CN112601506A - 多孔手术植入物及其制造方法 - Google Patents

多孔手术植入物及其制造方法 Download PDF

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Publication number
CN112601506A
CN112601506A CN201980054933.XA CN201980054933A CN112601506A CN 112601506 A CN112601506 A CN 112601506A CN 201980054933 A CN201980054933 A CN 201980054933A CN 112601506 A CN112601506 A CN 112601506A
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CN
China
Prior art keywords
particles
spinal implant
lateral side
end surface
mold portion
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Pending
Application number
CN201980054933.XA
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English (en)
Inventor
D·L·戴维斯
E·C·兰格
A·J·麦尔肯特
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Warsaw Plastic Surgery Co ltd
Warsaw Orthopedic Inc
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Warsaw Plastic Surgery Co ltd
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Publication of CN112601506A publication Critical patent/CN112601506A/zh
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    • 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
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  • Dispersion Chemistry (AREA)
  • Prostheses (AREA)

Abstract

提供了一种手术植入物和一种用于制造所述手术植入物的方法。所述手术植入物包含结合到其主体部分的上表面和下表面中的各种颗粒。所述颗粒可使用至少一个模具部分经由物理力被按压到所述上表面和所述下表面中。由所述至少一个模具部分施加的所述物理力可使所述上表面和所述下表面变形和/或挤压所述上表面和所述下表面，以使这些表面渗透有所述颗粒。所述颗粒可向所述植入物提供生物可吸收和/或机械增强的特性。

Description

多孔手术植入物及其制造方法
技术领域
本发明的技术大体上涉及一种手术植入物和一种制造结合生物可吸收和/或机械增强的特性的手术植入物的方法，其中结合到手术植入物中的颗粒用于提供生物可吸收和/或机械增强的特性。
背景技术
已在人体内使用手术植入物以帮助修复例如脊柱受损和骨折等解剖缺陷。当使用此类手术植入物时，通常依靠紧固件和/或植入物自身与周围解剖结构的相互作用以将手术植入物保持在体内的适当位置。例如，脊柱植入物可包含用于与周围解剖结构相互作用以将脊柱植入物保持在体内的适当位置的表面结构或表面粗糙部。举例来说，此类表面结构或表面粗糙部可提供脊柱植入物在邻近的椎体之间的椎间隙中的插入且抵抗脊柱植入物在邻近的椎体之间的椎间隙中的迁移。然而，考虑到需要防止手术植入物在体内的迁移，需要另外的不干扰此类植入物插入的方式来防止迁移。
发明内容
本公开的技术大体上涉及一种手术植入物和用于制造手术的方法，所述手术结合由与手术植入物和制造手术植入物的方法的材料不同的一种或多种材料制成的颗粒。
在一个方面中，本公开提供一种形成用于植入到人体内的脊柱植入物的方法，所述方法包含：提供脊柱植入物工件，其具有第一端表面、相对的第二端表面、第一横向侧表面、相对的第二横向侧表面、上表面和下表面；提供至少一个模具部分，其包含被配置成用于接触所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的至少一个的至少一个表面，所述至少一个模具部分的所述至少一个表面包含用于在所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个上对应地产生表面结构的表面结构；将颗粒定位在所述至少一个模具部分的所述至少一个表面与所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个之间；加热所述至少一个模具部分和/或所述脊柱植入物工件；经由所述至少一个模具部分的所述至少一个表面的物理力抵靠所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个按压所述颗粒，以将所述颗粒结合到所述脊柱植入物工件中，使得所述颗粒从所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个延伸到所述脊柱植入物工件中；以及在所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个上形成表面配置，所述表面配置对应于形成在所述至少一个模具部分的所述至少一个表面上的所述表面结构。
在另一方面中，本公开提供一种形成用于植入到人体内的脊柱植入物的方法，所述方法包含：提供脊柱植入物工件，其具有形成在其上的至少一个工作表面；提供至少一个模具部分，其包含被配置成用于接触所述至少一个工作表面的至少一个表面，所述至少一个模具部分的所述至少一个表面包含用于在所述至少一个工作表面上对应地产生表面结构的表面结构；将颗粒定位在所述至少一个模具部分的所述至少一个表面与所述至少一个工作表面之间；加热所述至少一个模具部分和/或所述脊柱植入物工件的所述至少一个工作表面；经由所述至少一个模具部分的所述至少一个表面的物理力抵靠所述至少一个工作表面按压所述颗粒，以将所述颗粒结合到所述脊柱植入物工件中；以及使用所述至少一个模具部分在所述至少一个工作表面上形成表面配置。
在又一方面中，本公开提供一种用于插入到邻近的椎体之间的椎间隙中的脊柱植入物，所述脊柱植入物包含：主体部分，其具有第一端表面、相对的第二端表面、第一横向侧表面、相对的第二横向侧表面、上表面和相对的下表面，所述第一横向侧表面和所述第二横向侧表面在所述第一端表面与所述第二端表面之间延伸，并且所述上表面和所述下表面在所述第一端表面与所述第二端表面之间延伸；其中所述上表面和所述下表面的部分各自包含用于接触所述邻近的椎体中的一个的终板以防止所述脊柱植入物在植入到所述椎间隙中之后迁移的表面结构或表面粗糙部；并且其中所述主体部分包含被物理地迫使进入所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的一个的颗粒，所述颗粒从所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述一个延伸到所述主体部分中，所述颗粒由生物可吸收的材料形成，所述生物可吸收的材料在所述脊柱植入物植入到所述椎间隙中之后提供所述颗粒的吸收。
本公开的一个或多个方面的细节在下面的附图和描述中阐述。本公开中所描述的技术的其它特征、目的和优点将从描述和附图以及从权利要求书中显而易见。
附图说明
图1为示出包含结合有颗粒的脊柱植入物的俯视透视图；
图2为示出用于将颗粒结合在图1的脊柱植入物的部分中的过程的第一部分的代表性侧面正视图；
图3为示出用于将颗粒结合在图1的脊柱植入物的部分中的过程的第二部分的代表性侧面正视图；
图4为示出用于将颗粒结合在图1的脊柱植入物的部分中的过程的第三部分的代表性侧面正视图；
图5为示出图1的脊柱植入物的部分插入到椎间隙中的侧面正视图；
图6为示出在颗粒已被吸收以在植入物中形成空隙之后的植入物的类似于图5的侧面正视图；并且
图7为示出在颗粒已被吸收且骨已形成在植入物中之后的植入物的类似于图5的侧面正视图。
具体实施方式
根据本公开的优选实施例的植入物在图1和4-7中整体上由数字10指示。如图1和4-7中所描绘，植入物10可为椎体间脊柱融合植入物，但本公开不限于此类应用。根据本公开的植入物可在需要具有例如生物可吸收和/或机械增强的特性的植入物的整个身体中使用。如下文所论述，植入物10可结合颗粒以提供生物可吸收和/或机械增强的特性。
如图1中所描绘，植入物10被配置成插入到邻近的椎体之间的椎间隙中。植入物10包含主体部分11，所述主体部分具有第一端表面12和第二端表面14，以及沿着延伸穿过第一端表面12和第二端表面14的第一中心轴线A1的在第一端表面12与第二端表面14之间的长度。此外，植入物10的主体部分11包含第一横向侧表面16和第二横向侧表面18，以及沿着延伸穿过第一横向侧表面16和第二横向侧表面18的第二中心轴线A2的在第一横向侧表面16与第二横向侧表面18之间的长度。
另外，如图1中所描绘，植入物10的主体部分11包含上表面20和下表面22，以及在上表面20与下表面22之间延伸穿过主体部分11的孔口24。孔口24可收纳骨向内生长且可填充有骨生长促进物质以促进此类骨向内生长。
第一端表面12、第二端表面14、第一横向侧表面16、第二横向侧表面18、上表面20和下表面22可包含被平坦化和/或平滑地或明显地轮廓化为具有各种凸部、凹部和/或其它表面结构或表面粗糙部的部分。此外，第一端表面12、第二端表面14、第一横向侧表面16、第二横向侧表面18、上表面20和下表面22可相对于彼此以各种角度布置。这些表面的平坦部、轮廓部、表面结构和/或角度可被配置成与解剖结构互补地介接。
如图1中所描绘，例如，第一端表面12、第一横向侧表面16和第二横向侧表面18具有平坦化表面；第二端表面14具有平滑轮廓化的凸表面；并且上表面20和下表面22具有各种突起部(或表面粗糙部)30。形成在上表面20和下表面22上的突起部30提供植入物10在椎间隙中的插入且抵抗所述植入物在椎间隙中的迁移。因而，考虑到突起部30的定向，所述突起部被定向成使得在插入到椎间隙中期间，第一端表面12为前端且第二端表面14为后端。然而，上表面20和下表面22可包含与突起部30相对地定向的突起部，使得前端和后端颠倒。
如上文所论述，植入物10包含孔口24。孔口24可被设定大小以在其中收纳骨生长促进材料，从而促进穿过邻近的椎体之间的植入物10的骨生长。植入物10可包含穿过第一端表面12、第二端表面14、第一横向侧表面16和第二横向侧表面18形成的额外孔口，并且这些孔口例如可用于促进仪器的附接和/或促进穿过所述孔口的骨生长。举例来说，第一横向侧表面16可包含可在第二横向侧表面18上重复的孔口32，并且第二端表面14可包含也可在第一端表面12上重复的孔口34。
植入物10可由包含金属、聚合物、陶瓷、生物制品和/或其它生物可吸收或非生物可吸收的材料的各种材料形成。这些材料可为多孔的，并且其孔隙率可促进骨向内生长。举例来说，主体部分11可由这些材料中的一种或多种形成，并且这些材料中的不同材料的如图1中所描绘的颗粒40可结合到主体部分11中。例如，颗粒40的大小可为100至1000微米，并且所述颗粒具有均一或不规则的形状。在本公开的优选实施例中，例如，植入物10的主体部分11可由聚醚醚酮(PEEK)形成，并且例如，结合在主体部分11中的颗粒40可由在骨中发现的有机和/或无机矿物形成。颗粒40可为主体部分11提供生物可吸收和/或机械增强的特性。
优选地，可使用物理过程将颗粒40按压到主体部分11的各个表面中，并且颗粒40到主体部分11中的此类浸渗可在形成主体部分的最终形状的大部分(如果不是全部)的模制过程期间和/或之后发生。举例来说，如图2-4中所描绘，模具部分42用于经由物理力将颗粒40按压到最终形成植入物10的主体部分11的工件44中。工件44为呈未完工形式的主体部分11，并且用于物理地迫使颗粒40进入工件44的模具部分42还可用于形成主体部分11的最终形式。在这样做时，模具部分42作用于工件44的上表面46，以通过将颗粒40浸渗进入并穿过上表面46而使上表面46变形和/或挤压所述上表面，且使上表面46变形和/或将所述上表面挤压成由模具42的形状规定的形状。在优选实施例中，经由内部或外部热源加热模具部分42以促进此过程，但在此过程期间也可不加热模具部分42。
如图2-4中所描绘，模具部分42包含至少一个工作表面，所述工作表面包含用于对应地产生形成在主体部分11的上表面20中的突起部30的表面结构48。模具部分42的工作表面还可具备用于在上表面20上对应地产生表面配置/结构的表面结构，所述表面配置/结构包含被平坦化和/或平滑地或明显地轮廓化为具有各种凸部、凹部和/或其它表面结构或表面粗糙部的部分。虽然图2-4中所描绘的模具部分42用于形成上表面20的最终形式(图4)，但可以类似方式使用模具部分42或其它模具以形成主体部分11的各个表面的最终形式。
在使用模具部分42期间，例如，颗粒40可被定位成邻近工件44的上表面46，并且模具部分42与颗粒40和工件44的上表面46接触。因此根据模具部分42的表面结构48的形状而形成上表面46，并且将颗粒按压进入并穿过上表面46以形成主体部分11的上表面20。
工件44可包含可浸渗有颗粒的另外的一个或多个表面。例如，工件44可包含用于在其中收纳颗粒40以形成主体部分11的下表面22的下表面(未展示)。此外，模具部分42的第二部分(未展示)或另外的一个或多个模具(未展示)可用于物理地迫使颗粒40进入工件44的下表面。因而，颗粒40可被定位成邻近工件44的下表面，并且模具部分42的第二部分或另一模具与颗粒40和工件44的下表面接触。因此根据模具部分42的第二部分或另一模具的表面结构(未展示)的形状而形成工件44的下表面，并且将颗粒按压进入并穿过工件44的下表面以形成主体部分11的下表面22。
在另一优选实施例中，可在工件44预成形以形成主体部分11的形状之后使用模具部分42。举例来说，工件44可被加工和/或模制以形成主体部分11的形状，并且此后，模具部分42可用于促进颗粒40浸渗到预成形的工件44中。模具部分42的第二部分(未展示)或另外的一个或多个模具(未展示)可类似地用于将颗粒40浸渗到预成形的工件44的另一表面中。并且在又一优选实施例中，工件44可在进行加工和/或模制以形成形状或主体部分11之前浸渗有颗粒40。
如果形成工件44的材料为例如PEEK的热塑性聚合物，则优选地加热模具部分42或其它上述模具，并且将用于颗粒40的一种或多种材料选择为耐受模具部分42的热。模具部分42可经由向其施加外部热源或内部热源被加热，并且模具部分42的温度应使得在不使工件44熔融的情况下使工件44的PEEK稍微可延展。即，模具部分42可被加热到高于形成工件44的热塑性聚合物的玻璃化转变温度。增加工件44的延展性可使得更易于通过将颗粒40浸渗进入并穿过上表面而使上表面46变形和/或挤压所述上表面，且更易于使上表面46变形和/或将所述上表面挤压成由模具42的形状规定的形状以形成上表面20。另外，工件44和/或颗粒40可在模具部分42或其它上述模具的使用之前被预加热以促进浸渗，并且预加热的工件44和/或预加热的颗粒40可与加热或未加热的模具部分42一起使用。此外，在此类浸渗之后，可经由热处理来处理工件44(或主体部分11)以恢复可能已在浸渗期间失去的机械特性。
如图1中所描绘，结合到主体部分11中的许多颗粒40结合到上表面20中和/或与其连通。如上文所论述，主体部分11的各个表面还可包含类似地放置的颗粒40。如图5-7中所描绘，当将植入物10插入到邻近的椎体之间的椎间隙中时，上表面20与邻近的椎体的上椎体50接触。具体地说，如图6中所描绘，上表面20和结合到上表面20中和/或与其连通的颗粒40与上椎体50的下表面52接触。如果将颗粒40选择为生物可吸收的，则颗粒40由身体吸收。先前由颗粒40填充的因其被吸收而留下的间隙60可为空隙62(图6)或填充有骨64(图7)。不管怎样，空隙62或骨64都可用于防止脊柱植入物10在椎间隙中迁移。举例来说，空隙62允许下表面(或终板)52的骨在其中沉降以防止脊柱植入物10移动，并且骨64用于将植入物10物理地接合到下表面52以防止脊柱植入物10移动。替代地，可在植入之前使用溶解过程以从植入物10去除颗粒44中的至少一些，并且接着可植入所得的至少部分多孔植入物10。此类溶解过程可包含将工件44浸泡在酸硷中以去除颗粒44中的至少一些。
应理解，本文中所公开的各个方面可以与说明书和附图中具体呈现的组合不同的组合进行组合。还应理解，取决于实例，本文中所描述的方法的过程中的任何一个的某些动作或事件可以不同序列执行，可添加、合并或完全忽视(例如，并非所有所描述的动作或事件都是实施所述技术所必需的)。另外，出于清晰的目的，虽然本公开的某一方面被描述为由单个模块或单元执行，但应理解，本公开的技术可由与例如医疗装置相关联的单元或模块的组合执行。

Claims (20)

1.一种形成用于植入到人体内的脊柱植入物的方法，所述方法包括：
提供脊柱植入物工件，其具有第一端表面、相对的第二端表面、第一横向侧表面、相对的第二横向侧表面、上表面和下表面；
提供至少一个模具部分，其包含被配置成用于接触所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的至少一个的至少一个表面，所述至少一个模具部分的所述至少一个表面包含用于在所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个上对应地产生表面结构的表面结构；
将颗粒定位在所述至少一个模具部分的所述至少一个表面与所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个之间；
加热所述至少一个模具部分和/或所述脊柱植入物工件；
经由所述至少一个模具部分的所述至少一个表面的物理力抵靠所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个按压所述颗粒，以将所述颗粒结合到所述脊柱植入物工件中，使得所述颗粒从所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个延伸到所述脊柱植入物工件中；以及
在所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个上形成表面配置，所述表面配置对应于形成在所述至少一个模具部分的所述至少一个表面上的所述表面结构。
2.根据权利要求1所述的方法，其中所述颗粒由生物可吸收的材料形成，所述生物可吸收的材料在所述脊柱植入物植入到所述人体内之后提供所述颗粒的吸收。
3.根据权利要求1所述的方法，其中，在所述颗粒的植入和吸收之后，所述主体部分中先前由所述颗粒占据的间隙为空隙或骨填料。
4.根据权利要求1所述的方法，其中所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述至少一个上的所述表面配置是通过使用所述至少一个模具部分而使所述脊柱植入物工件变形和/或挤压所述脊柱植入物工件形成的。
5.根据权利要求1所述的方法，其中所述脊柱植入物的所述颗粒由在骨中发现的有机和无机矿物中的至少一种形成。
6.根据权利要求5所述的方法，其中所述颗粒的大小为100至1000微米。
7.根据权利要求6所述的方法，其中所述颗粒具有均一或不规则的形状。
8.根据权利要求7所述的方法，其中所述脊柱植入物的所述主体部分由金属、聚合物、陶瓷、生物制品和/或其它生物可吸收或非生物可吸收的材料中的至少一种形成。
9.一种形成用于植入到人体内的脊柱植入物的方法，所述方法包括：
提供脊柱植入物工件，其具有形成在其上的至少一个工作表面；
提供至少一个模具部分，其包含被配置成用于接触所述至少一个工作表面的至少一个表面，所述至少一个模具部分的所述至少一个表面包含用于在所述至少一个工作表面上对应地产生表面结构的表面结构；
将颗粒定位在所述至少一个模具部分的所述至少一个表面与所述至少一个工作表面之间；
加热所述至少一个模具部分和/或所述脊柱植入物工件的所述至少一个工作表面；
经由所述至少一个模具部分的所述至少一个表面的物理力抵靠所述至少一个工作表面按压所述颗粒，以将所述颗粒结合到所述脊柱植入物工件中；以及
使用所述至少一个模具部分在所述至少一个工作表面上形成表面配置。
10.根据权利要求9所述的方法，其中所述颗粒由生物可吸收的材料形成，所述生物可吸收的材料在所述脊柱植入物植入到所述人体内之后提供所述颗粒的吸收。
11.根据权利要求10所述的方法，其中所述颗粒的大小为100至1000微米。
12.根据权利要求11所述的方法，其中所述颗粒具有均一或不规则的形状。
13.一种用于插入到邻近的椎体之间的椎间隙中的脊柱植入物，所述脊柱植入物包括：
主体部分，其具有第一端表面、相对的第二端表面、第一横向侧表面、相对的第二横向侧表面、上表面和相对的下表面，所述第一横向侧表面和所述第二横向侧表面在所述第一端表面与所述第二端表面之间延伸，并且所述上表面和所述下表面在所述第一端表面与所述第二端表面之间延伸；
其中所述上表面和所述下表面的部分各自包含用于接触所述邻近的椎体中的一个的终板以防止所述脊柱植入物在植入到所述椎间隙中之后迁移的表面结构或表面粗糙部；并且
其中所述主体部分包含被物理地迫使进入所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的一个的颗粒，所述颗粒从所述第一端表面、所述第二端表面、所述第一横向侧表面、所述第二横向侧表面、所述上表面和所述下表面中的所述一个延伸到所述主体部分中，所述颗粒由生物可吸收的材料形成，所述生物可吸收的材料在所述脊柱植入物植入到所述椎间隙中之后提供所述颗粒的吸收。
14.根据权利要求13所述的脊柱植入物，其中，在所述颗粒的植入和吸收之后，所述主体部分中先前由所述颗粒占据的间隙为空隙或骨填料。
15.根据权利要求14所述的脊柱植入物，其中所述颗粒提供在所述主体部分的所述上表面和所述下表面中，所述空隙经由所述颗粒的所述吸收而形成在所述主体部分的所述上表面和所述下表面中，并且所述空隙允许所述邻近的椎骨的终板的骨沉降在所述空隙中。
16.根据权利要求14所述的脊柱植入物，其中所述颗粒提供在所述主体部分的所述上表面和所述下表面中，所述骨填料从所述邻近的椎骨的终板延伸到所述主体部分中，并且所述骨填料用于将所述脊柱植入物物理地接合到所述邻近的椎骨。
17.根据权利要求13所述的脊柱植入物，其中所述脊柱植入物的所述颗粒由在骨中发现的有机和无机矿物中的至少一种形成。
18.根据权利要求17所述的脊柱植入物，其中所述颗粒的大小为100至1000微米。
19.根据权利要求18所述的脊柱植入物，其中所述颗粒具有均一或不规则的。
20.根据权利要求19所述的脊柱植入物，其中所述脊柱植入物的所述主体部分由金属、聚合物、陶瓷、生物制品和/或其它生物可吸收或非生物可吸收的材料中的至少一种形成。
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CA3110159A1 (en) 2020-02-27
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