CN103251462A - 包括网状物和穿孔膜的植入性医疗装置 - Google Patents
包括网状物和穿孔膜的植入性医疗装置 Download PDFInfo
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- CN103251462A CN103251462A CN2013100513135A CN201310051313A CN103251462A CN 103251462 A CN103251462 A CN 103251462A CN 2013100513135 A CN2013100513135 A CN 2013100513135A CN 201310051313 A CN201310051313 A CN 201310051313A CN 103251462 A CN103251462 A CN 103251462A
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Abstract
本公开涉及植入性医疗装置,所述装置包括至少一个网状物和在所述网状物上设置的至少一个穿孔膜,其中,所述膜的一部分能够被设置为远离所述网状物以对接触网状物的组织和远侧创伤或切开部位进行直接处理。
Description
相关申请的交叉引用
本申请要求享有于2012年2月16日提交的美国临时专利申请第61/599,526号的权益和优先权,其公开的全部内容在此通过引用并入本文。
技术领域
本公开主要涉及植入性医疗装置,且更具体而言,涉及一种植入性医疗装置,其包括至少一个网状物和在所述网状物的至少部分上设置的穿孔膜。
背景技术
在用于修复多种类型的缺损和损伤的腹腔镜检查和开放手术过程中可能使用外科用网状物。例如,外科用网状物通常用于疝修复。该网状物可以用来向外围组织提供支撑。
在疝修复过程中,可以在整个受损组织和该缺损周围的一些健康组织上放置网状物。通过将网状物附加到外围组织的固定装置可以使网状物保持在适当的位置。该网状物可以进一步包括附加层(例如膜)用于将止痛剂持续递送到网状植入物的附近以缓解急性术后痛。
和现有技术中的可以完全附着在网状物上的膜不同,本植入物的穿孔部分赋予所述植入物对膜进行操作的能力,而没有对网状物进行操作,反之亦然。迫切需要整合膜以适应独特的患者/结构特性,同时保持膜/网状物附着的完整性。
发明内容
因此,本公开涉及植入性医疗装置,所述装置包括外科用网状物和在所述网状物的至少部分上设置的穿孔膜。所述网状物通常可为制造用来促进组织向内生长和/或支撑受伤组织的织物或织品。所述膜本质上通常可为聚合物的,并且可以用来进一步增进组织向内生长至植入物,防止外围组织的粘连,递送治疗剂,和/或简单地向植入物提供额外的支撑。在某些实施方式中,将所述膜的至少一部分固定地附在网状物上。
在实施方式中,所述膜可以包括至少一个穿孔部分,所述穿孔部分的构造和尺寸使其能够被设置为远离所述网状物以允许直接处理患者组织。在某些实施方式中,所述膜包括多个穿孔,所述穿孔的构造和尺寸使得所述膜的至少一个部分被固定地附在所述网状物上并且所述膜的至少一个部分能够被设置为远离所述网状物。
所述植入性医疗装置可以进一步包括至少一种治疗剂。在实施方式中,所述膜可为单层。在另一些实施方式中,所述膜可以包括多个聚合物层。
此外,提供递送治疗剂的方法,所述方法包括:植入一种医疗装置,所述装置包括治疗剂、网状物和在所述网状物的至少一部分上设置的膜,其中,所述膜包括至少一个穿孔;将所述膜的至少一个穿孔部分修整至预定构造;和使经修整的穿孔部分被设置为远离所述网状物并且设置到创伤部位上。在某些实施方式中,所述方法进一步包括卷起所述医疗装置;经由具有细长管状部件的器械插入所述卷起的医疗装置;和在创伤部位处或附近设置所述医疗装置。
附图说明
结合附图,阅读以下说明,本公开的前述目的和优点将变得更加明显,其中:
图1A是根据在本公开中描述的一个实施方式的植入性医疗装置的俯视图;
图1B和1C分别是根据在本公开中描述的一个实施方式的具有能够被设置为远离网状物的膜的图1A的植入性医疗装置的透视图和侧视图;
图2A是根据在本公开中描述的一个实施方式的植入性医疗装置的俯视图;
图2B是根据在本公开中描述的另一个实施方式的穿孔膜的至少一个部分完全从网状物上移除的图2A的植入性医疗装置的俯视图;
图2C和2D分别是根据在本公开中描述的一个实施方式的穿孔膜的至少一个部分能够被设置为远离网状物的图2A的植入性医疗装置的俯视图和侧视图;
图3A是根据在本公开中描述的一个实施方式的植入性医疗装置的俯视图;
图3B是显示在网状物上的膜的帐篷状构造的图3A的植入性医疗装置的透视图;
图3C和3D是至少两个穿孔膜部分能够被设置为远离网状物的图3A的植入性医疗装置的透视图;
图4是根据在本公开中描述的一个实施方式的处于用于植入到创伤部位的卷状构型的植入性医疗装置的透视图;
图5是显示形成根据在本公开中描述的一个实施方式的医疗装置的三板编织的图;和
图6是根据在本公开中描述的另一个实施方式的容许在图5的医疗装置上形成针形细毛的装置的示意侧视图。
图7是显示形成根据在本公开中描述的一个实施方式的医疗装置的三板编织的图;和
图8是根据在本公开中描述的另一个实施方式的容许在图7的医疗装置上形成针形细毛的装置的示意侧视图。
具体实施方式
本公开涉及植入性医疗装置,所述装置包括外科用网状物和穿孔膜。通过被穿孔,所述膜可以包括以有组织的方式设置的一系列的小孔、窗孔、刺孔或狭缝。所述穿孔的构造和尺寸允许使用者将所述膜的第一个部分与所述膜的第二部分在原位分离或者在植入前分离。所述穿孔膜可以沿着穿孔线容易地分成部分或者容易地撕开。在实施方式中,所述穿孔膜可以以多种方式设置在所述网状物的至少一部分上。在实施方式中,所述膜可以进一步被修整和/或被设置为远离所述网状物,同时仍然保持一些点附在所述网状物上。在实施方式中,所述膜包括至少一个穿孔,所述穿孔的构造和尺寸使得所述膜的至少一个穿孔部分可以至少部分地与所述网状物分离。
在实施方式中,膜可以包括多个穿孔,所述穿孔的构造和尺寸使得所述膜的至少一个部分被固定地附在所述网状物上并且所述膜的至少一个穿孔部分能够被设置为远离所述网状物。
在一些实施方式中,所述膜包括至少一个穿孔部分,所述穿孔部分的构造和尺寸使其与所述网状物分离以允许所述穿孔部分从所述网状物的表面突出。在这种状态下,所述膜的与所述网状物分离的部分可被置于创伤组织。所述穿孔膜可以在原位或者在植入前被修整至预定的定制形状或定向。在实施方式中,所述膜可以包括刻度标记以使所述膜的限定部分在修整中容易识别。
在实施方式中,所述膜的至少一个部分被附在所述网状物上。在实施方式中,所述膜可在所述膜的周围边缘处被附在所述网状物上。在另一些实施方式中,所述膜可在所述膜的内部边缘处被附在所述网状物上,例如,在所述膜包括产生至少一个内部边缘的开口的实施方式中。在又一些实施方式中,所述膜可在所述网状物的内部附近(朝向中心)被附在所述网状物上。在还一些实施方式中,所述膜可同时在内部部分和外部部分上被附在所述网状物上从而形成帐篷状附着构造,其中,所述膜的层状面游离于所述网状物。
在实施方式中,所述穿孔膜可以包括面对所述膜的预切割的孔或切口以便于对在规定使用所述网状物上的任一或多个独立的膜区域的膜的穿孔部分进行操作和/或修整。在另一些实施方式中,可以用如手术刀或抓紧器的外科用工具刺穿所述膜以便于对所述膜的穿孔部分进行操作。
通过植入,可以在任何持续时间内将本文中描述的医疗装置置于体内(如腹腔部分内)的位置。此外,术语“植入”和“植入的”指的是在任何持续时间内使医疗装置置于体内(如腹腔部分内)的位置。
本文中描述的植入性医疗装置包括至少一个外科用网状物。本文中描述的外科用网状物可以包括由缠结细丝制成的多孔织品。所述细丝可为单丝或复丝,在实施方式中,可以将多个复丝组合形成纱。所述细丝可以以如下方式水平地或垂直地延伸:产生其中所述细丝彼此交叉产生共同相交的点的部分。所述外科用网状物可为织造的、无纺的、针织的或编织的。在一些实施方式中,所述细丝可以形成二维或三维网状物。二维和/或三维网状物基质的实例可以在美国专利第7,021,086号、美国专利第6,596,002号、美国专利第7,331,199号找到,其公开的全部内容在此通过引用并入本文。
适用于本公开的网状物包括,例如,如PARIETEXTM复合物网状物(购自Tyco Healthcare Group LP,d/b/a Covidien)的胶原复合物网状物。PARIETEXTM复合物网状物是在一侧结合有可再吸收的胶原膜的3维聚酯织物。其他适合的网状物包括Parietex ProgripTM自我固定的网状物(同样购自Covidien)。Parietex ProgripTM是包括聚乳酸(PLA)夹紧部件的聚酯网状物。其他适合的网状物包括以PARIETEXTM、SURGIPROTM名称出售的那些(全部购自Covidien);PROLENETM(购自Ethicon,Inc.);3D网状物、塞、和贴片(全部购自C.R.Bard,Inc.);PROLITETM、PROLITE ULTRATM(全部购自AtriumMedical);和(全部购自Davol,Inc.);以及和网状物(全部购自W.L.Gore)。另外,在本公开的范围和范畴内的网状物可以包括生物材料,例如,同种异体移植物(即,来自生活细胞的再生组织基质)、自体移植物、和异种移植物(即,购自Covidien的PERMACOLTM)。在候补的实施方式中,也可以利用处理的/纯化的组织。
在某些实施方式中,根据本发明可以使用ParietexTM复合物网状物或ParietexTM Pro-grip。
在某些实施方式中,所述医疗装置可以是在特里科(Tricot)或拉舍尔(Raschel)型经编机上编织的外科用网状物,所述经编机具有至少三个纱片或经纱以及同样多的导丝杆。
用如图5中的实线所示的生物相容性聚合物的第一单丝或复丝10穿线于后杆,一个导子满以及一个导子空。用如图5中的虚线所示的生物相容性聚合物的第二单丝或复丝11穿线于中间杆,一个导子满以及三个导子空。所述中间杆以使得在网状物的列之间获得Z字形透孔织物图形的方式工作。最终,用如图5中的细线所示的生物相容性聚合物的第三单丝或复丝12穿线于前杆,一个导子满,一个导子空,以及以链形缝法工作。第三细丝12(即,链形缝)束缚第一细丝10并且维持所述网状物的长度,同时有助于用由第二细丝11形成的中间板形成所述网状物。不同的细丝可以形成纱并且按照下列图表操作:
所述后杆将第一细丝或纱放置在链形缝下方并且被“捻”到不形成链形缝的针上的部分纬纱中。为此,在下一排,没有提供不形成链形缝的针允许避开形成从所述网状物的正面伸出的线圈14a的细丝。
在中间杆中—一个导子满,三个导子空—穿线,与移位相关,使其能够形成明亮背景质地,其宽度稳定,且透孔以容许优异的组织整合。
由此得到的网状物14可以设置有线圈14a(图6),线圈14a可以与所述网状物表面之一垂直。线圈14a还可以包括刚性并且保持直角,其可以由所用细丝的刚性或回复性获得。这种刚性对后续形成夹紧部件而言是必需的,夹紧部件确保了对使植入性医疗装置的至少一部分的夹紧功能。
在离开织机时,可以使网状物14经过使所述网状物的长度和宽度稳定的热固化处理。然后,可以使所述网状物经过形成夹紧部件的阶段,如图6中所示,其在于使所述网状物在包含电加热电阻的圆筒13上通过。分别通过两对辊(上游15a,15b和下游16a,16b),在圆筒13上将网状物14压平,所述辊能够垂直移位控制这种压力。
这种控制以及在圆筒13中设置的电阻温度和网状物14通过圆筒13的移动速度的控制使得可以熔化各线圈14a的头部从而使得各线圈14a均形成两个夹紧部件17。
各夹紧部件17因此可以具有相对于网状物14垂直伸出的基本直线体,并且在该直线体的游离端处,头部17a的宽度比所述直线体宽。头部17a具有一般的球状形状或蘑菇形状。夹紧部件17使网状物14在移植时能够附在组织上。另外,夹紧部件17在折叠或卷起时可以附在网状物14的其他部分上。所述夹紧部件可以沿着所述网状物的任何部分且以任何数量设置和/或配置。例如,在一些实施方式中,所述夹紧部件可以设置在所述网状物的与所述膜相同的部分上。在另一些实施方式中,所述夹紧部件可以设置在所述网状物的不包括所述膜的不同的部分上。
任何生物相容性材料可以用于形成本文中描述的网状物。例如,所述网状物可以由非可生物吸收的材料制成,例如,聚丙烯、聚对苯二甲酸乙二醇酯、聚四氟乙烯等。在其他的实施例中,所述网状物可以由可生物吸收的材料制成,例如,聚丙交酯、聚乙醇酸丙交酯、聚己酸内酯、聚二氧六环酮、多糖等。在实施方式中,所述网状物可以由可吸收材料和非可生物吸收的材料的组合制成。
本文中描述的医疗装置可以使用本领域技术人员熟知的任何方法形成。一些非限定性的实例包括织造、针织、编织、钩编、挤压、喷雾、铸塑、成型、及其组合。在实施方式中,所述医疗装置可包括织造、针织、编织、钩编的二维或三维外科用网状物。
本文中描述的医疗装置可以包括由任何生物相容性材料制成的聚合物膜层。所述生物相容性材料可为均聚物或共聚物,包括无规共聚物、嵌段共聚物或接枝共聚物。所述生物相容性材料可为线性聚合物、分枝聚合物或树形化合物。所述生物相容性材料可以是天然或合成来源。所述生物相容性材料可以是可生物吸收的或非可生物吸收的。
用于形成所述医疗装置的可生物吸收的材料的一些其他非限定性实例包括选自下列聚合物中:脂肪族聚酯;聚酰胺;聚胺;聚亚烷基草酸酯;聚酐;聚酰胺酯;共聚醚-酯;含有酪氨酸衍生的碳酸酯的聚碳酸酯;聚羟基链烷酸酯,例如,聚羟基丁酸、聚羟基戊酸和聚羟基丁酸酯;聚酰亚胺碳酸酯;聚亚氨基碳酸酯,例如,聚双酚A-亚氨基碳酸酯等;聚原酸酯;聚草酰酯,包括含有胺基团的那些;聚磷腈;聚延胡索酸丙二醇酯;聚氨基甲酸酯;聚合物药物,例如,聚二氟尼柳(polydiflunisol)、聚阿司匹林和蛋白质治疗剂;生物学改性(例如,蛋白质,肽)的可生物吸收的聚合物;和共聚物,嵌段共聚物,均聚物,混合物,及其组合。
更具体地,所述脂肪族聚酯包括,但不限于,丙交酯(包括乳酸,D-,L-和内消旋丙交酯)的均聚物和共聚物;乙交酯(包括羟基乙酸);ε-己内酯,p-二噁烷酮(1,4-二噁烷-2-酮);三亚甲基碳酸酯(1,3-二噁烷-2-酮);三亚甲基碳酸酯的烷基衍生物;Δ-戊内酯;β-丁内酯;γ-丁内酯;ε-癸内酯;羟基丁酸酯;羟基戊酸酯;1,4-二氧杂环庚烷-2-酮(包括其二聚物1,5,8,12-四环氧十四烷-7,14-二酮);1,5-二氧杂环庚烷-2-酮;6,6-二甲基-1,4-二噁烷-2-酮;2,5-二酮吗啉;新戊内酯;α,α二乙基丙内酯;亚乙基碳酸酯;亚乙基草酸酯;3-甲基-1,4-二噁烷-2,5-二酮;3,3-二乙基-1,4-二噁烷-2,5-二酮;6,8-二氧杂双环庚烷-7-酮;和聚合物混合物及其共聚物。
其他适合的可生物吸收的材料可以包括,但不限于:聚(氨基酸),包括蛋白质,例如,胶原(I、II和III)、弹性蛋白、纤维蛋白、纤维蛋白原、蚕丝和白蛋白;肽,包括层粘连蛋白和纤维结合蛋白(RGD)的序列;多糖,例如,透明质酸(HA)、葡聚糖、藻酸盐、几丁质、壳聚糖和纤维素;粘多糖;黏液,胶质;及其组合。
术语“胶原”是指包括人或动物来源的无论天然还是合成的任何类型的胶原,例如,富集I型人胶原,III型人胶原,还有富集的I+III型或IV型人胶原,或者,如I型或I+III型动物胶原的其他胶原。所述胶原可被氧化或未被氧化。在某些实施方式中,所述胶原可被氧化而未交联。例如,可以将天然胶原浸泡在酸溶液中和/或洗涤以清除特别是由胃蛋白酶消化而引起的端肽。
还可以通过氧化裂化改性所述胶原。为了这个目的,可以使用高碘酸或其盐的一种,M.TARDY等(FR-A-2 601 371和美国专利第4,931,546号,其公开的全部内容在此通过引用并入本文)描述了这项技术的应用。
简要回顾一下,该技术由在大约10°C和大约25°C之间的温度下使在酸溶液中的胶原与浓度在大约1和大约10-5M之间(在实施方式中在大约5x10-3和大约10-1M之间)的高碘酸或其盐的一种的溶液混合大约10分钟至大约72小时组成。
该过程分解胶原的一些成分,这些成分为羟基赖氨酸和糖,由此产生反应位点而没有引起交联。
胶原的氧化裂化允许随后在胶原材料中的适度交联,但并不排除通过其他的适度交联的方式(例如,通过β或γ照射)或者其他的适度交联的试剂(例如,化学试剂)以适合的低剂量和非毒性剂量赋予该功能的可能性。
对于一些应用,本文中描述的聚合物膜层可以包括未被氧化的胶原或者未被氧化的胶原和被氧化的胶原以任何比例的混合物。例如,在一些实施方式中,所述膜可以包括等份的被氧化的胶原和未被氧化的胶原的膜。在另一些实施方式中,被氧化的胶原可以表示为所述膜层的大约25-75%,而未被氧化的胶原可以表示为所述膜层的大约25-75%。
本文中公开的植入性医疗装置的特别实例包括聚丙烯、聚对苯二甲酸乙二醇酯或聚丁烯酯(polybutester)网状物与含有如脂肪族聚酯(例如,PGA,PLA,PLGA)、聚原酸酯、羟基丁酸酯、胶原、透明质酸、纤维素(例如,羧甲基纤维素)、乙烯基聚合物、不可降解的聚酯及其组合的材料的膜的结合。
所述网状物和/或所述膜可以进一步由至少一种可选成分组成。适合的可选成分的一些实例包括乳化剂、粘度增强剂、染料、颜料、香料、pH改性剂、润湿剂、增塑剂、抗氧剂等。可选成分可以表示为最高至所述网状物和/或膜的大约10重量%。
在实施方式中,所述穿孔膜可以包括产生膜的至少三个不同部分的至少两套穿孔。在一些实施方式中,中间膜部分的至少部分被固定地附在所述网状物上,并且两个或更多个外部部分的构造和尺寸为能够被设置为远离所述网状物。在实施方式中,所述穿孔没有完全延伸穿过所述膜的整个长度,允许膜部分的两个相对端(即,条带或指状区)以基本垂直的构造向上伸展以使膜的条带或指状区刺入创伤或组织,同时中间膜部分保持固定到所述网状物上。此外,可以想象,本文中公开的膜可以包括单层或多层。
在实施方式中,所述膜可以包括从膜的中心区域或范围向外延伸的多个穿孔,形成多个穿孔的类似三角形的部分。在一些实施方式中,所述膜可以包括明显比所述穿孔大的预切割的孔或切口,并且多个穿孔可以从预切割的孔或切口延伸至所述膜的外部边缘以便于穿孔部分的操作。在可选的实施方式中,外科医生可以使用手术刀或抓紧器沿着多个穿孔刺穿所述穿孔膜以便于穿孔部分的操作。在实施方式中,所述穿孔膜可以在所述膜的外部部分或边缘上被固定地附在网状物上。这样,通过经由形成“帐篷状”配置的预切割的孔对穿孔部分进行操作,外部穿孔部分可被伸展或上升远离所述网状物,以使所述膜的部分刺入创伤或组织并且远离所述网状物的表面。
在实施方式中,所述膜可以伸展超越所述网状物,其中,所述膜的内部部分被固定地附在所述网状物上,以及没有接触所述网状物的外部部分能够被修整并且能够伸展,从而对创伤部位进行直接处理。在另一些实施方式中,所述膜可以包括预定形状和构造使得所述膜不伸展超越所述网状物,并且只有所述膜的部分被固定地附在所述网状物上使得所述膜的外部指状区或条带能够被伸展或上升成为垂直构造,从而用于创伤部位或切开空间的直接处理。
所述膜和/或网状物可被预先形成或切成任何适合的形状,例如,圆形、正方形、星形、八角形、矩形、多边形、三角形、u形和卵形。在实施方式中,所述膜可被预先形成矩形条带。
在实施方式中,可以通过本领域中已知的任何手段(例如,通过钉、针、铆头、打孔机、刀片、模子、激光、超音波学及其组合)形成穿孔。
可以通过本领域技术人员已知的任何合适的方法形成本文中描述的膜。在某些实施方式中,可以形成包括适合的聚合物材料和任何可选成分的溶液。所述溶液可被铸塑成大批薄片、使用超声喷雾器喷涂、挤压和成型等,从而形成本文中描述的膜。用于制造聚合物溶液的适合溶剂包括,但不限于,二氯甲烷、氯仿、N-甲基吡咯烷酮、四氢呋喃、二甲基甲酰胺、甲醇、乙醇、己烷、丙酮及其组合。
在一些实施方式中,可以直接在所述网状物表面的部分上铸塑所述膜。在另一些实施方式中,可以直接在所述网状物的部分上喷涂所述膜。在又一些实施方式中,所述膜可以在被附在所述网状物之前形成。
在还一个实施方式中,所述膜可以在与所述网状物结合之前被穿孔。在又一个实施方式中,所述膜可以在与所述网状物结合之后被穿孔。在再一个实施方式中,可以使用超声喷雾嘴在惰性基质上形成所述聚合物膜层。
更具体地,可以使用喷雾技术(例如,超声喷雾)制造所述膜。例如,可以通过使包含适合用于形成所述膜的聚合物材料和可选的一种或多种治疗剂的一种或多种溶液通过超声喷雾嘴形成雾滴来制造本文中描述的膜。所述雾滴可以在向惰性基质(例如,有机硅板)和/或所述网状物的部分落下或被沉积到惰性基质和/或所述网状物的部分上的同时被混合以形成膜。在一些实施方式中,在喷所述膜之前,可以在所述网状物的部分上设置惰性基质以防止膜附着。因此,在所述膜形成时,所述膜会附在网状物的没有被惰性基质覆盖的部分,并且所述膜不会固定地附在网状物的被惰性基质覆盖的部分上。
可以使用包括但不限于溶剂焊接、粘合剂、薄膜铸塑等的方法将膜附在网状物上。或者,可以使用例如缝线将所述网状物和膜缝合在一起。
在某些实施方式中,所述植入性医疗装置包括治疗剂。本文中所用术语“治疗剂”具有最广泛的意义并且包括提供有益的、治疗的、药理学的和/或预防的效果的任何物质或这些物质的混合物。所述治疗剂可以是提供药理学效果的药物。
术语“药物”是指包括任何能够提供治疗效果的药剂,例如,防粘连剂、抗微生物剂、镇痛剂、退热药、麻醉剂(例如,局部和全身)、抗癫痫剂、抗组胺剂、抗炎剂、心血管药、诊断剂、拟交感神经药、拟胆碱药、抗毒蕈碱药、解痉剂、激素、生长因子、肌肉松弛剂、肾上腺素能神经元阻滞剂、抗肿瘤药、免疫原性制剂、免疫抑制剂、胃肠药、利尿剂、类固醇、脂类、脂多糖、多糖、血小板活化药、凝血因子和酶。此外,也可以使用治疗剂的组合。
可以作为药物包含的其他治疗剂包括:抗生育剂;拟副交感神经药;精神治疗药;镇静剂;减充血剂;镇静催眠药;磺胺药;拟交感神经药;疫苗;维生素;抗疟药;抗偏头痛药;抗帕金森药,例如左旋多巴;抗痉挛药;抗胆碱药(例如,奥昔布宁);止咳药;支气管扩张药;心血管药,例如冠状动脉扩张药和硝酸甘油;生物碱;镇痛药;麻醉剂,例如可待因、二氢可待因、杜冷丁、吗啡等;非麻醉性(止痛)药,例如水杨酸、阿司匹林、醋氨酚、右旋丙氧芬等;阿片受体拮抗剂,例如纳曲酮和纳洛酮;抗癌剂;抗惊厥药;止吐药;抗组胺剂;抗炎剂,例如激素制剂、氢化可的松、强的松龙、强的松、非激素制剂、别嘌呤醇、消炎痛、保泰松等;前列腺素和细胞毒类药物;化疗药物、雌激素;抗菌药物;抗生素;抗真菌药;抗病毒药;抗凝血剂;抗惊厥剂;抗抑郁药;以及免疫制剂。
可被包含在本文中描述的医疗装置中的合适的治疗剂的其他实例包括:例如,病毒和细胞;肽、多肽和蛋白质、及其类似物、突变蛋白质、和其活性片段;免疫球蛋白;抗体;细胞因子(例如,淋巴因子、单核因子、趋化因子);凝血因子;造血因子;白介素(IL-2、IL-3、IL-4、IL-6);干扰素(例如,β-IFN、α-IFN和γ-IFN);促红细胞生成素;核酸酶;肿瘤坏死因子;集落刺激因子(例如,GCSF、GM-CSF、MCSF);胰岛素;抗肿瘤剂和肿瘤抑制剂;血液蛋白,例如血纤蛋白、凝血酶、血纤蛋白原、合成凝血酶、合成血纤蛋白、合成血纤蛋白原;促性腺激素(例如,FSH、LH、CG等);激素和激素类似物(例如,生长激素);疫苗(例如,肿瘤、细菌和病毒抗原);生长激素释放抑制因子;抗原;血液凝结因子;生长因子(例如,神经生长因子、胰岛素样生长因子);成骨蛋白;TGF-B;蛋白抑制因子;蛋白拮抗剂;蛋白激动剂、核酸,例如反义分子、DNA、RNA、RNAi;寡聚核苷酸;多聚核苷酸;以及核酶。
可以在本医疗装置中使用的水溶性药物的一些具体的非限定性实例包括,利多卡因、布比卡因(bupivicaine)、丁卡因、普鲁卡因、辛可卡因、西罗莫司、紫杉醇、氯己定、聚亚己基(polyhexamethylene)、硫戊巴比妥钠、硫喷妥钠、氯胺酮、氟西泮、异戊巴比妥钠、苯巴比妥、溴戊酰脲、水合氯醛、苯妥英、乙苯妥英、三甲双酮、扑米酮、乙琥胺、卡马西平、丙戊酸盐、扑热息痛、非那西丁、阿司匹林、水杨酸钠、氨基比林、安替比林、安乃近、甲嘧啶唑、噻拉米特、perixazole、双氯芬酸、anfenac、丁丙诺啡、布托啡诺、依他佐辛、茶苯海明、地芬尼多、dl-异丙肾上腺素、氯丙嗪、左美丙嗪、硫利达嗪、氟奋乃静、替沃噻吨、三氟噻醇、酰胺哌啶酮、莫哌隆、卡匹帕明、氯卡帕明、丙米嗪、地昔帕明、马普替林、氯氮卓、氯卓酸钾、甲丙氨酯、羟嗪、saflazine、苯佐卡因、氯苯甘油氨酯、美索巴莫、乙酰胆碱、新施得明、阿托品、东莨菪碱、罂粟碱、比哌立登、苯海索、金刚烷胺、吡咯庚汀、普罗吩胺、左旋多巴、马扎替可、苯海拉明、卡比沙明、氯苯那敏、氯马斯汀、氨茶碱、胆碱、茶碱、咖啡因、苯甲酸钠、异丙肾上腺素、多巴胺、多巴酚丁胺、普萘洛尔、阿普洛尔、布拉洛尔、噻吗洛尔、美托洛尔、普鲁卡因胺、奎尼丁、阿义马林、维拉帕米、阿普林定、氢氯噻嗪、乙酰唑胺、异山梨醇、依他尼酸、卡托普利、依那普利、地拉普利、阿拉普利、肼屈嗪、六甲铵、可乐定、布尼洛尔、胍乙啶、倍他尼定、去氧肾上腺素、甲氧明、地尔硫卓、尼可地尔、烟卡酯、烟醇酒石酸盐、妥拉唑林、尼卡地平、艾芬地尔、哌啶氨基甲酸酯(piperidinocarbamate)、桂哌齐特、泰必利(thiapride)、地莫拉明、左洛啡烷、纳洛酮、氢化可的松、地塞米松、泼尼松龙、炔诺酮、氯米芬、四环素、水杨酸甲酯、异西喷地、克罗米通、水杨酸、制霉菌素、益康唑、氯康唑、维生素B1、环硫胺、维生素B2、维生素B3、维生素B5、维生素B6、维生素B7、维生素B9、维生素B12、维生素C、烟酸、叶酸、烟酰胺、泛酸钙、泛醇、panthetin、生物素、抗坏血酸、氨甲环酸、酚磺乙胺、硫酸鱼精蛋白、秋水仙碱、别嘌醇、妥拉磺脲、格列嘧啶钠、格列丁唑、硝呋氯乙酮、丁福明、乳清酸、硫唑嘌呤、乳果糖、氮芥、环磷酰胺、硫代TEPA、尼莫司汀、琉嘌呤苷、氟尿嘧啶、替加氟、长春碱、长春新碱、长春地辛、丝裂霉素C、柔红霉素、阿柔比星、丙卡巴肼、顺铂、甲氨蝶呤、苄青霉素、阿莫西林、青霉素、oxycillin、甲氧西林、羧苄西林、氨苄西林、头孢氨苄、头孢唑林、红霉素、吉他霉素、氯霉素、甲砜霉素、米诺环素、林可霉素、克林霉素、链霉素、卡那霉素、硫酸新霉素、庆大霉素、大观霉素、新霉素、万古霉素(vanomycin)、四环素、环丙沙星、对氨基苯磺酸、环丝氨酸、磺胺索嘧啶、异烟肼-利福平-毗嗪酰胺、乙胺丁醇、阿昔洛韦、丙氧鸟苷(gancyclovir)、阿糖腺苷、齐多夫定、双去氧肌苷、双去氧胞嘧啶、吗啡、可待因、羟考酮、氢可酮、可卡因、哌替啶、芬太尼、上述药物的聚合物形式以及其组合。
所述水溶性药物可无需转变为盐形式,即,盐酸四环素。在一些实施方式中,所述治疗剂可以包括麻醉剂,即,布比卡因,利多卡因,苯佐卡因等。
尽管已经出于举例说明的目的提供上述治疗剂,但是应当理解的是本公开并不限制于此。特别是,虽然以上具体地提到了某些治疗剂,但是应当理解的是本公开包括这些药剂的类似物、衍生物和轭合物。
应当注意的是,所述治疗剂可以与所述医疗装置的任何部分(包括所述网状物和/或所述膜层)结合。在一些实施方式中,所述治疗剂可被包含在所述膜中从而在植入之后提供治疗剂的持续释放。在一些实施方式中,所述治疗剂可被包含在所述网状物中。
在又一些实施方式中,可以使用在所述膜限定的穿孔来放置所述治疗剂。在该实施方式中,可以通过经由沿着穿孔撕开使所述膜的第一部分与所述膜的第二部分分离来促使治疗剂的释放。
现转到图1A,如图所示,植入性医疗装置100包括在网状物120上设置的穿孔膜110,其中,膜110覆盖网状物120的至少一面的部分。可以通过本领域中以及在本文中所述的任何适合的手段将固定部分110a附在网状物120上。尽管如图所示膜110接触网状物120,但可以想象,膜110具有部分地覆盖网状物120的能力。另外,尽管如图所示膜110具有“u”形形状,但可以想象,膜110可被形成任何适合的形状以及在本文中所提到的形状。
参照图1B和1C,如图所示,植入性医疗装置100包括具有至少一个穿孔部分的膜110,其中,指状区111a的构造和尺寸使其向上延伸成为相对于网状物120直立或基本垂直的构造。因为指状区111a没有被固定地附在网状物120上,所以膜110的指状区111a可被操作远离网状物120,同时膜110的固定地附着的部分110a保持接触网状物120。考虑到直接处理组织,可以沿着创伤部位或切开空间设置指状区111a。例如,在疝创伤修复过程中,可以将网状物120直接放在切开点处或切开点附近以使指状区111a可被设置垂直于网状物120(图1C)并且直接位于切开各面上以向创伤(未显示)提供治疗剂。在可选的实施方式中,指状区111a可以用于包裹敏感组织和/或器官。
参照图2A、2B和2C,如图所示,植入性医疗装置200具有网状物220和在其上的矩形穿孔膜210。膜210包括由穿孔212分成的三个部分,两个能够被设置为远离网状物220的外部部分和被固定地附在网状物220上的中间部分210a。尽管如图所示中间部分210a接触网状物220,但可以想象,膜的部分210a具有至少部分地覆盖网状物220的能力。还可想象,中间部分210a可以没有固定地附在网状物220上,而外部部分210b和210c中的至少一个或者外部部分210b和210c二者可被固定地附在所述网状物上。在本文中描述了适合的附着方法。另外,尽管如图所示膜210具有矩形形状,但可以想象,膜210可被形成如上所述的其他形状。
在实施方式中,植入性医疗装置200可以包括具有可以延伸完全穿过膜210的穿孔212的膜210(图2A)。在这些实施方式中,外部部分210b和210c中的至少一个可以通过沿着穿孔212撕开而与植入物200完全分离(图2B)。可以想象,使所述膜的部分完全分离的能力可以在所述膜包括至少一种治疗剂的实施方式中用于控制药物递送。可以进一步想象,在分离之后,使用者可以将分离的膜的部分重新配置到所述网状物的另一部分,和/或到创伤部位的不同区域,即,创伤的相对侧,另外的或不同的组织层等。与现有技术中的植入物不同,所述穿孔膜的在手术操作过程中与网状物分离的能力赋予使用者根据创伤部位的实际情况和/或患者的身体状态指示改变植入物的能力。
在可选的实施方式中,穿孔212可以没有完全穿过膜210的面延伸(图2C)使得指状区211a被形成并且能够向上延伸成为直立或基本垂直的构造,并且游离于网状物220(图2D)。考虑到组织的直接处理,指状区211a可被设置穿过创伤部位或切开空间。
现转到图3A,如图所示,植入性医疗装置300包括在网状物320上设置的膜310,其中,膜310在膜310的外部周边或边缘部分310a上被固定地附在网状物320上。如图所示,多个穿孔312从预切割的孔或切口330延伸使得外科医生可以独立地或共同地操作或向外延伸穿孔部分314以允许直接处理在所述网状物320周围的组织。尽管如图所示,切口330被置于所述膜的中心,但是所述切口可以相对于所述膜被设置在其他位置。尽管如图所示膜310经由外部周边或边缘部分310a被固定地附在网状物320上,但可以想象,膜310可以经由膜310的任何其他部分被附在网状物320上。另外,尽管如图所示膜310具有矩形形状,但可以想象,膜310可以形成如上所述的其他形状。
在实施方式中,膜310可被形成如图3B中所示的帐篷状配置。在实施方式中,如图3C和3D中所示,膜310可被操作向外延伸使得穿孔部分314a-d(选择地或整体上)可被向上延伸成为直立或基本垂直的构造,并且游离于网状物320或者与网状物320间隔一段距离。穿孔部分314a和/或314b和/或穿孔部分314c和/或314d可以向上在所述网状物部位上方延伸到创伤部位或患者组织上。可以想象,外科医生可以使用这种配置在所述膜的穿孔部分和所述网状物之间形成可以出于各种潜在原因而被利用的空间。例如,外科医生可以将至少一个指状区或外科用工具经由孔330插入到在所述膜和所述网状物之间的空间中以确保所述网状物完全平坦或展开。在另一个实施例中,外科用工具(如吻合器、夹具(clip applier)、缝合装置、超声喷雾器等)可以经由孔被设置并且进入到在所述膜和所述网状物之间的空间以将所述网状物固定到组织。
如上所述,并且如图3C中所示,第一穿孔部分314a和314b可被移动远离网状物320,同时第二穿孔部分314c和314d保持位于网状物320附近。可进一步想象,考虑到组织的直接处理,第一穿孔部分314a和314b可以置于穿过创伤部位或切开空间,同时第二穿孔部分314c和314d保持在创伤组织和所述网状物之间。尽管如图所示膜310具有从所述膜的中心向外延伸的多个穿孔,但可想象,可以使用本领域中的任何已知工具(如手术刀或抓紧器)将膜310切成预定形状使得穿孔部分314a和314b可被设置为远离网状物320。
本文中描述的植入物可以用于多种内窥镜检查的、腹腔镜检查的、关节镜的、腔内的、经腔的和/或开放的手术操作中。一些实例包括疝修复、阴道脱垂的修复、韧带修复、腱修复等。尽管本文中描述的聚合物膜可以由任何生物相容性材料制成,但是,在某些操作中,所述膜层可以由防粘性材料制成。例如,当将本文中描述的医疗装置植入到难以到达的组织时,将植入性装置600处理成如图4中所示的卷状构造会是有用的。卷状植入性医疗装置600可以经由手术装置(如腹腔镜、内窥镜、套管针、插管、阻塞器等)的细长管状部件插入并且随后放置难以到达的组织区域上。在实施方式中,植入性医疗装置600可以包括穿孔膜610以防止网状物620在卷状构造中自身缠绕。在植入部位处展开之后,可以按照需要移除或修整穿孔膜610,和/或可以将穿孔膜610植入到手术区域中的任何地方。
本文中还提供了治疗剂的递送方法,所述方法包括:植入一个医疗装置,该医疗装置包括网状物和在所述网状物的至少部分上设置的膜,其中,所述膜包括至少一个穿孔;非必需地将所述膜的至少一个穿孔部分修整至预定构造;和使经修整的穿孔部分被设置为远离所述网状物并且到创伤部位上。在某些实施方式中,如上所述,所述方法进一步包括卷起所述医疗装置;经由具有细长管状部件的器械插入卷起的医疗装置;和在创伤部位处或附近设置所述医疗装置。
将要理解的是,可以对本文中描述的实施方式进行各种改变。例如,在实施方式中,可以在经由插管、套管针或腹腔镜检查递送装置递送到身体之前卷起所述医疗装置。在另一个实施例中,本文中描述的医疗装置可以使用使用任何适合的灭菌方法(即γ照射)以及任何适合的医疗装置包装(即可注射的医疗装置包装)进行灭菌和包装。在另一些实施例中,本文中描述的植入物可以包括超过一个的膜、网状物和/或穿孔。因此,本领域技术人员将会想象到在权利要求的范围和实质内的其他改变。
Claims (20)
1.一种植入性医疗装置,所述装置包括:
网状物,和
穿孔膜,其设置在所述网状物的至少一部分上。
2.根据权利要求1所述的植入性医疗装置,其中,所述膜包括至少一个穿孔,所述穿孔的构造和尺寸使得所述膜的至少一个穿孔部分能够被设置为远离所述网状物。
3.权利要求1所述的植入性医疗装置,其中,所述膜的至少一个穿孔部分被设置为垂直地远离所述网状物。
4.权利要求1所述的植入性医疗装置,其中,所述膜的至少一个穿孔部分为在手术部位能够被修整为预定形状和尺寸。
5.权利要求1所述的植入性医疗装置,其中,所述膜的至少一个穿孔部分为在植入前能够被修整为预定形状和尺寸。
6.权利要求1所述的植入性医疗装置,其中,所述膜包括刻度标记。
7.权利要求1所述的植入性医疗装置,其中,所述膜包含的面积大于所述网状物。
8.权利要求1所述的植入性医疗装置,其中,所述膜包含的面积小于所述网状物。
9.权利要求1所述的植入性医疗装置,其中,所述膜进一步包含至少一种治疗剂。
10.权利要求1所述的植入性医疗装置,其中,所述膜在所述膜的至少一个周围边缘上被附在所述网状物上。
11.权利要求1所述的植入性医疗装置,其中,所述膜在所述膜的至少一个内部边缘上被附在所述网状物上。
12.权利要求1所述的植入性医疗装置,其中,所述膜在所述网状物的至少内部部分上被附在所述网状物上。
13.权利要求1所述的植入性医疗装置,其中,所述膜同时在所述膜的内部部分和外部部分上被附在所述网状物上从而形成帐篷状附着构造。
14.权利要求1所述的植入性医疗装置,其中,所述膜包含预切割的孔。
15.权利要求1所述的植入性医疗装置,其中,所述网状物进一步包括至少一个夹紧部件。
16.权利要求1所述的植入性医疗装置,其中,所述膜的至少部分被固定地附在所述网状物上。
17.一种植入性医疗装置,所述装置包括:
网状物;和
具有多个穿孔的膜,所述穿孔的构造和尺寸使得所述膜的至少一个部分被固定地附在所述网状物上并且所述膜的至少一个部分能够被设置为远离所述网状物。
18.一种递送治疗剂的方法,所述方法包括:
植入一种医疗装置,所述装置包括:
治疗剂,
网状物,和
膜,其设置在所述网状物的至少部分上,其中,所述膜包括至少一个穿孔部分;和
使所述穿孔部分设置为远离所述网状物并且放置到创伤部位上。
19.根据权利要求18所述的方法,进一步包括:
将所述膜的至少一个穿孔部分修整为预定构造。
20.根据权利要求18所述的方法,进一步包括:
卷起所述医疗装置;
经由具有细长管状部件的器械插入所述卷起的医疗装置;和
在创伤部位处或在创伤部位附近设置所述医疗装置。
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US201261599526P | 2012-02-16 | 2012-02-16 | |
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US13/749,090 | 2013-01-24 | ||
US13/749,090 US20130218125A1 (en) | 2012-02-16 | 2013-01-24 | Implantable Devices Including A Mesh And A Perforated Film |
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CN103251462A true CN103251462A (zh) | 2013-08-21 |
Family
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US (1) | US20130218125A1 (zh) |
EP (1) | EP2628592A1 (zh) |
JP (1) | JP2013165966A (zh) |
CN (1) | CN103251462A (zh) |
AU (1) | AU2013200621A1 (zh) |
CA (1) | CA2804464A1 (zh) |
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Also Published As
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CA2804464A1 (en) | 2013-08-16 |
AU2013200621A1 (en) | 2013-09-05 |
JP2013165966A (ja) | 2013-08-29 |
EP2628592A1 (en) | 2013-08-21 |
US20130218125A1 (en) | 2013-08-22 |
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