CN100528102C - 外科植入物 - Google Patents

外科植入物 Download PDF

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Publication number
CN100528102C
CN100528102C CNB028202333A CN02820233A CN100528102C CN 100528102 C CN100528102 C CN 100528102C CN B028202333 A CNB028202333 A CN B028202333A CN 02820233 A CN02820233 A CN 02820233A CN 100528102 C CN100528102 C CN 100528102C
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CN
China
Prior art keywords
implant
surface region
porous surface
utricule
vii
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
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CNB028202333A
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English (en)
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CN1568167A (zh
Inventor
P·昂温
G·布伦
M·H·亚各布斯
M·A·阿斯沃斯
X·吴
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Stanmore Implants Worldwide Ltd
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Stanmore Implants Worldwide Ltd
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Publication of CN1568167A publication Critical patent/CN1568167A/zh
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
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    • 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
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    • 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
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    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
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Abstract

一种外科植入物，其包括芯部区域和在该芯部区域的至少一部分之上延伸的多孔表面区域。该多孔表面区域具有预定的孔隙容积率。一种制造依据本发明的外科植入物的方法，其包括以下步骤：(i)围绕预成型的芯部在可密封囊体中装载具有预定颗粒尺寸分布的金属粉末；(ii)在所述囊体内使压力降低到低于大气压的预定压力；(iii)使用过程气体以使所述囊体加压到高于步骤(ii)的所述预定压力的预定压力；(iv)密封所述囊体；(v)在高温和高压下对所述加压的密封囊体加热预定时间，以便形成植入物前体；(vi)冷却所述密封的囊体；以及(vii)在高温和低于大气压的预定压力下对所述植入物前体加热预定时间，由此在所述植入物前体中产生孔隙。

Description

外科植入物
技术领域
本发明涉及一种外科植入物及其制造方法。
背景技术
存在有多种形式的外科植入物和装置，其包括：整形外科植入物(髋、肩、膝、踝、肘)，颅骨面部植入物和脊椎植入物(例如脊椎架或脊椎盘)。这种植入物通常依据强度和重量方面的因素由生物相容的金属例如钛、钛基合金、不锈钢或钴-铬合金。特别是用于代替骨骼的植入物来说，另一考虑因素是该植入物的弹性模量。弹性模量越接近自然骨骼的弹性模量，对于相邻骨骼的应力重新分布则越好。更好的应力重新分布使得该植入物的使用寿命更长。
为了增加周围组织与植入物的结合，已知的是，通过例如等离子喷涂在植入物表面上施加一涂层，这使得该植入物的表面粗糙化。涂层可由与植入物不同的成分制成，以便改善耐磨损性和/或提供强化的生物相容性，(例如由强惰性的TiN制成，其可作为涂层施加到含铝或含钒的植入物上，以便防止这些金属从植入物上浸析出来)。
发明内容
本发明的一目的在于提供一种改进的外科植入物，其与已知的植入物相比优选地具有改进的骨骼相容性和/或耐磨性和/或使用寿命和/或更高的强度。
依据本发明，提供了一种外科植入物，其包括：
(i)芯部区域，和
(ii)在所述芯部区域的至少一部分之上延伸的多孔表面区域，
其中，该多孔表面区域具有预定的孔隙容积率。
应当理解，在此使用术语，多孔区域的“孔隙容积率”是以百分比表示的在该区域内的空隙容积与该区域的总容积的比率。
植入物可以是按其所希望的应用场合所需的任何形状。例如，该植入物可以是细长的(例如柱形)或盘状。该植入物可具有不规则的形状，并且该多孔表面区域在该芯部区域上的厚度可改变。
优选的是，该孔隙容积率在该多孔表面区域内是20-50％。依据植入物的特性可选择预定的空隙容积率。较高的空隙容积率导致具有较低弹性模量的较轻的植入物。
优选的是，该孔隙是互连的并且在该多孔表面区域内大致均匀地分布。优选的是，至少一些(优选为大部分的)孔隙具有在100μm到大约750μm的范围内尺寸，优选为具有在大约200μm到大约500μm的范围内尺寸。
优选的是，该多孔表面区域至少大约1毫米厚并且优选为大约2-5毫米厚，最优选为2-3毫米厚。
在该多孔表面区域内不同的区域具有不同的孔隙尺寸分布和/或不同的孔隙容积率，以便使得在该多孔表面区域内存在有孔隙尺寸和/或孔隙容积率的梯度。例如，存在有沿植入物轴线的和/或沿垂直于该植入物轴线的孔隙容积率梯度。
芯部区域可以是完全致密的或多孔的。该芯部区域的孔隙度的程度可大于、小于、或等于该表面区域。
优选的是，该芯部区域与该表面区域相比其多孔的程度相对较低。
优选的是，该芯部区域具有0.7-1.0的理论密度的密度，(即0-30％的孔隙度)。
该芯部区域和该多孔表面区域可由相同或不同的材料制成。特别适当的材料包括钛(例如市场上可获得的纯钛[ASTM B 338 GR 2])、不锈钢、钛基合金、Ti-Al-V合金、Ti-Al-Nb合金、或钴-铬基合金制成。
特别优选的材料是市场上可获得的纯钛、Ti-6Al-4V、Ti-6Al-7Nb、Stellite 21(钨铬钴合金)、或不锈钢316L制成。
优选的是，该多孔表面区域扩散结合到芯部区域中。因此，应当理解，芯部区域与多孔表面区域之间的界面没有使得该植入物具有缺陷。
依据本发明的第二方面，提供了一种制造如本发明的所述第一方面所述的外科植入物的方法，其包括以下步骤：
(i)围绕预成型的芯部在可密封囊体中装载具有预定颗粒尺寸分布的金属粉末；
(ii)在所述囊体内使压力降低到低于大气压的预定压力；
(iii)使用过程气体以使所述囊体加压到高于步骤(ii)的所述预定压力的预定压力；
(iv)密封所述囊体；
(v)在高温和高压下对所述加压的密封囊体加热预定时间，以便形成植入物前体；
(vi)冷却所述密封的囊体；以及
(vii)在高温和低于大气压的预定压力下对所述植入物前体加热预定时间，由此在所述植入物前体中产生孔隙。
优选的是，在步骤(i)中使用的粉末具有在大约50μm到大约750μm的范围内颗粒尺寸，(即基本上所有的颗粒均在该指定的尺寸范围内)。该粉末可通过例如气体雾化或机械摩擦制成。
适当的是，芯部可与该囊体成一体，尽管该芯部可以是独立式的。在这两种情况中，芯部可由与该粉末相同或不同的材料制成，并且可由与该囊体其余部分相同或不同的材料制成。
优选的是，步骤(ii)的该预定压力为10-3mbar(0.1Pa)或更低。优选的是，步骤(vii)的该预定压力为10-3mbar(0.1Pa)或更低。
步骤(iii)的该过程气体可以是无反应性的气体(例如氩气)、或反应性气体(例如氮气)、或无反应性的气体和反应性气体的混合物，该无反应性的气体作为用于反应性气体的载体或冲淡剂。当氮气存在于该过程气体中时，最终形成的孔隙的表面被氮化，由此增加耐磨性和化学惰性。当金属粉末含有钛时，使用氮气是特别有利的。作为替代形式，可在步骤(vii)之后实施独立的氮化步骤，其优选为在大约800-1000℃的温度下和大约10-100MPa下进行1-8小时。
优选的是，步骤(iii)的该压力为大约1bar(1×105Pa)到5bar(5×105Pa)的正压。
优选的是，步骤(v)的高温为大约850-1100℃。优选的是，步骤(v)进行了超过大约1-4小时的时间段。
在步骤(vi)中，该密封的囊体(和其中的植入物前体)优选地冷却到室内温度。在植入物前体上在囊体内进行步骤(vii)。或者，在步骤(vi)之后在步骤(vii)之前，该植入物前体与该囊体分离。囊体通过例如在车床上加工去除从而适当地除去。优选的是，步骤(vii)的高温为大约900-1300℃。优选的是，步骤(vii)不超过80小时，优选为不超过60小时，并且更优选为不超过48小时。优选的是，步骤(vii)至少为6小时并且更优选为至少12小时。
如果在囊体中使用植入物前体来实施步骤(vii)，则在步骤(vii)之后，该囊体与该植入物通过例如加工而分离。
应当理解，由上述方法形成的植入物具有囊体的内表面的形状，因此需要进行附加的加工步骤以便获得植入物的最终所需的形状。然而，通过使用具有适当形状的内表面的囊体，可制成具有所需形状的植入物。制造适当形状的囊体的方法的示例可包括电成型和激光直接制造。
在以上方法的稍微的变型中，该金属粉末在封装之前部分地固结。这是通过选择性激光烧结金属粉末和聚合物粘合剂的混合物而实现的。不同的粉末粒度级可用于形成植入物的不同区域，并且在制造在多孔区域内具有孔隙度梯度的植入物方面，该变型是特别有利的。
依据本发明的第三方面，提供了一种制造如本发明第一方面所述的外科植入物的方法，其包括以下步骤：
(i)选择性地烧结金属颗粒的连续层，由此形成所需形状的植入物前体；以及
(ii)加热所述植入物前体，由此形成所述植入物。
优选的是，例如在真空炉中，在降低的压力下进行步骤(ii)。
通过围绕芯部烧结该颗粒来实施步骤(i)。优选的是，该芯部具有0.7-1.0的理论密度，(即具有0-30％的孔隙度)。然而，该芯部具有比该所得到的多孔表面区域相同、更高、或更低的密度。
优选的是，基本上所有的所述金属颗粒具有750μm或更小的尺寸，更优选为500μm或更小，最优选为150μm或更小。优选的是，所述金属颗粒具有至少50μm的尺寸。优选的是，所述颗粒处于与例如轻质和/或热敏聚合物粘合剂的混合物中。更优选的是，通过使激光器在金属粉末和粘合剂的所述混合物之上扫描来实施步骤(i)。优选的是，步骤(ii)在大约1000-1300℃的温度下实施。应当理解，在步骤(ii)中，任何存在的粘合剂被烧尽。
应当理解，实施步骤(i)以便使得区域具有大孔隙(macroporosity)。例如，激光烧结区域可设置有在从植入物的表面向内延伸的凹部，和/或设置有在植入物内的腔。此外，该腔和/或凹部可互连，以便在植入物中提供通道或沟道。还应当理解，这种大孔隙可引入到由使用选择性激光烧结的第二方面所述的变型方法制造的植入物中。
附图说明
以下参照附图并结合示例来详细描述本发明的实施例，在附图中：
图1是示出了由依据本发明的第三方面的方法如何来引入大孔隙的照片；
图2a是依据本发明的代替脊椎盘的示意截面图；
图2b是图2a所示的脊椎盘的平面图；
图2c是图2a的细节图；
图3a是依据本发明的代替脊椎架的示意截面图；
图3b是图3a所示的脊椎架的平面图；以及
图3c是图3a的细节图。
具体实施方式
示例1
100毫米长的由市场上可获得的纯钛(ASTM B 338 GR 2)制成的柱形容器具有大约22毫米的内径和大约25.4毫米的外径，该容器充有气体雾化的粉末，其由具有预定颗粒尺寸分布的(CrucibleResearch，USA的)Ti-6Al-4V合金的颗粒构成。如果需要，该粉末可流经适当筛孔的筛，以便获得特定的颗粒尺寸粒度级。该容器在没有振动即仅为“振实密度”的情况下填充。空气从容器中抽出(压力＜0.1Pa)并且用于氩气回填(105Pa)2分钟。在密封之后，容器在100Mpa的外界压力下在950℃下进行HIP(热等静压加压)4小时。随后，该容器被冷却到室内温度和大气压，Ar在压力下保留在合金基体中。植入物前体处理成从容器中析出并且在1050℃下在真空(＜0.1Pa)中热处理48小时。
对于不同的粉末粒度级，所获得植入物的孔隙度如下表1。
表1
示例2
使用具有尺寸分布180-250μm和150-500μm的粉末来重复示例1。在1000℃下执行HIP，并且(在从容器中取出之后)在1050℃下进行随后的热处理48小时。结果如表2所示。
表2
Figure C0282023300092
示例3
使用具有尺寸分布250-500μm的粉末来重复示例1。在1000℃下执行HIP，并且(在从容器中取出之后)在1050℃下进行随后的热处理12-48小时。结果如表3所示。
表3
Figure C0282023300101
示例4
使用具有尺寸分布＜150μm的粉末来重复示例1。在从容器中取出之后，在1050℃下进行随后的热处理。结果如表4所示。
表4
Figure C0282023300102
示例5
使用具有尺寸分布250-425μm的粉末来重复示例1。在从容器中取出之后，在不同的温度下进行48小时的随后的热处理。结果如表5所示。
表5
Figure C0282023300103
示例6
使用各种粉末来重复示例1。在(1100℃，48小时)的热处理之后，植入物在纯氮气中在950℃、50Mpa下进行6小时的压力氮化，以便使用氮化钛的薄层来涂敷孔隙的内表面。结果如表6所示。
表6
Figure C0282023300111
示例7
12.7毫米的由Ti-6Al-4V制成的实心柱形芯部居中地设置在如示例1所述的钛制容器中。芯部与内柱形壁之间的空间由(颗粒尺寸500-710μm的)Ti-6Al-4V粉末填充。该容器被抽空并用氩气回填到105Pa的正压，被密封并且在950℃、100Mpa下进行4小时的HIP。在从容器中取出之后，在1050℃下进行48小时随后的热处理。这获得到这样的样品，其具有29±5％的孔隙度的多孔涂层，其中43％的孔隙＞50μm，16％的孔隙＞100μm，以及6％的孔隙＞150μm。
示例8
使用具有颗粒尺寸＜125μm的粉末来重复示例1。在HIP之后，该部件加工成从容器中取出并且该部件的直径减小为大约17毫米。与示例1不同，在该阶段不进行热处理。所获得的柱形体随后以示例7相同的方式用作芯部，该容器具有38.1毫米的外径和大约35毫米的内径。随后重复示例7，在这种情况下该芯部由尺寸为250-425μm的颗粒包围。所获得的植入物具有多孔芯部和多孔外层，在多孔芯部中平均孔隙尺寸为26μm(孔隙度为28.9±2.1％)，并且在多孔外层中平均孔隙尺寸为113μm(孔隙度为24.9±1.9％)。
示例8示出了能够以可控的方式制造具有不同孔隙度的预定区域的植入物的方法。此外，应当理解，该过程可以延伸为制造具有大于2个不同孔隙度的不同层的植入物，即可制造分级的多孔结构。
示例9
使用具有预定尺寸分布的粉末来重复示例1。在(1100℃，48小时)的热处理之后，样品加工成可伸长的测试件，以便获得该多孔材料的特性。结果如表7所示。
表7
Ex.   粉末(μm)   孔隙度(％)   UTS(MPa)   E(GPa)   延伸率(％)   0.2％PS(MPa)   0.3％PS(MPa)
  7a   ＜500   24.6   386   58   .1   346   367
  7b   125-150   25.7   437   60   1.1   383   398
  7c   150-250   26.2   435   64   0.8   384   399
  7d   250-500   27.5   493   74   1.8   420   439
示例10
为了展示出预成型的芯部结合到多孔表面区域上的示例，其中在该芯部与表面区域之间的界面处具有强结合，在该处进行抗拉强度测试。在这些测试中，粉末(Ti-6Al-4V)同时固结并扩散结合到实心的Ti-6Al-4V条中，以便使界面处于该样品的计量长度的中点处。获得到两种粉末粒度级，125-150μm(测试样品a)和150-250μm(测试样品b)。在每种情况下，该样品容器用氩气回填到105Pa的正压。在950℃、100Mpa下进行4小时的初始HIP阶段。在1100℃下进行48小时随后的热处理阶段。获得到的孔隙度为大约40％(测试样品a)和30％(测试样品b)。
在这两种情况下，极限抗拉强度(UTS)为大约400MPa，并且在远离在多孔材料的主体内的界面处出现破损。常规的金相分析确认该界面没有受到影响，并且该界面没有污染(例如氧化物)并且不能与相邻的基体区分开。
示例11
参照图1，所示的部件通过选择性的激光烧结制成。激光器由计算机来控制，计算机安装有包含该部件的构形的CAD(计算机辅助设计)文件。该部件在加热到160℃(通常为100-200℃)的粉末层中制成。颗粒尺寸＜150μm的粉末和15％体积百分比的粘合剂(通常为5-25％体积百分比)被加热到60℃(通常为50-100℃)并且被输送到粉末层上，其中粉末层每层的成型厚度为200μm(通常为100-500μm)。选择性的烧结通过使用25W的激光器来实现。在该部件构造成之后，在400℃下进行30分钟(通常为在200-500℃下进行30-120分钟的)去粘合，在这之后在1100℃下(通常为1000-1350℃下)进行烧结。
如图1所示，部件2具有大致多孔的柱形区域(孔隙度大约为20-25％)，其中规则布置的圆形凹部6围绕其外周(“大孔隙”)。凹部6的周长为0.75毫米并且向内延伸3毫米。部件12类似于部件2，只是凹部6的直径为2毫米。
部件22也类似于部件2，只是凹部6的直径为1毫米并深度为5毫米。此外，设置有圆形布置的通道8。每一通道的直径为1.5毫米并且从该部件的顶表面延伸到其底部。
参照图2a-2c，示意地示出了替代的脊椎盘。该脊椎盘包括本领域已知的生物医学的半晶态的聚合物盘30(例如聚氨酯或聚乙烯)，依据本发明其夹在一对盘状金属端板32之间。该聚合物盘30由粘接剂固定到端板32上，但是应当理解，这些元件可熔接在一起或者该端板32可渗透到聚合物盘30中。
该盘32本身通常是肾形的(如图2b所示)，并且其在该聚合物盘30附近包括大致无孔隙的芯部区域32a并且在远离该聚合物盘30处包括多孔的外区域32b。该多孔的外区域有助于组织向内生长。
参照图3a-3c，脊椎架40为大致中空管状，其截面为矩形。大致完全致密的金属制成的芯部42由多孔的外金属区域44包围，(这有助于组织向内生长)。通道46延伸穿过该脊椎架40的中心。
从上述描述中可发现明显的是，通过粉末粒度级和过程参数的细心选择，依据用于植入物的特别端应用场合，可获得多孔表面区域的所需孔隙度和孔隙尺寸分布。尽管以上示例是柱形的杆，但是应当理解，其可容易地依据所需的用途来加工成适当的形状。同样，应当理解用于制备该植入物前体的的容器不必是柱形的并且可以是任何所需的形状。

Claims (23)

1.一种制造外科植入物的方法，该外科植入物具有芯部区域和在所述芯部区域的至少一部分之上延伸的多孔表面区域，该多孔表面区域具有预定的孔隙容积率，该方法包括以下步骤：
(i)围绕预成型的芯部在可密封囊体中装载具有预定颗粒尺寸分布的金属粉末；
(ii)在所述囊体内使压力降低到低于大气压的预定压力；
(iii)使用过程气体以使所述囊体加压到高于步骤(ii)的所述预定压力的预定压力；
(iv)密封所述囊体；
(v)在高温和高压下对所述加压的密封囊体加热预定时间，以便形成植入物前体；
(vi)冷却所述密封的囊体；以及
(vii)在高温和低于大气压的预定压力下对所述植入物前体加热预定时间，由此在所述植入物前体中产生孔隙。
2.如权利要求1所述方法，其特征在于，在步骤(i)中使用的粉末具有在50μm到750μm的范围内颗粒尺寸。
3.如权利要求1所述方法，其特征在于，步骤(ii)的该预定压力为10-3mbar或更低。
4.如权利要求1所述方法，其特征在于，步骤(vii)的该预定压力为10-3mbar或更低。
5.如权利要求1所述方法，其特征在于，步骤(iii)的该过程气体是无反应性的气体、或反应性气体、或无反应性的气体和反应性气体的混合物，该无反应性的气体作为用于反应性气体的载体或冲淡剂。
6.如权利要求5所述方法，其特征在于，氮气用作该反应性气体。
7.如权利要求1所述方法，其特征在于，在步骤(vii)之后进行氮化步骤。
8.如权利要求1所述方法，其特征在于，步骤(iii)的该压力为1×105Pa到5×105Pa的正压。
9.如权利要求1所述方法，其特征在于，步骤(v)的高温为850-1100℃。
10.如权利要求1所述方法，其特征在于，步骤(vii)的高温为900-1300℃。
11.如权利要求1所述方法，其特征在于，在步骤(vi)之后在步骤(vii)之前，该植入物前体与该囊体分离。
12.如权利要求1所述方法，其特征在于，在步骤(vii)之后，该囊体与该植入物前体通过加工而分离。
13.如权利要求1所述方法，其特征在于，通过选择性激光烧结金属粉末和聚合物粘合剂的混合物，从而使得该金属粉末在封装之前部分地固结。
14.一种按照权利要求1-13中任一项所述的方法制造的外科植入物。
15.如权利要求14所述的植入物，其特征在于，该孔隙容积率在该多孔表面区域内是20-50％。
16.如权利要求14所述的植入物，其特征在于，该孔隙是互连的并且在该多孔表面区域内大致均匀地分布。
17.如权利要求14所述的植入物，其特征在于，至少一些孔隙具有在100μm到750μm的范围内尺寸。
18.如权利要求14所述的植入物，其特征在于，该多孔表面区域至少1毫米厚。
19.如权利要求14所述的植入物，其特征在于，在该多孔表面区域内不同的区域具有不同的孔隙尺寸分布和/或不同的孔隙容积率，以便使得在该多孔表面区域内存在有孔隙尺寸和/或孔隙容积率的梯度。
20.如权利要求14所述的植入物，其特征在于，该芯部区域具有0.7-1.0的理论密度的密度。
21.如权利要求14所述的植入物，其特征在于，该芯部区域和/或该多孔表面区域由钛、市场上可获得的纯钛、不锈钢、钛基合金、Ti-Al-V合金、Ti-Al-Nb合金、或钴-铬基合金制成。
22.如权利要求21所述的植入物，其特征在于，该芯部区域和/或该多孔表面区域由Ti-6Al-4V、Ti-6Al-7Nb、钨铬钴合金21、或不锈钢316L制成。
23.如权利要求14所述的植入物，其特征在于，该多孔表面区域为2-5毫米厚。
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