CN116940291A - 骨科植入物及使用方法 - Google Patents
骨科植入物及使用方法 Download PDFInfo
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- CN116940291A CN116940291A CN202280010014.4A CN202280010014A CN116940291A CN 116940291 A CN116940291 A CN 116940291A CN 202280010014 A CN202280010014 A CN 202280010014A CN 116940291 A CN116940291 A CN 116940291A
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- Prior art keywords
- orthopedic implant
- bone
- elongate member
- sugar
- channel
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
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Landscapes
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- Materials For Medical Uses (AREA)
Abstract
本发明涉及一种骨科植入物。所述骨科植入物包括细长构件,所述细长构件具有第一端和与第一端相对的第二端。细长构件在第二端呈锥形,使得第二端的宽度小于第一端的宽度。骨科植入物还包括第一通道,所述第一通道定位在细长构件的第一侧上并且从第一端延伸到第二端。骨科植入物还包括第二通道,所述第二通道定位在细长构件的第二侧上并且从第一端延伸到第二端。骨科植入物还包括将第一通道连接到第二通道的一个或多个通孔。
Description
相关申请
本申请要求于2021年1月13日提交的,序列号为63/136911,名称为“骨科植入物和使用方法”的美国临时申请的优先权,其内容通过引用全部并入本文。
技术领域
本发明涉及骨科植入物和使用方法。骨科植入物的实施方案用于将各种装置固定到或固定在患者的骨头中。
背景技术
除非本文另有说明,否则本节中所述的材料不被承认为本申请权利要求的现有技术。
骨科领域的许多手术需要使用螺钉、锚钉、销钉或其他此类固定装置。在一个实例中,这种固定装置可用于将诸如韧带、肌腱或肌肉的软组织附接到软组织脱离后的表面。例如,肩关节修复过程中,肩袖可能会重新附接到肱骨头上。另一个实例中,固定装置可以用于前交叉韧带(ACL)的重建,以将替代韧带固定到胫骨和股骨上。固定装置也可用于将软组织固定到辅助附接部位以进行加固。例如,在泌尿外科应用中,固定装置可用于膀胱颈悬吊术,以将膀胱的一部分附接到相邻的骨表面。这种软组织附接可以在开放或闭合性外科手术中完成,后者通常被称为关节镜或内窥镜手术。术语“关节镜”和“内窥镜”在本文中可以互换使用,旨在涵盖关节镜、内窥镜、腹腔镜、宫腔镜或任何其他类似的外科手术,这些手术是用细长器械通过小孔插入身体进行的。各种固定装置的许多其他潜在用途也是可能的。
这种固定装置有多种形式。通常,金属螺钉(通常由钛制成)用于此目的,并且因为它们引起的炎症反应轻微,是外科医生的首选。然而,使用金属螺钉通常需要在愈合后进行第二次手术干预以移除螺钉。此外,由于机械应力主要由刚性金属螺钉限制,因此在愈合过程期间和之后,周围的骨科植入物不能承载足够的载荷,以产生生物强度强的结构。在某些情况下,这可能会导致植入数年后术后并发症的增加。
合成聚合物螺钉目前可用,是金属螺钉的替代选择。在手术后的几个月里,由于聚合物被降解并被身体吸收,螺钉部位被生物组织取代,因此生物力学应力从植入物或螺钉转移到愈合过程中产生的新形成的组织。这种合成聚合物螺钉通常富含聚乳酸和磷酸三钙,它们的组合需要很长时间才能被吸收到体内。使用不同类型的材料,如镁基、铁基和锌基合金,可能有助于加快吸收率,因为它们具有已知的生物相容性和材料特性。这种材料的问题在于,在其最纯粹的形式下,这些材料在体外和体内实验中显示出高腐蚀效应。
发明内容
鉴于上述情况,发明人认识到改进的骨科植入物是可取的。本发明提供了这样一种装置和使用方法。
在第一方面,本发明提供了一种骨科植入物。所述骨科植入物包括细长构件,所述细长构件具有第一端和与第一端相对的第二端。所述细长构件在第二端呈锥形,使得第二端的宽度小于第一端的宽度。所述骨科植入物还包括第一通道,所述第一通道位于所述细长构件的第一侧上并且从第一端延伸到第二端。所述骨科植入物还包括第二通道,所述第二通道位于所述细长构件的第二侧上并且从第一端延伸到第二端。所述骨科植入物还包括将第一通道连接到第二通道的一个或多个通孔。
在第二方面,本发明提供了一种将骨科植入物固定到骨头上的方法,所述方法包括:(a)提供第一方面的骨科植入物,(b)在骨头中形成骨道,(c)将骨科植入物的细长构件的第二端插入骨头中的骨道,以及(d)将未固化的骨刺激性材料应用于细长构件的第一通道和第二通道中的一个或多个。
通过阅读以下具体实施方式,并在适当的情况下参考附图,这些以及其他方面、优点和替代方案对本领域普通技术人员来说将变得显而易见。
附图说明
图1示出了根据示例性实施方案的骨科植入物的俯视图。
图2示出了根据示例性实施方案的图1的骨科植入物的侧视图。
图3示出了根据示例性实施方案的图1的骨科植入物的透视图。
图4示出了根据示例性实施方案的另一骨科植入物的透视图。
图5示出了根据示例性实施方案的另一骨科植入物的透视图。
具体实施方式
本文描述了示例方法和系统。应当理解,所述单词“示例”、“示例性”和“说明性”在本文中用于表示“用作示例、实例或说明”。本文中描述为“示例”或“示例性的”或“说明性的”的任何实施方案或特征不一定被解释为比其他实施方案或特征更优选或有利。本文所描述的示例性实施方案并不意味着是限制性的。容易理解的是,本发明的各方面,如本文中一般描述的和附图中所示,可以以各种不同的配置来布置、替换、组合、分离和设计,所有这些都被本文明确预期。
此外,图中所示的特定布置不应被视为限制。应该理解的是,其他实施方案可以或多或少地包括给定图中所示的每个元件。此外,所示元件中的一些可以组合或省略。此外,示例性实施方案可以包括未在附图中示出的元件。
如本文所用,就测量而言,“大约”是指+/-5%。
如本文所用,“骨刺激性”是指材料促进骨损伤或缺陷愈合的能力。
如本文所用,“骨传导性”是指一种材料作为活骨生长和愈合支架的能力。
如本文所用,“骨诱导性”是指材料刺激或诱导骨生长的能力。
如本文所用,“生物相容性”是指当将材料插入受体(例如,哺乳动物,包括人类,受体)时不会引起显著不良反应。
如本文所用,“可吸收”是指材料通过身体过程在体内被吸收的能力。被吸收的物质可能在患者体内变成骨头。
本发明提供了一种适用于骨科外科手术的骨科植入物。本文所述的骨科植入物可以与粘合剂或骨空隙填充剂结合使用。在一个实例中,使用包含聚乳酸和磷酸镁的聚合物进一步允许骨科植入物在体内被吸收,从而产生增加的固定强度并更快地吸收到体内。
参考附图,图1-3示出了示例性骨科植入物100。如图1-3所示,所述骨科植入物100包括细长构件102,所述细长构件102具有第一端104和与第一端104相对的第二端106。所述细长构件102在第二端106处呈锥形,使得第二端部106的宽度小于第一端部104的宽度。所述骨科植入物100还包括第一通道108,所述第一通道108位于细长构件102的第一侧110上并且从第一端104延伸到第二端106。所述骨科植入物100还包括第二通道112,所述第二通道位于细长构件102的第二侧114上并且从第一端104延伸到第二端106。所述骨科植入物100还包括将第一通道108连接到第二通道112的一个或多个通孔116。
如图1-3所示,所述骨科植入物100可包括第一部分和第二部分,所述第一部分中第一侧110和第二侧114相距固定距离,所述第二部分为锥形。所述第一侧110可以具有至少第一部分的曲率半径,第二侧114可以具有至少第一部分的曲率曲率半径。
如图1所示,在一个示例中,所述一个或多个通孔116包括多个通孔。所述第一通道108凹入细长构件102的第一侧110中,第二通道112凹入细长部件102的第二侧114中。
在一个示例中,如图1-3所示,所述细长构件的外表面没有螺纹。在这样的示例中,第一端104可以基本上是平的,使得其被配置为经由锤子或其他类似工具插入到结构中。
在另一个示例中,所述细长构件外表面的至少一部分包括多个螺纹。在这样的示例中,所述骨科植入物100还可以是位于所述细长构件102的第一端104处的传动套筒。这种传动套筒可以包括所述细长构件102的第一端104中的凹形切口。在一个示例中,骨科植入物100还包括联接到细长构件102的第一端104的头部。所述头部的直径可以大于细长构件102的直径,从而在使用时为骨科植入物100插入结构中时提供停止点。所述细长构件102可以与头部成一体,使得它们一体形成,或者细长构件102可单独地联接到头部。在这样的示例中,所述传动套筒可以与头部成一体,使得所述传动套筒包括头部中的凹形切口。
这种传动套筒被设计用于与合适的扭矩传递插入装置(如植入物驱动器)相互作用,从而允许传输所需的扭矩,以驱动植入物进入准备好的套筒。例如,所述传动套筒可以是细长构件102的第一端104中的多边形凹陷,而表征驱动器远端的扭矩传递特征是对应的多角形突起(例如在传统的六角扳手或“艾伦”扳手上发现的)。在另一个实施方案中,所述传动套筒可以是在细长构件102的第一端104中凹陷的一个或多个轴向延伸的槽,而驱动器是带槽的平刃或十字头(“十字槽螺丝帽”)螺丝刀。然而,其他实施方案对于本领域技术人员来说将是显而易见的。此外,本领域技术人员将容易理解,各个配合元件(例如,与各种相称的突出凸起(protrusion)、突起(protuberance)、凸块(tab)和塞缝片(spline)相匹配的凹陷的槽和沟)的位置可以根据需要进行交换和/或反转。
在一个示例中,所述细长构件102还包括用于实现进一步增强的骨融合和向内生长的生物活性治疗剂。在一个实例中,所述生物活性治疗剂以在细长构件102的外表面上的表面涂层的形式存在。在另一个示例中,所述骨科植入物100可以结合到形成骨科植入物100的材料中的多个孔中。这样的生物活性治疗剂可以包括天然或合成的治疗剂,例如骨形态发生蛋白(BMP)、生长因子、骨髓穿刺液、干细胞、祖细胞、抗生素、丁胺卡那霉素、丁酰苷菌素、双脱氧卡那霉素、福堤霉素、庆大霉素、卡那霉素、利维霉素、新霉素、奈替米星、核糖霉素、小诺霉素(sagamycin)、昔尔杜霉素及其差向异构体、西索米星、山梨菌素、奇霉素和妥布霉素,或其他骨传导性、骨诱导性、成骨性、生物活性或任何其他融合增强材料或有益的治疗剂。
所述细长构件102可以采用多种形式。在一个示例中,所述骨科植入物100的细长构件102可以包括钛、聚醚醚酮(PEEK)、聚氨酯、骨或其组合。
在另一个示例中,整个骨科植入物100由包括聚乳酸和磷酸镁或磷酸钾的聚合物制成。如本文所用,“聚乳酸”或聚丙交酯(PLA)是衍生自可再生资源的可生物降解且具有生物活性的热塑性脂族聚酯,并且可以采取多种形式,包括但不限于聚-L-乳酸(PLLA)、聚-D-乳酸(PDLA)和L-丙交酯-D-丙交酯共聚物(PLDLLA))。如本文所用,“磷酸镁”是以不同形式出现的镁和磷酸盐以及不同水合物的统称,包括但不限于磷酸二氢镁((Mg(H2PO4)2).xH2O)、磷酸二镁((MgHPO4).xH2O)、三磷酸镁((Mg3(PO4)2).xH2O)。如本文所用,“磷酸钙”是包含钙离子(Ca2+)和无机磷酸盐阴离子的材料和矿物家族,以多种形式出现,包括但不限于磷酸一钙、磷酸二钙、磷酸三钙、磷酸八钙、无定形磷酸钙、二磷酸二钙和三磷酸钙、羟基磷灰石、磷灰石和磷酸四钙。
由包括聚乳酸和磷酸镁或磷酸钾的聚合物制备整个骨科植入物100具有许多优点。特别地,这种材料允许骨科植入物100在体内被吸收,从而产生增加的固定强度并更快地吸收到体内。与传统的金属合金骨螺钉相比,在一段时间后不需要移除骨科植入物100,因为骨科植入物100的材料使得骨能够实际取代骨科植入物100的结构。因此,在骨科植入物100在体内被吸收之后,不存在留下的空隙。相反,骨科植入物100被体内自然生长的骨结构代替,并且由此产生的固定强度非常强。因此,所述骨科植入物100可以是完全可吸收的。
所得到的骨科植入物100表现出相对较高的承载支撑机械强度,同时额外地且期望地提供高骨传导和骨诱导特性,以实现增强的骨向内生长和融合。在使用中,构成骨科植入物100的包括聚乳酸和磷酸镁或磷酸钾的聚合物将诱导骨生长至骨科植入物中并被吸收。所述骨科植入物100最终被体内的骨替代,从而将骨科植入物100(例如,ACL重建手术中的替代韧带或肩袖再附手术中的现有肩袖)连接到的部件牢固地固定到身体的骨结构上。
在另一个示例中,所述细长构件102的外表面的至少一部分包括固化的骨刺激材料。这种骨刺激材料可以采取多种形式。所述骨刺激材料可以允许生物结构彼此原位(即体内)附接以及与人造结构的附接。骨刺激材料还可以促进骨、韧带、肌腱和邻近结构的修复。骨刺激材料还可以提供用于外科修复的骨替代物。骨刺激材料的制剂可在多种温度、pH范围、湿度水平和压力下使用。然而,所述制剂可以被设计为在所有生理温度、pH范围和流体浓度下使用。所述骨刺激材料通常(但不一定)在固化前是可注射的,并且在固化后可以表现出中性pH。它可能在一段时间内被宿主吸收。
在一个特定的示例中,固化的骨刺激材料包括约20-70%干重的KH2PO4、10-50%干重的氧化镁(MgO)、含钙化合物、聚乳酸以及磷酸镁或磷酸钾。固化的骨刺激材料可以具有骨传导和骨诱导特性。此外,固化的骨刺激材料可以是生物可吸收的。所述细长构件102的外表面上的固化的骨刺激材料的厚度可以在约200μm至约50mm的范围内。在一些示例中,固化的骨刺激材料不覆盖细长构件102整个外表面,从而存在裸露的钛聚醚醚酮(PEEK)、聚氨酯和/或骨的区域。在另一个示例中,如上所述,所述细长构件102的外表面可以包括多个螺纹或多个凹槽。在这样的示例中,固化的骨刺激材料被定位在多个凹槽中的一个或多个凹槽内。在另一个示例中,整个细长构件102包括固化的骨刺激材料。
根据本发明的另一方面,骨科植入物100可以另外携带一种或多种生物活性治疗剂,用于实现进一步增强的骨融合和向内生长。这种生物活性治疗剂可以包括天然或合成的治疗剂,例如骨形态发生蛋白(BMP)、生长因子、骨髓穿刺液、干细胞、祖细胞、抗生素或其他骨传导、骨诱导、骨形成、生物活性或任何其他融合增强材料或有益的治疗剂。在另一个示例中,生物活性治疗剂包括丁胺卡那霉素、丁酰苷菌素、双脱氧卡那霉素、福堤霉素、庆大霉素、卡那霉素、利维霉素、新霉素、奈替米星、核糖霉素、小诺霉素(sagamycin)、昔尔杜霉素及其差向异构体、西索米星、山梨菌素、奇霉素和妥布霉素中的一种。
所得到的骨科植入物100表现出相对较高的承载支撑机械强度,同时额外地且期望地提供高骨传导和骨诱导特性,以实现增强的骨向内生长和融合。在使用中,定位在骨科植入物100的细长构件102的外表面上的固化的骨刺激材料将诱导骨生长至骨科植入体100中并被吸收。骨刺激材料最终被骨替代,从而将骨科植入物100更牢固地嵌入体内。
当极力避免使用金属紧固件和其他非生物可吸收材料时,骨刺激材料在这种情况下(如整形外科)特别有用。当预期在手术后,例如在颅骨手术后,会产生一定量的膨胀或肿胀时,骨刺激材料也是有用的。这是一个很好的骨形成平台。骨刺激材料也可以用作锚固装置或移植材料。
通常,骨刺激材料来源于水合混合物,其包括:(a)KH2PO4,其量在约20-70%之间的干重,(b)MgO,其量为10-50%的干重,(c)含钙化合物,(d)糖。在一个特定的实例中,含钙化合物是Ca5(PO4)3OH。
骨刺激材料的非限制性示例性制剂包括以下:
制剂I*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选为约20-35的重量百分比,更优选为22-25的重量百分比。
制剂II*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂III*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂IV*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选约28-32的重量百分比。
制剂V*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂VI*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂VII*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂VIII*
*所有值均为重量
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂IX*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂X*
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选约20-35的重量百分比,更优选22-25的重量百分比。
制剂XI*
KH2PO4 45%
MgO(煅烧产物) 45%
Ca10(PO4)6(OH)2 10%
*所有值均为重量百分比
添加水至干制剂约40的重量百分比,优选在约20-35的重量百分比,更优选22-25的重量百分比。
上述配方和重量百分比仅仅是示例性的。还可以使用一系列干燥成分。例如,磷酸盐(即磷酸一钾(MKP))的合适范围通常为约20-70的重量百分比,优选为约40-65的重量百分比。在一些情况和/或实施方案中,优选使用范围为约40-50重量百分比的磷酸盐,而在另一些情况和/或实施方案中,可能优选使用范围在约50-65重量百分比的磷酸盐。
金属氧化物(即MgO)的合适范围通常在约10-60之间,优选在10-50之间,甚至更优选在重量百分比30-50之间。在一些情况和/或实施方案中,优选使用重量百分比约35-50之间。
含钙化合物可以以各种重量百分比加入。含钙化合物优选以约1-15的重量百分,更优选约1-10的重量百分比加入。在某些情况下可以采用更高的百分比。
糖(和/或其他含碳水化合物的物质)通常以干组合物0.5-20的重量百分比,优选约0.5-10的重量百分比存在。糖可以包括糖醇、糖酸、氨基糖、糖聚合物糖胺聚糖、糖脂、糖替代物及其组合中的一种。
水(或另一种水溶液)可以以大范围的重量百分比加入,通常重量百分比在约15-40之间,优选重量百分比在约20-35之间。例如,在本文一般描述的材料的某些实施方案中,加入重量百分比约28-32之间的水或其他水溶液。在本文一般描述的材料的其他实施方案中,加入重量百分比约28-32之间的水或其他水溶液。已经发现可以使用盐水溶液。一种示例性的盐水溶液是0.9%的盐水溶液。
对于一些实施方案(即,制剂III),已经发现添加重量百分比约37的水会产生奶油状纹理材料,所述材料极易使用,具有优异的粘合性能,并且易于通过注射器注射。
所述范围可能随着各种填料和其他组分的添加或其他原因而变化。
在一个实施方案中,MKP和MgO之间的重量百分比比值在约4:1和0.5:1之间。在另一实施方案中,其大约在2:1和1:1之间。
在不以任何方式限制本发明的情况下,在这样的实施方案中,发明人推测未反应的镁至少部分负责生物粘合剂的体内可膨胀性特性。具体而言,金属氧化物(即氧化镁)与活组织中及其周围的水和血清反应,产生Mg(OH)2和镁盐。已经发现,在一些实施方案中,所述材料在湿气中固化期间通常膨胀到体积的0.15%至0.20%之间。材料的膨胀被认为增加了材料的粘合特性。例如,所公开的材料已被证明能有效地将韧带等软组织附接到骨上,材料的膨胀通过机械强度增强了粘附性。
可用于本发明的骨刺激材料也可在序列号为6533821的美国专利、序列号为6787495的美国专利、序列号为7045476的美国专利、序列号为9078884的美国专利、公开号为2015/0250924美国专利申请和公开号为2015/0314045的美国专利申请,所有这些都以引用的方式整体并入本文。
在一些示例中,上述骨科植入物100的一个或多个部件是通过使用增材制造机器的增材制造工艺制造的,例如立体光刻、多喷建模、喷墨打印、选择性激光烧结/熔化和熔融丝制造等。增材制造使得骨科植入物100的一个或多个部件和其他物理物体能够通过使用逐层生成过程而被创建为内部连接的单件结构。增材制造涉及基于物体的设计将物理物体沉积在一种或多种选定材料中。例如,增材制造可以使用骨科植入物100的计算机辅助设计(CAD)作为指令来生成骨科植入物100的一个或多个部件。因此,骨科植入物100的设计的改变可以立即在骨科植入物100的后续物理创建中进行。这使得骨科植入物100的部件能够容易地调节或缩放以适应不同类型的应用(例如,用于各种尺寸的机翼)。在一个特定示例中,将未固化的骨刺激材料施加到骨科植入物100的外表面的步骤包括执行增材制造工艺以将未固化骨刺激材料沉积在骨科植入物100的外表面上。
增材制造中使用的逐层工艺可以沉积具有复杂设计的骨科植入物100的一个或多个部件,这对于用传统制造组装的装置来说是不可能的。反过来,所述骨科植入物100的设计可以包括旨在改进整体操作的方面。例如,所述设计可以结合物理元件,所述物理元件有助于以期望的方式重定向应力,这是传统制造的装置可能无法复制的。
增材制造还能够使用多材料增材制造工艺将骨科植入物100的一个或多个部件沉积在各种材料中。在这样的示例中,所述细长构件102可以由第一材料制成,并且未固化的骨刺激材料可以由不同于第一材料的第二材料制成。在另一个示例中,所述细长构件102和未固化的骨刺激材料由相同的材料制成。其他示例材料组合也是可能的。此外,所述骨科植入物100的一个或多个部件可以具有使用第一类型的材料形成的一些层和使用第二类型的材料产生的其他层。此外,在其它实例中使用各种工艺来生产骨科植入物100的一个或多个部件。这些工艺包含在表1中。
DEP | 直接能量沉积 |
DMLS | 直接金属激光烧结 |
DMP | 直接金属打印 |
EBAM | 电子束增材制造 |
EBM | 电子束发射 |
EBPD | 电子束粉末床 |
FDM | 熔融沉积成型 |
IPD | 间接动力床 |
LCT | 激光熔覆技术 |
LDT | 激光沉积技术 |
LDW | 激光沉积焊接 |
LDWM | 集成铣削的激光沉积焊接 |
LENS | 激光近净成型 |
LFMT | 激光自由曲面制造技术 |
LMD-p | 激光金属沉积粉末 |
LMD-w | 激光金属沉积线 |
LPB | 激光粉末床 |
LPD | 激光池沉积 |
LRT | 激光修复技术 |
PDED | 粉末定向能量沉积 |
SLA | 立体光刻 |
SLM | 选区激光熔化 |
SLS | 激光选区烧结 |
SPD | 小池沉积 |
表1
上述骨科植入物100的每个部件可以表示程序代码的一个模块、一段或一部分,所述程序代码包括一个或多个可由处理器或计算装置执行的指令,用于使用增材制造系统创建此类装置。程序代码可以存储在任何类型的计算机可读介质上,例如,包括磁盘或硬盘驱动器的存储装置。计算机可读介质可以包括非瞬态计算机可读介质,例如,诸如寄存器内存、处理器高速缓存和随机存取存储器(RAM)之类的短时间存储数据的计算机可读介质。计算机可读介质还可以包括非瞬态介质,例如辅助或持久长期存储器,例如只读存储器(ROM)、光盘或磁盘、光盘只读存储器(CD-ROM)。计算机可读介质也可以是任何其他易失性或非易失性存储系统。计算机可读介质可以被认为是例如计算机可读存储介质或有形存储装置。
此外,将未固化的骨刺激材料进行固化可包括在未固化的骨科植入物刺激材料应用于骨科植入物100的外表面之后对骨科植入物进行热处理。因为为了获得高质量的MgO膜需要高沉积温度,固化温度可以在25℃的间隔内从400℃变化到500℃。退火固化与骨刺激材料混合物的厚度成反比。在烤箱中烘烤之后,骨科植入物100可以被空气干燥。与仅将骨刺激材料施加到骨科植入物100的外表面并允许其在没有热的帮助下固化相比,热处理过程将成倍地减少干燥时间。
在操作中,本发明提供了一种将骨科植入物固定在骨科植入物上的方法,所述方法包括:(a)提供上述任何实施方案的骨科植入物100,(b)在骨中形成骨道,(c)将骨科植入物的细长构件的第二端插入所述骨中的骨道,以及(d)将未固化的骨刺激材料施加到细长构件的第一通道和第二通道中的一个或多个。
在一个实施方案中,所述方法还包括将韧带插入骨中的骨道中,并将骨科植入物的细长构件的第二端插入所述骨中的骨道中,使得细长构件填充隧道的大部分,其中韧带牢固地固定在细长构件和骨中骨道的内表面之间。
在另一实施方案中,所述方法还包括将骨移植物定位在细长构件102的第一通道108和第二通道112中的一个或多个中。
在另一实施方案中,本发明提供了一种将骨科植入物固定到骨上的方法,所述方法包括:(a)提供骨科植入物,(b)移除骨的一部分以形成空腔,以及(c)将骨科植入物插入骨的空腔中,其中整个骨科植入物包括固化的骨刺激材料,并且其中所述骨科植入物在体内被完全吸收,从而使得天然骨结构能够替代所述整形骨科植入物的结构,使骨科植入物在体内被吸收后不会留下空隙。
如上所述,由固化的骨刺激材料制成整个骨科植入物具有许多优点。特别地,这种材料允许骨科植入物在体内被吸收,从而产生增加的固定强度并更快地吸收到体内。与传统的金属合金骨螺钉相比,在一段时间后不需要移除骨科植入物,因为骨科植入物的材料使骨科植入物能够实际取代骨科植入物结构。因此,在骨科植入物在体内被吸收后,不存在留下的空隙。相反,骨科植入物被体内自然生长的骨结构所取代,由此产生的固定强度非常强。因此,骨科植入物可以是被完全可吸收。
骨科植入物的固化的骨刺激材料可以采用多种形式,如上所述。特别地,在一个实施例中,所述固化的骨刺激材料包括约20-70干重量百分比量的KH2PO4、10-50干重量百分比量的MgO、含钙化合物、聚乳酸和磷酸镁或磷酸钾。在一个实例中,所述聚乳酸包含聚L-乳酸(PLA)、L/DL聚乳酸(PLDLA)和聚乳酸-聚羟基乙酸共聚物(PLGA)中的一种。在一个实例中,经固化的骨刺激性材料进一步包含生物活性治疗剂。在一个这样的实例中,所述生物活性治疗剂包括丁胺卡那霉素、丁酰苷菌素、双脱氧卡那霉素、福堤霉素、庆大霉素、卡那霉素、利维霉素、新霉素、奈替米星、核糖霉素、小诺霉素(sagamycin)、昔尔杜霉素及其差向异构体、西索米星、山梨菌素、奇霉素和妥布霉素中的一种。在另一个实例中,所述固化的骨刺激性材料进一步包含糖,并且其中所述糖包含糖醇、糖酸、氨基糖、糖聚合物糖胺聚糖、糖脂、糖替代物及其组合中的一种。
此外,骨科植入物可以采用多种形式。在一个示例中,骨科植入物包括上述图1-3的骨科植入物100。在另一个示例中,如图4所示,所述骨科植入物包括销钉200。在另一个示例中,如图5所示,所述骨科植入物包括楔块300。基于上述方法,其他形式的骨科植入物也是可能的。
虽然本文公开了各个方面和实施方案,但其他方面和实施方案对本领域技术人员来说是显而易见的。本文公开的各个方面和实施方案仅用于说明目的,并非旨在限制,真正的范围由以下权利要求指示,以及此权利要求所享有的全部等同物的范围。还应理解,本文所用术语仅用于描述特定实方案的目的,而不旨在限制。
因为可以对所描述的示例进行许多详细的修改、变动和改变,所以前面的描述和附图中所示的所有内容都应被解释为说明性的,而不是限制性的。此外,应当理解,以下条款(以及条款的任何组合)进一步描述了本说明书的各方面。
Claims (27)
1.一种骨科植入物,包括:
细长构件,所述细长构件具有第一端和与所述第一端相对的第二端,其中所述细长构件在所述第二端处呈锥形,使得所述第二端的宽度小于所述第一端的宽度;
第一通道,所述第一通道定位在所述细长构件的第一侧上并且从所述第一端延伸到所述第二端;
第二通道,所述第二通道定位在所述细长构件的第二侧上并且从所述第一端延伸到所述第二端;和
一个或多个通孔,所述一个或多个通孔将所述第一通道连接到所述第二通道。
2.根据权利要求1所述的骨科植入物,其中所述一个或多个通孔包括多个通孔。
3.根据权利要求1-2中任一项所述的骨科植入物,其中所述第一通道凹入所述细长构件的所述第一侧中,并且其中所述第二通道凹入所述细长部件的所述第二侧中。
4.根据权利要求1-3中任一项所述的骨科植入物,其中所述细长构件包括钛、聚醚醚酮(PEEK)、聚氨酯或骨。
5.根据权利要求1-4中任一项所述的骨科植入物,其中所述细长构件的外表面的至少一部分包括固化的骨刺激材料。
6.根据权利要求5所述的骨科植入物,其中所述固化的骨刺激材料包含约20-70干质量百分比量的KH2PO4、10-50干质量百分比量的MgO、含钙化合物、聚乳酸以及磷酸镁或磷酸钾。
7.根据权利要求6所述的骨科植入物,其中所述聚乳酸包含聚L-乳酸(PLA)、L/DL聚乳酸(PLDLA)和聚乳酸-聚羟基乙酸共聚物(PLGA)中的一种。
8.根据权利要求6-7中任一项所述的骨科植入物,其进一步包含生物活性治疗剂。
9.根据权利要求8所述的骨科植入物,其中所述生物活性治疗剂包括丁胺卡那霉素、丁酰苷菌素、双脱氧卡那霉素、福堤霉素、庆大霉素、卡那霉素、利维霉素、新霉素、奈替米星、核糖霉素、小诺霉素、昔尔杜霉素及其差向异构体、西索米星、山梨菌素、奇霉素和妥布霉素中的一种。
10.根据权利要求6-9中任一项所述的骨科植入物,其中所述固化的骨刺激材料进一步包含糖,且其中所述糖包含糖醇、糖酸、氨基糖、糖聚合物糖胺聚糖、糖脂、糖替代物及其组合中的一种。
11.根据权利要求6-10中任一项所述的骨科植入物,其中所述细长构件的外表面上的所述固化的骨刺激材料的厚度在200μm至50mm的范围内。
12.根据权利要求6-11中任一项所述的骨科植入物,其中所述外表面包括多个凹槽,并且其中所述固化的骨刺激材料定位在所述多个凹槽中的一个或多个凹槽内。
13.根据权利要求6-12中任一项所述的骨科植入物,其中所述细长构件的整体包括所述固化的骨刺激材料。
14.根据权利要求1-13中任一项所述的骨科植入物,还包括在所述细长构件的外部的至少一部分上的多个螺纹。
15.根据权利要求1-14中任一项所述的骨科植入物,其中所述细长构件是可吸收的。
16.一种用于将骨科植入物固定到骨的方法,所述方法包括:
提供根据权利要求1-15中任一项所述的骨科植入物;
在骨中形成骨道;
将所述骨科植入物的细长构件的第二端插入骨中的骨道中;并
将未固化的骨刺激材料施加到细长构件的第一通道和第二通道中的一个或多个。
17.根据权利要求16所述的方法,进一步包括:
将韧带插入骨中的骨道中;和
将所述骨科植入物的细长构件的第二端插入骨中的骨道中,使得细长构件填充骨道的大部分,其中韧带牢固地固定在所述细长构件和骨中隧道的内表面之间。
18.根据权利要求16-17中任一项所述的方法,进一步包括:
将骨移植物定位在细长构件的第一通道和第二通道中的一个或多个中。
19.一种用于将骨科植入物固定到骨的方法,所述方法包括:
提供所述骨科植入物;
移除所述骨的一部分以产生空腔;和
将所述骨科植入物插入骨中的所述空腔中,其中所述骨科植入物的整体包括固化的骨刺激材料,并且其中所述骨科植入物在体内被完全吸收,从而使得天然骨结构能够替代所述骨科植入物的结构,使得在所述骨科植入物在体内被吸收之后不留下空隙。
20.根据权利要求19所述的方法,其中所述固化的骨刺激材料包含约20-70干重量百分比量的KH2PO4、10-50干重量百分比量的MgO、含钙化合物、聚乳酸以及磷酸镁或磷酸钾。
21.根据权利要求20所述的方法,其中所述聚乳酸包含聚L-乳酸(PLA)、L/DL聚乳酸(PLDLA)和聚乳酸-聚羟基乙酸共聚物(PLGA)中的一种。
22.根据权利要求20-21中任一项所述的方法,所述固化的骨刺激材料还包括生物活性治疗剂。
23.根据权利要求22所述的方法,其中所述生物活性治疗剂包括丁胺卡那霉素、丁酰苷菌素、双脱氧卡那霉素、福堤霉素、庆大霉素、卡那霉素、利维霉素、新霉素、奈替米星、核糖霉素、小诺霉素、昔尔杜霉素及其差向异构体、西索米星、山梨醇菌素、奇霉素和妥布霉素中的一种。
24.根据权利要求20-23中任一项所述的方法,其中所述固化的骨刺激性材料进一步包含糖,且其中所述糖包含糖醇、糖酸、氨基糖、糖聚合物糖胺聚糖、糖脂、糖替代物及其组合中的一种。
25.根据权利要求19-24中任一项所述的方法,其中所述骨科植入物包括:
细长构件,所述细长构件具有第一端和与所述第一端相对的第二端,其中所述细长构件在所述第二端处呈锥形,使得所述第二端的宽度小于所述第一端的宽度;
第一通道,所述第一通道定位在所述细长构件的第一侧上并且从所述第一端延伸到所述第二端;
第二通道,所述第二通道定位在所述细长构件的第二侧上并且从所述第一端延伸到所述第二端;和
一个或多个通孔,所述一个或多个通孔将所述第一通道连接到所述第二通道。
26.根据权利要求19-24中任一项所述的方法,其中所述骨科植入物包括销钉。
27.根据权利要求19-24中任一项所述的方法,其中所述骨科植入物包括楔块。
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US20070050031A1 (en) * | 2005-08-23 | 2007-03-01 | Hamid Khosrowshahi | Spinal implant and implant inserter |
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