CN102985021A - 髓内钉 - Google Patents

髓内钉 Download PDF

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Publication number
CN102985021A
CN102985021A CN2011800339585A CN201180033958A CN102985021A CN 102985021 A CN102985021 A CN 102985021A CN 2011800339585 A CN2011800339585 A CN 2011800339585A CN 201180033958 A CN201180033958 A CN 201180033958A CN 102985021 A CN102985021 A CN 102985021A
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CN
China
Prior art keywords
insert
cavity
intramedullary pin
lock hole
intramedullary
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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.)
Granted
Application number
CN2011800339585A
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English (en)
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CN102985021B (zh
Inventor
T·奥韦雷斯
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AO Technology AG
Synthes GmbH
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Synthes AG Chur
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Publication of CN102985021A publication Critical patent/CN102985021A/zh
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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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    • 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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Abstract

本申请公开了一种髓内装置，包括髓内钉（9），该髓内钉沿纵向轴线从近端延伸至远端，髓内钉的近侧部分包括：空腔（14），该空腔从在近端处的开口沿纵向轴线延伸；以及锁定孔（15），该锁定孔横向穿过钉延伸；该髓内钉还包括：第一插入件（2），该第一插入件的尺寸和形状设置成沿纵向轴线插入空腔中，并包括横向孔（20），该横向孔与锁定孔对齐；以及第二插入件（3），用于在第一插入件的近侧与空腔的内表面接合，以便将第一插入件保持在空腔内，并包括纵向穿过延伸的中心孔（30），用于与插入仪器连接。

Description

髓内钉
优先权
本申请要求美国临时专利申请No.61/362937的优先权，该美国临时专利申请No.61/362937的申请日为2010年7月9日，标题为“Intramedullary Nail”，该文献的全部内容结合在本申请中，作为参考。
技术领域
本发明通常涉及一种用于固定骨折骨的髓内钉，更特别是涉及一种髓内钉，该髓内钉包括用于插入仪器的附接结构和用于将锁定螺钉牢固固定在髓内钉上的插入件。
背景技术
髓内钉通常用作用于骨缝合术目的的骨固定装置。通常，这些髓内钉的特征在于横向穿过髓内钉插入的锁定螺钉，用于将髓内钉稳定在骨内或者用于固定各个骨段。这些髓内钉可以允许多个锁定螺钉以相对彼此不同的角度穿过其插入。锁定螺钉通常通过塑料衬套或环而固定在髓内钉中，从而防止螺钉由于微运动或其它负载而移出髓内钉。为了将这些螺钉固定在髓内钉中，通常应用干涉配合和使得螺钉强制攻丝至衬套中。其它固定特征包括金属界面，该金属界面可以机械变形和/或允许在金属中强制攻丝。这些衬套应当由可生物相容的材料形成。不过，这种材料的可用性有限制。一种这样的可用塑料材料是超高分子量聚乙烯（UHMWPE），它是在世界范围内被承认用于植入的材料。尽管这种材料的可生物相容性很理想，但是该材料很难使用普通的处理和模制技术来处理成具有所需精度。
包括横向锁定孔和用于将锁定螺钉固定在这些锁定孔内的插入件的锁定髓内钉的示例由欧洲专利No.B0306709DAUERER已知。这种已知的髓内钉包括具有横向孔的近侧和远侧插入件，该横向孔的直径小于锁定螺钉的外径，以便将锁定螺钉固定在髓内钉的锁定孔中。插入件可滑动地插入髓内钉的中心空腔内。不过，这种已知的髓内钉并不包括在近端处用于将插入仪器固定在钉上的附接结构。
与上述髓内钉相关联的一个问题涉及用于插入手柄或瞄准装置的附接机构，该附接机构通常布置在普通使用的髓内钉的近端处，且插入件必须有较小的外径，以便穿过附接机构的中心开口引入。
因此，还需要一种改进的髓内钉，用于在钉和骨之间刚性固定，该髓内钉包括用于外科手术仪器的附接机构以及插入件，该插入件使得锁定螺钉能够牢固固定在髓内钉的锁定孔中。
发明内容
本发明涉及一种髓内钉，该髓内钉具有用于插入仪器的附接机构和具有横向孔的插入件，该横向孔用于设置成将锁定螺钉牢固固定在髓内钉中。
根据本发明，髓内钉沿纵向轴线从近端延伸至远端，该钉包括：空腔，该空腔从在近端处的开口沿纵向轴线延伸；第一锁定孔，该第一锁定孔横向穿过钉延伸，且尺寸和形状设置成接收穿过的锁定螺钉；第一插入件，该第一插入件的尺寸和形状设置成插入空腔中，并包括第一横向孔，该第一横向孔布置成这样，当第一插入件处于空腔内的所需位置时，第一横向孔与第一锁定孔对齐，以使得穿过第一锁定孔插入的锁定螺钉通过第一横向孔而经过第一插入件；以及第二插入件，该第二插入件的尺寸和形状设置成在插入件近侧锁定地接收于空腔内，以便将插入件锁定在空腔内的所需位置。
根据本发明的髓内钉的一些优点是插入件并不必须通过附接机构（例如在髓内钉近端处的内螺纹）来装配，因此具有增大的直径。此外，由于增大的直径，插入件能够由超高分子量聚乙烯（UHMWPE）通过使用普通的处理和模制技术来制造。而且，由于插入件的增大直径，锁定螺钉能够牢固固定在插入件的横向孔中，因此固定在髓内钉的锁定孔中。
在髓内钉的一个示例实施例中，第一插入件具有外径D，中心孔具有内径d，其中，外径D大于第二插入件的中心孔的内径d。
在髓内钉的还一示例实施例中，第一插入件由超高分子量聚乙烯（UHMWPE）来制造。优选是，第二插入件和髓内钉由TAN来制造。
在髓内钉的另一示例实施例中，第一插入件具有用于防止第一插入件在髓内钉的空腔内旋转的防旋转机构。由于防旋转机构，第一插入件保持相对于髓内钉旋转固定位置，以使得在第一插入件中的横向孔与在髓内钉的近侧部分中的锁定孔对齐。
在髓内钉的再一示例实施例中，第一插入件有多于一个的横向孔。
在髓内钉的还一示例实施例中，在第一插入件中的至少两个横向孔沿不同方向延伸。
在髓内钉的还一示例实施例中，第二插入件通过一个或多个激光焊接部而固定在髓内钉的空腔中。优选是，激光焊接部是周向焊接部。也可选择，激光焊接部是两个较小的纵向激光焊接部。另外，第二插入件能够通过外螺纹或压配合而固定在髓内钉中的空腔内。
在另一示例实施例中，第一插入件具有圆柱形形状。
根据本发明的还一方面，提供了一种组件，该组件包括髓内钉以及一个或多个锁定螺钉，其中，锁定螺钉具有比第一插入件中的横向孔更大的直径。
根据本发明的另一方面，提供了一种根据本发明用于装配髓内钉的方法，该方法包括以下步骤：将第一插入件插入髓内钉的空腔中，该髓内钉沿纵向轴线从近端延伸至远端，并包括第一锁定孔，该第一锁定孔横向穿过该钉延伸，且尺寸和形状设置成接收穿过的锁定螺钉，空腔从在近端处的开口沿纵向轴线延伸，插入件包括第一横向孔，该第一横向孔布置成这样，当插入件处于在空腔内的所需位置时，第一横向孔与第一锁定孔对齐；以及将第二插入件插入髓内钉的空腔中，该第二插入件的尺寸和形状设置成在插入件的近侧锁定地接收于空腔中，以便将插入件锁定在空腔内的所需位置。
附图说明
下面将通过示例参考附图介绍本发明的优选实施例，附图中：
图1表示了根据本发明的髓内钉的示例实施例的分解透视图；
图2表示了图1的髓内钉的实施例的纵向剖面的分解图；
图3表示了图1的髓内钉的实施例在装配状态的纵向剖面；
图4表示了图1的髓内钉的实施例在装配状态的透视图；以及
图5表示了图1的髓内钉的实施例的侧视分解图。
具体实施方式
参考下面的说明和附图可以进一步理解本发明，附图中，相似元件以相同参考标号表示。本发明通常涉及一种用于固定骨折骨的髓内钉，更特别是涉及一种髓内钉，该髓内钉包括用于插入仪器的附接机构和用于将锁定螺钉牢固固定在髓内钉上的插入件。应当知道，这里使用的术语“近侧”和“远侧”将是指朝向（近侧）和远离（远侧）髓内钉的用户的方向。
如图1至5中所示，髓内钉1沿纵向轴线11从近端13延伸至远端，并包括穿过其近侧部分12延伸的空腔14。髓内钉1还包括可穿过空腔14插入的第一插入件2和第二插入件3。髓内钉1包括近侧部分12和远侧部分9，该近侧部分12包括纵向延伸穿过的空腔14以及多个锁定孔15，这些锁定孔15用于接收横向延伸穿过的锁定螺钉。第一插入件2插入空腔14中，第二插入件3在第一插入件2的近侧插入空腔14中。空腔14与纵向轴线11同轴地延伸，并在近端13处开口。空腔14可以包括在近端13处的扩大直径部分，该扩大直径部分包括绕其延伸的内螺纹19，用于与第二插入件3接合。而且，空腔14还可以包括收缩部分，该收缩部分形成轴向止动件16，以便防止第一插入件2越过它向远侧朝着髓内钉1的远侧部分9运动。多个锁定孔15横过纵向轴线11穿过髓内钉1的近侧部分12延伸。各锁定孔15有孔轴线17，并布置成使得各锁定孔15的孔轴线17与髓内钉1的纵向轴线11垂直相交。而且，锁定孔15沿髓内钉1的纵向轴线11相互间隔开。锁定孔15交错地布置，以使得四个锁定孔15的孔轴线17在与髓内钉1的纵向轴线11垂直的截面中看时相对彼此以一定角度延伸。在优选实施例中，髓内钉1包括四个锁定孔15。不过，本领域技术人员应当知道，髓内钉1可以包括任意数目的锁定孔15。
第一插入件2可以有沿中心轴线24从近端21延伸至远端22的圆柱形体27。第一插入件2包括在远端22处的偏心鼻状件25。第一插入件2同轴地定位在空腔14中，并包括横向延伸穿过的多个横向孔20，各横向孔20有孔轴线26。横向孔20布置成使得孔轴线26垂直于中心轴线24延伸，并均等地间隔开和相对彼此等角度延伸，与在髓内钉1的近侧部分12中的锁定孔15的位置相对应。因此，当插入空腔14中时，在第一插入件2中的横向孔20可以准确地与在髓内钉1的近侧部分12中的锁定孔15对齐。
如图3中所示，当第一插入件2插入空腔14中时，偏心鼻状件25与在空腔14中的互补形状偏心部分10接合。因此，偏心鼻状件25和偏心部分10形成防旋转机构6，该防旋转机构6防止第一插入件2相对于髓内钉1中的空腔14旋转。第一插入件2的圆柱形体27还可以包括在偏心鼻状件25近侧的止动面23，用于当第一插入件2完全插入空腔14内时与髓内钉1的空腔14中的轴向止动件16接触。第二插入件3也可以为圆柱形，包括中心孔30。第二插入件3同轴地牢固定位在空腔14中和在第一插入件2的近侧。第二插入件3可以有沿中心孔30内表面的内螺纹31和沿中心孔外表面的外螺纹32，该外螺纹32与空腔14的扩大直径部分的内螺纹19相对应，以使得第二插入件3可以与空腔14螺纹接合。空腔14还包括在其中的凸肩18，该凸肩18在扩大部分的远侧，使得第二插入件3接触凸肩18，并防止第二插入件经过该凸肩向远侧进一步运动到空腔14中。
第一插入件2已经介绍为具有偏心鼻状件25。不过，本领域技术人员应当知道，也能够有其它鼻状件结构。例如，鼻状件可以同心，但是有平的边缘，以便与空腔中的互补形状偏心部分一起提供防旋转机构。在其它示例中，鼻状件的特征可以为具有两个或更多互补边缘，这些互补边缘具有例如2级旋转对称性。
如图2中所示，空腔14的、接收第一插入件2并由轴向止动件16和凸肩18轴向限制的部分具有长度L，该长度L稍微大于第一插入件2的圆柱形体27的长度l2。第二插入件3的中心孔30可以用作固定结构，用于使得插入仪器例如插入手柄和/或瞄准装置与髓内钉1连接。第一插入件2具有外径D，中心孔30具有内径d，其中，插入件2的外径D大于第二插入件3的中心孔30的内径d。因此，一旦第一插入件2完全插入空腔14中，它就在第二插入件3插入时不能轴向移动，而是由第二插入件3保持在空腔14中。
如图4和5中所示，第二插入件3通过纵向激光焊接部5而固定在髓内钉1的空腔14中，该纵向激光焊接部5可以定位在长圆形开口28中，该长圆形开口28穿过髓内钉1的近侧部分12的壁延伸。在一个示例实施例中，髓内钉1包括两个纵向激光焊接部5和两个长圆形开口28，这两个长圆形开口28轴向定位在空腔14中的凸肩18和髓内钉1的近端13之间。而且，两个长圆形开口28具有长轴线，各长轴线平行于髓内钉1的纵向轴线11延伸，且当在垂直于纵向轴线11的截面中看时，两个长圆形开口28布置成相对彼此成一定角度。在另一实施例中，第二插入件3可以在髓内钉1的近端13处在第二插入件3的外表面和在近端13处的扩大直径部分（该扩大直径部分接收第二插入件3）的内部之间例如周向焊接在空腔14上。
而且，在第一插入件2中的横向孔20具有比用于将髓内钉1锁定在骨中的锁定螺钉（未示出）更小的直径。因此，锁定螺钉的螺纹切入限制相应横向孔20的壁中，使得锁定螺钉防松地固定在横向孔20中，因此固定在髓内钉1的锁定孔15内，从而能够使得锁定螺钉刚性固定在髓内钉1中。
尽管已经详细介绍了本发明和它的优点，但是应当知道，在不脱离由附加权利要求确定的本发明精神和范围的情况下能够进行多种变化、代替和改变。而且，本申请的范围并不局限于在说明书中所述的处理、机器、制造、物质组分、装置、方法和步骤的特殊实施例。如本领域普通技术人员由本发明的公开很容易知道，根据本发明可以使用目前已有或以后发展的、实现与这里所述的相应实施例基本相同功能或获得基本相同结果的处理、机器、制造、物质组分、装置、方法或步骤。
本领域技术人员应当知道，在不脱离附加权利要求广义范围的情况下可能对本发明进行多种变化和改变。其中的一些如上面所述，其它为本领域技术人员知道。

Claims (21)

1.一种髓内钉，所述髓内钉沿纵向轴线从近端延伸至远端，包括：
空腔，所述空腔从在近端处的开口沿纵向轴线延伸；
第一锁定孔，所述第一锁定孔横向延伸穿过髓内钉，所述第一锁定孔的尺寸和形状设置成接收穿过的锁定螺钉；
第一插入件，所述第一插入件的尺寸和形状设置成插入空腔中，第一插入件包括第一横向孔，所述第一横向孔布置成使得当第一插入件处于空腔内的所需位置时，第一横向孔与第一锁定孔对齐，以使得穿过第一锁定孔插入的锁定螺钉通过第一横向孔而经过第一插入件；以及
第二插入件，所述第二插入件的尺寸和形状设置成在插入件近侧被锁定地接收于空腔内，以便将插入件锁定在空腔内的所需位置。
2.根据权利要求1所述的髓内钉，其中：第二插入件包括中心孔，所述中心孔有连接机构，所述连接机构设置成锁定地接收要与髓内钉连接的仪器。
3.根据权利要求1所述的髓内钉，其中：第一插入件的外径D大于第二插入件的中心孔的内径d。
4.根据权利要求1所述的髓内钉，其中：第一插入件由超高分子量聚乙烯（UHMWPE）材料来形成。
5.根据权利要求1所述的髓内钉，其中：第一插入件包括这样的部分，所述部分的形状设置成接收于空腔的相应形状部分中，以使得第一插入件不能在空腔中旋转。
6.根据权利要求1所述的髓内钉，其中：髓内钉包括横向延伸穿过的第二锁定孔。
7.根据权利要求5所述的髓内钉，其中：第一锁定孔和第二锁定孔相对彼此成角度地延伸穿过。
8.根据权利要求5所述的髓内钉，其中：第一插入件包括第二横向孔，当第一插入件处于空腔内的所需位置时，所述第二横向孔与第二锁定孔对齐。
9.根据权利要求1所述的髓内钉，其中：第二插入件包括绕它的外表面的外螺纹，所述外螺纹与在空腔近端处的内螺纹接合。
10.根据权利要求1所述的髓内钉，其中：第二插入件通过激光焊接部而固定在髓内钉的空腔中。
11.根据权利要求1所述的髓内钉，其中：空腔包括防止第一插入件经过它向远侧运动的止动件。
12.一种髓内钉系统，包括：
髓内钉，所述髓内钉沿纵向轴线从近端延伸至远端，所述髓内钉包括：
空腔，所述空腔从在近端处的开口沿纵向轴线延伸；
第一锁定孔，所述第一锁定孔横向穿过髓内钉延伸，第一锁定孔的尺寸和形状设置成接收穿过的锁定螺钉；
第一插入件，所述第一插入件的尺寸和形状设置成插入空腔中，第一插入件包括第一横向孔，所述第一横向孔布置成使得当第一插入件处于空腔内的所需位置时，第一横向孔与第一锁定孔对齐；以及
第二插入件，所述第二插入件的尺寸和形状设置成在插入件的近侧锁定地接收于空腔内，以便将插入件锁定在空腔内的所需位置；以及
第一锁定螺钉，所述第一锁定螺钉的尺寸和形状设置成将穿过第一锁定孔插入，从而通过第一锁定孔而穿过第一插入件，所述第一锁定螺钉的直径大于第一插入件的第一横向孔的直径。
13.根据权利要求12所述的髓内钉系统，其中：第二插入件包括中心孔，所述中心孔具有设置成锁定地接收要与髓内钉连接的仪器的连接机构。
14.根据权利要求12所述的髓内钉系统，其中：第一插入件由超高分子量聚乙烯（UHMWPE）材料来形成。
15.根据权利要求12所述的髓内钉系统，其中：第一插入件包括这样的部分，所述部分的形状设置成被接收于空腔的相应形状部分中，以使得插入件不能在其中旋转。
16.根据权利要求12所述的髓内钉系统，其中：髓内钉包括横向延伸穿过的第二锁定孔。
17.根据权利要求16所述的髓内钉系统，其中：第一锁定孔和第二锁定孔相对彼此成角度地延伸穿过。
18.根据权利要求16所述的髓内钉系统，其中：第一插入件包括第二横向孔，当第一插入件处于空腔内的所需位置时，所述第二横向孔与第二锁定孔对齐。
19.根据权利要求16所述的髓内钉系统，还包括：第二锁定螺钉，以便穿过第二锁定孔插入，从而通过第二锁定孔而穿过第一插入件。
20.一种用于装配髓内钉的方法，包括：
将第一插入件插入髓内钉的空腔中，所述髓内钉沿纵向轴线从近端延伸至远端，并包括横向延伸穿过所述髓内钉的第一锁定孔，第一锁定孔的尺寸和形状设置成接收穿过的锁定螺钉，空腔从在近端处的开口沿纵向轴线延伸，第一插入件包括第一横向孔，所述第一横向孔布置成使得当第一插入件处于空腔内的所需位置时，第一横向孔与第一锁定孔对齐；以及
将第二插入件插入髓内钉的空腔中，所述第二插入件的尺寸和形状设置成在插入件的近侧锁定地接收于空腔中，以便将插入件锁定在空腔内的所需位置。
21.根据权利要求20所述的方法，还包括：通过激光焊接部而将第二插入件固定在空腔中。
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