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CN119097480A - 用于在椎骨之间接合的植入件以及植入件套件 - Google Patents

用于在椎骨之间接合的植入件以及植入件套件 Download PDF

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Publication number
CN119097480A
CN119097480A CN202410728544.3A CN202410728544A CN119097480A CN 119097480 A CN119097480 A CN 119097480A CN 202410728544 A CN202410728544 A CN 202410728544A CN 119097480 A CN119097480 A CN 119097480A
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CN
China
Prior art keywords
implant
abutment surface
end plate
webs
teeth
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.)
Pending
Application number
CN202410728544.3A
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English (en)
Inventor
T·比德尔曼
B·丹内克尔
L·比德尔曼
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biedermann Technologies GmbH and Co KG
Original Assignee
Biedermann Technologies GmbH and Co KG
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biedermann Technologies GmbH and Co KG filed Critical Biedermann Technologies GmbH and Co KG
Publication of CN119097480A publication Critical patent/CN119097480A/zh
Pending legal-status Critical Current

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    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891Plurality of protrusions
    • A61F2002/30892Plurality of protrusions parallel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2002/30904Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves serrated profile, i.e. saw-toothed
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • AHUMAN NECESSITIES
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    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
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    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/3097Designing or manufacturing processes using laser
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/44Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2002/4495Joints for the spine, e.g. vertebrae, spinal discs having a fabric structure, e.g. made from wires or fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0004Rounded shapes, e.g. with rounded corners
    • A61F2230/0008Rounded shapes, e.g. with rounded corners elliptical or oval

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

本申请提供了一种用于在椎骨之间接合的植入件,该植入件包括:整体式本体(10、40、50、50’),该整体式本体包括在第一端(10a、40a、50a)处的第一边缘和在与第一端(10a、40a、50a)相对的第二端(10b、40b、50b)处的第二边缘、在第一边缘和第二边缘之间延伸的外表面(3a),该本体确定了延伸穿过第一端(10a、40a、50a)和第二端(10b、40b、50b)的中心轴线(L)、形成第一边缘的多个齿(6)、设置在离第一边缘或第二边缘一定距离处和基本横过齿(6)延伸的抵靠表面(7a、41、41);其中,抵靠表面(7a,41,51)设置成与椎骨的一部分接合或与端板(20,20’)接合,该端板(20,20’)用于与椎骨接合。本申请还提供了一种用于在椎骨之间接合的植入件套件。

Description

用于在椎骨之间接合的植入件以及植入件套件
技术领域
本发明涉及一种用于在椎骨之间接合的植入件以及一种包括该植入件的植入件套件。特别是,本发明涉及一种植入件,该植入件的类型是要插入在椎骨之间的间隔件。
背景技术
从US 5702451中已知一种特别用于椎间盘的椎骨的空间保持器。该空间保持器包括护套,该护套有孔以及第一边缘和第二边缘。边缘有:周向相邻的凹口,各凹口沿朝向另一边缘的方向延伸;以及止动件,该止动件设置在至少一个边缘处,该止动件与外边缘间隔开。止动件由外轮廓与护套的内轮廓相对应的部件以及用于接合凹口的鼻状凸起形成。护套可以切割成一定长度。
US 7547325 B2介绍了一种用于插入在两个椎骨之间的空间保持器,该空间保持器有可变的轴向长度。空间保持器有套筒状的第一部件以及在该第一部件中引导的第二部件,该第二部件可相对于第一部件沿轴向方向运动,用于调节总长度。
上述类型的空间保持器或保持器(也称为间隔件)可以用于各种目的,例如用于已移除的一个或多个椎骨的间隔件,或者作为用于椎间盘的间隔件。由于各种可能的临床应用、患者的特定条件以及脊柱(间隔件要在该脊柱上使用)的不同位置,通常需要大量不同尺寸和具有不同特性的间隔件,以便选择合适的植入件。
发明内容
因此,本发明的目的是提供一种用于在椎骨之间接合的植入件和一种植入件套件,该植入件套件能够减少要为手术提供的植入件的库存。
该目的通过根据本申请的植入件和根据本申请的套件来解决。本申请还包括植入件的进一步发展。
根据本发明的方面,一种用于在椎骨之间接合的植入件包括整体式本体,该整体式本体包括在第一端处的第一边缘和在与第一端相对的第二端处的第二边缘、在第一边缘和第二边缘之间延伸的外表面,该本体确定了延伸穿过第一端和第二端的中心轴线、形成第一边缘的多个齿、以及设置在离第一边缘一定距离处并基本横过齿延伸(优选是沿朝向中心轴线的方向)的抵靠表面。抵靠表面设置成与椎骨的一部分接合,或者与用于接合椎骨的端板接合。在还一发展形式中,多个中间抵靠表面沿本体的长度来轴向设置。
植入件可以很容易地切割成所希望的长度。因此,能够在手术之前获得具有所希望长度的植入件,以使得植入件适应椎间空间的尺寸,植入件将布置在该椎间空间中。可选地,植入件能够在一端或两端处与合适的端板组合,例如在它切割后,该端板设置成与椎骨接合。这种端板可以有合适的特性,例如特定尺寸、接合结构或脊柱前凸角度。优选是,在两端处的端板能够与植入件本体可拆卸地连接。
植入件的网状结构可以促进组织和血管的向内生长。
根据还一方面,植入件是长度可调节的植入件,它包括:第一管状部件和第二管状部件,该第二管状部件可运动地定位在第一管状部件中;以及长度调节结构,用于调节第二管状部件相对于第一管状部件的轴向位置。至少第二管状部件是整体式本体,它包括在第一端处的第一边缘和在与第一端相对的第二端处的第二边缘、在第一边缘和第二边缘之间延伸的外表面,该本体确定延伸穿过第一端和第二端的中心轴线、形成第一边缘的多个齿、以及设置在离第一边缘一定距离处并基本横过齿朝向中心纵向轴线延伸的抵靠表面。
利用长度可调节的植入件,植入件的长度能够以小步长或准无级(quasi-stepless)的方式来调节。端板可以根据实际临床应用的要求来选择。在还一发展形式中,第二管状部件可以另外切割成一定长度,使得提供甚至更多的可变性。
长度调节结构能够使用在接合的倾斜表面之间的摩擦来锁定第二管状部件相对于第一管状部件的位置。因此,轴向位置能够利用器械而很容易地固定和释放。
而且,根据另一方面,提供了一种套件,它包括:第一植入件,该第一植入件设置为切割成一定长度;以及第二植入件,该第二植入件的长度可调节,优选是可逆地调节,该套件还可选地包括端板,该端板设置成可拆卸地安装在第一植入件或第二植入件上。可以提供用于各种目的的其它端板。
因此,该套件提供了模块化系统,该模块化系统能够包括多个植入件,这些植入件有从几个部件中选择的不同性质。这有助于医院节约成本。
根据还一方面,植入件利用增材制造技术来制造,例如激光烧结、激光熔化、电子束熔化、熔融沉积模制(FDM)等。利用这种技术,能够制造来自CAD数据的任何三维形状,特别是不能或几乎不能用减材方法制造的任何复杂形状。能够根据特定患者应用的需要来进行制造。
附图说明
由通过附图对实施例的说明,将清楚其他特征和优点。附图中:
图1:表示了根据第一实施例的植入件的透视图。
图2:表示了图1的植入件切割成所希望的长度和其它切割选项的透视图。
图3:表示了图1或图2的植入件的透视分解图,其中有能够可拆卸地安装在植入件上的端板。
图4:表示了处于装配状态的图3的植入件。
图5:表示了图1的植入件从顶部看的透视图。
图6:表示了图5的植入件从底部看的透视图。
图7:表示了图5和6的植入件的侧视图。
图8:表示了图5至7的植入件的俯视图。
图9:表示了图3和4的植入件的第一端板从顶部看的透视图,该第一端板设置成与植入件的第一端连接。
图10:表示了图9的端板从底部看的透视图。
图11:表示了图9和10的端板的俯视图。
图12:表示了图9至11的端板的侧视图。
图13:表示了图3和4中所示的第二端板从顶部看的透视图,该第二端板设置成与植入件的第二端连接。
图14:表示了图13的第二端板从底部看的透视图。
图15:表示了图13和14的第二端板的俯视图。
图16:表示了图13至15的第二端板的侧视图。
图17:表示了根据第二实施例的植入件的透视分解图。
图18:表示了图17的植入件处于装配状态的透视图。
图19:表示了图17和18的植入件的剖视图,该剖视图在包括植入件的纵向轴线并沿周向方向延伸穿过长度调节机构的中心的平面截取。
图20:表示了根据图17至19的植入件的长度调节机构的驱动部件从前部看的透视图。
图21:表示了图20的驱动部件的后视图。
图22:表示了图20和21的驱动部件的侧视图。
图23:表示了根据图17至19的植入件的长度调节机构的锁定部件从前部看的透视图。
图24:表示了图23的锁定部件从后部看的透视图。
图25:表示了图23和24的锁定部件的剖视图。
图26:表示了图17至19中所示的植入件的另一端板从底部看的透视图。
图27:表示了图26的端板从顶部看的透视图。
图28表示了图26和27的端板的俯视图
图29:表示了图26至28中所示的端板的侧视图。
图30:表示了根据还一实施例的、图17和19的植入件的管状部件的透视图。
图31:表示了图30的管状部件切割成一定长度的透视图。
图32:表示了包括根据第一实施例和根据第二实施例的植入件的套件的透视图。
具体实施方式
参考图1至8,根据第一实施例的植入件1包括整体式植入件本体10以及可选的第一端板20和第二端板30。植入件本体10可以形成为管状网。它有第一端10a和相对的第二端10b,并确定延伸穿过第一端10a和第二端10b的中心轴线L。在所示实施例中,中心轴线L也是细长本体的纵向轴线。与植入件本体10的中心轴线L垂直的外包封部可以是圆柱形、椭圆形或肾形,或者可以有适合布置在椎骨之间的任何其他形状。网包括孔2,该孔2沿周向方向以规则距离形成在外表面3a和内表面3b之间(图8)。孔2可以是菱形,并可以有平行于植入件本体10的中心轴线L延伸的纵向对角线。各孔2相对于菱形的纵向对角线镜像对称。沿轴向方向相邻行2a、2b的孔2可以相互偏移孔2的轴向高度的一半。这样,网格形成为具有腹板4a、4b,该腹板4a、4b以锐角相交,并与孔2的纵向对角线形成相等角度。沿周向方向,在各行中可以有相等数量的孔2。孔2和腹板4a、4b的尺寸使得在一行中有整数个孔2。
腹板4a、4b形成在第一端处的第一边缘5a和在第二端10b处的第二边缘5b。通过相交的腹板4a、4b,边缘5a包括齿6,该齿6布置成环绕中心轴线L的环。齿6的自由端可以位于与中心轴线L垂直的平面内。因此,齿6的自由端分别形成本体的第一端10a和第二端10b。应当注意,在所示实施例中,齿的环6是圆形,因为本体10具有圆柱形外部形状。不过,环可以有适合于本体外部形状的任何其他形状。在变化实施例中,齿的自由端可以布置在与本体的纵向轴线L成角度的平面中。
第一抵靠表面7a或止动件形成在离第一端10a一定距离处。第一抵靠表面7a用作端板20的支承件,该端板20将在第一端10a处与植入件本体连接。更详细地,第一抵靠表面7a在基本垂直于中心轴线L的平面中延伸,并可以是基本平坦。齿6沿轴向方向从第一抵靠表面7a凸出。第一抵靠表面7a包括多个径向延伸的腹板8,该腹板8从同轴内环9延伸直到齿6。因此,腹板8的宽度从内环9径向向外增加。腹板8相对于齿6以交替方式布置,即,腹板8的径向外端终止于在连续齿6之间的间隙中的内表面3b处。因此,腹板8的数量对应于孔2的数量。沿周向方向,在腹板8之间有间隙8a。环9和腹板8具有沿轴向方向的一定厚度,该厚度可以是孔2的高度的大约四分之一。
最后,在与环9相邻的各腹板8中有沿两个方向(即指向第一端10a和指向第二端10b)的尖状物800。该尖状物800的高度可以小于齿6的高度。
在第二端10b处有第二抵靠表面7b,该第二抵靠表面7b与第一抵靠表面7a相同,并设置在离齿6的自由端一定距离处。
与第一抵靠表面7a和第二抵靠表面7b相同的多个中间抵靠表面7形成在本体10内的等距轴向位置处,优选是在一行网状结构的轴向高度的一半的距离处。更详细地,另外的抵靠表面7设置在这样的位置处,使得通过在垂直于中心轴线L的平面中和在孔2沿轴向方向的中心处将植入件本体10切割成所希望的长度,从而提供了植入件本体,该植入件本体缩短了一个网行的轴向长度的一半(包括孔2的一半)的倍数。因此确定了切割段,如图2所示。各中间抵靠表面7可以在切割后形成第一抵靠表面7a,或者当植入件本体从第二端10b缩短时形成第二抵靠表面7b。而且,植入件本体在它上下倒置时具有相同的形状。在切割前,齿6的位置沿周向方向偏离相邻段的齿6的位置。
利用抵靠表面7a、7、7b的结构,纵向槽道由在腹板8之间的间隙8a以及在环9之间的周向槽道而形成。这可以提高植入件本体10的稳定性。
植入件本体10优选是使用增材制造方法来制造。在增材制造方法中,植入件本体基于表征植入件本体的形状和尺寸的三维数据而逐层构建。作为示例,基于粉末床的层制造技术(例如选择性激光熔化(SLM))包括以下步骤:将一层构建材料(例如粉末,特别是金属粉末或塑料粉末)施加到支承表面上,并在与植入件本体在相应层中的横截面相对应的位置处选择地固化或熔化粉末。随后,施加和熔化植入件本体的其它层的步骤重复进行,直到植入件本体完成。植入件本体在相应层中的横截面的数据和用于控制层制造装置的数据由植入件本体的CAD或CAM数据和相应的切片数据来产生。特别是,能够构建底切部分和复杂形状。制造的植入件本体可以显示制造方法的特性,例如稍微粗糙的表面或者在精细制备的切口部分中的激光轨迹。因此,可以识别制造方法。也可以考虑其他增材制造方法,例如电子束熔化、FDM(熔融沉积模制)等。
还参考图9至12,第一端板20或顶部端板设置成与植入件本体10的第一端10a连接。第一端板20是基本平坦的管状板形部件,具有设置成与椎骨(特别是椎体)接合的外表面20a和设置成与植入件本体10接合的相对内表面20b。如图11所示,在俯视图中,端板20的外轮廓可以是基本四边形,它的宽度大于植入件本体10的最大外宽度。不过,端板10的形状能够是适合与椎骨接合的任何形状和/或尺寸。端板20的管的内表面形成环21,该环21可以有比植入件本体的环9稍微更小的直径。凸起22沿轴向方向从环21伸出。凸起可以偏移180°,并设置成沿植入件本体10的环9的内表面滑动。凸起22可以有圆柱壁的一部分的形状。当端板20安装在植入件本体10上时,它们可以用于使端板20定心。提供了多个径向延伸的腹板23,这些腹板23从环21径向向外延伸。在腹板23之间形成间隙24或开口,该间隙24或开口用于接收植入件本体10的齿6的端部部分。因此,腹板23的数量对应于植入件本体的齿6的数量。每个间隙24有与齿6的位置相对应的径向外端部分25。更详细地,端部部分25的形状可以适应齿6的端部部分的形状,以使得它们可以以形状配合的方式容纳于其中。特别是,端部部分25的侧壁可以以网的腹板4a、4b相交的角度来倾斜。
当端板20安装到植入件本体10的第一端10a上时,端板20的腹板23抵靠形成植入件本体10的第一抵靠表面7a的腹板8。凸起22沿径向方向抵靠植入件本体10的环9的内表面。齿6延伸到在腹板23之间的间隙24的端部部分25中。
第一端板20可以有楔形形状,以便提供脊柱前凸角度。如在图12中特别可见,端板20在相对于中心轴线L的第一侧26a处更厚(与相对侧26b相比)。可以提供具有不同角度的各种端板20,以便产生模块化系统。而且,在腹板23的径向外侧部分处的外表面20a上和从间隙24的端部部分25径向向外的外表面20a上,可以分别提供尖状物27,该尖状物27形成环绕中心轴线L的环。尖状物27可以用于与椎骨接合。它们可以有与腹板23大致相同的宽度,或者可以有比腹板23稍微更小的宽度。
下面参考图13至16,第二端板30或底部端板也是基本平坦的管状板部件,具有设置成与椎骨接合的外表面30a和设置成与植入件本体10连接的相对内表面30b。第二端板30的外轮廓可以与第一端板20的外轮廓相同或不同。
第二端板30包括内环31。优选是彼此相对布置的两个凸起32从内表面30b凸出,以使得它们能够在植入件本体10的第二端10b处与第二抵靠表面7b的内环9接合和沿该内环9滑动。因此,与环9的内径相比,内环32的内表面有稍微更小的内径。多个腹板33从内环32径向向外延伸。因此,腹板33沿周向方向的宽度在邻近内环32处较小,并径向向外增加。腹板33的数量和位置对应于在植入件本体10的第二抵靠表面7b处的腹板8的数量和位置。在腹板33之间设置有间隙34或开口,各间隙34或开口在径向外端处有周向加宽部分35,用于接收植入件本体10的第二边缘7b的齿6。加宽部分35的相对侧35a可以有与齿6的倾斜度相对应的倾斜度,以使得齿6的端部部分能够匹配地接收在该加宽部分35中。
在外表面30a上在腹板33的径向外部位置处设置有与第一端板20的尖状物27类似的尖状物37,该尖状物37用于与椎骨接合。因此,尖状物37布置在环上,并可以有比腹板33的径向外部宽度更小的宽度。
如特别在图16中可见,第二端板30还可以包括脊柱前凸角,使得第二端板30的厚度在距中心轴线L的一侧36a处比在相对侧36b处更大。不同的第二端板可以设置有用于与椎骨接合的不同脊柱前凸角度和/或不同尺寸和/或不同接合特征。这样,可以提供模块化系统,该模块化系统只包括一个植入件本体和多个第一端板和第二端板,该第一端板和第二端板能够与植入件本体组合成植入件,用于接合在两个椎体之间。
优选是,第一端板20和第二端板30也通过如上所述的增材制造方法来制造。
植入件本体以及第一端板和第二端板可以由任何可生物相容材料来制造,不过优选是由钛或不锈钢或任何其他可生物相容金属或金属合金或塑料材料来制造。作为可生物相容合金,可以使用NiTi合金,例如镍钛诺。其他材料也能够是镁或镁合金。使用的可生物相容塑料材料可以是例如聚醚醚酮(PEEK)或聚-L-丙交酯酸(PLLA)。端板和植入件本体可以由相同材料制造,或者可以由不同材料制造。
在使用中,首先,植入件本体10以最初提供的长度使用,并与任何合适的第一端板20和/或第二端板30组合。可选地,植入件本体10可以在预定位置处切割成所希望的长度,以便提供与原始植入件本体相比具有相同形状但不同长度的植入件本体。然后,缩短的植入件本体与任何合适的端板组合,以便提供要布置在椎骨之间的植入件。端板20、30分别插在植入件本体的第一端10a和第二端10b上。缩短的植入件本体可以有齿,该齿与切除段的齿偏移,但是该缩短的植入件本体由于它的对称性而能够旋转,用于与第一端板20连接。第一端板20在加宽部分25中接收第一端10a的齿6。第二端板30在孔35的加宽部分35a中接收第二端10b的齿6。因此,端板相对于植入件本体旋转固定。当植入件1插入两个椎骨之间时,椎骨在端板上的压力将端板保持成牢固地固定在植入件本体上。
如图17至19所示,用于接合在两个椎骨之间的植入件100的第二实施例包括整体式第一管状本体40和整体式第二管状本体50,该整体式第二管状本体50可定位在第一管状本体40中,并沿轴向方向可相对于第一管状本体40运动。第一管状本体40和第二管状本体50通过长度调节结构60而彼此连接。长度调节结构60包括设置在第二管状部件50处的前进结构70和设置在第一管状部件40处的驱动部件80。应当注意,第一管状部件40和第二管状部件以及长度调节结构的部分优选是利用如上所述的增材制造方法来制造。长度调节结构能够很容易地集成在整体式部件中。另外,设置了锁定部件85,该锁定部件85设置成锁定第二管状部件50相对于第一管状部件40的轴向位置。第二端板30与第一实施例相同,并设置成与第一管状部件40连接。另外,设置了变化的第一端板20’,该第一端板20’设置成与第二管状部件50连接。
特别如图17和18所示,第一管状部件40是网状笼,它包括第一端40a、相对的第二端40b和由多个孔2(优选是菱形孔2)形成的网格或网。在第二端40b处,边缘包括多个齿6。在离齿6的自由端一定距离处形成抵靠表面41,该抵靠表面41包括内环42和多个腹板43,该腹板43沿径向方向从内环42延伸直到齿6。腹板43可以有朝向第一端40a的平坦表面,并可以有朝向第二端40b的V形径向延伸槽,但是它们也可以是朝向第二端40b平坦的。齿6设置成接收在第二端板30的开口34的加宽部分35中。第二端板30的腹板33设置成当第二端板30安装在第一管状部件40上时抵靠第一管状部件40的腹板43。
在第一管状部件40中在第二端40b上方的位置处设置有管状部分44,该管状部分44的管轴线t基本垂直于中心轴线L。管状部分44包括内螺纹45,该内螺纹45设置成与锁定部件85配合。管状部分44的轴向延伸部分可以达到第一端40a。
第二管状部件50包括网状笼,该网状笼有第一端50a、相对的第二端50b、与第一管状部件40类似由多个优选为菱形的孔2形成网格或网、以及在第一端50a处形成边缘的齿6。在第一端50a处离齿6的自由端一定距离处设置有第一抵靠表面51。类似于第一实施例的植入件本体,抵靠表面51包括内环52和径向延伸的腹板53,该腹板53位于与齿6相对应的位置处。在径向延伸的腹板53之间设置有间隙54。
基本U形部分56从第二端50b延伸直到在抵靠表面52处在齿6之间的间隙。U形部分56朝向第二端50b开口。沿垂直于中心轴线L的方向,U形部分56延伸到第二管状部件50的内部空心空间中,在U形部分56的一侧处形成前进结构70,该前进结构70设置成接合驱动部件80。前进结构70可以是例如棘齿结构或齿条。齿条的齿71布置成沿轴向方向一个接一个。当第二管状部件50插入第一管状部件40中,且U形部分56与第一管状部件40的管状部分44对齐时,U形部分56抵靠管状部分44的后侧。
如在图20至25中另外可见,长度调节结构60还包括驱动部件80和锁定部件85。驱动部件80包括在其后侧的小齿轮部分81,该小齿轮部分81设置成插入第一管状部件40中。小齿轮部分包括齿81a,该齿81a设置成在第二管状部件40处接合前进结构70的齿条。在小齿轮部分81附近形成有圆锥形部分82,其中,该圆锥形部分82沿离开小齿轮部分81的方向逐渐变细。在驱动部件80的前端处形成用于与工具(未示出)接合的凹口83,该工具用于旋转驱动部件80。
锁定部件85是具有外螺纹87的螺钉部件,该外螺纹87设置成与第一管状部件40的管状部分44的内螺纹45配合。在装配状态下,锁定部件85的后侧85a定向成朝向第二管状部件50,它的前侧85b定向成朝向第一管状部件40的外侧。而且,锁定部件85包括圆锥形通孔86,该圆锥形通孔86与螺纹同轴地延伸,使得它从后侧85a向前侧85b成圆锥形地逐渐缩小。圆锥形通孔86设置成接收驱动部件80的圆锥形部分82。而且,锁定部件85包括在前侧的径向延伸凹口88,用于与工具接合,该工具用于使锁定部件85在管状部分44中来回旋拧。
在装配状态下,锁定部件85位于第一管状部件40的管状部分44内,且驱动部件80布置成使得圆锥形部分82位于锁定部件85的圆锥形通孔86中,而小齿轮部分81与在第二管状部件50处的齿条接合。第二管状部件50可以插入到第一管状部件40中,以使得驱动部件80的小齿轮部分81处于最上侧位置,即靠近倒U形部分56的底部。通过与工具接合来旋转驱动部件80将使得第二管状部件50移出第一管状部件40至所希望的程度。第二管状部件50与第一管状部件40的相对位置能够通过将锁定部件85更深地拧入管状部分44中而锁定,使得驱动部件80的圆锥形部分82的圆锥形表面和锁定部件85的圆锥形通孔86的圆锥形表面接合,并通过摩擦而锁定驱动部件80,从而使驱动部件80不能进一步旋转。锁定能够通过沿相反方向旋转锁定部件85而释放。
第三端板20’设置成与第二管状部件的第一端50a接合。如图26至29所示,第三端板20’类似于第一端板20,相同或高度相似的部件用相同参考标号来标记,且不再重复它们的说明。第三端板20’可以有在外表面20a和内表面20b之间的通孔25,该通孔25布置在腹板23的径向外端处且与尖状物27相邻。通孔25用于接收第二管状部件50的齿6的一部分,因为第二管状部件50的抵靠表面51的腹板53处于与齿6相同的周向位置。在内侧20b处,圆形台阶28可以形成在从通孔25径向向外的位置处。第三端板20’可附接在第二管状部件50上,以使得齿6延伸到通孔25中。
第二端板30与第一实施例的第二端板30相同。
参考图30和图31,在第二实施例的变化形式中,第二管状部件50’可以切割成所希望的长度。为此,中间抵靠表面90形成在离第一端50a一定距离处,并在这样的位置,当在包括孔2的最大宽度的平面中切割第二管状部件50’时,中间抵靠表面90成为第一抵靠表面,如图31中详细可见。因此,能够如图所示切除第二管状部件50’的一部分,以使得中间抵靠表面90成为第一抵靠表面。当第二管状部件足够长时,可以设置多个中间抵靠表面90。第二管状部件50’可以与第三端板20’一起使用。当上部段切除时,剩余第二管状部件50’的齿6与切割之前的齿6偏离。因此,如在第一实施例中,中间抵靠表面90的齿6能够与在第三端板20’的腹板23之间的间隙24接合。
图32表示了植入件和端板的套件,它包括根据第一实施例的植入件10和根据第二实施例的植入件100,它们能够以可互换的方式与相同的第二端板或底部端板30一起使用。
可以设想上述实施例的变化形式。例如,孔可以有与菱形不同的形状。端板可以有另一形状,例如它们可以有圆形形状、椭圆形形状、肾形形状等。

Claims (15)

1.一种用于在椎骨之间接合的植入件,所述植入件包括:
整体式的本体(10、40、50、50’),所述整体式的本体(10、40、50、50’)包括在第一端(10a、40a、50a)处的第一边缘和在与第一端(10a、40a、50a)相对的第二端(10b、40b、50b)处的第二边缘、在第一边缘和第二边缘之间延伸的外表面(3a),所述本体确定延伸穿过第一端(10a、40a、50a)和第二端(10b、40b、50b)的中心轴线(L),
多个齿(6),所述齿(6)形成第一边缘,
抵靠表面(7a、41、51),所述抵靠表面(7a、41、51)设置在沿轴向方向离第一边缘或离第二边缘一定距离处,以使得齿(6)在抵靠表面上方凸出,所述抵靠表面大致横过齿(6)延伸;
其中,抵靠表面(7a、41、51)设置成与椎骨的一部分接合或与用于接合椎骨的端板(20、20’)接合。
2.根据权利要求1所述的植入件,其中:抵靠表面(7a、51)包括相对于中心轴线(L)径向延伸的多个腹板(8、43、53),所述多个腹板(8、43、53)沿周向方向彼此间隔开。
3.根据权利要求1或2所述的植入件,其中:在第一端(10a)处的抵靠表面是第一抵靠表面(7a),第二抵靠表面(7b)设置在离第二边缘一距离处,所述第二抵靠表面(7b)大致横过齿(6)延伸,优选是,第二抵靠表面(7b)包括相对于中心轴线(L)径向延伸的多个腹板(8),所述多个腹板(8)沿周向方向彼此间隔开,所述第二抵靠表面(7b)设置成与椎骨的一部分接合或与用于接合椎骨的端板接合。
4.根据权利要求1至3中任意一项所述的植入件,其中:至少一个另外的中间抵靠表面(7、90),优选是多个另外的抵靠表面沿轴向方向设置在第一端(10a、50a)和第二端(10b、50b)之间,优选是设置在相等距离处,且优选是,所述中间抵靠表面(7、90)与在第一端(10a、50a)处的抵靠表面(7a)相同。
5.根据权利要求1至4中任意一项所述的植入件,其中:本体(10、40、50、50’)包括具有多个孔(2)的网状结构,所述孔的一部分开口于第一端(10a、40a、50a)和/或第二端(10b、40b、50b),从而形成齿(6),优选是,孔(2)为菱形,具有平行于中心轴线(L)延伸的对角线。
6.根据权利要求4或5所述的植入件,其中:本体(10、50’)设置成在中间抵靠表面(7、90)之间在轴向位置处切割成一长度,以使得在切割的本体上方的一个特定中间抵靠表面在切割后形成在第一端(10a、50a)处的第一抵靠表面(7a、51)。
7.根据权利要求1至6中任意一项所述的植入件,其中:本体(10、40、50、50’)的形状是管状,第一抵靠表面(7a、41、51)沿从外表面(3a)径向向内的方向延伸。
8.根据权利要求1至7中任意一项所述的植入件,还包括:至少第一端板(20、20’),所述第一端板(20、20’)设置成与第一端(10a、50a)可拆卸地连接,其中,所述第一端板(20、20’)包括内表面(20b)和相对的外表面(20a),所述内表面(20b)设置成与本体的第一端连接,所述外表面(20a)设置成与椎骨接合,内表面(20b)设置成抵靠本体的第一抵靠表面(7a、51),多个孔(25、25’)设置在第一端板(20、20’)中,齿(6)能够接合在所述孔(25、25’)中,以便使第一端板(20、20’)与本体连接。
9.根据权利要求8所述的植入件,其中:内表面包括多个径向延伸的腹板(23,25’),所述孔(25’)形成在腹板中。
10.根据权利要求1至9中任意一项所述的植入件,还包括:至少第二端板(30),所述第二端板(30)设置成与第二端(10b、40b)可拆卸地连接,其中,第二端板(30)包括内表面(30b)和外表面(30a),所述内表面(30b)设置成与本体(10、40)的第二端(10b、40b)连接,所述外表面(30a)设置成与椎骨接合,多个孔(34、35、35a)设置在第二端板(30)中,在第二端(10b、40b)处的齿(6)能够接合在所述孔(34、35、35a)中,以便使第二端板与本体连接。
11.根据权利要求10所述的植入件,其中:第二端板(30)包括多个径向延伸的腹板(33),优选是,沿周向方向在腹板之间的空间(34)确定了孔。
12.根据权利要求1至11中任意一项所述的植入件,其中:本体形成为第一管状部件(40),设置第二管状部件(50),所述第二管状部件(50)确定另一本体,并能够可运动地定位在第一管状部件中,设置有长度调节结构(60),所述长度调节结构用于调节第二管状部件(50)相对于第一管状部件(40)的轴向位置,优选是,第二管状部件(50’)设置为切割成一长度。
13.根据权利要求12所述的植入件,其中:第一管状部件(40)或第二管状部件(50)包括驱动部件(80),第二管状部件(50)或第一管状部件(40)相应地包括前进结构(70),驱动部件(80)设置成接合在所述前进结构中,使得当驱动部件(80)被促动时,第二管状部件(50)相对于第一管状部件(40)轴向运动。
14.根据权利要求13所述的植入件,其中:长度调节结构(60)还包括锁定部件(85),用于锁定驱动部件(80)以固定植入件的轴向长度,优选是,锁定部件(85)和驱动部件(80)设置成通过倾斜表面而彼此接合,以便通过摩擦来锁定驱动部件(80)的位置。
15.一种用于在椎骨之间接合的植入件套件,所述植入件套件包括:
第一植入件(10),所述第一植入件(10)设置为切割成一长度;
第二植入件(100),所述第二植入件(100)的长度能够可逆地调节,优选是可逆地调节;以及可选的端板(30),所述端板(30)设置成能够可拆卸地安装在第一植入件(10)或第二植入件(10)上,优选是,第一植入件是根据权利要求1至11中任意一项所述的植入件,第二植入件是根据权利要求12至14所述的植入件。
CN202410728544.3A 2023-06-07 2024-06-06 用于在椎骨之间接合的植入件以及植入件套件 Pending CN119097480A (zh)

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