CN102781370B - 复合界面螺钉和驱动器 - Google Patents
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Abstract
本发明涉及一种输送设备。该输送设备包括手柄组件(11),该组件包括手柄(11a)和联接到手柄的连接器(11b),该连接器包括通道(11b’)和通向该通道的开口;以及联接到手柄的轴(12),该轴包括近端和远端,该远端包括螺纹(12c)、与该螺纹相交的沟槽(12d)和限深器(12e)。还公开了其他输送设备、螺钉和输送设备/螺钉的组合。
Description
相关申请的交叉引用
本申请是PCT专利申请,要求美国专利申请序列号No.61/312291、美国专利申请序列号No.61/334808以及美国专利申请序列号No.61/359080的优先权,这些申请的公开内容通过引用整体并入本文。
技术领域
本发明总体上涉及医疗装置和过程,并且更具体地涉及用于重建韧带的医疗装置和过程。
背景技术
在很多情况下,韧带因为事故而被撕裂或破裂。因此,已经开发了各种过程来修复或更换这样的损坏的韧带。
例如,在人类膝盖中,前十字韧带和后十字韧带(即“ACL”和“PCL”)在胫骨的顶端和股骨的底端之间延伸。通常,前十字韧带(即ACL)例如由于运动相关的伤害而破裂或撕裂。因此,已经开发了各种手术过程来重建ACL以便恢复膝盖的大体正常的功能。
在很多情况下,ACL可通过用移植韧带更换破裂的ACL来重建。更具体地,在这样的过程中,通常在胫骨的顶部和股骨的底部中都形成骨隧道,其中移植韧带的一端定位在股骨隧道中并且移植韧带的另一端定位在胫骨隧道中,并且移植韧带的中间部分跨越股骨的底部和胫骨的顶部之间的距离。移植韧带的两端以本领域公知的各种方式锚固在其相应的骨隧道中,从而移植韧带以与原始ACL大体相同的方式且具有大体相同功能地在股骨的底端和胫骨的顶端之间延伸。该移植韧带然后与周围的解剖结构配合,以便恢复膝盖的大体正常的功能。
在一些环境中,移植韧带可以是病人体内从别处获取的韧带或腱,例如附接或没有附接骨块的髌腱、半腱肌肌腱和/或股薄肌肌腱。
如上所述,在本领域中公知用于将移植韧带的两端锚固在股骨和胫骨隧道中的各种方法。
在可应用于股骨固定、胫骨固定或两者的一个公知的过程中,将移植韧带的端部置于骨隧道中,并且然后采用无头整形外科螺钉将移植韧带固定就位,在本领域中公知为“界面”螺钉。更具体地,采用该方法,将移植韧带的端部置于骨隧道中,并且然后使界面螺钉前进到骨隧道中,以使得界面螺钉平行于骨隧道延伸并且同时与移植韧带和骨隧道的侧壁两者接合。在该布置中,界面螺钉基本上横向地驱动移植韧带,而与骨隧道的相对侧壁接合,由此以所谓的“过盈配合”将移植韧带固定到宿主骨。之后,随着时间的推移(例如几个月),移植韧带和宿主骨在其接触点处生长在一起,从而在韧带和骨头之间提供强壮的自然接合。
界面螺钉已经证明是用于将移植韧带固定在骨隧道中的有效手段。然而,界面螺钉自身通常在骨隧道内占据大量的空间,这会限制在移植韧带和骨隧道的侧壁之间建立的表面积接触。还继而限制了骨头与韧带的向内生长的区域,从而因此会影响接合的强度。通过示例的方式但不是限制性的,已经估计到典型的界面螺钉妨碍了大约50%的潜在的骨头到韧带的结合区域。
为此,已经做出了大量的努力来提供由可吸收材料制作的界面螺钉,使得界面螺钉能随着时间的推移最终消失,并且骨头与韧带的向内生长可发生在骨隧道的整周上。为此目的,已经开发了各种可吸收的界面螺钉,其由生物相容的生物可吸收聚合物制成,例如聚乳酸(PLA)、聚乙醇酸(PGA)等。这些聚合物通常提供了使界面螺钉前进就位并且之后在骨头与韧带的向内生长发生的同时将移植韧带保持就位所需要的相当大的机械强度,而不会永久地保持就位。
一般说来,由这样的生物相容的生物可吸收聚合物制成的界面螺钉已经证明是临床上成功的。然而,这些可吸收的界面螺钉仍然存在若干缺点。首先,临床证据表明骨头与韧带的向内生长的质量与自然的骨头与韧带的向内生长有些不同,在于前述的生物可吸收聚合物倾向于由纤维块替换而不是秩序井然的组织基质。第二,临床证据表明吸收通常会花大量的时间,例如大约三年左右。因此,在该吸收时间期间,骨头与韧带的向内生长仍然由于界面螺钉的存在而显著地被限制。第三,临床证据表明,对于很多患者,吸收永远不会完成,使得大量异质块残留在体内。该问题通过可吸收的界面螺钉事实上通常倾向于相当大以便于为其提供足够的强度而有些加重,例如,界面螺钉通常具有8-12mm的直径(即外径)和20-25mm的长度。
因此,需要新的改进的界面固定系统,其(i)具有在骨头与韧带的向内生长发生的同时将移植韧带保持就位所需要的强度,以及(ii)促进较好的骨头与韧带的向内生长。
发明内容
在一个方面中,本发明涉及一种输送设备。该输送设备包括手柄组件,该组件包括手柄和联接到该手柄的连接器,该连接器包括通道和通向该通道的开口;联接到手柄的轴,该轴包括近端和远端,远端包括螺纹、与螺纹相交的沟槽以及限深器。
在另一个方面中,本发明涉及一种界面螺钉。该界面螺钉包括近端和远端,该螺钉包括以开放螺旋形式从近端延伸到远端的螺纹、在螺钉的部分长度上延伸的限深器以及沿着螺钉的内部纵向延伸的多个滑槽(runner)。
在又一个方面中,本发明涉及一种输送设备和螺钉的组合。该组合包括输送设备,输送设备包括手柄组件,该组件包括手柄和联接到该手柄的连接器,该连接器包括通道和通向该通道的开口;以及联接到手柄的轴,该轴包括近端和远端,该远端包括螺纹、与螺纹相交的沟槽和限深器;以及联接到输送设备的界面螺钉,界面螺钉包括近端和远端,该螺钉包括以开放螺旋形式从近端延伸到远端的螺纹、在螺钉的部分长度上延伸的限深器和沿着螺钉的内部纵向延伸的多个滑槽,该螺钉位于输送设备的远端上,使得螺钉的限深器的近端与输送设备的限深器接合。
本发明的应用性的进一步领域将会从下文提供的详细描述中变得清楚。应该理解的是,详细描述和特定示例尽管指示了本发明的优选实施例,但只是为了例示的目的而不旨在限制本发明的范围。
附图说明
合并在说明书中并且形成说明书的一部分的附图示出了本发明的实施例,并且与书面描述一起用来说明本发明的原理、特征和特性。在附图中:
图1表示本发明的输送设备的第一实施例。
图2表示图1的输送设备的轴的侧视图。
图2A表示图2的轴的远端的分解图。
图3表示图2的轴的剖视图。
图4表示图2的轴的远端的正视图。
图5表示用于与图2的轴一起使用的螺钉的立体图。
图6表示图5的螺钉的侧视图。
图7表示图6的螺钉的剖视图。
图8表示本发明的轴的第二实施例。
图9表示图8的轴的内部构件的侧视图。
图9A表示图9的内部构件的远端的分解图。
图10表示图9的轴的内部构件的剖视图。
图11表示图9的内部构件的远端的正视图。
图12表示图8的轴的外部构件的立体图。
图13表示图12的外部构件的剖视图。
图14和图15表示外部构件处于不同位置的图8的轴的侧视图。
图16表示本发明的轴和用于与该轴一起使用的螺钉的第三实施例的立体图。
图17表示图16的轴的立体图。
图18表示图16的螺钉的立体图。
图19表示图16的螺钉的侧视图。
图20表示图19的螺钉的剖视图。
图21表示本发明的轴和用于与该轴一起使用的螺钉的第四实施例的立体图。
图22表示图21的螺钉的立体图。
图23表示图21的轴的立体图。
图24表示图21的轴和与用于该轴一起使用的替代螺钉的立体图。
图25表示图24的螺钉的侧视图。
图26表示图24的螺钉的剖视图。
具体实施方式
下述的优选实施例的描述本质上仅仅是示例性的,绝不是用来限制本发明及其应用或使用的。
图1表示本发明的输送设备10的第一实施例。该设备10包括手柄组件11和联接到手柄组件11的轴12。手柄组件11包括手柄11a和联接到手柄11a的联接器11b。联接器11b具有通道11b’和通向通道11b’的开口11b"。开口11b"是“D”的形状。轴12的近端12a配置在通道11b’内。
图2、图2A和图3、图4表示轴12。轴12包括近端12a和远端12b。近端12a是“D”的形状来匹配开口11b"的形状。远端12b包括螺纹12c、沟槽12d和限深器12e。该沟槽12d在轴12的部分长度上延伸并且与螺纹12c相交。限深器12e与螺钉上的限深器一起使用,在韧带重建手术期间使用设备10将螺钉植入到骨隧道中。
图5到图7表示用于与本发明的输送设备10一起使用的螺钉20。螺钉20包括近端21和远端22。螺钉20的大部分包括开放螺旋线圈形式的螺纹23,即一连串连续的规则间隔开的匝以螺旋或盘旋形式大体上从近端21延伸到远端22,并且由线圈的匝之间的空间限定孔24。换句话说,界面螺钉20可以包括限定内部体积的开放螺旋线圈,并且内部体积通过开放螺旋线圈的匝之间的间隔与开放螺旋线圈外部的区域相通。远端22也包括在螺钉20的部分长度上延伸的限深器25。限深器25包括近端25a和远端25b。另外,多个纵向延伸的滑槽26沿着螺纹23的内部延伸。
轴12的远端12b经由开口27放置在螺钉20的内部内,直到限深器25的近端25a接合轴12的限深器12e。在轴12插入到螺钉20中期间,滑槽26接合沟槽12d并且变成容纳在沟槽12d内。如图1所示,轴12的远端12b也包括条纹标记12f,每个标记与数字12g相关联。一旦螺钉20放置在轴12上,螺钉20的近端21就与条纹标记/数字12f之一对齐,从而指示螺钉20的长度。
图8、图9-图9A和图10-图15表示本发明的替代轴30。轴30包括内部构件31和配置在内部构件31上的外部构件32。内部构件31的近端31a在形状上与轴12的近端12a类似。内部构件31的远端31b包括螺纹31c。沟槽31d沿着构件31延伸并和螺纹31c相交。另外,螺纹31e位于构件31的近端和远端31a、31b之间。外部构件32包括第一部分32a和第二部分32b。第一部分32a具有比第二部分32b大的直径。第一部分32a在外部构件32的内壁32d上也包括螺纹32c。
一旦外部构件32配置在内部构件31上,螺纹32c就接合螺纹31e来使外部构件32相对于内部构件31移动。使外部构件32相对于内部构件31移动允许内部构件31的远端31b的更多或更少部分显示出来。与轴12的远端12b类似,内部构件31的远端31b包括条纹标记/数字(未示出),其与第二部分32b的端部32b’对齐,从而指示将配置在内部构件31的远端31b上的螺钉40的长度。如图14和图15所示,外部构件32沿着内部构件31的长度位于不同的位置,来允许不同长度的螺钉40装载在内部构件31的远端31b上。
与手柄组件11类似的手柄组件联接到内部构件31的近端31a上。与螺钉20类似,螺钉40包括近端41和远端42。螺钉40包括具有内部的开放螺旋线圈形式的螺纹43、和沿着螺纹43的内部延伸的多个纵向延伸的滑槽45。螺钉40在美国专利申请公开NO.20080154314中更全面地描述,其公开的内容通过引用整体并入本文。一旦外部构件32移动来指示螺钉长度,螺钉40就装载到远端31b上,使得螺钉40的近端41接合端部32b’并且滑槽45接合沟槽31d并变成容纳在沟槽31d内。
图16-图20表示本发明的轴50和螺钉60的另一个替代实施例。轴50包括第一部分51和第二部分52,第一部分51包括近端51a和远端51b,第二部分52包括第一区域52a和第二区域52b。近端51a构造为联接到与手柄组件11类似的手柄组件。然而也可采用其他手柄组件。第一区域52a具有比第一部分51小的直径,使得在第一部分51的远端51b处存在第一限深器51b’。第二区域52b具有比第一区域52小的直径,使得在第一区域52a和第二区域52b之间存在第二限深器52c。第二区域52b的端部52b’是锥形的,以允许在韧带重建手术期间更容易地将锚60插入到骨头中,这将在下面进一步描述。第二部分52还包括在第一和第二区域52a、52b之间延伸的沟槽53。就本发明而言,存在有三个沟槽53。然而,第二部分52可包括更多或更少数量的沟槽53。
与图5-图7中所示的螺钉20类似,螺钉60包括近端61和远端62。螺钉60的大部分包括开放螺旋线圈形式的螺纹63,即一连串连续的规则间隔开的匝以螺旋或盘旋形式大体上从近端61延伸到远端62,并且由线圈的匝之间的空间限定孔64。换句话说,界面螺钉60可以包括限定内部体积的开放螺旋线圈,并且内部体积通过开放螺旋线圈的匝之间的间隔与开放螺旋线圈外部的区域连通。远端62也包括在螺钉60的部分长度上延伸的限深器65。限深器65包括近端65a和远端65b。与图5中最清楚示出的螺钉20的开放式限深器25不同,如图18中最清楚地所示,螺钉60的限深器65是闭合式限深器。另外,多个纵向延伸的滑槽66沿着螺纹63的内部延伸。
轴50的第二部分52经由开口67放置在螺钉60的内部内,直到限深器65的近端65a接合轴50的第二限深器52c。在轴50插入到螺钉60中期间,滑槽66接合沟槽53并且变成容纳在沟槽53内。螺钉60可以具有各种长度。例如,螺钉60可以具有其近端61会接合第一限深器51b’的长度。
如上所述,在韧带重建手术期间,将移植韧带的端部置于骨隧道中,并且接着通过使用轴12、30、50而使界面螺钉20、40、60前进到骨隧道中,使得界面螺钉20、40、60平行于骨隧道延伸并且同时与移植韧带和骨隧道的侧壁两者接合。螺钉20、40、60可用于股骨或胫骨隧道。通过使用螺钉20、40、60来重建韧带方法进一步示出在上面所示的′314公开文本中。
图21-图23表示本发明的螺钉100和输送设备200的又一个替代实施例。螺钉100包括近端101和远端102。螺钉100的大部分包括开放螺旋线圈形式的螺纹103,即一连串连续的规则间隔开的匝以螺旋或盘旋形式大体上从近端101延伸到远端102,并且由线圈的匝之间的空间限定孔104。换句话说,界面螺钉100可以包括限定内部体积的开放螺旋线圈,并且内部体积通过开放螺旋线圈的匝之间的间隔与开放螺旋线圈外部的区域连通。远端102还包括缝合桥105,缝合桥105在螺钉100的部分长度上延伸。缝合桥105包括近端105a和远端105b。远端105b包括凹形。在螺钉100内容纳有挠性构件110,例如缝线,以便缝线110在桥105的远端105b周围延伸。此外,纵向延伸的滑槽106从缝合桥105沿着螺纹103的内部延伸。就本发明而言,具有两个纵向延伸的滑槽10。然而,多于或少于两个滑槽都落在本发明的范围内。
输送设备200包括具有狭槽202的远端201和在该设备200的每一侧上从狭槽202延伸的沟槽203。如图21所示,螺钉100位于远端201上,使得缝合桥105容纳在狭槽202内并且滑槽106容纳在沟槽203内。输送设备200是被插管的,使得当螺钉100位于该设备200上时,缝线端部110a、110b延伸通过管子204。
图24-图26表示与螺钉100类似的螺钉300。然而,螺钉300另外包括位于远端302上的尖端311。该尖端311包括通孔312。该孔312帮助将缝线110定位在螺钉300的内部内。如图24所示,螺钉300位于输送设备200的远端201上,使得缝合桥305容纳在狭槽202内并且滑槽306容纳在沟槽203内。如上所述,输送设备200是被插管的,使得当螺钉300位于该设备200上时,缝线端部110a、110b延伸穿过管子204,如图24所示。
为了清楚的目的,仅示出了设备200的远端201。然而,该设备200与上述设备相似会包括近端,近端可联接到与上面手柄组件11类似的手柄组件。螺钉100、300用于修复软组织,特别是用于将组织重新附接到骨头上。该修复的一个例子是当螺钉100、300通过设备200的使用而输送到骨头中时,将该设备200从螺钉100、300移除,将组织在骨头上放置为与螺钉100、300相邻,将缝线端部110a、110b牵拉穿过该组织,并且然后将缝线端部110a、110b打结。在螺钉100、300插入到骨头中之前,可在骨头中制作孔。然而,螺钉300可不首先在骨头中制作孔地插入到骨头中。在这种情况下,使用尖端311来开始将螺钉300插入到骨头中,并且然后可以采用旋转运动来完成螺钉300到骨头中的插入。也可采用通过使用这些螺钉和输送设备来修复组织的其他方法。
手柄组件11的手柄11a由塑料制成,然而也可以使用其他非金属和金属材料。手柄11a的形状和尺寸可以是有助于容易将螺钉20插入到骨头中所需的任意形状和尺寸。联接器11b由金属材料制成,例如不锈钢或钛,但是也可以由强度足够承受在手术期间施加的力的其他金属和非金属材料制成。联接器11b压入配合到手柄11a,但是可以以本领域技术人员已知的任何其他方式联接到手柄11a。联接器11b的尺寸和形状可以是有助于容易将螺钉20插入到骨头中所需的任意尺寸和形状。通道11b’可以是容易将轴12联接到联接器11b所需的任意长度,并且开口11b"可以是容易将轴12联接到联接器11b所需的任意形状。
轴12可由金属材料制成,例如不锈钢和钛,然而也可使用能够承受在手术期间施加的力的其他金属和非金属材料。轴12的直径可以改变。轴12的近端12a可以是容易将端部12a穿过开口11b"插入到通道11b’中所需的任意形状。螺纹12c和沟槽12d的数量可以改变,并且沟槽12d长度也是可以改变的。限深器12e的位置也可以基于所使用的轴12的直径和螺钉20的直径而改变。沟槽12d、限深器12e和螺纹12c可以由本领域技术人员已知的任何方法形成。
螺钉20由聚合物材料通过模制方法制成。然而,也可以使用会允许螺钉20承受手术期间施加的力的其他材料和其他制作方法。限深器25是开放式的并且不在螺钉20的整个内径上延伸。限深器25覆盖的螺钉内径量可以改变并且限深器25的长度可基于螺钉的直径改变。滑槽26的数量和长度也可以改变。一旦螺钉20位于轴12上,轴12的远端12b就从螺钉20的远端22延伸。在螺钉20插入到骨头中期间,螺纹12c在骨头中产生螺纹,从而产生用于螺纹23的底座,如在′314公开文本中更全面描述的那样。轴12的远端12b从螺钉20的远端22延伸的量可以改变。
外部构件32的第一和第二部分32a、32b的直径可以改变,并且螺纹32c的数量也可改变。螺纹31c、31e和沟槽31d的数量可以改变并且沟槽31d的长度也可改变。内部和外部构件31、32可由金属材料例如不锈钢和钛通过本领域技术人员已知的方法制成。然而也可以采用其他材料。螺钉40由聚合物材料通过模制方法制成。然而,也可以使用其他材料和制作方法。滑槽45的数量和长度也可改变。一旦螺钉40位于轴30上,轴30的远端31b就从螺钉40的远端42延伸。在螺钉40插入到骨头中期间,螺纹31c在骨头中产生螺纹,从而产生用于螺纹43的底座,如在′314公开文本中更全面描述的那样。轴30的远端31b从螺钉40延伸的量可以改变。
轴50由金属材料例如不锈钢或钛制成,但也可由强度足够承受在手术期间施加到轴50的力的其他金属材料或非金属材料制成。轴50可通过本领域技术人员已知的方法制成。第一和第二部分51、52的直径可随着沟槽53的数量和长度而改变,并且限深器52c、51b’的位置可基于螺钉60的直径或其他因素而改变。替代锥形,端部52b’可以以允许更容易将螺钉60插入到骨头中的其他方式设计。螺钉60由聚合物材料通过模制方法制成。然而,也可以使用会允许螺钉承受在手术期间施加的力的其他材料和其他制作方法。滑槽66的数量和长度也可改变。一旦螺钉60位于轴50上,轴50的第二部分52就从螺钉60的远端62延伸。第二部分52从螺钉60延伸的量可以改变。此外,限深器65的长度也可基于螺钉60的直径或其他因素而改变。
输送设备200由金属材料例如不锈钢或钛制成,但也可由强度足够承受在手术期间施加到设备200的力的非金属材料制成。输送设备200通过本领域技术人员已知的方法制成。螺钉100、300由聚合物材料通过模制工艺制成,然而,也可以使用会允许螺钉承受在手术期间施加的力的其他材料和本领域技术人员已知的其他工艺。缝合桥105可具有形状不是凹形的远端105b,并且缝合桥105、狭槽202和沟槽203的长度可以改变。孔312的尺寸和形状可以改变。
在不脱离本发明的范围的情况下,可以对上面参考对应图示描述的示例性实施例作出各种变更,旨在前述描述中包含的并且在附图中示出的所有内容应解释为例示性的而不是限制性的。因此,本发明的广度和范围不应由任何上述示例性实施例限制,而应该仅根据本文所附的权利要求及其等同物限定。
Claims (3)
1.一种输送设备,包括:
手柄组件,该组件包括手柄和联接到该手柄的连接器,该连接器包括通道和通向该通道的开口;以及
联接到所述手柄的轴,该轴包括近端和远端,该远端包括螺纹、与该螺纹相交的沟槽和限深器;
其中,所述限深器构造成接合界面螺钉的远端上的限深器,使得所述输送设备的远端延伸超过所述螺钉的远端。
2.一种界面螺钉,包括:
近端和远端,该螺钉包括以开放螺旋形式从所述近端延伸到所述远端的螺纹;在所述螺钉的远端的部分长度上延伸的限深器;以及沿着所述螺钉的内部纵向延伸的多个滑槽;
其中,所述螺钉的限深器构造成接合输送设备的限深器,使得所述输送设备的远端延伸超过所述螺钉的远端。
3.一种输送设备和螺钉的组合,包括:
输送设备,包括手柄组件,该组件包括手柄和联接到该手柄的连接器,该连接器包括通道和通向该通道的开口;以及联接到所述手柄的轴,该轴包括近端和远端,该远端包括螺纹、与该螺纹相交的沟槽和限深器;以及
联接到所述输送设备的界面螺钉,包括近端和远端,该螺钉包括以开放螺旋形式从所述近端延伸到所述远端的螺纹;在所述螺钉的远端的部分长度上延伸的限深器;以及沿着所述螺钉的内部纵向延伸的多个滑槽,该螺钉位于所述输送设备的远端,使得该螺钉的限深器的近端与所述输送设备的限深器接合,使得所述输送设备的远端延伸超过所述螺钉的远端。
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US61/359,080 | 2010-06-28 | ||
PCT/US2011/027837 WO2011112776A1 (en) | 2010-03-10 | 2011-03-10 | Composite interference screws and drivers |
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JP5899124B2 (ja) | 2016-04-06 |
US20120059384A1 (en) | 2012-03-08 |
EP2544625B1 (en) | 2020-09-23 |
WO2011112776A1 (en) | 2011-09-15 |
EP2544625A1 (en) | 2013-01-16 |
CN102781370A (zh) | 2012-11-14 |
AU2011224326A1 (en) | 2012-09-20 |
JP2013521888A (ja) | 2013-06-13 |
AU2011224326B2 (en) | 2016-01-14 |
US8979865B2 (en) | 2015-03-17 |
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