CN100360193C - 医学或兽医学材料及其制造方法和应用 - Google Patents
医学或兽医学材料及其制造方法和应用 Download PDFInfo
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- CN100360193C CN100360193C CNB2003801074638A CN200380107463A CN100360193C CN 100360193 C CN100360193 C CN 100360193C CN B2003801074638 A CNB2003801074638 A CN B2003801074638A CN 200380107463 A CN200380107463 A CN 200380107463A CN 100360193 C CN100360193 C CN 100360193C
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Abstract
本发明公开了一种由包含一种或多种提供钙和磷的化合物的生物相容粘合剂构成的模制件形式材料，其特征在于其表面经过浸渍处理以确保加入粘合剂中的成分即钙和磷的表面附着以及表面接近。该材料可有利地用于制备骨内植入体或骨假体。
Description
本发明涉及一种可用于医学或兽医学领域的原材料，特别但不仅用于制备骨内植入体、特别是牙植入体以及用于制备骨假体。本发明还涉及所述材料的制备方法及其应用。
多种类型的材料、金属或塑料材料可被用于医学或兽医学领域来替换生物结构体(特别是骨)或用于固定功能器官(牙植入体等)。
可根据其固有的结构性质和其生物相容性(就耐受性而言或者更好地就生物接受性而言)选择所述材料。
文献FR-A-2722694记载了一种用于制备骨内植入体或骨假体的模制材料，该材料由包含羟基磷灰石、磷酸三钙、正磷酸和TiO2型沸石的热塑性聚合物(特别是聚醚醚酮，也称为PEEK)制得。
虽然这种类型的材料获得了令人鼓舞的结果，但是其生物整合的结果还不尽如人意。
本发明提供了一种源自前述文献FR-A-2722694所述材料的新型材料，该材料结合了良好的整体机械性能和很好的就生物接受性而言的生物相容性，使得可有效地用于医学领域和兽医学领域。
所述相应材料可以是由包含或多种用于添加钙和磷的化合物的生物相容粘合剂制成的模制件形式，该模制件已经经过表面浸渍处理。
所述浸渍可确保加至所述粘合剂中的成分特别是钙和磷的表面附着及由此导致的表面接近，这使得所述材料部件在进行生物植入后可引发或至少促进所述添加成分与周围化学成分、矿物或有机成分之间产生离子连接。如果存在可再吸收的添加成分，则一旦所述成分消失，那么组织、生物细胞或周围的化学成分可以在该材料中找到用于整合的位置。
这尤其能够改进粘连和细胞移植从而确保植入体具有良好的生物移植型接受性和良好的生物相容性。
根据其在特别通过注射成型操作的成型后的物理特性选择所述生物相容粘合剂。作为示例，也可以使用热塑性聚合物如聚醚醚酮、酮聚醚、酰胺嵌段聚醚、聚四氟乙烯或聚酰亚胺；也可以使用天然聚合物、特别是纤维素。所述聚合物可以是再吸收的或非再吸收的。
由于其杨氏模量高和令人关注的接近于骨的结构特性，因此优选使用聚醚醚酮(PEEK)。PEEK是一种由基于重复下述单元的芳族直链制成的半结晶聚合物：
这种聚合物特性的详细介绍参见1992年ICI MATERIALS出版的商业传单：《Victrek PEEK，the high temperature engineeringthermoplastic-properties and processing》。
有利地，钙和磷的添加物是由磷酸钙或包含所述成分的制品组成的，所述磷酸钙例如源自磷酸三钙(Ca3(PO4)2)、磷酸二钙或磷酸氢钙(CaHPO4)、羟基磷灰石((Ca5(PO4)3OH)或(Ca10(PO4)6H20))，和具有化学计量配方或不具有化学计量配方。
磷酸钙的存在使得所述材料接近于骨的天然组成从而可提高其生物相容性。优选使用至少部分可再吸收的含磷酸钙的制品。
具体而言，羟基磷灰石是一种可在骨中找到的组分。由于其可轻度再吸收(这有利于细胞整合)，因此可有利地以其非化学计量形式使用。
磷酸二钙或磷酸三钙的优点在于价格便宜，并且是用于形成羟基磷灰石的一种基本生物组分；其同样是可再吸收的并具有治疗功能。
这些不同的磷酸钙添加物也可以作为混合物使用。
除了加入磷酸钙，本发明的模制材料还可包含正磷酸(H3(PO4))。天然的正磷酸被认为是钙固定剂和酸化剂，它也是作为核酸基本单元的核苷酸的基本组分，可参与活性细胞核的构造。
此外，本发明的材料还有利地加载一种或多种能够引起或促进与周围介质静电连接的化合物。所述物料可选自沸石和/或特定氧化物：可以考虑使用陶瓷如二氧化钛(TiO2)、二氧化锆(ZrO2)、氧化铝(Al2O3)或二氧化硅(SiO2)。
所述物料是可提供离子连接功能的静电化合物；而且它们还具有高摩尔质量并有助于提高所述材料的辐射不透明度。
本发明的材料通过对组分的均匀混合物进行模制、注射或挤出成型而成型。使得所述材料和成型条件适于这种混合物、尤其是所用粘合剂的性质。
为了保持可模制材料具有足够的加工性能和抵抗性，聚合物粘合剂在最终材料中的含量为至少65重量％，优选65重量％-90重量％。
另一方面，为了添加足量用于促进生物整合性能的化学成分，补充组分(磷酸三钙和/或磷酸二钙和/或羟基磷灰石，其可以结合至少一种用于提高静电性能和辐射不透明度的化合物如沸石或氧化物型以及结合正磷酸)占最终材料的含量为10-35重量％。
一种良好的折衷方案，特别是根据机械性能而言，大体上相应于80重量％的聚合物粘合剂和20重量％的补充组分。
本发明还涉及所述材料的制备方法。该相应的方法包括：-将生物相容的可模制粘合剂与一种或多种用于添加钙和磷的组分均匀混合，-将由此得到的混合物进行模制加工，-对所述模制件进行一个或多个表面浸渍和净化处理，-对所述净化部件在无菌条件下进行处理。
表面浸渍处理有利地通过以经受超声波的溶液的至少一次浴、特别是浸渍制品而进行。
优选地，表面浸渍和净化处理包括将模制件依次经过经受超声波的盐酸或硫酸浴、丙酮浴、过氧化氢浴、次氯酸钠和消毒剂制品，其间通过包括水洗或经受超声波水浴的操作间隔。
实施例
由聚醚醚酮(PEEK)、磷酸三钙(Ca3(PO4)2)和二氧化钛(TiO2)制备基础混合物。
PEEK呈粉末或颗粒状(粒径：约100微米)，可购自Victrex EuropaGmbH，Hauptstr.11 D-65719 HOFHEIM-德国。
磷酸三钙可以粉末状(粒径约200微米)获得，如CoopérationPharmaceutique Francaise，77020 MELUN-法国有售。
氧化钛也可以粉末状获得，由Coopération Pharmaceutique Francaise，77020 MELUN-法国配售。
a)
比例
一些组合物的可能实例如下所示：
混合物1(10％电荷)
-PEEK ：90重量％
-Ca3(PO4)2 ：5重量％
-TiO2 ：5重量％
混合物2(20％电荷)
-PEEK ：80重量％
-Ca3(PO4)2 ：10重量％
-TiO2 ：10重量％
混合物3(30％电荷)
-PEEK ：70重量％
-Ca3(PO4)2 ：15重量％
-TiO2 ：15重量％
混合物4(40％电荷)
-PEEK ：65重量％
-Ca3(PO4)2 ：17.5重量％
-TiO2 ：17.5重量％
b)
混合
将每一混合物的组分置于汽轮混合机中直至完全均化。
c)
干燥
在空气循环炉内于150℃下干燥获得的每一均匀混合物3小时。
d)
模制
模制操作在KRAUSS-MAFFEL型注射压机中进行。型号90-340-32，KRAUSS MAFFEI FRANCE，92632 GENNEVILLIERS-FRANCE。
所述材料的制备条件和混合物的模制条件对应于上述商业传单《ICIMATERIALS》。
PEEK是半结晶热塑性塑料，因此需要将模具加热到至少高于其玻璃化转变温度(140℃)的温度。如果不这样的话，模制件的表面质量会受到影响。事实上，表面网状物将呈无定形相而核心呈结晶相，如果模具太冷，模制件甚至具有完全无定形的特性，机械性能则会大大下降。
通过能够将其保持在160℃左右的油再热器确保模具的温度调节。绝热装置限制热扩散并保护注射压机的***设备。所述装置可为由纤维玻璃复合物形成的绝缘板形式。
对于一系列注射操作，有利地将振动器安装在进料器上以促进所述混合物的流动。
一般来说，在340-400℃左右的温度和约70-140MPa的注射压力下进行模制。
模具可根据所需的部件成型，如用于制造骨假体，特别是整形外科应用。还可以获得批料，然后将其切割或机械加工成所需的形状，从而用于骨填充或植入体，如齿型。
e)
表面浸渍-净化
获得模制材料后，在无菌处理之前将前者件进行表面浸渍和净化处理。
所述操作有利地在第一步中通过将所述模制材料经过不同的超声波制品浴而进行；所用的每一制品均可起到表面浸渍剂或消毒剂的作用，或者同时具有这两种作用。
显然，确保表面浸渍操作的制品适于在结合超声波的情况下特别是表面接触磷和钙(以磷酸钙的形式)和二氧化钛。植入后磷酸钙的表面接近性可促进与环境的交换和某些存在于所述材料的生物环境中的化学成分的静电连接，所述交换和/或静电连接诱导细胞渗透进入被植入的材料中。另外，表面中存在二氧化钛会诱导这种交换和静电连接的存在。
此外，磷酸钙是至少部分可再吸收的，其在植入所述材料后的消失使得产生空穴或空腔网络，从而促进细胞渗透加入周围组织中。
用于这些表面浸渍和净化操作的制品可以为盐酸(HCl，例如30％的)或硫酸(H2SO4，如30％的)、丙酮(C3H6O)、过氧化氢(H2O2，如110体积或30％的)、和/或次氯酸钠(NaClO)，优选组合使用。有利地，使用具有纯粹消毒功能的补充制品浴，如Gigasept(注册商标)或Lysetol(注册商标)。
用于实施这些浸渍/净化操作的相应方法可包括将植入体置于下述相继不同的超声波浴中：
-HCl30％： 20mn
-H2O： 10mn(或冲洗)
-丙酮： 20mn
-H2O： 10mn(或冲洗)
-H2O230％： 20mn
-NaClO： 20mn
-H2O： 10mn(或冲洗)
-Gigasept12％： 60mn
-H2O Ppi： 20mn(或冲洗)
将该植入体***杀菌套中经过高压灭菌器，然后在约135℃的温度和约2150毫巴的压力下进行杀菌循环10分钟。这种采用高压灭菌器的杀菌操作有利于表面浸渍作用；它也可结合环氧乙烷处理或伽玛射线处理。
f)
结果
扫描电镜分析表明浸渍/净化和灭菌操作可促进表面上磷酸钙的出现。这些磷酸钙通过微孔显露出来并结晶。
植入后，表面分析表明材料表面存在孔洞和皲裂，另外存在碳、氧和氮，但是相对于初始的整体浓度而言可以发现很少的钙和磷。
这往往表明磷酸钙颗粒在表面上的部分消失，以及通过环绕生物材料而移生所述孔洞和皲裂，这是移植型生物接受性的标志。
从被***植入体的临床分析表明由于所述材料的物理和原子特性而在与其接触的地方形成皮骨。
这是一个真实的植入原理；这些结果证实了所述材料与周围组织整合的临床实际性。
Claims (23)
1、一种用于医学或兽医学应用的材料，该材料是由包含一种或多种用于添加钙和磷的化合物的生物相容粘合剂制成的模制件形式，其特征在于所述材料经过表面浸渍处理，所述表面浸渍处理通过至少一个经受超声波的浸渍制品浴进行。
2、如权利要求1所述的材料，其中所述材料是用于制备骨内植入体或者用于制备骨假体的材料。
3、如权利要求2所述的材料，其中所述材料是用于制备牙植入体的材料。
4、如权利要求1所述的材料，其特征在于其包含作为能够添加钙和磷的化合物的磷酸钙，该磷酸钙源自羟基磷灰石和/或磷酸二钙或磷酸三钙。
5、如权利要求1-4中任一项所述的材料，其特征在于其包含热塑性聚合物形式的粘合剂。
6、如权利要求5所述的材料，其特征在于其包含聚醚醚酮形式的粘合剂。
7、如权利要求1-4中任一项所述的材料，其特征在于其包含天然聚合物形式的粘合剂。
8、如权利要求7所述的材料，其特征在于其包含纤维素形式的粘合剂。
9、如权利要求1-4中任一项所述的材料，其特征在于其包含沸石或氧化物型的化合物。
10、如权利要求9所述的材料，其特征在于其包含TiO2、SiO2、Al2O3或ZrO2。
11、如权利要求1-4中任一项所述的材料，其特征在于其包含
-65-90重量％的聚合物粘合剂，和
-10-35重量％的羟基磷灰石和/或磷酸二钙或磷酸三钙形式的补充组分，其可与至少一种沸石或氧化物组合使用。
12、一种制备如权利要求1-11中任一项所述的医学或兽医学用材料的方法，其特征在于该方法包括：
-将生物相容的可模制粘合剂与一种或多种用于添加钙和磷的组分均匀混合，
-将由此得到的混合物进行模制加工，
-对所述模制件进行一个或多个表面浸渍和净化处理，所述表面浸渍处理通过至少一个经受超声波的浸渍制品浴进行，
-对所述净化部件在无菌条件下进行处理。
13、如权利要求12所述的方法，其特征在于所述表面处理通过将模制材料依次经过不同的经受超声波的浴进行。
14、如权利要求12或13所述的方法，其特征在于所述表面处理通过将模制材料至少经过盐酸或硫酸型酸浴进行。
15、如权利要求12或13所述的方法，其特征在于所述表面处理通过将所述材料至少经过一个丙酮浴进行。
16、如权利要求12或13所述的方法，其特征在于所述表面处理通过将所述材料经过至少一个过氧化氢浴进行。
17、如权利要求12或13所述的方法，其特征在于所述表面处理通过将所述材料经过至少一个次氯酸钠浴进行。
18、如权利要求12或13所述的方法，其特征在于其包括通过进行表面浸渍/净化处理的浴结合至少一个净化制品的补充浴对模制件进行净化处理。
19、如权利要求12或13所述的方法，其特征在于所述表面浸渍和净化处理包括将模制件依次经过经受超声波的盐酸或硫酸浴、丙酮浴、过氧化氢浴、次氯酸钠浴和消毒剂制品，其间通过包括水洗或经过超声波水浴的操作间隔。
20、如权利要求12或13所述的方法，其特征在于其包括在经过至少一个经受超声波的溶液浴后通过高压灭菌器对模制件进行杀菌处理。
21、如权利要求1-11中任一项所述的材料或根据权利要求12-20中任一项所述方法获得的材料的用途，其中所述用途是用于制备骨内植入体。
22、如权利要求21的用途，其中所述用途是用于制备牙植入体。
23、如权利要求1-11中任一项所述的材料或根据权利要求12-20中任一项所述方法获得的材料的用途，其中所述用途是用于制备骨假体。
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| JP6055962B2 (ja) * | 2011-07-13 | 2017-01-11 | キャサリン キャドレル | 骨肉インプラント合成部材およびその製造方法 |
| CN102643514B (zh) * | 2012-04-20 | 2014-01-29 | 华东理工大学 | 聚醚醚酮类复合材料、骨修复体及其制备方法和应用 |
| US20150366668A1 (en) * | 2014-06-23 | 2015-12-24 | Community Blood Center | Cellular-scale surface modification for increased osteogenic protein expression |
| FR3034772B1 (fr) * | 2015-04-07 | 2018-07-20 | Societe De Recherches Techniques Dentaires - Rtd | Polymere thermoplastique radio-opaque a usage dentaire |
| FR3039157B1 (fr) | 2015-07-22 | 2019-06-28 | Arkema France | Composition a base de polyarylene-ether-cetone (paek) stable a l'etat fondu et procede de stabilisation d'une telle composition |
| DE102016107223B4 (de) | 2016-04-19 | 2018-05-24 | Karl Leibinger Medizintechnik Gmbh & Co. Kg | Hybridimplantat aus einem Kompositmaterial |
| CN105999383A (zh) * | 2016-06-06 | 2016-10-12 | 湖州国信物资有限公司 | 一种具有抗炎杀菌功效的软组织用粘合剂 |
| CN108690189A (zh) * | 2017-04-07 | 2018-10-23 | 中国科学院苏州纳米技术与纳米仿生研究所 | 聚醚酮酮/羟基磷灰石复合材料、其制备方法与应用 |
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| CN108042851A (zh) * | 2017-12-25 | 2018-05-18 | 大连三生科技发展有限公司 | 一种种植牙牙冠的材料 |
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| CN108785742B (zh) * | 2018-09-04 | 2021-06-22 | 南宁越洋科技有限公司 | 一种具有良好成骨效能的人工牙的制备方法 |
| RU2729653C1 (ru) * | 2020-03-03 | 2020-08-11 | Федеральное государственное бюджетное учреждение науки Институт физики прочности и материаловедения Сибирского отделения Российской академии наук (ИФПМ СО РАН) | Высокопрочный антифрикционный композит на основе полиэфирэфиркетона для медицины и способ его изготовления |
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- 2003-12-23 AT AT03810017T patent/ATE533519T1/de active
- 2003-12-23 CN CNB2003801074638A patent/CN100360193C/zh not_active Expired - Fee Related
- 2003-12-23 ES ES03810017T patent/ES2376309T3/es not_active Expired - Lifetime
- 2003-12-23 BR BRPI0317726A patent/BRPI0317726B1/pt not_active IP Right Cessation
- 2003-12-23 EP EP03810017A patent/EP1581276B1/fr not_active Expired - Lifetime
- 2003-12-23 EP EP10183852A patent/EP2292279A3/fr not_active Withdrawn
- 2003-12-23 RU RU2005123359/15A patent/RU2338557C2/ru not_active IP Right Cessation
- 2003-12-23 WO PCT/FR2003/050208 patent/WO2004058319A1/fr not_active Application Discontinuation
- 2003-12-23 AU AU2003302201A patent/AU2003302201B2/en not_active Ceased
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| WO2002070031A1 (de) * | 2000-11-09 | 2002-09-12 | BLZ Bayerisches Laserzentrum Gemeinnützige Forschungsgesellschaft mbH | Knochenersatzwerkstoff und verfahren zur herstellung eines knochenersatz-implantats |
Cited By (10)
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| US9492584B2 (en) | 2009-11-25 | 2016-11-15 | Difusion Technologies, Inc. | Post-charging of zeolite doped plastics with antimicrobial metal ions |
| CN102834122A (zh) * | 2009-12-11 | 2012-12-19 | 扩散技术公司 | 制备聚醚醚酮抗微生物植入物的方法 |
| US8821912B2 (en) | 2009-12-11 | 2014-09-02 | Difusion Technologies, Inc. | Method of manufacturing antimicrobial implants of polyetheretherketone |
| US8840914B2 (en) | 2009-12-11 | 2014-09-23 | Difusion Technologies, Inc. | Method of manufacturing antimicrobial implants of polyetheretherketone |
| US9132576B2 (en) | 2009-12-11 | 2015-09-15 | Difusion Technologies, Inc. | Method of manufacturing antimicrobial implants of polyetheretherketone |
| US9107765B2 (en) | 2010-05-07 | 2015-08-18 | Difusion Technologies, Inc. | Medical implants with increased hydrophilicity |
| US9375321B2 (en) | 2010-05-07 | 2016-06-28 | Difusion Technologies, Inc. | Medical implants with increased hydrophilicity |
| CN105061989A (zh) * | 2015-09-02 | 2015-11-18 | 广东银禧科技股份有限公司 | 一种用于sls技术的聚醚醚酮/纳米羟基磷灰石复合材料及其制备方法 |
| CN105061989B (zh) * | 2015-09-02 | 2017-12-15 | 广东银禧科技股份有限公司 | 一种用于sls技术的聚醚醚酮/纳米羟基磷灰石复合材料及其制备方法 |
| US10106651B2 (en) | 2015-09-02 | 2018-10-23 | Guangdong Silver Age Sci & Tech Co., Ltd | PEEK/NANO-HA composites for SLS and preparation methods thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| EP1581276A1 (fr) | 2005-10-05 |
| CA2511622C (fr) | 2011-11-29 |
| ATE533519T1 (de) | 2011-12-15 |
| US7902270B2 (en) | 2011-03-08 |
| WO2004058319A1 (fr) | 2004-07-15 |
| AU2003302201B2 (en) | 2010-08-26 |
| EP1581276B1 (fr) | 2011-11-16 |
| CN1732025A (zh) | 2006-02-08 |
| CA2511622A1 (fr) | 2004-07-15 |
| EP2292279A3 (fr) | 2011-05-25 |
| RU2338557C2 (ru) | 2008-11-20 |
| EP2292279A2 (fr) | 2011-03-09 |
| FR2848856A1 (fr) | 2004-06-25 |
| AU2003302201A1 (en) | 2004-07-22 |
| US20060052479A1 (en) | 2006-03-09 |
| ES2376309T3 (es) | 2012-03-12 |
| FR2848856B1 (fr) | 2007-05-25 |
| BRPI0317726B1 (pt) | 2015-12-08 |
| BR0317726A (pt) | 2005-11-22 |
| RU2005123359A (ru) | 2005-12-20 |
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