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CN101959544B - 减荷和减压治疗系统和方法 - Google Patents

减荷和减压治疗系统和方法 Download PDF

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CN101959544B
CN101959544B CN2009801074194A CN200980107419A CN101959544B CN 101959544 B CN101959544 B CN 101959544B CN 2009801074194 A CN2009801074194 A CN 2009801074194A CN 200980107419 A CN200980107419 A CN 200980107419A CN 101959544 B CN101959544 B CN 101959544B
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拉里·塔布·伦道夫
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Abstract

一种减荷和减压治疗系统(100)包括减荷和减压治疗设备(102)，该减荷和减压治疗设备(102)具有由减荷歧管材料制成的跖元件(104)。减荷和减压治疗系统进一步包括流体地耦合于跖元件的压力传输层的减压接口(150)、减压源(154)和流体地耦合于减压源及减荷和减压治疗设备的减压传送管道(152)。减荷歧管材料包括第一屏障层、支撑层(128)、压力传输层和第二屏障层。减荷和减压治疗设备还可具有背侧元件(106)和桥接元件(108)。方法也被提出。

Description

减荷和减压治疗系统和方法
相关申请 
本发明根据美国法典第35篇第119条第(e)项要求题为“System and Method for Applying Reduced Pressure to a Tissue Site on a Foot”的2008年3月13日提交的第61/036,433号美国临时专利申请的提出的权益，为所有目的其通过引用并入本文。 
技术领域 
本发明大致涉及医疗系统，并且更具体地说，涉及减荷和减压治疗系统(offloading and reduced-pressure treatment system)、设备和方法。 
背景 
有时，处理患者的足部或其它四肢上的医疗问题是必须的。很多伤口或异常组织部位发生在患者的足部。例如，糖尿病患者频繁产生如溃疡的神经性足部症状。治疗四肢上并且尤其足部上的各种症状可能出现很多挑战。治疗可能需要调节、压力和切力的减缓，以及缓冲。设备通常用于这些目的。例如，利用全接触浇铸(total-contact casting)(TCC)制成的全接触铸件可通过增加整个小腿上承受的负荷用于提供减小的跖压力。大量的其它设备也可被使用，例如矫形动态系统夹板、神经性助行架(neuropathic walker)、全接触式踝-足矫形器、愈合凉鞋等。通常，这些设备包括对伤口或组织部位的有限的接近。 
概述 
本文所述的示例性实施方式的系统、设备和方法致力于解决在四肢上使用的现有医疗设备和系统的问题。根据示例性的实施方式，减荷和减压治疗系统包括具有由减荷歧管材料制成的跖元件(plantar member)的减荷和减压治疗设备。减荷歧管材料包括支撑层、压力传输层和第二屏障层。减荷和减压治疗系统还包括流体地耦合于跖元件的压力传输层的减压接口、减压源和流体地耦合于减压源及减荷和减压治疗设备的减压传送管道(reduced-pressure delivery conduit)。 
根据另一示例性的实施方式，减荷和减压治疗设备包括由减荷歧管材料制成的跖元件。减荷歧管材料包括具有第一表面和第二表面的支撑层以及具有第一表面和第二表面的压力传输层。压力传输元件的第一表面被耦合于支撑层的第二表面。减荷歧管材料还包括具有第一表面和第二表面的第二屏障层(second barrier layer)。第一屏障层的第一表面被耦合于压力传输层的第二表面。减荷和减压治疗设备还包括流体地耦合于跖元件的压力传输层的减压接口。减荷和减压治疗设备还可具有背侧元件(dorsal member)。 
根据另一示例性的实施方式，减荷和减压治疗设备包括由减荷歧管材料制成的跖元件。减荷歧管材料包括支撑层、压力传输层和第二屏障层。减荷和减压治疗设备还包括流体地耦合于跖元件的压力传输层的减压接口。支撑层和压力传输层可为由覆盖有非透气性材料的小孔(每厘米小于等于40个孔)开孔泡沫形成的单层。 
根据另一示例性的实施方式，制造减荷和减压治疗设备的方法包括下述步骤：提供一片减荷歧管材料并切割片以形成减荷和减压治疗设备。 
根据另一示例性的实施方式，用于治疗患者足部上的跖伤的方法包括如下步骤：提供由减荷歧管材料制成的并且具有跖元件的减荷和减压治疗设备。治疗患者足部上的跖伤的方法还包括：移除减荷歧管材料的一部分，以在接近患者的跖伤处形成第一空隙；将第一治疗歧管设置在第一空隙中；以及通过压力传输层将减压传送至第一空隙。 
根据另一示例性实施方式，用于治疗患者足部上的跖伤和背侧伤的方法包括如下步骤：提供由减荷歧管材料制成的减荷和减压治疗设备。减荷和减压治疗设备具有跖元件和背侧元件。用于治疗跖伤和背侧伤的方法还包括：移除减荷歧管材料的一部分，以在接近患者的跖伤处形成第一空隙；将第一治疗歧管设置在第一空隙中；移除减荷歧管材料的另一部分，以在 接近患者的背侧伤处形成第二空隙；将第二治疗歧管设置在第二空隙中；以及通过压力传输层将减压传送至第一空隙和第二空隙。 
示例性实施方式的其它目的、特征和优点将通过参照下面的附图和详细描述变得明显。 
附图详述 
为了提供对示例性的实施方式及其特征和优点中的一些的更全面的理解，现在将参考结合附图做出的下面的描述，其中： 
图1是示意性透视图，其中一部分示出了减荷和减压治疗系统的示例性实施方式的方框图； 
图2是图1的减荷和减压治疗系统的减荷歧管的一部分的横截面图； 
图3是图1的减荷和减压治疗系统的减荷和减压治疗设备的示例性实施方式的示意性透视图； 
图4是图1的减荷和减压治疗系统的减荷和减压治疗设备的示意性正视图； 
图5是图1的减荷和减压治疗系统的减荷和减压治疗设备的跖元件的纵向横截面的一部分； 
图6是图4的减荷和减压治疗设备的沿着线6-6取的横截面图； 
图7A是一片减荷歧管材料的示意性透视图； 
图7B是在切割之后和折叠之前的减荷和减压治疗设备的示意性透视图； 
图8A是减荷和减压治疗设备的示例性实施方式的示意性平面图； 
图8B是图8A的减荷和减压治疗设备的示例性实施方式的沿着线8B-8B取的放大的横截面图； 
图9是图8A和图8B的减荷和减压治疗设备的示例性实施方式的示意性分解透视图；以及 
图10是用于图8A的减荷和减压治疗设备的减荷歧管的一部分的横截面图。 
示例性实施方式的详述 
在下面的示例性实施方式的详细描述中，参考构成其一部分的附图。这些实施方式被充分详述，以使本领域相关技术人员能够实践本发明，并且应理解到，在不偏离本发明的精神或范围的情况下，可利用其它实施方式，并且可进行逻辑结构改变、机械改变、电气改变和化学改变。为了避免对本领域相关技术人员能够实践本文所述的实施方式不必要的细节，描述可能省略了本领域相关技术人员已知的某些信息。因此，下面的详细描述不应被理解成限制性的意义，并且示例性实施方式的范围仅由所附的权利要求限定。 
本文的系统、方法和设备有助于组织，例如，诸如足的四肢上的伤口的减荷和减压治疗。关于后者的治疗方式，临床研究和实践已经表明在组织部位附近提供减压增加且加速了组织部位处的新组织的增长。这种现象的应用是众多的，但是减压的应用在治疗伤口中已经特别成功。这种治疗(在医学界通常被称作“负压伤口治疗”、“减压治疗”或“真空治疗”)提供很多益处，可包括更快的愈合以及肉芽组织的加快形成。除非另外指示，否则本文所用的“或”不要求相互排斥。 
参照图1至图6，减荷和减压治疗系统100的示例性的实施方式被示出。减荷和减压治疗系统100包括减荷和减压治疗设备102，该减荷和减压治疗设备102具有跖元件104，并且可具有背侧元件106和桥接元件(bridge member)108。桥接元件108可具有中心桥接部分107和接口部分109。跖元件104可操作为接收患者足部110可能具有跖伤111(见图5)，例如，溃疡的跖区域。背侧元件106可作为减荷和减压治疗设备102的一部分被包含，并且背侧元件106可操作为接收患者足部110的背侧区域112，其可具有背侧伤114。跖元件104、背侧元件106和桥接元件108由减荷歧管材料116制成。 
参照图2，减荷歧管材料116的一部分的横截面图被示出。减荷歧管材料116具有第一面向组织的表面118和第二表面120。从减荷歧管材料116的第一面向组织的表面118开始，减荷歧管材料116具有支撑层128，该支撑层128具有第一面向组织的表面130和第二表面132。减荷歧管材料116还包括压力传输层134，该压力传输层134具有第一面向组织的表面136和第二表面138。压力传输层134的第一面向组织的表面136被耦合于支撑层128的第二表面132。减荷歧管材料116还包括第一屏障层140，该第一屏障层140具有第一面向组织的表面142和第二表面144。第一屏障层140的第一面向组织的表面142被耦合于压力传输层134的第二表面138。压力传输层134可被规定尺寸以小于支撑层128和第一屏障层140，使得压力传输层134可被完全地包含在支撑层128和第一屏障层140之间。 
如本文所使用的术语“耦合”包括通过单独物体的耦合，并且包括直接的耦合。术语“耦合”还包括两个或多个部件，该两个或多个部件由于部件中的每一个都是由同一块材料制成的而是彼此连续的。并且，术语“耦合”可包括例如通过化学键的化学耦合、机械耦合、热耦合或电气耦合。流体耦合意味着流体在指定零件或位置之间是相通的。三层(支撑层128、压力传输层134和第一屏障层140)的整个厚度优选地处于4mm至15mm的范围内，并且更优选地，处于6mm至10mm的范围内。 
第一屏障层140提供保护，并且帮助密封减荷和减压治疗设备102。第一屏障层140可由各种材料制成，例如，柔性的、非透气性的材料、流体不可渗透的或抗流体(fluid-resistant)的材料。合适的非透气性材料的非限制性实施例是聚氨基甲酸酯和织物材料，并且更具体的非限制性实施例是经线编织的织物上的聚氨基甲酸酯转移涂层(polyurethane transfer coating)(42％的聚氨基甲酸酯和58％的织物)。第一屏障层140还可为防刺穿的。 
支撑层128提供支撑结构，并且允许对身体压力进行减荷。就其本身而言，支撑层128将压力从正在被治疗的伤口周围移除。支撑层128可以能够缓冲、减震、缓解压力，或者甚至可以控制异常的脚和腿的运动。作为一个示例性的实施例，支撑层128可由闭孔泡沫(closed-cell foam)制 成。闭孔泡沫可由多孔的聚乙烯泡沫制成。 
压力传输层134允许减压通过层传输，并且允许传输任意的流体，例如，分泌液。一种用于压力传输层134的合适材料是柔性的、开孔泡沫(flexible，open-cell foam)，例如，由德克萨斯州(Texas)，圣安东尼奥市(San Antonio)的Kinetic Concepts公司可获得的 材料。 
在可选择的实施方式中，支撑层128和压力传输层134可为由小孔(每厘米40个小孔或更小)的开孔泡沫形成的单层，所述小孔的开孔泡沫由同样提供一些减荷力的非透气性材料覆盖。例如，小孔泡沫可被乙烯基材料覆盖。 
再次参照图1至图6，支撑层128的一部分可被切割并移除，以形成与跖伤111对准并且大于跖伤111的第一空隙146或跖间隙。按照这种方式，跖元件104在接近跖伤111处提供减荷功能。类似地，支撑层128的另一部分被切割并移除，以在背侧元件106的一部分上形成第二空隙148或背侧空隙。再次地，第二空隙148帮助对患者足部110上的背侧伤进行减压，或者保护并提供治疗空间。密封元件115，例如，诸如水解胶体环的粘合材料的环，可被用于在减荷和减压治疗设备102与接近背侧伤114的患者皮肤之间形成气动密封。类似于密封元件115的另一密封元件162可被放置在跖伤111周围。只有两个伤口，跖伤111和背侧伤114已经被示出，但是减荷和减压治疗设备102的另外部分可被移除，以形成治疗额外伤口的额外空隙。 
减压接口150可被放置在减荷和减压治疗设备102上的任意位置处，并且可被流体地耦合于减荷歧管材料116的压力传输层134，即与减荷歧管材料116的压力传输层134流体相通。如果实施方式只包括跖元件104，那么减压接口150被耦合于跖元件104的一部分。如果背侧元件106被包括在实施方式中，那么减压接口150可被耦合于背侧元件106或跖元件104。在图1所示的实施方式中，减压接口150被耦合于桥接元件108的一部分。在耦合减压接口150中，孔被形成为通过第一屏障层140，并且减压接口150开始与压力传输层134流体相通。桥接元件108给减压接口150提供了方便的位置，并且流体地耦合于跖元件104。如果背侧元件106 被包括，那么桥接元件108帮助耦合背侧元件106和跖元件104，并且将减压接口150流体地耦合于背侧元件106的压力传输层134。 
减压传送管道152流体地耦合于减压接口150和减压源154。减压接口150可为端口，例如，从德克萨斯州(Texas)，圣安东尼奥市(SanAntonio)的Kinetic Concepts公司可获得的TRAC 
Figure BPA00001213343900071
接口或SensaT.R.A.C.TM衬垫接口。减压源154可为用于提供减压的任意设备或装置，例如真空泵、手动致动的泵或壁吸式的源(wall suction source)。虽然被应用于例如伤口的组织部位的减压的量和性质将根据应用改变，但是减压通常将在-5mm Hg和-500mm Hg之间，并且更典型地在-150mm Hg和-300mm Hg之间。 
本文所使用的术语“减压”通常是指在正在接受治疗的组织部位处的小于环境压力的压力。在大多数情况下，减压将小于患者所处的大气压力。可选择地，减压可小于与组织部位处的组织相关联的流体静压。尽管术语“真空”和“负压”可被用于描述被应用于组织部位的压力，但是被应用于组织部位的实际压力减少可明显地小于通常与绝对真空相关联的压力减少。减压可首先在组织部位的区域内产生液体流。除非另外指示，否则本文所述的压力值为表压力。同样地，对减压的增加的提及通常是指绝对压力的减小，而减压的减小通常是指绝对压力的增加。与本文的使用相一致，减压或真空压力的增加通常是指绝对压力的相对减小。在一个示例性的实施方式中，圣安东尼奥(SanAntonio)的Kinetic Concepts公司的 治疗装置(Therapy Unit)可被用作减压源154。 
根据应用，多个设备可被流体地耦合于减压传送管道152。例如，液罐(fluid canister)156或代表性设备158可被包括。代表性设备158可为另一储液罐(fluid reservoir)或液罐，以容纳分泌物和其它去除的液体。可被包括在减压传送管道152上的代表性设备158的其它实施例包括下面的非限制性实施例：压力反馈设备、容量检测系统、血液检测系统、感染检测系统、流动监控系统、温度监控系统、过滤器等。这些设备中的一些可形成减压源154的组成部分。 
现在主要参照图1和图5，减荷和减压治疗设备102在跖伤111上的应用将被描述。当足部110被放置在跖元件104上时，医疗保健提供者在与跖伤111相对应或相对准的位置处移除支撑层128的第一部分。支撑层128可通过如手术刀的工具的辅助被切割并移除。当第一部分被移除时，第一空隙146被形成。 
第一治疗歧管160或跖治疗歧管被放置在第一空隙中。本文所使用的术语“歧管”通常是指被设置以辅助将减压应用于组织部位、将流体传送至组织部位，或将流体从组织部位处移除的物质或结构。歧管通常包括多个流动通道或路径，该多个流动通道或路径被互相连接以提高被提供给如跖伤111的组织部位或伤口的流体和从如跖伤111的组织部位或伤口移除的流体在第一治疗歧管160周围的分布。第一治疗歧管160可为能够被放置成与如跖伤111的组织部位或伤口相接触并且使减压分布于如跖伤111的组织部位或伤口的生物适合的材料。治疗歧管的实施例可包括但不限于，例如，具有布置以形成流动通道的如多孔泡沫、开孔泡沫、多孔组织收集(porous tissue collection)、流体、凝胶(gel)和包括或处理以包括流动通道的泡沫的结构元件的设备。第一治疗歧管160可为多孔的，并且可由泡沫、纱布、毡垫或适合于特殊生物应用的任何其它的材料制成。在一个实施方式中，治疗歧管是多孔泡沫，并且包括多个用作流动通道的互相连接的室或孔。多孔泡沫可为聚氨基甲酸酯、开孔、网状的泡沫，例如由德克萨斯州(Texas)，圣安东尼奥市(San Antonio)的Kinetic Concepts公司制造的 
Figure DEST_PATH_GSB00000543520700021
材料。在一些情况下，如第一治疗歧管160的治疗歧管也可被用于分配流体，例如药物、抗菌药、生长因子和针对如跖伤111的组织部位或伤口的各种溶液。例如吸收性材料、芯吸材料(wicking material)、疏水材料和亲水材料的其它层可被包括在治疗歧管中或在治疗歧管上。 
第一治疗歧管160可稍微高于第一空隙146的高度(用于图5所示的定向)，以提供与跖伤111的接触。可为如水解胶体的粘合剂的密封元件162被应用于接近跖伤111的足部110的跖区域，并且然后将足部110放置在跖元件104上。跖伤111与减荷和减压治疗设备102的第一空隙146对准，并且将足部110放置在跖元件104上。密封元件162在包括第一治疗歧管160的第一空隙146上在跖伤111周围形成气动密封。关于背侧元 件106，类似的步骤被完成，以在背侧元件106中创建第二空隙148，并且第二治疗歧管或背侧治疗歧管被放置在第二空隙148中。然后，已经被放置在足部110上的减荷和减压治疗设备102可被放置在铸造鞋、凉鞋或超大号鞋中。 
减压被提供给减压接口150。减压在减压传输层134中被传输给第一空隙146和第一治疗歧管160以及第二空隙148和第二治疗歧管。如图5中的箭头164所表明的，减压将来自跖伤111的任何流体拉动进入第一治疗歧管160并进入压力传输层134，并且如图6中的箭头166所表明的，流体被拉动进入减压接口150。传送给减压接口150的流体可由减压传送管道152传送给液罐156。 
现在参照图7A和图7B，用于制造减荷和减压治疗设备102的示例性过程被示出。减荷歧管材料116的片168可被提供。例如，30.5cm x 30.5cm的减荷歧管材料116的片可被提供，其用来形成用于足部或其它四肢上的减荷和减压治疗设备102。对应于患者的足部尺寸的图案170可被标记并切割。在当前的实施方式中，跖元件104被基于患者的特定尺寸来确定尺寸，并随后产生图案170。图案170被切割以形成如图7B所示的未折叠的减荷和减压治疗设备102。切割的减荷和减压治疗设备102的边缘172可覆盖有柔性的胶带或者喷射有速干的密封胶。然后，未折叠的减荷和减压治疗设备102被折叠，以将设备形成于图1、图3和图4所示的位置中。 
现在参照图8A、图8B和图9，减荷和减压治疗设备202的另一示例性的实施方式被提供。减荷和减压治疗设备202类似于图1至图7的减荷和减压治疗设备102，并且类似的或相同的零件通过利用100对参考数字进行索引的方式被指示。减荷和减压治疗设备202具有跖元件204，并且可具有背侧元件206和桥接元件208。桥接元件208可具有中心桥接部件207和接口部分209。跖元件204可操作为接收患者足部可具有跖伤的跖区域。背侧元件206可作为减荷和减压治疗设备202的一部分被包括，并且可操作为接收患者足部可具有背侧伤的背侧区域。跖元件204、背侧元件206和桥接元件208由减荷歧管材料216制成。 
减荷歧管材料216具有支撑层228、压力传输层234和第一屏障层240。支撑层228具有第一面向组织的表面和第二表面232。压力传输层234具有第一面向组织的表面和第二表面238。第一屏障层240具有第一面向组织的表面和第二表面244。 
减压接口250可被应用于任何地方，但是优选地在桥接元件208的接口部分209上。减压接口250被流体地耦合于减压传送管道252，该减压传送管道252被流体地耦合于减压源。 
减荷和减压治疗设备202包括从桥接元件208处延伸的扩展元件275。扩展元件275帮助在使用期间将减荷和减压治疗设备202固定在适当的位置。安全带276被连接于扩展元件275，并且可释放地连接于跖元件204的一部分。安全带276可为具有粘合剂或钩和环的元件(hook-and-loop member)等的一块消毒盖布材料(a piece of drape material)。 
参照图8A和图8B，可看到减荷和减压治疗设备202的额外特征。在该实施方式中，可看到支撑层228的调节部分278。在使用中，调节部分278被放置在患者的指骨或跖骨下面。调节部分278如需要可被切割，以适应不同尺寸的脚或鞋。调节部分278允许减荷和减压治疗设备202被加工为设定尺寸，并且然后被定制在针对特殊用户的某一范围内。 
参照图8A和图10，减荷和减压治疗设备202的边缘280具有密封282。密封282可以众多方式形成，例如粘贴、粘贴并利用夹具上的边缘按压以施加力(见图10)、结合、焊接、消毒盖布胶带(drape tape)、胶合等。密封282向压力传输层234的边的提供气动密封，并且将支撑层228、压力传输层234和第一屏障层240进行耦合。 
尽管本发明及其优点已经在某些示例性的非限制性实施方式的范围中被公开，但是应该理解到，在不偏离本发明的由附加权利要求限定的范围的情况下，可进行各种变化、替换、置换和改变。 

Claims (20)

1.一种减荷和减压治疗系统，包括：
减荷和减压治疗设备，其中，所述减荷和减压治疗设备包括：
跖元件，其由减荷歧管材料制成，其中，所述减荷歧管材料包括：
支撑层，其具有第一面向组织的表面和第二表面；
压力传输层，其具有第一面向组织的表面和第二表面，所述压力传输层的所述第一面向组织的表面耦合于所述支撑层的所述第二表面；以及
第一屏障层，其具有第一面向组织的表面和第二表面，所述第一屏障层的所述第一面向组织的表面耦合于所述压力传输层的所述第二表面；
减压接口，其流体地耦合于所述跖元件的所述压力传输层；
减压源；以及
减压传送管道，其流体地耦合于所述减压源及所述减压接口。
2.根据权利要求1所述的减荷和减压治疗系统，其中，所述压力传输层由所述支撑层、所述第一屏障层和密封件封装。
3.根据权利要求1所述的减荷和减压治疗系统，其中，所述减荷和减压治疗设备还包括由所述减荷歧管材料制成的背侧元件，其中，所述背侧元件的所述压力传输层被流体地耦合于所述跖元件的所述压力传输层。
4.根据权利要求1所述的减荷和减压治疗系统，其中，所述减荷和减压治疗设备还包括由所述减荷歧管材料制成的桥接元件，并且其中，所述桥接元件的所述压力传输层被流体地耦合于所述跖元件的所述压力传输层，并且其中，所述减压接口被耦合于所述桥接元件。
5.根据权利要求1所述的减荷和减压治疗系统，其中，所述减荷和减压治疗设备还包括：
背侧元件，其由所述减荷歧管材料制成，并且其中，所述背侧元件的所述压力传输层流体地耦合于所述跖元件的所述压力传输层；以及
桥接元件，其由所述减荷歧管材料制成，并且其中，所述桥接元件的所述压力传输层被流体地耦合于所述跖元件的所述压力传输层，并且其中，所述减压接口被耦合于所述桥接元件。
6.根据权利要求1所述的减荷和减压治疗系统，其中，所述减荷歧管材料包括：
包括开孔泡沫材料的所述压力传输层；以及
包括闭孔泡沫材料的所述支撑层。
7.根据权利要求1所述的减荷和减压治疗系统，其中，所述跖元件的所述支撑层的一部分是可去除的，以形成第一空隙，并且所述跖元件的所述压力传输层是可操作的，以将减压传输至所述第一空隙。
8.根据权利要求5所述的减荷和减压治疗系统，其中，所述跖元件的所述支撑层的一部分是可去除的，以形成第一空隙，所述跖元件的所述压力传输层是可操作的，以将减压传输至所述第一空隙，所述背侧元件的所述支撑层的一部分是可去除的，以形成第二空隙，并且所述背侧元件的所述压力传输层是可操作的，以将减压传输至所述第二空隙。
9.一种减荷和减压治疗设备，包括：
跖元件，所述跖元件由减荷歧管材料制成，其中，所述减荷歧管材料包括：
支撑层，其具有第一表面和第二表面；
压力传输层，其具有第一表面和第二表面，所述压力传输层的所述第一表面被耦合于所述支撑层的所述第二表面；以及
第一屏障层，其具有第一表面和第二表面，所述第一屏障层的所述第一表面被耦合于所述压力传输层的所述第二表面；以及
减压接口，其流体地耦合于所述跖元件的所述压力传输层。
10.根据权利要求9所述的减荷和减压治疗设备，其中，所述压力传输层由所述支撑层、所述第一屏障层和密封件封装。
11.根据权利要求9所述的减荷和减压治疗设备，还包括由所述减荷歧管材料制成的背侧元件，并且其中，所述背侧元件的所述压力传输层被流体地耦合于所述跖元件的所述压力传输层。
12.根据权利要求9所述的减荷和减压治疗设备，还包括由所述减荷歧管材料制成的桥接元件，其中，所述桥接元件的所述压力传输层被流体地耦合于所述跖元件的所述压力传输层，并且其中，所述减压接口被耦合于所述桥接元件。
13.根据权利要求9所述的减荷和减压治疗设备，还包括：
背侧元件，其由所述减荷歧管材料制成，并且其中，所述背侧元件的所述压力传输层被流体地耦合于所述跖元件的所述压力传输层；以及
桥接元件，其由所述减荷歧管材料制成，其中，所述桥接元件的所述压力传输层被耦合于所述跖元件的所述压力传输层，并且其中，所述减压接口被耦合于所述桥接元件。
14.根据权利要求13所述的减荷和减压治疗设备，其中，所述跖元件的所述支撑层的一部分是可去除的，以形成第一空隙，所述跖元件的所述压力传输层是可操作的，以将减压传输至所述第一空隙，所述背侧元件的所述支撑层的一部分是可操作的，以形成第二空隙，并且所述背侧元件的所述压力传输层是可操作的，以将减压传输至所述第二空隙。
15.根据权利要求9所述的减荷和减压治疗设备，其中，所述减荷歧管材料包括：
包括开孔泡沫材料的所述压力传输层；以及
包括闭孔泡沫材料的所述支撑层。
16.根据权利要求9所述的减荷和减压治疗设备，其中，所述跖元件的所述支撑层的一部分是可去除的，以形成第一空隙，并且所述跖元件的所述压力传输层是可操作的，以将减压传输至所述第一空隙。
17.根据权利要求9所述的减荷和减压治疗设备，其中，所述减荷歧管材料具有边缘，并且其中，所述减荷歧管材料在接近所述边缘处由密封元件密封。
18.根据权利要求9所述的减荷和减压治疗设备，其中，所述支撑层还包括用于帮助调节所述减荷和减压治疗设备的尺寸的调节部分。
19.一种减荷和减压治疗设备，包括：
跖元件，所述跖元件由减荷歧管材料制成，其中，所述减荷歧管材料包括：支撑层、压力传输层和第一屏障层；以及
减压接口，所述减压接口流体地耦合于所述跖元件的所述压力传输层，
其中，所述支撑层和所述压力传输层包括由小孔开孔泡沫形成的单层，所述小孔开孔泡沫由非透气性材料覆盖，其中所述小孔开孔泡沫具有小于或等于40个孔每厘米的线性孔密度。
20.根据权利要求19所述的减荷和减压治疗设备，其中，所述单层由所述非透气性材料封装。
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CN101965152A (zh) 2011-02-02
TW200946151A (en) 2009-11-16

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