CN1031330A - 用于组织固定的可吸收材料 - Google Patents

用于组织固定的可吸收材料 Download PDF

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CN1031330A
CN1031330A CN88104222A CN88104222A CN1031330A CN 1031330 A CN1031330 A CN 1031330A CN 88104222 A CN88104222 A CN 88104222A CN 88104222 A CN88104222 A CN 88104222A CN 1031330 A CN1031330 A CN 1031330A
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帕蒂·特美拉
太托·米康伦
于哈·赖贺
马库·塔明马基
彭蒂·洛康伦
让普·外尼昂帕阿
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Biocon Oy
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Abstract

本发明叙述了用于损伤的和/或手术的组织进 行外科固定的自增强、可吸收的材料和装置或它们的 部件或组份，该材料、装置或它们的部件或组份包含： (1)可吸收的聚合物、共聚物或聚合物混合物构成的 基质；(2)增强元或由至少部份嵌于基质中的增强元 所构成的结构，这些增强元具有与基质相同的化学元 素百分组成；(3)复盖基质-增强元体系表面实体部 分的涂层，该涂层具有与基质(1)和增强元(2)相同的 化学元素百分组成。

Description

本发明涉及合成的、聚合物基的外科材料，该材料在组织的条件下是可吸收的（可消溶的）且不引起有害的组织反应。
从几个专利中可以了解与可吸收的聚合物有关的缝合线和骨缝术装置的制造。可吸收的缝合线和聚乙交酯（PGA）
Figure 881042226_IMG2
的外科元件的制造在U.S.Pat.No.3    297    033和U.S.Pat.No.3    739    773中已有叙述。由聚丙交酯（PLA）
制造的缝合线在U.S.Pat.No.2    703    316中已有叙述。由乙交酯/丙交酯共聚物（PGA/PLA）
Figure 881042226_IMG4
制造的缝合线在U.S.Pat.No.3    839    297中已有叙述。由聚-β-羟基丁酸（PHB）
制造的缝合线和骨缝术装置在G.B.Pat.No.1    034    123中已有叙述。由聚二噁酮（PDS）
Figure 881042226_IMG6
制造的缝合线和骨缝术装置在U.S.Pat.No.4    052    988中已有叙述。U.S.Pat.No.4    343    931叙述了由聚酯酰胺（PEA）
Figure 881042226_IMG7
制造的可吸收的外科装置。
上述发明的可吸收的外科装置典型地是由螺钉、园柱型的脊髓钉或相应的结构固定到骨上的平板，它们通过熔融可吸收的聚合物，浇铸或把熔体压成适当的形状来制造。由熔融加工技术制造的这种样品的机械强度典型地与其他类似的合成聚合物具有相同大小的数量级。因此，由PGA、PLA、PHB和PGA/PLA制造的干燥的、未水解的样品的拉伸强度典型地具有40-80MPa的数量级（见如：Kulkarni，R.K.，Moore，E.G.，Hegyeli，A.F.和Fred，L.，J.Biomed.Mater.Res.，1971，5，169;Vert，M.，Chabot，F.和Leray，J.，Makromol.Chem.Suppl.，1981，5，30;Christel，P.，Chabot，F.，Leray，J.L.，Mcrin，C.和Vert，M.，在Biomaterials一书中（编辑G.D.Wintez，D.F.Gibbons和H.Plenk，Jr.），Wiley（1980），P.271;Tunc，D.C.，Transactions    of    9th    Annual    Meeting    of    the    Society    for    Biomaterials，Birmingham，USA，1983，P.47;Howells，E.R.，Chem.Ind.，1982，7，509）
上面所给的拉伸强度如果与致密骨的拉伸强度（大约80～200MPa）相比较是不大的。因此，上述材料的机械性能已经大大地限制了它们在外科实践中的应用。
曾试图在可吸收的聚合物基质中应用具有比基质本身熔点更高的可吸收的纤维作为增强元的方法来改善外科可吸收骨缝术材料的初始机械强度，如以聚乙交酯纤维增强的聚丙交酯基质（见U.S.Pat.No.4    279    249）。生物稳定的碳纤维也已经被用作增强元。当增强元的化学元素组成与基质材料不同时，材料照例彼此不能形成良好的粘合状态。另外，基质聚合物和增强纤维的化学组成差异的另一个结果是他们在组织的条件下有不同的吸收速率。另一方面，当碳纤维增强元被应用时，在基质聚合物被吸收后碳纤维残余物被留于组织中。
芬兰专利申请FI851828叙述了一种骨缝术装置或它的构成，它是自增强的，也就是说它至少是由可吸收的聚合物或共聚物基质所构成，这些基质被具有与其相应的化学元素组成的可吸收的纤维或相应的增强元所增强。
上述发明的可吸收的聚合物材料是有效地自增强的，这种自增强使材料具有高的初始机械强度和所述的化学结构，这种材料可被用作外科的可吸收的骨缝术装置或它们的构件，如用作以螺钉固定的骨缝术平板、固定螺钉或刚性板、或棒。
自增强意思是基质聚合物已经被具有高拉伸和/或剪切强度的纤维、薄膜纤维、棒或相应的增强元所增强，或者说增强是通过由上述元素构成的象线、编织带、条带、纺织物、无纺织物等这样一些结构来完成的，在这种增强方式中基质聚合物和增强元具有相同的化学元素百分组成。在这种情况下，在宏观的样品的制造中有效地利用增强元，如纤维（典型的强度500～2000MPa）的高初始强度是可能的。当纤维与和纤维具有相同的化学组成的聚合物、共聚物或聚合物混合物（基质聚合物）的熔体联接在一起时，获得一种复合的结构，在基质和增强纤维间有优异的粘结性，并且因此具有好的机械性能。
由于自增强材料的增强元明显地提高了材料的强度，因此当增强元的强度降低后整个材料的强度立即降低。自增强材料的制造是借助于加热和/或压力将作为基质的材料组份转变到使增强元和基质间能够形成粘结的物理状态的方法来完成的。在实践中，这可以在模具中完成，在这些模具中聚合物被处理。在材料压制过程中当基质材料是在一相对小的粘度状态下时（在流动态），基质材料从与模壁接触的增强元的表面流走，因此增强元仍然保持与模壁的接触。另一方面，在模塑加工期间当基质聚合物是处于非常高的粘度状态下时，增强元的全部表面的有效润湿会遇到相当的困难。由于上述的困难，增强元的部分表面在样品被从模中取出后典型地裸露在样品的表面。在纤维增强的复合材料的制造中，这一现象更通常地是众所周知的。因此，在常规的自增强材料的情况下，要完全消除部分纤维与水解环境的直接接触的现象是不可能的。此外，这些部分裸露的纤维在材料的表面上形成不利的应力集中点，这些应力集中点会降低材料的机械强度。上述的两个因素都降低材料的初始机械强度和抗水解性。在FI    Pat.Appl.852706的发明中，增强纤维与周围环境的直接接触已被消除了，该专利叙述了层状的骨缝术装置或它们的部件，这些装置或部件有一柔性的表面层可保护较刚性的核心。在有利的情况下，柔性的表面层可以起阻碍水解的作用，保护自增强结构的增强元。然而，由于柔性的表面聚合物和刚性的自增强核心处于不同的力学状态，在它们之间建立良好的粘着性通常是不可能的。我们可以观察到这样的差的粘着状态，例如在水解的条件下表面层从核心上发生松动。
在本发明中我们意外地发现，当自增强的材料被涂以与基质聚合物和增强元具有相同的化学元素百分组成的涂层时，我们得到了自增强的（层状的）涂敷材料，该材料在体内和体外的水解条件下与已知的未涂敷的自增强材料和/或已知的具有自增强的核心的涂敷的材料相比具有较好的初始强度性能和较好的机械强度保持性能。这项观察是意外的并且特别地令人吃惊，因为甚至由可相对迅速地吸收的材料（如聚羟基醋酸）制造的、固定于具有相同化学组成的自增强核表面的表面层较之与核具有不同化学组成但比核降解慢的表面层（如在自增强的聚羟基醋酸表面上的聚二噁酮表面层）在水解条件下仍带给材料更好的强度和/或强度保持性。本发明的材料可用于制造在水解条件下具有较好强度和强度保持性的外科固定装置，该装置因此对患者也比以往的自增强装置的材料更安全。
当自增强的材料结构被涂以一层与自增强核心具有相同的化学元素百分组成的表面层时，表面层和核之间产生了优异的粘结性、在这种情况下，涂层对材料的强度性能的积极效应是最好的。一层致密的，均质的表面层以几种方式对材料的机械性能作出贡献。首先，涂层复盖了增强元的裸露部分，以这种方式消除了自增强结构表面可以降低材料的力学强度的应力集中。第二，涂层通过改进材料的耐水解性减弱了水和溶解的材料进入自增强结构的扩散。再者，本发明的材料在自增强核心与涂层之间有优异的粘结性，因此，涂层在水解条件下不松动，而那些由于化学元素百分组成不同而与核粘结性差的涂层通常要松动。
本发明的材料用来制造用于不同外科目的的不同可吸收的固定装置或它们的部件或组件，采用内固定或外固定技术进行不同组织或部分组织相互之间的固定。本发明的这样的典型的装置有：如棒、板、螺钉、钉、髓内钉、夹板、夹钳等，它们可用于骨裂缝、切骨术、关节固定术、关节损伤和/或软骨组织的内部和/或外部固定。进一步地我们可以举出肘钉、夹板、板、夹钳和相应的装置，它们可用于损伤的和/或手术的软组织、筋膜、器官等相互间的固定。再者，我们可以举出线、带和相应物，它们可用于支持损伤或手术的腱或韧带。再者，这样的装置是板、槽和块，它们可用于骨和软骨组织的重造和加强。还有一些管状的或环状的装置，它们可用于血管、神经等长组织相互间的联接。再者，如以本发明的材料取代发明FI    Pat.Appl.864457中的生物复合材料的自增强组份。本发明的材料可以与不同的陶瓷材料相结合成为生物复合材料，按照不同的用途从不同的可吸收的聚合物、共聚物和聚合物混合物制造自增强的层状材料也是可能的。在表1中给出了一些能用于制造本发明的材料和装置的可吸收的聚合物。
表1给出的聚合物以外的另一些可吸收的聚合物也可被用于制造本发明的材料，这是很自然的。
图1示意地显示了本发明的典型的材料的结构。
本发明的自增强的、涂敷的材料可以这样制造，比如，首先采用如FI    Pat.Appl.851828的发明给出的一些方法来制造自增强的核心，然后以相同的聚合物的熔体或相同的聚合物的溶液涂敷自增强核，然后将溶剂蒸发掉。
不言而喻自增强的、涂敷的材料除了上述的组份外也可以包含不同的添加剂，如着色剂、陶瓷粉、抗生素、酶、蛋白质等添加剂，这些添加剂可以给材料带来专门的功能性优点或能改变材料的加工进程或性能。
下列一些非限定性的例子阐述了本发明。
实例1
在一加压的园柱形模腔中（长度50mm，直径φ3.2mm）将聚羟基醋酸缝合线（Dexon，size    2USP）在氮气氛和2000巴的压力下在218℃加热5分钟。软化的纤维材料被部分地熔结在一起。模具被迅速地冷却到室温。以上述方法制造的自增强的、可吸收的复合材料棒（样品系列1）的弯曲强度是340MPa。在一加热的、抽空的园柱型模腔中（长50mm，φ3.4mm）以聚羟基醋酸的熔体（Mw＝140，000）涂敷自增强的核，然后迅速地冷却模具，就制造出相应的涂敷的自增强核。这些自增强的、涂敷的、可吸收的复合材料棒（样品系列2）具有380MPa的弯曲强度。
样品系列1的自增强的棒被选作参考材料，它们在一加热的、抽空的园柱形模腔（长50mm，φ3.4mm）中被涂以聚二噁酮（PDS）熔体（Mw＝20，000）然后迅速地冷却模具。PDS涂敷的棒（样品系列3）具有360MPa的弯曲强度。
上面提及的棒的水解行为在体内和体外被研究。
体外
棒在37℃的蒸馏水中被水解3个星期，然后测量它们的弯曲强度。得到下列弯曲强度值（五次测量的平均值）：
样品系列1：200MPa
样品系列2：300MPa
样品系列3：230MPa
样品系列3中的一些棒，POS涂层在一些点已经松动，这可被观察到，因为在棒的表面上形成一些泡状物。
体内
棒被皮下植入到家兔背部三星期。棒的植入和取出手术的方法和技术公布在S.Vainionp 的论文中（Helsinki Unioersity，Helsinki，Finland，1987）。植入的棒被取出后，被立即储存于生理盐水溶液中，它们的弯曲强度在同一天内被测量。得到下列弯曲强度值（五次测量的平均值）：
样品系列1：110MPa
样品系列2：150MPa
样品系列3：110MPa
样品系列3的棒的PDS涂层清楚地从自增强的棒上松动。
上述的体外和体内水解研究显示出，本发明的材料（样品系列2）明显地比过去已知的相应的材料具有更好的强度和耐水解性能。
例2
例1的样品系列1的自增强的棒在一加热的、抽空的园柱形模腔（长50mm，直径3.4mm）中被涂以聚羟基醋酸的熔体（Mw＝250，000），迅速地冷却模具。棒在37℃的蒸馏水中水解三星期，然后测量它们的弯曲强度。这些自增强的、涂以高分子量PGA涂层的棒显示出其弯曲强度比例1的样品系列2的棒高6%。
例3
例1的样品系列1的自增强的棒在一加压的、抽空的园柱形模腔中（长50mm，直径3.2mm）在大约225℃的温度加热30分秒钟，然后模具被迅速地冷却到室温。这项处理在棒的表面上形成一薄皮状的、非纤维的涂层。棒在37℃的蒸馏水中水解三星期，然后测量它们的弯曲强度。这些自增强的、涂敷PGA的棒显示230MPa的弯曲强度（五次测量的平均值）
例4
通过一个由50%聚-L-丙交酯（PLLA，Mw＝250，000）和50%聚-D-丙交酯（PDLA，Mw＝250，000）构成的聚合物混合物的熔融纺丝工艺（这种聚合物混合物在Japanese    Pat.Appl.61-36321中已有叙述），纤维被制造出来。这样制造的纤维具有下列性能：熔点232℃，纤维直径40μm，拉伸强度440MPa。
上面的纤维按下列方法被用于制造可吸收的、增强的、涂敷的复合材料棒。首先，通过牵伸纤维穿过一可吸收的聚合物的熔体的方法使纤维被熔融涂敷上-薄的可吸收聚合物的表面层，这样的方法是：纤维与涂层的重量比是60/40。下列涂层被应用：（1）PLLA（Mw＝250，000）（2）PDLLA（Mw＝100，000），（3）PLLA（Mw＝250，000）和PLLA（Mw＝100，000）的1∶1的混合物，（4）PGA（Mw＝40，000）。涂敷的纤维样品在例1的第一个模具中在180℃-278℃的温度下被模压成长50mm，直径3.2mm的棒（试样1-4）。另外，按照例1给出的方法，将棒再涂敷一层0.1mm厚的涂层聚合物的熔体。棒的弯曲强度如下（·园括号中给出的是未涂敷的核的值）：（1）300（260），（2）240（220），（3）285（250）（4）240（225）。（1）-（4）的数字是指涂敷的原材料纤维号数。
例5
例1中样品系列2的自增强的、涂敷的棒被用牙科金刚锯切去两端，从两端各锯下长2mm的一小段。这就从它的两端暴露了棒的核心材料。切过的棒，以及作为参考的未切过的棒（样品系列2）在37℃的蒸馏水中水解三星期，然后测量棒的弯曲强度。切过的棒与未切过的棒显示相等的弯曲强度（约300MPa）。涂敷了的切过的和未切过的（例1的样品系列2）棒的剪切强度也在水解三星期后从棒的不同部分被测量。当在到棒的另一端的距离分别为3、10、20、30和40mm的距离进行测量时，未切开的棒显示出平均剪切强度为210±10MPa。当在到棒的切端的距离为4mm或更远的距离测量时，切过的端显示出相同的剪切强度。在到棒端的距离是4mm或更小处切过的棒在水解后端部的剪切强度（160+20MPa）较棒的中部区域的剪切强度（约210MPa）低。这表明棒端涂层的去除稍微增加了水进入棒的结构的扩散速率。然而切过的、部分涂敷的棒的剪切强度和弯曲强度优于相应的未涂敷的棒（例1的样品系列1的棒），后者在三星期水解后弯曲强度为200MPa，剪切强度为130±20MPa。
这个例子的研究表明，既使是自增强材料表面的部分涂敷，也会改进在水解条件下材料的强度保持性能。
表1、可吸收的聚合物
聚合物
聚乙交酯（PGA）
乙交酯的共聚物：
乙交酯/L-丙交酯共聚物（PGA/PLLA）
乙交酯/亚丙基碳酸酯共聚物（PGA/TMC）
聚丙交酯（PLA）
PLA的立规共聚物：
聚-L-丙交酯（PLLA）
聚-DL-丙交酯（PDLLA）
L-丙交酯/DL-丙交酯共聚物
PLA的共聚物：
丙交酯/四甲基乙交酯共聚物
丙交酯/亚丙基碳酸酯共聚物
丙交酯/δ-戊内酯共聚物
丙交酯/ε-己内酯共聚物
聚缩酚肽
PLA/聚氧化乙烯共聚物
不对称3，6-取代的聚-1，4-二噁烷-2，5-二酮
聚-β-羟基丁酸酯（PHBA）
PHBA/β-羟基戊酸酯共聚物（PHBA/HVA）
聚-β-羟基丙酸酯（PHPA）
聚-p-二噁酮
聚-δ-戊内酯
聚-ε-己内酯
甲基丙烯酸甲酯-N-乙烯基吡咯烷酮共聚物
聚酯酰氨
乙二酸的聚酯
聚二氢吡喃
聚烷基-2-氰基丙烯酸酯
聚氨酯（PU）
聚乙烯醇（PVA）
多肽
聚-β-羟基丁二酸（PMLA）
聚-β-链烯酸
参考：P.Toermaelae，S.Vainionp 和P.Rokkanen in IVA′s Beijer Symposium“Biomaterials and Biocompatibility”，Stockholm，Sweden，August 25-26，1987.

Claims (2)

1、用于对损伤的和/或手术的组织进行外科固定的自增强、可吸收材料和装置或它们的部件或组份，该材料、装置或它们的部件或组份包含：
(1)可吸收的聚合物、共聚物或聚合物混合物组成的基质
(2)增强元或由至少部份嵌于基质中的增强元所构成的结构，这些增强元具有与基质相同的化学元素百分组成。
(3)复盖基质-增强元体系表面实体部分的涂层，该涂层具有与基质(1)和增强元(2)相同的化学元素百分组成。
2、在外科手术中，权利要求1的自增强、涂层材料、装置或它们的部件或组份在损伤的和/或手术的组织固定或处理方面的应用。
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EP0323993A1 (en) 1989-07-19
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FI83477C (fi) 1991-07-25
JPH02501040A (ja) 1990-04-12
IN167230B (zh) 1990-09-22
FI873047A0 (fi) 1987-07-10
ZA884761B (en) 1989-03-29
AU606193B2 (en) 1991-01-31
BR8807125A (pt) 1989-10-31
NO891010L (no) 1989-03-09
GR1000102B (el) 1991-06-07
KR890701144A (ko) 1989-12-19
RU2059405C1 (ru) 1996-05-10
EP0323993B1 (en) 1992-09-30
DK116089D0 (da) 1989-03-10
GR880100451A (en) 1989-02-12
AU2077988A (en) 1989-02-13
DK116089A (da) 1989-03-10
DE3875096T2 (de) 1993-05-06
ATE81019T1 (de) 1992-10-15
JP2718428B2 (ja) 1998-02-25
WO1989000431A1 (en) 1989-01-26
FI83477B (fi) 1991-04-15
FI873047A (fi) 1989-01-11
ES2007525A6 (es) 1989-06-16

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