CN101360473B - 使用超声清创术处理伤口的系统 - Google Patents

使用超声清创术处理伤口的系统 Download PDF

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CN101360473B
CN101360473B CN2007800017142A CN200780001714A CN101360473B CN 101360473 B CN101360473 B CN 101360473B CN 2007800017142 A CN2007800017142 A CN 2007800017142A CN 200780001714 A CN200780001714 A CN 200780001714A CN 101360473 B CN101360473 B CN 101360473B
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乔纳森·P·贾伊伯
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Abstract

一种伤口处理系统包括分配歧管、减压源、流体输送源和超声能量换能器。减小的压力和流体输送可以通过分配歧管应用到伤口。超声能量换能器构造成将超声能量输送到伤口，以清除伤口。超声能量换能器既可以是压电换能器，又可以是表面声波装置。超声能量换能器可邻近分配歧管放置，以将超声能量直接输送到伤口，或者可连接到位于分配歧管和伤口之间的声传导膜。

Description

使用超声清创术处理伤口的系统
技术领域
本发明通常涉及伤口处理系统和方法，且更具体地说，涉及一种通过结合超声清创术(ultrasonic debridement)和减压治疗处理伤口的系统和方法。 
背景技术
皮肤伤口一般分为两种类别：慢性的和急性的。动物天生的愈合机制通过闭合伤口、填充失去的组织并用新的皮肤层覆盖伤口来快速地修复急性伤口。那些观察小孩的伤口愈合的人们常常在几天内就可观察到小的急性伤口的愈合。慢性伤口通常是其中天生的愈合机制被减弱的伤口。慢性伤口一般都会托延较长的时间，且可能不会愈合。这种伤口经常从较年长的或患有糖尿病的人上可观察到。与伤口关联的另一个问题是感染。感染是由在伤口内滋生、产生毒素并随后破化伤口附近组织的病原微生物或细菌侵入伤口引起的。为了减少伤口感染的机会，首先清洁伤口，以除去那些当伤口产生时就已经侵入伤口的微生物或细菌。然后，一般清除或对伤口消毒，以除去不能存活或坏死的组织以及驻留在伤口内的任何微生物或细菌。处理伤口的第三步是敷上敷料，以覆盖伤口，并敷药物促进其愈合。 
伤口清除通常用机械外科手术方法完成，被称为利刃清创术(sharpdebridement)。尤其，将不能存活或坏死的组织从伤口切除，并移去。有时，伤口的外科手术处理将引发身体对急性伤口的响应，伤口将愈合。 
虽然清创术过程通常涉及将伤口内的组织切除，但是目前的努力已经涉及到超声能量的使用。在下列美国专利中出现超声能量的使用和其在皮肤上的使用的描述：Suroff，4,040,414(超声人体护理设备和方法(UltrasonicPersonal Care Instrument and Method))；Beaty等人，5,312,329(压电超声 及电外科手持件(Piezo Ultrasonic and Electrosurgical Handpiece))；Sakurai等人，5,391,144(超声处理设备(Ultrasonic Treatment Apparatus))；Novak等人，6,171,265(供多功能操作内窥镜设备使用的手持件(Handpiece forUse With a Multifunctional Operating Endoscopic Instrument))；以及在下列公开的PCT申请中：Babaev，WO 97/17933(使用超声射线喷射表面的方法(Method of Spraying A Surface Using Ultrasonic Radiation))。在下列文章中发现了进一步的描述：King等人，Burns，Vol.22，No.4，Pg.307，(Debridement of Burn Wounds with a Surgical Ultrasonic Aspirator)；Vanderburgh等人，Gynecologic Oncology，Vol.39，Pg.103(1990)，(Debridement of Vaginal Radiation Ulcers Using the Surgical UltrasonicAspirator)；以及Herte等人，Society of Plastic and Reproductive SurgeonsPrelim.Rpt.(11.1978)，(Comparative Wound Healing in Animal SubjectsUsing the Cavitron Ultrasonic Surgical Aspirator vs.Conventional SurgicalInstrument)。 
进一步，在最近公布的Soring等人的题为用于杀菌外科的系统(Systemfor Antiseptic Surgery)的美国专利No.6,916,296中，使用超声的系统被提议用于伤口愈合。特别地，一种称为超声焊极(sonotrode)的装置被放置在伤口内的液体中。这种超声焊极在液体中产生导致细菌细胞破坏的超声振动和气穴。特别地，在流体中释放的高水平能量通过击穿细胞壁杀死细菌细胞。而且美国专利No.6,916,296报道了伤口中细菌数量的显著减少，其还教导高水平能量可在很短的时间段使用，或者低水平能量可在较长时间段使用-多达数分钟。 
实践中，使用超声清除伤口包括一般以集中方式应用的超大量的超声能量，以在较短的时间段内给相对较小的伤口区域能量。超声能量在任意给定时间传播的区域一般小于约5cm2。因为处理集中，所以超声能量一般仅在小于大约60秒内应用到任意特定区域。 
清创术之后，敷裹伤口，以覆盖伤口，并促进愈合。近年来，已经发现，伤口的减压应用在许多病例中促进愈合。这在慢性伤口中尤为明显，例如在较年长患者中发展的那些伤口，但是也可以发生在任意类型的伤口 中。研究还显示，经常冲洗伤口通过帮助除去伤口渗出物、无用的生物负荷，并可选地作为用于药物敷用和输送的有效输送工具而有助于促进愈合。在下列美国专利中发现了使用这些技术中的一些的伤口处理系统的示例：Zamierowski，4,969,880(伤口包扎及处理方法(Wound Dressing andTreatment Method))；Zamierowski，5,100,396(射流连接系统及方法(Fluidic Connection System and Method))；Zamierowski，5,261,893(包扎系统及方法(Fastening System and Method))；Zamierowski，5,527,293(包扎系统及方法(Fastening System and Method))；Argenta等人，5,636,643(使用减压的伤口处理(Wound Treatment Employing Reduced Pressure))；Argenta等人，5,645,081(使用减压处理破坏组织的方法及设备(Method oftreating tissue damage and apparatus for same))；Zamierowski，6,071,267(医学病人流体管理界面系统及方法(Medical Patient Fluid ManagementInterface System and Method))；Vogel等人，6,135,116(处理溃疡的方法(Method for Treating Ulcers))；以及Hun等人，6,142,982(便携式伤口处理设备(Portable wound treatment apparatus))。 
虽然超声清创术已经被教导作为一种最先清除伤口不能存活或坏死组织的方法，但是这种手术还没有作为用于加速伤口愈合的基础深厚的系统的部分获得接受，部分地由于传统的超声清创术涉及劳动密集程序。目前存在对在低能量水平在延长的时间期间内使用超声能量清除伤口的系统的需要。为了在实施中易于使用和改进，超声能量被应用的应用区域对比存在的程序应相对较大，其需要更集中的光束。也需要一种与减压疗法一起使用的非集中的低能量如超声的清创手术，以及任选地，与提供流体冲洗且移去清除组织的系统一起使用的系统。 
在此引用的所有的专利、专利申请及其它出版物在法律允许的最大程度上以引用方式并入。 
发明内容
本发明的系统和方法解决了由伤口处理系统组织敷裹引发的问题。依据本发明的一种实施方式，提供了一种伤口处理系统，其包括分配歧管 (distribution manifold)、减压源和超声能量换能器。减压源流体地连接到分配歧管，以将减小的压力输送到组织位置，而超声能量换能器邻近分配歧管设置。 
依据本发明的另一种实施方式，用于清除和愈合伤口位置的伤口处理系统包括分配歧管、流体地连接到分配歧管的减压源、声传导膜(acoustically-conducting membrane)和超声能量换能器。声传导膜设置在分配歧管和伤口位置之间，且超声能量换能器连接到膜。 
在本发明的又一种实施方式中，伤口处理系统包括用于敷裹伤口的装置、用于减小伤口处压力的装置和用于清除伤口的装置。 
依据本发明的又一种实施方式，一种用于处理伤口位置的超声伤口处理系统包括构造成在小于约1W/cm2的能量水平将超声能量输送到基本上所有伤口位置的超声能量换能器。超声能量在所选持续时间期间被输送，使得基本上所有伤口位置每天至少十分钟(10min/day)暴露到超声能量。 
在本发明的又一种实施方式中，伤口处理系统包括构造成与伤口流体相通放置的分配歧管。流体源流体地连接到分配歧管，并构造成在第一所选持续时间期间将流体输送到伤口。超声能量换能器构造成与伤口超声相通放置，并在第二所选持续时间期间将超声能量输送到伤口。减压源流体地连接到分配歧管，并构造成在第三所选持续时间期间将减小的压力输送到伤口。 
依据本发明的另一种实施方式，处理伤口的方法包括同时将减小的压力和超声能量应用到伤口，以清除并愈合伤口。 
在本发明的又一种实施方式中，处理伤口的方法包括将流体输送到伤口，并允许流体在所选持续时间在伤口驻留。超声能量在所选持续时间期间被应用到伤口，而减小的压力在所选持续时间后应用到伤口，以移去流体和任意清除的组织。 
在本发明的另一种实施方式中，多用途伤口敷裹物包括构造成将减小的压力分配到伤口位置的分配歧管。超声能量换能器邻近分配歧管设置，以给伤口位置提供超声清创术。 
在本发明的又一种实施方式中，多用途伤口敷裹物包括构造成将减小的压力分配到伤口位置的分配歧管。声传导膜设置在分配歧管的组织接触侧，并构造成接触伤口位置。超声能量换能器可操作地连接到声传导膜。 
参照下面的附图和详细描述，本发明的其它目的、特征和优点将变得明显。 
附图简要描述 
图1显示了依据本发明的实施方式用于将减小的压力和超声能量应用到伤口或组织位置的系统的前部截面图；以及 
图2显示了依据本发明的实施方式用于将减小的压力和超声能量应用到伤口或组织位置的系统的前部截面图。 
实现本发明的最佳方式 
在下列优选实施方式的详细描述中，参考形成其的一部分的附图，且其中，通过示例显示本发明可被实施的具体优选实施方式。足够详细地描述了这些实施方式，以使本领域的技术人员能够实施本发明，且应理解的是，可以使用其它的实施方式，并可以做出逻辑结构、机械、电及化学变化，而不偏离本发明的主旨和范围。为了避免本领域的技术人员实施本发明的不必要的细节，本描述省略本领域技术人员公知的某些信息。因此，接下来的详细描述不应被认为是限制的意思，且本发明的范围仅通过附加权利要求来界定。 
参照图1和图2，依据本发明的实施方式的伤口处理系统10包括具有对伤口提供超声清创术能力的多用途伤口敷裹物11、将减小的或低于大气压的压力输送到伤口的减压源12以及任选地用流体冲洗伤口的流体输送源14。可提供包括处理器17和用户界面18的电脑系统16来控制减压治疗、清创术和流体输送的所有系统功能。 
更具体地参照图1，伤口处理系统10优选地用来清除并促进伤口位置100的愈合。伤口位置100被组织102包围。伤口位置100的至少部分包括中间组织层104，该中间组织层104可包括健康的和不能存活的活细胞、死细胞及不同量的诸如微生物和细菌的沾染物的混合物。实验已经表明，此中间组织层可厚达5mm。虽然常规的伤口表面处理可去除伤口表面的死组织和细菌，但是表面下的细菌并没有被去除，且可继续藏匿感染。伤口的清创术将帮助去除这些隐藏的细菌。 
多用途伤口敷裹物11包括分配歧管20、超声能量换能器50、用于与分配歧管流体相通的管42、以及任选地，消毒盖布30。分配歧管20构造成邻近伤口位置100放置。分配歧管20包括多个液流通路或通道，以方便将减小的压力或流体从伤口位置分配或分配到伤口位置。在一种实施方式中，分配歧管20是多孔泡沫，且包括起到液流通路作用的多个互连室或孔。多孔泡沫可以是聚氨基甲酸酯敞开室的网状泡沫，如由得克萨斯州圣安东尼奥的Kinetic Concepts，Inc.制造的GranuFoam。如果使用敞开室泡沫，孔隙度可以不同，但是优选为大约400微米到600微米。 
当敞开的伤口位置被处理以密封和隔离伤口位置时，消毒盖布30被设置在分配歧管20上。如果被处理的伤口位置是皮下组织或深组织伤口位置，消毒盖布30可以不必在伤口位置维持减小的压力。消毒盖布30可以是任意生物相容的柔性材料。根据指定的应用，消毒盖布30可以是对液体、气体或两者不可渗透的或半渗透的。减压涂药器(reduced pressureapplicator)40放置在消毒盖布30下，且在分配歧管20上。管42在远端流体地连接到涂药器40，且在近端流体地连接到减压源12，减压源12可以是泵或壁式抽吸口(wall suction outlet)。在减压源12附近，管42示意性地表示为减压输送管42a。减压源能够通过减压输送管42a和分配歧管20给伤口供应减小的压力。虽然涂药器40提供一种将减小的压力从减压输送管42a传递到分配歧管20的装置，但是如果减压输送管42a被放置成与分配歧管20直接流体相通的话，则可以省掉涂药器40。 
流体输送管42b可设置成将流体输送到伤口，并可类似地由涂药器40流体地连接到分配歧管。图1和图2中的管42、42a和42b的表示显示了普通的涂药器可用于将减小的压力和流体输送到分配歧管20。这可通过将管42在任意时间仅用于一个目的而实现。更具体地说，管42可用于替换地输送减小的压力和流体。在另一种实施方式中，管42可以是具有减小的压力输送腔和流体输送腔的双腔管。在又一种实施方式(未显示)中，分开的管可用于与分配歧管20流体相通。如果使用分开的管，涂药器40的使用是任选的。 
超声能量换能器50可包括频率发生器和放大器，且用于将超声能量传递到伤口位置100。超声能量换能器可以是压电换能器或表面声波装置。在图1中，超声能量换能器50被放置在涂药器40和分配歧管20之间，以发出低水平超声能量。超声能量换能器50可连接到涂药器40和分配歧管20之中的一个或两者，或可替代地，可放置在涂药器40和分配歧管20之间，而没有物理连接到任一个。在一种实施方式中，超声能量换能器50可被嵌入分配歧管20内。 
分配歧管20起到传输介质的作用，以将超声能量传递到伤口位置100。当使用网状泡沫时，泡沫的传输效率可通过使用流体输送源用水、水溶液和水底溶液(sub-aqueous solution)或凝胶注入泡沫而加强。泡沫内流体的存在加强了泡沫传递超声能量的能力。在这点上，分配歧管为超声能量执行歧管和传输介质两种功能。应进一步注意，凝胶或其他加强传递的物质可被放置在分配歧管20内或上。例如，凝胶可在超声能量通过分配歧管20传递之前放置在分配歧管20和伤口位置100之间，以加强能量传递。 
由超声能量换能器50施加到伤口的超声能量的量小于传统的超声清创术换能器的量。优选地，如果使用高频(大约800kHz到4000kHz)换能器，施加到换能器的能量大约是1.0W/cm2，且更优选大约为0.5W/cm2。如果使用低频(大约20kHz到120kHz)换能器，施加到换能器的能量大约是0.5W/cm2，且更优选大约为0.1W/cm2。 
参照图2，超声能量换能器50可远离伤口位置100设置，且可操作地连接到位于分配歧管20和伤口位置100之间的声传导膜70。膜70可连接到分配歧管20，或可替代地，可以在减压和超声治疗管理之前无连接地放置在分配歧管20和伤口位置100之间。在此实施方式中，由超声能量换能器50产生的低水平超声能量被传输越过膜70，并辐射到中间组织层104。在某些情况中，膜70接近伤口位置100可改进伤口处理系统10的 清创术性能。因为超声能量一般在低能量时产生，因此超声能量换能器50可设置在或接近伤口位置100的周围。将膜70设置在分配歧管20和伤口位置100之间不会干扰分配歧管将减小的压力或流体输送到伤口位置100的能力。在这点上，膜70优选由天然多孔材料形成，或可替代地，被制造成包括洞、孔、凸出物或可促进膜内、膜周围和通过膜流动的其它结构特征。膜可由 
Figure S2007800017142D00081
金属箔薄片、或能够传导超声的任何其它材料制成。 
在操作中，这里描述的多用途敷裹物结合了减压治疗、超声清创术和用于清创、清洁和愈合伤口位置的任选流体输送。所有这些功能可以集成到组合系统中，单独或同时提供每种功能间歇的或连续的操作，而不改变功能之间的敷裹。因为敷裹物要在变化间留在适当的位置几天，所以超声能量换能器被最优化，以在较长时间段内以较低能量提供清创术。 
在一种示例性操作的实例中，冲洗或药物流体在第一所选持续时间期间由流体输送源14输送到分配歧管。优选地，第一所选持续时间大约是五分钟。在此持续时间期间，允许流体渗透分配歧管20，并冲洗伤口位置100。在第一所选持续时间期间后的第二所选持续时间期间，允许流体停留在伤口位置，且超声能量被超声能量换能器传递到伤口位置100。超声能量清除伤口不能存活和坏死的组织。优选地，第二所选持续时间期间大约是15分钟，或者大约是第一所选持续时间期间的三倍。在第二所选持续时间后，超声能量的传递停止，且减小的压力通过减压源施加到分配歧管。减小的压力将来自伤口和分配歧管的输送流体及伤口渗出物和清除组织移除。减小的压力的应用在第三所选持续时间期间继续，该第三所选持续时间优选约为四十分钟，或约为第二所选持续时间的三倍。上述示范的时间持续可以不同，且程序的每步(即流体输送、超声清创术及减压治疗)可以彼此独立地实施，或者与其它程序之中的一个或两个同时实施。 
从前述内容很显然，提供了具有显著优点的发明。虽然本发明仅显示了其形式的几种，但是它不只是局限的，且容许各种变化和修改，而不偏离其主旨。 

Claims (23)

1.一种伤口处理系统，包括：
分配歧管；
减压源，其流体地连接到所述分配歧管，以将减小的压力输送到组织位置；
超声能量换能器，其邻近所述分配歧管设置；
减压涂药器，其流体地连接在所述减压源和所述分配歧管之间；以及
消毒盖布，其设置在所述减压涂药器和所述分配歧管之上；且
其中所述超声能量换能器设置在所述减压涂药器和所述分配歧管之间；
其中所述超声能量换能器的频率在800kHz到4000kHz之间或在20kHz到120kHz之间，以用于清创。
2.如权利要求1所述的系统，其中所述超声能量换能器是压电换能器。
3.如权利要求1所述的系统，其中所述超声能量换能器是表面声波装置。
4.如权利要求1所述的系统，其中所述分配歧管是多孔泡沫。
5.如权利要求1所述的系统，进一步包括邻近所述分配歧管放置的消毒盖布，以覆盖所述分配歧管和所述超声能量换能器。
6.如权利要求1所述的系统，进一步包括流体地连接到所述分配歧管的流体输送管。
7.如权利要求6所述的系统，其中所述流体输送管构造成将流体和减小的压力输送到所述分配歧管。
8.如权利要求1所述的系统，进一步包括：
管，其流体地连接在所述减压涂药器和所述减压源之间；且
其中所述管构造成选择性地将减小的压力和流体之一输送到伤口位置。
9.一种用于清除和愈合伤口位置的伤口处理系统，包括：
分配歧管；
减压源，其流体地连接到所述分配歧管；
声传导膜，其设置在所述分配歧管和伤口位置之间；以及
超声能量换能器，其连接到所述声传导膜；
其中所述超声能量换能器的频率在800kHz到4000kHz之间或在20kHz到120kHz之间，以用于清创。
10.如权利要求9所述的系统，其中所述超声能量换能器是压电换能器。
11.如权利要求9所述的系统，其中所述超声能量换能器是表面声波装置。
12.如权利要求9所述的系统，其中当减小的压力通过所述分配歧管施加时，所述声传导膜处于所述分配歧管和所述伤口位置之间，并与所述分配歧管和所述伤口位置接触。
13.如权利要求9所述的系统，其中所述声传导膜允许在所述分配歧管和所述伤口位置之间流体相通。
14.如权利要求13所述的系统，其中所述声传导膜是多孔的。
15.如权利要求9所述的系统，其中所述超声能量换能器远离所述伤口位置放置。
16.如权利要求9所述的系统，其中所述分配歧管是多孔泡沫。
17.如权利要求9所述的系统，进一步包括设置在所述分配歧管和所述声传导膜上的消毒盖布。
18.一种伤口处理系统，包括：
分配歧管，其构造成与伤口流体相通地放置；
流体源，其流体地连接到所述分配歧管，并构造成在第一所选持续时间期间将流体输送到伤口；
超声能量换能器，其构造成与伤口超声相通地放置，并在第二所选持续时间期间将超声能量输送到伤口；以及
减压源，其流体地连接到所述分配歧管，并构造成在第三所选持续时间期间将减小的压力输送到伤口；
其中所述超声能量换能器的频率在800kHz到4000kHz之间或在20kHz到120kHz之间，以用于清创。
19.如权利要求18所述的系统，其中所述第一所选持续时间、所述第二所选持续时间和所述第三所选持续时间发生在不同的时间期间。
20.如权利要求18所述的系统，其中在所述第一所选持续时间期间输送的流体被允许在所述第二所选持续时间期间在伤口处驻留。
21.如权利要求20所述的系统，其中所述减小的压力移去流体和在超声能量施加期间清除的任意组织。
22.一种多用途的伤口敷裹物，包括：
分配歧管，其构造成将减小的压力分配到伤口位置；以及
超声能量换能器，其邻近所述分配歧管设置，以便为伤口位置提供超声清创术；
其中所述超声能量换能器的频率在800kHz到4000kHz之间或在20kHz到120kHz之间，以用于清创。
23.一种多用途的伤口敷裹物，包括：
分配歧管，其构造成将减小的压力分配到伤口位置；
声传导膜，其设置在所述分配歧管的组织接触侧，且构造成与所述伤口位置接触；以及
超声能量换能器，其可操作地连接到所述声传导膜；
其中所述超声能量换能器的频率在800kHz到4000kHz之间或在20kHz到120kHz之间，以用于清创。
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