CN102406964B - 挠性骨复合材料及其制备方法 - Google Patents
挠性骨复合材料及其制备方法 Download PDFInfo
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- CN102406964B CN102406964B CN201110355210.9A CN201110355210A CN102406964B CN 102406964 B CN102406964 B CN 102406964B CN 201110355210 A CN201110355210 A CN 201110355210A CN 102406964 B CN102406964 B CN 102406964B
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- polymeric layer
- calcium
- layer
- composite material
- flexible bone
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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Abstract
本发明通常涉及一种可移植的挠性骨复合材料以及其制备方法。该挠性骨复合材料包括至少一个聚合物层和至少一个含钙层。该聚合物层可以是包含合成聚合物的聚合物层。该含钙层可以包含钙化合物,如β-Ca3(PO4)2。本发明挠性骨复合材料可用作骨空隙填料并且其具有改进的加工性能。
Description
本申请是国际申请日为2005年6月10日、申请号为200580027197.7、发明名称为“挠性骨复合材料”的发明专利申请的分案申请。
技术领域
本发明包括含有至少一个聚合物层和至少一个含钙层的挠性骨复合材料,以及制备该挠性骨复合材料的方法。本发明挠性骨复合材料具有改进的加工性能。
背景技术
对于骨接合剂或磷酸钙组合物所关心的领域集中在用各种材料增强骨接合剂这方面。陶瓷骨接合剂常常虽然是坚固的,但是易碎的并且不足以耐受突发故障(例如,破裂)以作为基体材料。聚合物可以用于增强陶瓷骨接合剂。例如,含有浸渍有增强填料颗粒、晶须(whisker)或网丝的坚固且有弹性基质的可移植复合材料是已知的。与传统的非再吸收性的金属或复合材料相比,再吸收性移植物材料,例如聚丙交酯和聚乙交酯,在例如骨固定或修复应用中,例如具有在一段时间后可生物降解和无需除去的生物相容的优点。这些特性对于移植基体是很有用的,所述移植基质被设计为用于例如骨空隙或缺损的愈合和/或再生长的临时放置的填料(并且有时,稳定组分)。
发明内容
本发明包括含有至少一个聚合物层和至少一个含钙层的挠性骨复合材料。
在一种实施方式中,挠性骨复合材料包括:(a)具有第一侧面和第二侧面的聚合物层;和(b)固定于或物理和/或化学附着于聚合物层第一侧面的第一含钙层。
在另一种实施方式中,挠性骨复合材料包括:(a)具有第一侧面和第二侧面的穿孔聚合物层;和(b)固定于或物理和/或化学附着于聚合物层第一侧面的含钙层。
本发明还包括制造含有至少一个聚合物层和至少一个含钙层的挠性骨复合材料的方法。
在一种实施方式中,本发明包括一种制造含有具有第一侧面和第二侧面的聚合物层的挠性骨复合材料的方法,包括:将钙化合物布置在聚合物层第一侧面上以形成第一含钙层。
在另一种实施方式中,本发明包括一种制造含有具有第一侧面和第二侧面的聚合物层的挠性骨复合材料的方法,包括:使第一钙化合物与聚合物层的第一侧面接触以形成第一中间体复合材料;和在足以使第一钙化合物固定于或物理和/或化学附着于聚合物层第一侧面的温度下加热第一中间体复合材料,并得到第一含钙层。
在另一种实施方式中,本发明包括一种制造含有具有第一侧面和第二侧面的聚合物层的挠性骨复合材料的方法,包括:将含有聚合物和溶剂的溶液在剥离表面(release surface)上流延;使溶液凝胶化;使钙化合物与凝胶的第一侧面接触;并使溶剂从凝胶中蒸发以形成具有固定于或物理和/或化学附着于聚合物层第一侧面的第一含钙层的挠性骨复合材料。
在另一种实施方式中,本发明包括一种制造含有具有第一侧面和第二侧面的穿孔聚合物层的挠性骨复合材料的方法,包括:对聚合物层穿孔以形成穿孔聚合物层;加热穿孔聚合物层;使第一钙化合物与穿孔聚合膜的第一侧面接触以形成第一中间体复合材料;使第一中间体复合材料冷却至足以使第一钙化合物固定于或物理和/或化学附着于穿孔聚合物层第一侧面的温度,并得到第一含钙层。
在另一种实施方式中,本发明包括一种用于处理危急病人的硬组织缺损的方法。
在另一种实施方式中,本发明包括一种用于处理危急病人的骨质缺损的方法,包括:将治疗有效量的含有至少一个聚合物层和至少一个含钙层的挠性骨复合材料移植到缺损中。
在另一种实施方式中,本发明包括一种可模塑以填充空隙如骨空隙的挠性骨接合剂组合物,以及其制造方法。在另一种实施方式中,本发明包括一种用于移植的挠性含钙复合材料,其由于成分性能的特殊组合因而显示出在主要机械性能上的改进。
在另一种实施方式中,本发明还包括套件,其包括包含含有至少一个聚合物层和至少一个含钙层的挠性骨复合材料的容器。
更具体地说,本发明包括:
<1>一种挠性骨复合材料,其包括:
(a)包含合成的再吸收性聚合物并且具有第一侧面和第二侧面的第一聚合物层;和
(b)化学、物理或以这两种形式附着于该聚合物层第一侧面的第一含钙层。
<2>根据<1>的挠性骨复合材料,其中该第一含钙层包含基本上不含羟基磷灰石的钙化合物。
<3>根据<2>的挠性骨复合材料,其中该钙化合物包括钙的磷酸盐、钙的硫酸盐、钙的碳酸盐、或其任意组合。
<4>根据<3>的挠性骨复合材料,其中该钙的磷酸盐包括CaHPO4·nH2O、α-Ca3(PO4)2、α-bar-Ca3(PO4)2、β-Ca3(PO4)2、Ca5(PO4)3OH、Ca10(PO4)6(OH)2、Ca4O(PO4)2、CaP4O11、Ca2P2O7、Ca(H2PO4)2·nH2O、Ca8H2(PO4)6·nH2O、或其任意组合,其中n是0到5的数。
<5>根据<4>的挠性骨复合材料,其中该钙的磷酸盐包括β-Ca3(PO4)2。
<6>根据<2>的挠性骨复合材料,其中该钙化合物是颗粒的形式。
<7>根据<1>的挠性骨复合材料,其中该合成的再吸收性聚合物包括选自L-乳酸、D-乳酸、L-丙交酯、D-丙交酯、D,L-丙交酯、乙交酯、内酯、内酰胺、ε-己内酯、亚丙基碳酸酯、环状碳酸酯、环醚、对-二酮、β-羟基丁酸、β-羟基丙酸、β-羟基戊酸以及其组合的重复单元。
<8>根据<7>的挠性骨复合材料,其中该合成的再吸收性聚合物包括选自L-乳酸、D-乳酸、L-丙交酯、D-丙交酯、D,L-丙交酯、ε-己内酯、亚丙基碳酸酯、对-二酮以及其组合的重复单元。
<9>根据<8>的挠性骨复合材料,其中该合成的再吸收性聚合物是L-丙交酯和ε-己内酯的共聚物。
<10>根据<1>的挠性骨复合材料,其中该聚合物层厚度为约0.01-1.0mm。
<11>根据<10>的挠性骨复合材料,其中该聚合物层厚度为约0.05-0.15mm。
<12>根据<1>的挠性骨复合材料,其中该聚合物层中具有穿孔。
<13>根据<12>的挠性骨复合材料,其中该穿孔包括孔、狭缝或其组合。
<14>根据<1>的挠性骨复合材料,进一步包括第二含钙层,其中该第二含钙层物理、化学或以这两种形式附着于该聚合物层第二侧面。
<15>根据<14>的挠性骨复合材料,其中该第二含钙层包括钙的磷酸盐、钙的硫酸盐、钙的碳酸盐、或其任意组合。
<16>根据<15>的挠性骨复合材料,其中该钙的磷酸盐包括β-Ca3(PO4)2。
<17>根据<16>的挠性骨复合材料,其中β-Ca3(PO4)2基本上不含羟基磷灰石。
<18>根据<1>的挠性骨复合材料,进一步包括化学治疗物质、生物治疗物质、或其组合。
<19>一种挠性骨复合材料,其包括:
(a)包含合成的再吸收性聚合物并且具有第一侧面和第二侧面的第一聚合物层;和
(b)化学、物理或以这两种形式附着于该聚合物层第一侧面的包含β-Ca3(PO4)2的第一含钙层。
<20>根据<19>的挠性骨复合材料,其中β-Ca3(PO4)2基本上不含羟基磷灰石。
<21>一种挠性骨复合材料,其包括:
(a)包含合成的再吸收性聚合物并且具有第一侧面和第二侧面的第一穿孔聚合物层;和
(b)物理、化学或以这两种形式附着于该聚合物层第一侧面的第一含钙层。
<22>根据<21>的挠性骨复合材料,其中该第一含钙层包含基本上不含羟基磷灰石的钙化合物。
<23>根据<22>的挠性骨复合材料,其中该钙化合物包括钙的磷酸盐、钙的硫酸盐、钙的碳酸盐、或其任意组合。
<24>根据<23>的挠性骨复合材料,其中该钙的磷酸盐是非晶磷酸钙、结晶磷酸钙、或其组合。
<25>根据<23>的挠性骨复合材料,其中该钙的磷酸盐为CaHPO4·nH2O、α-Ca3(PO4)2、α-bar-Ca3(PO4)2、β-Ca3(PO4)2、Ca5(PO4)3OH、Ca10(PO4)6(OH)2、Ca4O(PO4)2、CaP4O11、Ca2P2O7、Ca(H2PO4)2·nH2O、Ca8H2(PO4)6·nH2O、或其任意组合,其中n是0到5的数。
<26>根据<25>的挠性骨复合材料,进一步包括化学治疗物质、生物治疗物质、或其组合。
<27>一种具有外部和内部的多层挠性骨复合材料,其包括:
(a)第一复合材料,其包括:
包含合成聚合物并且具有第一侧面和第二侧面的第一聚合物层;和
物理、化学或以这两种形式附着于该第一聚合物层第一侧面的第一含钙层;和
(b)第二复合材料,其包括:
包含合成的再吸收性聚合物并且具有第一侧面和第二侧面的第二聚合物层;和
物理、化学或以这两种形式地附着于该第二聚合物层第一侧面的第二含钙层,
其中该第一复合材料物理、化学或以这两种形式附着于该第二复合材料以形成具有交替的聚合物层和含钙层的多层挠性骨复合材料。
<28>根据<27>的挠性骨复合材料,其中该第一聚合物层位于该挠性骨复合材料的外部上且主要包含合成的非再吸收性聚合物,并且其中该第二聚合物层位于该挠性骨复合材料的内部且主要包含合成的再吸收性聚合物。
<29>一种处理危急病人的骨缺损的方法,包括将治疗有效量的<1>的挠性骨复合材料移植到该缺损处。
本发明的细节在后面的所附说明书和实施例中进行陈述。虽然类似或相当于此处所述内容的任何方法和材料可以用于实践或用于本发明的试验,但是现在描述说明性的方法和材料。本发明的其它特征、目的和优点从说明书和权利要求来看是明晰的。在说明书和所附权利要求中,除非上下文清楚规定,否则单数形式还包括复数。
附图说明
图1描述了本发明挠性骨复合材料一种实施方式的剖视图,该挠性骨复合材料含有聚合物层和含钙层。
图2描述了本发明挠性骨复合材料一种实施方式的剖视图,该挠性骨复合材料含有第一含钙层、聚合物层和第二含钙层。
图3描述了本发明挠性骨复合材料一种实施方式的剖视图,该挠性骨复合材料含有第一聚合物层、含钙层和第二聚合物层。
图4A描述了本发明聚合物层一种实施方式的透视图,所述层穿有孔。
图4B描述了本发明聚合物层一种实施方式的透视图,所述层穿有狭缝。
图5描述了本发明多层挠性骨复合材料的剖视图,其多层挠性骨复合材料含有第一挠性骨复合材料和第二挠性骨复合材料。
图6描述了本发明示范性挠性骨复合材料的剖视图,该挠性骨复合材料含有聚合物层和含钙层,其中该复合材料被卷起来。
具体实施方式
如上所述,本发明包括含有至少一个聚合物层和至少一个含钙层的挠性骨复合材料。通常,该至少一个聚合物层具有第一侧面和第二侧面并且该至少一个含钙层至少布置在该至少一个聚合物层的第一侧面上。
聚合物层包含聚合物。该聚合物可以是再吸收性聚合物、非再吸收性聚合物或其组合。在一种实施方式中,聚合物层含有少于约10重量%的非再吸收性聚合物,优选少于约5重量%的非再吸收聚合物,更优选少于约1重量%的非再吸收性聚合物,基于聚合物层的总重量。
在一种优选实施方式中,聚合物层包含再吸收性聚合物,且聚合物层基本上不含非再吸收性聚合物。优选地,再吸收性聚合物层在体内是可再吸收的,并且其包含再吸收性聚合物。
聚合物层中的聚合物可以包括合成聚合物、非合成聚合物(即,从植物或动物得到的聚合物)、或其组合。在一种实施方式中,聚合物层包含合成聚合物,并且聚合物层基本上不含非合成聚合物。例如,聚合物层可以含有少于约10重量%的非合成聚合物,优选少于约5重量%的非合成聚合物,更优选少于约1重量%的非合成聚合物,基于聚合物层的总重量。
在一种实施方式中,挠性骨复合材料包括包含合成聚合物的聚合物层和含钙层。
在另一种实施方式中,挠性骨复合材料包含:(a)含有合成聚合物的聚合物层,其中聚合物层基本上不含非合成聚合物,和(b)含钙层。此处所用的措辞“基本上不含”应理解为表示基本上不含的组分以少于约0.5重量%的量存在,优选少于约0.2重量%,更优选少于约0.1重量%,并且常常不存在。
在另一种实施方式中,挠性骨复合材料包含:(a)含有合成聚合物的聚合物层,其中聚合物层基本上不含非合成聚合物并且基本上不含非再吸收性聚合物,和(b)含钙层。
在一种实施方式中,挠性骨复合材料包含:(a)含有合成的再吸收性聚合物并且具有第一侧面和第二侧面的聚合物层;和(b)贴附于或化学和/或物理附着于聚合物层第一侧面的第一含钙层。
在另一种实施方式中,挠性骨复合材料包含:(a)多于一个的聚合物层,至少第一聚合物层,优选外层,其含有合成的非再吸收性聚合物并且具有第一侧面和第二侧面,其中第一聚合物层基本上不含再吸收性聚合物,和至少第二聚合物层,优选内层,其含有再吸收性聚合物并且具有第一侧面和第二侧面;和(b)贴附于或化学和/或物理附着于至少第一聚合物层第一侧面和至少第二聚合物层第一侧面的第一含钙层。
此处所用的术语“聚合物”包括均聚物和共聚物(即,包含两种或多种不同单体单元的聚合物)。此处所用的通用术语“共聚物”包括但不限于,交替共聚物、无规共聚物、嵌段共聚物、或其任意组合。
在一种实施方式中,聚合物层含有少于约25重量%的含钙化合物,基于聚合物层的总重量。在另一种实施方式中,聚合物层含有少于约10重量%的含钙化合物,基于聚合物层的总重量。在另一种实施方式中,聚合物层含有少于约1重量%的含钙化合物,基于聚合物层的总重量。聚合物层优选基本上不含钙化合物。
可用于制备聚合物层的聚合物例子包括但不限于,选自以下的单体的均聚物或共聚物:L-丙交酯、L-乳酸、D-丙交酯、D-乳酸、乙交酯、α-羟基丁酸、α-羟基戊酸、α-羟基乙酸、α-羟基己酸、α-羟基庚酸、α-羟基癸酸、α-羟基十四烷酸、α-羟基辛酸、α-羟基硬脂酸、羟基丁酸酯、羟基戊酸酯、β-propiolactide、β-propiolactic acid、γ-己内酯、β-己内酯、ε-己内酯、γ-丁内酯、新戊内酯、四甲基乙交酯、四甲基乙醇酸、二甲基乙醇酸、亚丙基碳酸酯、二酮(dioxanone)、形成液晶聚合物的那些单体、形成纤维素的那些单体、形成乙酸纤维素的那些单体、形成羧甲基纤维素的那些单体、形成羟丙基甲基纤维素的那些单体、包括选自聚己酸内酯、聚(环氧乙烷)、聚乙二醇、聚(己二酸乙二酯)、聚(环氧丁烷)及其混合物的大二醇(macrodiol),选自六亚甲基二异氰酸酯、异佛尔酮二异氰酸酯、环己烷二异氰酸酯、氢化的亚甲基二亚苯基二异氰酸酯及其混合物的异氰酸酯官能化合物,以及选自乙二胺、1,4-丁二醇、1,2-丁二醇、2-氨基-1-丁醇、硫代二亚乙基二醇、2-巯基***、3-己炔-2,5-二醇、柠檬酸及其混合物的增链剂的聚氨酯前体,以及上述两种或多种的任意组合。
在一种实施方式中,聚合物层包含再吸收性聚合物。再吸收性聚合物的非限制性例子包括,例如衍生自选自下列的单体的聚合物:L-乳酸、D-乳酸、L-丙交酯、D-丙交酯、D,L-丙交酯、乙交酯、内酯、内酰胺、ε-己内酯、亚丙基碳酸酯、环状碳酸酯、环醚、对-二酮、β-羟基丁酸、β-羟基丙酸、β-羟基戊酸、糖类、胶原、纤维蛋白、白蛋白、以及上述两种或多种的任意组合。
在另一种实施方式中,聚合物层包含再吸收性合成聚合物。再吸收性合成聚合物的非限制性例子包括,例如聚(L-丙交酯)(共)聚合物、聚(D-丙交酯)(共)聚合物、聚乙交酯(共)聚合物、聚己酸内酯(共)聚合物、聚(四甲基乙醇酸)(共)聚合物、聚二酮(共)聚合物、聚羟基丁酸酯(共)聚合物、聚羟基戊酸酯(共)聚合物、聚(L-丙交酯-共-乙交酯)共聚物、聚(乙交酯-共-亚丙基碳酸酯)共聚物、聚(乙交酯-共-己内酯)共聚物、聚(乙交酯-共-二酮-共-亚丙基碳酸酯)共聚物、聚(四甲基乙醇酸-共-二酮-共-亚丙基碳酸酯)共聚物、聚(乙交酯-共-己内酯-共-L-丙交酯-共-亚丙基碳酸酯)共聚物、聚(丙交酯-共-己内酯)共聚物、聚(羟基丁酸酯-共-羟基戊酸酯)共聚物、液晶(共)聚合物、其组合、或其共聚物。
在一种实施方式中,聚合物层包含聚(L-丙交酯-共-乙交酯)共聚物。
在另一种实施方式中,聚合物层包含选自L-丙交酯、D-丙交酯、D,L-丙交酯、ε-己内酯、亚丙基碳酸酯、对-二酮的单体、以及上述两种或多种的任意组合。
在另一种实施方式中,聚合物层包含L-丙交酯和ε-己内酯的共聚物。
在另一种实施方式中,聚合物层包含70%L-丙交酯和30%ε-己内酯的共聚物(例如,70:30聚(L-丙交酯-共-ε-己内酯))。
在一种实施方式中,聚(L-丙交酯-共-乙交酯)共聚物包含至少约15%的乙交酯重复单元和至少约15%的L-乳酸重复单元。在另一种实施方式中,聚(L-丙交酯-共-乙交酯)共聚物包含约82%的乙交酯重复单元和约18%的L-乳酸重复单元。在另一种实施方式中,聚(L-丙交酯-共-乙交酯)共聚物包含约18%的乙交酯重复单元和约82%的L-乳酸重复单元。
在另一种实施方式中,聚合物层包含非再吸收性聚合物。非再吸收性聚合物的非限制性例子包括,例如聚乙烯、聚丙烯和聚氨酯。
聚合物层可商购得到,或者可以通过使用任何适当的方法,例如下述那些方法,使多种类型的单体(例如,L-丙交酯、乙交酯)聚合而制备。当聚合物层包含两种或多种不同单体时,即共聚物时,可以使用任何能够形成共聚物使得生物降解或再吸收性以及机械性能(例如,在移植之前和移植期间)足以满足将使用该共聚物的应用的要求的方法。例如,这样一种聚合方法可以在美国专利No.6,096,855中找到,此处其所有公开内容通过参考引入本文。制备聚(D,L-丙交酯-共-乙交酯)和其它无规共聚物的共聚方法的其他例子公开于美国专利No.4,157,437和国际公开No.WO97/36553中,此处它们的所有公开内容同样通过参考引入本文。
有利地,在一种实施方式中,形成聚合物层的聚合物必须具有足够的分子量以便能够在所需应用中(例如,机械地)实施。通常,足够高的分子量可以通过使基本上所有(即,优选至少约98摩尔%,更优选至少约99摩尔%,并最优选少约99.5摩尔%)单体的和/或二聚的共聚物取代基聚合而得到。此处所用的术语“分子量”应理解为表示聚合程度,或共聚物链中单体或二聚的单元的数量或重量平均值。此处所用的分子量可以通过许多的已知方法估计,例如,通过凝胶渗透色谱法或尺寸排阻色谱法(GPC或SEC),通过特性粘度或固有粘度分析(I.V.),或通过可以进行关联以估算共聚物分子量的等效科学技术。
当通过相对于聚苯乙烯标准的GPC或SEC测量时,在一种实施方式中,本发明聚合物(在加工或制造成薄膜之前)可以显示出至少约75,000g/mol的数均分子量,例如从约150,000g/mol到约1,000,000g/mol或从约250,000g/mol到约900,000g/mol。在另一种实施方式中,这种测量还可以获得至少约125,000g/mol的重均分子量,例如至少约250,000g/mol或从约400,000g/mol到约2,500,000g/mol。或者,在一些实施方式中,数均分子量可以在约16,000g/mol和约75,000g/mol之间或在约18,000g/mol和约50,000g/mol之间,并且数均分子量可以在约50,000g/mol和约150,000g/mol之间或在约60,000g/mol和约120,000g/mol之间。
在另一种实施方式中,这种测量还可以显示出从约1.3到约3.5的多分散性(即,重均分子量与数均分子量的比率),例如从约1.6到约2.8,或从约1.85到约2.5。将使用聚合物层的所需应用通常应确定分子量值的可接受范围,例如用于药物输送、上颌面移植或其中增强的生物降解或再吸收性为最重要的其它应用的共聚物可以优选显示出上述范围中较低部分或低于上述范围的数均和/或重均分子量,而用于针、杆、锚、肘钉、或其它机械增强和/或承载应用的共聚物可以优选显示出上述范围的中间或较高部分或高于上述范围的数均和/或重均分子量。
当在氯仿中约0.1w/v的浓度下测量I.V.时,在一种实施方式中,本发明聚合物(在加工或制造成薄膜之前)可以显示出至少约1.0dl/g的特性粘度,例如从约2.5dl/g到约8dl/g,从约3dl/g到约7dl/g,或从约4dl/g到约6.5dl/g。在另一种实施方式中,本发明聚(L-丙交酯-共-乙交酯)共聚物的特性粘度可以高于约4.5dl/g。使用该聚合物的所需应用通常应确定特性粘度值的可接受范围,例如用于药物输送、上颌面移植或其中增强的生物降解或再吸收性为最重要的共聚物可以优选显示出比上述范围低的特性粘度或固有粘度,而用于针、杆、锚、肘钉、或其它机械增强和/或承载应用的复合材料的薄膜可以优选显示出在上述范围中或比上述范围高的特性粘度或固有粘度。
聚合物可以具有低水分(水)含量(即,在与含钙化合物组分结合之前),例如,不超过约1.5重量%或不超过约1重量%。在一种实施方式中,水分含量或水含量可以不超过约500ppm,例如不超过约250ppm或不超过约150ppm。在另一种实施方式中,本发明聚合物的水分含量或水含量可以不超过约200ppm或不超过约100ppm。
在一些实施方式中,聚合物可以经过干燥步骤和/或挥发性有机化合物(VOC)的移除步骤,以便除去聚合物中可存在的水、有机溶剂、未反应的单体或二聚物、或其它低分子量和/或挥发性杂质或化合物。该干燥/移除步骤可以包括但不限于,加入相对干燥的惰性气体(例如,干燥的氮气、氩气等,或含有这种气体的混合物),使用真空(例如,使得压力不超过约10托,例如超过约5托或不超过约1托),使用升高的温度(例如,至少约50℃,例如至少约65℃,如从约70℃到约120℃,并且优选,只要该共聚物至少为部分结晶的,升高的温度不超过在其熔点以下约5℃,例如不超过在其熔点以下约10℃),或它们的任意组合。该干燥/移除步骤通常进行足以使水分含量达到可接受或优选限度内的一段时间。在其进行时,该步骤可以有利地包括使用升高的温度和使用真空的组合并进行至少约4小时,例如至少约12小时,或另一方面进行不超过约24小时或从约16小时到约20小时。
聚合物可以显示出宽范围的结晶度,并根据使用它们的所需应用,具有优选的值。在一种实施方式中,聚合物层是半结晶的并且可以显示出从约15%到约30%的结晶度,例如从约20%到约30%,或例如从约20%到约26%。在另一种实施方式中,本发明的层可以显示出低于约15%的结晶度。在一种交替的实施方式中,本发明的层可以显示出从约15%到约50%的结晶度。在另一种交替的实施方式中,本发明的层可以显示出低于约10%,低于约5%,低于约1%的结晶度,或者可以基本上不显示结晶度(即,低于约0.5%,优选低于约0.1%,或处于通过一种或多种实验方法无法定量检测出的值)。“结晶度”可以通过许多公知的实验技术测量,并且当该术语用于此处时,其反映了结晶区域和薄膜非晶或无定形区域相比的体积、横截面积或通过样品的线性路径的相对比例。适于测量结晶度的实验技术包括但不限于,差示扫描量热法(DSC)、x-射线散射或衍射法(例如,XRD、WARD、WAXS等)等。
聚合物还可以显示出宽范围的晶格完整(或晶格不完整)度,并且根据使用它们的所需应用,也具有优选的值。晶格完整度或不完整度可以通过例如DSC或其它公知的实验技术进行测量,并且在此处可以用熔化热(ΔHf)表示,该熔化热以使共聚物晶体熔化或去结晶所需的每单位材料的能量(例如,以焦耳/克,J/g,或毫焦耳/毫克,mJ/mg为单位)表示共聚物晶体的相对完整性或不完整性。在一种实施方式中,本发明薄膜是半结晶的,并且可以显示出低于约50J/g的熔化热,例如低于约30J/g或低于约25J/g。在另一种实施方式中,本发明薄膜可以显示出从约50J/g到约70J/g的熔化热。在交替的实施方式中,本发明薄膜可以显示出从约0.5J/g到约15J/g,从约0.1J/g到约10J/g,从约15J/g到约25J/g的熔化热,或者可以基本上不显示熔化热(即,低于约0.1J/g,或处于通过一种或多种实验方法无法定量检测出的值)。
聚合物的熔点和玻璃化温度也可以变化,并且根据使用它们的所需应用具有优选的值。熔点和玻璃化温度可以通过例如DSC或其它公知的实验技术进行测量,并且通常取决于温度上升或下降的速率。以约5℃/分钟到约20℃/分钟,特别是约10℃/分钟的速率改变温度进行标准DSC测试。在一种实施方式中,本发明聚合物层由标准DSC测试测量的熔点可以在约90℃和约225℃之间,例如从约110℃到约165℃,或从约130℃到约150℃。在另一种实施方式中,本发明聚合物层由标准DSC测试测量的玻璃化温度可以在约30℃和约100℃之间,例如在约40℃和约60℃之间。
聚合物各种机械性能的值可以大幅变化,特别取决于使用它们的所需应用和将它们形成用于所述应用的物体或设备的方法。例如,在一种实施方式中,聚合物的抗张强度可以为从约10到约100MPa。在另一种实施方式中,聚合物的弹性模量可以为从约0.1到约6GPa。
当聚合物和/或组合物用于移植和体内应用时,可以希望对这样的聚合物和/或复合材料进行杀菌以使由例如感染、异物排斥等引起的体内反应最小化。因为本发明再吸收性聚合物在水存在下可再吸收或降解,因此除高压灭菌外的杀菌方法是特别适合的。这种杀菌方法可以包括但不限于,环氧乙烷照射、γ-射线照射、电子束源照射、冷(或至少低温)等离子体源、或其组合。根据照射剂量和持续时间,该杀菌方法是一种使聚合物支化、接枝或交联的可能方法。
在一种实施方式中,这些杀菌方法的单或多剂量可以足以防止、抑制或削减体内反应的量对本发明聚合物、物体或设备进行。在一种优选的实施方式中,杀菌包括射线或环氧乙烷单剂量照射。在另一种优选的实施方式中,杀菌包括用约25kGy的γ-射线对聚(L-丙交酯-共-ε-己内酯)共聚物进行单剂量照射。
当再吸收性聚合物层包括再吸收性聚合物时,含有该聚合物层的挠性骨复合材料趋于显示出从约1个月到约2.5年内在体内或体外的完全再吸收,例如从约2个月到约2年。此处所用的“完全再吸收”是指这样的情况,其中根据目测在移植的位置没有聚合材料的痕迹,或者根据降解聚合物移植位置的样品分析,不存在由聚合物降解产生的低聚材料生成物,其中所述聚合物数均分子量为大于约1,000g/mol或不超过约500g/mol。在另一种实施方式中,本发明聚合物和/或组合物在体内移植后或在约37℃(±1℃)的温度下暴露于pH约7.4(±0.2)磷酸盐缓冲盐水(PBS)溶液后,通常应保持其至少一部分的机械性能。
聚合物层可以通过本领域的已知方法进行制备。例如,在一种实施方式中,聚合物层可以用常规的粘弹性液体成型或液体固化方法制备,该方法包括但不限于,挤出、压缩模塑、注射模塑、热成型、吹塑、旋转模塑、压延和流延(参见,例如,Joel R.Fried、Polymer Science and Technology,第373-384页(1995),和K.J.Mackenzie、"Film and Sheeting Materials"in10Kirk Othmer:Encyclopedia of Chemical Technology775-787(1993),前述参考文献各自的所有内容通过参考引入本文)。
例如,在另一种实施方式中,聚合物层可以通过压缩模塑或压延进行制备。
在一种实施方式中,聚合物层是薄膜的形式。
聚合物层的量和厚度可以变化。通常,聚合物层以足以为含钙层提供挠性平台的量存在。在一种实施方式中,聚合物层以基于挠性骨复合材料总量的约1重量%到约99重量%的量存在。在另一种实施方式中,聚合物层以基于挠性骨复合材料总量的约10重量%到约75重量%的量存在。在另一种实施方式中,聚合物层以基于挠性骨复合材料总量的约25重量%到约30重量%的量存在。
聚合物层可以具有任何适当的厚度。例如,聚合物层可以具有约0.01mm到约1.0mm的厚度。在一种实施方式中,聚合物层具有约0.05mm到约0.5mm的厚度。在另一种实施方式中,聚合物层具有约0.05mm到约0.25mm的厚度。在一种优选的实施方式中,聚合物层具有约0.05mm到约0.15mm的厚度。
在一种实施方式中,聚合物层可以穿有一个或多个穿孔。这种穿孔可提供液体穿过聚合物层的路径。该穿孔可以具有任意尺寸和形状,并以任意图案分布。例如,在一些实施方式中,穿孔可以均匀分布在聚合物层上。当聚合物层被穿孔时,在一种实施方式中,基于聚合物层第一或第二侧面的总表面积,穿孔程度按面积计可以为约1%到约90%;在另一种实施方式中,基于聚合物层第一或第二侧面的总表面积,穿孔程度按面积计可以为约5%到约75%;以及在另一种实施方式中,基于聚合物层第一或第二侧面的总表面积,穿孔程度按面积计可以为约15%到约50%。在一种优选的实施方式中,基于聚合物层第一或第二层的总表面积,穿孔程度按面积计可以为约22%。
对聚合物层穿孔的方法包括但不限于,使用冲头、冲模、压延辊穿出通过聚合物层的孔,或者使用刮刀或解剖刀切开聚合物层。
穿孔层中孔的直径可以变化,或可以在预定容差范围内。在一种实施方式中,孔的直径范围为约0.4mm到约6.5mm;在另一种实施方式中,孔的直径范围为约0.8mm到约3.5mm;并且在另一种实施方式中,孔的直径范围为约1.0mm到约2mm。在一种优选的实施方式中,孔的直径约1.5mm。
在某些实施方式中,在通过使用刮刀或解剖刀切开薄膜对聚合物层穿孔时,切口或狭缝的长度可以变化。在一种实施方式中,切口的长度范围为约0.5到约10mm;在另一种实施方式中,切口的长度范围为约1到约5mm;在另一种实施方式中,切口的长度范围为约2到约3mm。
在一种实施方式中,本发明包括一种挠性骨复合材料,其包括:(a)具有第一侧面和第二侧面的穿孔聚合物层;和(b)贴附于或物理和/或化学附着于聚合物层第一侧面的含钙层。在另一种实施方式中,本发明包括一种挠性骨复合材料,其包括:(a)具有第一侧面和第二侧面的穿孔的再吸收性聚合物层;和(b)贴附于或物理和/或化学附着于该再吸收性聚合物层第一侧面的含钙层。
在另一种实施方式中,挠性骨复合材料包括第二再吸收性聚合物层。在另一种实施方式中,第二聚合物层可以贴附于或物理和/或化学附着于聚合物层第二侧面或第一含钙层。可用于制造第二聚合物层的聚合物层的非限制性例子包括对于聚合物层的上述均聚物或共聚物。
在一种实施方式中,第二聚合物层是再吸收性的,并且包括合成聚合物。
在另一种实施方式中,和上述聚合物层一样,第二聚合物层是穿孔的。
在再一种实施方式中,第二再吸收性聚合物层是非穿孔的。
第二聚合物层的厚度可以为任何适当的厚度,和上述聚合物层一样。在一种实施方式中,聚合物层和第二聚合物层具有相同的厚度。在另一种实施方式中,聚合物层和第二聚合物层的厚度是不同的。
如上所述,挠性骨复合材料包括含有钙化合物的第一含钙层。含钙层可以贴附于或物理和/或化学附着于聚合物层的至少一个侧面,例如第一侧面。将含钙层贴附或物理和/或化学附着在聚合物层上的方法如下所述。
钙化合物可以是多孔的或无孔的。术语“多孔的”包括但不限于,大孔隙度(平均孔径大于或等于100微米),中孔隙度(平均孔径小于100微米但大于或等于10微米)和微孔隙度(平均孔径小于10微米)。
孔可以具有任意尺寸、形状或分布,或在预定容差范围内。此外,孔可以是互连的或非互连的。在一种实施方式中,孔径范围在尺寸上最高约为750微米。在另一种实施方式中,钙化合物是多孔的,孔径范围最高约为500微米,且约75%的孔在尺寸上为至少约100微米和剩余25%的孔在尺寸上不超过10微米。
在钙化合物贴附于或物理和/或化学附着于聚合物层的情况下,钙化合物外表面的大部分未被聚合物覆盖。钙化合物有限的外表面覆盖率可提供增强的再吸收。
在一种实施方式中,含钙层含有少于约25重量%的聚合物,基于含钙层总重量。在另一种实施方式中,含钙层含有少于约10重量%的聚合物,基于含钙层总重量。在另一种实施方式中,含钙层含有少于约1重量%的聚合物,基于含钙层总重量。含钙层优选基本上不含聚合物。
在一种实施方式中,钙化合物具有少于约5重量%,优选少于约1重量%,更优选少于约0.5重量%的羟基磷灰石,基于钙化合物的总重量。在另一种实施方式中,钙化合物基本上不含羟基磷灰石。
在另一种实施方式中,含钙层可以包括任何钙骨接合剂。有用的钙化合物的非限制性例子包括钙的磷酸盐、钙的硫酸盐、钙的碳酸盐或其任意组合。钙化合物优选为钙盐。
在一种实施方式中,第一含钙层包括钙的磷酸盐。钙的磷酸盐的非限制性例子包括非晶磷酸钙、结晶磷酸钙或其任意组合。
在另一种实施方式中,第一含钙层包括钙的磷酸盐,其中钙的磷酸盐是CaHPO4·nH2O、α-Ca3(PO4)2、α-bar-Ca3(PO4)2、β-Ca3(PO4)2、Ca5(PO4)3OH、Ca10(PO4)6(OH)2、Ca4O(PO4)2、CaP4O11、Ca2P2O7、Ca(H2PO4)2·nH2O、Ca8H2(PO4)6·nH2O、或它们的任意组合,其中n是0到5的数。
在另一种实施方式中,第一含钙层包括β-Ca3(PO4)2。
在另一种实施方式中,第一含钙层包括β-Ca3(PO4)2,其中β-Ca3(PO4)2基本上不含羟基磷灰石。
在另一种实施方式中,第一含钙层包括钙的硫酸盐。钙的硫酸盐可以是非晶或结晶的。有用的钙的硫酸盐的非限制性例子包括Ca(SO4)、α-Ca(SO4)·1/2H2O、β-Ca(SO4)·1/2H2O、或它们的任意组合。
本发明中所用的钙化合物可以具有任意形状,其包括例如球形、立方形、楔形、长方形、圆柱形、或它们的组合。在一种实施方式中,钙化合物是球形的。在另一种实施方式中,钙化合物是立方形的。
钙化合物可以是任意尺寸或形状的微粒或颗粒。颗粒可以商购获得,或者可以通过将钙化合物研磨或碾磨至预期粒度或粒径而得到。颗粒可以通过例如筛分而分类以获得期望的粒径范围(参见,Perry's Chemical EngineeringHandbook,第21章、第13-19页(Don W.Green ed.1984))。
在一种实施方式中,颗粒平均直径范围在尺寸上为约0.05mm到约10mm。在另一种实施方式中,颗粒平均直径范围在尺寸上为约0.075mm到约5mm。在另一种实施方式中,颗粒平均直径范围在尺寸上为约0.075mm到约1mm。在另一种实施方式中,颗粒平均直径范围在尺寸上为约1.4mm到约2.8mm。在另一种实施方式中,颗粒平均直径范围在尺寸上为约2.8mm到约5.6mm。在另一种实施方式中,颗粒平均直径范围在尺寸上为约0.1mm到约0.750mm。
钙化合物的比表面积可以变化。例如,当钙化合物是颗粒时,比表面积范围可以从约0.1m2/g到约100m2/g。
第一含钙层的量和厚度可以变化。通常,贴附于或物理和/或化学附着于聚合物层第一侧面的含钙层的量是足以提供预期的治疗效果但仍然保持组合物的期望性能例如挠性和耐分层性的量。
在一种实施方式中,钙化合物的量范围为约1重量%到约99重量%,基于挠性骨复合材料(即,聚合物层和第一含钙层)的总重量;在另一种实施方式中,钙化合物的量范围为约5重量%到约95重量%,基于挠性骨复合材料的总重量;在另一种实施方式中,钙化合物的量范围为约70重量%到约85重量%,基于挠性骨复合材料的总重量。
在一种实施方式中,第一含钙层具有范围为约0.05mm到约10mm的厚度。在另一种实施方式中,第一含钙层具有范围为约0.075mm到约7.5mm的厚度。在另一种实施方式中,第一含钙层具有范围为约2.8mm到约5.6mm的厚度。在另一种实施方式中,第一含钙层具有范围为约1.4mm到约2.8mm的厚度。在另一种实施方式中,第一含钙层具有范围为约0.1mm到约0.750mm的厚度。
布置在或物理和/或化学附着在聚合物层第一侧面的钙化合物微粒或颗粒的密度可以变化。也就是说,钙化合物微粒之间的间距可以变化。例如,在一种实施方式中,大多数微粒在至少一个其它钙化合物微粒的约0.75mm内。在另一种实施方式中,大多数微粒在至少一个其它钙化合物微粒的约0.25mm内。在另一种实施方式中,大多数微粒在至少一个其它钙化合物微粒的约0.1mm内。在另一种实施方式中,大多数微粒与至少一个其它钙化合物微粒接触。
可以使用任何适当厚度的第一含钙层。例如,将具有近似等于第一含钙层期望厚度的直径的第一钙化合物颗粒贴附于或物理和/或化学附着于如下所述的聚合物侧面。
另外,可以使用大于一种的含钙层以形成挠性骨复合材料。例如,挠性骨复合材料可以包含贴附于或物理和/或化学附着于聚合物层第二侧面的第二含钙层。
第二含钙层包含第二钙化合物。有用的第二钙化合物的非限制性例子包括上文对第一钙化合物所述的那些。第二钙化合物可以和第一钙化合物相同或不同。
在一种实施方式中,第二钙化合物基本上不含羟基磷灰石。在一种实施方式中,第二钙化合物是钙盐。
在另一种实施方式中,第二钙化合物是钙的磷酸盐。在另一种实施方式中,第二钙化合物是β-Ca3(PO4)2。在另一种实施方式中,第二钙化合物是β-Ca3(PO4)2,其中β-Ca3(PO4)2基本上不含羟基磷灰石。
第二含钙层的厚度可以和第一含钙层相同或不同。通常,第二含钙层的厚度范围为约0.05mm到约10mm。
挠性复合材料可以在移植之前或之后成型至任意厚度或形状。
此外,在一些实施方式中,可以将两种或多种挠性复合材料在彼此上层叠以提供具有多层聚合物层和含钙层的更厚的复合材料。例如,在一种实施方式中,多层挠性骨复合材料可以包括:(a)第一复合材料,其包含:具有第一侧面和第二侧面的第一聚合物层;和贴附于或物理和/或化学附着于聚合物层第一侧面的第一含钙层;和(b)第二复合材料,其包括:具有第一侧面和第二侧面的聚合物层;和贴附于或物理和/或化学附着于聚合物层第一侧面的第二含钙层;其中第一复合材料贴附于或物理和/或化学附着于第二复合材料以形成具有交替的聚合物层和含钙层的多层挠性骨复合材料。还可以添加额外的复合材料以形成多层挠性骨复合材料。用于制造多层挠性骨复合材料的复合材料可以是相同的或不同的。在一些多层的实施方式中,一个或多个外层含有非再吸收性聚合物并且一个或多个内层主要含有再吸收性聚合物是有利的。
多层挠性骨复合材料可以包含多孔含钙组分、无孔含钙组分、或其组合。在一种实施方式中,多层挠性骨复合材料包含多孔含钙组分和无孔含钙组分。在另一种实施方式中,多层挠性骨复合材料包含多孔含钙组分。
多层挠性骨复合材料可以包括再吸收性聚合物层、非再吸收性聚合物层、或其组合。多层挠性骨复合材料优选包括含合成聚合物的至少一个再吸收性聚合物层。
可以使用任何适当的方法将多个复合材料互相贴附或物理和/或化学附着。例如,在一种实施方式中,当两个或多个复合材料互相层叠时,可以任选加热所得的复合材料。例如,在一些实施方式中,层叠的复合材料可以在对流烘箱中加热足以使聚合物层发粘的时间和温度,接着冷却。在另一种实施方式中,对加热的多层复合材料施压。
在另一种实施方式中,可以将挠性合成复合材料卷起来,例如像果冻卷一样,以提供较厚的复合材料。在某些实施方式中,在辊外部上(例如,在如图6所示的设备的外周上)卷起的复合材料部分主要包含非再吸收性聚合物,和在辊内部上卷起的复合材料部分主要包含再吸收性聚合物是期望的。
在一些实施方式中,挠性复合材料是可锻和可模压的,并且可以在移植之前或移植期间成型或切割为期望的形状。例如,在一种实施方式中,挠性复合材料可以使用例如刀、剪刀、轧刀或具有模具的冲压而切割为期望尺寸和/或形状。
在一种实施方式中,挠性复合材料在移植之前被切割为期望形状。在另一种实施方式中,挠性复合材料在移植期间被模塑为期望形状。在另一种实施方式中,挠性复合材料在移植之前被切割为一种形状,并在移植期间进一步被模塑。
任选地,在制造后,本发明挠性骨复合材料的一个或多个表面可以被处理以改变钙一个或多个表面的一种或多种化学和/或物理性能,例如,提高表面亲水性或降低水接触角。在一种实施方式中,处理可以包括暴露于能够使一个或多个表面变成反应性的能量源,例如辐射如伽马射线、等离子体(使用例如,气体如氧气、二氧化碳、氩气、氨气或氦气等、或者其组合)等、或者其组合,该处理可以单独进行或与暴露于另一种反应性环境组合进行(例如,存在空气、氧气或臭氧等,暴露于化学反应性官能团等,或其组合)。
在一种实施方式中,本发明挠性骨复合材料的一个或多个表面用氧等离子体处理。在另一种实施方式中,本发明挠性骨复合材料的一个或多个表面用二氧化碳等离子体处理。在另一种实施方式中,根据HYDROLASTTM方法对本发明挠性骨复合材料的一个或多个表面进行处理以形成接枝表面,该方法可以从Billerica,MA的AST Industies、Inc.购得,其中一个或多个表面被暴露于气体等离子体如氧气中,并接着与聚合/低聚化合物例如聚(氧化烯)/聚(亚烷基二醇)如PEO/PEG或聚(亚烷基亚胺)如PEI反应。
交替地或附加地,并且也是任选地,在制造之后,本发明挠性骨复合材料可以例如通过长期暴露于降解手段如热而老化。在一种实施方式中,可以实施这种任选的过程,例如,以改变在体内或体外的本发明挠性骨复合材料的降解动力学,或获得一组期望的化学和/或物理性能。
图1-6显示了本发明挠性骨复合材料实施方式的例子,其中钙化合物为颗粒形式。图1描述了本发明示范性的挠性骨复合材料10,其具有聚合物层30和包含颗粒形式钙化合物22的含钙层20。聚合物层30具有第一侧面32和第二侧面34,并且颗粒22贴附于或物理和/或化学附着于聚合物层30的第一侧面32。
图2描述了挠性骨复合材料10的实施方式,其具有含颗粒22的含钙层20、聚合物层30和含颗粒22的第二含钙层25。如图2所描述的,第一含钙层20和第二含钙层25分别贴附于或物理和/或化学附着于聚合物层30的第一侧面32和第二侧面34。
图3描述了本发明的挠性骨复合材料10的实施方式,其具有第一聚合物层30,包含颗粒22的含钙层20和第二聚合物层35。如图3所描述的,含钙层20布置在第一聚合物层30和第二聚合物层35之间。
图4A和4B描述了用于本发明挠性复合材料的聚合物层30的实施方式,其中聚合物层30是穿孔的。在图4A中,聚合物层30中的穿孔40基本上是圆的。在图4B中,聚合物层30中的穿孔42是狭缝形式。
图5描述了具有第一复合材料10和层叠在第一挠性骨复合材料10上的第二复合材料15的多层挠性骨复合材料50。在图5中,显示了多层挠性骨复合材料50。第一复合材料10具有第一聚合物层30和含有贴附于或物理和/或化学附着于聚合物层30一个侧面上的颗粒22的第二含钙层20;且第二复合材料15具有第二聚合物层35和含有贴附于或物理和/或化学附着于聚合物层35一个侧面上的颗粒22的第二含钙层25。
图6描述了本发明示范性的挠性骨复合材料10,其具有聚合物层30和含有贴附于或物理和/或化学附着于聚合物层30一个侧面上的颗粒22的含钙层20,其中复合材料10是卷起来的。
任选地,一种治疗物质例如,但不限于,化学治疗物质和/或生物治疗物质可以包含在本发明挠性骨复合材料中或其上。在一种实施方式中,这些治疗物质可以存在于含钙层中或其上、聚合物层中或其上或两者中或其上。在另一种实施方式中,治疗物质可以被添加至各个层,可以浸渍在这些层中,可以附着于这些层的表面上,或可以作为控释制剂包括在这些层的一个或多个中。治疗物质的非限制性例子包括但决不限于,抗微生物剂、抗生素、化学疗法药物、生长因子(特别是骨诱导生长因子)如骨形成蛋白、内皮细胞生长因子、***等、或它们的组合。
当治疗物质是抗微生物剂时,在挠性骨复合材料中可以存在一种并且通常不超过三种,并通常不超过两种抗微生物剂。有用的抗微生物剂的非限制性例子包括:抗阿米巴药,例如胂噻醇、卡马风、卡巴胂、吐根酚碱、氯倍他胺、氯喹、克痢酰胺、金霉素、去氢依米丁、双溴丙脒、二氯尼特、双苯他胂、依米丁、烟曲霉素、格劳卡苷、甘铋胂、8-羟基-7-碘-5-喹啉-磺酸、氯碘羟喹、双碘喹啉、巴龙霉素、泛喹酮、聚苯胂酸、普罗帕脒、喹法米特、Scenidazole、磺胺苯胂、替克洛生、四环素、硫柳脲苯胂、硫卡巴胂、替硝唑;抗生素,例如氨基糖苷类(如阿米卡星、阿泊拉霉素、阿贝卡星、班贝霉素、布替罗星、地贝卡星、双氢链霉素、阿司米星、庆大霉素、异帕米星、Kaniamycin、小诺米星、新霉素、十一烯酸新霉素、奈替米星、巴龙霉素、核糖霉素、西索米星、大观霉素、链霉素、妥布霉素、丙大观霉素)、Amphenicols(叠氮氯霉素、氯霉素、氟苯尼考、甲砜霉素)、安沙霉素类(利福米特、利福平、利福霉素、利福喷汀、利福昔明)、β-内酰胺类(碳头孢烯类、氯碳头孢、碳青霉烯类(比阿培南、亚胺培南、美罗培南、帕尼培南)、头孢菌素类(头孢克洛、头孢羟氨苄、头孢孟多、头孢曲秦、头孢西酮、头孢唑林、头孢卡品Povoxil、头孢立定、头孢地尼、头孢托仑、头孢吡肟、头孢他美、头孢克肟、Cefinenoxine、头孢地嗪、头孢尼西、头孢哌酮、头孢雷特、头孢噻肟、头孢替安、头孢唑兰、头孢咪唑、头孢匹胺、头孢匹罗、头孢泊肟、头孢丙烯、头孢沙定、头孢磺啶、头孢他啶、头孢特仑、头孢替唑、头孢布烯、头孢唑肟、头孢曲松、头孢呋辛、头孢唑南、头孢乙腈钠、头孢氨苄、头孢来星、头孢噻啶、头孢菌素、头孢噻吩、头孢匹林钠、头孢拉定、Pivcefalexin)、头霉素类(头孢拉宗、头孢美唑、头孢米诺、头孢替坦、头孢西丁)、单杆菌类(氨曲南、卡芦莫南、替吉莫南)、氧头孢烯类(Oxacephens)(氟氧头孢、拉氧头孢)、青霉素类(美西林、美西林Pivoxil、阿莫西林、氨苄西林、阿帕西林、阿扑西林、阿度西林、阿洛西林、巴卡西林、苄青霉素酸、苄青霉素钠、羧苄西林、卡茚西林、氯甲西林、氯唑西林、环已西林、双氯西林、依匹西林、芬贝西林、氟氯西林、海他西林、仑氨西林、美坦西林、甲氧西林钠、美洛西林、Naacillin钠、苯唑西林、培那西林、氢碘酸喷沙西林、青霉素G苯乙苄胺、青霉素G苄星、青霉素G二苯甲胺、青霉素G钙、青霉素G Hydrabamine、青霉素G钾、青霉素G普鲁卡因、青霉素N、青霉素0、青霉素V、青霉素V苄星、青霉素V Hydrabamine、青哌环素、苯氧乙基青霉素钾、哌拉西林、匹氨西林、丙匹西林、喹那西林、磺苄青霉素、舒他西林、酞氨西林、替莫西林、替卡西林)、利替培南)、林肯胺类(氯林肯霉素、林肯霉素)、大环内酯类(阿奇霉素、Capbomycin、克拉霉素、地红霉素、红霉素、醋硬脂红霉素、依托红霉素、葡庚糖酸红霉素、乳糖红霉素、红霉素丙酸酯、硬脂酸红霉素硬脂酸酯、交沙霉素、白霉素、麦迪霉素、米卡霉素、竹桃霉素、普利霉素、罗他霉素、蔷薇霉素、罗红霉素、螺旋霉素、醋竹桃霉素)、多肽类(双霉素、杆菌肽、缠霉素、粘菌素、恩多霉素、恩维霉素、夫沙芬净、短杆菌肽S、短杆菌肽(类)、米卡霉素、多粘菌素、原始霉素、利托菌素、替考拉宁、硫链丝菌素、结核放线菌素、短杆菌酪肽、短杆菌素、万古霉素、紫霉素、维吉霉素、杆菌肽锌)、四环素类(阿哌环素、金霉素、氯莫环素、地美环素、强力霉素、胍甲环素、赖甲环素、甲氯环素、甲烯土霉素、米诺环素、土霉素、青哌环素、匹哌环素、罗利环素、山环素、四环素)、环丝氨酸、莫匹罗星、抗结核菌素;合成抗菌剂,例如2,4-二氨基嘧啶类(溴莫普林、Textroxoprim、甲氧苄啶)、硝基呋喃类(呋喃他酮、呋唑氯铵、硝呋拉定、硝呋太尔、硝呋复林、硝呋吡醇、硝呋拉嗪、硝呋妥因醇、Nitrofirantoin)、喹诺酮及其类似物(西诺沙星、环丙沙星、克林沙星、二氟沙星、依诺沙星、氟罗沙星、氟甲喹、格帕沙星、洛美沙星、米洛沙星、那氟沙星、Nadilixic Acid、诺氟沙星、氧氟沙星、奥索利酸、帕珠沙星、培氟沙星、吡哌酸、吡咯米酸、罗索沙星、芦氟沙星、司帕沙星、替马沙星、托氟沙星、曲伐沙星)、磺胺类(乙酰基磺胺甲氧嗪、苄磺胺、氯胺B、氯胺T、二氯胺T、N2-甲酰磺胺异二甲嘧啶、N4-β-D-葡萄糖基磺胺、磺胺米隆、4’-(甲基氨磺酰基)sulfanilanilide、诺丙磺胺、酞磺醋胺、酞磺胺噻唑、柳氮磺嘧啶、琥珀磺胺噻唑、磺胺苯酰、磺胺醋酰、磺胺氯达嗪、磺胺柯定、磺胺乙胞嘧啶、磺胺嘧啶、磺胺戊烯、磺胺地索辛、磺胺多辛、磺胺乙二唑、磺胺胍、磺胺二甲唑咪、磺胺林、磺胺洛西、磺胺甲嘧啶、磺胺对甲氧嘧啶、磺胺二甲嘧啶、磺胺甲二唑、磺胺甲氧甲嘧啶、磺胺甲唑、磺胺甲氧嗪、磺胺美曲、磺胺米柯定、磺胺唑、磺胺、4-磺胺水杨酸、N4-磺胺酰基磺胺、磺胺酰脲、N-磺胺酰基-3,4-丙谷胺、磺胺硝苯、磺胺异甲基嘧啶、磺胺苯吡唑、磺胺普罗林、磺胺吡嗪、磺胺吡啶、磺胺异噻唑、磺胺均三嗪、磺胺噻唑、磺胺硫脲、磺胺托拉米、磺胺索嘧啶、磺胺异唑)、砜类(二乙酰氨苯砜、氨苯砜乙酸、醋胺磺氨苯砜钠、氨苯砜、地百里砜、葡胺苯砜钠、苯丙砜、琥珀氨苯砜、磺胺酸、对磺胺酰基苄胺、亚磺氨苯砜钠、噻唑砜)、氯福克酚、海克西定、乌洛托品、脱水亚甲基柠檬酸乌洛托品、马尿酸乌洛托品、孟德拉明、碘基水杨酸乌洛托品、硝羟喹啉、牛磺罗定、希波酚(Xibomol);抗麻风药抗菌剂,例如二乙酰氨苯砜、醋胺磺氨苯砜钠、氯苯吩嗪、氨苯砜、地百里砜、葡胺苯砜钠、副大风子酸、苯丙砜、琥珀氨苯砜、亚磺氨苯砜钠,抗真菌剂例如烯丙胺类布替萘芬、萘替芬、特比萘芬、咪唑类(例如,联苯苄唑、布康唑、Cholordantoin、氯米达唑、氯康唑、克霉唑、益康唑、恩康唑、芬替康唑、氟曲马唑、异康唑、酮康唑、拉诺康唑、咪康唑、奥莫康唑、硝酸奥昔康唑、舍他康唑、硫康唑、噻康唑)、硫代氨甲酸酯类(Tolcilate、托林达酯、托萘酯)、***类(氟康唑、伊曲康唑、沙康唑、特康唑)、吖啶琐辛、阿莫罗芬、苯柳胺酯、溴柳氯苯胺、丁氯柳胺、丙酸钙、Chlorphenesin、环吡酮、氯羟喹、科帕腊芬内特、盐酸地马唑、依沙酰胺、氟胞嘧啶、哈利他唑、海克替啶、氯氟卡班、硝呋太尔、碘化钾、丙酸、巯氧吡啶、水杨苯胺、丙酸钠、舒苯汀、替诺尼唑、三醋汀、苄硫噻二嗪乙酸、十一碳烯酸、丙酸锌等。
可用于本发明的其它抗微生物剂包括Q-内酰胺酶抑制剂(例如,棒酸、舒巴坦、***巴坦);Chldramphenicols(例如,叠氮氯霉素、氯霉素、Thiaphenicol);夫西地酸;合成剂例如甲氧苄啶,任选与磺酰胺类结合)和硝基咪唑(例如,甲硝基羟乙唑、替硝唑、尼莫拉唑);抗分支杆菌剂(例如,缠霉素、氯苯吩嗪、氨苯砜、乙胺丁醇、异烟肼、吡嗪酰胺、利福布汀、利福平、链霉素、硫代酰胺);抗病毒剂(例如,Acryclovir、三环癸胺、叠氮胸苷、更昔洛韦、碘苷、三氮唑苷、三氟尿苷、阿糖腺苷);干扰素类(例如,干扰素α、干扰素β);和防腐剂(例如,氯己定、龙胆根紫、奥替尼啶、聚维酮碘、季铵化合物、磺胺嘧啶银、三氯生)。
治疗物质可以进一步包含生物治疗物质,例如蛋白质。在一种实施方式中,可以添加骨联合蛋白质以改进组合物的物理性能,增强再吸收性、血管生成、细胞进入和增殖、矿化、骨形成、破骨细胞和/或成骨细胞的生长等。特别关心的蛋白质是不同类型的骨胶原,特别是1型的。其它蛋白质包括骨连接素、骨唾液蛋白(Bsp)、α-2HS-糖蛋白、骨Gla-蛋白(Bgp)、基质Gla-蛋白、骨磷酸糖蛋白、骨磷蛋白、骨蛋白多糖、protolipids、骨形态(morphogenic)蛋白(例如,BMP-1、-2A、-2B、-3、-3b、-4、-5、-6、-7、-8、-8b、-9、-10、-11、-12、-13、-14、-15)、软骨诱导因子、血小板衍生的生长因子(PDGF-1、-2)、内皮细胞生长因子(ECGF-l、-2a、-2b)、骨生长因子(SKF=IGF-2)、***(IGF-1、IGF-2)、成纤维细胞生长因子(ODGF-1、-2、-3、-4、-5、-6、-7、-8、-9、-10、-11、-12、-13、-14、-15、-16、-17、-18、-19、-20、-21、-22、-23)、集落刺激因子、转化生长因子(例如,TGF-β)、血管内皮生长因子(VEGF)、生长/分化因子(GDF-1、-3、-5、-6、-7、-8、-9、-9B、-10、-11、-15、-16)、成骨蛋白(OP-1=BMP-7、OP-2=BMP-8、OP-3=BMP-8b)、骨生长激素、甲状旁腺激素(PTH)、胰岛素、降钙素等。蛋白质还可以包括与软骨联合的蛋白质,例如软骨破裂蛋白质(chondrocalcining protein);与牙质联合的蛋白质,例如磷蛋白、糖蛋白和Gla蛋白;或与搪瓷联合的蛋白质,例如釉原蛋白(amelognin)和釉蛋白(enamelin)。用于本发明的所关心的结构蛋白包括但不限于,纤维蛋白、纤维蛋白原、角蛋白、微管蛋白、弹性蛋白等。在一种实施方式中,血蛋白可单独或一起在等离子体或血清中使用,例如血清白蛋白。
在一些实施方式中,治疗物质可以进一步包括非蛋白质生长因子如***素类和他汀类(例如,辛伐他汀、洛伐他汀)。
在一种实施方式中,治疗物质是生长因子例如但不限于,骨形态蛋白、内皮细胞生长因子、***等、或它们的组合。
可以使用任何合适量的治疗物质。例如,挠性骨复合材料中存在的抗微生物剂的量可为足以提供与对照相比至少降低了产品附近微生物有机体生长速度的产品的量。在许多实施方式中,抗生素的量将足以提供直径至少约10mm,并通常至少约15mm的抑制区域,通过Poser等的美国专利No.5,968,253中所述的抗菌活性试验进行测定,该专利全文通过参考清楚地引入本文。在该挠性骨复合材料中所用的治疗物质的量可以根据各种因素如修复位置、病人年龄和健康状况等而变化,并且可以由本领域技术人员决定。
包含治疗物质的挠性骨复合材料还可以用于将这些物质局部传递至例如所关心的生理位置。例如,包含抗微生物剂的挠性骨复合材料可用于需要在延长时间内将抗微生物剂释放至局部环境的方法,该时间通常至少约为5天,并通常至少约为10天,且更通常至少约为20天,其中根据制备产物的特定组合物,挠性骨复合材料可以在长达40天或更长时间内将抗微生物剂释放至其局部环境内。因此,包含抗微生物剂的挠性骨复合材料可用作长期的抗微生物剂传递载体,即,作为抗微生物剂储留物质,其中期望在延长时间内将抗微生物剂局部传递。主题组合物可特别用作用于骨组织,并特别是松质骨组织的局部抗微生物剂传递载体。
除治疗物质外,或者替代治疗物质,本发明挠性骨复合材料可以含有细胞,特别是单核细胞,例如(在体内)分化为或可分化为与骨有关的细胞(即,骨原细胞、前体或有关的物质例如成骨细胞、成骨细胞前体、骨髓细胞、血细胞、包括平滑肌细胞等的***细胞、***前体(progenitor)、间充质干细胞、骨胶原、纤维蛋白等、或它们的组合)。不管是在表面还是在内部含有这种细胞的挠性骨复合材料都可以有利地用作组织工程的基质。
当使用时,不管是外源的、自生的还是异体的细胞,都可以通过已知的或常规的方法进行采集和/或分离,例如通过骨髓的离心分离而分离单核细胞,接着,例如在骨原介质中进行细胞播种和培养。
本发明还包括制造含有聚合物层和含钙层的挠性骨复合材料的方法。
挠性骨复合材料可以通过形成上述聚合物层并将第一钙化合物沉积在聚合物层的第一侧面上以在聚合物层上形成第一含钙层而制备。将钙化合物贴附于或物理和/或化学附着于聚合物层第一侧面表面上的任何适当方法都可以使用。例如,在一种实施方式中,可以通过将聚合物层加热足以使配置在聚合物层第一侧面表面上的钙化合物物理和/或化学附着于或粘附于表面上的时间和温度,而将钙化合物贴附于或物理和/或化学附着于聚合物层第一侧面上,例如,通过加热聚合物层直至其发粘。在另一种非限制性实施方式中,钙化合物贴附于或物理和/或化学附着于凝胶(其形成了第一聚合物层)表面而在第一聚合物层上形成含钙层。任选地,将钙化合物贴附于或物理和/或化学附着于聚合物层的方法可以包括施加压力。
在一种实施方式中,挠性骨复合材料通过如下制造:形成具有第一侧面和第二侧面的聚合物层;使第一钙化合物与聚合物层的第一侧面接触以形成第一中间体复合材料;在足以使第一钙化合物贴附于或物理和/或化学附着于聚合物层第一侧面的温度下加热第一中间体复合材料。
在一种实施方式中,本发明聚合物层可以在与钙化合物接触之前穿孔。
在另一种实施方式中,本发明包括一种制造含有具有第一侧面和第二侧面的穿孔聚合物层的挠性骨复合材料的方法,包括:对聚合物层穿孔以形成穿孔聚合物层;加热穿孔聚合物层;使第一钙化合物与穿孔聚合物层的第一侧面接触以形成第一中间体复合材料;使第一中间体复合材料冷却至足以使第一钙化合物贴附于或物理和/或化学附着于穿孔聚合物层第一侧面的温度以得到第一含钙层。
在一种实施方式中,加热穿孔聚合物层足以使聚合物层发粘的时间和温度。
制造挠性骨复合材料的另一种方法包括:将含有聚合物和溶剂的溶液流延在剥离表面上;使溶液形成凝胶;使钙化合物与凝胶的第一侧面接触;并使溶剂从凝胶中蒸发以形成具有贴附于或物理和/或化学附着于聚合物层第一侧面的含钙层的挠性骨复合材料。
一旦制备,该挠性骨复合材料可以在减压下干燥,并在适当的湿度下包装和杀菌。
本发明的另一方面包括用于储存、制备、混合和/或管理本发明复合材料的套件或包装装置。
本发明挠性骨复合材料可以用作或用于移植医疗设备等。特别地,这样的应用或设备可以包括但不限于,单独的或与一种或多种其它常规设备组合的骨移植物容器(例如,骨移植物或骨移植物替代品)或骨空隙填料,所述其它常规设备包括但不限于,骨固定板(例如,颅面的、上颌面的、矫形的、骨架的等);螺丝、大头钉、夹子、肘钉、钉子、针或棒、锚(例如,用于缝合、骨等);架子、气味(scents)、网络(例如,硬的、可膨胀的、机织的、针织的、编织的等);用于细胞密封、组织工程、药物输送的海绵、移植物(例如,载体、骨内生长诱导催化剂如骨形态蛋白、生长因子、肽等、抗病毒素、抗生素等);单丝或复丝结构、片、覆盖层、薄膜(例如,多孔、微孔、再吸收的等);泡沫(例如,开孔或闭孔)、螺丝增强、头盖重建;和/或其组合。当用于移植医疗设备或与移植医疗设备一起使用时,该挠性骨复合材料优选是生物吸收性的和/或再吸收性的。
任何移植挠性骨复合材料的方法都可以使用。例如,在一种实施方式中,该挠性骨复合材料可以被放进空隙中、放置在骨上、卷起并装进空隙中、折叠起并装进空隙中等。
在一种实施方式中,本发明包括处理危急病人的硬组织缺损例如骨或软骨的方法,包括将治疗有效量的本发明挠性骨复合材料移植进缺损中。这种骨缺损包括但不限于,骨空隙、骨移植、脊柱缺损、矫形缺损、或上颌面缺损。在一种实施方式中,骨缺损是骨空隙。
在另一种实施方式中,本发明包括一种处理骨缺损的方法,进一步包括使用具有挠性复合材料的固定设备。固定设备的非限制性例子包括,板、螺丝、大头钉、针、棒、脊椎垫片或其任意组合。
在另一种实施方式中,本发明包括一种吸出危急病人骨髓的方法,包括:将治疗有效量的挠性骨复合材料移植到接近骨髓的区域中。例如,在一种实施方式中,该挠性骨复合材料可以被沉浸在吸出的骨髓中并如上所述进行移植。
实施例
通过参考以下实施例对本发明优选实施方式和对比实施方式进行说明,所述实施例是用于举例说明而绝非用于限制本发明的范围。
实施例1
使用No.3895型Carver压塑机(Carver,Inc.,Wabash,IN),通过将聚合物放置在喷射有Price-Driscoll抗粘结脱模剂(Price-Driscoll Corp.,Waterford,CT)的不锈钢垫片(约0.12mm)之间,并使用约0.11mm的黄铜垫片控制聚合物厚度以及使用下列压缩条件:压板设定点温度约150℃;负荷约10,000kg;泵约80%;停留时间约50秒,由此将约2.94g特性粘度约为1.5dl/g的70:30聚(L-丙交酯-共-己内酯)(PURASORB,Purac,Lincolnshire,IL)压缩模塑为薄膜。在压缩之后,在冷却板上冷却薄膜以得到厚度约为0.10-0.12mm的聚合物层。
实施例2
除了将Kapton聚酰亚胺剥离片(DuPont,Wilmington,DE)(约1mil厚)放置在聚合物和不锈钢垫片之间外,如实施例1所述由约2.99g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层。所得聚合物薄膜在用冷空气冷却之后容易地从片上剥离,以得到厚度约为0.15-0.18mm并且直径为130mm的聚合物层。
实施例3
除了负荷约为15,000kg并且停留时间约为60秒之外,如实施例2所述由约2.96g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层。所得聚合物薄膜厚度约为0.13-0.15mm并且直径约为143mm。
实施例4
除了负荷约为20,000kg外,如实施例3所述由约2.95g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层。所得聚合物层显示出有气泡,这是由于制备过程中聚合物铺展太薄。该聚合物层厚度约为0.13-0.14mm并且直径约为146mm。
实施例5
除了压板设定点约为158℃和负荷约为20,000kg外,如实施例3所述由约2.97g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层。所得聚合物薄膜厚度约为0.11-0.14mm并且直径约为149mm。
实施例6
除了压板设定点约为160℃,负荷约为24,000kg以及停留时间约为70秒外,如实施例1所述由约2.95g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层。所得聚合物层厚度约为0.11-0.13mm并且直径约为150mm。
实施例7
如实施例6所述由约3.40g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层。所得聚合物层厚度约为0.11-0.13mm并且直径约为160mm。
实施例8
除了停留时间为75秒外,如实施例7所述由约3.43g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层。所得聚合物层厚度约为0.11-0.13mm并且直径约为160mm。
实施例9
如实施例8所述由约3.40g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层,以得到厚度约为0.11-0.13mm并且直径约为160mm的聚合物层。
实施例10
如实施例7所述由约3.51g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层,以得到厚度约为0.11-0.13mm并且直径约为160mm的聚合物层。
实施例11
如实施例7所述由约3.49g的70:30聚(L-丙交酯-共-ε-己内酯)制备聚合物层,以得到厚度约为0.11-0.13mm并且直径约为160mm的聚合物层。
实施例12
根据实施例7制备70:30聚(L-丙交酯-共-ε-己内酯)共聚物的聚合物带(厚度约0.1mm;宽度约10mm),并将其放置在保持在约37℃下的磷酸盐缓冲溶液(pH约7.4)中。从缓冲液中移出该带子,并测定其抗拉强度。参见表1中的结果。
表1.保持在磷酸盐缓冲溶液(pH~7.4)中的70:30聚(L-丙交酯-共-ε-己内酯)
共聚物的抗拉强度的变化。
周 | 抗拉强度峰值(MPa) | 屈服强度0.2%偏移(MPa) | 模量(MPa) |
0 | 42.4 | 10.8 | 360.9 |
2 | 30.0 | 7.6 | 141.0 |
4 | 27.8 | 7.1 | 133.9 |
8 | 15.7 | 6.5 | 147.9 |
12 | 5.2 | 3.8 | 117.9 |
实施例13
除了压板设定点温度约为160℃,负荷约为24,000kg以及停留时间约为70秒外,如实施例2所述制备60:14:26聚(乙交酯-共-二酮-共-亚丙基碳酸酯)的聚合物层。
实施例14
将实施例13的60:14:26聚(乙交酯-共-二酮-共-亚丙基碳酸酯)共聚物的聚合物带(直径约0.1mm;宽度约10mm)放置在保持在约37℃下的磷酸盐缓冲溶液(pH约7.4)中。从缓冲液中移出该带子,并测定其抗拉强度。结果示于表2中。
表2.保持在磷酸盐缓冲溶液(pH~7.4)中的60:14:26聚(乙交酯-共-二酮-共-亚丙基碳酸酯)共聚物的抗拉强度的变化。
周 | 抗拉强度峰值(MPa) | 屈服强度0.2%偏移(MPa) | 模量(MPa) |
0 | 62.1 | 16.4 | 355.7 |
1 | 49.5 | 16.9 | 352.6 |
2 | 23.9 | 15.1 | 412.0 |
实施例15
通过将聚合物层放置在软基底上并使用1/16”冲头和木锤在聚合物层中冲出相隔约4-5mm的约1/16”(1.5875mm)的孔而对实施例11的聚合物层穿孔。将所得的穿孔聚合物层放置在直径约1.4-2.8mm的β-Ca3(PO4)2层(可购于Synthes,Paoli,PA,其商品名为chronOSTM)之间。将层叠的组合物放置在不锈钢模具中,用媒介纸粘合剂(medium paper binders)将模具结合在一起。并将模具放置在约130℃的常规烘箱中约15分钟以得到具有穿孔的再吸收性聚合物层的挠性骨复合材料。
实施例16
除了未对聚合物层穿孔并且在约140℃的对流烘箱中加热模具外,如实施例15所述制备挠性骨复合材料。
实施例17
除了用解剖刀每相隔4-5mm切开聚合物层(长约2-3mm)外,如实施例16中所述制备挠性骨复合材料。
实施例18
除了chronOSTM颗粒直径约为0.5-0.7mm,并且在约145℃的对流烘箱中加热模具约20分钟外,如实施例15中所述制备挠性骨复合材料。
实施例19-22-复合材料血液摄取中表面处理的效果
以实施例18所述的相同方式制造本发明的四种类型挠性骨复合材料(但是具有实施例11的聚合物层直径约为250mm,聚合物层的厚度从约0.09mm到约0.17mm变化,并且聚合物重量显示出和增大的直径成比例的改变),并将它们记做实施例19-22。实施例19的复合材料含有天然的或未处理的表面,而实施例20-22的复合材料的表面分别通过暴露于氧等离子体、二氧化碳等离子体和HYDROLASTTM处理(其是可商购于Billerica,MA的AST Products,Inc.,的等离子体/接枝处理方法,并且特别描述于美国专利No.5,700,559、5,807,636和5,837,377中,这些专利的所有内容通过参考引入本文)处理以使它们更加亲水。氧和二氧化碳等离子体处理的条件类似于HYDROLASTTM处理方法的等离子体部分中所用的那些条件,在这些情况下它们包括在压力约30毫托并且功率约250瓦特下的RF等离子体。
对于实施例19-22的每一个,一些挠性骨复合材料以制造状态使用,而其它的在约45℃下老化约21天。实施例19-22的挠性骨复合材料,制造状态和老化的两者,都在环境条件下沉浸于牛血中约30秒以测定血液摄取程度。下面的表3显示出该结果。平均摄取值表示在约15个单独样品上试验的平均值。
表3.处理的vs.未处理的,老化的vs制造时的本发明挠性骨复合材料的牛血摄取
虽然本发明根据一些优选的实施方式进行了描述,但是很显然,本领域技术人员可以在不脱离本发明范围,并特别是在不脱离所附权利要求所定义的范围的情况下对其进行改进和改变。
Claims (17)
1.一种挠性骨复合材料,其包括:
(a)包含再吸收性聚合物、非再吸收性聚合物或其组合并且具有第一侧面和第二侧面的第一聚合物层;和
(b)贴附于或化学和/或物理附着于该第一聚合物层的第一侧面的包含钙化合物的颗粒的第一含钙层,其中所述第一含钙层含有少于25重量%的聚合物,基于所述第一含钙层的总重量,并且其中所述颗粒的外表面的大部分未被聚合物覆盖,其中所述钙化合物包含钙的磷酸盐、钙的硫酸盐、钙的碳酸盐、或其任意组合。
2.根据权利要求1的挠性骨复合材料,其中所述第一聚合物层是穿孔的。
3.根据权利要求1的挠性骨复合材料,其中所述第一聚合物层含有少于25重量%的钙化合物,基于所述第一聚合物层的总重量。
4.根据权利要求1的挠性骨复合材料,其中所述颗粒的比表面积为0.1m2/g到100m2/g。
5.根据权利要求1的挠性骨复合材料,其中所述颗粒的平均直径为0.05mm到10mm。
6.根据权利要求1的挠性骨复合材料,其中所述钙化合物是多孔的。
7.根据权利要求1的挠性骨复合材料,其中所述钙化合物包含骨接合剂。
8.根据权利要求1的挠性骨复合材料,进一步包括附着于所述第一聚合物层的第二侧面的第二含钙层,该第二含钙层包含钙化合物的颗粒,其中所述钙化合物包含钙的磷酸盐、钙的硫酸盐、钙的碳酸盐、或其任意组合。
9.用于制备挠性骨复合材料的方法,其包括:
形成具有第一侧面和第二侧面的聚合物层;
将钙化合物沉积在所述聚合物层的第一侧面以在该聚合物层上形成第一含钙层,其中所述钙化合物包含钙的磷酸盐、钙的硫酸盐、钙的碳酸盐、或其任意组合;和
将所述钙化合物贴附于或化学和/或物理附着于所述聚合物层的第一侧面,其中所述钙化合物的外表面的大部分未被聚合物覆盖,
其中所述第一含钙层含有少于25重量%的聚合物,基于所述第一含钙层的总重量。
10.根据权利要求9的方法,其中将所述钙化合物贴附于或化学和/或物理附着于所述聚合物层的第一侧面包括将所述钙化合物物理附着于所述聚合物层的第一侧面。
11.根据权利要求9的方法,其中将所述钙化合物贴附于或化学和/或物理附着于所述聚合物层的第一侧面包括将所述钙化合物化学附着于所述聚合物层的第一侧面。
12.根据权利要求9的方法,其中将所述钙化合物贴附于或化学和/或物理附着于所述聚合物层的第一侧面包括将所述聚合物层加热到足以使该聚合物层发粘的温度。
13.根据权利要求9的方法,进一步包括对所述聚合物层穿孔。
14.根据权利要求13的方法,其中在将所述钙化合物沉积在所述聚合物层的第一侧面之前对所述聚合物层穿孔。
15.根据权利要求9的方法,其中形成所述聚合物层包括将含有聚合物和溶剂的溶液在剥离表面上流延;和使溶液形成凝胶;并且其中将所述钙化合物沉积在所述聚合物层的第一侧面包括使钙化合物与凝胶的第一表面接触。
16.根据权利要求15的方法,其中将所述钙化合物贴附于或化学和/或物理附着于所述聚合物层的第一侧面包括使溶剂从凝胶中蒸发。
17.根据权利要求9的方法,其中所述钙化合物为颗粒的形式。
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JP2008502455A (ja) | 2008-01-31 |
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AU2005254025A1 (en) | 2005-12-29 |
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CN101018572B (zh) | 2011-12-28 |
BRPI0511957A (pt) | 2008-01-22 |
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US8771721B2 (en) | 2014-07-08 |
JP5921796B2 (ja) | 2016-05-24 |
AU2005254025B2 (en) | 2011-06-16 |
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