CN104507508A - 多组分结合用于制造带有功能表面的医用产品的可塑配制物 - Google Patents
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Abstract
本发明涉及用于制造带有功能表面的医用产品的方法。本发明尤其涉及可利用其制造带有对骨骼有亲和力的表面的陶瓷植入物的方法以及这种类型的制成的医用产品。
Description
技术领域
本发明涉及用于制造带有功能表面的医用产品的方法。本发明尤其涉及可利用其制造带有对骨骼有亲和力的表面的陶瓷植入物的方法以及这种类型的制成的医用产品。
背景技术
结构化的陶瓷部件(尤其植入物、假体等等)现在常常设有功能涂层,例如对骨骼有亲和力的或抗菌的涂层或层。功能表面应改善部件结合到身体中。在此经常尤其关心部件的更快且更坚固的并入,这例如可通过多孔的涂层或表面来实现。存在于部件的表面上的小孔可实现且促进骨骼组成部分的生长,从而可通过内生的并入实现可靠地固定植入物。另一方面,通常还必须控制可发炎的过程,其在将植入物插入到身体中时通常是不可避免的。用作关节替代物的部件原则上需要功能层以用于与骨骼相连接。
由现有技术已知这种植入物(尤其还包含陶瓷)。其通常以多个工序制成,其中,在实心的且起承载作用的基体上以某种方式(例如通过涂覆)施加有功能性的或多孔的表面。这种制造方法相对耗时且很麻烦,因为需要用于成形基体和紧接着进行表面处理的不同的方法。
发明内容
因此,本发明的目的在于提供一种方法,其简化利用芯体材料和功能表面材料制造植入物(例如假体)。
该目的通过根据权利要求1所述的方法来实现;在从属权利要求中限定了方法的有利的设计方案。
相应地,用于制造带有功能表面的植入物的根据本发明的方法设置成,在一个工序中制成基体和功能表面。
根据一优选的改进方案,本发明包括陶瓷部件,其带有在一个工序中制成的实心的承载区域和多孔的对骨骼有亲和力的边界层或表面。
为待制成的高性能陶瓷制备相应的粉末混合物,在其中,根据现有技术不仅实现均匀化单独的添加料,而且实现粉末团状物的散开。例如在此考虑二氧化锆、氮化硅、氧化铝或复合材料(例如ZTA)和/或所提及的材料的混合物。此外,可使用离析物,其可转化成所提及的物质,例如通过必要时在特定的环境下的烧结。粉末混合物混有可塑的粘合系统且由此形成模制材料(进料(Feedstock)),利用其通过高压或低压喷射模制或通过挤压实现定型。
进料的一部分可混有不可塑的颗粒状的添加料(占位料),其在定型之后(例如在紧接的烧结工艺中)在很大程度上无残留地被再次去除,并且在此留下小孔。作为添加料,例如可添加聚乙烯、聚苯乙烯或类似的有机的碳化合物或石墨。根据本发明的一优选的实施方式,占位料被如此引入到进料中,即,在烧结之后在本体中留有小孔,其对于在骨骼中的生长特性特别有利。
用于制造带有至少一个功能表面的植入物的一特别优选的方法包括以下步骤:
a) 制备陶瓷粉末混合物,
b) 为陶瓷粉末混合物混以可塑的粘合系统,其中,可塑的粘合系统与紧随的定型方法相匹配,并且陶瓷粉末混合物与可塑的粘合系统一起形成第一进料,
c1) 分开第一进料,并且为进料的一部分混以添加料以用于形成第二进料,或者
c2) 根据步骤a)和b)制成第二进料,
d) 执行定型方法,在其中由第一进料和第二进料成形基体和对骨骼有亲和力的表面,
e) 使生坯脱脂,
f) 将植入物的在先前的步骤中成形和脱脂的脱脂坯(Braunling)烧结成带有功能的和尤其对骨骼有亲和力的表面的制成的植入物。
根据本发明的一特别优选的实施方式,第一进料和第二进料不仅可在带有占位料(Platzhalter)/添加料的情况下而且可在没有占位料/添加料的情况下以以下方式制成和进行处理:
· 带有和没有占位料的进料可经由喷射模制和/或挤压相应单独地用于定型;
· 在定型工艺中,进料可在受控的条件下彼此连接。在此,所选择的有机的粘合系统实现可塑的物质的粘附连接。典型地在80°C-170°C之间的温度的情况下热激活定型工艺;
· 如此调节进料:其可在相同的条件下烧结,并且在此具有如此类似的烧结动力学,即,实心的进料与含有占位料的进料的连接在烧结时得到保持,并且在此通过烧结出现固体连接;
· 两种进料通过双组分喷射模制或双组分挤压来处理并且在此引起期望的形状。根据本发明,由于多组分定型,为构件的随后的实心的承载区域填充有实心的进料,并且为多孔的、对骨骼有亲和力的区域填充有含有添加料/占位料的进料。由此可在这两种方法的限制的范围内制成任意的模制体,利用其可实际上任意地实现带有对骨骼有亲和力的多孔的表面的实心的固体的目标。取决于应用,例如对于用于脊椎植入物的隔离物(Spacer),多孔的区域还可占据构件的更大的区域或连续的通道;
· 在热激活的定型之后在冷却之后出现相对坚固的“生坯”,其含有陶瓷粉末、有机的增塑剂和占位料。然后将增塑剂例如通过蒸发或酸洗去除;
· 烧结脱脂的生坯(脱脂坯),其中,根据本发明出现期望的实心的和多孔的区域。将占位料烧尽。在实心的与多孔的陶瓷之间的过渡区域通过烧结工艺加固。
Claims (14)
1. 一种用于制造带有至少一个功能表面的植入物的方法,其特征在于,在一个工序中制成基体和所述功能表面。
2. 根据权利要求1所述的方法,其特征在于,所述功能表面为对骨骼有亲和力的表面。
3. 根据上述权利要求中任一项所述的方法,其特征在于,将陶瓷粉末用作基础材料。
4. 根据上述权利要求所述的方法,其特征在于,陶瓷粉末包括二氧化锆、氮化硅、氧化铝和/或复合材料例如ZTA,和/或可转变成这些物质。
5. 根据上述权利要求中任一项所述的方法,其特征在于,所述基体和对骨骼有亲和力的表面的材料由相同的基础材料制成。
6. 根据上述权利要求中任一项所述的方法,其特征在于,所述基体和对骨骼有亲和力的表面的材料包括可塑的粘合系统,其使得能够在硬化之后实现在所述基体与对骨骼有亲和力的表面的材料之间的粘附连接,其中,可塑的粘合系统优选为有机的粘合系统。
7. 根据上述权利要求中任一项所述的方法,其特征在于,为基础材料的用作用于对骨骼有亲和力的表面的材料的基部的部分添加添加料,其在定型之后尤其通过烧尽被再次去除,由此调节对骨骼有亲和力的表面的限定的孔隙度。
8. 根据上述权利要求所述的方法,其特征在于,添加料是颗粒状的,并且优选包括聚乙烯、聚苯乙烯、石墨和/或有机的碳化合物和/或这些物质的混合物。
9. 根据权利要求2至8中任一项所述的方法,包括以下步骤:
a) 制备陶瓷粉末混合物,
b) 为陶瓷粉末混合物混以可塑的粘合系统,其中,可塑的粘合系统与紧随的定型方法相匹配,并且陶瓷粉末混合物与可塑的粘合系统一起形成第一进料,
c1) 分开第一进料,并且为进料的一部分混以添加料以用于形成第二进料,或者
c2) 根据步骤a)和b)制成第二进料,
d) 执行定型方法,在其中,由第一进料和第二进料成形基体和对骨骼有亲和力的表面,
e) 使生坯脱脂,
f) 将植入物的在先前的步骤中成形和脱脂的脱脂坯烧结成带有对骨骼有亲和力的表面的制成的植入物。
10. 根据权利要求9所述的方法,其特征在于,基体和/或对骨骼有亲和力的表面通过高压或低压喷射模制或者挤压成形,尤其通过双组分喷射模制或者双组分挤压成形。
11. 根据权利要求10所述的方法,其特征在于,优选在80°C-170°C之间的温度的情况下热激活定型工艺。
12. 根据权利要求9至11中任一项所述的方法,其特征在于,进料如此组成,即,其可在相同的条件下烧结,并且在此具有如此相似的烧结动力学,使得在基体与对骨骼有亲和力的表面之间出现牢固的连接。
13. 一种植入物,包括基体和至少一个功能表面。
14. 根据权利要求13所述的植入物,其特征在于,所述功能表面为对骨骼有亲和力的表面,并且尤其为多孔的表面。
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US (1) | US9717824B2 (zh) |
EP (1) | EP2879725B1 (zh) |
JP (1) | JP6290208B2 (zh) |
KR (1) | KR102230646B1 (zh) |
CN (1) | CN104507508B (zh) |
AU (1) | AU2013298687B2 (zh) |
BR (1) | BR112015002060B1 (zh) |
CA (1) | CA2880109A1 (zh) |
DE (1) | DE102013214657A1 (zh) |
RU (1) | RU2676758C2 (zh) |
WO (1) | WO2014019954A1 (zh) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
KR102230646B1 (ko) * | 2012-07-30 | 2021-03-19 | 세람테크 게엠베하 | 기능성 표면을 갖는 의료 제품들을 제조하기 위한 플라스틱 제제들의 다성분 결합 |
RU2017104139A (ru) * | 2014-07-09 | 2018-08-10 | Керамтек Гмбх | Цельнокерамический протез коленного сустава с пористой задней стороной, обращенной к кости |
KR20170031167A (ko) * | 2014-07-09 | 2017-03-20 | 세람테크 게엠베하 | 다공성 후방 외부 표면을 갖는 전체적으로 세라믹인 관골구 |
AU2015286969A1 (en) * | 2014-07-09 | 2017-02-16 | Ceramtec Gmbh | Entirely ceramic resurfacing prosthesis having a porous inner face |
WO2018087246A1 (de) * | 2016-11-09 | 2018-05-17 | Ceramtec Gmbh | Implantat mit ringinsert |
JP7379379B2 (ja) * | 2018-05-07 | 2023-11-14 | セラムテック ゲゼルシャフト ミット ベシュレンクテル ハフツング | 球形の滑動パートナーとの滑動対を形成するためのインプラント |
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US4969913A (en) * | 1987-09-28 | 1990-11-13 | Asahi Kogaku Kogyo K.K. | Ceramics composites |
DE19945529A1 (de) * | 1999-09-23 | 2001-04-05 | Anton Bohmann | Implantat zur funktionserhaltenden Rekonstruktion von Skelettdefekten und Verfahren für die Herstellung |
US6302913B1 (en) * | 1994-05-24 | 2001-10-16 | Implico B.V. | Biomaterial and bone implant for bone repair and replacement |
DE102007020471A1 (de) * | 2007-04-27 | 2008-11-06 | Ceramtec Ag Innovative Ceramic Engineering | Sinterformkörper |
US20100076570A1 (en) * | 2006-09-26 | 2010-03-25 | Tim Band | Medical implant |
Family Cites Families (7)
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EP0107476A3 (en) * | 1982-10-25 | 1985-01-02 | Calcitek, Inc. | Bone graft substitute |
JPH09299472A (ja) * | 1996-05-10 | 1997-11-25 | Ngk Spark Plug Co Ltd | 生体インプラント材料及びその製造方法 |
JPH11178913A (ja) * | 1997-12-22 | 1999-07-06 | Kyocera Corp | 生体補綴部材 |
JP2005278874A (ja) * | 2004-03-29 | 2005-10-13 | Kyocera Corp | 人工関節 |
CA2649108A1 (en) * | 2006-04-11 | 2007-10-25 | Smith & Nephew, Inc. | Ceramic metal composite for orthopaedic implants |
DE102008001402A1 (de) | 2008-04-28 | 2009-10-29 | Ceramtec Ag | Formkörper mit poröser Oberfläche und Verfahren zu seiner Herstellung |
KR102230646B1 (ko) * | 2012-07-30 | 2021-03-19 | 세람테크 게엠베하 | 기능성 표면을 갖는 의료 제품들을 제조하기 위한 플라스틱 제제들의 다성분 결합 |
-
2013
- 2013-07-26 KR KR1020157005366A patent/KR102230646B1/ko active IP Right Grant
- 2013-07-26 EP EP13744487.3A patent/EP2879725B1/de active Active
- 2013-07-26 WO PCT/EP2013/065810 patent/WO2014019954A1/de active Application Filing
- 2013-07-26 BR BR112015002060A patent/BR112015002060B1/pt active IP Right Grant
- 2013-07-26 AU AU2013298687A patent/AU2013298687B2/en not_active Expired - Fee Related
- 2013-07-26 CN CN201380040674.8A patent/CN104507508B/zh active Active
- 2013-07-26 RU RU2015106834A patent/RU2676758C2/ru active
- 2013-07-26 CA CA2880109A patent/CA2880109A1/en not_active Abandoned
- 2013-07-26 DE DE102013214657.4A patent/DE102013214657A1/de not_active Withdrawn
- 2013-07-26 JP JP2015524739A patent/JP6290208B2/ja active Active
- 2013-07-26 US US14/416,986 patent/US9717824B2/en active Active
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4969913A (en) * | 1987-09-28 | 1990-11-13 | Asahi Kogaku Kogyo K.K. | Ceramics composites |
US6302913B1 (en) * | 1994-05-24 | 2001-10-16 | Implico B.V. | Biomaterial and bone implant for bone repair and replacement |
DE19945529A1 (de) * | 1999-09-23 | 2001-04-05 | Anton Bohmann | Implantat zur funktionserhaltenden Rekonstruktion von Skelettdefekten und Verfahren für die Herstellung |
US20100076570A1 (en) * | 2006-09-26 | 2010-03-25 | Tim Band | Medical implant |
DE102007020471A1 (de) * | 2007-04-27 | 2008-11-06 | Ceramtec Ag Innovative Ceramic Engineering | Sinterformkörper |
Also Published As
Publication number | Publication date |
---|---|
JP6290208B2 (ja) | 2018-03-07 |
CN104507508B (zh) | 2019-06-04 |
RU2015106834A (ru) | 2016-09-20 |
EP2879725B1 (de) | 2020-09-16 |
US20150224228A1 (en) | 2015-08-13 |
JP2015526170A (ja) | 2015-09-10 |
KR20150039216A (ko) | 2015-04-09 |
CA2880109A1 (en) | 2014-02-06 |
WO2014019954A1 (de) | 2014-02-06 |
AU2013298687A1 (en) | 2015-03-12 |
BR112015002060A2 (pt) | 2017-07-04 |
EP2879725A1 (de) | 2015-06-10 |
RU2676758C2 (ru) | 2019-01-11 |
AU2013298687B2 (en) | 2016-09-29 |
DE102013214657A1 (de) | 2014-01-30 |
US9717824B2 (en) | 2017-08-01 |
KR102230646B1 (ko) | 2021-03-19 |
BR112015002060B1 (pt) | 2020-05-05 |
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