CN102580146B - 旨在与患者的组织接触的医疗器械及相关的制造方法 - Google Patents
旨在与患者的组织接触的医疗器械及相关的制造方法 Download PDFInfo
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Abstract
本发明涉及旨在与患者的组织接触的医疗器械及相关的制造方法。根据本发明的器械包含主体(12)，所述主体(12)包括不含氧化纤维素的纤维。所述主体(12)还包括含有氧化纤维素的纤维。
Description
本发明涉及旨在与患者的组织接触的医疗器械，包含具有纤维的主体，所述纤维不具有氧化纤维素。
这样的医疗器械旨在例如形成假体或血管内置假体、引导组织再生膜、管、固定板(setting plate)、透析导管、灌注导管、输液导管、人工营养导管、经皮植入物、用于组织工程的格栅(lattice)、微孔和大孔的骨代用品、硬脑膜代用品、细胞疗法基质(matrix)、缝合线、医用绷带或血管补片。
从FR 2742042的已知的是形成管状血管假体(vascular prosthesis)的前述类型的医疗器械。
血管假体通常由组织或紧密针织的织品制成。在它们被植入前，它们被确保生物相容性和器械的密封的两者的涂层涂覆。
该涂层例如用胶原、明胶或其他包含生物可再吸收的聚合物的基本成分(base)形成。
血管假体，一旦被植入体内，旨在将血液运输以代替被梗塞或破坏的血管。
为此，在细胞移植织物基底的壁以维持密封前，一旦假体被植入，则涂覆层保证假体的密封。
为此，在缝合假体后当外科医生恢复血压时，胶原涂层阻止血液流通和渗漏通过假体针织的网孔，以使得患者不会损失太多血液。
这样的假体是十分令人满意的，尤其对于密封。
尽管如此，在一些情况下它可能可用于废除动物来源的涂层、同时维持好的密封和好的机械性能。
因此，本发明的一个目的是获得一种医疗器械，尤其是血管假体，其具有合适的机械结构，同时保持令人满意的密封和止血性能。
为此，本发明涉及前述类型的医疗器械，其特征在于，主体包括含有氧化纤维素的纤维。
单独考虑或根据所有技术上可行的组合，根据本发明的器械可包括一个或多个以下特征：
-至少部分不具有氧化纤维素的纤维与含有氧化纤维素的纤维进行并合以形成至少一种复合线，该复合线被编织、织造或针织，以形成主体；
-含氧化纤维素的纤维形成至少一种(个)第一种线，不含氧化纤维素的纤维形成至少一种(个)第二种线，第一种和第二种线被编织、织造或针织，以形成主体；
-主体是非织造的；
-非织造的主体的纤维在优选的方向被定向。
-不含氧化纤维素的纤维选自不具有氧化纤维素的天然聚合物和合成聚合物。
-不含氧化纤维素的纤维由聚合物形成，所述聚合物来自由聚酰胺类、聚烯烃类、卤代聚合物类、聚酯类、聚氨酯类、氟聚合物类、聚乳酸类或聚缩水甘油基酸类或其混合物组成的组；
-在含有氧化纤维素的纤维中含有的氧化纤维素被官能团官能化；
-氧化纤维素包括由脱水葡萄糖单元的碳6支持的羧基，该羧基被官能团官能化；
-官能团选自生物活性剂例如抗凝剂、抗血栓形成剂、抗有丝分裂剂、抗增殖剂、抗粘附剂、抗迁移剂、细胞粘附促进剂、生长因子、抗寄生虫分子、抗炎剂、生成血管剂、血管生成抑制剂、维生素、激素、蛋白质、抗真菌剂、抗微生物分子、防腐剂、交联剂、造影剂；
-主体形成管或片材；
-主体将液密壁划界，有利的是对血液密封；
-器械形成假体或血管内置假体、引导组织再生膜、管、固定板、透析导管、灌注导管、输液导管、人工营养导管、经皮植入物、组织工程用格栅、微孔和大孔的骨代用品、硬脑膜代用品、细胞疗法基质、缝合线、医用绷带或血管补片。
本发明还涉及旨在与患者的组织接触的医疗器械的制造方法，其特征在于，它包括用于制造包括不含氧化纤维素的纤维和敖汉氧化纤维素的纤维的主体的步骤。
单独考虑或根据所有技术上可行的组合，根据本发明的方法可包含一个或多个以下特征：
-它包括以下步骤：
-提供不含氧化纤维素的纤维和包含旨在被氧化的纤维素的纤维；
-由不具有氧化纤维素的纤维和旨在被氧化的纤维素纤维形成主体；
-在主体的形成后，旨在被氧化的纤维素纤维选择性的氧化以形成氧化纤维素；
-在主体的形成前，它包含至少一种包括不含氧化纤维素的纤维和旨在被氧化的纤维素纤维的复合线的并合(assembly)，以及将复合线进行编织、针织或织造以形成主体；
-主体的形成包括提供至少一种由不含氧化纤维素的纤维形成的第一种线和至少一种由旨在被氧化的纤维素纤维形成的第二种线，然后将第一种线和第二种线进行编织、织造或针织以形成主体；
-它包括在氧化步骤后被官能团氧化的纤维素的至少部分官能化。
本发明将通过阅读以下作为实施例而单独提供的说明书并参照附图而得到更好的理解，其中：
-图1是形成血管假体的根据本发明的第一医疗器械的侧视图；
-图2是说明制造根据本发明的器械的方法的不同步骤的官能的概述图；
-图3是根据本发明的第二医疗器械的类似图1的图；
-图4是例如形成包扎纱布或血管补片的根据本发明的第三器械的类似图1的视图。
根据本发明的第一医疗器械10显示于图1中。
根据本发明，第一医疗器械10包含主体12，所述主体12包括不含氧化纤维素的纤维和含氧化纤维素的纤维。
在该实施例中，主体12例如由用织造、编织或针织的线的基本成分而制成的织品形成。在以后将描述的可选择方式中，主体12是通过将相互连接的纤维进行并合而制成的非织造物。
主体12是肉眼可见的主体，即具有至少一个大于5mm的直径，优选至少等于1cm。
含有氧化纤维素的纤维由具有通式-(C6H10O5)n-的纤维素纤维获得。以已知的方式，纤维素是属于多糖类的均聚物。它由通过糖苷键β-1，4而连接的葡萄糖分子的直链形成。
在本发明的意义中，“氧化纤维素”是指其中至少部分由脱水葡萄糖单元的碳6支持的伯醇基团被氧化成可被官能化的羧酸的纤维素，如以下所看到的。
氧化纤维素的氧化度大于1％。优选地，该氧化度在1％-25％之间，优选地5％-20％，以及有利的是12％-18％。
在说明书的上下文中，部分氧化的聚合物基的材料的“氧化度”是指在100g所述材料中含有的羧酸基团的质量，以百分数计。
氧化度可通过滴定法、根据美国药典(uSP，1990)推荐的钙交换法(calciumexchange method)(Sobue and Okubo，1956)，根据以下协议来确定：
在250mL的爱伦美氏烧瓶中，引入0.10g部分氧化的纤维素组织以分析，加入50mL纯化水和30mL 0.5N的醋酸钙溶液。在定轨混合器(orbital mixer)中搅拌混合物3小时。
移取30mL样品，并在酚酞的存在下用NaOH的水溶液(0.01N)滴定。通过比较不含氧化纤维素的对照样品的体积来校正消耗的NaOH的体积。
羧酸官能的相应等效量与氧化度相关。氧化度，以％表示，使用下式来计算：
其中：
-N(mol/L)是NaOH溶液的当量浓度(此处N＝0.01mol/L)，
-V(L)是滴定样品而消耗的NaOH溶液的体积，
-MCOOH(g/mol)是羧酸官能的摩尔质量(MCOOH＝45g/mol)，
-m组织(g)是被分析的部分氧化的纤维素组织的质量(m＝0.10g)。
术语“纤维”被理解为呈现束形式的似长丝的或由长丝形成的基本构成。纤维不同于泡沫，尤其是因为它具有比宽大的长，有利的是长比宽大10倍。
在本说明书的上下文中，“连结的纤维基的材料”或“纤维质材料”是指包含一组结合在一起的纤维的固体材料，例如以线的形式，或者以由织造或针织的线制成的织品的形式，例如，或者以非织造的形式，或者以形成定向的基质的纤维的合股(ply)的形式。
在本说明书的上下文中，“线”是指纤维的线性并合或相互牢固连接的纤维。因此纤维素线必须与纤维素纤维区别，其标明是一个单独的物体，而不是物质的连结并合。典型地，线是通过将相同类型的纤维进行纺丝而获得的，但也可以通过将不同的纤维例如如结合有合成纤维的纤维素纤维进行纺丝而获得。
构成纤维素纤维的聚合物包括脱水葡萄糖单元。它可以例如包括纤维素纤维，即用糖苷键β-1，4构成葡萄糖均聚物。或者，它可以包括改性纤维素，条件是它包括可能与其他单元连接的脱水葡萄糖单元，例如，纤维胶，其对应于从再生纤维素获得的线。或者，它可以包括细菌纤维素。在纤维氧化前，构成纤维的聚合物的氧化度通常小于1％。
纤维素纤维例如从天然纤维素基、即直接来源于植物的纤维获得，或者通过植物的收割，或者通过植物的机械处理而得到，例如扯碎、压榨、粉碎和/或分离。纤维素纤维也可以是改性纤维素纤维，即与化学组分反应了的天然纤维素或溶解的天然纤维素。
在本发明的意义中，术语“纤维素纤维”也包括再生纤维素纤维，即天然纤维素可能被改良、在溶剂中溶解、然后重新形成的以纤维的形式。
含有纤维素的纤维含有至少1摩尔％、例如大于50摩尔％的纤维素或纤维素衍生物。
天然植物纤维素纤维的例子是棉花、大麻、黄麻、羊毛或木浆。
使用用于处理天然纤维素的方法获得人造纤维素纤维。
这些纤维例如一般由国际人造纤维标准化局(BI SFA)定义，作为通过纤维素的羟基的乙酰化而获得的“醋酸盐(酯)”或“三醋酸盐(酯)”型的纤维素纤维，由海藻酸的金属性盐、例如如海藻酸的碱或碱土金属盐、例如海藻酸钙获得的“海藻酸盐”型的纤维，或使用“铜铵”法而获得的“铜”型纤维素基纤维，其中天然纤维素溶解在包含铜和胺的化合物、例如二羟基四胺铜(cupratetratamine dihydroxide)。
有利的是，纤维素纤维是粘胶纤维。
在本发明的意义中，“粘胶纤维”是指根据BISFA的定义使用“粘胶”法获得的纤维，其中，有利的是，黄原酸纤维素的基本成分溶液从一个或多个再生浴中以纤维的形式被拉出。然而这些纤维有时具有大的耐破坏性，并合适作为“模(modal)”。
在某些情况下，且或者，纤维素纤维是lyocell纤维。“lyocell纤维”是指使用纺丝法由包含有机化学产物和水的混合物的有机溶剂而获得的纤维素纤维，术语“通过溶剂的纺丝”是指纤维素在溶剂中溶解、不形成纤维素的副产物。
在被BI SFA称作“Lyocell”的该方法中，天然纤维素是例如溶解在水和胺N-氧化物、例如叔胺-N-氧化物如N-甲基吗啉N-氧化物的混合物中，并通过沉淀浴中的空气通道被挤出以形成纤维。
在本发明的意义中，“不含氧化纤维素的纤维”是指不含纤维素的纤维如合成纤维或包含纤维素的纤维，但其氧化度小于1％。
“合成纤维”是指不具有天然前体聚合物的纤维，例如通过合成单体的聚合而获得的纤维，例如油副产品。
合成纤维尤其包含聚酰胺类，例如尼龙类，聚酯类例如聚对苯二甲酸乙二醇酯，聚丙烯酸酯类，聚氨酯类，聚乳酸类和聚乙醇酸类，聚乙二醇类，聚乙烯型的聚(α-烯烃类)和卤代聚合物如聚(卤代-α-烯烃类)例如以名称销售的聚四氟乙烯(PTFE)或聚偏氟乙烯，它们的共聚物或那些聚合物的组合。
有利的是，纤维是聚对苯二甲酸乙二醇酯纤维或四氟乙烯(PTFE)纤维。
在本发明的第一个实施方式中，不含氧化纤维素的纤维和包含氧化纤维素或旨在被氧化的纤维素的纤维被并合在一起以形成复合线，例如通过整经方法。
复合线单独地或与其它复合线或与不含包含氧化纤维素的纤维的线、例如用如上述所定义的合成聚合物的基本成分制成的线、例如如PET或PTFE线，被织造、编织或针织。
由氧化纤维素纤维形成的线例如具有20dtex与200dtex之间的纤度，尤其包含在40dtex与160dtex之间。该纤度例如对于针织假体包含在50dtex与150dtex之间，对于织造假体在100与150dtex之间。
在一个有利的实施例中，复合线包括并合在一起的PET或PTFE纤维和氧化纤维素纤维。
因此纤维素的氧化或在复合线的生产之前或之后进行。
在本发明的第二个实施方式中，主体12用至少一种第一种线的基本成分和至少一种第二种线的基本成分制成，所述第一种线唯一地由含有氧化纤维素或旨在被氧化的纤维素的纤维形成，所述第二种线唯一地由不含氧化纤维素的纤维形成。
第一种和第二种线有利地被编织、织造或针织以形成主体12。
因此纤维素的氧化或者在主体12生产之前或者之后进行。
在一个有利的实施例中，第二种线是PET或PTFE线。
根据本发明的一个有利的可选择方式，部分氧化的纤维素通过官能团而被官能化。
氧化步骤使得可以将聚合物官能化用于各种基团的化学接枝(grafting)，所述基团可以将氧化的纤维质材料与它的生物环境的相互作用进行修饰。
在一个实施方式中，官能团键合或取代部分被氧化的聚合物的羧酸官能的羟基，以使得部分被氧化的纤维素通过官能团在脱水葡萄糖单元的碳6上存在的羧酸官能上的键合或加成而被官能化。
该官能团有利地选自抗凝剂、抗血栓形成剂、抗有丝分裂剂、抗增殖剂、抗粘附剂、抗迁移剂、细胞粘附促进剂、生长因子、抗寄生虫分子、抗炎剂、生成血管剂、血管生成抑制剂、维生素、激素、蛋白质、抗真菌剂、抗微生物分子、防腐剂、交联剂、造影剂。这些官能团例如选自上述的那些。
例如官能团通过在羧酸基团的氧原子之一和含有所述官能团或它的前体的亲电子基团之间形成共价键而被接枝到羧酸官能上。例如，通过形成酯-COO(R)官能，其中R是官能团，或通过形成酰胺-CO-NR1R2官能，其中R1和/或R2是官能团。
氧化纤维素的羧酸基团典型地在官能化之前通过使用偶联剂和/或偶联助剂而被活化。
偶联剂的例子是水溶性的碳化二亚胺类例如1-乙基-3-(3-二甲基氨基丙基)碳化二亚胺(EDC)、1-乙基-3-(3-三甲基氨基丙基)碳化二亚胺(ETC)和1-环己基-3-(2-吗啉代乙基)碳化二亚胺(CMC)以及它们的盐和混合物。在本发明的上下文中，EDC的使用是优选的。
偶联助剂的例子是N-羟基琥珀酰亚胺(NHS)、N-羟基苯并三唑(HOBt)、3，4-二氢-3-羟基-4-氧-1，2，3-苯并三唑(HOOBt)、1-羟基-7-氮杂苯并三唑(HAt)和N-羟基磺基琥珀酰亚胺(磺基NHS)和其混合物。不受限于NHS的选择，这是本发明中优选使用的。
当官能团是交联剂时，它键合于部分氧化的聚合物的至少两个不同的羧酸官能，或键合于部分氧化的聚合物上可用的羟基官能。
交联剂的例子在US 6921819中给出，且可例如选自多胺或脂肪族二胺，在活化试剂例如EDC或二缩水甘油醚例如双酚二缩水甘油醚、1，4-丁二醇二缩水甘油醚(BDDE)、1，2-双(2，3-环氧丙氧基)亚乙基戒1-(2，3-环氧丙基)-2，3-环氧环己烷的存在下。
交联剂的含量使得可以在材料被植入患者的体中并与患者的组织接触的情况下控制包含部分氧化的纤维素的纤维的再吸收。
造影剂的例子是钆或铁氧化物基的超顺磁性纳米颗粒的螯合配合物。
“造影剂”是指这样的试剂：在在经过患者的皮肤而形成的器械的图像上相对于医疗器械的其余部分有对比地看上去是可见的，尤其是通过射线照相术或通过核磁共振。
任选地，官能团物理地结合到部分氧化的聚合物的羧基上，例如官能团结合到多胺时通过离子键。
由含氧化纤维素的纤维和不含氧化纤维素的纤维形成的主体12形成壁14，所述壁14对体液例如血液密封，有利的是不存在另外的密封涂层。
因此，壁14是止血的，即当植入假体时，它阻止血液的通过，尤其是通过血液与氧化纤维素接触时的所谓的“凝血”作用或凝结。
主体12对血液的密封是例如通过标准ISO 7198来确定。
而且，含有氧化纤维素的纤维是可再吸收的，一旦被植入患者体内，其有利于纤维细胞的再生，甚至是器官的细胞再生。
在图1中所说明的实施例中，器械10的主体12是包括基本上圆柱的壁14的管。
在一个可选择方式中，主体12具有圆柱的主要部分和通常呈Y形的两个分岔。
主体12在内部对导管16进行划界，所述导管用于在壁14的末端出现的血液的循环。
壁14通过含有氧化纤维素的纤维和不合氧化纤维素的纤维的存在而阻止血液从导管16向外面通过，尤其是不存在密封涂覆时。
根据本发明的医疗器械10的制造方法概略地示于图2中。
该方法包含用于提供至少一种包括旨在被氧化的纤维素的线的初始步骤50、然后用于生产主体12的步骤、然后用于旨在被氧化的纤维素的选择性氧化的步骤54。
该方法还包括用于氧化纤维素的官能化的任选步骤56。
在供给步骤50和上述的第一实施方式中，至少一种线是由旨在被氧化的纤维素纤维、和不含氧化纤维素的纤维例如合成纤维制成。
这些纤维并合在一起以形成连续的线，例如通过整经(beaming)。
在第二个实施方式中，至少一种第一种线用包含旨在被氧化的纤维素的纤维的基本成分形成，以及至少一种第二种线由不含氧化纤维素的纤维例如合成纤维形成。
然后，在步骤52中，主体12通过将该线或每根线交织而制成，例如通过织造、编织或针织以形成包含网孔的壁14。含有旨在被氧化的纤维素的纤维不包含显著量的氧化纤维素，它们是特别结实的。它们可以容易地被织造、编织或针织，同时限制断裂的风险。
旨在被氧化的纤维素纤维具有有利地低于1％的氧化度。它们优选地是天然或合成的纤维素纤维，或可能含有纤维素、但不含氧化纤维素、没有接受特别的氧化化学处理的合成纤维或其他天然纤维。
在一个受欢迎的实施方式中，线通过针织以织品的形式被成形。可以考虑不同的网孔，尤其是平针织物(传统上用220dtex的线与42根长丝的针织)或钩编编织品(有利的是用110dtex的线与40根长丝而针织)。
典型地，织品具有在50g/m2至100g/m2附近的克重。
然后，在步骤54中，进行旨在被氧化的纤维素的选择性氧化，不存在不具有氧化纤维素的纤维的显著氧化。
该选择性氧化例如使用将旨在被氧化的纤维素在溶剂的存在下接受氮氧化物例如NO2的作用的方法来完成。这样的方法例如包括将主体浸泡在带有气态NO2的喷射的溶剂浴中，如例如在专利申请EP 0492990中所描述的。
或者，选择性氧化通过使用次卤化物(hypohalite)的在主体12中存在的氧化纤维素的氧化而完成，有利的是在氧铵盐(oxoammaonium salt)的存在下，如SYMATESE公司的国际专利申请WO2009/016325中所描述的。有利的是，次卤化物和次氯酸钠和氧胺盐是2，2，6，6-四甲基哌啶-1-氧化物(Tempo)。
在一个优选的可选择方式中，纤维素通过将其与包含次卤化物、石盐(halite)和氧铵盐或所述盐的前体进行接触而被氧化，这导致获得具有被连结的纤维的基本成分的材料，所述被连结的纤维具有部分被氧化的聚合物的基本成分。这样的方法描述在申请人以申请号1060416而申请的法国专利申请中。
氧化步骤不改变纤维质材料的宏观结构，仅改变其分子结构。单独的纤维素纤维，即不相互固定的纤维，特别地从根据本发明方法而处理的纤维质材料的定义中排除。
一旦进行氧化操作，则氧化纤维素的氧化度大于1％，使用上述方法测量。优选地，氧化度包括从1％至25％，优选地从5％至20％，以及有利的是从12％至18％。
任选地，在步骤56中，氧化纤维素通过在脱水葡萄糖单元的碳6上存在的羧酸官能上结合或加成官能团而被官能化。
官能团例如选自上述的那些。这些基团例如如上所述通过取代羧酸的羟基官能而共价键合到氧化纤维素。
或者，官能团通过离子键合、通过电离的羧酸和具有不同的极性的离子之间的相互作用而键合。
一旦被制造，医疗器械有利的是与患者的组织接触地放置，例如通过被移植到患者体内。
在图1举例说明的实施例中，血液在被壁14划界的导管16中循环，由于氧化纤维素的存在而没有渗出通过所述壁14。
器械10的一个可选择方式58示于图3中。不像图1中所示的器械10，图3中所示的器械58包含主体12，所述主体12包含包括被造影剂官能化的氧化纤维素经纱60。
经纱60例如沿着壁14的母线延伸。因此，当通过患者的组织成像时，例如通过使用X射线的射线照相术或通过核磁共振，纱60是可见的。
根据本发明的第三器械70示于图4中。不像第一种器械，该器械包括厚度小于它的最大长度和宽度的以叶的形状的主体12。
有利的是，主体12在接触时是可变形的。主体12是例如包扎纱布或血管补片。
在一个可选择方式中，主体12是非织造的。在本发明的意义中，“非织造”是指包含不含氧化纤维素的纤维和含氧化纤维素的纤维的被作用物(substrate)，其中单独的纤维或长丝以合股的形式在结构中无序的方式放置，并且其既没有被织造也没有被针织。或者在机械作用的影响下例如如水的喷射，或者在温度作用的影响下，或通过添加粘接剂，非织造主体的纤维通常相互连接。
这样的“非织造”例如在标准ISO9092定义为被方向地或随机地定向的纤维网或合股，通过摩擦和/或内聚和/或粘附而结合，排除通过织造、针织、簇绒或缝制而获得的产品和纸。
在本发明的意义中，非织造主体例如使用干燥法、尤其是通过进行梳理，或使用参照使用术语“气流成网(air laid )”的空气动力学法而获得。或者，根据本发明的非织造主体以类似于用于纸的方法使用湿法而获得。
在一个可选择方式中，在纤维相互结合前，旨在形成非织造主体的纤维在优选的方向上被定向。该优选的定向在将纤维结合后保持在主体12中。一旦主体12被植入患者，该纤维的定向有利于细胞移植。
纤维的优选的定向例如通过根据被称之为“静电纺纱”的方法使纤维经受静电场而获得。
在其它可选择方式中，器械形成血管内置假体、引导组织再生膜、管、固定板、透析导管、灌注导管、输液导管、人工营养导管、经皮植入物、组织工程用格栅、微孔和大孔的骨代用品、硬脑膜代用品、细胞疗法基质、缝合线、医用绷带或血管补片。
在变形中，在氧化纤维素的羧基和官能团之间插入间隔基团。该间隔基团有利的是为不稳定的且能选择性地被断裂。
如它从前述的说明中直接地和毫无疑义地得出，含有氧化纤维素的纤维是可再吸收的。
这些纤维的再吸收的特性能例如使用可根据2009年12月的标准NF-EN ISO10993-6进行的协议来核实。
根据上述标准的附录B的B3段所定义的一些试验试样是由植入物制备的。将每个试样称重。
在试样中含有的纤维素的总量例如通过定量来测量。接下来，纤维素的初始氧化度通过上述的方法来确定。
然后，根据上述标准的第5段中公开的方法植入一些试样，例如植入大鼠。
随后，在试验时间、例如标准中定义的、例如等于52周后，将植入的试样被复原。
测量每个试样的重量损失。试样中可用的纤维素的总量、以及纤维素的氧化度如上测量。重量的损失，连同纤维素的总量的减少和纤维素的氧化度的降低，表明植入物中初始可用的氧化纤维素至少是部分可再吸收的。
相反，当它们根据以上定义的协议被植入时，不可再吸收的纤维素具有比它们的初始质量的10％低的质量变化。
如上所示，不含纤维素的不可再吸收的纤维有利的是选自聚酰胺，例如尼龙类、聚对苯二甲酸酯、聚丙烯酸酯类、液压稳定或水解稳定的聚氨酯类、聚乙烯二醇类、聚乙烯型的聚(α-烯烃类)和卤代聚合物类例如聚(卤代-α-烯烃类)例如以名称销售的聚四氟乙烯(PTFE)或聚偏氟乙烯、它们的共聚物或那些聚合物的组合。
更普遍地，不含氧化纤维素的不可再吸收的纤维由非生物降解的合成聚合物和共聚物形成，例如书籍“再生医学的原理(Principles of RegenerativeMedicine)”，第2版，2011，Elsevier，第33章，第590-596页中所公开的。
这些聚合物包括聚乙烯和衍生物，尤其是聚乙烯、聚丙烯、聚苯乙烯、卤代聚合物例如聚(四氟乙烯)、丙烯酸类和甲基丙烯酸类聚合物和聚酰胺类，例如聚(甲基丙烯酸甲酯)、聚(甲基丙烯酸2-羟乙酯)、聚(N-异丙基丙烯酰胺)，它们的共聚物或它们的混合物，聚(N-异丙基丙烯酰胺)有利的是作为共聚物使用。
在变形中，不含氧化纤维素的不可再吸收的纤维由聚醚例如PEEK形成，或由聚乙二醇形成，有利的是作为共聚物使用。在变形中，不含氧化纤维素的不可再吸收的纤维由选自聚硅氧烷类或有机硅类例如聚(二甲基硅氧烷)和它们的共聚物的聚合物形成。
在另一个变形中，不含氧化纤维素的不可再吸收的纤维由聚合物形成，该聚合物选自聚(对苯二甲酸乙二酯)或一些液压稳定或水解稳定的聚氨酯类，如通过双氯甲酸酯与二胺的反应或通过二异氰酸酯与二羟基组分的反应而获得的聚合物、或它们的共聚物。
在另一个变形中，不含氧化纤维素的不可再吸收的纤维由聚缩醛型的聚合物或共聚物形成，例如包含聚甲醛的模式。
Claims (14)
1.一种制造旨在与患者的组织接触的医疗器械(10；58；70)的方法，它包括生产主体(12)的步骤，所述主体(12)包括不含氧化纤维素的纤维和包含氧化纤维素的纤维，该不含氧化纤维素的纤维是不可再吸收的，该包含氧化纤维素的纤维是可再吸收的，
其特征在于，它包括以下步骤：
-提供不含氧化纤维素的纤维和包含旨在被氧化的纤维素的纤维；
-由不含氧化纤维素的纤维和旨在被氧化的纤维素纤维形成主体(12)；
-在主体(12)的形成后，旨在被氧化的纤维素纤维的选择性氧化以形成氧化纤维素。
2.根据权利要求1所述的方法，包括在主体(12)的形成前、至少一种包括不含氧化纤维素的纤维和旨在被氧化的纤维素纤维的复合线的并合，以及对复合线进行编织、针织或织造以形成主体(12)。
3.根据权利要求1或2所述的方法，其中，主体(12)的形成包括提供至少一种由不含氧化纤维素的纤维形成的第一种线和至少一种由旨在被氧化的纤维素纤维形成的第二种线，然后将第一种线和第二种线进行编织、织造或针织以形成主体(12)。
4.根据权利要求1或2所述的方法，其中，不含氧化纤维素的纤维是由聚合物形成，所述聚合物来自由聚酰胺类、聚烯烃类、卤代聚合物类、聚对苯二甲酸乙二醇酯、水解稳定的聚氨酯类、聚醚类、聚硅氧烷类、聚甲醛类、它们的共聚物或其混合物组成的组。
5.根据权利要求1或2所述的方法，在氧化步骤之后，包括通过官能团的氧化的纤维素的至少部分官能化的步骤。
6.根据权利要求5所述的方法，其中，该氧化纤维素包括主要由脱水葡糖单元的碳6支持的羧基，该羧基在至少部分官能化步骤的过程中被官能团官能化。
7.根据权利要求5所述的方法，其中，所述官能团选自生物活性剂如抗凝剂、抗血栓形成剂、抗有丝分裂剂、抗增殖剂、抗粘附剂、抗迁移剂、细胞粘附促进剂、生长因子、抗寄生虫分子、抗炎剂、生成血管剂、血管生成抑制剂、维生素、激素、蛋白质、抗真菌剂、抗微生物分子、防腐剂、交联剂、造影剂。
8.根据权利要求1或2所述的方法，其中，主体(12)是非织造的。
9.根据权利要求8所述的方法，其中，非织造主体的纤维在优选的方向上被定向，然后将纤维相互结合以形成主体，使得纤维的定向保持在所述主体中。
10.根据权利要求1或2所述的方法，其中，主体(12)形成管或片材，和/或主体(12)对壁进行划界，该壁对体液密封。
11.根据权利要求10所述的方法，其中，所述体液为血液。
12.根据权利要求1或2所述的方法，其中，所述器械形成假体、管、固定板、细胞疗法基质、缝合线或医用绷带。
13.根据权利要求12所述的方法，其中，所述假体为血管内置假体、引导组织再生膜、经皮植入物、组织工程用格栅、微孔和大孔的骨代用品、硬脑膜代用品或血管补片。
14.根据权利要求12所述的方法，其中，所述管为透析导管、灌注导管、输液导管、人工营养导管。
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| FR1060414A FR2968564B1 (fr) | 2010-12-13 | 2010-12-13 | Dispositif medical destine a entrer en contact avec un tissu d'un patient et procede de fabrication associe. |
| FR1060414 | 2010-12-13 |
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| CN102580146A CN102580146A (zh) | 2012-07-18 |
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| BR (1) | BRPI1105160A2 (zh) |
| FR (1) | FR2968564B1 (zh) |
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| CN1181979A (zh) * | 1996-06-28 | 1998-05-20 | 庄臣及庄臣医药有限公司 | 防止手术后粘连的生物可消溶的氧化纤维素复合材料 |
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| US2423707A (en) * | 1945-03-02 | 1947-07-08 | Eastman Kodak Co | Fabric or gauze of uniformly oxidized cellulose |
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| JP2771026B2 (ja) * | 1990-09-20 | 1998-07-02 | 株式会社ニッショー | 医療用補綴材料 |
| US5180398A (en) | 1990-12-20 | 1993-01-19 | Johnson & Johnson Medical, Inc. | Cellulose oxidation by a perfluorinated hydrocarbon solution of nitrogen dioxide |
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| FR2742042B1 (fr) | 1995-12-11 | 1998-03-20 | Perouse Implant Lab | Prothese vasculaire enduite et procede pour leur preparation |
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| GB2344519B (en) * | 1998-12-07 | 2004-05-19 | Johnson & Johnson Medical Ltd | Sterile therapeutic compositions |
| FR2811996B1 (fr) | 2000-07-19 | 2003-08-08 | Corneal Ind | Reticulation de polysaccharide(s), preparation d'hydrogel(s) ; polysaccharide(s) et hydrogel(s) obtenus,leurs utilisations |
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2010
- 2010-12-13 FR FR1060414A patent/FR2968564B1/fr not_active Expired - Fee Related
-
2011
- 2011-12-09 US US13/316,022 patent/US8753664B2/en not_active Expired - Fee Related
- 2011-12-12 JP JP2011271722A patent/JP2012125575A/ja active Pending
- 2011-12-12 BR BRPI1105160-4A2A patent/BRPI1105160A2/pt not_active Application Discontinuation
- 2011-12-12 EP EP11306638A patent/EP2462964A1/fr not_active Withdrawn
- 2011-12-13 CN CN201110463280.6A patent/CN102580146B/zh not_active Expired - Fee Related
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1181979A (zh) * | 1996-06-28 | 1998-05-20 | 庄臣及庄臣医药有限公司 | 防止手术后粘连的生物可消溶的氧化纤维素复合材料 |
Also Published As
| Publication number | Publication date |
|---|---|
| FR2968564A1 (fr) | 2012-06-15 |
| EP2462964A1 (fr) | 2012-06-13 |
| JP2012125575A (ja) | 2012-07-05 |
| CN102580146A (zh) | 2012-07-18 |
| US20120177719A1 (en) | 2012-07-12 |
| US8753664B2 (en) | 2014-06-17 |
| FR2968564B1 (fr) | 2013-06-21 |
| BRPI1105160A2 (pt) | 2013-11-26 |
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