CN102048564A - 部分厚度肩袖修复系统和方法 - Google Patents
部分厚度肩袖修复系统和方法 Download PDFInfo
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Abstract
本发明涉及部分厚度肩袖修复系统和方法。具体而言,公开了一种缝合锚,所述缝合锚具有细长的主体,所述主体具有远端、近端和外表面。轴向取向的芯从近端伸入主体中,且芯的近侧部分具有用于接合工具的多个毗邻表面。所述芯包括一个或多个轴向的缝合通道,所述缝合通道通向芯内部的缝合附连件。缝合线的长度从所述主体近端伸入至少一个缝合通道并延伸至所述缝合附连件。螺纹围绕与所述至少一个缝合通道相邻的所述主体外表面的一部分螺旋延伸。所述主体在所述芯和所述主体外表面之间具有壁厚度,且其中所述缝合通道包括其中所述壁厚度趋于零的所述区域。
Description
背景技术
本发明涉及用于进行部分厚度肩袖(rotator cuff)撕裂修复的系统和方法。
肩膀的肩袖中PASTA(部分关节表面肌腱撕脱)损伤会特别难以修复。肩袖包括一组环绕肩膀和肌腱的肌肉,所述肌腱将所述肌肉附连至肱头上。肌腱在其附连至肱头之处有连接点(footprint),并且在PASTA损伤中,肌腱连接点的一部分变成与所述肱头分离。此类损伤最常见于冈上肌腱上。用于治疗的一种选择为使用针对全厚度撕裂的标准技术完成撕裂和修复的过程。由此失去了对现有附连的保存,并且必须对整个肌腱进行再附连。另一选择是产生穿过肌腱的切口,并置入贯穿肌腱的标准缝合锚。这就对肌腱造成了显著的创伤。
发明内容
本发明提供了用于修复PASTA损伤的系统和方法,所述系统和方法与现有治疗选择相比具有优势。根据本发明的缝合锚含有细长的主体,所述主体具有远端、近端和外表面。轴向取向的芯从近端伸入主体中,且芯的近侧部分具有用于接合工具的多个毗邻表面。芯具有至少一个轴向取向的缝合通道。缝合附连件与所述芯相关联。螺纹围绕与至少一个缝合通道相邻的主体外表面的一部分延伸。所述主体在所述芯和主体外表面之间具有壁厚度,所述缝合通道包括其中壁厚度趋于零的区域。
优选地,基本上沿所述芯的整个长度的壁厚度为零。
优选地,所述毗邻表面形成了工具接纳凹陷,而且其中至少一个缝合通道包括所述工具接纳凹陷第一侧的第一缝合通道和所述工具接纳凹陷第二侧的第二缝合通道。缝合线的长度可向下穿过所述第一缝合通道至缝合附连件,然后从第二缝合通道退出。优选地,所述工具接纳凹陷基本上从主体近端延伸至缝合附连件,并提供对工具的良好保持并降低工具使用时锚主体上的应力。在一个实施例中,所述螺纹的最大外径小于4mm,其中所述缝合线具有2号(gauge #2)或更小的标号。优选地,所述螺纹的最大外径小于3.5mm,更优选地,最大外径为2.8mm。
优选地,所述缝合锚的抗拔力至少为25磅。
在一个实施例中,所述主体由生物可吸收聚合物形成,在可供选择的实施例中由钛形成。
优选地,所述缝合附连件包括置于所述芯内并允许缝合线穿过其中滑动的横向构件。
优选地,所述缝合锚还包括插入毗邻表面之间形成的工具接纳凹陷的驱动器,所述驱动器包括与毗邻表面相接合的互补表面,并由此对缝合锚主体施加扭矩。优选地,所述驱动器还包括至少一个缝合接纳槽,所述缝合接纳槽与互补表面相邻并与所述锚主体中的至少一个缝合通道对准。
根据本发明的方法用于进行部分厚度肩袖修复。所述方法包括以下步骤:透过所述肩袖的肌腱插入最大直径为4.0mm的第一缝合锚并将其锚定入肱骨中;将第二缝合锚插入肱骨中;使第一长度的缝合线从所述第一缝合锚穿过肌腱并到达所述第二缝合锚,由此将肌腱固定至肱骨。
在所述方法的一个实施例中,所述第一缝合锚由生物可吸收材料形成。优选地,在插入后,所述第一缝合锚并不依附于肱骨表面。优选地,所述方法还包括使第二长度的缝合线通过第一缝合锚并穿透肌腱的步骤。所述方法还可包括将第三缝合锚锚入肱骨中,并使第二缝合线到达所述第三缝合锚。
优选地,所述第一缝合锚的最大直径为3.5mm,更优选地为2.8mm。
附图说明
图1为根据本发明的缝合锚的透视图;
图2为装载于驱动器上的图1的缝合锚的侧正视图;
图3为图1的缝合锚的俯视平面图;
图4为肱骨和相关联的经受PASTA损伤的肩袖肌腱的侧正视图,其示出了插透肌腱并到达用于放置缝合锚的所需位置的K线;
图5为图4的肌腱的侧正视图,其示出了K线上穿过肌腱的套管系统;
图6为图5的套管系统的透视图;
图7为图4的肌腱的侧正视图,其示出了装载于驱动器上的缝合锚,其经由套管系统的外侧部分穿过肌腱;
图8为图4的肌腱的侧正视图,其示出了植入肌腱下的肱骨的缝合锚以及从前套管外的缝合锚通过的缝合线;
图9为图4的肌腱的侧正视图,其示出了穿过肌腱某一位置的脊髓针以及经过所述脊髓针并出离前套管的缝合回收器;
图10为图4的肌腱的侧正视图,其示出了从所述缝合锚经过并在不同位置穿过肌腱的缝合线;以及
图11为图4的肌腱的侧正视图,其示出了打结在一起的缝合线,以将肌腱压至肱骨上,从而实现对PASTA损伤的修复。
具体实施方式
图1示出了根据本发明的缝合锚10。该缝合锚包括具有尖远侧顶端14和近端16的细长主体12。轴向通路18从近端16延伸进入主体12中。通路18沿着其侧面20开口。线22环绕着主体12。缝合桥24在其远侧部分26横向地跨过通路18。
现同时转向图2和图3,嵌入体28装入通路18中。缝合线30的长度绕经缝合桥24并接收于嵌入体28上的纵向槽32内。如图3最佳所见,近端16处的通路18的截面形状基本上为六边形34,其中在其相对拐角上具有一对缝合通道36。缝合通道36通向缝合桥24的任一侧。嵌入体28具有互补的形状,以装入六边形34内,且其槽32与缝合锚10上的缝合通道36对齐。
使如图所示的缝合锚10(具有贯穿主体12以使通路18只对线22开放的缝合通道36)的截面最小化,以使其对将穿过的软组织的创伤最小,同时仍具有足够的机械强度,以使驱动器28驱动其进入骨内。在骨内可能需要附加固定强度的情况下,缝合锚10的截面可以增大,在这种情况下,缝合通道36进而不一定需要横向地贯穿主体12。所述锚10可以由任何合适的生物相容性材料形成,例如不锈钢、钛、钴铬合金、PEEK(聚芳基醚酮)、其它生物相容性聚合物、高分子-陶瓷复合材料、生物可吸收聚合物等。
图4至图10示出了使用图1的缝合锚10修复PASTA损伤的工序。如图4可见,以经由皮肤的方式或以关节镜方式,将克氏线(K线)38在第一位置39插透肩袖的肌腱40,到达所需锚部位42,该锚部位位于其附连点44下并设置于相关联的肱骨头46上。K线38可以穿入所述部位42,或者仅设置在部位42处。为了便于操纵K线38,优选地,K线38的外表面是有纹理的,且可被设置有可拆除的近侧柄部(未示出)。肱骨头46上的该部位42为将植入缝合锚10(见图1)的位置。
如图5可见,套管系统48经过K线38并穿过肌腱40到达部位42处。图6更为详细地示出了套管48。其包括具有尖远侧顶端52、近侧柄部54和贯穿其中的内腔56的内套管50。内套管50装于外套管58内,所述外套管58具有远端60、近侧柄部62和贯穿其中的内腔64。内套管50的远侧顶端52稍微地伸出外套管58的远端60之外,而且远端60呈锥形,使得与穿过肌腱40的芯不同,远侧顶端52产生小洞而且远侧顶端52和远端60的锥度使套管系统48可以推开组织并产生穿过肌腱40的且具有最小伤害的最小洞。先将套管插透狭长切口并插入组织中。套管系统48使组织轻轻地扩张,以将对组织的创伤降低到最低。外套管58具有提供贯穿深度的视觉指示的线条66,还具有帮助进行锚插入和估算进入骨中的合适深度的可视窗口68。为了防止插入过程中内套管50相对外套管58滑动,优选地提供帮助保持它们在一起的措施。图示的是互锁的凸块70和槽72,但是也可使用其它选项,如摩擦件、螺线、磁体等。
如图7可见,在准备插入锚10时除去K线38和内套管50,并使外套管58保持在锚部位42处。将缝合锚10预装载于嵌入体28上,并将缝合线30原位绕过缝合桥24,穿过缝合通道36和槽32(参见图2),缝合锚向下穿过外套管内腔60到达锚部位42,然后被驱动进入肱骨头46中。如果锚10由生物相容性金属(如不锈钢或钛)形成,则可简单地经由嵌入体28旋入。如果相反地锚10由生物可吸收聚合物或其它强度较低的材料形成,在将锚10插入内腔60之前,应例如用钻、螺丝攻或锥在部位42处穿过套管46形成先导洞。然后,可除去嵌入体28和外套管58,并留下第一缝合线74和第二缝合线76,所述第一和第二缝合线分别向上穿过套管48所穿过的第一位置39处的肌腱40。如图8所示,随后将第一缝合线74通过辅助套管78,如经由抓紧器(未示出)进行取回。
如图9所示,使骨髓针80穿过与第一位置39相隔的第二位置82处的肌腱40。使具有缝合捕获环86的软线缝合捕获设备84(如得自DePuy Mitek,Inc.(Raynham,MA)的Chia Percpasser)穿过骨髓针80,并经过辅助套管78取出,使得第一缝合线74可经缝合捕获环86穿出。在将脊髓针80和缝合捕获设备84穿过皮肤拉回时,这将拉动第一缝合线74经过第二位置82处的肌腱40。对于快速工序而言,现在可将第一和第二缝合线74和76打结在一起,束缚肌腱40。然而,优选的是,重复图8和图9的工序,使第二缝合线76穿过如图10所示的第三位置88处的肌腱40,所述第三位置88位于第一位置39的相对侧。为了便于打结,优选将缝合线74和76从单一出口(如辅助套管78)和其它穿过皮肤的出口中拉出。如图11所示,随后可以系出结90,并向下压以使肌腱40牢固地固定在肱骨头46上。通过使缝合线74和76穿过第一位置39相对两侧的位置82和88处的肌腱40,由于穿过套管系统48在此位置引起的缺损在系紧结90时自然被拉到一起。
根据PASTA损伤的程度,可能有利的是,在肌腱40下放置不止一个的缝合锚10。在这种情况下,可将由此出来的缝合线系在一起。将更优选的是,在将其打结在一起之前,优选以底垫方式(mattress pattern)将它们穿过如图9和图10所示不同位置处的肌腱。另外,可使用一种或多种如美国专利申请No.2008/0033486(将其通过引用并入本文)公开的无结缝合锚(未示出)进行修复,将该缝合锚置于肌腱40的横向位置92处,其中来自一个或多个锚10的缝合线74和76可以在双列工序中、优选地还采用底垫方式进行移动。如果采用了横向锚,则一种这样方法是前后放置一对本发明的缝合锚10,并使来自各锚的一条线74相互系扣,使另外的线76跨过横向锚(优选地不打结),以使其形成三角形。
缝合锚10和套管系统48也可用于进行SLAP(从前到后的上盂唇撕裂)损伤的修复。通常将大得多的常用套管(7-8mm)贯穿肩袖放置,以进入上盂唇进行SLAP修复。本发明的套管系统小很多,还由于其易于使组织膨胀而非穿过大切口插入,该套管系统将使肩袖受到较小的创伤。所述工序可如下:插入K线38,然后使套管系统48以前文所述的方式穿过肩袖间隙;在关节盂缘钻出洞;插入锚10;除去套管系统48;用缝合输送器使缝合线穿过所述唇;和打结。
尽管本发明联系其具体实施例进行了特别说明,但是应当理解这是说明性而非限制性的,并且所附权利要求的范围在现有技术所允许的条件下应作宽泛解释。
Claims (21)
1.一种缝合锚,包括:
细长主体,其具有远端、近端和外表面;
轴向取向的芯,其从所述近端进入所述主体;
所述芯的近侧部分,其具有用于接合工具的多个毗邻表面;
所述芯包括至少一个轴向取向的缝合通道;
缝合附连件,所述缝合附连件与所述芯相关联;
螺纹,其围绕与所述至少一个缝合通道相邻的所述主体的外表面的一部分;以及
所述主体在所述芯和所述主体的外表面之间具有壁厚度,所述缝合通道包括所述壁厚度趋于零的区域。
2.根据权利要求1所述的缝合锚,其中沿所述芯的基本上整个长度的所述壁厚度为零。
3.根据权利要求1所述的缝合锚,其中所述毗邻表面形成了工具接纳凹陷,且其中所述至少一个缝合通道包括所述工具接纳凹陷的第一侧的第一缝合通道和所述工具接纳凹陷的第二侧的第二缝合通道。
4.根据权利要求3所述的缝合锚,其中所述缝合线的长度向下穿过所述第一缝合通道至所述缝合附连件,然后从所述第二缝合通道退出。
5.根据权利要求4所述的缝合锚,其中所述工具接纳凹陷基本上从所述主体的近端延伸至所述缝合附连件。
6.根据权利要求4所述的缝合锚,其中所述螺纹的最大外径小于4mm,且其中所述缝合线具有2号或更小的标号。
7.根据权利要求6所述的缝合锚,其中所述螺纹的最大外径小于3.5mm。
8.根据权利要求7所述的缝合锚,其中所述螺纹的最大外径为2.8mm。
9.根据权利要求8所述的缝合锚,所述缝合锚的抗拔力至少为25磅。
10.根据权利要求1所述的缝合锚,其中所述主体由生物可吸收聚合物形成。
11.根据权利要求1所述的缝合锚,其中所述主体由钛形成。
12.根据权利要求1所述的缝合锚,其中所述缝合附连件包括置于所述芯内的横向构件。
13.根据权利要求1所述的缝合锚,还包括插入所述毗邻表面之间形成的工具接纳凹陷的驱动器,所述驱动器包括与所述毗邻表面相接合的互补表面,并由此对所述缝合锚主体施加扭矩。
14.根据权利要求13所述的缝合锚,其中所述驱动器还包含至少一个缝合接纳槽,所述缝合接纳槽与所述互补表面相邻并与所述缝合锚的主体中的所述至少一个缝合通道对准。
15.一种进行部分厚度肩袖修复的方法,所述方法包括以下步骤:穿过所述肩袖的肌腱插入最大直径为4.0mm的第一缝合锚并将其锚定入肱骨中;
将第二缝合锚插入所述肱骨中;
使第一长度的缝合线从所述第一缝合锚穿过所述肌腱并到达所述第二缝合锚,由此将所述肌腱固定至所述肱骨。
16.根据权利要求15所述的方法,其中所述第一缝合锚由生物可吸收材料形成。
17.根据权利要求15所述的方法,其中所述第一缝合锚并不依附于所述肱骨的表面。
18.根据权利要求15所述的方法,还包括使第二长度的缝合线通过所述第一缝合锚并穿透所述肌腱的步骤。
19.根据权利要求18所述的方法,还包括将第三缝合锚锚入所述肱骨中并使所述第二缝合线到达所述第三缝合锚的步骤。
20.根据权利要求15所述的方法,其中所述第一缝合锚的最大直径为3.5mm。
21.根据权利要求20所述的方法,其中所述第一缝合锚的最大直径为2.8mm。
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US20110106154A1 (en) | 2011-05-05 |
BRPI1004169A2 (pt) | 2012-06-12 |
US8672967B2 (en) | 2014-03-18 |
CA2719269A1 (en) | 2011-04-30 |
BRPI1004169B1 (pt) | 2020-05-12 |
JP6199005B2 (ja) | 2017-09-20 |
AU2010233027A1 (en) | 2011-05-19 |
JP2011092733A (ja) | 2011-05-12 |
EP2316379B1 (en) | 2018-10-24 |
US20140148850A1 (en) | 2014-05-29 |
US20190298333A1 (en) | 2019-10-03 |
US20220273285A1 (en) | 2022-09-01 |
EP2316379A1 (en) | 2011-05-04 |
CN102048564B (zh) | 2015-11-25 |
AU2010233027B2 (en) | 2016-02-25 |
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