蓝牙LE、WiFi、一种或多种IR信号等)。所述接收装置可包括工作站、个人计算机、膝上型计算机、平板计算机、智能电话、可穿戴式计算机或专用接收器等。
所述传感或治疗元件可包括温度计、运动传感器、化学传感器、压力传感器、治疗递送元件或其他传感器中的一种或多种。运动传感器例如可包括应变仪、机电传感器、电磁传感器、加速计、光学传感器或其他运动传感器中的一种或多种。化学传感器例如可以被配置用于测量血液成分、经皮氧气、经皮二氧化碳、葡萄糖水平或pH中的一种或多种。治疗递送元件例如可包括用于光疗的光源、机械振动元件、超声源、药物递送元件、加热元件、冷却元件、充电元件或超声源中的一种或多种。
本公开内容的各方面还提供了治疗伤口或切口的方法。可以邻近所述伤口或切口的第一侧边而粘附伤口或切口闭合设备的第一板。可以邻近所述伤口或切口的第二侧边而粘附所述闭合设备的第二板。可以将所述第一板和第二板横向地拉在一起以将所述伤口或切口的第一侧边和第二侧边拉在一起。可以使用安置于所述第一板或第二板中的一个或多个之上或之内的治疗或传感元件感测(一个或多个)生理参数。所述治疗或传感元件可以间歇地(例如，按使用者的决断，诸如根据时间表)和/或连续地(包含按紧密的时间间隔，或者每一个或多个小时、一个或多个分钟或一个或多个秒进行一次或者进行设定的次数)感测(一个或多个)所述生理参数。例如，举几例来说，(一个或多个)所述生理参数可包括温度、运动、水分、压力、生理学标记物的浓度、pH、氧气水平、二氧化碳水平或葡萄糖水平中的一个或多个。
所述方法还可以包括使用所述治疗或传感装置向患者提供治疗的步骤。举几例来说，所述治疗可包括光疗、振动疗法、超声疗法、药物递送、热疗、冷疗或电疗中的一种或多种。
所述方法还可以包括向外部接收装置传输感测的(一个或多个)生理参数的步骤。所述传输可以随着通过所述治疗或传感装置进行的对(一个或多个)所述生理参数的感测或检测实时进行。举几例来说，所述外部接收装置可包括工作站、个人计算机、膝上型计算机、平板计算机、智能电话、可穿戴式计算机或专用接收器中的一种或多种。
援引并入
本说明书中提及的所有出版物、专利和专利申请均通过引用并入本文，其程度如同具体地且个别地指出要通过引用而并入每一个别出版物、专利或专利申请。
附图说明
所附权利要求书中具体阐述了本公开内容的新颖特征。通过参考阐述了利用本公开内容原理的说明性实施方式的以下详细描述以及附图，将获得对本公开内容的特征和优点的更好的理解，在附图中：
图1示出了根据许多实施方式的伤口闭合器械的透视图；
图2示出了图1的伤口闭合器械的板的剖面图；
图3示出了根据许多实施方式、带有安置于其粘附层之下而在皮肤之上的传感器或治疗元件的图1的伤口闭合器械的板的剖面图；
图4示出了根据许多实施方式、带有安置于其粘附层内的传感器或治疗元件的图1的伤口闭合器械的板的剖面图；
图5示出了根据许多实施方式、带有安置于其基体层与粘附层之间的传感器或治疗元件的图1的伤口闭合器械的板的剖面图；
图6示出了根据许多实施方式、带有安置于其力分布结构层与基体层之间的传感器或治疗元件的图1的伤口闭合器械的板的剖面图；
图7示出了根据许多实施方式、带有安置于其力分布结构层之上的传感器或治疗元件的图1的伤口闭合器械的板的剖面图；
图8示出了根据许多实施方式、带有安置于其粘附层之内的传感器或治疗元件并且还被提供有针对该传感器的可接近式袋的图1的伤口闭合器械的板的剖面图；
图9示出了根据许多实施方式、带有安置于其基体层与粘附层之间的传感器或治疗元件并且还被提供有针对该传感器或治疗元件的可接近式袋的图1的伤口闭合器械的板的剖面图；
图10示出了根据许多实施方式、带有安置于其力分布结构与基体层之间的传感器或治疗元件并且还被提供有可接近式袋的图1的伤口闭合器械的板的剖面图；
图11示出了根据许多实施方式、带有安置于其顶面之上的传感器或治疗元件的图1的伤口闭合器械的板的剖面图；
图12示出了根据许多实施方式、图1的伤口闭合器械和盖板的透视图，所述盖板具有并于其上或其内的一个或者多个传感器或治疗元件；以及
图13示出了根据许多实施方式、使用带有集成的治疗或传感元件的伤口闭合设备的治疗方法的流程图。
具体实施方式
本公开内容涉及并入治疗和/或传感能力的伤口闭合装置以及其使用方法。
治疗和/或感测能力的并入。
图1示出了基本的伤口闭合装置100的布局。伤口闭合装置100可包括第一板102和第二板104。在使用中，第一板102和第二板104在被横向地拉到一起以闭合切口并且保持其闭合之前，可以跨该切口的侧边平行地布置。图2示出了装置100的板102或104之一的剖面图。装置100可包括多个层，所述多个层包括用以更均匀地分布施加来维持伤口或切口闭合的力的负荷分布元件100、安置在第一板102上表面上的可调节式锚固扎带锚固件112、负荷分布元件112之下的基体层114，可能对于压力敏感的粘附层116、可调节式扎带118以及第二板104顶面之上的可调节式扎带齿杆120。可调节式扎带118可以通过可调节式扎带锚固件112和可调节式扎带齿杆120连接第一板102和第二板104。例如，可以拉动单个可调节式扎带118穿过可调节式扎带齿杆120以将板102和104拉到一起。在均提交于2013年7月24日的美国临时申请号61/958,254和61/958,259，以及提交于2014年2月14日的美国专利申请号14/180,524中进一步描述了切口或伤口闭合设备，上述申请的内容通过引用并入于此。可以通过以下方法中的一种或多种来实现治疗或传感元件并入到伤口闭合装中。
粘附层116可包括亲水性粘附材料，诸如水胶体、水凝胶、丙烯酸类聚合物或聚(乙二醇)中的一种或多种。水胶体粘合剂可具有非常粘并且能够吸收水分和使皮肤细胞脱落的益处。因此，水胶体粘合剂可特别适合于长期佩戴应用(例如，长达14天)。基体层114可包括橡胶、乳胶、氨基甲酸乙酯、聚氨基甲酸乙酯、硅酮、热塑性弹性体(TPE)、织造织物或短纤织物中的一种或多种。负荷分布元件112可以由与基体层114相似的材料制成。上层——基体层114和负荷分布元件112——通常会是柔性的，但足够坚硬，以牢固地闭合组织并使对切口和周围组织的扰动最小化。底层116通常会是柔性的并且比上层114、116更有弹性，以保持粘附、使起泡最小化以及除此之外减小刺激。
本文所公开的切口闭合器械或切口闭合器械组装件的一个或多个组件，可以包括、涂有或以其他方式并入抗真菌材料、抗细菌材料、抗微生物材料、防腐材料或药用材料中的一种或多种。例如，此类材料可以并入到水胶体粘附层中，作为皮肤与粘附层之间的另一层或涂层(覆盖粘附层的至少一部分)，并入到基部组装件覆盖物或至少其粘附层中，等等。可以在装置或设备组件上提供一个或多个孔、沟槽、开口、孔隙或类似的结构以促进这样的并入。在许多实施方式中，此类材料可以包括银、碘化物、锌、氯、铜或诸如茶树油等天然材料中的一种或多种作为活性剂。此类抗真菌材料、抗细菌材料、抗微生物材料、防腐材料或药用材料的示例包括但不限于可从英国的Smith&Nephew plc购得的ActicoatTM系列材料、可从英国的Smith&Nephewplc购得的湿度控制系列材料、可从丹麦的Coloplast A/S购得的泡沫系列材料、可从英国的Urgo Limited(法国的Laboratoires URGO的子公司)购得的银系列材料、可从英国的Smith&Nephew plc购得的水胶体系列材料、可从新泽西州Skillman的ConvaTec Inc.购得的Ag系列材料、可从德克萨斯州San Antonio的Kinetic Concepts,Inc.购得的系列材料、可从德克萨斯州San Antonio的Kinetic Concepts,Inc.购得的Silver 220、可从英国的Urgo Limited(法国的LaboratoiresURGO的子公司)购得的SSD系列材料、可从德克萨斯州San Antonio的Kinetic Concepts,Inc.购得的系列材料、可从英国的Smith&Nephew plc购得的系列材料、可从英国的Aspen Medical Europe Ltd.购得的Sorbsan SilverTM系列材料、可从伊利诺伊州Burr Ridge的Ferris Mfg.Corp.购得的Polymem系列材料、可从德克萨斯州San Antonio的Kinetic Concepts,Inc.购得的PromogramTM系列材料、可从德克萨斯州San Antonio的KineticConcepts,Inc.购得的Promogram PrismaTM系列材料、以及可从伊利诺伊州Mundelein的Medline Industries,Inc.购得的系列材料。在共同拥有的美国专利号8,313,508、8,323,313和8,439,945；美国专利公开号2013/0066365；以及PCT申请号US 2010/000430、US2011/139912、US 2011/40213、US 2011/34649和US 2013/067024中描述的闭合装置的组件也可包含、涂有或以其他方式并入抗真菌材料、抗细菌材料、抗微生物材料、防腐材料或药用材料中的一种或多种，包括但不限于以上列出的材料中的一种或多种。
在许多实施方式中，向本文所述的伤口闭合器械中直接并入局部药物制剂。由于伤口闭合装置往往被应用于紧邻需要药物保护的伤口或切口之处，因而此类药物向闭合装置中的直接并入可能是有益的。例如，在有感染风险的伤口中，抗微生物药剂的并入可能是有益的。抗微生物药剂可包括抗生素药物以及防腐金属离子和关联的化合物，这可以包括银、碘、铜和氯或者诸如茶树油等天然材料。例如，在易被真菌感染的伤口中，可以获准使用诸如锌等药物制剂。这些制剂中的任何制剂的组合也可能是有益的，并且因此可以并入到伤口闭合器械中。
局部药物制剂能够以这样的方式并入到闭合装置中：给予闭合装置在保持伤口充足地含水的同时将渗出液芯吸出伤口(例如，导引不期望的生物体离开伤口和/或防止皮肤浸渍)以改善愈合的能力。
如图3、图4、图5和图6中所示，可以将一个或多个治疗或传感元件130嵌入板100的材料中。一个或多个治疗或传感元件130可以嵌入装置的压力敏感粘附层116(图4)或附接至所述层的底部(图3)，或者处于装置100的各层之间的层叠体中，诸如基体层114与粘附层116之间的层叠体中(图5)以及负荷分布层110与基体层114之间的层叠体中(图6)。
如图8、图9和图10中所示，可以将(一个或多个)治疗或传感元件130嵌入在板102或104中的一个或多个之内所创造的袋中。(一个或多个)治疗或传感元件130可以通过在粘附层116内创造袋或包膜116a(图8)、通过在邻接的基体层114与粘附层116之间(例如，在基体层104的单膜或织物与压力敏感皮肤粘附层116之间；图9)创造袋或包膜115a或者通过在邻接的负荷分布元件层110与基体层114之间(例如，基体层104的单膜或织物与负荷分布层110的闭合机构之间；图10)创造袋或包膜113a而并入装置100中。潜在地，这样的袋116a、115a和/或113a可以具有由特殊材料(诸如导电材料、对特定波长透明的材料等)制成的特殊的皮肤窗口。备选地或组合地，如图8、图9和图10中分别所示，可以分别经穿过板102或104的各层的通路116b、115b和/或113b接近这样的袋116a、115a和/或113a。
如图7和图11中所示，可以将(一个或多个)治疗或传感元件130附接至装置100的顶面或上表面。可以将(一个或多个)元件130以永久的方式(例如，胶合、钉合、缝合)或可释放的方式(例如，可移除的粘合剂、钩环、按扣、夹子、纽扣或无源触点(例如，通过另一手段固定到位，诸如通过胶带、附加的绷带、弹性/压缩式包裹物、磁体固定到位))附接至装置100的顶部。
如图12中所示，(一个或多个)治疗或传感元件130可以附接或嵌入于装置100的可移除或可附接的部分上。(一个或多个)元件130可以附接至装置100的一个节段，该节段在与伤口闭合的时间不同的时间(例如，闭合后的24小时)被附接或者在从皮肤移除整个装置100之前从装置100移除(例如，(经由穿孔、钩环紧固件等移除)，以使得(一个或多个)传感器或治疗元件130在适当的时间或者在适当的持续时间内提供最大临床效用。附接或集成的方式例如可以将(一个或多个)传感器或治疗元件130直接放置在切口上或与之接触，这通常是在沿着伤口的每一侧的两个粘附条带或板102和104之间的装置100中心。
(一个或多个)治疗或传感元件130可以附接至患者而不用管伤口闭合机构的特殊性。(一个或多个元件)130可以在与闭合机构(例如，粘附闭合装置、钉、缝合线)无关的位置处附接至患者，使得其可以提供与集成到闭合机构中的任何元件相同的反馈。(一个或多个)元件130还可以具有用于远离外科切口或根本没有切口的地方的应用的效用，以便为术后治疗和其他非外科治疗这二者引导物理治疗和恢复。
激活和/或感测的方式。
(一个或多个)治疗或传感元件130可以被激活或者至少可以用以下方式传输感测的信息。
(一个或多个)治疗或传感元件130可以与接收元件直接接触。接收元件可包括计算装置(例如，工作站、个人计算机、平板计算机、智能电话、可穿戴式计算机等)或专用的诊断装置。连接可以通过电线以永久的(例如，“硬接线”)方式或可释放的(经由连接器)方式连接到伤口闭合装置100来实现。类似地，可以采用通过机械“管道”(例如，填充有流体的管子)连接的方式(永久的或可释放的)的加热或冷却。对于电构造或机械构造而言，可以使用诸如粘合剂、层叠体、系杆、夹子等元件在闭合装置100之上、之下或之内(嵌入、层叠)为电线或管子安排路线。可以采用以蛇形或其他类似图案的连接元件布置来为装置100提供机械顺应性。
(一个或多个)治疗或传感元件130可以与接收元件无线连接。无线发射器和/或接收器可以集成到闭合装置100中以接收和/或发送关于(一个或多个)治疗或传感器元件130的信号。这一发射器和/或接收器例如可以包括用电池操作的、低功率蓝牙或其他无线电传输元件以向诸如上文所描述的那些装置等另一接收装置发送/接收。
伤口闭合装置100可以是并入了(一个或多个)治疗或传感元件130的激活、感测和/或显示能力的独立装置。伤口闭合装置100还可以含有必要的电或机械元件以提供治疗或记录传感器数据。例如，伤口闭合装置100可以包括电池供电的数据记录器，可以以计划间隔或随机间隔将所述记录器下载到另一接收装置。与接收装置的这一连接还可以采取自包含式内部反馈环路的形式，在其中监测传感器数据并且当传感器数据超过预先设定的阈值时激活电或机械元件。一个示例可以是在伤口闭合装置100中的振动刺激，所述振动刺激在诸如运动(相对的或绝对的)、温度或压力等感测的参数超过预先设定的阈值时通知患者。另一示例可以是光学或磁性传感器，用来检测一个或多个治疗或传感元件130之间的接近度。
传感器。
以下部分提供了治疗或传感元件130可能包括的传感器的示例。一种类型的传感器130可以集成到伤口闭合装置100中，或者可以将若干不同的传感器和/或治疗元件130嵌入到单一伤口闭合装置100中。
(一个或多个)治疗或传感元件130可包括皮肤温度感测元件。伤口闭合装置100可以使用红外传感器或者使用直接或间接地测量温度的任何其他方式来测量温度。温度感测元件130和/或包含这样的元件的伤口闭合装置100可以与周围环境隔离以防止误读(例如，通过隔离层等从外面覆盖)。温度传感器130可以间歇地或连续地记录温度。温度感测伤口闭合装置100可以被设定用于发送警报，该温度感测伤口闭合装置100具有设定引起警报所需的温度的能力。由于感染常常与充血和温升相关联，因此温度感测伤口闭合装置100可以作为感染的早期检测的方法。警报可以以许多方式—可听见的、可视LED、振动、至智能电话或其他类型的计算装置的蓝牙连接等。
备选地或组合地，(一个或多个)治疗或传感元件130可包括机械运动传感器。可以经由以应变仪、机电传感器、电磁传感器、加速计或光学传感器的形式的集成的传感器感测机械运动。可以使用一个或多个传感器130来限定在3D空间中相对于其自身和/或其他传感器的位置变化，或者可以仅仅记录二进制接近触发器。传感器130可以检测所达到的最大距离或范围，或者可以测量在一段时间内运动的频率和范围(例如，在术后最初的三天期间患者每天弯曲膝盖的次数)。传感器数据可以经由集成的数据记录工具收集，或者通过有线或无线(例如，蓝牙)传输到诸如专用数据录记器、智能电话应用或其他医疗装置等外部装置，在所述外部装置处能够将数据呈现出来(例如，数据表、数据汇总或图形形式)，可以使用数据来触发警报，或者可以在不需要患者返回诊所的情况下将数据传输至远程的临床医师以便监测患者。
对机械运动的检测可以向从业医师警示患者的关节在手术后的可动性的范围或频率，例如，以便在关节手术或置换后监测对推荐的治疗方案的遵从性。例如，如果吩咐患者以一定的频率且在一定的范围弯曲关节，若患者未遵守这一方案，该装置100就会警示从业医师以便可以采取纠正动作。备选地或组合地，可以利用视觉指示器(例如，经由颜色变化)指示运动的量或程度。一个示例将是检测并且指示关节在连续的锻炼期间所达到的最大运动范围，以便通知患者何时改变他/她的治疗方案或者向其增加元素，而无需临床医师的监测和输入。这样的指示的提供可以通过提供自引导的治疗程序来减少总治疗成本。另一示例可以是可听见的蜂鸣声，当关节已经达到所需弯曲量时会听到该可听见的蜂鸣声(发出蜂鸣声或警报可以是可编程的)。
备选地或组合地，(一个或多个)治疗或传感元件130可包括用于确定血液或组织的化学成分的传感器。(一个或多个)传感器130可包括所集成的经皮血液成分测量元件，用于出于评估伤口状况的目的而测量例如氧气、二氧化碳、葡萄糖、pH等。经皮氧气或二氧化碳测量可以作为对组织活力、炎症、感染等的良好指示。
备选地或组合地，(一个或多个)治疗或传感元件130可包括用于检测机械压力的传感器。可以经由集成的(一个或多个)传感器130测量可以指示水肿和肿胀的程度的机械压力。肿胀的程度可以用于警示护理者给予减轻肿胀的治疗(例如，冰袋)或者自动触发或控制集成到装置中或应用于装置顶部上的冷水循环系统的温度。
备选地或组合地，(一个或多个)治疗或传感元件130可包括可以集成到装置100中的一种或多种类型的一个或多个治疗元件。(一个或多个)治疗或传感元件130的治疗类型的示例描述如下。虽然描述了某些治疗类型，但是还可以设想到可以通过一个或多个治疗或传感元件递送的许多其他治疗类型。
(一个或多个)治疗或传感元件130可包括被配置用于向皮肤递送光的集成光疗递送元件。光的递送可以提供许多不同的治疗。
若干不同波长的光可以刺激氧气流动和身体产生一氧化氮，这转而可以使肌肉纤维放松并且使血管变宽以增加血液流向伤口。
可以将紫外光，尤其是UV-C，连续地或间歇地递送至皮肤以消灭细菌并防止感染。在一些实施方式中，装置100可以使用电池供电，并且使光照在特定点上。在一些实施方式中，UV生成装置可以连接至光纤，所述光纤会携载光并且使其照在沿着切口的长度的若干位置上。这种光纤可包括编织或交织的光纤阵列，在该光纤阵列内每一光纤弯曲时该阵列优先泄漏光。
可以使用红外光来影响细胞中线粒体酶(例如，细胞色素c氧化酶)的功能，该线粒体酶可以增加ATP的产生并且改善细胞的抗缺血性。红外光还可以刺激能够提供缺血保护的热休克蛋白的创造。
备选地或组合地，(一个或多个)治疗或传感元件130递送机械振动治疗。机械振动可以集成到装置100中并且可以通过集成微型马达或其他振动元件而递送至皮肤，并且可以用作治疗(例如，疼痛减轻)或警示信号。作为一种治疗，以一定频率和振幅的振动可以使感觉神经饱和而减少外科手术部位处和/或周围组织中的疼痛。可以采用超声振动来较深地穿透组织以便帮助局部组织循环。作为警报，振动可以用于警示患者需要活动的事件，诸如温升或肿胀的检测。
备选地或组合地，(一个或多个)治疗或传感元件130可以递送治疗化学药品或药物。装置100可以集成一个元件，通过该元件将化学制剂连续地(恒定的浓度或随时间逐渐减少)、间歇地、事件驱动地(诸如当皮肤超过一定温度时)或者按需地(诸如通过按下装置上的按钮或特征件)递送至皮肤。化学制剂可以嵌入到装置材料中，或可以储存在单独的但连接的贮器中。递送可以是被动的或主动的，诸如经由电离子透入疗法或电动给药(EMDA)以穿过皮肤递送药物或其他化学药品，经由经皮微针阵列，经由通过微型喷嘴(例如，喷雾)或者能够破坏局部组织和递送制剂的流体的高压微爆而应用到皮肤上。
备选地或组合地，(一个或多个)治疗或传感元件130可以递送热疗。可以将小的加热元件嵌入到装置100中，所述加热元件可以用于对伤口部位提供局部加热。
备选地或组合地，(一个或多个)治疗或传感元件130可以递送冷疗。可以通过向皮肤引入冷却的空气或水使伤口部位冷却。可以将(一个或多个)冷却元件以嵌入式通道的形式集成到装置100中，以在皮肤处或附近携载冷却介质，在那里该冷却介质从皮肤吸收热(有效地使皮肤冷却)并且循环回冷却/泵系统。冷却可以减轻疼痛感并且可以减少在伤口部位的肿胀。
备选地或组合地，(一个或多个)治疗或传感元件130可以递送电信号。例如弱电流等电信号的应用可用于使伤口部位处的细菌的增殖最小化并且可以用于促进加热。还可以采用较高的射频电流用于患者的易发生出血性并发症的组织内的局部血液凝固(例如，关于肝素(Heparin)、华法林(Warfarin)或波立维(Plavix))。
备选地或组合地，(一个或多个)治疗或传感元件130可以利用超声作为一种治疗。
图13示出了使用带有集成的治疗或传感元件的伤口闭合设备(诸如上文所描述的装置100)的治疗方法1300的流程图。在步骤1310中，可以将伤口闭合设备100的第一板102粘附至患者的切口或伤口的第一侧边。在步骤1320中，可以将伤口闭合设备100的第二板104粘附至切口或伤口的第二侧边。在步骤1330中，可以连接第一板102和第二板104，诸如通过用多个锚固扎带和扎带支架将它们的顶部负荷分布层彼此连接。在步骤1340中，可以将第一板102和第二板104横向地拉在一起以将切口或伤口的侧边拉在一起且固定在一起。在步骤1350中，闭合装置100的(一个或多个)治疗或传感元件130可以用上文所描述的任何方式感测一个或多个生理参数。在步骤1360中，(一个或多个)治疗或传感元件130可以用上文所描述的任何方式向使用者和/或接收装置传输感测的(一个或多个)生理参数。在步骤1370中，(一个或多个)治疗或传感元件130可以用上文所描述的任何方式对患者应用治疗。在步骤1380中，可以响应于接收到的(一个或多个)生理参数用上文所描述的任何方式修改通过(一个或多个)治疗或传感元件130应用的或以其它方式应用的治疗。
尽管上文步骤示出了根据许多实施方式的治疗患者的方法1300，但是本领域技术人员将会认识到基于上文所述教导的许多变化。这些步骤可以按不同的次序完成。可以对步骤进行添加或删除。一些步骤可以包括子步骤。每当对治疗有益时许多步骤都可以重复进行。
可以利用本文所描述的装置100和/或者(一个或多个)治疗或传感元件130的电路来执行方法1300的一个或多个步骤。可以对该电路进行编程以提供该方法的一个或多个步骤，并且程序可包括存储在计算机可读存储器上的程序指令或逻辑电路(诸如，可编程阵列逻辑或现场可编程门阵列)的程序化步骤。
虽然本文已经示出和描述了本公开内容的优选实施方式，但对于本领域技术人员显而易见的是，这样的实施方式只是以示例的方式提供的。本领域技术人员现将在不偏离本公开内容的情况下想到许多更改、改变和替代。应当理解，在实践本公开内容的发明的过程中可以采用对本文所描述的本公开内容实施方式的各种替代方案。以下权利要求旨在限定本发明的范围，并因此覆盖这些权利要求范围内的方法和结构及其等效项。

Claims (18)

1.一种伤口或切口闭合设备，其包括：
第一板，其用于横向地邻近伤口或切口的第一侧边而放置，所述第一板包括第一底部粘附层、第一中间基体层和第一上负荷分布层；
第二板，其用于横向地邻近所述伤口或切口的第二侧边而放置，所述第二板包括第二底部粘附层、第二中间基体层和可连接至所述第一上负荷分布层的第二上负荷分布层；以及
传感或治疗元件，其被安置成邻近或者集成至所述第一板或第二板中的一个或多个中。
2.如权利要求1所述的伤口或切口闭合设备，其中所述传感或治疗元件被安置成邻近或集成至所述第一底部粘附层、所述第二底部粘附层、所述第一中间基体层、所述第二中间基体层、所述第一上负荷分布层或所述第二上负荷分布层中的一个或多个中。
3.如权利要求2所述的伤口或切口闭合设备，其中所述传感或治疗元件被安置于所述第一板或第二板中的一个或多个的层中的两个或更多个层之间的袋内。
4.如权利要求3所述的伤口或切口闭合设备，其中所述第一板或第二板具有穿过一个或多个所述层的通路以允许接近所述袋。
5.如权利要求1所述的伤口或切口闭合设备，其中所述传感或治疗元件被配置用于与所述伤口或切口闭合设备外部的接收装置通信。
6.如权利要求5所述的伤口或切口闭合设备，其中所述传感或治疗元件被配置用于与所述接收装置无线通信。
7.如权利要求5所述的伤口或切口闭合设备，其中所述接收装置包括工作站、个人计算机、膝上型计算机、平板计算机、智能电话、可穿戴式计算机或专用接收器。
8.如权利要求1所述的伤口或切口闭合设备，其中所述第一上负荷分布层和第二上负荷分布层通过一个或多个扎带和扎带齿杆彼此连接。
9.如权利要求1所述的伤口或切口闭合设备，其中所述传感或治疗元件包括温度计、运动传感器、化学传感器、压力传感器或治疗递送元件中的一种或多种。
10.如权利要求9所述的伤口或切口闭合设备，其中所述运动传感器包括应变仪、机电传感器、电磁传感器、加速计或光学传感器中的一种或多种。
11.如权利要求9所述的伤口或切口闭合设备，其中所述化学传感器被配置用于测量血液成分、经皮氧气、经皮二氧化碳、葡萄糖水平或pH中的一个或多个。
12.如权利要求9所述的伤口或切口闭合设备，其中所述治疗递送元件包括用于光疗的光源、机械振动元件、超声源、药物递送元件、加热元件、冷却元件、或充电元件中的一种或多种。
13.一种治疗伤口或切口的方法，所述方法包括：
邻近所述伤口或切口的第一侧边而粘附伤口或切口闭合设备的第一板；
邻近所述伤口或切口的第二侧边而粘附所述闭合设备的第二板；
将所述第一板和第二板横向地拉在一起以将所述伤口或切口的第一侧边和第二侧边拉在一起；以及
用安置于所述第一板或第二板中的一个或多个之上或之内的治疗或传感元件感测生理参数。
14.如权利要求13所述的方法，还包括用所述治疗或传感元件向患者提供治疗。
15.如权利要求14所述的方法，其中所述治疗包括光疗、振动疗法、超声疗法、药物递送、热疗、冷疗或电疗中的一种或多种。
16.如权利要求13所述的方法，还包括向外部接收装置传输感测的生理参数。
17.如权利要求16所述的方法，其中所述外部接收装置包括工作站、个人计算机、膝上型计算机、平板计算机、智能电话、可穿戴式计算机或专用接收器中的一种或多种。
18.如权利要求13所述的方法，其中所述生理参数包括温度、运动、水分、压力、生理学标记物的浓度、pH、氧气水平、二氧化碳水平或葡萄糖水平中的一个或多个。
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