CN102089017A - 透明减压敷料和系统 - Google Patents

透明减压敷料和系统 Download PDF

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CN102089017A
CN102089017A CN2009801196219A CN200980119621A CN102089017A CN 102089017 A CN102089017 A CN 102089017A CN 2009801196219 A CN2009801196219 A CN 2009801196219A CN 200980119621 A CN200980119621 A CN 200980119621A CN 102089017 A CN102089017 A CN 102089017A
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bolster
dressing
transparent
wound
patient
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CN102089017B (zh
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埃里克·伍德森·巴塔
贾斯汀·亚历山大·龙恩
小理查德·马文·卡扎拉
马修·弗朗西斯·卡瓦诺二世
迈克尔·理查德·吉鲁阿尔
肯尼思·米切尔·诺尔斯
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3M Innovative Properties Co
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KCI Licensing Inc
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    • A61F13/0209Adhesive plasters or dressings having a fluid handling member the fluid handling member being absorbent fibrous layer, e.g. woven or nonwoven absorbent pad, island dressings comprising superabsorbent material
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    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05KPRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
    • H05K999/00PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS dummy group
    • H05K999/99PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS dummy group dummy group
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Abstract

提出一种透明敷料组件,其与减压系统一起使用来利用减压治疗患者身上的伤口,其允许在治疗期间的伤口的可视观察。敷料组件包括:用于当在减压之下时提供指向力的垫枕(46)、用于覆盖垫枕并在垫枕和患者的表皮之上提供密封的密封构件(72),并且其中,垫枕和密封构件由足以允许从系统外部的一点感知颜色的透明材料形成。其他系统、敷料和方法被提出。

Description

透明减压敷料和系统
相关申请
根据35U.S.C.§119(e),本发明要求以下申请的权益:于2008年5月30日提交的美国临时专利申请序列号61/057,807、题为“Reduced-PressureSurgical Wound Treatment System”;于2008年5月30日提交的美国临时专利申请序列号61/057,798、题为“Dressing Assembly For Subcutaneous WoundTreatment Using Reduce Pressure”;于2008年5月30日提交的美国临时专利申请序列号61/057,808、题为“See-Through,Reduced-Pressure Dressing”;于2008年5月30日提交的美国临时专利申请序列号61/057,802、题为“Reduced-Pressure Dressing Assembly For Use in Applying a ClosingForce”;于2008年5月30日提交的美国临时专利申请序列号61/057,803、题为“Reduced-Pressure,Linear-Wound Treatment System”;于2008年5月30日提交的美国临时专利申请序列号61/057,800、题为“Reduced-Pressure,Compression System and Apparatus for use on a Curved Body Part”;于2008年5月30日提交的美国临时专利申请序列号61/057,797、题为
“Reduced-Pressure,Compression System and Apparatus for use on BreastTissue”;于2008年5月30日提交的美国临时专利申请序列号61/057,805、题为“Super-Absorbent,Reduced-Pressure Wound Dressing and System”;于2008年5月30日提交的美国临时专利申请序列号61/057,810、题为
“Reduced-Pressure,Compression System and Apparatus for use on a Joint”;于2008年12月10日提交的美国临时专利申请序列号61/121,362、题为“Reduced-Pressure Wound Treatment System Employing an AnisotropicDrape”;以及于2009年1月12日提交的美国临时专利申请序列号61/144,067、题为“Reduced-Pressure,Compression System and Apparatus foruse on a Joint”。为了全部目的,这些临时申请的全部在此以引用的方式并入。
背景
本发明通常涉及医学治疗系统,并且更特别地,涉及适合于与诸如手术伤口的线形伤口(linear wound)一起使用的减压伤口治疗系统。
在世界各地,医生每年执行数百万的外科手术过程。许多过程作为开放性外科手术被执行,并且越来越多的数量使用微创外科手术被执行,诸如关节内窥镜、腹腔镜和内窥镜过程。作为一个例子,美国美学整形外科学会报告,2007年在美国有多于450,000的吸脂术过程。
外科手术过程伴随在皮肤和相关组织上的严重的伤口,例如切口或线形伤口。除外科手术伤口之外,线形伤口还由外伤引起。在许多实例中,使用诸如钉、缝合线或粘合剂的机械装置闭合线形切口,然后伤口仅用干的、消毒的绷带覆盖。绷带必须经常被去掉以查看伤口,以监控伤口的发展以及对感染或其他问题进行检查。除非另外指出,作为在此使用的,“或”不需要相互排他性。
简要概述
关于伤口护理的某些方面的缺点由此处的例证性实施方式解决。本发明可用在线形伤口、区域伤口或其他伤口上。“线形伤口”通常指的是是否在一条线上的裂口或切口。根据一个例证性实施方式,一种与减压系统一起使用来治疗患者身上的线形伤口的透明敷料组件包括用于当在减压之下时提供闭合力的闭合敷料垫枕和用于覆盖闭合敷料垫枕并在闭合敷料垫枕之上提供密封的密封构件。闭合敷料垫枕和密封构件由足以允许从透明敷料组件外部的一点感知颜色的透明材料形成。闭合敷料垫枕可包括顶壁和底壁。顶壁和底壁以隔开关系连接。底壁具有中心部分、第一侧部和第二侧部。第一闭合构件形成在第一侧部上,以及第二闭合构件形成在第二侧部上。当被置于减压之下时,第一闭合构件和第二闭合构件朝向彼此移动。
根据另一例证性实施方式,提出一种利用减压治疗患者身上的伤口的系统,其允许在治疗期间的伤口的可视观察。该系统包括:透明敷料垫枕,其用于在伤口之上放置在患者的表皮上;透明密封子系统,其用于在闭合垫枕之上提供流体密封;以及减压子系统,其用于将减压输送到密封子系统。密封子系统和减压子系统是可操作的以将减压输送到透明敷料垫枕,借此系统产生在伤口处实现的指向力并将减压输送到伤口。透明构件是可操作的以允许光通过,以使伤口的颜色、颜色的深浅或伤口边缘能够从系统外部的一位置被感知。
根据另一例证性实施方式,一种制造透明敷料组件的方法包括以下步骤:形成垫枕,该垫枕用于当在减压之下时向伤口治疗区域提供指向力;以及提供透明密封构件以覆盖垫枕,并且该透明密封构件允许在垫枕和患者的表皮之上的流体密封。形成垫枕的步骤包括由透明材料形成垫枕。
根据另一例证性实施方式,一种与在患者身上的减压治疗系统一起使用的敷料组件包括:垫枕,其用于放置在患者身上的伤口之上并用于当在减压之下时提供指向力;密封构件,其用于覆盖垫枕并在垫枕和患者的表皮的一部分之上提供流体密封;以及可视检查设备,其用于可视地检测在患者身上的伤口的颜色。在下面还进一步地提出其他例证性实施方式。
例证性实施方式的其他特征和优点参考下述的附图和详细的描述将变得明显。
附图的简要描述
结合附图参考下述的详细描述将获得对本发明的方法和装置的更加完全的理解,其中:
图1是用于治疗患者身上的线形伤口的系统的例证性实施方式的带有一部分横截面的示意性透视图;
图2是在治疗患者身上的线形伤口时使用的闭合敷料垫枕的例证性实施方式的示意性透视图;
图3A是用于治疗患者身上的线形伤口的系统的例证性实施方式的示意性横截面;
图3B是来自图3A的细节的示意性横截面;
图3C是来自图3A的细节的示意性横截面;
图4A是在治疗患者身上的线形伤口时使用的闭合敷料垫枕的例证性实施方式的示意性透视图;
图4B是图4A的闭合敷料垫枕的部分分解透视图,其显示管道连接器的一个例证性实施方式;
图4C是图4A的闭合敷料垫枕的横截面;
图4D是图4C的闭合敷料垫枕的细节;
图5是用于治疗患者身上的线形伤口的闭合敷料垫枕的例证性实施方式的示意性透视图;
图6是用于治疗患者身上的线形伤口的系统的例证性实施方式的一部分的示意性横截面;
图7是用于治疗患者身上的线形伤口的系统的一部分的例证性实施方式的示意性横截面;以及
图8是用于治疗受损皮下组织的系统的例证性实施方式的带有一部分横截面的示意性透视图,该系统允许从系统外部的一点看见伤口。
优选实施方式的详细描述
在下述的优选实施方式的详细描述中,对于形成本文中的一部分的、并且作为说明在其中示出可实施本发明的具体的优选实施方式的附图作出参考。这些实施方式充分详细地被描述以使本领域技术人员能够实施本发明,并且应理解,其他实施方式可被利用且逻辑结构的、机械的、电的和化学的改变可被作出而没有脱离本发明的精神或范围。为了避免使本领域技术人员能够实施本发明所不需要的细节,描述可能省略了某些对于本领域技术人员已知的信息。因此,下述的详细描述不被理解为限制性意义,且本发明的范围仅由所附的权利要求来限定。
参考图1-3,显示用于治疗诸如裂口或更典型地切口14的线形伤口12的减压系统10的例证性实施方式。减压系统10可固定或支撑切口周围的组织,增强切口14的抗张强度;压缩皮下组织20;除去间质流体,其可帮助减少或消除浮肿;以及使线形伤口12与感染源隔离。减压系统10可特别适合于用于处于危险中的患者,例如极为肥胖的患者、糖尿病患者、吸烟者等。
虽然线形伤口12可延伸到不同深度,但是在该例子中,切口14延伸通过表皮16、真皮18并延伸到皮下组织20中。在该例子中,受损的皮下组织22包括皮下空隙24或死区。虽然在该实施方式中没示出,但是线形伤口12可具有任何数量的在线形伤口上使用的闭合设备(closing device),例如,机械闭合设备(缝合线、钉、夹具等)、粘合剂、粘结剂等。伤口可以是或可包括移植物。
减压系统10可包括敷料组件40,其可被放置在线形伤口12之上并和减压一起被使用以供应指向力(directed force),该指向力可包括压缩力42或闭合力44(或关于敷料组件的外部边缘的内向力)。敷料组件40可包括闭合敷料垫枕46,其在减压之下产生指向力,例如压缩力42或闭合力44。闭合敷料垫枕46可由垫枕主体50形成。闭合敷料垫枕46优选地由允许弯曲然而是足够刚性的以输送闭合力的材料制成。
垫枕主体50可包括第一闭合构件52和第二闭合构件54。可包括另外的闭合构件,诸如构件56、58、60和62。密封子系统70和减压子系统90与闭合敷料垫枕46配合以产生指向力,例如闭合力44或压缩力42。
闭合敷料垫枕46可由一材料制成,该材料有助于将减压分配到线形伤口12、提供压缩力42以及通过例如闭合构件56的闭合构件提供闭合力44——优选地是大体上在表皮16的平面内的力。另外,用于闭合敷料垫枕46的材料优选地是半透明的或透明的,以致光可通过以允许人们通过该垫枕材料从减压系统10外部的一点查看线形伤口12。可形成闭合敷料垫枕46的材料在下面更进一步地被描述。
如在前提到的,减压系统10可允许从减压系统10外部的一点直观地察觉伤口颜色、颜色的深浅、伤口边缘或其他特征。像这样,颜色、颜色的深浅、伤口边缘的性质或其他特征可由卫生保健提供者确定而不需要敷料组件40的去除,并且从而可避免增加并发症的风险和敷料更换的疼痛。像这样,另一敷料组件40或其一部分的费用也可被避免。减压系统10还可向线形伤口12提供压缩力42,并且该力可帮助线形伤口12、皮下组织22或皮下空隙24愈合,并可相对于剪应力(shear)稳定线形伤口12。减压系统10还可帮助除去来自线形伤口12的渗出液并帮助闭合空隙24。
密封子系统70可包括密封构件72。密封构件72具有第一侧面74和面向内的第二侧面76。密封构件72的一部分可延伸超出闭合敷料垫枕46,例如超出边缘48,以形成襟翼(flap)或披盖物外延77,其具有第一侧面78和面向内的第二侧面79。密封构件72可以是任何提供流体密封的材料,其允许减压被保持。例如,密封构件可以是不可渗透的或半渗透的弹性材料。“弹性的”表示具有弹性体的特性。其通常指的是具有类橡胶特性的聚合材料。更具体地,大部分弹性体具有大于100%的伸长率和相当量的回弹。材料的回弹指的是材料从弹性形变恢复的能力。弹性体的例子可包括但不限于,天然橡胶、聚异戊二烯、苯乙烯丁二烯橡胶、氯丁二烯橡胶、聚丁二烯、丁腈橡胶、丁基橡胶、乙丙橡胶、三元乙丙橡胶、氯磺化聚乙烯、聚硫橡胶、聚氨基甲酸酯、EVA膜、共聚多酯以及硅树脂。密封构件材料的具体例子包括硅树脂披盖物、3M
Figure BPA00001259627700061
披盖物、丙烯酸披盖物(诸如来自Avery Dennison的可用的一种)或切割披盖物(incise drape)。
密封装置80或连接设备可被用于帮助在披盖物外延77和患者的表皮16之间提供流体密封。在本实施方式中,密封装置80可以是粘合剂82,其应用于襟翼外延77的面向内的第二侧面79,以提供相对于表皮16的这样的密封。密封装置80可被用于保持密封构件72贴着患者的表皮16或诸如垫(gasket)或附加密封构件的另一层。密封装置80可采用许多形式。例如,密封装置80可以是医学上可接受的、压敏粘合剂,其围绕密封构件72的外围延伸。
减压子系统90包括减压源92,或治疗单元。减压源92提供减压。减压源92可以是任何用于供应减压的设备,诸如真空泵、壁式吸入装置(wallsuction)或其他源。尽管施加到组织的减压的量和性质一般将根据应用改变,但是减压一般将在-5mm Hg至-500mm Hg之间,且更典型地在-100mm Hg至-300mm Hg之间。在一实施方式中,减压被保持在-200mm Hg左右。为了方便且灵活的目的,减压源92可以是电池运转单元,其能够提供连续的和断续的减压。减压源92或治疗单元可以包括罐94或贮器,并且可设置有窗口96以允许患者或卫生保健提供者查看罐94的填充状态。减压子系统90还包括减压输送导管98或医学管道,其流动地连接到减压接驳体100,诸如端口102。减压输送导管98和减压接驳体100允许减压被输送到密封子系统70中。
作为在此使用的,“减压”通常指的是压力小于正在治疗之下的线形伤口12、组织部位或治疗部位处的环境压力。在大多数情形下,该减压将小于患者所处于的大气压力。可选择地,减压可小于在组织部位处的流体静压力。除非另外指出,在此确定的压力的值是表压。输送的减压可以是恒定的或变化的(规范的或随机的),并且可以被连续地或断续地输送。尽管术语“真空”和“负压”可被用于描述施加到组织部位的压力,但是施加到组织部位的实际压力可多于与绝对真空正常关联的压力。与在此的使用一致,减压或真空压力的增加一般指的是绝对压力的相对减少。
闭合敷料垫枕46可由聚合物制成并且优选地是柔软的聚合物。在一个例证性实施方式中,闭合敷料垫枕46是具有50Shore A的硬度的材料,但是其他材料和特征是可能的。闭合敷料垫枕46和垫枕主体50可由透明材料制成,密封构件72一样,以便允许从减压系统10外部的一点查看线形伤口12的颜色、颜色的深浅、伤口边缘或其他特征(见图6)。线形伤口12的颜色变化或颜色的深浅的变化可以表明感染或其他问题的发生,并且这种可视的提示向卫生保健提供者提供有用的信息。垫枕主体50可由例如柔软的聚合物、医学等级的硅树脂或其他适当的材料的柔性的闭合垫枕材料制成。闭合敷料垫枕46可被挤压、灌注模制、注射模制、吹塑模制或由其他制造技术形成。“柔性的”表示能够移动而足以产生内向闭合力。
现主要参考图2,闭合敷料垫枕46被示出带有形成在垫枕主体50的第二壁55或底壁的面向内的第二侧面或表面49上的多个孔64。孔64形成在中心部分66下,并且特别是靠近垫枕主体50的中心线68。显示一个孔64的细节在图3C中示出。第一壁53或顶壁和第二壁55以隔开关系被连接以形成中空区域或中心隔间57。再次主要参考图2,孔64便于由垫枕主体50将减压传输到线形伤口12。不同图案的附加的孔可设置在垫枕主体50上以便于减压到患者的表皮16的传递,并且特别是到线形伤口12的传递。一个或多个孔,诸如孔65,可形成在垫枕主体50的第一壁53的第一侧面47上。闭合构件52、54、56、58、60和62在面向内的第二侧面49上示出。闭合构件52、56和58在中心部分66的第一侧部并且闭合构件54、60和62在中心部分66的第二侧部。
如在图3A和3B中清楚地示出的,倾斜表面69具有关于垂直延伸的假想平面(对于在图2中所示的方向垂直)形成的角。与表面63相对的倾斜表面69示出关于在倾斜表面69的顶点处形成的参考垂直平面59形成角度61。
在操作中,当需要治疗时,闭合敷料垫枕46被放置在线形伤口12之上,同时在线形伤口12之上的中心部分66接近中心伤口区域45。如果闭合敷料垫枕46没有被预先制造成带有在第一侧面47上应用的密封构件72,那么密封构件72在闭合敷料垫枕46的第一侧面47之上被应用并且超出闭合敷料垫枕46以形成襟翼外延或披盖物外延77。披盖物外延77被向下用带粘贴或者粘合剂82被应用以在密封构件72和患者的表皮16之间提供流体密封。“流体密封”或者“密封”表示考虑到涉及的特定减压子系统而足以在需要的部位保持减压的密封。
减压子系统90通过减压接驳体100流体地连接到密封子系统70。减压源92被启动,并且产生减压并通过减压输送导管98将减压输送到减压接驳体100。当启动时,减压源92将减压输送到密封子系统70并且减压引起闭合敷料垫枕46产生压缩力42。闭合敷料垫枕46的几何结构可使弯曲力矩关于中心部分66产生,并且从而引起闭合构件52、54、56、58、60和62产生向下和向内的合力(对于所示的方向)。该作用产生指向力,例如压缩力42或闭合力44。可在线形伤口12处或靠近线形伤口12感受这些力。
主要参考图2,闭合力或压缩力的产生更加详细地被描述。在相邻的闭合构件58和56、56和52、52和54、54和60以及60和62之间的倾斜表面69中的每一个形成三角形状的脊的一部分,每一个具有顶点:第一顶点67、第二顶点71、中心顶点75、第三顶点83和第四顶点85。当减压进入孔65时,中心隔间57被抽空直到顶点67、71、75、83和85中的一些或全部遇到第一壁53。减压还从中心隔间57通过孔64输送,并且减压可提供较高地推进顶点或尽力使与每个顶点关联的角度更小的力。由于这些作用中的一个或多个,闭合构件52、54、56、58、60和62被朝向中心线68推进,并通过来自闭合构件52、54、56、58、60和62的相对于患者的表皮的摩擦,在患者的表皮上产生闭合力。随着第一壁53和第二壁55被减压牵引而朝向患者或在从第一壁53到第二壁55前进的方向上被牵引,可产生压缩力。
现主要参考图4A、4B、4C和4D,显示闭合敷料垫枕146的另一例证性实施方式。闭合敷料垫枕146具有形成有第一闭合构件152和第二闭合构件154的垫枕主体150。还示出第三闭合构件156和第四闭合构件158。闭合构件152和156在是中心平面168或中心部分的一侧的第一侧面或第一部分153上形成,并且可延长闭合敷料垫枕146的纵向长度。闭合构件154和158在是在中心平面168的另一侧上的第二部分或侧面155上形成。
中心槽区157可帮助垫枕主体50在该区域弯曲,因为在减压之下产生了弯曲力矩。弯曲力矩有助于将闭合构件152、154、156和158压到患者的表皮中并可提供指向力,例如朝向中心伤口区域(例如图1中的区域45)指引的压缩力和闭合力。在该例证性实施方式中,已经关于挤压的强度和容易度从一材料,例如硅树脂,选择了垫枕主体50的形状,并且以使垫枕主体50以所需的方式塌陷或移动以产生指向力,例如压缩或闭合力。闭合敷料垫枕146可由透明的或至少部分透明的材料制成,以使闭合敷料垫枕146可帮助从利用闭合敷料垫枕146的系统外部的一点查看在闭合敷料垫枕146下面的线形伤口的颜色、颜色的深浅、伤口边缘或其他特征。
如在图4A和4B中所示的,管道连接器199可用于向闭合敷料垫枕提供减压。管道连接器199被依尺寸制作并配置为与在闭合敷料垫枕146上的中心槽区157配合。管道连接器199流体地连接到减压输送导管198,由此将减压输送到闭合敷料垫枕146。孔151允许减压传递到闭合敷料垫枕146之内。如在图4C中清楚所示的,孔164可在闭合敷料垫枕146的一部分中形成以帮助将减压传递到下面的线形伤口。
现主要参考图4C-4D,闭合力或压缩力的产生将更加详细地被描述。在该例证性实施方式中,垫枕主体150已经被挤压有中心隔间123和多个隔间。多个隔间中的六个111、113、115、117、119和121在第一部分153上形成。中心隔间123大体上邻接中心槽157形成。多个隔间中的六个125、127、129、131、133、135和137在第二部分155上形成。在该实施方式中,仅中心隔间123接收减压并通过孔151这样做。
多个隔间,例如隔间111、113、115、117、119、121、125、127、129、131、133、135和137,使用第一壁139(或顶壁)、第二壁141(或底壁)和多个网状构件(web member)143形成。除了中心槽157的下部部分145被设计为在减压之下相对于中心隔间123的搁板部分(shelf portion)161塌陷之外,多个隔间提供强度以防止第一壁139相对于第二壁141塌陷。应当注意的是,第一闭合构件152和第二闭合构件154被分离隔开,并且依尺寸制作并配置为提供治疗槽163。治疗槽163可具有穹顶形切口(dome-cutout)165和倾斜壁167。第一闭合构件152在关于中心平面168的第一侧部上形成,并且第二闭合构件154在关于中心平面168的第二侧部上形成。
当减压被输送到孔151时,减压进入中心隔间123并通过孔164输送到治疗槽163中。减压导致中心槽157的下部部分145塌陷并接触中心隔间123的搁板部分161。另外,在治疗槽163中的减压牵引倾斜壁169朝向彼此。这些作用中的一个或多个导致垫枕主体150关于中心平面164折曲或弯曲,并且从而推进闭合构件朝向中心平面164。多个隔间优选地不塌陷并继续提供强度。而且,当减压向内,即在从第一壁139到第二壁141前进的方向上,牵引闭合敷料垫枕146时,产生压缩力。
现主要参考图5,显示闭合敷料垫枕246的另一实施方式。闭合敷料垫枕246包括垫枕主体250,其形成有在第一侧面253或第一侧部上的第一闭合构件252和在第二侧面255或第二侧部上的第二闭合构件254。第一和第二闭合构件252具有倾斜壁,其朝向芯吸材料固定器236向上成角度(对于所示的方向)。关于中心部分268,覆盖片265或覆盖物可覆盖并固定闭合构件252和254。在闭合构件252和254之间的间隙形成固定芯吸材料238的芯吸材料固定器236。芯吸材料238的形状和芯吸材料238的物质可以可操作来帮助保持在下面的线形伤口(例如,图1中的线形伤口12)干燥和干净。
可被用于芯吸材料238的材料包括疏水材料、亲水材料和在别处列出的可用于下面所描述的成形敷料垫枕532(见图8)的全部材料。覆盖片265和闭合构件252和254可由透明材料制成,其允许闭合敷料垫枕246和一系统一起使用,该系统允许卫生保健提供者从闭合敷料垫枕246外部(见图6的例子)或系统外部的一点查看在闭合敷料垫枕246下面的线形伤口的颜色、颜色的深浅、伤口边缘或其他特征。
在操作中,闭合敷料垫枕246可在减压之下产生弯曲力矩,引起第一闭合构件252的下部部分和第二闭合构件254的下部部分在患者的表皮上向下(对于所示的方向)且向内压,从而引起朝向线形伤口的压缩力或闭合力。输送到芯吸材料固定器236的减压可移动第一闭合构件252和第二闭合构件254相互更加靠近,并且从而提供闭合力。闭合敷料垫枕246被依尺寸制作并配置以使芯吸材料238可与线形伤口接触,并且从而有助于除去任何可能已经从线形伤口流出的流体。任何这样的流体将被输送到减压接驳体并随后在减压源的影响下通过减压导管输送到罐。
上面所显示的例证性的闭合敷料垫枕46、146和246可提供从闭合敷料垫枕外部的一位置的伤口的颜色、颜色的深浅、伤口边缘或其他特征的可视测定。对于现在将要论述的其他类型的敷料,该特征也是可能的。现参考图6,显示减压治疗系统310的一部分。减压治疗系统310包括透明敷料组件340,其具有垫枕主体350。垫枕主体350可由任何数量的诸如垫枕网状物或垫枕泡沫的材料制成,只要在泡沫(透明的泡沫)上或在材料的结构元件之间的孔间距允许足够的光通过材料以使线形伤口312的颜色、颜色的深浅、伤口边缘或其他特征可以从减压治疗系统310外部的一点被看到,例如,可以在由参考数字384所示的视线位置上被看到。例如,垫枕主体350可由硅树脂或多孔泡沫形成,例如,从德克萨斯州(Texas)圣安东尼奥(San Antonio)的Kinetic Concepts,Inc.可获得的
Figure BPA00001259627700121
材料。孔的尺寸和密度可被改变以帮助提供透明的特征。
在可选择的例证性实施方式中,诸如由透明的硅树脂制成的窗口的窗口386可被放置在垫枕材料的一部分之上,以使当向垫枕主体350提供减压并且窗口386在垫枕材料上被进一步向下压缩时,线形伤口312变得通过窗口386从垫枕主体350和系统310外部的一点是可视的。例如,患者或卫生保健提供者可在视线388上看见线形伤口312。
在另一可选择的、例证性的实施方式中,透明的珠子可被用作垫枕主体350或包括在垫枕主体350内。珠子可被布置在垫枕主体内以使在负压之下,珠子在伤口之上聚集,从而允许患者或卫生保健提供者从垫枕主体350和系统310外或外部的一点看透伤口。主体垫枕350可以是网状材料,当它们在减压之下聚集时珠子可以移动。
在另一实施方式中,窗口可以被形成以使当从垫枕主体350除去减压时,有偏向的部分(biased portion)移动到一旁,从而允许人们查看线形伤口312。例如,当减压压缩垫枕主体350的两个部分时,这两个部分可交迭,但是当减压被除去时,这两个部分分离并允许清楚地查看线形伤口。像这样,将意识到,许多可视检查设备可被用于允许可视地检测伤口的颜色和其他特征。可视检查设备可以是透明垫枕和透明密封构件、窗口386、允许足够的光通过的垫枕材料、多个透明的珠子、或垫枕的当不在减压之下时允许可视检查的可移动部分。
垫枕主体350被示出由密封构件372覆盖,密封构件372延伸超出垫枕主体350,例如超出边缘348,以形成披盖物外延377。披盖物外延377可使用诸如披盖物带383或其他密封设备的密封装置380密封,以在密封构件372和患者的表皮314之间形成流体密封。
现主要参考图7,显示用于治疗线形伤口412的例证性系统410的一部分。系统410包括敷料组件440。敷料组件440包括敷料垫枕446,其具有敷料主体450。敷料主体450可形成有两个部分:第一侧面或第一侧部453,和第二侧面或第二侧部455。第一部分453和第二部分455可整体连接或可以是两个分离件。第一部分453形成有闭合构件452和456。第二部分455形成有闭合构件454和460。在减压之下,闭合构件452、454、456和460产生朝向线形伤口412的压缩力和闭合力。敷料主体450被示出由密封构件472覆盖,密封构件472用密封装置480密封以提供相对于患者的表皮416的密封。
在第一部分453上的第一壁437和在第二部分455上的第二壁439可共同形成用于固定芯吸材料438的芯吸材料固定器436。芯吸材料438可保持贴着线形伤口412,以当在减压之下放置了敷料组件440时帮助除去任何流体,例如渗出液。
现主要参考图8,显示例证性透明的伤口治疗系统510,其允许卫生保健提供者查看治疗部位,例如线形伤口512、区域伤口、完好表皮514的一部分等,并且可提供压缩力。透明的伤口治疗系统510可提供皮下受损组织的治疗,并且可允许从透明的伤口治疗系统510外部的一位置查看治疗部位。
在环绕线形伤口512的切口周围区域示出透明的伤口治疗系统510,线形伤口512通过表皮514、真皮516并到达下皮中或皮下组织518中。皮下组织518可包括许多组织类型,诸如脂肪组织或肌肉。受损的皮下组织部位520被显示从线形伤口512延伸出,并在该实例中包括皮下缺损、死区或空隙522。受损的皮下组织部位520可由诸如吸脂术的外科手术过程引起。受损的皮下组织部位520可包括诸如空隙522的空隙、开口空间和不同缺损,其对于大量原因可能是麻烦的,诸如可导致浮肿的流体积聚。
线形伤口512可以用任何闭合设备或技术来闭合,诸如钉、缝合线或粘合剂,但在该例证性实施方式中用钉513示出。透明的伤口治疗系统510可用于治疗一区域且特别是可用于治疗皮下组织部位520和环绕皮下组织部位520的组织,但是透明的伤口治疗系统510也可被用于治疗线形伤口512的更受限的区域。
透明的伤口治疗系统510包括敷料组件530,其包括成形敷料垫枕532、密封子系统560和减压子系统580。在操作中,透明的伤口治疗系统510可产生一指向力,其可包括净压缩力,由参考数字524表示,其在皮下组织部位520中实现。如下面进一步描述的,成形敷料垫枕532可被形成并配置为允许压缩力524在患者的表皮514之上相当均匀地分配。另外,如果与在表皮514上的其他区域相比存在实质上增加的力的区域,那么皮肤刺激可发生。
指向力还可包括闭合力或内向力,即朝向敷料组件530的内部部分的力。闭合力由参考数字526表示。闭合力526充分地保持在表皮514的平面内。换句话说,闭合力526主要在表皮514内起作用。另外,透明的伤口治疗系统510是可操作的以将减压输送到线形伤口512,并且取决于愈合的阶段和线形伤口512的性质,通过线形伤口512,以使在任何皮下空隙522的水平处实现减压以帮助近似使在该区域的组织靠拢在一起以及帮助除去任何空气或任何其他流体。
敷料组件530包括成形敷料垫枕532,其具有第一侧面534和面向内的第二侧面536。尽管较大或较小尺寸可在不同应用中被使用,但是成形敷料垫枕532可依尺寸制作并形成以充分匹配受损的皮下组织部位520的估计区域。成形敷料垫枕532具有边缘538。成形敷料垫枕532可由许多不同的医学垫枕材料,即适合于在医学应用中使用的且可无菌形成的材料制成。在一个例证性实施方式中,成形敷料垫枕532由是歧管材料的医学垫枕材料制成。在一个例证性实施方式中,成形敷料垫枕532由为多孔且可渗透的类似泡沫的材料的垫枕材料制成,且更特别地由为当在减压之下时允许伤口流体的良好渗透性的网状、开孔聚氨基甲酸脂或聚醚泡沫的垫枕材料制成。已经被使用的一种这样的泡沫材料是从德克萨斯州圣安东尼奥的Kinetic Concepts,Inc.(KCI)可获得的
Figure BPA00001259627700141
材料。任何材料或材料的组合可被用于垫枕材料,只要该垫枕材料是可操作的以分配减压或分支减压。
作为在此使用的术语“歧管”通常指的是被设置以帮助施加减压、将流体输送到组织部位或从组织部位除去流体的物质或结构。垫枕材料还可以是材料的组合或分层;例如,亲水泡沫的第一垫枕层可以被布置为邻接疏水泡沫的第二垫枕层以形成垫枕材料。作为在此使用的术语“流体”通常指的是气体或液体,但也可以包括任何其他可流动的物质,包括但不限于凝胶、胶质和泡沫。
一般是在大约400至600微米的范围的
Figure BPA00001259627700151
材料的网状小孔在实现歧管功能中是有益的,但其他材料可被使用。医学垫枕材料的密度,例如
Figure BPA00001259627700152
材料的密度,一般在大约1.31b/ft3-1.61b/ft3(20.8kg/m3-25.6kg/m3)的范围内。在一些情况下,具有比
Figure BPA00001259627700153
材料的密度高的密度的材料可以是可取的。例如,可使用具有比1.61b/ft3(25.6kg/m3)大的密度的
Figure BPA00001259627700154
材料或类似材料。作为另一例子,可使用具有比2.01b/ft3(32kg/m3)或5.01b/ft3(80.1kg/m3)大的或甚至更大的密度的
Figure BPA00001259627700155
材料或类似材料。材料的密度越大,对于指定的减压可产生的压缩力越大。如果带有比组织部位处的组织小的密度的泡沫被用作医学垫枕材料,则可产生举力(lifting force)。
垫枕材料可以是稍后被毡制成泡沫的原始厚度的大约1/3的厚度的网状泡沫。在许多可能的材料之中,下述的可被使用:
Figure BPA00001259627700156
材料或
Figure BPA00001259627700157
技术泡沫(www. foamex.com)。在一些实例中,在微焊工艺中将银离子添加到垫枕材料,或将其他物质诸如抗菌剂添加到垫枕材料,可能是可取的。垫枕材料可以是各向同性或各向异性的,取决于在减压期间所需要的指向力的精确的方向。垫枕材料可通过添加丝、毡制一部分、选择性地添加粘合剂等而被制成各向异性的。垫枕材料可以是生物可吸收的材料。
密封子系统560包括密封构件562,或披盖物,其类似于密封构件72。密封构件562可以被连接到成形敷料垫枕532。例如,密封构件562和成形敷料垫枕532可使用诸如丙烯酸粘合剂、硅树脂粘合剂、水凝胶、水解胶体等粘合剂来连接。作为另一例子,密封构件562和成形敷料垫枕532可通过热结合、超声结合、和射频结合等而被结合。可图案式地或完全地进行连接。结构可被添加到结合部以使密封构件562在期望的方向上表现各向异性,即构成各向异性的披盖物材料。各向异性披盖物材料有助于敷料组件530主要在指定方向上移动,即仅环绕确定的轴。
在图8的例证性实施方式中,密封构件562可依尺寸制作以延伸超出成形敷料垫枕532,例如超出在末端533上的边缘538,以形成披盖物外延564或外延。披盖物外延564具有第一表面566和面向内的第二表面568。密封构件562可使用密封装置569而相对于患者的表皮514被密封,其有助于提供密封并允许由治疗部位处的减压子系统580来维持减压。密封装置569可采用许多形式,诸如粘合剂570;密封带、或披盖物带或条;双面披盖物带;糊剂;水解胶体;水凝胶;或其他密封设备。如果带被使用,则其可由与带有预施加的、压敏粘合剂的密封构件562相同的材料形成。压敏粘合剂570可应用在披盖物外延564的面向内的第二表面568上。压敏粘合剂570提供在密封构件562和患者的表皮514之间的密封。在密封构件562被固定到患者之前,压敏粘合剂570可具有覆盖压敏粘合剂570的可移动的条或背板。
减压子系统580包括减压源582或治疗单元,其可采用许多不同的形式。减压源582作为透明的伤口治疗系统510的一部分提供减压。减压源582可以是用于供应减压的任何设备,诸如真空泵、壁式吸入装置、或其他源。尽管施加到组织的减压的量和性质一般地将根据应用而改变,但是减压一般将在-5mm Hg和-500mm Hg之间且更典型地在-100mm Hg和-300mm Hg之间。为了最大化患者的灵活性和舒适,减压源582可以是电池供电的、单一使用的减压发生器,其使在手术室中的应用便利并且为在复原阶段期间的患者提供灵活性和方便。
在图8的例证性实施方式中,示出具有电池箱584和容器区域586的减压源582,容器区域586带有在容器区域586内提供流体的水平的可视指示的窗口588。放入的隔膜过滤器,诸如疏水的或疏油的过滤器,可被散置在减压输送导管或管道590和减压源582之间。
由减压源582产生的减压通过减压输送导管590输送到减压接驳体592,减压接驳体592可以是弯管端口594。在一个例证性实施方式中,弯管端口594是从德克萨斯州的圣安东尼奥的KCI可获得的
Figure BPA00001259627700161
技术端口。减压接驳体592允许减压被输送到密封子系统560并在密封子系统560的内部部分内实现。在该例证性实施方式中,弯管端口594延伸通过密封构件562并进入成形敷料垫枕532中。
在操作中,透明的伤口治疗系统510被应用于线形伤口512。透明的伤口治疗系统510可在对患者进行手术过程之后在手术室中被应用于线形伤口512。成形敷料垫枕532的面向内的第二表面536被放置成贴着患者的表皮514,使成形敷料垫枕532在受损的皮下组织部位520之上并使成形敷料垫枕532的一部分在线形伤口512之上。敷料组件530可被依尺寸制作,用于在由卫生保健提供者执行的过程中涉及的一般应用。敷料组件530可被依尺寸制作、形成并配置为对不同的解剖学应用,诸如腹部、胸部、臂、大腿等,起作用。
如果密封构件562还没有被连接,那么密封构件562被放置在成形敷料垫枕532的第一侧面534之上,使一部分延伸超出成形敷料垫枕532以形成披盖物外延564。然后,披盖物外延564可以向下用带粘贴或使用粘合剂570在密封构件562和患者的表皮514之间形成密封。密封仅需要足以允许透明的伤口治疗系统510在所需治疗区域上保持减压。减压接驳体592和减压源582使用减压输送导管590流体地连接。然后,减压源582可被激活并且将减压输送到成形敷料垫枕532。
当成形敷料垫枕532处的压力被减小时,成形敷料垫枕532压缩并横向收缩,并且形成半刚性基质,并且大量有利的力和动作可发生。减压进一步地仍通过成形敷料垫枕532被传输,以使减压被输送到线形伤口512。至少在愈合过程的早期阶段,减压还可通过线形伤口512并进入到皮下组织部位520中被实现。像这样,减压可帮助闭合诸如皮下空隙522的缺损,并且通常对区域提供稳定性。输送到成形敷料垫枕532的减压还产生可再次提供稳定性和治疗的压缩力524。压缩力524不只是在表皮514顶部处。压缩力524向下延伸较深并可在皮下组织部位520的水平处被感受。压缩力可帮助闭合缺损并提供稳定性。
在手术室中应用透明的伤口治疗系统510并允许透明的伤口治疗系统510保持在患者身上直到已经进行充分的愈合,这可能是可取的。在这点上,可能是可取的是,由透明材料形成密封构件562、成形敷料垫枕532和任何其他层以允许卫生保健提供者得到关于线形伤口512和受损的皮下组织部位520的愈合的可视提示,而没有必要除去敷料组件530。
根据一个例证性实施方式,用于与减压系统一起使用来治疗患者身上的线形伤口的透明敷料组件包括:用于当在减压之下时提供闭合力的闭合敷料垫枕和用于覆盖闭合敷料垫枕并在闭合敷料垫枕之上提供密封的密封构件。闭合敷料垫枕和密封构件由足以允许从透明敷料组件外部的一点感知颜色的透明材料形成。闭合敷料垫枕可包括顶壁和底壁。顶壁和底壁以隔开关系被连接。底壁包括中心部分、第一侧部和第二侧部。第一闭合构件形成在第一侧部上,并且第二闭合构件形成在第二侧部上。当被置于减压之下时,第一闭合构件和第二闭合构件朝向彼此移动。
根据一个例证性实施方式,利用减压治疗患者身上的伤口且允许在治疗期间可视地观察伤口的系统包括用于在伤口之上放置在患者的表皮的一部分上的敷料垫枕。敷料垫枕由透明材料形成。系统还包括用于在闭合垫枕和患者的表皮之上提供密封的密封子系统和用于将减压输送到密封子系统的减压子系统。密封子系统和减压子系统是可操作的以将减压输送到敷料垫枕。敷料垫枕、密封子系统和减压子系统是可操作的以产生指向力并将减压输送到伤口。密封子系统包括透明的密封构件。敷料垫枕和密封子系统是可操作的以允许光通过,以使伤口的颜色的深浅可从系统外部的一位置被感知。敷料垫枕具有第一表面、面向内的第二表面,并且包括形成敷料垫枕的一部分的倾斜末端。敷料垫枕由具有密度大于20kg/m3的医学垫枕材料形成。敷料垫枕具有当在减压之下时均匀地分配指向力的特征。
尽管本发明及其优点已经在某些例证性的、非限制的实施方式的背景下被公开,但是应当理解的是,能够作出各种变化、代替、置换和改变而没有脱离如由所附的权利要求所限定的本发明的范围。将意识到的是,连同任何一个实施方式描述的任何特征也可以被应用于任何其他实施方式。

Claims (25)

1.一种透明敷料组件,其与减压系统一起使用来治疗患者身上的线形伤口,所述透明敷料组件包括:
闭合敷料垫枕,其用于当在减压之下时提供闭合力,所述闭合敷料垫枕包括:
顶壁,
底壁,所述顶壁和所述底壁以隔开关系连接,所述底壁具有中心部分、第一侧部和第二侧部,
第一闭合构件,其形成在所述第一侧部上,以及
第二闭合构件,其形成在所述第二侧部上;
密封构件,其用于覆盖所述闭合敷料垫枕并在所述闭合敷料垫枕之上提供密封;并且
其中,所述闭合敷料垫枕和所述密封构件由足以允许从所述透明敷料组件外部的一点感知颜色的透明材料形成。
2.如权利要求1所述的透明敷料组件,其中,所述第一闭合构件和所述第二闭合构件是可操作的以在减压之下朝向彼此移动。
3.如权利要求1所述的透明敷料组件,其中,所述密封构件包括由透明弹性材料制成的密封构件。
4.如权利要求1所述的透明敷料组件,其中,所述闭合敷料垫枕包括透明硅树脂。
5.如权利要求1所述的透明敷料组件,其中,所述密封构件包括由透明弹性材料制成的密封构件,并且所述闭合敷料垫枕由透明硅树脂形成。
6.一种用于治疗患者身上的伤口的系统,其利用减压治疗患者身上的伤口且允许在治疗期间可视地观察伤口,所述系统包括:
敷料垫枕,其用于在所述伤口之上放置在患者的表皮的一部分上,所述敷料垫枕由透明材料形成;
密封子系统,其用于在所述闭合垫枕和患者的表皮之上提供密封;
减压子系统,其用于将减压输送到所述密封子系统;
其中,所述密封子系统和所述减压子系统是可操作的以将减压输送到所述敷料垫枕;
其中,所述敷料垫枕、所述密封子系统和所述减压子系统是可操作的以产生指向力并将减压输送到所述伤口;
其中,所述密封子系统包括透明密封构件;并且
其中,所述敷料垫枕和所述密封子系统是可操作的以允许光通过,以使所述伤口的颜色的深浅能够从所述系统外部的一位置被感知。
7.如权利要求6所述的系统,其中,所述敷料垫枕包括:
顶壁,
底壁,所述顶壁和所述底壁以隔开关系连接,所述底壁具有中心部分、第一侧部和第二侧部,
第一闭合构件,其形成在所述第一侧部上,以及
第二闭合构件,其形成在所述第二侧部上。
8.如权利要求6所述的系统,其中,所述敷料垫枕具有第一表面、面向内的第二表面,并包括:
倾斜末端,其形成所述敷料垫枕的一部分;
其中,所述敷料垫枕由医学垫枕材料形成;
其中,所述医学垫枕材料具有大于20kg/m3的密度;并且
其中,所述敷料垫枕具有当在减压之下时均匀分布指向力的特征。
9.如权利要求6所述的系统,其中,所述密封子系统包括由至少部分透明的弹性材料制成的密封构件。
10.如权利要求6所述的系统,其中,所述敷料垫枕由硅树脂形成,并且所述密封子系统包括由透明弹性材料制成的密封构件。
11.如权利要求6所述的系统,还包括:硅树脂窗口构件,所述硅树脂窗口构件被布置在所述敷料垫枕上并在减压之下可操作以提高对所述伤口的颜色的感知。
12.一种制造透明敷料组件的方法,包括以下步骤:
形成垫枕,所述垫枕用于当在减压之下时向伤口治疗区域提供指向力;
提供密封构件,以覆盖所述垫枕,所述密封构件由透明材料形成,并且允许当应用时在所述垫枕和患者的表皮之上的密封;并且
其中,形成垫枕的步骤包括:由透明材料形成垫枕。
13.如权利要求12所述的方法,其中,形成垫枕的步骤包括:由透明硅树脂形成垫枕。
14.如权利要求12所述的方法,其中,形成垫枕的步骤包括:挤压出垫枕。
15.如权利要求12所述的方法,其中,形成垫枕的步骤包括:模制垫枕。
16.一种与在患者身上的减压治疗系统一起使用的敷料组件,所述敷料组件包括:
垫枕,其用于放置在患者身上的伤口之上并用于提供指向力;
密封构件,其用于覆盖所述垫枕并在所述垫枕和患者的表皮之上提供密封;以及
可视检查设备,其用于从所述敷料组件外部的一位置可视地检测患者身上的伤口的颜色。
17.如权利要求16所述的敷料组件,其中,所述可视检查设备包括形成所述密封构件所使用的透明材料,并且所述垫枕包括透明材料。
18.如权利要求16所述的敷料组件,其中,所述可视检查设备包括具有结构元件的垫枕材料,所述结构元件间隔分开的宽度足以允许通过所述垫枕材料和透明密封构件感知颜色。
19.如权利要求16所述的敷料组件,其中,所述可视检查设备包括具有结构元件的垫枕材料,所述结构元件间隔分开的宽度足以允许通过所述垫枕材料和透明密封构件感知颜色;并且其中,所述垫枕材料包括透明泡沫。
20.如权利要求16所述的敷料组件,其中,所述可视检查设备包括具有结构元件的垫枕材料,所述结构元件间隔分开的宽度足以允许通过所述垫枕材料和透明密封构件感知颜色;并且其中,所述垫枕材料包括垫枕网状物。
21.如权利要求16所述的敷料组件,其中,所述可视检查设备包括垫枕材料,并且还包括布置在所述垫枕材料上的垫枕窗口,以使当所述垫枕窗口通过减压而压紧所述垫枕材料时,能通过所述垫枕材料和所述垫枕窗口检测颜色。
22.如权利要求16所述的敷料组件,其中,所述密封构件包括透明弹性材料。
23.如权利要求16所述的敷料组件,其中,所述垫枕包括硅树脂,并且所述密封构件包括透明弹性材料。
24.一种用于处理患者身上的线形伤口的方法,所述方法包括以下步骤:
在所述线形伤口之上和患者的表皮顶部上部置透明敷料组件;
在所述透明敷料组件和患者的表皮的一部分之上部置透明密封构件以形成流体密封;
向所述透明敷料组件提供减压,借此产生指向力;以及
通过所述透明敷料组件和所述透明密封构件可视地观察所述线形伤口。
25.如权利要求24所述的方法,其中,所述透明垫枕包括由透明硅树脂形成的垫枕。
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CN103747814B (zh) * 2011-08-31 2017-11-28 凯希特许有限公司 减压治疗与清创系统以及方法
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