CN111904507B - 外科缝合装置 - Google Patents
外科缝合装置 Download PDFInfo
- Publication number
- CN111904507B CN111904507B CN202010373240.1A CN202010373240A CN111904507B CN 111904507 B CN111904507 B CN 111904507B CN 202010373240 A CN202010373240 A CN 202010373240A CN 111904507 B CN111904507 B CN 111904507B
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- China
- Prior art keywords
- buttress
- surgical stapling
- stapling device
- jaw member
- surgical
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
外科缝合设备具有附接到其上的支撑件。支撑件包括细长的矩形体,所述矩形体具有近侧部分、远侧部分和沿着所述细长的矩形体从所述近侧部分延伸到所述远侧部分的相对的横向侧。支撑件至少在所述近侧部分上具有一层治疗剂。在实施例中,支撑件在所述近侧部分和所述远侧部分都具有所述治疗剂。
Description
相关申请的交叉引用
本申请要求2019年5月8日提交的美国临时专利申请第62/844,870号的申请日的权益。
技术领域
本公开涉及用于伤口闭合装置的医疗装置,包括手术装置如支撑件。由本公开的材料形成的医疗装置能够向患者递送治疗剂。
背景技术
外科医生使用外科缝合器械顺序地或同时地将一排或多排紧固件(例如,缝合钉或两部分紧固件)应用到身体组织,以实现将身体组织的片段连接在一起的目的。这种器械通常包括一对钳口或指状结构,待连接的身体组织放置在其间。当致动或“击发”缝合器械时,纵向移动的击发杆接触其中一个钳口中的缝合钉驱动构件。缝合钉驱动构件推动外科缝合钉穿过身体组织并进入相对钳口中的砧座中,所述砧座成形缝合钉。如果要移除或分离组织,可以在装置的钳口中提供刀片来切割缝合钉线之间的组织。
对于一些外科手术,可能需要在治疗部位处引入治疗剂。
仍然需要能够用作抵靠组织密封和/或加强缝合钉线的支撑件的改进的外科修复材料,和将治疗剂引入患者的改进的方法。
发明内容
本公开涉及可用于修复组织的医疗装置(包括外科缝合装置)。
在其他实施例中,本公开的外科缝合装置包括端部执行器,所述端部执行器包括彼此枢转地耦合的砧座钳口构件和仓钳口构件,砧座钳口构件和仓钳口构件能够相对移动,使得端部执行器能够在打开位置和夹紧位置之间移动。在实施例中,支撑件附接到仓钳口构件,支撑件具有远侧部分和近侧部分,远侧部分和近侧部分中的至少一个上具有治疗剂。
在一些实施例中,治疗剂作为涂层应用到支撑件的远侧部分,以在支撑件的远侧部分形成第一突片,并且治疗剂作为涂层应用到支撑件的近侧部分,以在支撑件的近侧部分处形成第二突片。
在其他实施例中,第二支撑件附接到砧座钳口构件,第二支撑件具有远侧部分和近侧部分,远侧部分和近侧部分中的至少一个上具有治疗剂。
在实施例中,治疗剂作为涂层应用到第二支撑件的远侧部分,以在第二支撑件的远侧部分形成第一突片,并且治疗剂作为涂层应用到第二支撑件的近侧部分,以在第二支撑件的近侧部分处形成第二突片。在其他实施例中,治疗剂作为涂层应用到支撑件的远侧部分和/或近侧部分,使得涂层不位于缝合钉穿透支撑件的位置。
在一些实施例中,治疗剂可以是以下的任意组合:氨基酸;肽;多肽;蛋白质;多糖;突变蛋白;免疫球蛋白;抗体;细胞因子;凝血因子;造血因子;白细胞介素(1至18);干扰素;促红细胞生成素;核酸酶;肿瘤坏死因子;集落刺激因子;胰岛素;抗肿瘤剂和肿瘤抑制剂;血蛋白;纤维蛋白;凝血酶;纤维蛋白原;合成凝血酶;合成纤维蛋白;合成纤维蛋白原;促性腺激素;激素和激素类似物;疫苗;生长抑素;抗原;凝血因子;生长因子;骨形态发生蛋白;TGF-B;蛋白质抑制剂;蛋白质拮抗剂;蛋白质激动剂;核酸,如反义分子、DNA、RNA、RNAi、寡核苷酸、多核苷酸;细胞;病毒;抗炎剂;抗菌剂;抗微生物剂和核酶。
在其他实施例中,治疗剂是化疗药物。合适的化疗药物包括例如以下的任意组合:紫杉醇和其衍生物、多西他赛(docetaxel)和其衍生物、阿布拉尼(abraxane)、三苯氧胺、环磷酰胺、放线菌素、博莱霉素、放线菌素D、柔红霉素、阿霉素、盐酸阿霉素、表阿霉素(epirubicin)、丝裂霉素、甲氨蝶呤、氟尿嘧啶、吉西他滨(gemcitabine)、盐酸吉西他滨、卡铂、卡莫司汀(carmustine)、甲基-CCNU、顺铂、鬼臼乙叉甙(etoposide)、喜树碱和其衍生物、苯芥胆甾醇(phenesterine)、长春碱、长春新碱、戈舍瑞林(goserelin)、亮丙瑞林(leuprolide)、干扰素α、视黄酸、氮芥烷化剂、哌泊舒凡(piposulfan)、长春瑞滨(vinorelbine)、伊立替康(irinotecan)、盐酸伊立替康、长春碱、培美曲塞(pemetrexed)、甲苯磺酸索拉非尼(sorafenib tosylate)、依维莫司(everolimus)、盐酸埃罗替尼(erlotinib hydrochloride)、苹果酸舒尼替尼(sunitinib malate)、卡培他滨奥沙利铂(capecitabine oxaliplatin)、亚叶酸钙、贝伐单抗(bevacizumab)、西妥昔单抗(cetuximab)、雷莫芦单抗(ramucirumab)、曲妥单抗(trastuzumab)、阿特朱单抗(atezolizumab)、康纳单抗(canakinumab)以及其组合。
在实施例中,治疗剂与赋形剂组合,所述赋形剂包括表面活性剂/增溶剂、盐、酸、稳定剂、多元醇、水溶助剂、低分子量聚(乙二醇)或其任意组合。
合适的表面活性剂包括环糊精、十二烷基硫酸钠、辛基葡糖苷、脱水山梨醇脂肪酸酯或其组合。
在一些实施例中,盐包括氯化钠。
合适的酸包括油酸、柠檬酸、抗坏血酸或其组合。
在一些实施例中,稳定剂包括丁基化羟基甲苯或丁基化羟基茴香醚。
在实施例中,多元醇包括D-山梨醇、甘露醇或其组合。
在一些实施例中,支撑件通过至少一条缝合线附接到仓钳口构件。
在其他实施例中,第二支撑件通过至少一条缝合线附接到砧座钳口构件。
在其他实施例中,本公开的外科缝合装置包括端部执行器,所述端部执行器包括彼此枢转地耦合的砧座钳口构件和仓组件,砧座钳口构件和仓钳口构件可相对移动,使得端部执行器可在打开位置与夹紧位置之间移动。外科缝合装置包括附接到仓钳口构件的支撑件,所述支撑件具有远侧部分和近侧部分,远侧部分和近侧部分中的至少一个上具有化疗药物。
在一些实施例中,化疗药物作为涂层应用到支撑件的远侧部分,以在支撑件的远侧部分形成第一突片,并且化疗药物作为涂层应用到支撑件的近侧部分,以在支撑件的近侧部分处形成第二突片。
在其他实施例中,第二支撑件附接到砧座钳口构件,第二支撑件具有远侧部分和近侧部分,远侧部分和近侧部分中的至少一个上具有化疗药物。
化疗药物可以作为涂层应用到第二支撑件的远侧部分,以在第二支撑件的远侧部分形成第一突片,并且化疗药物可以作为涂层应用到第二支撑件的近侧部分,以在第二支撑件的近侧部分形成第二突片。
还提供了用本公开的缝合装置缝合组织的方法。
附图说明
本文参照附图描述了当前公开的外科缝合装置的实施例,其中:
图1是根据本公开的实施例的外科缝合设备的透视图,所述外科缝合设备包括手柄壳体、适配器组件、端部执行器和附接到其上的支撑件;
图2是图1中所示的细节表示区域的放大图;
图3是图1中所示的外科缝合设备的端部执行器的仓组件的透视图,示出了根据本公开的实施例的支撑件可以如何附接到其上;
图4是图3中所示的外科缝合设备的端部执行器的仓组件的俯视图,示出了附接到其上的支撑件;
图5是图1的外科缝合设备击发后,组织的缝合和划分的部分的透视图;以及
图6是图1的外科缝合设备击发后,图5的组织的缝合和划分的部分的侧视图。
具体实施方式
在下文中,根据与组织固定装置一起使用的支撑件(在实施例中是外科缝合钉)讨论了本公开的各种示例性实施例。尽管以下公开详细讨论了这些与支撑件一起使用的缝合钉,但是可以理解,本公开的外科支撑件包括一系列支撑材料和薄膜基材料,这些材料可以用于机械地支撑组织,沿着缝合钉或缝合线加固组织,以及减少流体泄漏和/或组织出血的发生率。
本公开的外科支撑件可以与用于闭合组织的任何伤口、缺损和/或开口的任何固定装置一起使用。因此,虽然结合外科缝合设备讨论了外科支撑件,但是可以预见,可以结合本公开的外科支撑件使用其他固定装置,如大头钉、缝线、夹子、粘合剂等,以将医疗装置固定到组织上。
本公开提供了一种能够在患者体内局部和区域性地递送治疗剂的线性缝合器支撑件,所述支撑件不会由于治疗剂涂层与钉部位的共同定位而妨碍吻合部位处或缝合钉线内的愈合。
本公开的外科支撑件是具有远端和近端的大致矩形主体的形式,其具有从远端到近端沿着细长矩形主体部分的长度延伸的相对横向侧。外科支撑件的远端和近端,有时在本文中称为“突片”,其上具有治疗剂。突片就位以帮助将预加载的支撑件附接到仓面和/或砧座面,并且一旦缝合钉已经在组织中击发,突片就保持在缝合钉线的端部处,从而将支撑件附接到其上。
包括在治疗层(其在本公开的外科支撑件上形成突片)中的治疗剂适合于在放置本公开的外科支撑件的部位处或附近的组织的进一步治疗。因此,本公开描述了用于将治疗剂靶向递送至患者的外科支撑件以及使用所述外科支撑件的方法和机构。
治疗剂可以图案化或作为单一涂层应用在突片上。由于突片没有结合到缝合钉线中,在双或三次缝合技术过程的情况下,组织的多次缝合可以横切并移除患病组织。
对于结肠直肠和胃手术,来自本公开的支撑件的治疗剂可以洗脱到腹膜腔中,并通过正常的淋巴引流路径来治疗所涉及的淋巴结。对于胸部手术,治疗剂可以在吻合或其他缝合部位附近释放,并通过正常的淋巴引流路径来治疗所涉及的淋巴结。当多条缝合钉线以缝合钉线端部重叠的方式连续击发时,仅在远侧或近侧支撑件上的治疗剂将能够通过每条缝合钉线递送治疗剂,而不会结合到缝合钉线的缝合区域中。这些实施例中的每一个都提供了这样的优点,即治疗剂涂层从缝合钉部位移开,因此相较于治疗剂涂覆在支撑件的缝合区域上的实施例对缝合钉线愈合造成的风险较小。
应理解,多种外科缝合设备可以与本公开的外科支撑件一起使用。例如,可以使用线性缝合器,如例如,包括通过柯惠(Covidien)(诺斯黑文,康涅狄格州)可获得的EndoGIATMReinforced Reload with Tri-Staple TechnologyTM和其他具有Tri-StapleTM的缝合器,以及同样通过柯惠可获得的其他吻合缝合器,例如EEATM、CEEATM、GIATM、EndoGIATM和TATM。还应当理解,本公开的原理同样适用于具有替代构造的外科缝合器,如例如具有圆形仓和砧座的端对端吻合缝合器(参见,例如,共同拥有美国专利第5,915,616号,发明名称为“外科紧固件应用设备(Surgical Fastener Applying Apparatus)”,其全部公开通过引用并入本文);腹腔镜缝合器(参见,例如,共同拥有的美国专利第6,330,965号和第6,241,139号,每个的发明名称均为“外科缝合设备(Surgical Stapling Apparatus)”,每个专利的全部公开内容通过引用并入本文);以及横向吻合缝合器(参见,例如,共同拥有的美国专利第5,964,394号和第7,334,717号,每个的发明名称均为“外科紧固件应用设备(SurgicalFastener Applying Apparatus)”,每个专利的全部公开内容通过引用并入本文)。
现在将参照附图详细描述当前公开的外科支撑件和外科缝合设备的实施例,其中相似的附图标记表示相似或相同的元件。在以下讨论中,术语“近侧”和“尾部”可以互换使用,并且应理解为是指在正确使用期间更靠近临床医生的结构部分。术语“远侧”和“前导端”也可以互换使用,并且应理解为是指在正确使用期间远离临床医生的结构部分。如本文所用,术语“患者”应理解为是指人类受试者或其他动物,并且术语“临床医生”应理解为是指医生、护士或其他护理提供者,并且可包括支持人员。
现在参照图1,公开了一种示例性外科缝合设备或外科缝合器10,用于缝合组织并将外科支撑件应用到组织。外科缝合设备10通常包括手柄12,所述手柄具有从手柄12向远侧延伸的细长管状构件14。端部执行器16安装在细长管状构件14的远端18上。端部执行器16包括砧座组件和仓组件,所述砧座组件包括钉锁紧砧座钳口构件20,并且仓组件包括构造成容纳钉仓32的钉仓钳口构件22。端部执行器16可以永久地固定到细长管状构件14上,或者可以是可拆卸的,并因此可以用新的端部执行器16替换。钉锁紧砧座钳口构件20可移动地安装在端部执行器16的远端18上,并且能够在与钉仓钳口构件22间隔开的打开位置和基本邻近钉仓钳口构件22的关闭位置之间移动。
如图1中所示,外科缝合设备10还包括能够移动地安装在手柄12上的触发器33。触发器33的致动首先操作以相对于钉仓钳口构件22将砧座钳口构件20从打开位置移动到关闭位置,并且随后致动外科缝合设备10以将缝合钉线应用到组织。为了相对于要缝合的组织正确地定向端部执行器16,外科缝合设备10另外设置有安装在手柄12上的旋钮34。旋钮34相对于手柄12的旋转使细长管状构件14和端部执行器16相对于手柄12旋转,从而相对于待缝合的组织适当地定向端部执行器16。
可以参照共同拥有的美国专利第5,915,616号、第6,330,965号和第6,241,139号详细讨论外科缝合装置10的构造和操作,其中每一个专利的公开内容通过引用并入本文。
如图2至3中所描绘的,砧座钳口构件20可以设置有外科支撑件24,并且钉仓钳口构件22可以设置有外科支撑件24a。为了便于参考,下面的描述将集中在固定在钉仓钳口构件22上的外科支撑件24a上,但是应理解,固定在砧座钳口构件20上的外科支撑件24可以由与固定在钉仓钳口构件22上的外科支撑件24a相同的材料形成,具有相同的构造和性质。
参考图2至4,钉仓钳口构件22可以设置有外科支撑件24a。外科支撑件24a用于加强和密封由外科缝合设备10应用到组织上的缝合钉线。外科支撑件24a可以被构造成任何形状、大小或尺寸,以适合任何外科缝合、紧固或击发设备。如图3中所示,外科支撑件24a可以用缝线28附接到仓钳口构件22。
当外科缝合设备10完全致动时,设置在刀槽25(图3)内的刀(未示出)切割砧座钳口构件20与钉仓钳口构件22之间捕获的组织。
本公开的外科支撑件可以由生物相容的基底材料制成。这种基底可以由生物可吸收的、不可吸收的、天然的和/或合成的材料形成。
在实施例中,本公开的外科支撑件可以是生物可降解的,使得支撑件不必从体内取出。本文使用的术语“生物可降解的”被定义为包括生物可吸收的和生物再吸收的材料。生物可降解的是指外科支撑件在身体条件下分解或失去结构完整性(例如,酶降解或水解),或在身体的生理条件下分解(物理或化学),从而使得降解产物可被身体排泄或吸收。
可用于形成本公开的外科支撑件的材料的非限制性实例包括但不限于:聚乳酸、聚乙醇酸、聚三亚甲基碳酸酯、聚二氧环己酮、聚羟基丁酸酯、聚磷嗪、聚对苯二甲酸乙二醇酯、聚乙二醇、聚氧化乙烯、聚丙烯酰胺、聚羟乙基甲基丙烯酸酯、聚乙烯吡咯烷酮、聚乙烯醇、聚丙烯酸、聚乙酸酯、聚己内酯、聚丙烯、脂肪族聚酯、甘油、聚(氨基酸)、共聚(醚-酯)、聚草酸亚烷基酯、聚酰胺、聚(亚氨基碳酸酯)、聚草酸亚烷基酯、聚氧杂酯、聚原酸酯、聚磷腈和其共聚物、嵌段共聚物、均聚物、共混物以及其组合。
在实施例中,天然生物聚合物可用于形成本公开的外科支撑件。合适的天然生物聚合物包括但不限于胶原、明胶、纤维蛋白、纤维蛋白原、弹性蛋白、角蛋白、白蛋白、纤维素、氧化纤维素、羟乙基纤维素、羟丙基纤维素、羧乙基纤维素、羧甲基纤维素、甲壳质、壳聚糖以及其组合。此外,天然生物聚合物可与本文所描述的任何其他聚合物材料组合,以产生本公开的外科支撑件。
外科支撑件也可以由多孔或无孔的材料形成。当然,应当理解,多孔、非多孔、天然、合成、生物可吸收和/或非生物可吸收材料的任意组合都可以用于形成本公开的外科支撑件。
在一些实施例中,本公开的外科支撑件可以由多孔材料形成。本公开的外科支撑件的任何多孔部分可以在其表面的至少一部分之上具有开口或孔。合适的多孔材料包括但不限于纤维结构(例如,针织结构、编织结构、非编织结构等)和/或泡沫(例如,开孔或闭孔泡沫)。
在实施例中,孔可以具有足够的数量和大小,以便在外科支撑件的整个厚度上相互连接。机织织物、针织织物、非织造织物和开孔泡沫是结构的说明性示例,其中孔可以具有足够的数量和大小,以便在外科支撑件的整个厚度上相互连接。
在其他实施例中,孔可以不在外科支撑件的整个厚度上相互连接。闭孔泡沫或熔融非织造材料是其中孔可能不在外科支撑件的整个厚度上相互连接的结构的说明性示例。在一些实施例中,孔可以位于外科支撑件的一部分上,医疗装置的其他部分具有无孔纹理。本领域技术人员可以设想本公开的多孔医疗装置的多种孔分布模式和构型。
在本公开的外科支撑件是多孔的并且包括纤维材料的情况下,外科支撑件可以使用任何合适的方法形成,包括但不限于针织、编织、无纺技术(包括熔喷)、湿纺、电纺、挤出、共挤出等。在实施例中,外科支撑件具有三维结构,如美国专利第7,021,086号和第6,443,964号中描述的纺织品,其全部公开内容通过引用并入本文。
用于形成基底的织物的多孔性可以允许生物流体和/或细胞成分的渗透,这反过来可以加速任何治疗剂从本公开的外科支撑件中的释放动力学,从而增加治疗剂从外科支撑件到周围组织和流体中的释放速率。
用于形成本公开的外科支撑件的基底可以具有大约0.05mm至大约0.5mm的厚度,在实施例中为大约0.1mm至大约0.2mm。
在用于形成外科支撑件的基底是多孔的情况下,本公开的外科支撑件可以具有大约65%至大约85%的孔体积,在实施例中为大约70%至大约80%。
如图3至4中所描绘的,在实施例中,本公开的外科支撑件24a可以包括细长的矩形主体部分27。外科支撑件24a的矩形主体部分27具有远侧部分40和近侧部分42。在一些实施例中,本公开的外科支撑件24a在远侧部分40处具有治疗剂,在近侧部分42处具有治疗剂,或者两者都具有。治疗剂可以结合在用于形成支撑件24a的远侧部分40和近侧部分42的材料中,或者如图3至4中所示,治疗剂可以作为涂层应用,从而在支撑件24a的远侧部分40形成第一突片46,和在近侧部分42形成第二突片48。
虽然上述公开内容集中在外科支撑件24a上,但应当理解,外科支撑件24可以具有类似的构造,具有在其远侧部分和近侧部分处具有治疗剂的突片46a和48a(图6)。
转到图5至6,在实施例中,本文所描述的支撑件24、24a可用于通过接近外科缝合设备的钉仓钳口构件22和砧座钳口构件20之间的伤口组织的边缘来密封伤口。外科缝合设备10的击发迫使至少一个缝合钉50的缝合钉腿56、58穿过钉仓钳口构件22上的开口、钉仓钳口构件22上的支撑件24a、组织、砧座钳口构件20上的支撑件24以及砧座(未示出)上的开口,以将支撑件24、24a固定到组织上,使得组织夹在两者之间,从而固定相邻的组织并密封组织。
在图5至6中示出了用缝合钉50划分并缝合的最终组织“T”。具体地,与钉仓钳口构件22相关联的外科支撑件24a通过缝合钉50的后摆54固定在组织“T”上,而与砧座钳口构件20相关联的外科支撑件24通过缝合钉腿56和58固定在组织“T”上。因此,外科支撑件24、24a被缝合到组织“T”上,从而密封和加强由缝合钉50产生的缝合钉线。
如图6中所,其中具有治疗剂的突片46、46a、48和48a没有结合在缝合钉线中,并且没有缝合的组织。
虽然以上描述是针对矩形支撑件的,但应理解,根据本公开,可以使用任何合适的支撑件构造。例如,可以使用具有细长矩形主体,且在支撑件的端部具有头部部分和尾部部分的支撑件。例如,其他合适的支撑件包括在2017年6月30日提交的美国专利申请系列第15/639,367号和美国专利第8,157,151号、第8,561,873号和第9,693,772号中公开的支撑件,其全部公开内容通过引用并入本文。
可以添加到本公开的外科支撑件中的治疗剂包括但不限于:药物;氨基酸;肽;多肽;蛋白质;多糖;突变蛋白;免疫球蛋白;抗体;细胞因子(例如,淋巴因子、单因子、趋化因子);凝血因子;造血因子;白细胞介素(1至18);干扰素(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;纤维蛋白;凝血酶;纤维蛋白原;合成凝血酶;合成纤维蛋白;合成纤维蛋白原;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、促黄体激素释放因子);疫苗(例如,肿瘤、细菌和病毒抗原);生长抑素;抗原;凝血因子;生长因子(例如,神经生长因子、胰岛素样生长因子);骨形态发生蛋白;TGF-B;蛋白质抑制剂;蛋白质拮抗剂;蛋白质激动剂;核酸,如反义分子、DNA、RNA、RNAi、寡核苷酸、多核苷酸;细胞;病毒;抗炎剂;抗菌剂;抗微生物剂和核酶。
在实施例中,应用于本公开的外科支撑件的治疗剂可以包括抗肿瘤剂和/或肿瘤抑制剂,在实施例中,称为“化疗剂”和/或“抗肿瘤剂”。合适的化疗剂包括例如:紫杉醇和其衍生物、多西他赛和其衍生物、阿布拉尼、三苯氧胺、环磷酰胺、放线菌素、博莱霉素、放线菌素D、柔红霉素、阿霉素、盐酸阿霉素、表阿霉素、丝裂霉素、甲氨蝶呤、氟尿嘧啶、吉西他滨、盐酸吉西他滨、卡铂、卡莫司汀(BCNU)、甲基-CCNU、顺铂、鬼臼乙叉甙、喜树碱和其衍生物、苯芥胆甾醇、长春碱、长春新碱、戈舍瑞林、亮丙瑞林、干扰素α、视黄酸(ATRA)、氮芥烷化剂、哌泊舒凡、长春瑞滨、伊立替康、盐酸伊立替康、长春碱、培美曲塞、索拉非尼甲苯磺酸酯、依维莫司、盐酸埃罗替尼、苹果酸舒尼替尼、卡培他滨奥沙利铂、亚叶酸钙、贝伐单抗、西妥昔单抗、雷莫芦单抗、曲妥单抗、阿特朱单抗、康纳单抗及其组合等。
在实施例中,紫杉醇和/或紫杉醇衍生物可用作治疗剂。紫杉醇可以有多种形式,本文称为“多晶型”,包括无定形紫杉醇、结晶紫杉醇(有时称为结晶紫杉醇二水合物)和/或无水紫杉醇,或其混合物。
根据本公开,用于形成治疗层的紫杉醇的多晶型形式可以根据水性组合物、溶剂极性以及溶剂系统中用于形成用于应用治疗层的溶液的质子和非质子溶剂的组成而变化。例如,紫杉醇在甲醇中10%v/v的水中溶解,并且然后从其中干燥,将产生主要为结晶的紫杉醇二水合物层,而同样的紫杉醇溶解在非极性溶剂二氯甲烷中,并且然后从其中干燥,将产生主要为无定形的层。
紫杉醇的结晶度将影响其在水性体系中的溶解度。因此,可以调节和选择治疗层中紫杉醇的多晶型形式,以提供治疗剂从本公开的外科支撑件的定制释放。尽管任何形式的药物都是疏水性的,但无定形紫杉醇在水性环境中更易溶解,而结晶紫杉醇在水性环境中较不易溶解。因此,在实施例中,可以使用紫杉醇的多于一种的多晶型形式来提供具有多种紫杉醇释放特征的植入物。例如,本公开的外科支撑件上同时具有无定形紫杉醇和结晶紫杉醇(二水合物或无水)可以在植入时释放一团治疗剂(主要由无定形紫杉醇溶解产生),同时也缓慢释放治疗剂(主要由结晶紫杉醇(二水合物或无水)溶解产生)。
在没有赋形剂的实施例中,在外科支撑件上形成至少一个突片的治疗层中无定形紫杉醇的量可以为治疗层重量的0%至大约100%,在实施例中为治疗层重量的大约10%至大约90%,其中结晶紫杉醇的存在量为治疗层重量的大约0%至大约100%,在实施例中为治疗层重量的大约90%至大约10%。
本公开的外科支撑件可在大约18小时至大约96小时(在实施例中大约24小时至大约72小时)的时间段内,在体内释放无定形紫杉醇,并在大约3天至大约14天(在实施例中大约7天至大约10天)的时间段内,在体内释放结晶紫杉醇。
在一些实施例中,在外科支撑件的至少一个端部形成突片的治疗层可以由聚合材料或本领域技术人员所知的其他载体组分形成。在实施例中,这种层可以包括例如可降解材料,如由单体(如乙交酯、丙交酯、三亚甲基碳酸酯、对二氧环己酮、ε-己内酯以及其组合)制备的材料。
在其他实施例中,除了上述治疗剂之外,无论治疗剂是否与一些附加的聚合材料一起应用以形成治疗层,在本公开的外科支撑件上形成突片时应用于基底材料的治疗层也可以包括赋形剂,以增强治疗剂粘附于外科支撑件的能力,以及改变治疗剂从外科支撑件的洗脱。
在实施例中,可与治疗剂组合以形成治疗层的合适赋形剂包括表面活性剂,如但不限于环糊精,如2-羟丙基-β-环糊精和甲基-β-环糊精,十二烷基硫酸钠,辛基葡糖苷,和脱水山梨糖醇脂肪酸酯,如脱水山梨糖醇单油酸酯、脱水山梨糖醇单月桂酸酯和脱水山梨糖醇的聚乙氧基化脂肪酸酯,有时在本文中称为聚山梨醇酯,包括以TWEENTM的名称销售的那些。这种聚山梨醇酯的示例包括聚山梨醇酯80(TWEENTM80)、聚山梨醇酯20(TWEENTM20)、聚山梨醇酯60(TWEENTM60)、聚山梨醇酯65(TWEENTM65)、聚山梨醇酯85(TWEENTM85)、其组合等。在实施例中,低分子量聚乙二醇可以作为赋形剂加入,可以单独加入,也可以与任何其他上述赋形剂组合加入。
在其他实施例中,合适的赋形剂可包括盐类如氯化钠和/或其他物质如尿素、油酸、柠檬酸和抗坏血酸。在又其他实施例中,赋形剂可以是稳定剂,如丁基化羟基甲苯(BHT)或丁基化羟基茴香醚(BHA)。
还有其他合适的赋形剂包括多元醇,如D-山梨醇、甘露醇以及其组合等。
在一些实施例中,作为水溶助剂的赋形剂可以包括在本公开的治疗层中。这些材料将水吸引到治疗层中,从而可以增强其降解并导致治疗剂从治疗层中释放。
在实施例中,治疗剂、载体组分和/或赋形剂可以在用于本公开的外科支撑件的溶液中。可以使用任何合适的溶剂来形成这种溶液。用于形成这种溶液的合适溶剂包括任何药学上可接受的溶剂,包括但不限于盐水、水、醇、丙酮、二甲基亚砜、乙酸乙酯、N-甲基吡咯烷酮、其组合等。形成这种溶液的方法在本领域技术人员的范围内,包括但不限于混合、掺混、超声处理、加热、其组合等。
在实施例中,通过选择不同的溶剂系统,由于用来形成包括治疗剂的溶液的溶剂会导致出现的不同的治疗剂形态和结晶度,因此可以实现不同的治疗剂溶解速率。
在实施例中,治疗剂、任何载体组分和/或任何赋形剂可以通过针沉积过程应用到本公开的外科支撑件上。如上所述,在实施例中,治疗剂在溶液中,然后将其应用于本公开的外科支撑件。
在实施例中,治疗剂、任何载体组分和/或任何赋形剂可以在将外科支撑件固定到一些其他医疗设备之前应用于本公开的医疗装置。例如,在外科支撑件的情况下,外科支撑件可以在附接到外科缝合器之前根据本公开进行涂覆。
在实施例中,可以在本公开的外科支撑件上的治疗剂涂层之上应用附加的外层。在实施例中,这种附加的层可以是不可渗透的、半渗透的或多孔的,以允许调节治疗剂从本公开的外科支撑件上的治疗剂涂层释放的速率。
用于在外科支撑件上形成外层的合适材料包括,例如,可降解材料,如由单体(如乙交酯、丙交酯、三亚甲基碳酸酯、对二氧环己酮、ε-己内酯以及其组合)制备的材料。在实施例中,用于在外科支撑件上形成外层的合适材料包括例如磷酰胆碱聚合物。
根据本公开,应用包括治疗剂、溶剂、任何载体组分和/或任何赋形剂的治疗层,使得沉积适量的治疗剂并保持牢固地附着于外科支撑件,在其至少一个端部上形成一个突片。
应用后,可以通过本领域技术人员范围内的方法从涂覆溶液中除去溶剂。例如,可以通过加热、气流、时间、减压、其组合等来促进溶剂蒸发,以增加药物在医疗装置上沉积的准确性。此外,溶剂的这一辅助蒸发可以应用于外科支撑件的整个表面,部分地应用于医疗装置的表面的仅一部分,或者仅应用于沉积器械(例如,针尖)周围。
驱除溶剂会留下治疗剂和任何载体组分和/或赋形剂,从而在外科支撑件上形成治疗层。
根据本公开,可以重复所述过程,使得可以进行多次通过,使得外科支撑件的表面具有用于施用一定剂量的治疗剂的所需量的治疗剂。在实施例中,重复上述过程导致多个层的沉积,使得支撑件上的整个治疗层非常均匀和坚固,并且非常好地粘附到外科支撑件材料上。这与其他过程形成对比,如浸涂和其他类似的涂覆方法,这些方法缺乏根据本公开生产的涂层/层的坚固性和粘附性。
所述过程的设计利用了药物在其上分散以形成涂层的织物的毛细作用。适当控制分散的速度和速率,以产生所需的涂层。在涂层之间,所述过程可以具有预定的暂停,以确保在更多治疗剂沉积为下一层之前,每个涂层具有适当的干燥时间。
利用本公开的过程,所述过程的不同阶段的药物损失有限。这有利于将治疗剂隔离到其预期停留的区域,并且就所用治疗剂的量的而言,节省了成本。
从制造的角度来看,所述过程也非常有效。使用本公开的过程,可以直接涂覆在外科支撑件上,而不是涂覆在仓和砧座组件上,这就节省了材料处理、人工成本和质量相关成本。此外,对操作者来说更安全。例如,所述过程经开发而优于对运行过程的操作人员来说非常危险的喷涂。正常的空气流动罩足以安全地操作这一过程。此外,这一过程不需要隔离器,这使得它非常适合长期生产。
所述过程还被设计成能够将药物高精度地沉积在装置的特定区域。外科支撑件表面的某些部分可以通过设计而不被涂覆,以提高外科支撑件的性能,例如围绕缝合钉线的组织愈合更好。此外,可以将不同量的治疗剂应用到外科支撑件的不同区域,从而在外科支撑件上产生治疗剂的浓度梯度和/或从外科支撑件的选定部分集中应用治疗剂。
在实施例中,多层治疗剂可以轻松地沉积在外科支撑件上。在一些情况下,不同的治疗剂应用于不同的层。因此,通过使用多层,不同的治疗益处可以结合在一个外科支撑件上。在其他实施例中,不同的治疗剂可以沉积在外科支撑件表面的不同区域上,例如,一种治疗剂可以应用于一个区/区域,而另一治疗剂可以应用于另一区/区域。
在形成后,本公开的外科支撑件可在其上的经涂覆的支撑件中具有治疗剂,其量为经涂覆的支撑件重量的大约0.1%至大约50%,在实施例中为经涂覆的支撑件重量的大约1%至大约10%。虽然不需要赋形剂,但如果存在的话,非聚合赋形剂可以按经涂覆的支撑件重量的大约0.01%至大约80%的量存在,在实施例中为经涂覆的支撑件重量的大约1%至大约11%。在其他实施例中,如果存在的话,聚合赋形剂可以按经涂覆的支撑件重量的大约0.014%至大约14%的量存在,在实施例中为经涂覆的支撑件重量的大约5%至大约15%。
在形成后,本公开的外科支撑件可在其上形成突片的治疗层中具有治疗剂,其量为治疗层重量的大约0.01%至大约100%,在实施例中为治疗层重量的大约1%至大约75%。虽然不需要赋形剂,但如果存在的话,非聚合赋形剂可以按治疗层重量的大约1%至大约99%的量存在,在实施例中为治疗层重量的大约8.5%至大约79.4%,并且最优选在实施例中为9.5%至大约15%。在实施例中,如果存在的话,聚合赋形剂可以按治疗层重量的大约1%至大约99%的量存在,在实施例中为治疗层重量的大约5%至大约15%。
具有治疗剂和非聚合赋形剂的治疗层可以具有大约13nm至大约2.9μm的厚度,在实施例中为大约25nm至大约100nm。
具有治疗剂和聚合赋形剂的治疗层可以具有大约2nm至大约1.1μm的厚度,在实施例中为大约30nm至大约100nm。
在其他实施例中,治疗层可以包括很少或不包括赋形剂,因此可以将非常薄的治疗层应用到基底上。这将保持基底的孔隙率。这种治疗层可以具有大约11nm至大约218nm的厚度,在实施例中为大约25nm至大约75nm。
本公开的外科支撑件可以在大约18小时至大约4周(在实施例中大约48小时至大约2周)的时间段内,从其中释放治疗剂。
如上所述,本公开的外科支撑件可以与任何固定装置一起使用,以进一步帮助密封组织。例如,本公开的外科支撑件可以与缝合钉、大头钉、夹子、缝线、粘合剂、其组合等结合使用。
在实施例中,提供了本公开的外科支撑件,以加强和密封由外科缝合设备应用到组织的缝合钉线。支撑件可以被构造成任何形状、大小或尺寸,以适合任何外科缝合、紧固或击发设备。
当应用于出血组织部位时,本公开的外科支撑件可能影响所述组织的止血。本文使用的术语“止血”是指抑制流血。
除了在外科支撑件的应用部位提供止血之外,本公开的外科支撑件还可以在植入部位和身体的其他部位提供用治疗剂对组织进行治疗。
应理解,可以对本文公开的实施例进行各种修改。因此,以上描述不应被理解为限制性的,而仅仅是优选实施例的范例。本领域技术人员将在本公开的范围和精神内预见其他修改。这种修改和变化旨在落入以下权利要求的范围内。
Claims (18)
1.一种外科缝合装置,其包含:
端部执行器,其包括彼此枢转地耦合的砧座钳口构件和仓钳口构件,所述砧座钳口构件和仓钳口构件能够相对移动,使得所述端部执行器能够在打开位置与夹紧位置之间移动;和
支撑件,其附接到所述仓钳口构件,所述支撑件具有远侧部分和近侧部分,所述远侧部分和所述近侧部分中的至少一个上具有治疗剂,
其中所述治疗剂作为涂层应用到所述支撑件的所述远侧部分,以在所述支撑件的所述远侧部分处形成第一突片,并且所述治疗剂作为涂层应用到所述支撑件的所述近侧部分,以在所述支撑件的所述近侧部分处形成第二突片,使得所述涂层不位于缝合钉穿透所述支撑件的位置。
2.根据权利要求1所述的外科缝合装置,其中第二支撑件附接到所述砧座钳口构件,所述第二支撑件具有远侧部分和近侧部分,所述远侧部分和所述近侧部分中的至少一个上具有治疗剂。
3.根据权利要求2所述的外科缝合装置,其中所述治疗剂作为涂层应用到所述第二支撑件的所述远侧部分,以在所述第二支撑件的所述远侧部分处形成第一突片,并且所述治疗剂作为涂层应用到所述第二支撑件的所述近侧部分,以在所述第二支撑件的所述近侧部分处形成第二突片。
4.根据权利要求1所述的外科缝合装置,其中所述治疗剂是以下的任意组合:氨基酸;肽;多肽;蛋白质;多糖;突变蛋白;免疫球蛋白;抗体;细胞因子;造血因子;白细胞介素1至18;干扰素;促红细胞生成素;核酸酶;肿瘤坏死因子;集落刺激因子;胰岛素;抗肿瘤剂和肿瘤抑制剂;血蛋白;纤维蛋白;凝血酶;纤维蛋白原;合成凝血酶;合成纤维蛋白;合成纤维蛋白原;促性腺激素;激素和激素类似物;疫苗;生长抑素;抗原;凝血因子;生长因子;骨形态发生蛋白;TGF-B;蛋白质抑制剂;蛋白质拮抗剂;蛋白质激动剂;核酸,如反义分子、DNA、RNA、RNAi、寡核苷酸、多核苷酸;细胞;病毒;抗炎剂;抗菌剂;抗微生物剂和核酶。
5.根据权利要求1所述的外科缝合装置,其中所述治疗剂是化疗药物。
6.根据权利要求5所述的外科缝合装置,其中所述化疗药物是以下的任意组合:紫杉醇和其衍生物、多西他赛(docetaxel)和其衍生物、阿布拉尼(abraxane)、三苯氧胺、环磷酰胺、放线菌素、博莱霉素(bleomycin)、放线菌素D、柔红霉素(daunorubicin)、阿霉素(doxorubicin)、盐酸阿霉素、表阿霉素(epirubicin)、丝裂霉素(mitomycin)、甲氨蝶呤、氟尿嘧啶、吉西他滨(gemcitabine)、盐酸吉西他滨、卡铂(carboplatin)、卡莫司汀(carmustine)、甲基-CCNU、顺铂(cisplatin)、鬼臼乙叉甙(etoposide)、喜树碱和其衍生物、苯芥胆甾醇(phenesterine)、长春碱(vinblastine)、长春新碱(vincristine)、戈舍瑞林(goserelin)、亮丙瑞林(leuprolide)、干扰素α、视黄酸、氮芥烷化剂、哌泊舒凡(piposulfan)、长春瑞滨(vinorelbine)、伊立替康(irinotecan)、盐酸伊立替康、长春碱、培美曲塞(pemetrexed)、甲苯磺酸索拉非尼(sorafenib tosylate)、依维莫司(everolimus)、盐酸埃罗替尼(erlotinib hydrochloride)、苹果酸舒尼替尼(sunitinibmalate)、卡培他滨奥沙利铂(capecitabine oxaliplatin)、亚叶酸钙、贝伐单抗(bevacizumab)、西妥昔单抗(cetuximab)、雷莫芦单抗(ramucirumab)、曲妥单抗(trastuzumab)、阿特朱单抗(atezolizumab)、康纳单抗(canakinumab)以及其组合。
7.根据权利要求1所述的外科缝合装置,其中所述治疗剂与赋形剂组合,所述赋形剂包括表面活性剂、盐、酸、稳定剂、多元醇、水溶助剂、低分子量聚(乙二醇)或其任意组合。
8.根据权利要求7所述的外科缝合装置,其中所述表面活性剂是环糊精、十二烷基硫酸钠、辛基葡糖苷、脱水山梨醇脂肪酸酯或其组合。
9.根据权利要求7所述的外科缝合装置,其中所述盐包括氯化钠。
10.根据权利要求7所述的外科缝合装置,其中所述酸包括油酸、柠檬酸、抗坏血酸或其组合。
11.根据权利要求7所述的外科缝合装置,其中所述稳定剂包括丁基化羟基甲苯。
12.根据权利要求7所述的外科缝合装置,其中所述多元醇包括D-山梨醇、甘露醇或其组合。
13.根据权利要求1所述的外科缝合装置,其中所述支撑件通过至少一条缝合线附接到所述仓钳口构件。
14.根据权利要求2所述的外科缝合装置,其中所述第二支撑件通过至少一条缝合线附接到所述砧座钳口构件。
15.一种外科缝合装置,其包含:
端部执行器,其包括彼此枢转地耦合的砧座钳口构件和仓钳口构件,所述砧座钳口构件和仓钳口构件能够相对移动,使得所述端部执行器能够在打开位置与夹紧位置之间移动;和
支撑件,其附接到所述仓钳口构件,所述支撑件具有远侧部分和近侧部分,所述远侧部分和所述近侧部分中的至少一个上具有化疗药物,
其中所述化疗药物作为涂层应用到所述支撑件的所述远侧部分,以在所述支撑件的所述远侧部分处形成第一突片,并且所述化疗药物作为涂层应用到所述支撑件的所述近侧部分,以在所述支撑件的所述近侧部分处形成第二突片,使得所述涂层不位于缝合钉穿透所述支撑件的位置。
16.根据权利要求15所述的外科缝合装置,其中第二支撑件附接到所述砧座钳口构件,所述第二支撑件具有远侧部分和近侧部分,所述远侧部分和所述近侧部分中的至少一个上具有化疗药物。
17.根据权利要求16所述的外科缝合装置,其中所述化疗药物作为涂层应用到所述第二支撑件的所述远侧部分,以在所述第二支撑件的所述远侧部分处形成第一突片,并且所述化疗药物作为涂层应用到所述第二支撑件的所述近侧部分,以在所述第二支撑件的所述近侧部分处形成第二突片。
18.根据权利要求16所述的外科缝合装置,其中所述化疗药物是以下的任意组合:紫杉醇和其衍生物、多西他赛和其衍生物、阿布拉尼、三苯氧胺、环磷酰胺、放线菌素、博莱霉素、放线菌素D、柔红霉素、阿霉素、盐酸阿霉素、表阿霉素、丝裂霉素、甲氨蝶呤、氟尿嘧啶、吉西他滨、盐酸吉西他滨、卡铂、卡莫司汀、甲基-CCNU、顺铂、鬼臼乙叉甙、喜树碱和其衍生物、苯芥胆甾醇、长春新碱、戈舍瑞林、亮丙瑞林、干扰素α、视黄酸、氮芥烷化剂、哌泊舒凡、长春瑞滨、伊立替康、盐酸伊立替康、长春碱、培美曲塞、甲苯磺酸索拉非尼、依维莫司、盐酸埃罗替尼、苹果酸舒尼替尼、卡培他滨奥沙利铂、亚叶酸钙、贝伐单抗、西妥昔单抗、雷莫芦单抗、曲妥单抗、阿特朱单抗、康纳单抗以及其组合。
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