CN1276712A - 骨块固定移植物 - Google Patents

骨块固定移植物 Download PDF

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CN1276712A
CN1276712A CN98810352.4A CN98810352A CN1276712A CN 1276712 A CN1276712 A CN 1276712A CN 98810352 A CN98810352 A CN 98810352A CN 1276712 A CN1276712 A CN 1276712A
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graft
bone
boring
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implant
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M·舍尔曼
A·凯科南
T·波约南
P·特尔麦莱
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Bionx Implants Oy
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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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    • A61F2/08—Muscles; Tendons; Ligaments
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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
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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Abstract

本发明描述了一种可被生物吸收的移植物,该移植物由可被生物吸收的聚合物、共聚物、聚合物合金或包括增加强度的纤维和/或填充颗粒的复合物制成。该移植物被放入骨中的孔或所钻通道中,以便将骨移植片固定到钻孔中。所述移植物包括:1)至少一个细长的主体,2)至少一个将该移植物锁定到钻孔中的抓持部件,以及3)一个将骨块定位于移植物和钻孔壁之间的平台表面。移植物还可设有4)一个制动装置,该装置有效地防止骨块从钻孔中滑出。

Description

骨块固定移植物
本发明涉及外科移植物，该移植物由可被生物吸收的(可被生物降解的)聚合物、共聚物、聚合物合金或复合物制成。该移植物用于将骨块(移植片)固定到骨中的钻孔内。本发明还涉及将这种移植物插入到病人体内的方法。
在外科中通常公知的是采用从病人膝部取出的骨-髌骨或腱-骨移植物来替代严重受损的前十字韧带(ACL)。在外科手术中，将一个骨移植物固定到从膝关节至远端股骨的钻孔中，而将另一骨移植片固定到至近端胫骨的钻孔中。骨塞被骨固定螺钉固定到钻孔中，该螺钉在大多数情况下被称为干扰螺钉。将一个螺钉插入到钻孔和骨移植物之间的空间内，以便将骨移植物锁定在钻孔中。位于骨块之间的髌骨腱部分起到新ACL的作用。骨-腱-骨的外科手术技术例如在Bach，B.R.的“在ACL外科手术中采用Kurosaka螺钉进行干扰固定的潜在缺陷”(美国膝部外科杂志，第2卷，1989年第2期，第76-82页(参考文献1))已有描述。该文献的内容在此通过参考被引入本申请中。
如干扰螺钉等固定螺钉一般由如不锈钢或钛等金属制成，或采用可被生物吸收的聚合物，如聚交酯制成。适于制作骨-腱-骨移植物固定螺钉的金属和/或可被生物吸收的聚合材料和复合物在文献中已有描述，例如Barber，A.F.，Burton，E.F.，McGuire，D.A.和Paulos，L.E.的“可吸收干扰螺钉的初步结果”(关节内窥镜检查及相关外科杂志，第11卷，1995年第5期，第537-548页(参考文献2))；以及Bach，B.R.的“用于前十字韧带不足中的关节内窥镜检查辅助的髌骨腱置换物”(美国膝部外科杂志，第2卷，1989年第1期，第3-20页(参考文献3))。上述文献公开的内容在此通过参考被引入本申请中。
在骨-腱-骨手术中采用螺钉作为用于骨移植物的固定移植物由于下述原因而变得很复杂：-如果螺钉相对于骨块来说太大，并且/或者在钻孔和骨块之间的空间太小，则在螺钉的安装过程中，螺钉上的螺纹会将骨块切断；-在螺钉的安装过程中，螺钉的螺纹会损伤腱；-在螺钉安装过程中，骨块(和腱)会随螺钉一起旋转，这样骨移植物不再处于最佳位置，并且/或者损伤骨移植物；-可出现移植物和/或螺钉的偏离；以及-可被生物吸收的螺钉在插入过程中会断裂。类似上面列举的复杂问题在前面作为参考的文献中已有讨论。
因此，采用能够在将螺钉插入到钻孔过程中避免上述如现有的装置中之复杂问题的骨-腱-骨固定移植物是十分有益的。本发明令人吃惊地大大消除了上述使用现有技术所存在的那些问题。在本发明中，一可被生物吸收的移植物由可被生物吸收的聚合物、共聚物、聚合物合金或包括增加强度的纤维和/或填充颗粒的复合物制成，该移植物被推入骨中的孔或所钻的通道中，以便将骨移植物固定到钻孔中，其中所述移植物包括：1)至少一个细长的主体，2)至少一个将该移植物锁定到钻孔中的抓持部件，以及3)一个将骨块定位于移植物和钻孔壁之间的平台表面。移植物还可设有4)一个附加的制动装置，该装置可防止骨块从钻孔中滑出。
这样，由于采用了按照本发明制作的外科移植物，在现有的用于骨-腱-骨固定的移植物中存在的前述困难和功能局限性可被消除。
下面结合附图的说明将展示本发明。在附图中，图1为一纵剖面图，示出了本发明移植物的一个实施例。图2为一纵剖面图，示出了本发明移植物的第二实施例。图3为一纵剖面图，示出了本发明移植物的第三实施例。图4为一横剖面图，示出了位于骨钻孔中之骨移植物用的一般几何形状。图5示出了本发明设有脊状抓持部件的移植物。图6示出了本发明设有倒钩状抓持部件的移植物。图7为图6所示带有骨块移植物沿A-A平面剖取的剖面图。图8为本发明移植物具有一个孔的透视图，其中所述孔用于一安装器具的端接头。
如图1所示，一本发明的外科固定移植物包括(a)一个细长的主体(1)；(b)至少一个抓持部件(2)，该部件将移植物锁定在骨内的钻孔(3)中，这样在移植物的插入过程中，抓持部件至少部分沉入骨(4)内部；以及(c)一个平台表面(5)，在该平台表面上，骨移植片(6)(从(6)露出腱(7))位于移植物(1)和钻孔(3)表面之间。当移植物(1)以及骨移植片(6)的最大厚度之和大于钻孔(3)的直径时，采用一个紧固压力使移植物(1)和骨移植片(6)安装到钻孔(3)中。
另外如图2所示，移植物(1)还可具有一个制动装置(8)(例如凸起、倒钩、门槛等)，该装置位于平台表面(5)的前面或在其近端。制动装置有效地防止骨移植片(6)在与移植物(1)一起被压入钻孔之后从钻孔(3)中滑出，并且同时制动装置还允许腱(7)从钻孔(3)中突现出来。
例如在图1和2中示出的本发明抓持部件包括至少一个从移植物的表面突现出来的凸起、螺纹、横向脊、倒钩、椎状凸起等。抓持部件的几何形状为使得移植物(1)很容易地滑入钻孔(3)中，但不能再向后滑动。按照图3所示的本发明优选实施例所述，抓持部件包括从移植物(1)的表面突现出来的倒钩(9)。图3所示的倒钩(9)在移植物(1)和骨移植片(6)被推入钻孔(3)时仅呈现很小的阻力，但在移植物插入到钻孔中之后，倒钩防止移植物(1)从钻孔(3)中滑出。由于骨移植片(6)被相对于移植物(1)锁定在钻孔(3)中，因此也有效地防止了插置后的骨移植片(6)从钻孔(3)中向后滑出。
图4示出了在骨的钻孔(3)中的骨移植片(6)的典型剖面。观察图4所示的几何形状可以看出，移植物最优选的是为柱形，而平台表面和制动装置构成在移植物的柱形表面上。
图5为本发明典型移植物(1)的透视图，该移植物具有围绕在其柱形主体周围的作为抓持部件(2)的环形脊件和一个门槛状的制动装置(8)以及一个锯齿状平台表面(5)。
图6为本发明另一柱形移植物的透视图，该移植物在其表面上具有作为抓持部件(2)的倒钩和一个制动装置(8)，其中制动装置设有一为腱用的槽(8’)。移植物的平台表面(5)深凹入移植物主体的内部，以形成接纳骨移植片的狭槽(10)的底。
图7为图6所示移植物沿平面A处的截面图，示出了移植物(1)内部的狭槽(10)、位于平台表面(5)上并在狭槽(10)内部的骨移植片(6)和在移植物(1)的表面上的抓持部件(倒钩)(9)。
按照本发明所述，骨块可在它们插入到骨中的钻孔内之前与移植物相连接，或者骨块可先插入到钻孔中，然后再将移植物插入到钻孔中。这样，本发明的移植物可以在关节内窥镜的帮助下沿骨块，或在骨块首先被定位于钻孔内部之后采用下面列出的技术或几种技术组合推入到骨中的钻孔内：-通过管状套管将移植物推入到钻孔中其位置上；-在移植物上制出一个纵向孔以接纳一导引线，沿导引线将移植物推入到它在钻孔中的位置处；以及-如透视图8示意性地示出的那样，在移植物的近端部分制出一个小螺纹孔(11)，将一(例如刺刀连接状的)安装器具的端接头固定到孔(11)中，采用该器具将接合好的移植物推入到钻孔中其位置处。
同样地，在骨块首先插入到钻孔中的情况下，可采用与前述相同的方式，在关节内窥镜的帮助下将骨块推入到钻孔中。
按照本发明的优选实施例，移植物具有洞或多个敞口孔，以促进组织或骨骼长到移植物内部。这些洞或孔的直径一般为100μm到2000μm。洞或孔可由病人的网状骨填充，或由陶瓷骨替代粉末或颗粒(例如生物玻璃)填充，以便加速它们被新骨填充。当移植物在钻孔中被生物降解和消失时，在移植物的洞或孔内的这种新骨质可促进钻孔的最终愈合和钻孔内骨块的固定。
因此，由于采用了本发明的移植物，从而能够有效地将骨移植片接合并固定到骨中的钻孔内，并能抵制使骨移植片松动的力，且不需花费很长时间也不会有采用螺钉固定而损伤骨移植片和/或固定到骨移植片上的腱移植片的危险。
本发明的固定移植物可采用下列材料制成：可被生物吸收的(可生物降解的或可再吸收的)聚合物、共聚物、聚合物合金或例如聚-α-羟基酸的复合物和其它脂肪质可生物降解的聚酯、聚酐类，聚原酸酯(polyorthoesters)，聚有机磷腈，以及在许多出版物中公开的其它可被生物吸收的聚合物，例如芬兰专利申请FI-952884和FI-955547，以及PCT申请WO90/04982，这些文献公开的内容在此通过参考被引入本申请中。
可制成本发明移植物的可生物降解的聚合物可采用一种聚合物或聚合物合金。移植物也可采用加强材料来增加强度，该加强材料为由可再吸收的聚合物或聚合物合金制成的纤维，或为可生物降解的玻璃纤维，如p-tricalciumphosphate纤维、生物-玻璃纤维或钙铝纤维(例如参见欧洲专利申请EP-A-0146398，该文献公开的内容在此通过参考被引入本申请中)。陶瓷粉也可用作添加剂(填充物)用于本发明的移植物中，以促进新骨成形。
本发明的移植物还可包含层状部分，例如包括：(a)一改善移植物韧性、以及/或用于释放药物或其它生物活性物质、以及/或用作水解阻挡层的挠性表面层，以及(b)一刚性内层。
可采用塑料技术中的各种方法，用可生物降解的聚合物和适于可生物降解的加强纤维来制造本发明的外科移植物，这些方法例如为注模、挤压及震动成型(例如参见美国专利US4,968,317，该文献公开的内容在此通过参考被引入本申请中)，或采用加压成型，其中通过加热和/或加压而使原材料成形为移植物片。也可考虑采用机械加工(例如切割、钻、用车床加工、磨削等)。
也可采用下述方法制造本发明的移植物：采用前述聚合物原材料，使聚合物的至少一部分溶解在合适的溶剂中，或采用该溶剂使聚合物变柔软，然后加压和/或微微加热，从而将聚合物压制成移植物片，其中使溶解的或变软的聚合物胶化以形成一宏观的移植物，此后，溶剂通过蒸发除去。
显然，本发明的移植物也可包含各种添加剂，以利于材料的加工(例如稳定剂、抗氧化剂或可塑剂)，或改变其性能(例如可塑剂或陶瓷粉材料或如碳纤维类的生物稳定纤维)，或有利于其处理(例如着色剂)。
按照本发明的一个优选实施例，移植物(和/或它的表面层)包含一些生物活性剂，如抗生素、化学疗法制剂、促进伤口愈合的制剂、生长素、骨成形蛋白质、抗凝血剂(例如肝磷脂)等。这些生物活性移植物在临床应用中优点特别突出，因为它们除了具有机械效果之外，在各种组织中还具有生物化学、医学和其它的效果。

Claims (14)

1.一种用于将骨块固定到骨之钻孔(3)内的外科移植物，所述移植物包括：至少一个由可被生物吸收的聚合物、共聚物、聚合物合金或复合物制成的细长的主体(1)；至少一个在细长主体(1)上的抓持部件(2)，该部件用于将移植物锁定在钻孔(3)中；以及一位于细长主体(1)上用于接纳骨块(6)的平台表面。
2.如权利要求1的外科移植物，还包括一用于防止骨块从钻孔(3)中滑出的制动装置(8)。
3.如权利要求1的外科移植物，其中所述至少一个抓持部件(2)包括至少一个凸起。
4.如权利要求1的外科移植物，其中所述至少一个抓持部件(2)包括至少一个螺纹。
5.如权利要求1的外科移植物，其中所述至少一个抓持部件(2)包括至少一个横向的脊件。
6.如权利要求1的外科移植物，其中所述至少一个抓持部件(2)包括至少一个倒钩(9)。
7.如权利要求2的外科移植物，其中所述制动装置(8)包括至少一个凸起。
8.如权利要求2的外科移植物，其中所述制动装置(8)包括至少一个倒钩。
9.如权利要求2的外科移植物，其中所述制动装置(8)包括至少一个门槛。
10.如权利要求1的外科移植物，其中所述细长主体(1)包括柱形。
11.如权利要求1的外科移植物，其中所述细长主体(1)是多孔的。
12.如权利要求1的外科移植物，其中所述移植物能够释放一药剂或其它生物活性物质。
13.一种将权利要求1的外科移植物和一个骨块(6)插入到骨中的钻孔(3)内的方法，包括以下步骤：a.使骨块(6)接合到细长主体(1)上；  b.将骨块(6)和细长主体(1)插入到钻孔(3)中；以及c.采用移植物上的抓持装置(2)将移植物锁定在钻孔(3)内。
14.一种将权利要求1的外科移植物和一个骨块(6)插入到骨中的钻孔(3)内的方法，包括以下步骤：a.将骨块(6)插入到钻孔(3)中；b.将细长主体(1)插入到钻孔(3)中；c.通过移植物上的抓持装置(2)将移植物锁定在钻孔(3)内。
CN98810352.4A 1997-08-19 1998-08-18 骨块固定移植物 Pending CN1276712A (zh)

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DE69829514D1 (de) 2005-04-28
EP1332730B1 (en) 2005-03-23
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ATE261280T1 (de) 2004-03-15
EP1332730A3 (en) 2003-08-13
WO1999008625A1 (en) 1999-02-25
ATE291395T1 (de) 2005-04-15
CA2294022A1 (en) 1999-02-25
EP1332730A2 (en) 2003-08-06
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DE69822306D1 (de) 2004-04-15
US6001100A (en) 1999-12-14

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