CN101563118A - 具有带主流道的歧管和阻塞预防构件的用于施用减压治疗的系统 - Google Patents

具有带主流道的歧管和阻塞预防构件的用于施用减压治疗的系统 Download PDF

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Publication number
CN101563118A
CN101563118A CNA200780017531XA CN200780017531A CN101563118A CN 101563118 A CN101563118 A CN 101563118A CN A200780017531X A CNA200780017531X A CN A200780017531XA CN 200780017531 A CN200780017531 A CN 200780017531A CN 101563118 A CN101563118 A CN 101563118A
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tissue
reduced pressure
flexible wall
sprue
tissue site
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CN101563118B (zh
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道格拉斯·A·科内特
迈克尔·曼畏林
拉里·D·斯温
乔纳森·凯根
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3M Innovative Properties Co
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KCI Licensing Inc
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Abstract

一种减压传送系统被提供,并包括主歧管、阻塞预防构件以及与主歧管流体相通的第一和第二导管。主歧管包括围绕主流道的柔性壁,并适合于放置在组织部位附近。阻塞预防构件设置在主流道内。多个孔布置在柔性壁中以与主流道相通。第一导管流体连接到主流道以通过主流道和多个孔传送减小的压力。第二导管包括在所述主流道或第一导管的出口附近的出口,以清洗主流道或第一导管而防止阻塞。

Description

具有带主流道的歧管和阻塞预防构件的用于施用减压治疗的系统
发明背景
1.发明领域
本发明一般涉及促进组织生长的系统或方法,尤其涉及用于将减压组织治疗应用于组织部位的系统。
2.相关技术的描述
减压治疗越来越多地用于促进软组织创伤中的创伤愈合,这些软组织创伤如果没有减压治疗就愈合缓慢或不愈合。一般来说,减小的压力通过开孔泡沫被施加到创伤部位,该开孔泡沫用作分布减小的压力的歧管(manifold)。开孔泡沫按规定尺寸制造成适合现有的创伤,放置成与创伤接触,并接着当创伤开始愈合和变得更小时,用较小的泡沫块定期更换。频繁更换开孔泡沫对于最小化生长到泡沫的孔内的组织的数量是必要的。相当多的组织内部生长可能在移除泡沫期间给患者造成痛苦。
减压治疗一般应用于不愈合的开放创伤。在一些情况下,正愈合的组织是位于皮下的,而在其它情况下,组织位于皮肤组织之内或之上。传统上,减压治疗主要应用于软组织。减压治疗一般不用于治疗闭合的深层组织创伤,因为很难接近这样的创伤。此外,主要由于接近问题,减压治疗不用在治愈骨缺损或促进骨生长方面。用外科手术暴露骨骼以应用减压治疗,可能产生比它解决的问题更多的问题。最后,用于应用减压治疗的装置和系统比开孔泡沫块稍微有所进步,开孔泡沫块被手工成形以适合创伤部位并接着在减压治疗期之后被移除。
发明概述
由现有的创伤愈合系统和方法提出的问题通过本发明的系统和方法来解决。根据本发明的一个实施方式提供了减压传送系统,以将减小的压力施加到组织部位。减压传送系统包括主歧管(primary manifold),其具有围绕主流道(primary flow passage)的柔性壁并适合于设置在组织部位附近。柔性壁包括具有多个凸出物的内表面,凸出物从内表面的至少一部分延伸并进入主流道。柔性壁进一步包括贯穿柔性壁的与主流道相通的多个孔。第一导管流体连接到主流道,以通过主流道和多个孔传送减小的压力。第二导管包括位于主流道或第一导管的至少一个出口附近的至少一个出口,以清除在第一导管的至少一个出口处或附近的阻塞物。
根据本发明的另一实施方式,减压传送系统被提供并包括主歧管,主歧管具有围绕主流道的柔性壁,并适合于放置在组织部位附近。柔性壁进一步包括贯穿柔性壁的与主流道相通的多个孔。微孔材料位于主流道内,且微孔材料包括多个流动通道(flow channel)。第一导管流体连接到主流道,以通过主流道、微孔材料和多个孔传送减小的压力。第二导管包括位于主流道或第一导管的至少一个出口附近的至少一个出口,以清除在第一导管的至少一个出口处或附近的阻塞物。
根据本发明的又一实施方式,减压传送系统被提供并包括主歧管,主歧管具有围绕主流道的柔性壁,并适合于放置在组织部位附近。主歧管包括位于主流道内的阻塞预防构件。多个孔布置在柔性壁内以与主流道相通。次级歧管(secondary manifold)设置成与主歧管相邻,并适合于接触组织部位,以便次级歧管与主歧管流体相通,但适合于阻止主歧管和组织部位之间的接触。第一导管流体连接到主流道,以通过主流道和多个孔传送减小的压力。
在本发明的另一实施方式中,用于在组织处促进组织生长的方法包括将主歧管放置在组织部位附近。主歧管包括围绕主流道的柔性壁。柔性壁包括贯穿柔性壁的与主流道相通的多个孔。主歧管进一步包括位于主流道内的阻塞预防构件。本方法进一步包括通过外科手术将次级歧管放置成与组织部位接触,以便次级歧管与主歧管流体相通,但防止主歧管和组织部位之间的接触。将减小的压力通过主流道、多个孔和次级歧管传送到组织部位。
参考附图和接下来的详细描述,本发明的其它目的、特征和优点将变得明显。
附图简述
本专利或申请文件包括用彩色制成的至少一个附图。具有彩色附图的本专利或专利申请出版物的复制品将在请求并支付必要的费用时由事务所提供。
图1描绘了根据本发明的实施方式的减压传送装置的透视图,该减压传送装置具有从柔性障壁(flexible barrier)延伸的多个凸出物以产生多个流动通道;
图2示出图1的减压传送装置的正视图;
图3描绘了图1的减压传送装置的顶视图;
图4A示出图1的减压传送装置的侧视图,该减压传送装置具有单腔减压传送管(reduced-pressure delivery tube);
图4B描绘了图1的减压传送装置的可选实施方式的侧视图,该减压传送装置具有双腔减压传送管;
图5示出图1的减压传送装置的放大透视图;
图6描绘了根据本发明的实施方式的减压传送装置的透视图,该减压传送装置具有附着到柔性障壁的微孔材料,该柔性障壁具有隆起部分和一对翼状部分,微孔材料具有多个流动通道;
图7示出图6的减压传送装置的正视图;
图8描绘了沿XVII-XVII截取的图7的减压传送装置的横截面侧视图;
图8A示出根据本发明的实施方式的减压传送装置的横截面正视图;
图8B描绘了图8A的减压传送装置的侧视图;
图9示出根据本发明的实施方式的减压传送装置的正视图,该减压传送装置用于将减压组织治疗应用于患者的骨骼;
图10描绘了兔子颅骨的彩色组织切片,其显示未试验过的、未损坏的骨骼;
图11示出兔子颅骨的彩色组织切片,其显示在应用了减压组织治疗之后,肉芽组织的感应;
图12描绘了兔子颅骨的彩色组织切片,其显示在应用了减压组织治疗之后,新骨骼的沉积;
图13示出兔子颅骨的彩色组织切片,其显示在应用了减压组织治疗之后,新骨骼的沉积;
图14描绘了兔子颅骨的彩色照片,该颅骨具有在颅骨内形成的两个临界尺寸缺损;
图15示出图14的兔子颅骨的彩色照片,其显示插在一个临界尺寸缺损内的磷酸钙支架和覆盖第二个临界尺寸缺损的不锈钢筛网(screen);
图16描绘了图14的兔子颅骨的彩色照片,其显示减压组织治疗对临界尺寸缺损的应用;
图17示出在减压组织治疗之后兔子颅骨的彩色组织切片,该组织切片显示新骨骼在磷酸钙支架内的沉积;
图18描绘了在六天的减压组织治疗和术后两周之后,图15的填充支架的临界尺寸缺损的射线照片(radiograph);
图19示出在六天的减压组织治疗和术后十二周之后,图15的填充支架的临界尺寸缺损的射线照片;
图20描绘了根据本发明的实施方式的减压传送系统的正视图,该减压传送系统具有用于将减压传送装置经由皮肤插到组织部位的歧管传送管;
图21示出图20的歧管传送管的放大正视图,歧管传送管包括具有柔性障壁和/或处于压缩位置中的微孔材料的减压传送装置;
图22描绘了图21的歧管传送管的放大正视图,减压传送装置的柔性障壁和/或微孔材料显示为从歧管传送管被推开之后处于膨胀位置中;
图23示出根据本发明的实施方式的减压传送系统的正视图,该减压传送系统具有用于将减压传送装置经由皮肤插到组织部位的歧管传送管,该减压传送装置显示为处于歧管传送管的外部,但被不可透过膜限制在压缩位置中;
图24描绘了图23的减压传送系统的正视图,减压传送装置显示为处于歧管传送管的外部,但被不可透过膜限制在松弛位置中;
图25示出图23的减压传送系统的正视图,减压传送装置显示为处于歧管传送管的外部,但被不可透过膜限制在膨胀位置中;
图25A示出图23的减压传送系统的正视图,减压传送装置显示为处于歧管传送管的外部,但被不可透过膜包围在膨胀位置中;
图26描绘了根据本发明的实施方式的减压传送系统的正视图,该减压传送系统具有用于将减压传送装置经由皮肤插到组织部位的歧管传送管,该减压传送装置显示为处于歧管传送管的外部,但被具有胶密封物(glue seal)的不可透过膜限制;
图26A描绘了根据本发明的实施方式的减压传送系统的正视图;
图27示出根据本发明的实施方式的减压传送系统的正视图,该减压传送系统具有用于将减压传送装置经由皮肤插入到组织部位的歧管传送管;
图27A示出根据本发明的实施方式的减压传送系统的正视图,该减压传送系统具有用于将减压传送装置经由皮肤插到位于组织部位处的不可透过膜的歧管传送管;
图28描绘了根据本发明的实施方式对组织部位施用减压组织治疗的方法的流程图;
图29示出根据本发明的实施方式对组织部位施用减压组织治疗的方法的流程图;
图30描绘了根据本发明的实施方式对组织部位施用减压组织治疗的方法的流程图;
图31示出根据本发明的实施方式对组织部位施用减压组织治疗的方法的流程图;
图32描绘了根据本发明的实施方式的减压传送装置的横截面正视图,该减压传送装置包括具有多个流动通道的髋假体,用于将减小的压力施加到围绕髋假体的骨骼的区域;
图33示出图32的髋假体的横截面正视图,该髋假体具有第二多个流动通道,用于将流体传送到围绕髋假体的骨骼的区域;
图34描绘了根据本发明的实施方式使用减压组织治疗来修复患者的关节的方法的流程图;
图35示出根据本发明的实施方式的减压传送装置的横截面正视图,该减压传送装置包括具有多个流动通道的矫形固定装置,用于将减小的压力施加到与矫形固定装置相邻的骨骼的区域;
图36描绘了图35的矫形固定装置的横截面正视图,该矫形固定装置具有第二多个流动通道,用于将流体传送到与矫形固定装置相邻的骨骼的区域;
图37示出根据本发明的实施方式使用减压组织治疗来治愈骨骼的骨缺损的方法的流程图;
图38描绘了根据本发明的实施方式对组织部位施用减压组织治疗的方法的流程图;以及
图39示出根据本发明的实施方式对组织部位施用减压组织治疗的方法的流程图。
图40-48描绘了根据本发明的实施方式的减压传送系统的不同视图,该减压传送系统具有主歧管,该主歧管包括围绕主流道的柔性壁和在柔性壁内的多个孔;
图49-50示出根据本发明的实施方式的减压传送系统的透视图和顶部横截面视图,该减压传送系统具有整体地连接到减压传送管的主歧管;
图51描绘了图40-50的主歧管的透视图,该主歧管与次级歧管一起应用于骨组织部位;以及
图52示出根据本发明的实施方式的减压传送系统的示意图,该减压传送系统具有流体连接到第二导管的阀。
优选实施方式的详细描述
在优选实施方式的下面的详细描述中,参考了形成其中一部分的附图,且其中以实例的方式示出了可实践本发明的特定的优选实施方式。这些实施方式被足够详细地描述,以使本领域中的技术人员能够实践本发明,并且应理解,可利用其它实施方式,而且还可进行逻辑结构、机械、电子和化学的改变,而不偏离本发明的实质或范围。为了避免对于本领域的技术人员实践本发明来说并不必要的细节,本说明书可能省略了对本领域的技术人员来说已知的某些信息。因此,下面的详细描述不应在限制的意义上理解,且本发明的范围仅由所附权利要求限定。
如这里使用的,术语“弹性的”意指具有弹性体的特性。术语“弹性体”通常指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弹性。材料的弹性指材料从弹性变形中恢复的能力。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、聚氨基甲酸酯和硅氧烷。
如这里使用的,术语“柔性的”指能够弯曲或折曲的物体或材料。弹性材料一般是柔性的,但这里对柔性材料的提及不必将材料选择限制为只有弹性体。关于本发明的材料或减压传送装置使用的术语“柔性的”,通常指材料符合或精密地匹配组织部位的形状的能力。例如,用于治疗骨缺损的减压传送装置的柔韧性质可允许装置被包裹或折叠在具有缺损的骨骼部分周围。
如这里使用的,术语“流体”通常指气体或液体,但也可包括任何其它可流动物质(flowable material),包括但不限于凝胶、胶质和泡沫。
如这里使用的,术语“不可透过的”通常指膜、罩、薄板或其它物质阻挡或减慢液体或气体透过的能力。不可透过性可用于指能抵抗液体透过同时允许气体透过膜的罩、薄板或其它膜。虽然不可透过膜可为不透液体的,但该膜可简单地减小全部或仅仅某些液体的透过率。使用术语“不可透过的”并不意味着暗示不可透过膜高于或低于对不可透过性的任何特定的工业标准测量,例如水蒸汽透过率(WVTR)的特定值。
如这里使用的,术语“歧管”通常指设置成有助于将减小的压力施加到组织部位、将流体传送到组织部位或从组织部位移除流体的物质或结构。歧管一般包括多个流动通道或路径,这些流动通道或路径互相连接,以改善被提供给歧管周围的组织区域的流体以及从该区域移除的流体的分布。歧管的例子可没有限制地包括具有布置成形成流动通道的结构性元件的装置、多孔泡沫例如开孔泡沫、多孔组织群、以及包括或制备以包括流动通道的液体、凝胶和泡沫。
如这里使用的,术语“减小的压力”通常指在受到治疗的组织部位处小于环境压力的压力。在大多数情况下,该减小的压力小于患者所处于的大气压力。可选地,减小的压力可小于在组织部位处的组织的流体静压。虽然术语“真空”和“负压”可用于描述施加到组织部位的压力,但施加到组织部位的实际压力可明显小于通常与绝对真空相关的压力。减小的压力最初可在管内和组织部位的区域内产生流体流动。当组织部位周围的流体静压接近于期望的减小的压力时,流动可减退,且减小的压力接着被维持。除非另外指出,这里所述的压力值是表压力。
如这里使用的,术语“支架”指用于增强或促进细胞的生长和/或组织的形成的物质或结构。支架一般是提供细胞生长的模板的三维多孔结构。支架可被灌输有、涂有或包含细胞、生长因子或其它营养素,以促进细胞生长。支架可用作根据这里描述的实施方式的歧管,以对组织部位施用减压组织治疗。
如这里使用的,术语“组织部位”指位于任何组织之上或之内的创伤或缺损,包括但不限于骨组织、脂肪组织、肌肉组织、神经组织、皮肤组织、血管组织、结缔组织、软骨、腱或韧带。而且,术语“组织部位”可指不必然地受到创伤或有缺损的任何组织的区域,而可以是被期望增加或促进额外组织的生长的区域。例如,减压组织治疗可用在某些组织区域中,以培养可被获取并移植到另一组织位置的额外组织。
参考图1-5,根据本发明的原理的减压传送装置或翼状歧管211包括具有隆起部分215和一对翼状部分219的柔性障壁213。每个翼状部分219沿着隆起部分215的相对侧设置。隆起部分215形成可以延伸或可以不延伸翼状歧管211的整个长度的弓形通道223。虽然隆起部分215可位于翼状歧管211的中央,使得翼状部分219的宽度相等,但是隆起部分215也可如图1-5所示的偏移,导致一个翼状部分219比另一翼状部分219宽。如果翼状歧管211与骨再生或愈合结合使用,那么一个翼状部分219的额外宽度可能特别有用,且较宽的翼状歧管211将包裹在附着到骨骼的固定构件的周围。
柔性障壁213优选地由弹性材料例如硅氧烷聚合物形成。适当的硅氧烷聚合物的例子包括由Nusil Technologies of Carpinteria,California制造的MED-6015。然而应注意,柔性障壁213可由任何其它生物相容的柔性材料制成。柔性障壁213包括增加柔性障壁213的强度和耐久性的柔性衬底227。包括柔性衬底227的柔性障壁213在弓形通道223中的厚度可小于在翼状部分219中的厚度。如果使用硅氧烷聚合物来形成柔性障壁213,则还可使用硅氧烷粘合剂(silicone adhesive)来帮助与柔性衬底227结合。硅氧烷粘合剂的例子可包括同样由Nusil Technologies出售的MED-1011。柔性衬底227优选地由聚酯针织织物制成,例如由C.R.Bard of Tempe,Arizona制造的Bard 6013。然而,柔性衬底227可由能够增加柔性障壁213的强度和耐久性的任何生物相容的柔性材料制成。在某些情况下,如果柔性障壁213由适当强度的材料制成,则柔性衬底227可省略。
优选地,柔性障壁213或柔性衬底227是液体、空气和其它气体不可透过的,或可选地,柔性衬底227和柔性障壁213都是液体、空气和其它气体不可透过的。
柔性障壁213和柔性衬底227还可由生物再吸收材料构成,在使用减压传送装置211之后,此材料不必从患者身体上移除。适当的生物再吸收材料可没有限制地包括聚乳酸(PLA)和聚乙醇酸(PGA)的聚合混合物。聚合混合物还可没有限制地包括聚碳酸酯、聚丙烯延胡索酸酯(polyfumarate)和己内酯(capralactone)。柔性障壁213和柔性衬底227可进一步用作新细胞生长的支架,或支架材料可结合柔性障壁213和柔性衬底227使用,以促进细胞生长。适当的支架材料可没有限制地包括磷酸钙、胶原、PLA/PGA、珊瑚羟基磷灰石、碳酸盐或经处理的同种异基因移植物。优选地,支架材料具有高空隙率(即,高空气含量)。
在一个实施方式中,柔性衬底227可粘性地附着到柔性障壁213的表面。如果使用硅氧烷聚合物来形成柔性障壁213,则还可使用硅氧烷粘合剂来将柔性衬底227附着到柔性障壁213。虽然当柔性衬底227被表面粘结到柔性衬底213时,粘合剂是附着的优选方法,但可使用任何适当的附着方式。
柔性障壁213包括在柔性障壁213的表面上从翼状部分219延伸的多个凸出物231。凸出物231可为圆柱形、球形、半球形、立方体或任何其它形状,只要每个凸出物231的至少一些部分处在一个平面内,该平面不同于与凸出物231附着到的柔性衬底213的侧面相关的平面。在这方面,特定的凸出物231甚至不需要具有与其它凸出物231相同的形状或尺寸;事实上,凸出物231可包括不同形状和尺寸的随机混合。因此,每个凸出物231从柔性障壁213延伸的距离可改变,但在多个凸出物231中间也可是统一的。
凸出物231在柔性障壁231上的设置,产生凸出物之间的多个流动通道233。当凸出物231具有统一的形状和尺寸并在柔性障壁213上均匀地间隔开时,在凸出物231之间产生的流动通道233类似地是均匀的。凸出物231的尺寸、形状和间距的变化,可用于改变流动通道233的尺寸和流动特征。
减压传送管241位于弓形通道223内并附着到柔性障壁213,如图5所示。减压传送管241可单独地附着到柔性障壁213或柔性衬底227,或管241可附着到柔性障壁213和柔性衬底227两者。减压传送管241包括在管241的远端处的远端口243。管241可设置成使得远端口243位于沿着弓形通道223的任何点处,但管241优选地设置成使得远端口243大约位于沿着弓形通道223的纵向长度的中间处。通过沿着定向成与管241的纵轴小于90度的平面切割管241,优选地使远端口243在形状上为椭圆形或卵形的。虽然口243也可为圆形的,但口243的椭圆形状增加了与在凸出物231之间形成的流动通道233的流体相通。
减压传送管241优选地由涂有paralyne的硅氧烷或氨基甲酸乙酯制成。然而,任何医用级管形材料可用于构造减压传送管241。可涂覆管的其它涂层包括肝磷脂、抗凝血剂、抗纤维蛋白原(anti-fibrinogen)、抗粘剂、抗凝血酶原(anti-thrombinogen)和亲水涂层。
在一个实施方式中,减压传送管241还可包括沿着减压传送管241设置的排放开口(vent opening)或排放口251,作为对远端口243的替换物或除了远端口243以外的附加开口,以进一步增加减压传送管241和流动通道233之间的流体相通。如图1-5所示,减压传送管241可沿着弓形通道223的纵向长度的仅仅一部分设置,或可选地可沿着弓形通道223的整个纵向长度设置。如果设置成使得减压传送管241占据弓形通道223的整个长度,则远端口243可被盖住,以便管241和流动通道233之间的全部流体相通都通过排放开口251来实现。
减压传送管241进一步包括在管241的近端处的近端口255。近端口255配置成与减压源紧密配合,下面参考图9更详细地描述减压源。减压传送管241在图1-3、4A和5中示出,并仅包括单腔或单通路(passageway)259。然而,减压传送管241可能包括多腔,例如在图4B中示出的双腔管261。双腔管261包括第一腔263和第二腔265。双腔管的使用提供了在减压传送管241的近端和流动通道233之间的流体相通的分离的路径。例如,双腔管261的使用可用于允许在减压源和流动通道233之间沿着第一腔263的相通。第二腔265可用于将流体引到流动通道233。该流体是过滤的空气或其它气体、抗菌剂、抗病毒剂、细胞生长促进剂、冲洗液、化学活性液或任何其它流体。如果希望通过分离的流体相通路径将多种流体引到流动通道233,则减压传送管可设置有多于两个的腔。
仍然参考图4B,水平隔板271将减压传送管261的第一和第二腔263、265分开,导致第一腔263设置在第二腔265的上方。第一和第二腔263、265的相对位置可改变,取决于如何在腔263、265和流动通道233之间设置流体相通。例如,当第一腔263设置成如图4B所述时,类似于排放开口251的排放开口可设置成允许与流动通道233相通。当第二腔263设置成如图4B所述时,第二腔263可通过类似于远端口243的远端口与流动通道233相通。可选地,减压传送管的多个腔可与使腔分离的垂直隔板并排设置,或腔可同心或同轴地布置。
对本领域中普通技术人员应很明显,流体相通的独立路径的提供可用很多不同的方法实现,包括提供如上所述的多腔管的方法。可选地,通过将单腔管附着到另一单腔管,或通过使用具有单腔或多腔的分离的未附着的管,可提供流体相通的独立路径。
如果使用分离的管提供与流动通道233流体相通的分离路径,则隆起部分215可包括多个弓形通道223,对每个管有一个弓形通道。可选地,弓形通道223可被扩大以容纳多个管。下面参考图9更详细地讨论具有与流体传送管分离的减压传送管的减压传送装置的例子。
参考图6-8,根据本发明的原理的减压传送装置或翼状歧管311包括具有隆起部分315和一对翼状部分319的柔性障壁313。每个翼状部分319沿着隆起部分315的相对侧设置。隆起部分315形成可以延伸或可以不延伸翼状歧管311的整个长度的弓形通道323。虽然隆起部分315可位于翼状歧管311的中央,使得翼状部分319的尺寸相等,但是隆起部分315也可如图6-8所示的偏移,导致一个翼状部分319比另一个翼状部分319宽。如果翼状歧管311与骨再生或愈合结合使用,一个翼状部分319的额外宽度可能特别有用,且较宽的翼状歧管311将包裹在附着到骨骼的固定构件的周围。
微孔材料327附着到柔性障壁313,并可设置为覆盖柔性障壁313的整个表面的单块材料,越过隆起部分315和两个翼状部分319延伸。微孔材料327包括布置成与柔性障壁313相邻的附着表面(在图6中不可见)、与附着表面相对的主要分布表面329和多个周界表面330。
在一个实施方式中,柔性障壁313可类似于柔性障壁213并包括柔性衬底。虽然粘合剂是将微孔材料327附着到柔性障壁313的优选方法,但是柔性障壁313和微孔材料327可通过任何适当的附着方法附着,或留给用户在治疗的部位装配。柔性障壁313和/或柔性衬底用作对于流体例如液体、空气和其它气体透过的不可透过的障壁。
在一个实施方式中,柔性障壁和柔性衬底可以不单独地设置成支持微孔材料327。更确切地,微孔材料327可具有形成整体的障壁层,该障壁层是微孔材料327的不可透过的部分。障壁层可由闭孔材料形成以阻止流体的透过,从而代替柔性障壁313。如果形成整体的障壁层用于微孔材料327,则障壁层可包括隆起部分和翼状部分,如前面参考柔性障壁313所述的。
柔性障壁313优选地由弹性材料例如硅氧烷聚合物制成。适当的硅氧烷聚合物的例子包括由Nusil Technologies of Carpinteria,California制造的MED-6015。然而应注意,柔性障壁313可由任何其它生物相容的柔性材料制成。如果柔性障壁装入或以其它方式合并柔性衬底,则柔性衬底优选地由聚酯针织织物制成,例如由C.R.Bard of Tempe,Arizona制造的Bard6013。然而,柔性衬底227可由能够增加柔性障壁313的强度和耐久性的任何生物相容的柔性材料制成。
在一个实施方式中,微孔材料327是具有范围为约400-600微米的小孔尺寸的开孔网状聚醚型氨基甲酸乙酯(polyetherurethane)泡沫。该泡沫的例子可包括由Kinetic Concepts,Inc.of San Antonio,Texas制造的GranuFoam。微孔材料327还可为纱布、毡制垫(felted mat)、或在三个维度上通过多个通道提供流体相通的任何其它生物相容的材料。
微孔材料327主要是“开孔”材料,该“开孔”材料包括流体连接到相邻孔的多个孔。多个流动通道由微孔材料327的“开孔”形成,并在这些“开孔”之间形成。流动通道使得流体相通遍及微孔材料327的具有开孔的那部分。孔和流动通道可在形状和尺寸上是统一的,或可包括形状和尺寸的图案化或随机变化。微孔材料327的孔的形状和尺寸的变化导致流动通道中的变化,且这样的特征可用于改变通过微孔材料327的流体的流动特征。微孔材料327可进一步包括包含“闭孔”的部分。微孔材料327的这些闭孔部分包括多个孔,其中大多数没有流体连接到相邻的孔。闭孔部分的例子在上面被描述为可代替柔性障壁313的障壁层。类似地,闭孔部分可选择性地布置在微孔材料327中,以阻止流体通过微孔材料327的周界表面330透过。
柔性障壁313和微孔材料327还可由生物再吸收材料构成,在使用减压传送装置311之后,这些生物再吸收材料不必从患者的身体移除。适当的生物再吸收材料可没有限制地包括聚乳酸(PLA)和聚乙醇酸(PGA)的聚合混合物。聚合混合物还可没有限制地包括聚碳酸酯、聚丙烯延胡索酸盐和己内酯。柔性障壁313和微孔材料327可进一步用作新细胞生长的支架,或支架材料可结合柔性障壁313、柔性衬底327和/或微孔材料327使用,以促进细胞生长。适当的支架材料可没有限制地包括磷酸钙、胶原、PLA/PGA、珊瑚羟基磷灰石、碳酸盐或经处理的同种异基因移植物。优选地,支架材料具有高空隙率(即,高空气含量)。
减压传送管341设置在弓形通道323内,并附着到柔性障壁313。减压传送管341还可附着到微孔材料327,或在只有微孔材料327存在的情况下,减压传送管341可只附着到微孔材料327。减压传送管341包括在管341的远端处的远端口343,其类似于图5的远端口243。减压传送管341可设置成使得远端口343位于沿着弓形通道323的任何点处,但优选地大约位于沿着弓形通道323的纵向长度的中间处。通过沿着定向成与管341的纵轴小于90度的平面切割管341,优选地将远端口343制成在形状上为椭圆形或卵形的。虽然口也可为圆形的,但是口的椭圆形状增加了与微孔材料327中的流动通道的流体相通。
在一个实施方式中,减压传送管341也可包括排放开口或排放口(未示出),类似于图5的排放开口251。排放开口沿着管341设置,作为对远端口343的替换物或除了远端口343以外的附加开口,以进一步增加减压传送管341和流动通道之间的流体相通。如前所述,减压传送管341可沿着弓形通道323的纵向长度的仅仅一部分设置,或可选地可沿着弓形通道323的整个纵向长度设置。如果设置成使得减压传送管341占据整个弓形通道323,则远端口343可被盖住,以便管341和流动通道之间的全部流体相通都通过排放开口来实现。
优选地,微孔材料327覆盖并直接接触减压传送管341。微孔材料327可连接到减压传送管341,或微孔材料327可简单地附着到柔性障壁313。如果减压传送管341设置成使得它仅延伸到弓形通道323的中点,则微孔材料327也可在弓形通道323不包括减压传送管341的那个区域内,连接到柔性障壁313的隆起部分315。
减压传送管341进一步包括在管341的近端处的近端口355。近端口355配置成与减压源紧密配合,下面参考图9更详细地描述减压源。在图6-8中示出的减压传送管341仅包括单腔或单通路359。然而,减压传送管341可能包括多个腔,例如前面参考图4B描述的多腔。多腔管的使用提供了在减压传送管341的近端和流动通道之间的流体相通的分离的路径,如前所述。流体相通的这些分离的路径还可由具有与流动通道相通的单腔或多腔的分离的管提供。
参考图8A和8B,根据本发明的原理的减压传送装置371包括减压传送管373,减压传送管373具有在减压传送管373的远端377处的延伸部分375。延伸部分375优选地被成形为弓形,以匹配减压传送管373的曲率。延伸部分375可通过移除减压传送管373在远端377的一部分来形成,从而形成具有肩部383的切口381。多个凸出物385布置在减压传送管373的内表面387上,以在凸出物385之间形成多个流动通道391。凸出物385可在尺寸、形状和间距上与参考图1-5描述的凸出物类似。减压传送装置371特别适合于将减小的压力施加到能够接纳在切口381内的结缔组织上的组织,并使这些结缔组织上的组织再生。韧带、腱和软骨是可由减压传送装置371治疗的组织的非限制性的例子。
参考图9,类似于在这里描述的其它减压传送装置,减压传送装置411用于将减压组织治疗应用于组织部位413,例如患者的人类骨骼415。当用于促进骨组织生长时,减压组织治疗可增加与骨折、不愈合、空隙或其它骨缺损相关的愈合率。进一步认为,减压组织治疗可用于提高骨髓炎的恢复。该治疗可进一步用于增加遭受骨质疏松症的患者的局部骨密度。最后,减压组织治疗可用于加快和提高矫形移植物例如髋移植物、膝移植物和固定装置的骨结合。
仍然参考图9,减压传送装置411包括具有近端421的减压传送管419,近端421流体连接到减压源427。减压源427是泵或任何其它装置,这些装置能够通过减压传送管419和与减压传送装置411相关的多个流动通道,将减小的压力施加到组织部位413。将减小的压力施加到组织部位413是通过将减压传送装置411的翼状部分设置成与组织部位413相邻来实现的,这在此特定的例子中包括将翼状部分包裹在骨骼415中的空隙缺损429周围。减压传送装置411可通过外科手术或经由皮肤插入。当经由皮肤插入时,减压传送管419优选地通过消毒的穿透患者的皮肤组织的插入鞘插入。
减压组织治疗的应用一般在组织部位413周围的区域内产生肉芽组织。肉芽组织是通常在体内组织修复之前形成的常见组织。在正常情况下,肉芽组织可响应于外来物体或在创伤愈合期间形成。肉芽组织一般用作健康置换组织的支架,并进一步导致一些疤痕组织的生长。肉芽组织是高度血管化的,且在存在减小的压力的情况下,高度血管化组织的增加的生长和生长率将促进组织部位413处的新组织生长。
仍然参考图9,流体传送管431可在远端流体连接到减压传送装置411的流动通道。流体传送管431包括流体连接到流体传送源433的近端432。如果传送到组织部位的流体是空气,则空气优选地由至少能够过滤小至0.22μm的微粒的过滤器434过滤,以便净化和消毒空气。将空气引到组织部位413对便于组织部位413的良好引流很重要,特别是当组织部位413位于皮肤的表面之下时,从而减少或阻止了减压传送管419的阻塞。流体传送管431和流体传送源433也可用于将其它流体引到组织部位413,没有限制地包括抗菌剂、抗病毒剂、细胞生长促进剂、冲洗液或其它化学活性剂。当经由皮肤插入时,流体传送管431优选地通过消毒的穿透患者的皮肤组织的插入鞘插入。
压力传感器435可操作地连接到流体传送管431,以指示是否流体传送管431由于血液或其它体液而阻塞。压力传感器435可操作地连接到流体传送源433以提供反馈,以便控制被引到组织部位413的流体的数量。止回阀(未示出)也可操作地连接在流体传送管431的远端附近,以阻止血液或其它体液进入流体传送管431。
由减压传送管419和流体传送管431提供的流体相通的独立路径可用很多不同的方法实现,包括提供如前面参考图4B描述的单腔管、多腔管的方法。本领域中的普通技术人员应认识到,如果使用多腔管,传感器、阀和与流体传送管431相关的其它部件也可类似地与减压传送管419内特定的腔相关。优选地,与组织部位流体相通的任何腔或管涂有抗凝血剂,以阻止腔或管内体液或血液的阻塞。可涂覆腔或管的其它涂层没有限制地包括肝磷脂、抗凝血剂、抗纤维蛋白原、抗粘剂、抗凝血酶原和亲水涂层。
参考图10-19,试验显示了减压组织治疗在应用于骨组织时的积极效果。在一个特定的试验中,减压组织治疗应用于几个兔子的颅骨,以确定其对骨生长和再生的效果试验的特定目的是发现减压组织治疗对颅骨上没有缺损或损伤的兔子的效果,减压组织治疗对颅骨上具有临界尺寸缺损的兔子的效果,以及使用支架材料通过减压组织治疗来治疗颅骨上的临界尺寸缺损的效果。下面在表1中列出特定的试验方案和兔子的数量。
Figure A20078001753100241
表1:试验方案
临界尺寸缺损是组织(例如,颅骨)内的缺损,其尺寸足够大,使得该缺损不能完全通过活体内的恢复来痊愈。对于兔子,钻直径大约为15mm的贯穿颅骨的全厚度孔,产生颅骨的临界尺寸缺损。
更具体地参考图10,其示出具有未试验过的、未损坏的骨骼的兔子颅骨的组织切片。颅骨的骨组织染色为品红色,周围的软组织为白色,且骨膜层被黄色的星号加亮。在图11中,示出在应用了减压组织治疗6天且之后立即进行组织获取后的兔子颅骨。骨骼和骨膜是可见的,且已经形成一层肉芽组织。在图12中,示出在应用了减压组织治疗6天且之后立即进行组织获取后的兔子颅骨。图12的组织切片以在肉芽组织下形成新的骨组织为特征。骨组织由黄色的星号加亮。在图13中,示出在应用了减压组织治疗6天且之后立即进行组织获取后的兔子颅骨。新的骨骼和骨膜是可见的。响应于减压组织治疗的骨组织形成的此组织学表现,非常类似于在经受新骨骼的非常快速的生长和沉积的非常年幼的动物中的骨形成的组织学表现。
更具体地参考图14-19,示出一些照片和组织切片,其显示对具有临界尺寸缺损的兔子颅骨进行减压组织治疗的程序和结果。在图14中,示出兔子颅骨,其上产生了两个临界尺寸缺损。全厚度临界尺寸缺损大约直径为15mm。在图15中,不锈钢筛网放置在一个临界尺寸缺损上,而磷酸钙支架放置在第二个临界尺寸缺损内。在图16中,类似于这里描述的那些装置的减压组织治疗装置用于将减小的压力施加到临界尺寸缺损。施加到每个缺损的压力数量是-125mm Hg表压力。根据图1中列出的方案之一,施加减小的压力。在图17中,示出了在6天的减压组织治疗和术后12周获取之后的颅骨的组织切片。所示切片包括用红箭头表示的磷酸钙支架。减压组织治疗的应用导致新的骨组织的明显生长,新的骨组织在图17中用黄色的星号加亮。骨生长的数量明显大于包含相同的磷酸钙支架但不用减压组织治疗处理的临界尺寸缺损。该观测暗示可能存在得到丰富的新骨骼响应所需的治疗的阈值水平或持续时间。减压组织治疗的效果在术后12周收集的样本中最明显,这指示减压组织治疗发起导致新骨组织的形成增强的一连串生物事件。
用不锈钢筛网(图15)覆盖但在缺损中没有支架材料的临界尺寸缺损,用作具有最少新骨骼生长的动物体内控制器。这些数据突出了适当的支架材料的优点和减压组织治疗对支架整合(integration)和生物性能的积极效果。在图18和19中,示出在六天的减压组织治疗之后的填充支架的临界尺寸缺损的射线照片。图18示出术后2周的缺损,并示出支架内的一些新的骨沉积。支架的主要结构仍然是明显的。图19示出术后12周的缺损,并显示由于组织整合,即,支架基体内的新骨骼形成,临界尺寸缺损几乎完全愈合,并且主要支架结构接近完全的损耗。
参考图20,根据本发明的实施方式的减压传送系统711将减压组织治疗传送到患者的组织部位713。减压传送系统711包括歧管传送管721。歧管传送管721可为导管或套管,并可包括部件,例如允许歧管传送管721被引导到组织部位713的操纵单元725和导向线(guide wire)727。导向线727和歧管传送管721的放置和引导,可使用内窥镜检查法、超声波、荧光透视法、听诊、触诊或任何其它适当的定位技术来实现。歧管传送管721设置成将减压传送装置经由皮肤插到患者的组织部位713。当经由皮肤插入时,歧管传送管721优选地通过消毒的穿透患者的皮肤组织的插入鞘插入。
在图20中,组织部位713包括与患者骨骼733上的骨折731相邻的骨组织。歧管传送管721通过患者的皮肤735和骨骼733周围的任何软组织739插入。如前面讨论的,组织部位713还可包括任何其它类型的组织,没有限制地包括脂肪组织、肌肉组织、神经组织、皮肤组织、血管组织、结缔组织、软骨、腱或韧带。
参考图21和22,其进一步示出减压传送系统711。歧管传送管721可包括锥形远端743,以便容易通过患者的皮肤735和软组织739进行插入。锥形远端743可进一步配置成能径向向外弯曲到开放位置,使得远端743的内径实质上等于或大于管721的其它部分的内径。远端743的开放位置在图21中由虚线737简要示出。
歧管传送管721进一步包括通路751,通路751中包括减压传送装置761或任何其它减压传送装置。减压传送装置761包括类似于参考图6-8描述的柔性障壁765和/或微孔材料767。柔性障壁765和/或微孔材料767优选地被卷绕、折叠或以其它方式压缩在减压传送管769周围,以减小通道751内减压传送装置761的横截面面积。
在将歧管传送管721的远端743放置在组织部位713处之后,可将减压传送装置761放置在通路751内,并引导到组织部位713。可选地,在歧管传送管721插入患者体内之前,减压传送装置761可预先放置在通路751内。如果推动减压传送装置761穿过通路751,则可使用生物相容的润滑剂来减小减压传送装置761和歧管传送管721之间的摩擦。当远端743放置在组织部位713且减压传送装置761被传送到远端743时,减压传送装置761接着被推向远端743,使远端743径向向外膨胀到开放位置中。减压传送装置761从歧管传送管721中推出,优选地进入相邻于组织部位713的空隙或空间。空隙或空间一般由软组织的剥离形成,这可通过经由皮肤的装置实现。在一些情况下,组织部位713可位于创伤部位,且空隙可由于创伤的解剖而自然地出现。在其它例子中,可通过气囊剥离、锐性剥离、钝性剥离、水剥离(hydrodissection)、气动剥离、超声波剥离、电烙剥离(electrocauterydissection)、激光剥离或任何其它适当的剥离技术,来产生空隙。当减压传送装置761进入与组织部位713相邻的空隙时,减压传送装置761的柔性障壁765和/或微孔材料767展开、张开或解压缩(见图22),以便减压传送装置761可放置成与组织部位713接触。虽然不是必需,柔性障壁765和/或微孔材料767可能受到通过减压传送管769提供的真空或减小的压力,以压缩柔性障壁765和/或微孔材料767。通过缓解经由减压传送管769提供的减小的压力,或通过经由减压传送管769提供正压力,来帮助展开过程,可实现柔性障壁765和/或微孔材料767的展开。减压传送装置761的最终放置和操作,可使用内窥镜检查法、超声波、荧光透视法、听诊、触诊或任何其它适当的定位技术来实现。在放置减压传送装置761之后,歧管传送管721优选地从患者身上移除,但与减压传送装置761相关的减压传送管保持在原位,以允许减小的压力经由皮肤施加到组织部位713。
参考图23-25,根据本发明的实施方式的减压传送系统811包括具有锥形远端843的歧管传送管821,锥形远端821配置成能径向向外弯曲到开放位置,使得远端843的内径实质上等于或大于管821的其它部分的内径。远端843的开放位置在图23-25中由虚线837简要示出。
歧管传送管821进一步包括通路,通路中包括减压传送装置861,类似于在这里描述的任何其它减压传送装置。减压传送装置861包括柔性障壁865和/或微孔材料867,柔性障壁865和/或微孔材料867优选地被卷绕、折叠或以其他方式压缩在减压传送管869周围,以减小通路内减压传送装置861的横截面面积。
具有内部空间873的不可透过膜871布置在减压传送装置861周围,以便减压传送装置861包括在不可透过膜871的内部空间873内。不可透过膜871可为气囊、鞘或能够阻止流体透过的任何其它类型的膜,以便不可透过膜871可呈现压缩位置(见图23)、松弛位置(见图24)和膨胀位置(见图25和25A)中的至少一个。不可透过膜871可密封地连接到歧管传送管821,使得不可透过膜871的内部空间873与歧管传送管821的通路流体相通。不可透过膜871可以可选地附着到减压传送管869,使得不可透过膜871的内部空间873与减压传送管869的通路流体相通。不可透过膜871可替代地附着到与内部空间873流体相通的分离的控制管或控制腔(见例如图25A)。
在一个实施方式中,不可透过膜871可设置成进一步减小通路内减压传送装置861的横截面积。为了实现这一点,施加到不可透过膜871的内部空间873的压力小于不可透过膜871周围的环境压力。内部空间873内相当大一部分的空气或其它流体因而被排空,从而将不可透过膜871置于图23所示的压缩位置中。在压缩位置中,不可透过膜871向内拉,以便将压缩力施加到减压传送装置861,以进一步减小减压传送装置861的横截面积。如前面参考图21和22所述的,在将歧管传送管821的远端843放置在组织部位之后,可将减压传送装置861传送到组织部位。减压传送装置861和不可透过膜871的放置和操作,可使用内窥镜检查法、超声波、荧光透视法、听诊、触诊或任何其它适当的定位技术来实现。不可透过膜871可包括不透X线标志物(radio-opaque marker)881,不透X线标志物881可在移除不可透过膜871之前提高其在荧光透视下的显象。
在推动减压传送装置861穿过远端843之后,可减弱施加到内部空间873的减小的压力,以将不可透过膜871放置在松弛位置中(见图24),从而有利于减压传送装置861更容易从不可透过膜871移除。可提供移除工具885,例如套针、通管针或其它尖锐的器械,以割裂不可透过膜871。优选地,移除工具885通过减压传送管869插入,并能够前进而与不可透过膜871接触。在割裂不可透过膜871之后,移除工具885和不可透过膜871可通过歧管传送管821收回,允许减压传送装置861的柔性障壁865和/或微孔材料867展开、张开或解压缩,以便减压传送装置861可放置成与组织部位接触。在放松传送到内部空间873的减小的压力以及移除不可透过膜871之后,柔性障壁865和/或微孔材料867的展开可自动出现。在一些情况下,正压力可通过减压传送管869传送,以帮助展开或解压缩柔性障壁865和/或微孔材料867。在最终放置了减压传送装置861之后,歧管传送管821优选地从患者身上移除,但与减压传送装置861相关的减压传送管869保持在原位,以允许减小的压力经由皮肤施加到组织部位。
在靠着组织部位放置减压传送装置861之前,不可透过膜871还可用于剥离与组织部位相邻的组织。在推动减压传送装置861和完整的不可透过膜871穿过歧管传送管821的远端843之后,空气或其它流体可被注入或抽入不可透过膜871的内部空间873中。优选地使用液体来使不可透过膜871膨胀,因为液体的不可压缩性允许不可透过膜871更均匀和一致地膨胀。不可透过膜871可如图25所示的径向膨胀,或根据其制造方法和与歧管传送管821的附着方式而定向地膨胀。随着由于空气或流体的压力而使不可透过膜871向外膨胀到膨胀位置中(见图25),剥离出与组织部位相邻的空隙。当空隙足够大时,液体、空气或其它流体可从内部空间873释放,以允许不可透过膜871呈现松弛位置。不可透过膜871可接着如前面解释的被割裂,且减压传送装置861相邻于组织部位被插入。
参考图25A,如果不可透过膜871主要用于剥离邻近组织部位的组织,则不可透过膜871可密封地附着到歧管传送管821,以便内部空间873与相关于或附着到歧管传送管821的次级腔或管891流体相通。次级腔891可用于将液体、空气或其它流体传送到内部空间873,以将不可透过膜871置于膨胀位置中。在剥离之后,不可透过膜871可被放松并割裂,如前面参考图24所述的。
参考图26,根据本发明的实施方式的减压传送系统911包括具有锥形远端943的歧管传送管921,锥形远端943配置成能径向向外弯曲到开放位置,使得远端943的内径实质上等于或大于管921的其它部分的内径。远端943的开放位置在图26中由虚线937简要示出。
歧管传送管921进一步包括通路,通路中包括减压传送装置961,类似于在这里描述的其它减压传送装置。减压传送装置961包括柔性障壁965和/或微孔材料967,柔性障壁965和/或微孔材料967优选地被卷绕、折叠或以其他方式压缩在减压传送管969周围,以减小歧管传送管921的通路内减压传送装置961的横截面面积。
具有内部空间973的不可透过膜971布置在减压传送装置961周围,以便减压传送装置961包括在不可透过膜971的内部空间973内。不可透过膜971在不可透过膜971的一端上包括胶密封物977,以提供从不可透过膜971移除减压传送装置961的可选方法。不可透过膜971可密封地连接到歧管传送管921的另一端,使得不可透过膜971的内部空间973与歧管传送管921的通路流体相通。可选地,不可透过膜971可附着到与内部空间973流体相通的分离的控制管(未示出)。
类似于图23的不可透过膜871,不可透过膜971能够阻止流体透过,以便不可透过膜971可呈现压缩位置、松弛位置和膨胀位置中的至少一个。因为用于将不可透过膜971置于压缩位置和膨胀位置中的程序类似于不可透过膜871的程序,只描述移除减压传送装置961的不同过程。
减压传送装置961被传送到不可透过膜971内的组织部位,并接着使用内窥镜检查法、超声波、荧光透视法、听诊、触诊或任何其它适当的定位技术被适当地定位。不可透过膜971可包括不透X线标志物981,不透X线标志物981可在移除不可透过膜971之前提高其在荧光透视下的显象。接着推动减压传送装置961穿过歧管传送管921的远端943。可减少施加到内部空间973的减小的压力,以将不可透过膜971置于松弛位置中。接着推动减压传送装置961穿过胶密封物977,以退出不可透过膜971。
参考图26A,根据本发明的实施方式的减压传送系统985可不包括类似于图26的歧管传送管921的歧管传送管。代替地,减压传送系统985可包括导向线987、减压传送管989和减压传送装置991。减压传送装置991包括流体连接到减压传送管989的多个流动通道。不是使用独立的歧管传送管来传送减压传送装置991,而是将减压传送装置991和减压传送管989设置在被经由皮肤引导到组织部位993的导向线987上。优选地,导向线987和减压传送管989通过消毒的鞘穿入患者的皮肤。通过沿着导向线987引导减压传送管989和减压传送装置991,减压传送装置991可放置在组织部位993,以允许经由皮肤应用减压组织治疗。
因为减压传送装置991在传送到组织部位993期间没有被限制在歧管传送管内,在传送期间将减压传送装置991保持在压缩位置中是优选的。如果将弹性泡沫用作减压传送装置991,则可将生物相容的可溶粘合剂涂到泡沫和被压缩的泡沫上。当到达组织部位时,通过减压传送管989传送的体液或其它流体溶解粘合剂,从而允许泡沫膨胀成与组织部位接触。可选地,减压传送装置991可由压缩的干燥水凝胶形成。水凝胶在传送到组织部位993之后吸收湿气,从而允许减压传送装置991膨胀。又一减压传送装置991可由热活性材料(例如聚乙二醇)制成,该热活性材料当被暴露给患者的体热时在组织部位993膨胀。在又一实施方式中,压缩的减压传送装置991可在可溶性膜中被传送到组织部位993。
参考图27,根据本发明的实施方式的减压传送系统1011包括具有远端1043的歧管传送管1021,远端1043穿过患者的组织插入以接近组织部位1025。组织部位1025可包括与创伤或其它缺损相关的空隙1029,或可选地,空隙可通过剥离产生,包括这里描述的剥离技术。
在将远端1043放置在与组织部位1025相邻的空隙1029内之后,将可注射的、可灌入的或可流动的减压传送装置1035通过歧管传送管1021传送到组织部位1025。优选地,在传送到组织部位期间,减压传送装置1035以易流动的状态存在,并接着在到达之后形成用于分布减小的压力或流体的多个流动通道。在一些情况下,在到达组织部位之后,可通过干燥过程、固化过程或其它化学或物理反应来将可流动物质硬化成固体状态。在其它情况下,可流动物质可在传送到组织部位之后,在原位形成泡沫。在组织部位1025处还可存在凝胶类状态的其他可流动物质,但仍然具有用于传送减小的压力的多个流动通道。传送到组织部位1025的减压传送装置1035的数量可足以部分或全部充满空隙1029。减压传送装置1035可包括歧管和支架的两个方面。作为歧管,减压传送装置1035包括可在传送到空隙1029之后在材料内形成的多个小孔或开孔。小孔或开孔彼此相通,从而产生多个流动通道。流动通道用于对组织部位1025施加和分布减小的压力。作为支架,减压传送装置1035是生物再吸收的,并用作新组织可在其上和其内生长的基质。
在一个实施方式中,减压传送装置1035可包括致孔剂(poragen),例如NaCl,或遍及液体或粘性凝胶分布的其它盐类。在液体或粘性凝胶被传送到组织部位1025之后,这些材料适应空隙1029并接着固化成固体状态。水溶的NaCl致孔剂在有体液的情况下溶解,留下具有相互连接的小孔的结构或流动通道。减小的压力和/或流体被传送到流动通道。当新组织生长时,组织生长到减压传送装置1035的小孔中,并接着在减压传送装置1035退化时最终取代它。在此特定的例子中,减压传送装置1035不仅用作歧管,而且还作为用于新组织生长的支架。
在另一实施方式中,减压传送装置1035是与400μm甘露糖小珠(bead)混合的藻酸盐。致孔剂或小珠可由局部体液或由传送到组织部位处的减压传送装置1035的冲洗流体或其它流体溶解。在致孔剂或小珠溶解之后,以前被致孔剂或小珠占据的空间变成空隙,该空隙与其它空隙相互连接以在减压传送装置1035内形成流动通道。
使用致孔剂来产生材料中的流动通道是有效的,但它也形成在尺寸上被限制为大约选定致孔剂的微粒尺寸的小孔和流动通道。代替致孔剂,由于气态副产品的形成,化学反应可用于产生较大的小孔。例如,在一个实施方式中,可流动物质可被传送到组织部位1025,该物质包括碳酸氢钠和柠檬酸微粒(可使用非化学计量的数量)。当可流动物质在原位形成泡沫或固体时,体液将引起碳酸氢钠和柠檬酸之间的酸碱反应。所产生的作为结果的二氧化碳气体微粒在整个减压传送装置1035中产生比依赖于致孔剂溶解的技术更大的小孔和流动通道。
减压传送装置1035从液体或粘性凝胶到固体或泡沫的转换,可通过pH、温度、光、或与体液、传送到组织部位的化学制品或其它物质的反应来触发。转换也可通过混合多个反应成分而出现。在一个实施方式中,通过选择从任何生物再吸收的聚合物制成的生物再吸收的微球体,来制备减压传送装置1035。微球体分散在溶液中,该溶液包含光引发剂和水凝胶形成材料,例如透明质酸、胶原或具有光反应基团的聚乙二醇。微球体-凝胶混合物被暴露给光一段短暂的时间,以部分地交联水凝胶并将水凝胶固定在微球体上。额外的溶液被排出,且微球体接着被干燥。微球体通过注射或灌注被传送到组织部位,并且在传送之后,混合物吸收湿气,且水凝胶涂层变成水合的。混合物接着被再次暴露给光,光使微球体交联,从而产生多个流动通道。交联的微球体接着用作将减小的压力传送到组织部位的支架,并用作促进新组织生长的多孔支架。
除了这里描述的前面的实施方式以外,减压传送装置1035可由各种材料制成,没有限制地包括磷酸钙、胶原、藻酸盐、纤维素或任何其它等效材料,这些等效材料能够作为气体、液体、凝胶、糊剂、油灰、泥浆、悬浮液或其它可流动物质被传送到组织部位,并能够形成与组织部位流体相通的多个流动路径。可流动物质可进一步包括微粒固体,例如小珠,如果微粒固体在尺寸上足够小,则其能够流过歧管传送管1021。以可流动的状态传送到组织部位的物质可在原位聚合或形成胶体。
如前所述,减压传送装置1035可被直接注射或灌注到与组织部位1025相邻的空隙1029中。参看图27A,歧管传送管1021可包括在歧管传送管1021的远端1043处的不可透过膜或半透过膜1051。膜1051包括内部空间1055,内部空间1055与附着到歧管传送管1021的次级腔1057流体相通。歧管传送管1021被引导到在导向线1061之上的组织部位1025。
减压传送装置1035可通过次级腔1057被注射或灌注,以填充膜1051的内部空间1055。当流体或凝胶充满膜1051时,膜1051膨胀以充满空隙1029,使得膜与组织部位1025接触。当膜1051膨胀时,膜1051可用于剥离邻近或接近组织部位1025的另外组织。膜1051如果是不能透过的,就可被物理地割裂和移除,留下与组织部位1025接触的减压传送装置1035。可选地,膜1051可由可溶性材料制成,当存在可传送到膜1051的体液或生物相容的溶剂时,该可溶性材料溶解。如果膜1051是半透过的,则膜1051可保留在原位。半透过膜1051允许将减小的压力和其它可能的流体传送到组织部位1025。
参看图28,对组织部位施用减压组织治疗的方法1111包括在1115通过外科手术邻近组织部位插入歧管,歧管具有从柔性障壁延伸的多个凸出物,以在凸出物之间产生流动通道。在1119,将歧管放置成使得至少一部分凸出物与组织部位接触。在1123,将减小的压力通过歧管施加到组织部位。
参看图29,对组织部位施用减压组织治疗的方法1211包括在1215邻近组织部位而经由皮肤插入歧管。歧管可包括从柔性障壁延伸的多个凸出物,以在凸出物之间产生流动通道。可选地,歧管可包括微孔材料,在该微孔材料内具有多个流动通道。可选地,歧管可由可注射的或可灌注的材料形成,该材料被传送到组织部位,并在到达组织部位后形成多个流动通道。在1219,将歧管放置成使得至少一部分流动通道与组织部位流体相通。在1223,将减小的压力通过歧管施加到组织部位。
参考图30,对组织部位施用减压组织治疗的方法1311包括在1315通过患者的组织经由皮肤插入具有通路的管,以邻近于组织部位而放置管的远端。在1319,使与管相关的气囊充气,以剥离与组织部位相邻的组织,从而产生空隙。在1323,通过通路传送歧管。歧管可包括从柔性障壁延伸的多个凸出物,以在凸出物之间产生流动通道。可选地,歧管可包括微孔材料,在该微孔材料内具有多个流动通道。可选地,歧管可由被传送到组织部位的可注射的或可灌注的物质形成,如前面参考图27所述的。在1327,将歧管放置在空隙内,使得至少一部分流动通道与组织部位流体相通。在1331,将减小的压力经由减压传送管或任何其它传送装置,通过歧管施加到组织部位。
参考图31,对组织部位施用减压组织治疗的方法1411包括在1415通过患者的组织经由皮肤插入具有通路的管,以邻近于组织部位而放置管的远端。在1423,在不可透过鞘内通过通路将歧管传送到组织部位,在1419使不可透过鞘受到小于该鞘的环境压力的第一减小的压力。在1427,割裂鞘以将歧管放置成与组织部位接触。在1431,将第二减小的压力通过歧管施加到组织部位。
参考图32和33,根据本发明的实施方式的减压传送装置1511包括用于更换患者的股骨1517的现有股骨头的矫形髋假体1515。髋假体1515包括干部分1521和头部分1525。干部分1521被延长以插在通道1529内,通道1529是在股骨1517的杆中被扩大出来的。多孔涂层1535布置在干部分周围,并优选地由烧结的或玻璃化的陶瓷或金属构成。可选地,具有多孔特征的微孔材料可布置在干部分周围。多个流动通道1541布置在髋假体1515的干部分1521内,使得流动通道1541与多孔涂层1535流体相通。连接口1545流体连接到流动通道1541,该口配置成可释放地连接到减压传送管1551和减压传送源1553。流动通道1541用于在移植之后将减小的压力传送到多孔涂层1553和/或围绕髋假体1515的骨骼。流动通道1541可包括与一些侧支线1547流体相通的主供给线1543,侧支线1547与多孔涂层1535相通。侧支线1545可定向成与主供给线1543垂直,如图32所示,或可定向成与主供给线1543成一角度。用于分布减小的压力的可选方法包括提供中空髋假体,以及用能够与多孔涂层1535流体相通的多孔(优选地开孔)材料填充该假体的内部空间。
更具体地参考图33,髋假体1515可进一步包括干部分1521内的第二多个流动通道1561,以向多孔涂层1535和/或围绕髋假体1515的骨骼提供流体。流体可包括过滤的空气或其它气体、抗菌剂、抗病毒剂、细胞生长促进剂、冲洗液、化学活性液或任何其它流体。如果希望将多种流体引到围绕髋假体1515的骨骼,则可提供流体相通的额外路径。连接口1565流体连接到流动通道1561,口1565配置成可释放地连接到流体传送管1571和流体传送源1573。流动通道1561可包括与一些侧支线1585流体相通的主供给线1583,侧支线1585与多孔涂层1535相通。侧支线1585可定向成与主供给线1583垂直,如图33所示,或可定向成与主供给线1583成一角度。
减小的压力到第一多个流动通道1541的传送以及流体到第二多个流动通道1561的传送,可由分离的管例如减压传送管1551和流体传送管1571实现。可选地,以前在这里描述的具有多腔的管可用于分离用于传送减小的压力和流体的相通路径。应进一步注意,虽然在髋假体1515内提供流体相通的分离路径是优选的,但是第一多个流动通道1541可用于将减小的压力和流体都传送到围绕髋假体1515的骨骼。
如前所述,减小的压力施加到骨组织促进和加快了新的骨组织的生长。通过使用髋假体1515作为支架以将减小的压力传送到围绕髋假体的骨骼的区域,股骨1517的恢复更快,且髋假体1515更成功地与骨骼结合。提供第二多个流动通道1561以给围绕髋假体1515的骨骼提供排放开口,提高了在假体周围新骨骼的成功产生。
在通过髋假体1515施加减小的压力一段选定数量的时间之后,减压传送管1551和流体传送管1571可从连接口1545、1565断开,并从患者身上移除,优选地没有手术侵入过程。连接口1545、1565和管1551、1571之间的连接可为手工可释放的连接,该手工可释放的连接通过将面向轴的张力施加到在患者体外的管1551、1571来实现。可选地,连接口1545、1565在有选定流体或化学制品的情况下可为生物再吸收的或可溶解的,以便管1551、1571的释放可通过将连接口1545、1565暴露给流体或化学制品来获得。管1551、1571也可由在一段时间内溶解的生物再吸收材料或在有特定的化学制品或其它物质的情况下溶解的活性材料制成。
减压传送源1553可设置在患者体外并连接到减压传送管1551,以将减小的压力传送到髋假体1515。可选地,减压传送源1553可在患者体内被移植在髋假体1515上(on-board)或附近。患者体内减压传送源1553的放置消除了对经由皮肤的流体连接的需要。被移植的减压传送源1553可为可操作地连接到流动通道1541的传统的泵。泵可由移植在患者体内的电池供电,或可由电力地且经由皮肤地连接到泵的外部电池供电。泵还可通过化学反应直接驱动,该化学反应传送减小的压力并通过流动通道1541、1561使流体流通。
虽然在图32和33中只示出髋假体1515的干部分1521和头部分1525,应注意,这里描述的用于应用减压组织治疗的流动通道和装置,可应用于接触骨骼或其它组织的髋假体1515的任何部件,包括例如髋臼杯。
参考图34,用于修复患者的关节的方法1611在1615包括将假体移植在与关节相邻的骨骼内。假体可为如上所述的髋假体,或帮助恢复患者关节的活动性的任何其它假体。假体包括配置成与骨骼流体相通的多个流动通道。在1619,减小的压力通过多个流动通道施加到骨骼,以提高假体的骨结合(oseointegration)。
参考图35和36,跟据本发明的实施方式的减压传送装置1711包括矫形固定装置1715,其用于固定包括骨折1719或其它缺损的患者骨骼1717。在图35和36中示出的矫形固定装置1715是具有多个通道1721的板,通道1721用于以螺钉1725、销、螺栓或其它紧固件将矫形固定装置1715锚定到骨骼1717。多孔涂层1753可布置在将与骨骼1717接触的矫形固定装置1715的表面上。多孔涂层优选地由烧结的或玻璃化的陶瓷或金属构成。可选地,具有多孔特征的微孔材料可布置在骨骼1717和矫形固定装置1715之间。多个流动通道1741布置在矫形固定装置1715内,使得流动通道1741与多孔涂层1735流体相通。连接口1745流体连接到流动通道1741,口配置成连接到减压传送管1751和减压传送源1753。流动通道1741用于在矫形固定装置1715固定到骨骼1717之后,将减小的压力传送到多孔涂层1753和/或围绕矫形固定装置1715的骨骼。流动通道1741可包括与一些侧支线1747流体相通的主供给线1743,侧支线1747与多孔涂层1735相通。侧支线1747可定向成与主供给线1743垂直,如图35所示,或可定向成与主供给线1743成一角度。用于分布减小的压力的可选方法包括提供中空矫形固定装置,以及用能够与多孔涂层1735流体相通的多孔(优选地开孔)材料填充矫形固定装置的内部空间。
矫形固定装置1715可为如图35所示的板,或可选地可为固定装置,例如套筒、支架、支柱、或用于稳定骨骼的一部分的任何其它装置。矫形固定装置1715可进一步为用于附着修复装置或其它矫形装置或移植组织(例如骨组织或软骨)的紧固件,假定紧固件包括用于将减小的压力传送到相邻于或包围紧固件的组织的流动通道。这些紧固件的例子可包括销、螺栓、螺钉或任何其它适当的紧固件。
更具体地参考图36,矫形固定装置1715可进一步包括矫形固定装置1715内的第二多个流动通道1761,以向多孔涂层1735和/或围绕矫形固定装置1715的骨骼提供流体。流体可包括过滤的空气或其它气体、抗菌剂、抗病毒剂、细胞生长促进剂、冲洗液、化学活性液或任何其它流体。如果希望将多种流体引到围绕矫形固定装置1715的骨骼,则可提供流体相通的额外路径。连接口1765流体连接到流动通道1761,口1765配置成连接到流体传送管1771和流体传送源1773。流动通道1761可包括与一些侧支线1785流体相通的主供给线1783,侧支线1785与多孔涂层1735相通。侧支线1785可定向成与主供给线1783垂直,如图33所示,或可定向成与主供给线1783成一角度。
减小的压力到第一多个流动通道1741的传送以及流体到第二多个流动通道1761的传送,可由分离的管例如减压传送管1751和流体传送管1771实现。可选地,以前在这里描述的具有多腔的管可用于分离用于传送减小的压力和流体的相通路径。应进一步注意,虽然在矫形固定装置1715内提供流体相通的分离路径是优选的,第一多个流动通道1741可用于将减小的压力和流体都传送到与矫形固定装置1715相邻的骨骼。
使用矫形固定装置1715作为支架以将减小的压力传送到与矫形固定装置1715相邻的骨骼区域,加快和提高了骨骼1717的缺损1719的恢复。提供第二多个流动通道1761以将流体传送到围绕矫形固定装置1715的骨骼,提高了在矫形固定装置附近新骨骼的成功产生。
参考图37,用于治愈骨骼的骨缺损的方法1811包括在1815使用矫形固定装置来固定骨骼。矫形固定装置包括布置在矫形固定装置中的多个流动通道。在1819,减小的压力通过多个流动通道施加到骨缺损。
参考图38,用于对组织部位施用减压组织治疗的方法1911包括在1915放置具有多个流动通道的歧管,使得流动通道的至少一部分与组织部位流体相通。将减小的压力在1919通过流动通道施加到组织部位,且流体在1923通过流动通道传送到组织部位。
参考图39,用于对组织部位施用减压组织治疗的方法2015包括在2015邻近于组织部位而放置歧管传送管的远端。在2019,将流体通过歧管传送管传送到组织部位。流体能够填充与组织部位相邻的空隙,并变成具有与组织部位流体相通的多个流动通道的固态歧管。将减小的压力在2023通过固态歧管的流动通道施加到组织部位。
参考图40-48,减压传送系统2111包括主歧管2115,主歧管2115具有围绕主流道2121的柔性壁2117。柔性壁2117在近端2123连接到减压传送管2125。因为减压传送管2125的形状一般在横截面上是圆形的,且因为主歧管2115的形状在横截面上可不为圆形(即,图40-45中的矩形和图46-48中的三角形),所以可在减压传送管2125和主歧管2115之间设置过渡区域2129。主歧管2115可黏附地连接到减压传送管2125,使用其它方法例如熔融或夹物模压(insert molding)连接,或可选地可通过共挤整体地连接。减压传送管2125将减小的压力传送到主歧管2115,用于分布在组织部位处或附近。
阻塞预防构件2135设置在主歧管内以阻止歧管2115倒塌,并且因而阻止在施加减小的压力期间主流道2121的阻塞。在一个实施方式中,阻塞预防构件2135可为多个凸出物2137(见图44),凸出物2137布置在柔性壁2117的内表面2141上,并延伸到主流道2121中。在另一实施方式中,阻塞预防构件2135可为布置在内表面2141上的单脊或多脊2145(见图40和41)。在又一实施方式中,阻塞预防构件2135可包括布置在主流道内的微孔材料2149,例如图47所示。阻塞预防构件2135可为任何材料或结构,该材料或结构能够插在流道内或能够为整体的或以其它方式附着到柔性壁2117。阻塞预防构件2135能够防止柔性壁2117的完全倒塌,同时仍然允许流体流过主流道2121。
柔性壁2117进一步包括贯穿柔性壁2117的与主流道2121相通的多个孔2155。孔2155允许传送到主流道2121的减小的压力分布到组织部位。孔2155可选择性地设置在歧管2115的周界周围,以优先引导真空的传送。例如,在图51中,孔可设置成面向骨骼、面向上覆组织或两者。
减压传送管2125优选地包括具有流体连接到主流道2121的至少一个出口的第一导管2161,以将减小的压力传送到主流道2121。第二导管2163也可设置成用流体清洗主流道2121和第一导管2161,以防止或溶解由创伤渗出物或从组织部位流出的其它流体引起的阻塞物。第二导管2163优选地包括至少一个出口,所述至少一个出口设置在至少一个主流道2121和第一导管2161的至少一个出口附近。
更具体地参考图40和41,减压传送系统2111的第二导管2163可包括用于清洗主流道2121和第一导管2161的多个导管。虽然与附着到减压传送管2125的端部相对的柔性壁2117的端部可为开放的,如图40所示,已经发现,覆盖柔性壁2117的端部可提高清洗功能的性能和可靠性。优选地,头部空间2171设置在柔性壁的覆盖端部和第二导管2163的端部之间。头部空间2171允许在清洗过程期间清洗流体的增强,这帮助驱动清洗流体通过主流道2121并进入第一导管2161。
同样在图41中示出的是用作阻塞预防构件2135的间隔物。位于中央的间隔物使主流道2121分成两个室,如果一个室变得阻塞且清洗不能溶解阻塞物,这允许主歧管2115的继续操作。
参考图49和50,减压传送系统2211包括对于减压传送管2217是整体的主歧管2215。减压传送管2217包括中央腔2223和多个辅助腔2225。虽然辅助腔2225可用于测量组织部位处或附近的压力,辅助腔2225可进一步用于清洗中央腔2223以阻止或溶解阻塞物。多个孔2231与中央腔2223相通,以分布由中央腔2223传送的减小的压力。如图50所示,优选地,孔2231不穿过辅助腔2225。同样在图50中示出的是减压传送管的埋头端,其增加了辅助腔2225的端部处的头部空间2241。如果组织、支架或其它材料在施加减小的压力期间与减压传送管2217的端部啮合,则头部空间2241继续允许清洗流体传送到中央腔2223。
在操作中,图40-50的减压传送系统2111、2211可直接应用于组织部位,以将减小的压力分布到组织部位。主歧管的低剖面(low-profile)形状,对于这里描述的经由皮肤的安装和移除技术是高度期望的。类似地,主歧管也可通过外科手术插入。
参考图51,主歧管2115、2215可结合次级歧管2321使用。在图51中,次级歧管2321包括两层毡制垫。次级歧管2321的第一层放置成与包括骨折的骨组织部位接触。主歧管2115放置成与第一层接触,且次级歧管2321的第二层放置在主歧管2115的顶部和第一层上。次级歧管2321允许主歧管2115和组织部位之间的流体相通,然而阻止组织部位和主歧管2115之间的直接接触。
优选地,次级歧管2321是生物可吸收的,这允许次级歧管2321保持在原位,从而允许减压治疗的完成。当完成减压治疗时,主歧管2115可从次级歧管的层之间移除,而很少或没有干扰组织部位。在一个实施方式中,主歧管可涂有润滑材料或水凝胶形成材料,以使从层之间的移除容易。
次级歧管优选地用作新组织生长的支架。作为支架,次级歧管可包含从一组下列项中选择的至少一种物质:聚乳酸、聚乙醇酸、聚己内酯、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮(polydioxanone)、聚原酸酯(polyorthoesther)、聚磷腈、聚氨基甲酸酯、胶原、透明质酸、壳聚糖、羟基磷灰石、磷酸钙、硫酸钙、碳酸钙、生物玻璃、不锈钢、钛、钽、同种异基因移植物和自体移植物。
上面描述的减压传送系统2111、2211的清洗功能可通过这里描述的任何歧管使用。清洗传送减小的压力的歧管或导管的能力阻止阻塞物形成,而阻塞物形成会阻碍对减小的压力的施用。当组织部位附近的压力到达平衡,且流体在组织部位周围的流出变慢时,一般形成这些阻塞物。已经发现,以选定的时间间隔用空气清洗歧管和减压导管一段选定数量的时间,有助于阻止或溶解阻塞物。
更具体地,空气通过第二导管传送,第二导管与传送减小的压力的第一导管分离。第二导管的出口优选地接近于歧管或第一导管的出口。虽然空气可被压入或“推到”第二导管的出口,但是空气优选地通过第二导管由组织部位处的减小的压力抽出。已经发现,在很多实例中,在施加减小的压力期间以60秒的时间间隔传送空气2秒钟,足以阻止阻塞物形成。此清洗方案提供了足够的空气,来使流体在歧管和第一导管内充分地移动,同时防止引入太多的空气。引入太多的空气,或以太高的时间间隔频率引入空气,将导致减压系统不能在清洗周期之间恢复到目标减压。用于传送清洗流体的选定数量的时间和清洗流体被传送的选定时间间隔,一般根据系统部件(例如泵、管道系统等)的设计和尺寸变化。然而,空气应以某数量和频率传送,该数量和频率高到足以充分清除阻塞物,同时允许在清洗周期之间恢复完整的目标压力。
参考图52,在一个例证性实施方式中,减压传送系统2411包括流体连接到第一导管2419和第二导管2423的歧管2415。第一导管2419连接到减压源2429,以向歧管2415提供减小的压力。第二导管2423包括出口2435,出口2435设置成与歧管2415流体相通,并接近第一导管2419的出口。第二导管2423流体连接到阀2439,当阀置于开放位置中时,阀2439能够允许第二导管2423和周围空气之间的相通。阀2439可操作地连接到控制器2453,控制器2453能够控制阀2439的打开和关闭,来用环境空气调节第二导管的清洗,以防止歧管2451和第一导管2419内的阻塞。
应注意,包括液体或气体的任何流体可用于实现这里描述的清洗技术。虽然对清洗流体的驱动力优选地是在组织部位处减小的压力的引出,流体类似地可由类似于参考图9讨论的流体传送装置传送。
根据这里描述的系统和方法,可通过将充足的减小的压力施加到组织部位,并接着在选定的一段时间内维持所述充足的减小的压力,来实现对组织部位施用减压组织治疗。可选地,施加到组织部位的减小的压力可在本质上为周期性的。更具体地,所施加的减小的压力的数量可根据选定的时间周期变化。施加减小的压力的又一方法可随机地改变减小的压力的数量。类似地,传送到组织部位的流体的速率或体积可为恒定的、周期性的或在本质上随机的。流体传送如果是周期性的,则可出现在施加减小的压力期间,或可出现在没有施加减小的压力的循环周期期间。虽然施加到组织部位的减小的压力的数量一般根据组织部位的病理和施用压组织治疗的情况而变化,减小的压力一般在约-5mm Hg和-500mm Hg之间,但更优选地在约-5mm Hg和-300mm Hg之间。
虽然参考人类患者的组织生长和痊愈描述了本发明的系统和方法,应认识到,用于应用减压组织治疗的这些系统和方法可用在希望促进组织生长或痊愈的任何活的器官中。类似地,本发明的系统和方法可应用于任何组织,没有限制地包括骨组织、脂肪组织、肌肉组织、神经组织、皮肤组织、血管组织、结缔组织、软骨、腱或韧带。虽然组织的痊愈可为应用如这里描述的减压组织治疗的一个焦点,减压组织治疗的应用也可用于在没有生病、没有缺陷或损坏的组织内产生组织生长,特别是位于患者皮肤之下的组织。例如,可能希望使用经由皮肤的移植技术来应用减压组织治疗,以使额外的组织在组织部位生长,该额外的组织可接着被获取。获取的组织可被移植到另一组织部位以代替生病或损坏的组织,或可选地获取的组织可被移植到另一患者。
这里描述的减压传送装置可结合支架材料使用,以增加新组织的生长和生长率,注意到这一点也是重要的。支架材料可设置在组织部位和减压传送装置之间,或减压传送装置本身由用作新组织生长的支架的生物再吸收材料制成。
从前述内容应明显看出,提供了具有相当多的优点的发明。虽然本发明仅以其一些形式显示,但是本发明不被其所限制,而是容许各种变化和更改而不偏离其精神。

Claims (46)

1.一种用于将减压组织治疗应用于组织部位的减压传送系统,其包括:
主歧管,其具有围绕主流道的柔性壁,并适合于放置在组织部位附近,所述柔性壁包括具有多个凸出物的内表面,所述凸出物从所述内表面的至少一部分延伸并进入所述主流道,所述柔性壁进一步包括贯穿所述柔性壁并与所述主流道相通的多个孔;
第一导管,其流体连接到所述主流道,以通过所述主流道和所述多个孔传送减小的压力;以及
第二导管,其具有在所述主流道或所述第一导管的至少一个出口附近的至少一个出口,以清除在所述第一导管的所述至少一个出口处或附近的阻塞物。
2.如权利要求1所述的系统,其中所述第一导管和第二导管是多腔管的一部分。
3.如权利要求2所述的系统,其中所述柔性壁和多腔管是共挤的。
4.如权利要求1所述的系统,其中
所述第一导管和第二导管是多腔管的一部分;
所述柔性壁在一端连接到所述多腔管;且
所述主流道在所述柔性壁的与连接到所述多腔管的一端相对的一端被盖住。
5.如权利要求1所述的系统,其中所述第二导管至少部分地设置在所述柔性壁内。
6.如权利要求1所述的系统,其中所述柔性壁由医用级硅氧烷聚合物构成。
7.如权利要求1所述的系统,其中所述柔性壁在横截面上实质上是矩形的。
8.如权利要求1所述的系统,其中所述柔性壁沿着其轴向长度的至少一部分实质上是圆柱形的。
9.如权利要求8所述的系统,其中实质上圆柱形的所述柔性壁对着360度的弧。
10.如权利要求1所述的系统,其中所述凸出物通过防止所述柔性壁在通过所述主流道施加减小的压力期间完全倒塌,来防止所述主流道的阻塞。
11.如权利要求1所述的系统,其中所述组织部位包括选自以下组中的组织:脂肪组织、肌肉组织、神经组织、皮肤组织、血管组织、结缔组织、软骨、腱和韧带。
12.如权利要求1所述的系统,其进一步包括次级歧管,所述次级歧管适合于放置成与所述主歧管相邻,并将减小的压力从所述主歧管传递到组织部位。
13.如权利要求12所述的系统,其中所述次级歧管是生物可吸收的。
14.如权利要求12所述的系统,其中所述次级歧管是毡制垫。
15.如权利要求12所述的系统,其中所述次级歧管是支架,并包含选自以下组中的至少一种物质:聚乳酸、聚乙醇酸、聚己内酯、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮、聚原酸酯、聚磷腈、聚氨基甲酸酯、胶原、透明质酸、壳聚糖、羟基磷灰石、磷酸钙、硫酸钙、碳酸钙、生物玻璃、不锈钢、钛、钽、同种异基因移植物和自体移植物。
16.一种用于将减压组织治疗应用于组织部位的减压传送系统,其包括:
主歧管,其具有围绕主流道的柔性壁,并适合于放置在组织部位附近,所述柔性壁包括贯穿所述柔性壁并与所述主流道相通的多个孔;
微孔材料,其设置在所述主流道内,所述微孔材料具有多个流动通道;
第一导管,其流体连接到所述主流道,以通过所述主流道、所述微孔材料和所述多个孔传送减小的压力;以及
第二导管,其具有在所述主流道或所述第一导管的至少一个出口附近的至少一个出口,以清除在所述第一导管的所述至少一个出口处或附近的阻塞物。
17.如权利要求16所述的系统,其中所述第一导管和第二导管是多腔管的一部分。
18.如权利要求17所述的系统,其中所述柔性壁和多腔管是共挤的。
19.如权利要求16所述的系统,其中
所述第一导管和第二导管是多腔管的一部分;
所述柔性壁在一端连接到所述多腔管;且
所述主流道在所述柔性壁的与连接到所述多腔管的一端相对的一端被盖住。
20.如权利要求16所述的系统,其中所述第二导管至少部分地设置在所述柔性壁内。
21.如权利要求16所述的系统,其中所述柔性壁由医用级硅氧烷聚合物构成。
22.如权利要求16所述的系统,其中所述柔性壁被加固以防止在减小的压力下倒塌。
23.如权利要求16所述的系统,其中所述柔性壁在横截面上实质上是矩形的。
24.如权利要求16所述的系统,其中所述柔性壁沿着其轴向长度的至少一部分实质上是圆柱形的。
25.如权利要求24所述的系统,其中实质上圆柱形的所述柔性壁对着360度的弧。
26.如权利要求16所述的系统,其中所述微孔材料通过防止所述柔性壁在通过所述主流道施加减小的压力期间完全倒塌,来防止所述主流道的阻塞。
27.如权利要求16所述的系统,其中所述组织部位包括选自以下组中的组织:脂肪组织、肌肉组织、神经组织、皮肤组织、血管组织、结缔组织、软骨、腱和韧带。
28.如权利要求16所述的系统,其中所述微孔材料是网状、聚氨基甲酸酯泡沫。
29.如权利要求16所述的系统,其进一步包括次级歧管,所述次级歧管适合于设置成与所述主歧管相邻,并将减小的压力从所述主歧管传递到组织部位。
30.如权利要求29所述的系统,其中所述次级歧管是生物可吸收的。
31.如权利要求29所述的系统,其中所述次级歧管是毡制垫。
32.如权利要求29所述的系统,其中所述次级歧管是支架,并包含选自以下组中的至少一种物质:聚乳酸、聚乙醇酸、聚己内酯、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮、聚原酸酯、聚磷腈、聚氨基甲酸酯、胶原、透明质酸、壳聚糖、羟基磷灰石、磷酸钙、硫酸钙、碳酸钙、生物玻璃、不锈钢、钛、钽、同种异基因移植物和自体移植物。
33.一种用于将减压组织治疗应用于组织部位的减压传送系统,其包括:
主歧管,其具有围绕主流道的柔性壁,并适合于放置在组织部位附近,所述主歧管包括设置在所述主流道内的阻塞预防构件,所述柔性壁包括贯穿所述柔性壁并与所述主流道相通的多个孔;
次级歧管,其设置成与所述主歧管相邻,并适合于接触组织部位,以便所述次级歧管与所述主歧管流体相通,但适合于防止所述主歧管和组织部位之间的接触;
第一导管,其流体连接到所述主流道,以通过所述主流道和所述多个孔传送减小的压力。
34.如权利要求33所述的系统,其中所述阻塞预防构件是布置在所述柔性壁的内表面上并延伸到所述主流道内的多个凸出物。
35.如权利要求33所述的系统,其中所述阻塞预防构件是布置在所述主流道内的微孔材料。
36.如权利要求33所述的系统,其中所述次级歧管是生物可吸收的。
37.如权利要求33所述的系统,其中所述次级歧管是毡制垫。
38.如权利要求33所述的系统,其中所述次级歧管是支架,并包含选自以下组中的至少一种物质:聚乳酸、聚乙醇酸、聚己内酯、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮、聚原酸酯、聚磷腈、聚氨基甲酸酯、胶原、透明质酸、壳聚糖、羟基磷灰石、磷酸钙、硫酸钙、碳酸钙、生物玻璃、不锈钢、钛、钽、同种异基因移植物和自体移植物。
39.一种在组织部位处促进组织生长的方法,其包括:
通过外科手术将主歧管放置在组织部位附近,所述主歧管具有围绕主流道的柔性壁,所述柔性壁包括贯穿所述柔性壁并与所述主流道相通的多个孔,所述主歧管进一步包括设置在所述主流道内的阻塞预防构件;
通过外科手术将次级歧管放置成与组织部位接触,以便所述次级歧管与所述主歧管流体相通,但防止所述主歧管和组织部位之间的接触;以及
将减小的压力通过所述主流道、所述多个孔和所述次级歧管传送到组织部位。
40.如权利要求39所述的方法,其中所述阻塞预防构件是布置在所述主流道内的微孔材料,所述微孔材料具有多个流动通道。
41.如权利要求39所述的方法,其中所述阻塞预防构件是从所述柔性壁的内表面延伸并进入所述主流道内的多个凸出物。
42.如权利要求39所述的系统,其中所述次级歧管是毡制垫。
43.如权利要求39所述的系统,其中所述次级歧管是支架,并包含选自以下组中的至少一种物质:聚乳酸、聚乙醇酸、聚己内酯、聚羟基丁酸酯、聚羟基戊酸酯、聚对二氧环己酮、聚原酸酯、聚磷腈、聚氨基甲酸酯、胶原、透明质酸、壳聚糖、羟基磷灰石、磷酸钙、硫酸钙、碳酸钙、生物玻璃、不锈钢、钛、钽、同种异基因移植物和自体移植物。
44.如权利要求39所述的方法,其进一步包括:
在减压组织治疗结束之后,经由皮肤移除所述主歧管。
45.如权利要求39所述的方法,其进一步包括:
在减压组织治疗结束之后,经由皮肤移除所述主歧管;且
其中所述次级歧管是生物可吸收的。
46.如权利要求39所述的方法,其进一步包括用环境空气清洗所述主流道,以防止所述主流道内出现阻塞。
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