CN1044219A - 口外使用的可植入固定装置 - Google Patents

口外使用的可植入固定装置 Download PDF

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CN1044219A
CN1044219A CN89109214A CN89109214A CN1044219A CN 1044219 A CN1044219 A CN 1044219A CN 89109214 A CN89109214 A CN 89109214A CN 89109214 A CN89109214 A CN 89109214A CN 1044219 A CN1044219 A CN 1044219A
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阿塞尔·基尔施
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IMZ Fertigungs und Vertriebsgesellschaft fuer dentale Technologie mbH
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    • A—HUMAN NECESSITIES
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    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A—HUMAN NECESSITIES
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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
    • A—HUMAN NECESSITIES
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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
    • A61F2/02—Prostheses implantable into the body
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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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/0817—Structure of the anchor
    • A61F2002/0823—Modular anchors comprising a plurality of separate parts
    • A61F2002/0829—Modular anchors comprising a plurality of separate parts without deformation of anchor parts, e.g. fixation screws on bone surface, extending barbs, cams, butterflies, spring-loaded pins
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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
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/0847—Mode of fixation of anchor to tendon or ligament
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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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/08—Muscles; Tendons; Ligaments
    • A61F2/0811—Fixation devices for tendons or ligaments
    • A61F2002/0876—Position of anchor in respect to the bone
    • A61F2002/0888—Anchor in or on a blind hole or on the bone surface without formation of a tunnel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
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    • A61F2002/30079—Properties of materials and coating materials magnetic
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    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract

一种口外使用的可植入固定装置，它具有一基本结构(10)，基本结构(10)可植入骨中，并具有切制或压制螺纹的螺旋(20)以及可与基本结构(10)连接的一个植入柱(30)。

Description

本发明涉及口外使用的可植入固定装置。
多年来，人造韧带的植入已有应用，这种人造韧带联接人类骨胳可以相对活动的部分。当膝关节十字韧带损伤或慢性不稳定时，如果关节内人体固有的改造失败，就可以植入一套合成材料的十字韧带。已经证实一种特殊的聚四氟乙烯适于该目的，其商业名称为GORE-TEX，因为它在生物学方面是惰性的，因而尤其适用于人体。
长期以来，人们假定这种人造韧带的固定装置只起很小的作用，因为随着时间的推移，它们会与内生组织长在一起。但是，人们已经发现，对于植入的十字韧带组的组织反应变化幅度很大。因此，不能假定在所有情况下人造韧带都可以可靠地长入内生组织（Ruston    N.Dandy    DJ.Naylor    CPE.The    Clinical，arthroscopic    and    historical    findings    after    replacement    of    the    anterior    cruciate    ligament    with    carbon-fibre.J.Bone    Joint    Surg（Br）1983：65-B：308-9）。因此，在许多情况下，固定装置必须在长时间内完成其功能以便于能够承受很大的力，甚至一般的运动过程中在膝关节中都会出现这种很大的力。
文献和实践中提供了许多人造韧带的固定方案。除了普通的薛尔曼氏螺旋外，专门的皮质螺旋已经研制出来用于专门的固定环。此外，还采用了里沙尔氏夹，它具有在预先钻孔中可靠固定底座的倒钩。碳纤维聚砜材料制造的系缆柱状的固定装置具有一个裂口柄，靠着敲入一中间销使其裂开。另外，也提出了专门的可植入的固定件并通过套筒结合皮质螺旋的方案（Andrew    A.Amis，The    strength    of    artificial    ligament    anchorages，J.Bone    Joint    Surg.（Br）1988：70-B：397-403）。
前述人造韧带的公知的固定装置要么植入复杂，要么稳定性不够，不能承受例如在膝关节附近可能出现的很大的力而不损伤。因此，固定装置中往往出现永久性变形，甚至断裂，或者对周围骨质产生损伤，不得不进行另外的外科治疗。
但是，口外使用的固定装置不仅应用于人造韧带，而也可应用于其它领域。
当发生严重的烧伤等皮损伤时，为避免感染，必须用适当的材料覆盖受伤部位。由于损伤面对压力和疼痛特别敏感，同时可能在小的表面区域具有显著的可塑性。所以在覆盖材料的迅速、可靠固定时会遇到具体问题。至今为止尚未提出解决这些问题的可行方案。
本发明的目的是提供一种口外使用的迅速、可靠的可移入固定装置，具体来说，该装置是应用于固定人造韧带和损伤面的覆盖材料。
按照本发明，上述目的是这样实现的：上述类型的固定装置具有可植入骨中的并具有切削或压制的螺纹的基本结构以及可与该基本结构连接的植入柱。
由于基本结构的切削或压制用螺纹，可在任何骨料中迅速可靠地植入本发明的固定装置。
与公知的固定装置相比具有同等稳定性的情况下，本发明的固定装置的特殊优点在于：作用于人造韧带等被固定物上的力对于被植入的基本结构几乎没有任何作用，而是几乎全部作用在插入基本结构中的植入柱上。如果发生了前面提到的变形和断裂，可以方便迅速地更换植入柱，从而避免了外科治疗。
当用做损伤覆盖材料的固定装置时，按照本发明的基本结构可以特别容易地植入头部区域，因为那里许多地方的骨头直接处于皮下。因此，在植入过程中几乎无需损害肌肉组织。本发明的固定装置可以迅速可靠地装在损坏或损伤区域的周围，然后可用于固定必要的覆盖材料。
按照本发明的固定装置显然并不局限于前面提到的用途，还可以用于将不规则材料固定在骨头上，例如可以用于头发移植。
为了保证基本结构在骨中的最佳固定，螺旋位于其上缘附近。本发明提出，螺旋在基本结构上最多绕1.5圈，最好绕1至1.25圈，螺旋的螺距或导程介于1和2之间，最好为1.5。有了这样的螺旋结构就可以把基本结构可靠地固定在骨料中而无需在其全长上设置螺纹。当用做损伤的覆盖材料的固定装置时，基本结构甚至可以在紧靠螺旋之下终止，也就是说缩短长度，因而可特别迅速地，但又可靠地旋入骨中。这样就可以在骨中可靠地固定基本结构而无需穿透过深。螺旋的螺纹断面角可以是大约60°，或者当用于特别容易受伤的骨头区域，例如头部区域时，锐边螺旋很容易引起撕裂或剥落，可以做成倒圆。
特别适于制做基本结构的材料是钛或钛合金，这种材料对人的体液的敏感性有限，对拉力有很高的稳定性。
基本结构最好在外面涂覆亲组织的材料，羟基磷灰石等离子涂覆已证实最适用于此目的。这种材料也是牙釉的主要成分之一，可以可靠地避免包围基本结构的组织的排异反应。
因此，基本结构可以尽可能简单可靠地旋于骨中，如果必要，也可以再次从中取出，已经证实，在基本结构的上端面设置接合相应专用扳手的盲孔是比较有利的。
为了防止基本结构意外地，过深地穿入骨中，这一点在易受损伤的骨胳区域尤为重要，按照本发明，基本结构具有一个加宽的上部边缘区域。
按照本发明的一个优选实施例，设置一个隔套，隔套可以安装在基本结构的上缘做为延伸。这一隔套的特殊优点在于：它能刚性地延伸基本结构，基本结构起初在其上缘加固于重新闭合的皮下的骨中，不会产生变形运动引起的疼痛。隔套最好由电绝缘材料制成，为了保证隔套与皮的最佳相容性，最好采用氧化铝，氧化镁和/或二氧化锆等陶瓷材料。至于隔套的设计，已经证实最好借助一内锥使其接合入基本结构，这样可保证零件的强大摩擦和可靠连接。
插入基本结构的植入柱可以旋入或以卡口的方式连接于基本结构。为了简捷地装配植入柱，本发明在其上端面位置设有接合相应专用扳手的盲孔。
人造韧带，损伤覆盖材料和任意其它材料可以用不同方式固定。因此，可以在待固定的材料中设置孔或成排的孔，在孔中接合植入柱。按照本发明的一个实施例，植入柱具有一个加宽的头部，该头部在使植入柱插过一个固定孔后接合并固定要被固定的材料。但是，按照本发明的另一个实施例，上述固定可以是由植入柱顶部的一个或多个钩实现的。当固定人造韧带时，有关的纤维束可熔融成矩形连接块，在这些连接块中已熔入相应形状的植入柱。为了实现人造韧带相应长度的接合，最好在其端部具有成排的孔。
在固定损伤覆盖材料时不会发生大的拉力，因此，可以想到在植入柱顶部进行其它形式的固定。按照本发明在植入柱顶部中放置一块磁铁。要固定到植入柱上的材料可以简便地安装，并同样简便地借助于磁铁拆下。相同的功能也可以由Velcro紧固用的附着表面，粘着平面或其它等同的固定方法完成。
现在对照以下附图对本发明做详细描述：
图1是本发明的用于固定人造韧带的固定装置的推荐实施例的纵剖面;
图2是本发明的用于固定人造韧带的固定装置的另一个推荐实施例的纵剖面，其中有一个延伸的隔套;
图3是本发明的用于固定损伤覆盖材料的固定装置的一个实施例的纵剖面;
图4是图3所示实施例的平面图。
图1所示本发明固定装置有一个基本结构10，它旋入病人暴露的骨胳部分上预先钻好的孔中，并与骨骼骨质愈合。基本结构10最好用钛或钛合金制成，其外表面用滚花或喷砂的方法进行粗糙处理，或者如前所述以亲组织的方式进行涂覆。为了有助于基本结构的骨质愈合，在基本结构上可以设置陷窝14，当本发明的固定装置用于固定人造韧带时，这一点尤为重要。
基本结构10在顶部有开口，其内面的结构使植入柱30可以旋入或者以卡口方式插入。植入柱顶部32以蘑菇状方式加宽，以便于在植入柱穿过固定环，固定孔等需要固定的材料上的孔后，植入柱可与其接合。
紧靠基本结构10的端面之下设有带1.25螺纹的螺旋，其螺距或导程为1.5，其螺纹断面角为60°，该螺旋以攻丝的方式穿入骨中。在图2所示实施例中，与图1不同，它设有一隔套40，隔套40借助一内锥42穿入基本结构10，在此实施例中，植入柱30的顶部有一钩34，钩34用与图1中蘑菇状加宽部分22相同的方式，与需要加固的材料中的相应固定环或孔接合。
图3所示本发明固定装置的实施例最好用于固定损伤的覆盖材料。基本结构10的顶部12是加宽的以防止基本结构10意外地过深刺入骨中。基本结构10紧靠螺旋20之下终止因而很短。螺旋20有1.25螺纹，其螺距为1.5，在本实施例中，螺旋被倒圆后以压制螺纹的方式压入骨中。在植入柱的顶部设有一磁铁36，它与相应的磁铁相互作用用来固定损伤的覆盖材料以及其它各种材料，例如头发移植等。
图4是图3所示固定装置实施例的平面图。在基本结构10的加宽顶部12的边缘上，设有接合专用扳手的盲孔14以便快速装卸基本结构。图4的中央圆圈表示植入柱的圆周，其中央载有一圆形磁铁板36。在这个位置上，显然也可以设置前述的其它固定设施，例如Velcro闭合的附着表面或者粘着面。
在本说明书。权利要求书和附图中公开的本发明的特征，对于单一出现或以组合形式出现的本发明的不同实施例来说都可能是十分重要的。

Claims (25)

1、一种口外使用的可植入固定装置，其特征在于：一个基本结构(10)可以植入骨中并具有一个切制或压制螺纹的螺旋(20)以及一个可连接于基本结构(10)的植入柱(30)。
2、按照权利要求1所述的可植入固定装置，其特征在于：螺旋（20）的位置靠近基本结构（10）的上缘。
3、按照权利要求1或2所述的可植入固定装置，其特征在于：螺旋（20）在基本结构（10）上最多延伸1.5匝。
4、按照权利要求3所述的可植入固定装置，其特征在于：螺旋（20）在基本结构（10）上延伸1至1.25匝。
5、按照前述权利要求之一所述的可植入固定装置，其特征在于：螺旋（20）的螺距或导程介于1和2之间。
6、按照权利要求5所述的可植入固定装置，其特征在于：螺旋（20）的螺距或导程为1.5。
7、按照前述权利要求之一所述的可植入固定装置，其特征在于：螺旋（20）螺纹断面角大约为60°。
8、按照权利要求1至6之一所述的可植入固定装置，其特征在于：螺旋（20）是倒圆的。
9、按照前述权利要求之一所述的可植入固定装置，其特征在于：基本结构（10）是由钛或钛合金制成的。
10、按照前述权利要求之一所述的可植入固定装置，其特征在于：基本结构（10）以亲组织的方式进行外部涂覆。
11、按照权利要求10所述的可植入固定装置，其特征在于：在基本结构（10）的外表面进行羟基磷灰石等离子涂覆。
12、按照前述权利要求之一所述的可植入固定装置，其特征在于：基本结构（10）在其上端面有盲孔（14）。
13、按照前述权利要求之一所述的可植入固定装置，其特征在于：基本结构（10）具有加宽的顶部（12）。
14、按照前述权利要求之一所述的可植入固定装置，其特征在于：该装置设有一隔套（40），隔套（40）可以做为延伸部分安装在基本结构（10）的上缘。
15、按照权利要求13所述的可植入固定装置，其特征在于：隔套（40）借助一内锥（42）接合在基本结构（10）的开口端内。
16、按照权利要求13或14所述的可植入固定装置：其特征在于：隔套（40）是由电绝缘材料制成的。
17、按照权利要求15所述的可植入固定装置，其特征在于：隔套（40）是由氧化铝，氧化镁和/或二氧化锆制成的。
18、按照前述权利要求之一所述的可植入固定装置，其特征在于：植入柱（30）可以旋在基本结构（10）上。
19、按照权利要求1至17之一所述的可植入固定装置，其特征在于：植入柱（30）以卡口的方式连接于基本结构（10）。
20、按照前述权利要求之一所述的可植入固定装置，其特征在于：植入柱（30）在其上端面具有盲孔。
21、按照前述权利要求之一所述的可植入固定装置，其特征在于：植入柱（30）具有加宽的头部（32）。
22、按照前述权利要求之一所述的可植入固定装置，其特征在于：植入柱（30）的顶部设有至少一个钩（34）。
23、按照权利要求1至21之一所述的可植入固定装置，其特征在于：一块磁铁（36）插在植入柱（30）的顶部内。
24、按照权利要求1至21之一所述的可植入固定装置，其特征在于：植入柱（30）的顶部具有至少一个Velcro闭合用的附着表面。
25、按照权利要求1至21之一所述的可植入固定装置，其特征在于：植入柱（30）的顶部具有至少一个粘着面。
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