CN103585682A - 用于在乳房组织上使用的减压压缩系统和装置 - Google Patents

用于在乳房组织上使用的减压压缩系统和装置 Download PDF

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CN103585682A
CN103585682A CN201310466785.7A CN201310466785A CN103585682A CN 103585682 A CN103585682 A CN 103585682A CN 201310466785 A CN201310466785 A CN 201310466785A CN 103585682 A CN103585682 A CN 103585682A
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dressing
decompression
bolster
breast
dressing bolster
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CN103585682B (zh
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罗伯特·佩顿·威尔克斯
贾斯汀·亚历山大·龙恩
小理查德·马文·卡扎拉
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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

一种系统使用减压来向人的乳房区域提供治疗力。该系统包括成形并配置为被放置在乳房区域上的敷料组件(2)、用于保持敷料组件靠着乳房区域的至少一部分的可释放环形连接器、以及用于在靠着人的表皮的敷料组件之上提供流体密封的密封子系统。系统包括用于向敷料组件提供减压的减压子系统。当减压被提供时,系统产生逆着人的乳房区域的至少一部分的力。敷料组件可被形成为具有由垫枕材料形成的第一罩杯和第二罩杯的胸罩。

Description

用于在乳房组织上使用的减压压缩系统和装置
本申请是申请日为2009年5月29日,申请号为200980118521.4,发明名称为“用于在乳房组织上使用的减压压缩系统和装置”的申请的分案申请。
相关申请
根据美国法典第35卷第119条(e)款,本发明要求下列申请的汇集的利益:于2008年5月30日提交的题为“Reduced-pressure Surgical WoundTreatment System”的美国临时专利申请序列号61/057,807;于2008年5月30日提交的题为“Dressing Assembly For Subcutaneous Wound treatmentUsing Reduce Pressure”的美国临时专利申请序列号61/057,798;于2008年5月30日提交的题为“See-Through,Reduced-Pressure Dressing”的美国临时专利申请序列号61/057,808;于2008年5月30日提交的题为“Reduced-Pressure Dressing Assembly For Use in Applying a Closing Force”的美国临时专利申请序列号61/057,802;于2008年5月30日提交的题为“Reduced-Pressure,Linear-Wound Treatment System”的美国临时专利申请序列号61/057,803;于2008年5月30日提交的题为“Reduced-Pressure,Compression System and Apparatus for use on a Curved Body Part”的美国临时专利申请序列号61/057,800;于2008年5月30日提交的题为“Reduced-Pressure,Compression System and Apparatus for use on BreastTissue”的美国临时专利申请序列号61/057,797;于2008年5月30日提交的题为“Super-Absorbent,Reduced-Pressure Wound Dressing and System”的美国临时专利申请序列号61/057,805;于2008年5月30日提交的题为“Reduced-Pressure,Compression System and Apparatus for use on a Joint”的美国临时专利申请序列号61/057,810;于2008年12月10日提交的题为“Reduced-Pressure Wound treatment System Employing an AnisotropicDrape”的美国临时专利申请序列号61/121,362;以及于2009年1月12日提交的题为“Reduced-Pressure,Compression System and Apparatus for useon a Joint”的美国临时专利申请序列号61/144,067。为了全部目的,所有这些临时申请在此通过引用被并入。
技术领域
本发明通常涉及医疗系统,并且更特别地涉及减压伤口治疗系统。
背景
在世界各地医生每年执行数百万的手术过程。许多过程作为开放性手术被执行,并且越来越多的过程使用微创手术被执行,例如内窥镜检查、关节镜检查和腹腔镜检查过程。作为一个例子,美国美学整形外科学会报道,2007年在美国有多于450,000例的吸脂术过程。
手术过程涉及在皮肤和相关组织中的明显伤口,例如切口。在许多实例中,在过程结束时使用诸如U形钉或缝合线的机械装置闭合切口,或者使用粘合剂闭合。此后,伤口经常仅用干燥的消过毒的绷带覆盖。当然,通常不只在表皮处有破裂。
使用许多手术过程,特别是那些用微创技术完成的过程,大量破裂或损伤是在表皮下面或在皮下水平处。再次作为一个例子,在一种类型的吸脂术过程中,在采用肿胀液(盐水、轻微镇痛剂和肾上腺素)之后,外科医生将使用套管针和有吸力的套管以除去脂肪区域。在这样做时,在远离切口(通过其放置套管)或其他切口(通过其放置设备)的组织部位处形成皮下空隙和其他组织缺损是普遍的。损伤的组织将需要时间和照顾来治愈,并且引起大量潜在的并发症和风险,列举一些,包括浮肿、血清肿、血肿、进一步的瘀伤和瘀斑。
简要概述
根据例证性实施方式,一种用于向人的乳房区域提供力的系统包括成形并配置为被放置在乳房区域上的敷料组件。敷料组件包括敷料垫枕。系统还包括用于保持敷料组件靠着乳房区域的至少一部分的可释放环形连接器和用于在敷料组件上和靠着人的表皮提供流体密封的密封子系统。系统还包括用于向敷料组件提供减压的减压子系统。在减压下,系统是可操作的以产生逆着人的乳房区域的至少一部分的力。
根据另一例证性实施方式,一种用于向人的乳房组织提供治疗支撑的减压系统包括用于放置在人的躯干上的敷料组件,其中敷料组件的至少一部分用于接近乳房组织而放置。敷料组件包括敷料垫枕和内部表面构件。系统还包括用于保持敷料组件靠着躯干的至少一部分的可释放环形连接器。系统还包括用于在靠着人的敷料组件之上提供流体密封的密封子系统和用于向敷料组件提供减压的减压子系统。敷料组件、密封子系统和减压子系统在减压下是可操作的以向乳房组织提供支撑力并将减压输送到乳房组织以除去任何流体,例如渗出液。
根据例证性实施方式,一种减压治疗胸罩包括具有敷料垫枕的、用于放置在躯干上的、带有接近乳房组织的至少一部分的胸罩敷料组件、第一乳房罩杯和第二乳房罩杯。第一乳房罩杯形成为敷料垫枕的一部分并和第一袋状物一起形成。第一袋状物被依尺寸制造并配置为接纳乳房组织。第二乳房罩杯形成为敷料垫枕的一部分并和第二袋状物一起形成。第二袋状物被依尺寸制造并配置为接纳乳房组织。治疗胸罩还可包括用于保持敷料组件靠着躯干的至少一部分的可释放环形连接器和用于在胸罩和佩戴者的表皮之上提供流体密封的密封构件。治疗胸罩可具有用于接收减压并将减压输送到敷料垫枕的减压接驳体(reduced-pressure interface)。治疗胸罩在减压下是可操作的以向乳房组织提供力。
根据另一例证性实施方式,一种制造减压治疗胸罩的方法包括步骤:形成具有敷料垫枕的、用于放置在躯干上的、带有接近乳房组织的至少一部分的胸罩敷料组件;形成第一乳房罩杯和第二乳房罩杯。第一乳房罩杯形成为敷料垫枕的一部分并形成有第一袋状物。第一袋状物被依尺寸制造并配置为接纳乳房组织。第二乳房罩杯形成为敷料垫枕的一部分并形成有第二袋状物。第二袋状物被依尺寸制造并配置为接纳乳房组织。制造的方法还包括提供用于保持胸罩敷料组件靠着躯干的至少一部分的可释放环形连接器;以及将密封构件连接到胸罩敷料组件。密封构件在胸罩和人的表皮上提供流体密封。制造的方法还包括形成用于接收减压并将减压输送到胸罩敷料组件的减压接驳体的步骤。
在本发明的一个方面,提供了一种用于向人的乳房区域提供力的系统,所述系统包括:敷料组件,其成形并配置为被放置在乳房区域上,并且其中所述敷料组件包括:敷料垫枕,其依尺寸制造并配置为在人的躯干的至少一部分周围环绕地延伸,并且依尺寸制造并配置为被放置在人的乳房区域的至少一部分上,所述敷料垫枕具有第一表面和面向内的第二表面,以及内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面连接到所述敷料垫枕的面向内的第二表面;可释放环形连接器,其用于保持所述敷料组件靠着所述乳房区域的至少一部分;密封子系统,其用于对所述敷料组件和人的表皮的一部分提供流体密封;以及减压子系统,其用于向所述敷料组件提供减压,借此所述系统可操作来对人的所述乳房区域的至少一部分产生力。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件还可包括:第一乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的一部分之上延伸;以及第二乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的另一部分之上延伸。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件还可包括具有第一表面和面向内的第二表面的外部表面构件,其中所述外部表面构件的面向内的第二表面被布置成靠着所述敷料垫枕的第一表面;以及所述内部表面构件和所述外部表面构件可连接以在所述敷料垫枕之上形成流体密封,并且其中所连接的内部表面构件和外部表面构件包括所述密封子系统。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件可包括:第一乳房罩杯,其形成为所述敷料垫枕的一部分,并且形成有第一袋状物,所述第一袋状物依尺寸制造并配置成接纳乳房组织;以及第二乳房罩杯,其形成为所述敷料垫枕的一部分,并且形成有第二袋状物,所述第二袋状物依尺寸制造并配置为接纳乳房组织。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件可包括:第一乳房罩杯,其形成为所述敷料垫枕的一部分,并且形成有第一袋状物,所述第一袋状物依尺寸制造并配置为覆盖人的胸部的一部分。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料垫枕可包括各向异性垫枕材料。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料垫枕可包括各向异性垫枕材料并具有第一轴、第二轴和第三轴,并且其中压缩模数在所述第一轴、所述第二轴和所述第三轴的至少两个之间可不同。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件可包括:内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面连接到所述敷料垫枕的面向内的第二表面;以及其中所述内部表面构件包括弹性材料。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件可包括:内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面连接到所述敷料垫枕的面向内的第二表面;以及其中所述内部表面构件包括弹力纤维。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件可包括:内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面连接到所述敷料垫枕的面向内的第二表面;第一乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的一部分之上延伸;第二乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的另一部分之上延伸;外部表面构件,其具有第一表面和面向内的第二表面,所述外部表面构件的第一表面被布置成接近所述敷料垫枕的面向内的第二表面;以及其中所述外部表面构件包括弹力纤维。
在本发明的用于向人的乳房区域提供力的系统中,所述敷料组件可包括:内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面被布置成接近于所述敷料垫枕的面向内的第二表面;第一乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的一部分之上延伸;第二乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的另一部分之上延伸;外部表面构件,其具有第一表面和面向内的第二表面,所述外部表面构件的第一表面被布置成接近所述敷料垫枕的面向内的第二表面;以及其中所述外部表面构件包括弹力纤维。
在本发明的另一个方面,提供了一种用于向人的乳房组织提供治疗支撑的减压系统,所述系统包括:敷料组件,其用于放置在人的躯干上,其中所述敷料组件的至少一部分依尺寸制造并配置为接近所述乳房组织而放置,所述敷料组件包括敷料垫枕和内部表面构件;其中所述敷料组件包括具有第一端和第二端的纵向部分;可释放环形连接器,其连接到所述第一端和所述第二端,用于将所述第一端和所述第二端可释放地连接在一起;密封子系统,其用于在靠着人的所述敷料组件之上提供流体密封;减压子系统,其用于向所述敷料组件提供减压;以及其中所述敷料组件、所述密封子系统和所述减压子系统是可操作的以向所述乳房组织提供支撑力并将减压输送到所述乳房组织。
在本发明的用于向人的乳房组织提供治疗支撑的减压系统中,所述内部表面构件可包括弹性材料。
在本发明的用于向人的乳房组织提供治疗支撑的减压系统中,所述内部表面构件可包括弹力纤维。
本发明的用于向人的乳房组织提供治疗支撑的减压系统还可包括外部表面构件,并且其中所述外部表面构件包括弹性材料。
本发明的用于向人的乳房组织提供治疗支撑的减压系统还可包括外部表面构件,并且其中所述外部表面构件包括弹力纤维。
本发明的用于向人的乳房组织提供治疗支撑的减压系统还可包括外部表面构件,并且其中所述内部表面构件和所述外部表面构件被连接以密封所述敷料垫枕,并且其中所述内部表面构件和所述外部表面构件包括所述密封子系统。
在本发明的另一个方面,提供了一种减压治疗胸罩,包括:胸罩敷料组件,其包括:敷料垫枕,其用于放置在躯干上且至少一部分接近乳房组织,第一乳房罩杯,其形成为所述敷料垫枕的一部分并形成有第一袋状物,所述第一袋状物依尺寸制造并配置为接纳乳房组织,以及第二乳房罩杯,其形成为所述敷料垫枕的一部分并形成有第二袋状物,所述第二袋状物依尺寸制造并配置为接纳乳房组织;可释放环形连接器,其用于在使用期间保持所述胸罩敷料组件靠着躯干;密封构件,其用于对所述胸罩和穿戴者的表皮提供流体密封;减压接驳体,其用于接收减压并将减压输送到所述胸罩敷料组件;以及其中所述胸罩敷料组件在减压下是可操作的以向所述乳房组织提供支撑力。
在本发明的减压治疗胸罩中,所述胸罩敷料组件可具有第一表面和面向内的第二表面,并且所述减压治疗胸罩还可包括:内部表面构件,其具有依尺寸制造以在期望的支撑区域之上延伸的第一表面和面向内的第二表面;以及外部表面构件,其具有第一表面和面向内的第二表面,其中所述外部表面构件的第二表面被布置成靠着所述敷料垫枕的第一表面。
在本发明的减压治疗胸罩中,所述敷料垫枕可包括各向异性材料。
在本发明的减压治疗胸罩中,所述胸罩敷料组件可具有第一表面和面向内的第二表面,并且还可包括:内部表面构件,其具有依尺寸制造以在期望的支撑区域之上延伸的第一表面和面向内的第二表面;外部表面构件,其具有第一表面和面向内的第二表面,其中所述外部表面构件的第二表面被布置成靠着所述敷料垫枕的第一表面;以及其中所述内部表面构件包括弹性材料。
在本发明的减压治疗胸罩中,所述胸罩敷料组件可具有第一表面和面向内的第二表面,并且还可包括:内部表面构件,其具有第一表面和面向内的第二表面;外部表面构件,其具有第一表面和面向内的第二表面,其中所述外部表面构件的面向内的第二表面被布置成靠着所述敷料垫枕的第一表面;以及其中所述内部表面构件包括弹力纤维。
在本发明的减压治疗胸罩中,所述胸罩敷料组件可具有第一表面和面向内的第二表面,并且所述减压治疗胸罩还可包括:内部表面构件,其具有依尺寸制造以在期望的支撑区域之上延伸的第一表面和面向内的第二表面;外部表面构件,其具有第一表面和面向内的第二表面,其中所述外部表面构件的第二表面被布置成靠着所述敷料垫枕的第一表面;以及其中所述外部表面构件包括弹性材料。
在本发明的减压治疗胸罩中,所述胸罩敷料组件可具有第一表面和面向内的第二表面,并且还包括:内部表面构件,其具有依尺寸制造以在期望的支撑区域之上延伸的第一表面和面向内的第二表面;外部表面构件,其具有第一表面和面向内的第二表面,其中所述外部表面构件的第二表面被布置成靠着所述敷料垫枕的第一表面;以及其中所述外部表面构件包括弹力纤维。
在本发明的另一个方面,提供了一种制造减压治疗胸罩的方法,包括:形成胸罩敷料组件,所述胸罩敷料组件具有敷料垫枕,所述敷料垫枕用于放置在躯干上且至少一部分接近乳房组织;形成第一乳房罩杯,所述第一乳房罩杯形成为所述敷料垫枕的一部分并形成有第一袋状物,所述第一袋状物依尺寸制造并配置为接纳乳房组织;形成第二乳房罩杯,所述第二乳房罩杯形成为所述敷料垫枕的一部分并形成有第二袋状物,所述第二袋状物依尺寸制造并配置为接纳乳房组织;提供用于保持所述胸罩靠着穿戴者的躯干的可释放环形连接器;将密封构件连接到所述敷料垫枕,所述密封构件用于对所述胸罩和穿戴者的表皮的一部分提供流体密封;以及形成用于接收减压并将减压输送到所述胸罩的减压接驳体。
在本发明的另一个方面,提供了一种用减压处理乳房组织的方法,所述方法包括以下步骤:接近所述乳房组织部置敷料组件;将所述敷料组件连接到患者的躯干;在所述乳房组织之上密封所述敷料组件;以及向所述敷料组件的敷料垫枕提供减压。
在本发明的用减压处理乳房组织的方法中,所述敷料组件可包括:敷料垫枕,其依尺寸制造并配置为在人的躯干的至少一部分周围环绕地延伸,并且依尺寸制造并配置为被放置在人的乳房区域的至少一部分上,所述垫枕具有第一表面和面向内的第二表面;以及内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面连接到所述敷料垫枕的面向内的第二表面。
在本发明的用减压处理乳房组织的方法中,所述敷料组件包括第一隔间和第二隔间,并且其中提供减压的所述步骤包括向所述第一隔间提供第一减压以及向所述第二隔间提供第二减压。
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。
附图的简要说明
当结合附图理解时,本发明的更加完全的理解可通过参考下述的详细描述来获得,其中:
图1是被示为在患者的躯干上的减压系统的例证性实施方式的一部分的示意性透视图;
图2是被示为在切口之上且在损伤的皮下组织的上方的减压系统的例证性实施方式的、一部分在横截面中的示意性透视图;
图3是被示为在完好的皮肤上且在损伤的皮下组织的区域之上的减压系统的例证性实施方式的一部分的横截面;
图4是被示为应用在患者的躯干上的减压系统的例证性实施方式的一部分的示意性横截面;
图5是被示为应用在患者的躯干上的减压系统的例证性实施方式的一部分的示意性横截面;
图6是被示为在躯干上的减压系统的例证性实施方式的一部分的前部示意性透视图;
图7是在图6中所示的例证性系统的一部分的后部示意性透视图;
图8是减压压缩系统的例证性实施方式的一部分的示意性横截面;
图9是显示垫枕材料的示意性透视图;
图10是用于向乳房组织提供支撑的胸罩的例证性实施方式的前部示意性透视图;
图11是从一侧截取的图10的胸罩的横截面;
图12是图10-11的胸罩的前部示意性透视图,胸罩的一部分被释放以显示胸罩的背部部分;
图13是图10-12的胸罩的一部分的示意性横截面;以及
图14是显示例证性的可选方面的图10-12的胸罩的一部分的示意性横截面。
详细描述
在下述的例证性实施方式的详细描述中,对于形成本文中的一部分的、并且作为例子在其中示出可实践本发明的具体实施方式的附图作出参考。这些实施方式足够详细地被描述以使本领域技术人员能够实践本发明,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践本发明所不必要的细节,描述可省略对于本领域技术人员已知的某些信息。因此,下述的详细描述不应在限制的意义上被理解,且本发明的范围仅由附加的权利要求来限定。
参考图1,示出用于向在患者的躯干4上的期望治疗区域3提供力的系统2。系统2可被应用于患者的身体的指定部分希望得到支撑的任何情况中,患者的身体的指定部分是例如躯干、臂、腿或其他弯曲的身体部分,但在躯干4的背景下被描述。当为了治疗原因需要力时,例如向期望治疗区域提供压缩力或内向力以及提升力或向上的力同时可选地除去诸如渗出液的流体时,系统2可被应用。系统2可被应用于治疗皮下组织、治疗表面组织或提供支撑。除非另外指出,如在此使用的,“或”不需要相互排他性。当完全为了美容原因或任一原因需要支撑时系统2可被简单地应用。
系统2允许支撑相对容易地被提供到人体的一部分,并且系统2允许不同尺寸的身体部分被单个系统或装置适应,从而减少对大量存货的需要。当用于伤口时,该系统2可保持伤口干燥、减少死区形成、改进灌注、减少血清肿和血肿形成、以及减少对于某些手术过程继发的瘀伤和浮肿。系统2还为使用该系统2的患者或人提供相当的舒适。由系统2逐渐形成的力可通过改变输送到系统2的减压来改变,并且反馈回路可用于允许减压的自动调节,以甚至在肿胀增加或减少时也将期望压缩力维持在治疗部位上。
现在参考图2,显示根据一个例证性实施方式的例证性系统10,其用于治疗在切口周围区域中的损伤的皮下组织。在环绕切口12的切口周围区域中示出系统10,切口12通过表皮14或皮肤以及真皮16并到达下皮或皮下组织18中。皮下组织18可包括许多组织类型,例如脂肪组织或肌肉。示出损伤的皮下组织部位20从切口12延伸并在这种情况下包括皮下缺损或空隙22。损伤的皮下组织20经常由诸如吸脂术的手术过程引起。损伤的皮下组织20可包括空隙例如空隙22、开放空间和各种缺损,由于许多原因这些缺损可能是麻烦的。例如,空隙22可允许流体产生且可导致浮肿。如在此使用的术语“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。
切口12可使用任何闭合设备例如U形钉、缝合线或粘合剂来闭合,但在该例证性实施方式中被示为用缝合线13。系统10一般用于治疗一区域且特别是一般用于治疗皮下组织部位20和环绕皮下组织20的组织,但是系统10也可被用于治疗切口12的更有限的区域。
系统10包括敷料组件30,其包括成形敷料垫枕32(或敷料垫枕)、密封子系统60和减压子系统80。系统10产生由参考数字24表示的在皮下组织20处实现的净压缩力。如下面进一步描述的,成形敷料垫枕32可被成形并配置为允许压缩力24相当均匀地分布在患者的表皮14上和表皮14之下。否则,如果与其他区域相比存在实际上增加力的区域,那么可能导致皮肤刺激。系统10还可以是可操作的以产生内向力(或闭合力),即,朝着敷料组件30的内部部分。内向力由参考数字26表示。内向力26可实质上保持在表皮14的平面内。换句话说,内向力26主要在表皮14内起作用。另外,系统10是可操作的以将减压输送到切口12。减压可在皮下空隙22的水平处被实现以帮助使在该区域中的组织靠近——集中在一起——以及帮助除去任何空气或任何其他流体,例如渗出液。
敷料组件30包括成形敷料垫枕32,其具有第一侧面34和向内(面向组织)的第二侧面36。尽管较大或较小的尺寸可被使用,但是成形敷料垫枕32可依尺寸制造并成形以实质上匹配损伤的皮下组织20的估计区域。成形敷料垫枕32具有外围边缘38。成形敷料垫枕32可由许多不同的垫枕材料制成。在一例证性实施方式中,成形敷料垫枕32由多孔和渗透性的泡沫状材料以及更特别地由当在减压之下允许伤口流体的良好渗透性的网状、开孔(open-cell)聚氨脂或聚醚泡沫制成。已经被使用的一种这样的泡沫材料是从德克萨斯州(Texas)圣安东尼奥(San Antonio)的KineticConcepts,Inc.(KCI)可获得的
Figure BDA0000392585470000121
材料。任何材料或材料的组合可被用于垫枕材料,假定垫枕材料是可操作的以分布减压并提供期望的力。
成形敷料垫枕32可以是一歧管,其被依尺寸制造并成形以均匀地分布力并且分布减压。如在此使用的术语“歧管”通常指的是被设置以帮助将减压施加到组织部分、将流体输送到组织部位或从组织部位除去流体的物体或结构。歧管一般包括多个流动通路或路径,其被相互连接以改进向歧管周围的组织部位提供的和从歧管周围的组织部位除去的流体的分布。歧管可以是能够与组织部位接触而放置并将减压分布到组织部位的生物相容材料。例如,歧管的例子可没有限制地包括具有布置为形成流动通路的结构元件的设备,例如,多孔泡沫、开孔泡沫、多孔组织聚积物、液体、凝胶、以及包括或固化成包括流动通路的泡沫。歧管可以是多孔的并可由泡沫、纱布、毡垫或任何其他适合于特定生物学应用的材料制成。其他实施方式可包括“闭孔(close cell)”。在一些情况下,歧管还可被用于将流体例如药物、抗菌药、生长因子及不同的溶液分布到组织部位。其他层可被包括在歧管中或上,例如吸收性材料、芯吸材料、疏水材料和亲水材料。
在从大约400至600微米的范围内的
Figure BDA0000392585470000122
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。医疗垫枕材料例如材料的密度一般在大约1.3lb/ft3-1.6lb/ft3(20.8kg/m3-25.6kg/m3)的范围内。在一些情况下,具有比
Figure BDA0000392585470000124
材料密度高(小孔尺寸较小)的材料可能是合乎需要的。例如,可使用具有比1.6lb/ft3(25.6kg/m3)大的密度的
Figure BDA0000392585470000131
材料或类似材料。作为另一例子,可使用具有比2.0lb/ft3(32kg/m3)或5.0lb/ft3(80.1kg/m3)大的或甚至更大的密度的
Figure BDA0000392585470000135
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就越大。如果具有比组织部位处的组织小的密度的泡沫被用作医疗垫枕材料,则可产生提升力。在一例证性实施方式中,敷料组件的一部分例如边缘可施加压缩力,而另一部分例如中心部分可提供提升力。
垫枕材料可以是稍后被粘结到泡沫的原始厚度的大约三分之一(1/3)的厚度的网状泡沫。在许多可能的垫枕材料之中,下述材料可被使用:材料或工业泡沫(www.foamex.com)。在一些实例中,在微焊工艺中将银离子添加到泡沫或将其他物质如抗菌剂添加到垫枕材料可能是合乎需要的。垫枕材料可以是各向同性或各向异性的,取决于在减压的施加期间所需要的压缩力24的精确的方向。垫枕材料还可以是生物可吸收的材料。
密封子系统60包括上覆盖布(over-drape)62(盖布)或密封构件。上覆盖布62可以是弹性材料或者可以是提供流体密封的任何材料。“流体密封”或“密封”表示给定所涉及的特定减压子系统足以将减压保持在期望部位的密封。“弹性”表示具有弹性体的特性并且通常指的是具有类似橡胶的特性的聚合材料。更具体地,大多数弹性体具有大于100%的伸长率和相当大的回弹。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、丁苯橡胶、氯丁橡胶、聚丁二烯、丁腈橡胶、丁基橡胶、乙丙橡胶、三元乙丙单体、氯磺化聚乙烯、聚硫橡胶、聚氨酯、EVA薄膜、共聚酯以及硅树脂。作为非限制的例子,上覆盖布62可以由包括硅酮、
Figure BDA0000392585470000134
盖布材料例如来自Avery的一种可用的丙烯酸盖布材料、或切割盖布材料的材料形成。
上覆盖布62可以连接到垫枕32。该连接可以用许多方式发生。上覆盖布62和垫枕32可使用诸如丙烯酸酯粘合剂、硅酮粘合剂、水凝胶、水解胶体等粘合剂被连接。上覆盖布62和垫枕32可通过热粘合、超声焊接和射频粘接等被结合。连接可以按不连续的模式或更完全地发生。结构构件可被添加到结合物以使上覆盖布62在期望的方向上表现各向异性,即,产生各向异性的盖布材料。各向异性盖布材料帮助敷料组件30主要在指定方向上移动,即,仅环绕某个轴或某些轴。
在图2的例证性实施方式中,上覆盖布62可依尺寸制造以延伸出在成形敷料垫枕32的末端33上的外围边缘38,以形成盖布外延部分64。盖布外延部分64具有第一表面66和面向内的第二表面68。上覆盖布62可使用提供密封的密封装置或设备69靠着患者的表皮14被密封。上覆盖布62和密封装置69允许减压通过减压子系统80被维持在组织部位处。密封装置69可采用许多形式,例如粘合剂70;密封胶带、或盖布胶带或条;双面盖布胶带;糊剂;水解胶体;水凝胶;或其他密封工具。如果胶带被使用,它可由与带有预涂覆的压敏粘合剂的上覆盖布62相同的材料形成。压敏粘合剂70可应用在盖布外延部分64的第二表面68上。粘合剂70提供在上覆盖布62和患者的表皮14之间的大量流体密封。粘合剂70可具有覆盖粘合剂70的可移除的条,其在盖布外延部分64被应用于患者的表皮14之前被移除。
减压子系统80包括减压源82,其可采用许多不同的形式。减压源82作为系统10的一部分提供减压。减压源82可以是用于供应减压的任何设备,例如真空泵、壁式吸入装置或其他源。当施加到组织部位和成形敷料垫枕32的减压的数量和性质将一般根据应用改变时,减压一般将在-5mmHg和-500mm Hg之间且更一般地在-100mm Hg和-300mm Hg之间。
如在此使用的,“减压”通常指的是压力小于正在受到治疗的组织部位处的环境压力。在大多数情形下,该减压将小于患者处于的大气压力。可选地,减压可小于在组织部位处的流体静压。除非另外指出,在此规定的压力的值是表压。输送的减压可以是恒定的或变化的(一致的或随机的)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大于通常与完全真空相关联的压力。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。
为了最大化患者的灵活性和舒适,减压源82可以是电池供电的、单次使用的减压发生器。这样的减压源82便于在手术室中的应用并且在复原阶段期间为患者提供灵活性和方便。减压源82具有电池盒84和罐区域86,罐区域86带有在金属容器86内提供流体的水平的视觉指示的窗口88。放入的隔膜过滤器例如疏水的或疏油的过滤器可散置在减压输送导管或管道90和减压源82之间。
对于许多过程,认为患者将被指导佩戴系统10三到五天且可能被指导佩戴系统1015天或更多天。尽管如此,和使用传统压缩衣服(现今其在许多过程后被穿戴长至6周)的治疗相比,这个治疗时间是受欢迎的时间段。相应地,电池寿命和/或功率供应可能需要适应长达15天的操作。也可利用其他减压源,例如从德克萨斯州的圣安东尼奥的KCI可获得的V.A.C.
Figure BDA0000392585470000151
治疗单元,或者壁式吸入单元。减压源82还可由便携式机械设备提供,例如在管中的活塞,取决于使用成形敷料垫枕32和表皮14之间的流体密封有多少泄露。
由减压源82产生的减压通过减压输送导管90被输送到减压接驳体92,其可以是肘形口94。在一例证性实施方式中,口94是从德克萨斯州的圣安东尼奥的KCI可获得的工艺口。减压接驳体92允许减压被输送到密封子系统60并在密封子系统60的内部部分内实现。在该例证性实施方式中,口94通过上覆盖布62延伸并进入成形敷料垫枕32中。
在操作中,系统10可在对患者进行手术过程之后或在另一时间在手术室中被应用。成形敷料垫枕32的第二表面36靠着患者的表皮14被放置,成形敷料垫枕32在损伤的皮下组织部位20之上并且一部分在切口12之上。敷料组件30可被依尺寸制造,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30可被依尺寸制造、成形并配置为对不同的组织应用例如腹部、胸部、大腿、臂等起作用。
如果上覆盖布62还没有被连接(见下面的其他例证性实施方式)到成形敷料垫枕32,那么上覆盖布62被放置在成形敷料垫枕32的第一表面34之上,多余的部分延伸出外围边缘38以形成盖布外延部分64。然后盖布外延部分64可以用胶带粘到表皮14(见图3中的172)或使用形成在上覆盖布62和患者的表皮14之间的流体密封的粘合剂70(图2)粘住。流体密封仅需要足以允许系统10将减压保持在治疗部位上。减压接驳体92和减压源82使用减压输送导管90流体地被连接。然后减压源82可被激活并且减压被输送到成形敷料垫枕32。
当成形敷料垫枕32处的压力被减小时,成形敷料垫枕32压缩并横向收缩,并且形成半刚性基材,并且作为结果,大量有利的力和动作发生。减压进一步地仍通过成形敷料垫枕32被传输,以便在患者表皮14在切口12处感受减压。至少在愈合过程的早期阶段,减压通过切口12并在皮下组织20中被实现,并且压力的减少帮助闭合诸如皮下空隙22的缺损,并且通常提供对于区域的稳定性。输送到成形敷料垫枕32的减压还产生可再次提供稳定性和治疗的压缩力24。压缩力24不只在表皮14处。压缩力24向下延伸较深并可在皮下组织20的水平处被感受到。
上覆盖布62和成形敷料垫枕32在减压的影响下横向收缩,并且当向下的力通过表皮14的泊松比作用时,产生内向力26,其可帮助将闭合力保持在切口12上并通常可提供对于切口12或治疗部位的额外的稳定性。内向力26可部分地依赖于在成形敷料垫枕32和表皮14之间的摩擦以将力传递到表皮14,并且可涉及力经由粘合剂70或如果使用胶带(见图3中的172)则通过摩擦从盖布外延64到表皮14的传输。同时,输送到成形敷料垫枕32或通过成形敷料垫枕32输送的减压有助于除去来自切口12的任何渗出液或其他流体。系统10还允许用力的均匀施加使表皮平滑——它勾画表皮14的轮廓并使表皮14平滑。所有这些动作可改进切口12和损伤的皮下组织20的愈合。
一个操作关注是,在部置和使用系统10中避免皮肤刺激。相应地,注意避免皮肤刺激例如患者的表皮14的起泡,其可归因于次剪切、次应变或其他效应。由于这个原因,成形敷料垫枕32的末端33可成形以提供压缩力的均匀分布。末端33是垫枕32的外部成形部分,并且外围边缘通常是成形敷料垫枕32的最外侧部分或与患者的表皮连接的最外侧部分。末端33可以是斜切表面,但在系统110中可使用其他形状,例如弓形形状(图2)。均匀地分布合成力的形状是期望的。为了比较,当使用带有直角边缘的敷料垫枕时,当上覆盖布被应用在敷料垫枕之上且应用到患者的表皮上时“帐篷状区域”可形成。“帐篷状区域”被认为促成带有皮肤刺激的组织。“帐篷状区域”可通过使成形垫枕32成形或通过将上覆盖布连接到敷料垫枕的侧面区域来避免。
成形敷料垫枕32的成形边缘或末端允许压缩力24被产生而没有大的“边缘效应”;也就是说,没有使剪切力或应力上升到引起皮肤刺激例如红斑或水泡的水平。成形部分逐渐地分布力以避免刺激。这种谨慎地将力施加到表皮14以避免刺激的方式通常被称作“均匀地分布”压缩力24,但不是严格地以字面意义被使用。可能存在一些变化,但不足以引起表皮14的刺激。作为另一抵抗皮肤刺激的预防,可在成形敷料垫枕32和患者的表皮14之间添加内层(见图11中的857),或者在其他位置上放置内层,如下面进一步与其他例证性实施方式结合说明的。
在手术室中应用系统10并允许系统10保持在患者身上直到充分的愈合发生可能是合乎需要的。在这点上,可能希望由透视材料形成上覆盖布62、成形敷料垫枕32和任何其他层以允许卫生保健提供者得到关于切口12和损伤的皮下组织20的愈合的视觉提示,而不必除去敷料组件30。
现参考图3,显示用于治疗在患者中的损伤的皮下组织的系统110的另一例证性实施方式。系统110在大部分方面与图2的系统10相似,并且在该实施方式中通常通过将数字调整100来指示相似的部件。在该特定的例证性实施方式中,系统110被放置在完好的表皮115之上,即在该实例中不存在切口或其他线状伤口。然而,存在包括皮下空隙122的损伤的皮下组织120。系统110帮助治疗损伤的皮下组织120而无论是否存在切口。
系统110包括具有成形敷料垫枕132的敷料组件130。成形敷料垫枕132具有第一侧面134和面向内的第二侧面136。虽然图2的成形敷料垫枕32以梯形横截面被示出,图3的成形敷料垫枕132具有以椭圆形状形成的横截面,末端133具有圆弧边缘或具有弓形边缘。成形敷料垫枕132可以成形有双斜面横截面或其他形状。与之前一样,成形敷料垫枕132的形状便于压缩力均匀地分布到在减压期间避免皮肤刺激的程度。在图3的例证性实施方式中,密封装置169提供在上覆盖布162和患者的表皮114之间的流体密封。在该例子中,密封装置169是密封胶带172。
系统110包括密封子系统160以提供在成形敷料垫枕132之上的流体密封。减压输送导管190将减压输送到减压接驳体192,例如口194,其与密封子系统160的内部部分处于流体连通。
在该例证性实施方式中,环境压力在上覆盖布162的第一表面161上提供力131,并且成形敷料垫枕132的收缩产生压缩力124以提供净力,该净力向下在皮肤内被感受并且到达真皮116以及可到达其他皮下水平118。同时,产生指向内的、实质上在平面内的力。可通过两种不同的机制产生内向力。首先,内向力127是由正被压缩的成形敷料垫枕132引起的内向收缩力,并且当成形敷料垫枕132压缩时,成形敷料垫枕132被向内拉。同时,当减压被施加时,上覆盖布162被拉到接近末端133的区域中,如由箭头128所示的。因为盖布外延部分164被固定到表皮114,合成力128的水平分量将向内拉表皮114,如由内向力129所示的。
现参考图4,用于治疗组织部位220例如损伤的皮下组织部位的系统210被示为在弯曲的身体部分200例如患者的躯干上。系统210包括敷料组件230和密封子系统260。敷料组件230包括成形敷料垫枕232。密封子系统260包括带有外延部分264的上覆盖布262。外延部分264可通过诸如粘合剂270的密封装置被固定到患者的表皮214。减压源(未示出)将减压提供到减压输送导管290,其将减压输送到减压接驳体292。
减压接驳体292将减压输送到成形敷料垫枕232。当成形敷料垫枕232在减压的影响下被压缩时,产生被输送到组织部位220的净压缩力224。在该实施方式中,成形敷料垫枕232的末端233形成有直角末端。上覆盖布262形成在空隙235周围的“帐篷状”区域229。在减压之下,上覆盖布262被拉到空隙235中,从而产生内向收缩力226的力被施加。
在系统210中,成形敷料垫枕232的弯曲还帮助产生压缩力。成形敷料垫枕232的第一表面234具有比成形敷料垫枕232的面向内的第二表面236的表面积大的表面积。因此,在减压之下,表面积中的该差别也便于净压缩力224的产生。
现参考图5,显示用于治疗组织部位320例如损伤的皮下组织部位的例证性系统310。系统310通常在大部分方面与图4的系统210相似,并且相似的部件通过将图4的参考数字调整100来指示。系统310被应用于弯曲的身体部分300例如患者的躯干。系统310显示接近表皮314部置的完全环形的敷料组件330。
敷料垫枕332靠着表皮314布置,并且盖布或上覆盖布362被用于形成包含敷料垫枕332的密封的区域。减压通过减压导管390被输送到减压接驳体392。减压接驳体392将减压输送到敷料垫枕332。在减压的施加期间产生的切向力在系统310中组合以产生内向的压缩力324。因为没有力卸载到盖布和皮肤,压缩力可以高于水平或局部躯干施用。
现参考图6-8,显示用于治疗患者的治疗区域412的系统410。在该说明中提供的治疗是到治疗区域412的力,其在患者的躯干404上。治疗还可以包括在一个切口或多个切口处的流体的除去。对于该例证性实施方式,期望治疗区域412被显示为患者的腹部。如果患者已进行例如肿胀性吸脂术,那么可能希望使用系统410来施加在一个切口或多个切口处实现的压缩力,施加在真皮416处和损伤的皮下组织420处实现的压缩力,提供皮下组织418的接近以及稳定逆着垂直应力的组织,以及除去任何排出的流体例如肿胀液或渗出液。系统410包括至少部分地在患者的躯干404周围环绕地延伸的敷料组件430。敷料组件430包括敷料垫枕432,其具有第一外围边缘439。
如在图8中清楚显示的,敷料垫枕432具有第一表面434和面向内(或面向组织)的第二表面436。敷料垫枕432分布减压并向期望治疗区域例如治疗区域412提供可以是压缩力或提升力的力。具有第一表面442和面向内的第二表面444的内部表面构件440可被布置在患者的表皮414和敷料垫枕432之间。敷料垫枕432的第二表面436可被连接,例如粘结或合并到内部表面构件440的第一表面442。内部表面构件440可与敷料垫枕432无关。内部表面构件440可以是流体可渗透的或不可渗透的,并且可在敷料垫枕432和患者的表皮之间提供障碍。在一例证性实施方式中,内部表面构件440避免可由与患者的皮肤接合的敷料垫枕432引起的皮肤刺激,并且便于除去在使用减压的表面处的汗和其他流体。
敷料垫枕432可由在该申请的其它地方所描述的任何垫枕材料制成。敷料垫枕432可包括不始终一致的垫枕材料,因为人们可能希望敷料垫枕432在一些部位刚性较大(并且不提供同样多的提升力)或者人们可能希望敷料垫枕432在一些部位刚性较小并产生最大提升力,例如,如在下面的胸罩实施方式上的乳房处。垫枕材料可使用具有变化的特性的垫枕材料或使用被组合来形成垫枕材料的两种或更多不同的材料而被制成刚性更大或刚性更小的。在一些应用中,由蜂窝材料例如来自加利福尼亚(California)桑尼维尔(Sunnyvale)的Supracor Systems的
Figure BDA0000392585470000201
融合结合蜂窝材料形成垫枕材料可能是合乎需要的。
敷料组件430还可包括外部表面构件446或外部构件,其具有第一侧面448和第二侧面450。内部表面构件440或内部构件以及外部表面构件446可由诸如弹力纤维(spandex)材料的预拉弹性材料制成;例如,可使用
Figure BDA0000392585470000202
牌材料。内部表面构件440具有高收缩性以避免起皱,这将导致靠着皮肤的接触负载。此外,用于内部表面构件440的材料的低摩擦力有助于减少对表皮的剪切伤害的可能性。此外,内部表面构件440或层的渗透性导致减压传输到组织部位并提供渗出液除去的路径。内部表面构件440或内部构件以及外部表面构件446可被连接以形成包围敷料垫枕432的外壳。
外部表面构件446的第二侧面450可被连接到敷料垫枕432的第一表面434。不同构件(例如,表面436到表面442和表面450到434)的连接可以用许多方式出现;下面是很多例子。一种方法可使用诸如丙烯酸酯粘合剂、硅酮粘合剂、水凝胶、水解胶体等的粘合剂,或者可使用诸如热粘合、超声焊接或射频粘接等的结合。连接可以按模式出现或可覆盖整体。结构构件可被添加到连接以使构件在期望的方向上表现各向异性。另外,支柱或其他机械元件可在垫枕内被供应以改变敷料垫枕432的压缩和特征。
敷料组件430在图6到8中被显示有实质上矩形的横截面,但是可利用其他形状来提供更多的垂直提升力(对于在图6和7中所示的方向是垂直的)。虽然敷料垫枕432被示为整体构件,但敷料垫枕432也可形成有垫枕材料的不同部分,每个部分具有不同的减压供应,并且甚至可具有带有正压的部分。关于后者,可添加一个或多个密封的室,正压可被提供到密封室以帮助重新分布负载或添加结构元件。
敷料垫枕432和任何附加层例如内部表面构件440和外部表面构件446可用上覆盖布462覆盖,上覆盖布462是密封子系统460的一部分。上覆盖布462可延伸出外围边缘438和439以形成盖布外延部分464,其具有第一侧面466和第二侧面468。流体密封可通过使用密封装置469在盖布外延部分464和患者的表皮414之间形成,密封装置469是例如密封胶带、或盖布胶带471、粘合剂(见图1中的粘合剂5)、糊剂、水解胶体、水凝胶或其他密封工具。盖布胶带471包括粘合剂473。在一些应用中,衬垫材料可在表皮414和敷料垫枕432或上覆盖布462之间被添加。在另一实施方式中,上覆盖布462可仅被应用在敷料垫枕432的第一侧面上,而且接着宽盖布胶带用于密封有或没有外延部分464的敷料垫枕432的边缘或外围部分。
密封子系统460提供流体密封,或用其他方式允许系统410将减压维持在期望的治疗部位412处。密封子系统460优选地包括上覆盖布462和密封装置469。虽然被描述为形成流体密封,实际上可能存在一些渗漏,并且作为结果的小的空气泄漏实际上提供遍及敷料组件430的低速率气流,其被分布且有助于除去湿气。在可选的实施方式中,代替使用上覆盖布462,外部表面构件446可被制造有气密外部部分,并且盖布胶带可被控制以覆盖垫枕材料的边缘以及其他没有被另外密封的部分。
减压子系统480被部分地显示并且相似于在前面提出的实施方式的减压子系统,例如图2的80。减压子系统480包括减压接驳体492例如肘形口494,其允许减压源通过减压导管479将减压输送到敷料组件430中,并且特别地到敷料垫枕432中。减压子系统480可被控制,以便改变压力以当患者的尺寸由于浮肿减少而改变时提供恒定的压缩水平。减压源可提供不变的减压或可变的减压。与上面所描述的其他实施方式一样,减压源可采用许多不同的形式,包括本文在别处提及的那些形式。
如在图7中清楚示出的,敷料组件430可包括在敷料垫枕432的一部分上的过渡区域452。过渡区域452可为锥形或被另外成形以减少厚度并增加柔韧性以及最大化在边界处的剪切顺应性。这可有助于分布任何集中的剪切负载,例如由敷料组件430的收缩、患者活动性和负载集中所引起的那些剪切负载,其中负载集中由在敷料/夹板区域和无支撑的真皮之间的刚度不连续性所引起。过渡区域452可过渡到一个或多个连接片454或接合元件454。
接合元件454的一部分可包括扣件456,其可以是钩和环扣件、挂钩、或连接接合元件454的两部分的其他工具。接合元件454和扣件456形成环形连接器,并且和敷料组件430一起完成在弯曲的身体部分周围的路径或形成完整的可释放环形构件458。因此,可释放环形构件458在患者的躯干404周围延伸以允许可释放环形构件458被保持为靠着躯干404,并且特别是甚至在减压被减压子系统480输送之前保持垫枕432靠着期望治疗区域412。附加的盖布胶带可被用于在接合元件454和扣件456之上提供流体密封。
过渡区域452可包括敷料组件430的第一端453和第二端455,特别是显示在患者的躯干404周围的纵向部分457的端部。因此两端被集合在一起并可释放地由包括接合元件454和扣件456的可释放环形构件458保持。
敷料垫枕432的第一表面434和第二表面436的表面积的差异促成净压缩(内向)力的产生。净压缩力随敷料垫枕432的第一表面434的周长与敷料垫枕432的第二表面436的周长的比率的增加而线性地增加。因此,为了使较大的压缩产生,敷料垫枕432可被制成较厚的以增加该比率。敷料垫枕432的弯曲硬度还可影响所产生的压缩力的输送。如果敷料430具有低弯曲硬度,那么净压缩力被相当均匀地分布。简要参考图9,沿平行于542的第二轴和平行于540的第一轴的低弹性硬度有助于减小敷料垫枕532的弯曲硬度。
现返回图6-8,在操作中,敷料组件430被放置在患者的弯曲身体部分例如躯干404周围,敷料垫枕432靠着期望治疗区域412。可释放环形连接器458被利用(即,使接合元件454和扣件456活动)以形成完整的可释放环形构件。减压子系统480可被启动以使减压子系统480将减压输送到使减压被输送到敷料垫枕432的密封子系统460。敷料垫枕432然后可在减压下压缩并塌陷以将支撑力输送到期望治疗区域412。支撑力可包括压缩力,其作用到患者的躯干中并向下到表皮414、真皮416中以及向下到皮下水平418到损伤的皮下组织420。在图8中由参考数字424示出对于一段的净压缩力。横向力426,即,朝着外围边缘439,或者提升或向上的力426也可产生。
现参考图9,示出由各向异性材料制成的敷料垫枕532的一部分。可使用的一种各向异性材料是AirX压缩材料,或者织物,其从Tytex Group(www.tytex.com)可获得。敷料垫枕532具有第一表面534和第二表面536。它还具有对于图6和7中所示的实施方式与人的头部最接近的顶部537,以及对于图6和7中所示的实施方式与人的脚最接近的底部539。为了描述的目的,敷料垫枕532具有分别平行于参考线540、542和544的三个轴。敷料垫枕532的材料可能是各向异性的,这意味着它沿着不同轴具有不同的机械特性。例如,压缩模数在第一、第二和第三轴的至少两个之间可不同。在一例证性实施方式中,当提供增强的力是合乎需要的时,各向异性材料可被选择并定向以优选地沿着一个或多个轴延伸或收缩。如现在将被考虑的,将相似的系统应用到乳房组织可能是特别合乎需要的。
参考图10-14,显示用于向乳房组织提供支撑力的系统610。系统610包括治疗胸罩612以向在患者的躯干604的上部部分上的乳房区域616中的乳房组织614提供支撑。可在接近乳房组织614或在乳房组织614上的限定的支撑区域618中提供支撑,乳房组织614可以是手术过程例如部分或全部乳房切除或隆胸手术过程的对象。在乳房切除的情况下,支撑区域618可支撑剩余的乳房组织。
系统610包括敷料组件630,其包括具有第一表面634和面向内的第二表面636的敷料垫枕632。敷料组件630可包括具有第一表面640和面向内的第二表面642的内部表面构件638。内部表面构件638可在第一表面640上被连接到敷料垫枕632的第二表面636。敷料组件630还可包括外部表面构件644,其具有第一表面646和面向内的第二表面648。外部表面构件644可在第二表面上被连接到垫枕632的第一表面634。
密封子系统660提供流体密封,其当在来自减压子系统680的减压下时足以维持在期望的支撑区域618中逆着患者的表皮的减压。密封子系统660可采用许多不同的形式。本实施方式包括上覆盖布662,其覆盖敷料垫枕632并可延伸出敷料垫枕632的外围边缘650以形成外延部分664,密封装置667可被应用于该外延部分664以形成与表皮的流体密封。密封装置667可采用许多形式,例如粘合剂、密封胶带668或条、双面密封胶带、糊剂、水解胶体、水凝胶或其他密封工具。密封装置667还可包括如在图13中所示的附加元件。
现参考图13,密封装置667可简单地是胶带668或如前所述的粘合剂,或者可进一步包括密封垫枕670,其可以是比敷料垫枕632在更多的压力下。密封垫枕670具有在密封垫枕670之上的上覆盖布662的一部分,并且可形成减压子系统680将减压输送到的隔间或者可被流动地连接到敷料垫枕632以接收来自减压子系统680的减压。
现参考图14,显示密封装置667的例证性的、可选的实施方式。在该实施方式中,外部表面构件644和内部表面构件638超出外围边缘650被彼此邻接地放置。外部表面构件644的第二表面648和内部表面构件638的第一表面640可通过任何已知的手段被彼此连接。构件可以用许多不同的方式被连接,包括下述方式中的一种:使用诸如丙烯酸酯粘合剂、硅酮粘合剂、水凝胶、水解胶体等的粘合剂;通过热粘合、超声焊接和射频粘接等被粘结;或其他手段。连接可以按模式或更完全地发生。结构可被添加到结合物以使材料在期望的方向上表现各向异性。在图14中的实施方式显示被应用在内部表面构件638的第二表面642和患者的表皮611之间的粘合条674。在靠着表皮611应用粘合条674之前,粘合条674可被可除去的衬背或条覆盖。
现主要参考图10-12,输送到支撑区域618的支撑力现将根据治疗胸罩被解释。如前所描述的,胸罩612结合敷料组件630被形成,并且包括第一乳房罩杯682和第二乳房罩杯684。在形成乳房罩杯682和684中增加一个或多个接缝686可能是必需的。每个乳房罩杯682、684形成袋状物,例如在图11中所示的袋状物688。袋状物688用于接纳乳房组织614,或者在乳房切除的情况下可接纳临时的术后修复的,例如用超吸收材料覆盖的硅胶嵌入物,其用于帮助收集渗出液的过程并有助于将压力施加到下面的伤口。在可选的实施方式中,可形成覆盖两个乳房或更一般地患者的胸部的一部分的单个罩杯。
治疗胸罩612可分为两部分以对于每个乳房罩杯682、684有带有单独的密封子系统的单独的垫枕,以便不同的压力水平可以被供应到每个乳房罩杯682、684以适应不同尺寸或情况。例如,如果一个乳房已经是乳房切除的对象而另一个不是,则可能期望有不同的减压。
现主要参考图12,治疗胸罩612可具有包括接合元件654的过渡区域652。接合元件654可以是网状材料和一个或多个扣件656,其与在相对的过渡区域652上的接收扣件(没有明确示出,但类似于在图7中的扣件456)连接。扣件656可以是钩和环构件、拉链构件、摁扣或其他工具。在一些情况中在扣件656的顶部之上应用盖布胶带以提供充分的流体密封可能是合乎需要的。仅部分地示出的减压子系统680通过减压导管687输送减压,减压导管687通过诸如肘形口694的减压接驳体692与敷料垫枕632流体连通。
在操作中,系统610通过将治疗胸罩612放置在躯干604上被利用,以便垫枕632的至少一部分接近乳房组织614,并且优选地接近支撑区域618。敷料组件630连同接合元件654和扣件656一起形成可释放环形连接器698,其将治疗胸罩612保持在适当的位置,甚至在来自减压子系统680的减压被施加之前。一旦治疗胸罩612在适当的位置,减压子系统680就被启动并且减压通过减压接驳体692被输送到敷料垫枕632。敷料垫枕632在减压的影响下塌陷并收缩,从而使张力遍及环形连接器698产生且提供压缩力和对支撑区域618或乳房组织614的支撑(向上)力的组成部分。
系统和装置已被示出应用在不同的身体部分例如腹部和乳房上,但其他应用被包括。例如,系统可被用在人的大腿上,在这样的情况下,垫枕组件可由类似于单车短裤的短裤保持在适当的位置。作为另一个例子,所描述的用于乳房组织的系统和装置可被修改以形成大的单个前罩杯,其能够被用于举起并支撑血管翳或其他组织悬挂片(hanging flap)。作为又一个例子,以与对于乳房组织呈现的式样类似的式样制成的减压罩杯能够被用于在手术之后的睾丸支撑并且可被合并到短裤中。
根据另一例证性实施方式,向人的弯曲身体部分的至少一部分提供力的方法包括在弯曲的身体部分上部置敷料组件的步骤。敷料组件包括用于在期望治疗区域之上放置并具有第一表面和面向内的第二表面的内部表面构件。敷料垫枕具有第一表面和面向内的第二表面。敷料垫枕的面向内的第二表面靠着内部表面构件的第一表面布置。敷料组件可被密封到弯曲的身体部分。方法还包括将减压提供到敷料组件。当减压被施加时,敷料垫枕从处于环境压力的第一体积(V1)变为处于减压的第二体积(V2)。换句话说,第一体积大于第二体积:V1>V2。当体积变化时,产生可包括压缩部分、提升部分或内向闭合部分的指向力。
尽管本发明及其优点已经在某些例证性的非限制性实施方式的背景下被公开,应当理解的是,各种变化、代替、置换和改变能够被作出而没有偏离如由附加的权利要求所限定的本发明的范围。将认识到,结合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 (10)

1.一种用于向人的乳房区域提供力的系统,所述系统包括:
敷料组件,其成形并配置为被放置在乳房区域上,并且其中所述敷料组件包括:
敷料垫枕,
敷料垫枕,其依尺寸制造并配置为在人的躯干的至少一部分周围环绕地延伸,并且依尺寸制造并配置为被放置在人的乳房区域的至少一部分上,所述垫枕具有第一表面和面向内的第二表面,以及
内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面连接到所述敷料垫枕的面向内的第二表面;
可释放环形连接器,其用于保持所述敷料组件靠着所述乳房区域的至少一部分;
密封子系统,其用于对所述敷料组件和人的表皮的一部分提供流体密封;以及
减压子系统,其用于向所述敷料组件提供减压,借此所述系统可操作来对人的所述乳房区域的至少一部分产生力。
2.如权利要求1所述的系统,其中所述敷料组件还包括:
第一乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的一部分之上延伸;以及
第二乳房罩杯,其形成为所述敷料垫枕的一部分,并且依尺寸制造并配置为在所述乳房区域的另一部分之上延伸。
3.一种用于向人的乳房组织提供治疗支撑的减压系统,所述系统包括:
敷料组件,其用于放置在人的躯干上,其中所述敷料组件的至少一部分依尺寸制造并配置为接近所述乳房组织而放置,所述敷料组件包括敷料垫枕和内部表面构件;
其中所述敷料组件包括具有第一端和第二端的纵向部分;
可释放环形连接器,其连接到所述第一端和所述第二端,用于将所述第一端和所述第二端可释放地连接在一起;
密封子系统,其用于在靠着人的所述敷料组件之上提供流体密封;
减压子系统,其用于向所述敷料组件提供减压;以及
其中所述敷料组件、所述密封子系统和所述减压子系统是可操作的以向所述乳房组织提供支撑力并将减压输送到所述乳房组织。
4.如权利要求3所述的系统,其中所述内部表面构件包括弹性材料。
5.一种减压治疗胸罩,包括:
胸罩敷料组件,其包括:
敷料垫枕,其用于放置在躯干上且至少一部分接近乳房组织,
第一乳房罩杯,其形成为所述敷料垫枕的一部分并形成有第一袋状物,所述第一袋状物依尺寸制造并配置为接纳乳房组织,以及
第二乳房罩杯,其形成为所述敷料垫枕的一部分并形成有第二袋状物,所述第二袋状物依尺寸制造并配置为接纳乳房组织;
可释放环形连接器,其用于在使用期间保持所述胸罩敷料组件靠着躯干;
密封构件,其用于对所述胸罩和穿戴者的表皮提供流体密封;
减压接驳体,其用于接收减压并将减压输送到所述胸罩敷料组件;以及
其中所述胸罩敷料组件在减压下是可操作的以向所述乳房组织提供支撑力。
6.如权利要求5所述的减压治疗胸罩,其中所述胸罩敷料组件具有第一表面和面向内的第二表面,并且所述减压治疗胸罩还包括:
内部表面构件,其具有依尺寸制造以在期望的支撑区域之上延伸的第一表面和面向内的第二表面;以及
外部表面构件,其具有第一表面和面向内的第二表面,其中所述外部表面构件的第二表面被布置成靠着所述敷料垫枕的第一表面。
7.一种制造减压治疗胸罩的方法,包括:
形成胸罩敷料组件,所述胸罩敷料组件具有敷料垫枕,所述敷料垫枕用于放置在躯干上且至少一部分接近乳房组织;
形成第一乳房罩杯,所述第一乳房罩杯形成为所述敷料垫枕的一部分并形成有第一袋状物,所述第一袋状物依尺寸制造并配置为接纳乳房组织;
形成第二乳房罩杯,所述第二乳房罩杯形成为所述敷料垫枕的一部分并形成有第二袋状物,所述第二袋状物依尺寸制造并配置为接纳乳房组织;
提供用于保持所述胸罩靠着穿戴者的躯干的可释放环形连接器;
将密封构件连接到所述敷料垫枕,所述密封构件用于对所述胸罩和穿戴者的表皮的一部分提供流体密封;以及
形成用于接收减压并将减压输送到所述胸罩的减压接驳体。
8.一种用减压处理乳房组织的方法,所述方法包括以下步骤:
接近所述乳房组织部置敷料组件;
将所述敷料组件连接到患者的躯干;
在所述乳房组织之上密封所述敷料组件;以及
向所述敷料组件的敷料垫枕提供减压。
9.如权利要求8所述的方法,其中所述敷料组件包括:
敷料垫枕,其依尺寸制造并配置为在人的躯干的至少一部分周围环绕地延伸,并且依尺寸制造并配置为被放置在人的乳房区域的至少一部分上,所述垫枕具有第一表面和面向内的第二表面;以及
内部表面构件,其具有第一表面和面向内的第二表面,并且所述内部表面构件的第一表面连接到所述敷料垫枕的面向内的第二表面。
10.如权利要求8所述的方法,其中所述敷料组件包括第一隔间和第二隔间,并且其中提供减压的所述步骤包括向所述第一隔间提供第一减压以及向所述第二隔间提供第二减压。
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