CN101208053A - 微创可致动骨固定装置、系统和使用方法 - Google Patents
微创可致动骨固定装置、系统和使用方法 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
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- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
- A61B17/7266—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7241—Intramedullary pins, nails or other devices with special means of locking the nail to the bone the nail having separate elements through which screws pass
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7291—Intramedullary pins, nails or other devices for small bones, e.g. in the foot, ankle, hand or wrist
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
Abstract
本发明提供了用于患病或者骨折骨的微创可致动骨加强、固定和治疗的方法和装置,其包括可选地涂敷有治疗剂的支撑结构。当在外科部位展开时,支撑结构或者装置可收缩,并且支撑结构或装置包括固定零件诸如锚,以便一旦被展开就牢固地定位在合适的位置中。骨接合剂或者其它材料可被提供以可替代地紧固用于治疗的被定位支撑结构。
Description
交叉引用
本申请要求2005年5月18日提交的题为“Method and System forProviding Reinforcement of Bones”、申请号为60/682652的美国临时申请的优先权,其内容通过全文引用而包含在本申请中。
技术领域
本发明涉及提供骨加强的方法和系统。更具体地,本发明涉及提供用于重建和加强骨(包括患病、骨质疏松和骨折的骨)的重建外科手术过程和装置的方法和系统。
背景技术
骨折是人群中年轻人和老年人都常见的医学状况。但是,随着老龄化人口的增加,部分由于骨质疏松性骨折的风险,骨质疏松已经变得越来越受到更加显著的医学关注。骨质疏松和骨关节炎是影响肌骨骼系统中最常见的状态以及运动痛苦和无力的常见原因。骨质疏松在人类和动物(例如马)中都可发生。骨质疏松(OP)和骨关节炎(OA)在年龄超过五十岁的人口中的很大部分中发生。国际骨质疏松基金会估计,多达四千四百万美国人受到骨质疏松症和骨密度低的影响,在超过65岁的人中导致了超过300000人骨折。1997年,用于与骨质疏松症有关的骨折的估计花费为130亿美元。该数据在2002年增加到170亿美元并且预计到2040年增加到2100-2400亿美元。目前,预期超过50岁的两位女性中有一位、四位男性中有一位将遭受与骨质疏松症有关的骨折。骨质疏松症是老年人中引起骨折的最重要的潜在原因。
骨折的一种目前的治疗包括外科复位折断的骨。在外科手术后,身体的骨折区域(即骨折的骨定位的区域)常常被定位在外部石膏中一段时间以确保骨折的骨正确愈合。在恢复正常活动之前,对于骨愈合和患者除去石膏来说这可花费数月。
在一些情况下,骨髓内(IM)杆或者钉子被用于对准和稳定骨折。在所述情况下,金属杆被设置在骨腔内被并固定(通常为两端)在合适的位置。例如参见FixionTMIM(Nail),www.disc-o-tech.com。这种方法要求切割、进入骨腔并设置IM钉。钉子可随后被除去或者留在原位。常规IM钉手术要求类似但可能更大的开口以到达其中长的金属钉穿过骨折设置在其中的空间,并且随后除去金属钉或者当金属钉没有被除去时将IM钉长期植入。IM钉的外径必须被选择成用于该空间的最小内径。因此,部分IM钉可以不与腔接触。此外,骨和IM钉之间的微小运动可引起骨痛或者骨疽。在其它情况下,可发生感染。IM钉可在骨折愈合后被除去。这使得后续外科手术具有各种后来侵入手术的并发症和风险。
外部固定是用于修复骨折的另一种技术。在该方法中,杆可在表皮之外横跨骨折部位。杆使用经皮螺钉与骨连接。如果使用外部固定,患者将具有多个切口、螺钉和经皮感染途径。此外,外部固定是大表面侵入的,体积大并且易于通过环境条件因疏忽操作而造成痛苦,例如撞击在物体上和放置在装置上。
有关骨修复的其它概念例如在如下文件中公开:Scholten的美国专利US5108404:Surgical Protocol for Fixation of Bone UsingInflatable Device;Raftopoulos等人的US4453539:ExpandableIntramedullary Nail for the Fixation of Bone Fractures;Raftopolous的US4854312:Expanding Nail;Frey等人的US4932969:JointEndoprosthesis;Kuslich的US5571189:Expandable Fabric Implant forStabilizing the Spinal Motion Segment;Stednitz的US4522200:Adjustable Rod;Aginsky的US4204531:Nail with ExpandingMechanism;Berger的US5480400:Method and Device for InternalFixation of Bone Fractures;Poddar的US5102413:Inflatable BoneFixation Device;Krajicek的US5303718:Method and Device for theOsteosynthesis of Bones;Hogfors等人的US6358283:ImplantableDevice for Lengthening and Correcting Malpositions of Skeletal Bones;Beyar等人的US6127597:Systems for Percutaneous Bone and SpinalStabilization,Fixation and Repair;Warburton的US6527775:Interlocking Fixation Device for the Distal Radius;Levy等人的美国专利公开US2006/0084998A1:Expandable Orthopedic Device;以及Myers Surgical Solutions,LLC的PCT申请W02005/112804A1:Fracture Fixation and Site Stabilization System。
考虑到前述问题,需要具有提供一种有效的微创骨加强的装置、系统和方法以治疗骨折或者患病的骨。
发明内容
本发明的一种实施方式提供了用于骨或者肌骨骼系统的其它区域的固定、加强和重建的低重量体积比的机械支架。装置的输送方法是本发明的另一方面。根据本发明的各个实施方式的装置的输送方法减小了在外科手术期间形成的损伤,降低了与感染有关的风险,从而缩短了患者的恢复时间。在一种实施方式中,结构可包括可膨胀和可收缩结构以允许重新设置和除去加强结构或框架。
根据本发明的各实施方式,机械支撑结构或者装置可由各种材料制成,诸如金属、合成物、塑料或者无定形材料,包括但不限于钢、不锈钢、镀钴铬钢、钛、镍钛合金(镍钛诺)、超弹性合金和聚乙基甲基丙烯酸酯(PMMA)。支撑结构或者装置还可包括生物相容性的并提供机械强度的其它聚合物材料,包括具有携带并输送治疗剂能力(包括生物可吸收特性)的聚合材料,以及合成材料和钛合成材料和聚醚醚酮(PEEKTM),聚合物和矿物质的合成材料,聚合物和玻璃纤维的合成材料,金属、聚合物和矿物质的合成材料。
在本发明的范围内,每种前述类型的装置还可被涂敷有合成或者动物源蛋白质,或者包括胶原涂敷结构和放射性或者短距离放射治疗材料。此外,支撑结构或者装置的构造可包括不透射线的标记物或成分,在设置在骨骼或者肌骨骼系统的其它区域中的过程中或其后,它们用于辅助定位。
此外,在一种实施方式中,加强装置可以是骨包含的,使加强装置可被整合到骨中。
在进一步的实施方式中,提供了一种低重量体积比机械支撑结构或者装置,其与其它合适的材料结合配置以形成原位合成结构。所述合适的材料的示例可包括但不限于骨水泥、高密度聚乙烯、Kapton,聚醚醚酮(PEEKTM)以及其它工程聚合物。
一旦配置,在体内的配置部位处支撑结构或者装置可以是电、热或者机械被动或主动的。因此,例如,支撑结构或者装置包括镍钛诺,装置的形状可以使用热、电或者机械操作来动态改变。例如,一旦配置,镍钛诺装置或者支撑结构可被膨胀或收缩,以通过使用一种或多种热、电或机械方法来移动骨或者肌骨骼系统的其它区域或者解剖区域。
本发明的实施方式包括可锁定骨固定装置,包括:适于定位在骨中形成的空间的套筒;适于导引套筒运动的导丝;和适于从装置的末端将套筒固定在骨的空间中的可致动锁。套筒可被构造成柔性的,具有窗,可膨胀和/或可生物吸收。此外,如果需要,套筒可从骨内的空间被除去。装置适于并被构造成经过在骨的骨隆突中形成的进入窗进入骨内空间。在进一步的实施方式中,第二套筒可被提供,其适于配合在第一套筒中。在提供第二套筒的情况下,第二套筒可被用于控制可收缩交错接合突或者齿。该套筒可通过被构造成沿着其长度具有槽或者窗来实现这种控制,当槽被定位在齿的上方时齿延伸穿过该槽或窗。一旦齿经过第二套筒被暴露,齿或者交错接合突适于接合骨。在本发明的又一实施方式中,悬臂适于将可锁定骨固定装置保持在空间中。本发明的另一种实施方式包括由用户在空间内调节待膨胀和收缩套筒。在又一实施方式中,装置适于由导管输送。在另一实施方式中,装置的远端适于提供钝套管(obdurator)表面。在装置的又一实施方式中,装置的远端被构造成提供导引尖。在装置的另一实施方式中,装置适于接受外部刺激以提供对骨的治疗。在装置的又一实施方式中,当装置被设置在内腔或身体或者骨骼开口中时装置适于接收合成材料。
在本发明的另一种实施方式中,提供了骨固定装置,包括:在沿着其长度适于接合骨的位置处具有可收缩交错接合突的第一套筒;和尺寸适于致动第一套筒的交错接合突的第二套筒。骨固定装置可被构造成提供柔性的第一或第二套筒。在另一种实施方式中,第一或第二套筒可被设置有窗,可膨胀和/或可由可生物吸收材料形成。在又一种实施方式中,第一或者第二套筒可被除去。在本发明的再一种实施方式中,第一和第二套筒适于经过在骨的骨隆突中形成的进入窗进入骨的空间。在又一种实施方式中,第二套筒可被构造成提供可收缩交错接合突或者齿。在一些实施方式中,还可沿着装置的长度提供窗,可收缩交错接合突经过该窗来接合骨。在一些实施方式中,窗可以在第二套筒上。在一些实施方式中,当由第二套筒致动时可收缩交错接合突可适于接合骨。在另一些其他实施方式中,悬臂将骨固定装置保持在骨的空间中。此外,第一或第二套筒适于在一些实施方式中通过用户在骨中膨胀和收缩。在另一些其他实施方式中,装置适于由导管或者导管状装置输送。导管可以是单腔或者多腔管。导管可采用能够提供动力或者形成装置以便引入和设置的方法或装置。在一些实施方式中,装置的远端适于提供钝套管(obdurator)表面。另外,装置的远端可以具有导引尖。在另一些其他实施方式中,装置适于将治疗刺激输送到骨。在其它实施方式中,装置适于将治疗刺激输送到骨中的生物过程。这些过程本质上是细胞的并且提供治疗药物给患者的与骨不相关的状态。一种所述治疗应用是贫血或血友病。在一些其它实施方式中,当装置被设置在腔中时,装置适于接收合成材料。
在本发明的又一实施方式中,公开了修复骨折的方法,其包括:沿着骨的长度经过骨末端的进入点处的骨隆突进入骨折处;经过骨末端处的进入点将骨固定装置推进到空间中;沿着其长度弯曲一部分骨固定装置以横跨骨折处;并将骨固定装置锁定到骨空间内的位置中。该方法还可包括在将骨固定装置推进到空间中之前将套筒经过骨隆突推进并穿过骨折处的步骤。在方法的又一种实施方式中,可包括将骨固定装置锚定在空间中的步骤。在方法的再一种实施方式中,骨固定装置的第一套筒和第二套筒可被接合以将交错接合突膨胀到骨中。
本发明的一个方面公开了一种可拆卸骨固定装置,其具有引入、展开和远距离致动的单个末端,其中骨固定装置稳定骨。骨固定装置适于在装置开始与骨相互作用处的一个区域或位置中提供单个末端。装置可被展开,使装置与骨相互作用。在其与骨相互作用过程中,远距离致动启动、解除启动、复原骨(reduce bone)、使骨位移、锁定、设置、除去、夹持、硬化装置、压缩、调节、轴向调节、扭转调节、角度调节并释放装置。可拆卸提取器可被设置在装置的一些实施方式中,使装置通过从单个末端展开和远距离致动以被设置和提取。本发明的装置可适于并被构造成提供至少一个套筒。此外,套筒可被构造成沿着所有的角度和方向都是柔性的。所提供的柔性在直角坐标、极坐标、柱面坐标系统中为选择平面和角度。此外,在一些实施方式中,套筒被构造成在单个末端具有远距离致动。另外,套筒被构造成具有窗口。在进一步的实施方式中,套筒被构造成使骨内生长最小化。本发明的另一方面包括骨固定装置,其具有通过改变直角坐标、极坐标或柱面坐标系统的至少一维尺寸来与骨相互作用的机械几何结构。此外,在一些实施方式中,生物可吸收材料可与该装置结合使用,例如通过提供由生物可吸收材料构造的装置的特定子元件。在一些实施方式中,可提供第二套筒,其中第二套筒可拆卸、具有展开、远距离致动和单个末端。在采用第二套筒的实施方式中,第二套筒可适于提供可展开交替接合突或者沿着其长度提供窗,可展开交替接合突适于通过该窗接合骨。在一些实施方式中,当由套筒致动时可展开交错接合突进一步适于接合骨。在一些实施方式中,骨固定装置进一步包括适于将可展开骨固定装置保持在空间中的悬臂。套筒可进一步适于由用户在空间中膨胀和收缩。装置的一端可被构造成提供适于推进到骨中的钝套管表面。导引尖还可被提供,以便于引导装置经过骨。此外,可展开骨固定装置可适于接受外部刺激以提供对骨的治疗。装置还可适于提供整体刺激物,其为骨提供治疗。在其它实施方式中,装置可适于向骨输送治疗刺激。
本发明还包括一种用于修复骨折的方法,包括:经进入口处的骨隆突沿着骨长度接近骨折;经进入口将骨固定装置引入骨髓腔;沿着其长度弯曲骨固定装置以行进到骨的骨髓空间中;沿着其长度弯曲骨固定装置以横跨骨折部位;将柔性肘设置在骨折部位处的骨髓腔中;硬化骨固定装置;将骨固定装置锁定到骨;使用骨髓腔中处于合适位置中的骨固定装置复原骨折;锁定柔性肘以实现骨折的骨髓内复原。所述方法可进一步包括经进入口处的骨隆突将导丝引入到骨髓空间的步骤。另外,导丝可经过进入口处的骨隆突被铰扩。被铰扩的骨腔的位置可由骨折解剖和骨解剖结构确定。在该方法的一些实施方式中,套筒可沿着骨固定装置行进。在这些实施方式中,套筒可用于从固定装置打开长钉。一旦长钉被从固定装置上打开,然后长钉将装置固定到骨上。还可以采用锁定蝴蝶环,以将装置锁定到骨。在一些实施方式中蝴蝶环可被锁定到固定装置。另外,环可以螺纹方式连接在装置上。在其它实施方式中,导引夹具经蝴蝶环导引螺钉。此外,自攻螺钉可将蝴蝶环锁定到骨和骨固定装置。定位螺钉还可被用于将装置锁定在骨折部位。装置还可被硬化。在执行本发明的方法时,骨折碎片可被复原。
本发明的另一方面包括带倒刺的螺钉,其包括套筒、一个或多个在套筒的远端的可展开的齿和适于从装置末端将套筒固定在骨的空间内的可致动锁。
当考虑本发明的下列详细描述和附图时,将理解本发明的这些和其它特征和优点。
在本说明书中提及的所有公开出版物、专利和专利申请都通过全文引用而包含在本申请中,其包含的程度如同每个独立出版物、专利或者专利申请通过引用而特别和独立指出被包含的程度相同。
附图说明
本发明的新特征在所附权利要求书中特别阐明。通过参考阐明示例性实施方式的下列详细描述可得到对本发明的特征和优点的理解,在典型实施方式中本发明的原理将被利用,其附图为:
图1A-B示出了处于展开前和展开状态的可致动骨固定装置;
图2A-C示出了适用于可致动骨固定装置的支承件的图示;
图3A-C示出了适用于可致动骨固定装置的支承件的图示;
图4A-F示出了适用于可致动骨固定装置的保持件;
图5A-B示出了适用于可致动骨固定装置的外置致动器;
图6A-D示出了适用于可致动骨固定装置的外置致动器的替代实施方式;
图7A-C示出了适用于可致动骨固定装置的销;
图8A-D示出了适用于骨固定装置的外部套筒的构造;
图9A-D示出了适用于骨固定装置的外部套筒的替代构造;
图10A-B示出了处于展开前和展开状态的可致动骨固定装置的另一种实施方式。
图11A-B示出了处于展开前和展开状态的可致动骨固定装置的又一种实施方式。
图12A-C示出了图11中显示的可致动骨固定装置的实施方式的近端,包括组成部件;
图13A-B示出了适用于本发明的装置的万向接头或者u-接头;
图14示出了适用于本发明的装置的柔性连接组件;
图15A-B示出了远端组件的构造;
图16A-C示出了干骺端轴(metaphyseal shaft);
图17示出了干骺端锁定凸缘;
图18示出了干骺端锁定螺钉;
图19示出了干骺端定位螺钉;
图20A-B示出了适用于本发明的装置的u-接头的替代实施方式;
图21A-B示出了适用于本发明的柔性连接组件的替代实施方式;
图22A-B示出了适用于柔性连接组件的栓钉;
图23A-B示出了柔性连接组件的替代实施方式;
图24A-B示出了柔性连接组件的鞘;
图25A-B示出了套管捕获销;
图26A-B示出了柔性连接栓钉;
图27示出了柔性锁定销;
图28A-B示出了柔性连接锁定销;
图29示出了套管捕获销;
图30A-D示出了骨干锚;
图31A-B示出了去除工具;
图32示出了在桡骨中展开的本发明的装置;
图33示出了根据本发明的另一种可致动骨固定装置;
图34示出了骨中骨干到干骺端的剖面;
图35示出了进入到骨髓腔的外科进入点;
图36示出了定位在进入腔中的本发明的装置;
图37示出了根据本发明的可致动带倒刺螺钉;
图38示出了展开的带倒刺螺钉;
图39示出了带倒刺螺钉的侧面图示;
图40示出了根据本发明的两部分带倒刺螺钉;
图41示出了使用横向定位的可致动带倒刺螺钉展开的被展开可致动骨固定装置;
图42示出了使用径向定位的带倒刺螺钉展开的被展开可致动骨固定装置;
图43示出了使用混合定向带倒刺螺钉展开的被展开可致动骨固定装置;
图44示出了具有进入点指示的患者的股骨;
图45示出了具有进入轴的钻的患者的股骨;
图46示出了具有在骨中钻孔的取芯铰刀的股骨;
图47示出了用于双向流路以便从骨中除去碎片的灌洗系统;
图48示出了在骨中的可致动骨固定装置;
图49示出了图48的装置的透视图;
图50示出了图48的装置的剖视图;
图51示出了展开的穿骨(cross-bone)固定装置;
图52示出了将加强装置定位在所需的位置;
图53A-E示出了在骨中应用多个结构加强装置;
图54示出了可膨胀装置;
图55示出了钻心到骨的上转子区域的装置;
图56示出了将装置输送到上转子中。
具体实施方式
作为背景技术并为本发明提供上下文,对理解有用的是骨常常被描述为专门连接组织,其用于三种主要解剖学功能。第一,骨通过提供用于运动的结构和肌肉连接提供了力学功能。第二,骨通过提供钙和磷酸盐的储备提供了新陈代谢功能。最后,骨通过封闭骨髓和重要器官提供了保护功能。骨可被分为长骨(例如桡骨、股骨、胫骨和肱骨)和扁平骨(例如头骨、肩胛骨和下颚骨)。每种骨类型具有不同的胚胎学模板。此外每种骨类型含有变化比例的皮质骨和松质骨。
皮质骨(致密)形成长骨的轴或者骨干和扁平骨的外鞘。皮质骨提供主要的机械和保护功能。松质骨(多孔)一般在长骨的末端或者骨骺和扁平骨的皮质中。松质骨由相互连接的松质骨板和杆的网络构成,并且是骨重塑和矿物质体内平衡吸收的主要部位。在发育过程中,骨骺和骨干之间的生长区是干骺端。最后,缺少皮质骨和松质骨的组织化结构的编织骨是骨折修复过程中首先敷设的骨。一旦骨经受骨折,骨片段以使编织骨能够被敷设在骨折的表面上的方式被彼此靠近定位。这种解剖和生理的描述被提供以便促进对本发明的理解。本领域技术人员将会理解,本发明的范围和本质不限于所提供的解剖学探讨。此外,应当理解,作为在这里没有描述的各种因素的结果,在个体的解剖学特征方面可以有变化。
图1A-B示出了处于展开前和展开状态中的可致动骨固定装置100。骨固定装置100具有近端102和远端104。在本文中所使用的近端和远端指的是装置的末端相对于装置的其余部分或者相对端的位置,如同其在附图中显示的那样。近端可被用于指由用户或者医生操纵的末端。近端可被构造成使其一部分保持在骨之外。作为替代,近端被构造成使其不保留在骨之外。因此,远端可被用于指被插入并在骨中行进且离医生最远的装置末端。如同本领域技术人员理解的那样,近端和远端的使用在另一种环境下可发生变化,例如解剖环境下。
骨固定装置适于加强和/或修复骨。此外,骨固定装置适于解剖上的舒适。再次,骨固定装置适于穿过骨折部。一旦被致动,装置锚定到一部分骨中然后将受骨折影响的骨片段拉到一起。在存在另外的骨折片段处还可使用Kirshner或者K-线。
骨固定装置100具有在近端102处的致动器110。致动器110使用户能够控制装置的运动、插入、展开、去除和操作。致动器110具有与轴或者导丝120上的螺纹112接合的内螺纹(未显示)。轴120延伸穿过近端支承件132、中间支撑件134并终止于远端支承件136。位于插入轴120上的支承件之间的是锚定件140。支承件控制装置100的平移和弯曲。在一些实施方式中,支承件可承受例如达到8001b的轴向负载力。锚定件140具有径向延伸的齿或者夹持器142,其在装置100致动时展开以将装置与骨互锁(将在下面解释)。
外鞘150是装置100的元件。外鞘围绕装置100的一部分暴露长度。槽152沿着其长度设置,当装置被致动时使锚定件140的齿142能够径向延伸离开装置100的外表面并进入骨。槽152还可适于促进或控制装置的弯曲(在下面详细解释)。在图1A中,装置以展开前状态即在展开锚定齿之前被示出。在展开之前,锚定件140的齿142被定位在套筒150中。当装置被致动时,如图1B中所示,致动器110旋转,使驱动轴120被拉到致动器110中。将驱动轴120拉到致动器中相对于套筒150向近端拉动支承件和锚定件,从而将锚定件140和齿142定位在槽152附近。在该实施方式中,齿142由可膨胀材料诸如形状记忆金属(例如镍钛诺)制成,以便当装置致动时回复到不受限制的位置。该致动导致齿径向运动远离装置的轴。在需要或者希望时齿可通过反转致动器110的旋转方向而回缩,从而相对于套筒向远端推动支承件和锚定件。齿142的倾斜和角度帮助槽152的边缘使齿142向内凸轮运动到图1A中显示的位置。
图2A-C示出了例如在远端适用于可致动骨固定装置的支承件230(同样参见图1中的支承件136)。如图2A-B中所示,如图所示,支承件具有大致球形形状,其中腔232穿过其定位以便容纳驱动轴或者导丝,诸如上面所示。如图所示,腔具有在第一末端的第一圆周233和在第二末端的第二圆周233A。第一圆周233是适应并构造成容纳陷型或者不连续的中间干涉锁定零件的远端圆周(在执行期间如图被定向)。陷型零件防止装置的远端支承件136从近端向远端平移,从而保持装置100的所有近端内部元件。图2C示出了支承件的剖面图,进一步示出了大体为圆形外形,并且第一直径233对应于第一圆周,第二直径233A对应于第二圆周。当被定位在远端时,支承件可作为适于方便骨穿刺的钝套管。
图3A-C示出了适用于可致动骨固定装置的另一种支承件330。如图所示,支承件具有大体上为球形形状,腔332穿过其被定位。在该实施方式中示出的腔具有沿着其长度不变或者大体上不变的直径,适于容纳装置100的驱动轴或者导丝120。另外的制动器336、缺口或者腔可被提供。制动器336可被构造在表面上使制动器可被定位在支承件330的相对侧上,如图所示,而不与形成以容纳驱动轴的腔332交叉或者穿过腔332。制动器可被形成以容纳销,或者被形成以提供穿过支承件的另外的腔,或者被压缩或型煅在驱动轴上或者可被构造成任何其它合适的构造。如图3C所示,腔332横穿支承件330,同时制动器被形成在相对侧上并与腔332围绕其定位的轴成90°定向。其它定向和构造也是可能的,也不脱离本发明的范围。
现在转到图4A-F,示出了适用于本发明的可致动骨固定装置的保持或者锚定件。图4A-B示出了在齿442展开之前的锚定件440的透视图。锚定件440适于配合在套筒150(图1A-B)中并且具有中心腔444,驱动轴120(图1A-B)或者导丝可穿过其定位。锚定件440的一部分外表面可被构造成形成一个或多个齿442。齿442可与锚定件440一体形成。齿442和/或锚定件440可由任何合适的材料制成,包括镍钛诺。在使用形状记忆合金时,齿442可被构造成当齿没有被限制在套筒内时采取预定的形状,如图4E中所示。另外的槽446可沿着锚定件的长度被提供。槽446可被用于接合例如从外套筒延伸的销以便控制锚定件在套筒中的旋转运动。转向图4D-E,齿442弯曲远离锚定件440的外表面。图4F示出了在本文中图示的锚定装置的剖面,其中齿442被偏转远离锚定件的侧面。齿可从交替表面发出并在腔444的中心线处交叉,从而形成更长的悬臂件。
图5A-B示出了适用于可致动骨固定装置的致动器。致动器510具有圆柱体512,该圆柱体具有带内螺纹内部514或者任何其它能够致动以便暴露齿442的构造。设置凸缘516,其可被用于将装置锚定在表面(诸如骨)上。另外,凸缘516的顶面可适于能够控制致动器510和驱动轴120(如图1中所示)。一个或多个窗518可被提供以接合例如螺钉。窗518可提供机构将装置锚定在骨的表面上(与仅仅抵接在骨的表面上相反)。凸缘516的外周表面517还可进一步设置有标记513或者适于提供指示,以便于通过为用户提供齿相对于鞘上的槽以及相对于骨内的平面的相对位置的指示来展开齿。由此建立装置的柔性方向同时建立骨中的柔性方向。另外,可提供形成键槽的中央窗519以便接合另外的工具或装置,以控制骨固定装置的展开。例如,中央窗519可以是狭槽形状以容纳例如平头螺杆驱动器的头部。
图6A-D示出了适用于可致动骨固定装置的致动器610的替代实施方式。在图6A-B中示出的实施方式中,中央窗619适于接合具有螺纹末端的工具。图6C-D示出了致动器610的俯视图和侧视图。与图5中示出的装置类似,致动器610具有圆柱体612,该圆柱体具有带内螺纹的内部614或者任何其它能够致动以便暴露齿642的构造。设置凸缘616,其可被用于将装置锚定在表面(诸如骨)上。另外,凸缘616的顶面可适于能够控制致动器610和驱动轴120(如图1中所示)。一个或多个窗618可被提供以接合例如螺钉。窗618可提供机构以将装置锚定在骨的表面上(与仅仅抵接在骨的表面上相反)。另外,形成键槽的中央窗619可被提供以便接合另外的工具或装置,以控制骨固定装置的展开。例如,中央窗619可以是狭槽形状以容纳例如平头螺杆驱动器的头部。
图7A-C示出了适用于可致动骨固定装置的销760,以防止锚定件相对于鞘的旋转运动。销760具有适于接合套筒的内部部分的头部762和配合在锚定机构的槽中的颈764。
图8A-D示出了适用于骨固定装置的外部套筒850的构造。在所示的构造中,C-切口852和852A沿着鞘850的长度被使用。C-切口的使用提供了沿着鞘的中心轴线垂直于所描述的页面的平面中的柔性。如图所示,与图1中显示的单个类型的C-切口不同,可使用两种类型的C-切口。在远端804,C-切口成对设置在长度上的位置中并从相对侧向着鞘的中心平面延伸。C-切口使装置的齿442能够向外延伸离开中心轴进入骨中。向着近端802,C-切口高度更小并延伸穿过鞘的中心平面(例如其中导丝或者控制杆穿过装置的中心定位的平面)。因此,从一侧观察,切口具有S形轮廓,如图8C所示。远端切口提供了柔性并且当装置被致动时使齿442能够延伸穿过切口。近端切口也提供了柔性,但由于切口的定向和设计的原因提供了不同程度的柔性。如图8D(其为沿着图8C的线D-D的剖面)中所示,C-切口的近端组给出了鞘被分节的外观,而远端切口看起来是相对的C-切口。通过这种方法,平面优先的柔性被建立在代表性但非限制性的装置的实施方式中。如同本领域技术人员所理解的那样,两种以上类型的C-切口可被使用而不脱离本发明的范围。
图9A-D示出了适用于骨固定装置的外套筒的又一种替代实施方式。在所示的装置中,与在图8中示出的近端组切口上提供深的C-切口不同的是,提供了螺旋切口954。螺旋切口提供了沿着所有方向和所有平面中的柔性。如图所示,C-切口952沿着鞘950的至少一部分长度被使用。
现在转向图10A-B,图示了处于展开前和展开状态的可致动骨固定装置1000的另一种实施方式。该实施方式使用具有两种类型C-切口的外鞘1050,如同参照上面图8中显示和描述的那样。C-切口1052沿着鞘1050的长度被使用。如上所述,C-切口的使用提供了沿着鞘的中心轴线垂直于页面的平面中的柔性。如图8所示,两种类型(或者更多)的C-切口可被使用,这与图1中显示的单个类型的C-切口不同。在远端1004,C-切口成对设置在长度上的位置中并从相对侧向着鞘的中心平面延伸。C-切口使装置的齿1042能够向外延伸离开中心轴进入骨中。向着近端1002,C-切口高度更小并延伸穿过鞘的中心平面(例如其中导丝或者控制杆穿过装置的中心而定位的平面)。因此,从一侧观察,切口具有S形轮廓,如图10B所示。远端切口提供了柔性并且当装置被致动时使齿1042能够延伸穿过切口。近端切口也提供了柔性,但由于切口的定向和设计的原因提供了不同程度的柔性。
图11A-B示出了处于展开前和展开状态的可致动骨固定装置1100的另一种实施方式。装置1100具有近端1102和远端1104。部分1106是设置在骨的干骺端部分中的装置的一部分。部分1106还可设置在其它类型的骨中包括骺骨和骨干。部分1108是装置的安放在骨干中的部分。近端组件1110执行与干骺端骨的连接。从图11中也可看出的是干骺端锁定凸缘1112和干骺端锁定螺钉1114。部分1130是提供关节运动和对准的万向接头。部分1132是万向接头鞘。柔性连接件1140提供了侧向中间平面中的柔性。部分1142是柔性连接件鞘。部分1150是具有槽1152的装置的外鞘。部分1160是远端组件。部分1162是套筒并且部分1164是远端柔性连接栓钉。部分1170是具有齿1172的骨干锚。在远端1104和近端1102,柔性连接部分1140可适于接合骨干锚定件1170。如图所示,锚定件1170紧密配合在柔性连接部分1130周围。每个骨干锚定件1170可具有一个或多个齿或者夹持器1172,当展开时它们适于使齿在骨中相互交叉。齿1172可被构造成使齿偏转远离锚定件1170并进入骨中。齿1172以一定角度延伸,以使其以最短长度进行最大锚定。当齿1172插进骨中时,齿对抗扭转并对抗近端和旋转运动。外鞘1150定位成将齿1172保持在装置的部分附近,直到槽1152邻近齿1172,然后齿1172可在该位置处与骨接合。远端1104可适于形成套筒1162以便在骨中保持和/或形成装置通过其穿刺的空间。如图11B所示,当邻近槽1152时齿1172从装置1100张开。
图12A-C示出了近端组件1200的实施方式。该组件由干骺端轴1210、一个或多个干骺端锁定凸缘1220、干骺端锁定螺钉1230和干骺端定位螺钉1240构成。干骺端定位螺钉1900在图19中另外详细显示。干骺端轴1210将固定力经过万向接头1130转移到骨干部分1108。干骺端锁定凸缘1220支承在干骺端轴1210上。干骺端锁定螺钉1230螺旋连接经过干骺端锁定凸缘1220,切入(cut into)干骺端锁定凸缘1220并将其保持到干骺端轴1210,并将骨、悬臂、动物组织紧固到干骺端轴1210。
图13A-B示出了万向接头1300的实施方式。该实施方式由鞘1310(鞘2200在图20中进一步详细显示)和骨干销1320(骨干销2100在图21中进一步详细显示)构成。万向接头1300允许干骺端部分1106相对于骨干部分1108进行半球形旋转。骨干销1320将万向接头1300与第一近端柔性连接件1400连接。
图14示出了柔性连接组件1400的实施方式。柔性连接组件1400包括凹形销(female pin)1420(凹形销2300在图23A-B中进一步详细显示)、栓钉1410(栓钉2200在图22A-B中进一步详细显示)和鞘1430(鞘2400在图24A-B中进一步详细显示)。柔性连接栓钉2200具有支承表面2214,其被捕获在鞘2400中并在其中轴向并且倾斜滑动。柔性连接凹形销支承表面2312与鞘支承表面2430交界。栓钉2316和凹形销中的腔2218和2316容纳柔性连接锁定销2800。柔性连接栓钉2200和柔性连接凹形销2300的形状允许在柔性连接锁定销2800设置之前介导(medial)侧向柔性。穿过柔性连接栓钉2200的腔2218容纳柔性连接锁定销2800。当插入并靠近柔性连接锁定销2800的远端致动时,柔性连接栓钉2200和凹形销2300由此被平移,使锁定力被施加在鞘2400和柔性连接凹形销之间。该锁定系统施加对骨干和干骺端的中间侧平面中的运动的抵抗力。穿过柔性连接栓钉2200的腔2218被成形为使得使整个组件的球面角度净空(clearance)达到180度,其通常为30到45度。图30显示了骨干锚3000的实施方式,其包括齿3010和环形部分3020。骨干锚在柔性连接件1400的轴2400上滑动并与其刚性干涉。锚定件3000的齿3010被设置成专门并最大固定骨干、干骺端和骺骨。与齿3010的旋转和形状耦合的角度可采取销、杆、矩形、平截圆锥体、锥体或者其它多边形的形式。齿3010的数目通常为两个,但不限于两个。在所示的实施方式中,齿3010被定向以防止当在骨中展开时装置的轴向和旋转运动。若干组齿3010可被并列以阻止远端向近端以及近端向远端的轴向运动。本领域已知的是,骨髓内空间与内径不一致,骨干锚3000可被专门设计以通过改变齿3010的形状来容纳内径的这些不一致。
图15A-B示出了远端组件1500的实施方式。远端组件1500包括套筒或者远端支承表面1510(远端支承表面2500在图25中进一步详细显示)、远端柔性连接栓钉1520(柔性连接栓钉2600在图26中进一步详细显示)、套筒捕获销1530(套筒捕获销2700在图27中进一步详细显示)、柔性连接锁定销1540(柔性连接锁定销2800在图28A-B中进一步详细显示)。在图29中,远端支承表面2500与柔性连接销2800和外鞘2900连接。套筒捕获销2700限制了外鞘2900相对于锚定件3000的齿3010的运动范围。
图16A-C示出了干骺端轴1600的实施方式。该实施方式的支承表面1630与干骺端锁定凸缘1700交界,它可以是平滑的、锯齿状的、有节的、带键的、槽形、多边形或者椭圆形的。连接表面1610将干骺端轴1600与图13的万向接头1300连接。干骺端轴1600提供了将固定力从图11的干骺端部分1106传递到万向接头1300的手段。在干骺端轴1600中的是通过万向接头1300将图12的近端组件1200锁定到图11的骨干部分1108的部件,该部件还防止垂直和平行于骨干纵轴的360度的球面运动。
图17示出了干骺端锁定凸缘1700的替代实施方式。螺钉孔1710容纳图18的干骺端锁定螺钉1800。开口1716容纳图16的干骺端轴1600。窗口1712暴露干骺端轴1600并容纳图18的干骺端锁定螺纹1810和1820,从而经过干骺端锁定螺钉1800将力传递到干骺端轴1600并将干骺端锁定凸缘1700锁定到干骺端轴1600。开口1716允许干骺端锁定凸缘1700围绕干骺端轴1600进行360度旋转。由垂直于轴的轴线的线和垂直于螺钉孔1710的轴线的平面描述的角度1720可以是0到180度。该实施方式是描述性的而不是限制性的。干骺端锁定凸缘1700、干骺端锁定螺钉1800和干骺端轴1600的功能允许干骺端固定移动到骨干固定,其可在与骨干的轴线平行和垂直的轴中360球面度中无限调节。
图18示出了干骺端锁定螺钉1800的实施方式。干骺端锁定螺钉的螺纹1810和1820在直径上可以是单螺距牙底(single pitch root)或者多螺距、牙底和直径。螺纹1820和1810可呈现各种特征诸如平滑的、锯齿状的、有节的、带键的、槽形、多边形或者椭圆形的。干骺端锁定螺钉1800可经过其轴线插入导管,允许通过导丝展开。
图31示出了用于本发明的可植入装置的展开/除去工具3100的实施方式。工具3100由手柄3110、柔性轴3120和带螺纹插口3130组成。
图32示出了来自具有骨折部3202的手臂的桡骨3201、具有植入其中的装置3203的桡骨和具有植入其中的装置的一部分桡骨的剖视图。虽然图32显示了桡骨3201中骨折部3202的位置,应当理解本发明及其各种实施方式可被应用于变化角度和位于骨结构中任何位置的骨折。此外,本领域技术人员还应当理解,本发明的各种实施方式可被应用于包括人的动物中的任何骨,并且骨折的本质可以是由于外伤或者由于相关疾病诸如骨质疏松症引起的单处、复合或者粉碎性骨折。如图32所示,装置3203经过皮质骨在骨隆突3204处进入骨。装置3203经过皮质骨3205行进并如图所示被定位在骨髓或者其它骨髓内成分中的骨髓内空间3206中。
图33示出了具有沿着其至少一部分长度的线形式外鞘3320的可致动骨固定装置3310的另一种实施方式。线形式鞘可被焊接到例如不锈钢海波管(hypotube),并可被构造成提供处于转弯(turned-out)位置的末端以防止旋转。
在穿过骨干到干骺端的骨固定方面的挑战已经使干骺端的松质骨安全。该骨为海绵状并且易碎或者是空的,特别是在骨质疏松症患者中。医生必须在刚性到刚性表面固定和刚性到多孔表面固定之间选择。这里描述能够实现骨骼中刚性到多孔固定的系统的一种实施方式。图34是动物或者人的一种骨骼的骨干到干骺端的过渡的剖面图。示出了干骺端的松质骨或者多孔骨3401。骨髓内空间3402沿着骨的轴线被示出。图34示出了具有横向骨折和倾斜骨折骨碎片3404的骨3403的一部分。在实践中的挑战是将这三个骨碎片(一个骨干和两个干骺端)接合在一起。本发明的实施方式能够在骨干的所有直角坐标、极坐标、球面和柱面坐标轴中形成刚性连接的基础。图35显示了在形成腔3501之后从干骺端骨到骨干外科进入到骨髓内空间3502。在前述发明说明书中描述的装置3601被设置在腔中并如图36所示展开。图37示出了新的带倒刺螺钉。带倒刺螺钉包括工具界面诸如六边形头部、平头、梅花头或者Phillips头螺钉驱动零件3701。特征3702是螺纹连接并锁定到装置3601的干骺端部分的螺纹或者经过干骺端锁定凸缘1700进行连接和锁定的螺纹。带倒刺螺钉包括镍钛或者其它刚性金属、聚合物或者能够在显著张力下变形而不屈服或断裂的线或者细丝3703。在一种实施方式中,线或者细丝在末端3704被切成斜角以形成锋利或者穿刺端。当除去抑制力诸如外鞘3705或者通过热、电或者机械方式致动时,细丝经历物理变化并将形状改变成3801或者其它形状,如图38中所示。多个线或者细丝3901可沿着带倒刺螺钉的长度定位,如图39所示。线或者细丝可用于多种目的,诸如形成螺纹以便于设置带倒刺螺钉。然后,当除去限制力或者施加外部动力时,双重目的的螺钉零件4001然后可转动并形成弧形以捕获骨,如图40中所示。带倒刺螺钉可经过装置3601被展开,由螺纹4001保持到装置3601,并横过装置3601的位置来捕获骨,如图41中的4101所示。带倒刺螺钉可从装置3601沿径向捕获骨,如图42中的4201所示。骨碎片捕获的混合模式可被利用并显示在图43中。
当展开时可致动带倒刺螺钉适于为小直径提供大量的表面积;提供螺钉和倒刺捕获形式的组合;将螺纹锁定到装置3601;并通过除去外力或者通过热、电、光或者机械方式将能量施加到装置来致动。任何频率的电机械放射光谱可被用于将所述能量施加到系统。
如同本领域技术人员可以理解的那样,可致动带倒刺螺钉可被构造成提供更高的保持力并通过采用在经历变化之后改变它们的捕获半径的刚性材料捕获。此外,倒刺可被构造成代替螺纹以帮助带倒刺螺钉的插入。
可以根据本发明来联想到其它实施方式、方法和用途。因此,例如,钻可被用于在定位在具有骨折的骨的图44所示近端4401或者远端4402的骨隆突处开孔,以进入皮质(松质)骨;其中在解剖学上,文中的近端是最靠近身体中线的末端,在解剖学上,文中的远端是离身体中线最远的末端。例如,在肱部上,肱部的头部处(定位在近端或者最靠近身体中线)或者在侧面或者中上髁(定位在远端,或者离中线最远);在桡骨上,在桡骨头部处(近端)或者桡骨茎突(远端);在尺骨上,在尺骨头部处(近端)或者尺骨茎突(远端);对于股骨来说,在更大的转节(近端)或者外上髁或者中上髁(远端);对于胫骨来说,在中髁(近端)或者中踝(远端);对于腓骨来说,在腓颈处(近端)或者外踝(远端)处;肋骨;锁骨;指骨;掌骨;腕骨;跖骨;跗骨;胸骨和具有足够内部尺寸容纳机械固定的其它骨。如同本领域技术人员所理解的那样,取决于骨折的位置和性质和待实现的修复,与本文中描述的不同的进入位置也是合适的。另外,在本文中教导的装置不限于仅仅在上述列出的长骨上使用,而且还可用于身体的其他区域,也不脱离本发明的范围。使装置用于扁平骨以及长骨也在本发明的范围之内。
根据方法的一种实施方式,如图45中所示的切口4501可在患者皮肤上大体上与例如骨折骨的近端或远端对准的位置处(例如松质骨被定位的骨的末端处)形成。切口由此允许皮肤大体上围绕待拉回或者待回折的位置处的切口,以便暴露骨折骨的末端。进入部位的位置由外科医生基于用于本发明的各种装置的最佳进入点的诊断来选取。进入点包括被认为微创的骨区域。这些部位包括在肘、膝盖和踝处的交叉点处的骨区域,例如定位在长骨末端的皮质骨或松质骨。
钻头4502可由外科医生操作以钻孔,在骨折骨的中央部分中形成空间。参见McDowell等人的美国专利US6699253,题为Self-Centering Bone Drill。但是,如同本领域技术人员理解的那样,能够经过组织层并进入骨折骨进行开孔的任何工具都可使用,都不脱离本发明的范围。这种装置的一个例子包括但不限于如图46中所示的取芯铰刀4601,其可被用于对骨钻孔(将在下面讨论)。参见Carlo Jr.的美国专利US6162226:Long Bone Reamer with Depth StopIndictor。在一种实施方式中取芯铰刀可被构造成从进入点收集骨堵塞物(bone plug)用于进一步封闭外科手术形成的伤口。该方法可促进愈合,并提高与强度、感染、和任何异物的免疫排斥有关的外科结果。
钻或者绞刀可沿着骨的长度被操作以便到达骨折的位置。如同本领域技术人员所理解的那样,柔性铰刀的使用可要求远端导引件4602以防止对周围骨因疏忽而造成的伤害或损伤。为了提供所述导引件,线或者最小剖面尺寸的其它薄弹性、柔性机构可被提供以提供所述导引件。导丝在进入部位形成和空间暴露之后被设置。第二进入孔4603可在远离最初的进口处形成。导丝然后使用标准技术被展开到骨空间中,从近端进入孔穿过骨到达第二进入孔。此外,装置可使用其远端作为套管以形成穿过骨的通路,经过骨髓内空间和/或穿过骨折是理想的。
定中机构4604可被用于“悬浮”导丝离开空间和骨内部特征的末端。导丝和定中机构在整个手术过程中可被留在合适的位置中并且对随后的清洁和加强装置的设置来说存在相当大的好处。第二远端进口可以是可选的。定中机构或者在荧光镜下的观察可排除对远端进口的需要。在使用导丝的该实施方式中,定中机构可独立于远端进口使用。另一种实施方式消除了对远端进口和定中机构的需要。在该实施方式中,仅仅导丝被用于将铰除工具定位在中心。在另一种实施方式中不使用导丝。铰除工具通过在荧光镜下观察的技术或者其它方式定位在中心。
此后,骨中的通道诸如骨髓内空间被形成并且被清洁,以在将加强装置经过骨折骨内的空间展开之前除去骨和脂肪残余。对骨中形成的通道的冲洗和清洁可使用本领域公知的技术来完成。例如,可使用水、盐溶液或林格液来完成冲洗。包括其它溶液的溶液也可以是有益的,例如具有功能或者治疗优点的溶液,以及生长刺激和抗感染剂诸如抗生素的溶液,包括庆大霉素(gentomiacin)。
还可使用灌洗系统,诸如图47中显示的灌洗系统4701,其包括双向流路管件。灌洗系统可被用于从由于使用钻或者取芯铰刀的空间中清除骨碎片和脂肪残余。在一种实施方式中,灌洗系统包括在骨折骨的空间中提供的盐溶液的流入物,同时通过流路调整的真空抽吸除去在盐溶液中被松开的骨和残余碎片。以此方式,骨折骨内的空间可被清洁并准备将加强装置展开到骨的骨折部位。参见Greenwald等人的美国专利US4294251:Method of Suction Lavage。
取芯铰刀或者钻可被用于在骨折骨内形成空间并通过骨折本身的位置。灌洗系统可类似地被构造成清洁空间内包括骨折位置处的残余。铰刀或者钻可独立或者与穿过骨折部位的保护鞘结合横过骨折部位。如同本领域技术人员所理解的那样,空间可从两端、从近端开口和从远端开口到骨折部位被铰扩。
如上所述,根据本发明的一种实施方式,通过将切口限制在与骨折骨的近端对应的相当小的位置,在治疗骨骨折时对患者身体的生理损伤基本上被最小化,允许患者更快康复和伤口愈合。
该手术可使用比用于骨髓内钉手术更小的开口。此外,装置及其操作最小化或者消除了痛苦或骨坏疽的风险。
用于装置和元件的替代材料对本领域技术人员来说是公知的,例如包括合适的生物相容性材料诸如金属(例如不锈钢、形状记忆合金诸如镍钛合金镍钛诺)和工程塑料(例如聚碳酸酯)。例如,见Jervis的美国专利US5190546:Medical Devices Incorporating SIMMemory Alloy Elements和Flomenblit的美国专利US5964770:HighStrength Medical Devices of Shape Memory Alloy。在一种实施方式中,外骨骼或者外鞘可由材料诸如钛、钻铬不锈钢制成。作为替代,鞘可由生物相容性聚合物诸如聚醚醚酮(PEEK)、聚芳基酰胺、聚乙烯和聚砜制成。
如同本领域技术人员所理解的那样,用于制备装置的任何元件的聚合物或者热塑性塑料实际上都可包括对本领域技术人员来说公知的辐射可透过的聚合物,包括但不限于聚醚醚酮(PEEK)、聚苯砜(Radel)或者聚醚酰亚胺树脂(Ultem)。如果需要,聚合物还可包括半透明或者透明材料,或者其中第一材料具有第一辐射不透性和第二材料具有第二辐射不透性的结合。合适的PEEK可包括被认可用于医疗植入物的未填充PEEK。装置和元件可通过压延、热压铸、压力成型和/或切削加工技术制成,如同本领域技术人员所理解的那样。
可适用于一些实施方式的其它聚合物例如其它等级的PEEK(诸如30%玻璃填充或者30%碳填充的PEEK)提供的所述材料由FDA或者其它调节体清洁用于可植入装置。玻璃填充的PEEK的使用在需要降低器械的膨胀率并增大PEEK的挠曲模量的情况下可能是理想的。已知玻璃填充的PEEK对于改进强度、硬度或者稳定性是理想的,而已知碳填充的PEEK对于增强PEEK的压缩强度和硬度并降低其膨胀率是理想的。还有其它合适的生物相容性热塑或者热塑性缩聚物材料可以是合适的,包括具有良好的记忆、柔性和/或可偏转、具有非常低的吸湿性和良好的耐磨损和/或抗腐蚀性的材料可被使用而不脱离本发明的范围。这些包括聚醚酮酮(PEKK)、聚醚酮(PEK)、聚醚酮醚酮酮(PEKEKK)和聚醚醚酮酮(PEEKK)和常用的聚芳基醚醚酮。此外,其它聚酮以及其它热塑料可被使用。可在工具或者工具元件中使用的合适聚合物可参见下列文献,所有这些文献都通过引用而包含在本申请中。这些文献包括:VictrexManufacturing Ltd.的PCT公开WO02/02158A1,题为Bio-CompatiblePolymeric Materials;Victrex Manufacturing Ltd.的PCT公开WO02/00275A1,题为Bio-Compatible Polymeric Materials;VictrexManufacturing Ltd.的PCT公开WO02/00270A1,题为Bio-CompatiblePolymeric Materials。由于良好的氧化稳定性、生物相容性、机械强度和抗腐蚀性能,还有其它材料诸如可购自Polymer TechnologyGroup,Berkeley,Calif的Bionate,聚碳酸酯聚氨酯也可以是合适的。其它热塑材料和高分子量聚合物也可被用做需要射线可透的器械的一部分。
此外,外骨骼结构或者鞘可以是金属成分的混合物以适应交错接合或者铸模外骨骼的管状部件。
在再一种实施方式中,装置或元件可被涂敷有治疗剂或者可由具有接合在其中的治疗剂的聚合物构造。
装置可以是各种长度和直径。装置的长度和直径可由骨折部位和患者解剖学或者生理考虑来确定。长度必须横过骨折穿过其弯曲角(angularity)到内径。直径范围从空间的最小内径到最大内径。虽然不限制于这些值,但长度可从1000mm到1mm的范围内变化并且直径可从0.1mm到100mm的范围。交错接合零件被设计成穿刺骨折位置处25%到75%的皮质骨。装置的设计允许在不同装置中和在同一装置内多个长度的交错接合。
当完全展开时,交错接合的零件可被构造成打开并进入周围的骨以保持骨折骨碎片的位置。这可通过使用如图49中所示的内部套筒4901来实现。在本发明的一种实施方式中,在骨折部位的骨已经实质上且完全愈合的预定时间段之后,穿骨的(cross bone)骨折固定组件可被除去。在一种实施方式中,如图48中所示的内部套筒4801然后被除去并且导丝4802可被用于除去穿骨的骨折固定组件4803。作为替代,在本发明的范围内,穿骨的骨折固定组件可被水久定位在空间中以便基本上完全保持与骨折部位的骨组织的整体完整性。
如同本领域技术人员所理解的那样,装置可被构造成当交错接合的零件展开时(例如齿膨胀离开中心轴时)可除去外部套筒。在另一种实施方式中,如图50中显示的内部套筒5001可被除去,引起齿5002向着外骨骼或鞘5003的中心轴线向内回缩。在根据该设计的一种实施方式中,当除去内部套筒时装置对骨的连接力可被消除。外骨骼或鞘的齿可向着装置的中心轴线回缩或者当向着骨中的近端开口拉动装置时,齿与骨脱离接合。这允许装置易于除去。在一种实施方式中,外骨骼或者鞘可通过向与沿着远离外骨骼的相反方向施加力来除去。
虽然上面的描述涉及穿骨展开,该固定装置适于连通穿过任何被减弱骨区域的解剖力。被减弱骨的位置通过适当的诊断来识别。在本发明的范围内的如图51中所示的穿骨固定装置5101可穿过被减弱骨的区域展开。在本发明的范围内,穿骨固定装置可由用于长骨的大直径或者用于手或脚骨的小尺寸制成。装置的直径和长度被设计为用于固定在骨内。
在将加强装置定位在空间中所需位置以便与骨折基本接触之后,使用如图52中所示的K-线驱动器5201,骨碎片与完全展开的加强装置5202连接,正确定位在空间中并在结构上膨胀到完全充满其定位的空间。K-线5203即薄的刚性线可被用于固定骨碎片。这些线可经过骨钻孔以将碎片保持在合适的位置中。如同本领域技术人员所理解的那样,K-线还可被经皮(经过皮肤)设置。
更具体地,当从中央窗完成对上述引入物的去除时,骨碎片可通过使用K-线驱动器展开的K-线与装置连接,使得在恢复过程期间,骨碎片基本上且完全与通过加强装置引导的骨结构对准。此外,可选地,在除去引入物之后骨粘接剂、异形骨、采集的骨(harvestedbone)、尸体骨或者其它合适的骨基质可被引入到空间中,以基本上填充从切口部位到加强装置的空间。此外,在封闭切口部位之前,骨堵塞物可在骨的空间开口处被展开以完全密封骨基质和/或密封空间。
在装置已经按照本文中描述的任一技术植入之后,切口部位使例如用缝合封闭,以允许骨折和碎片愈合。
在装置的另一种实施方式中,其包括具有穿过减弱或者骨折骨的内或者外部位置的多个独立的结构元件。虽然每个独立结构元件单独地设置在骨中,另外的线、螺纹、缝合线可穿过骨将它们连接在一起,使多个结构元件被连接并形成刚性构造,抵抗解剖和典型的患者负载和力。在图53中显示了由高抗张强度连接元件连接的独立结构元件的例子5301、5302、5303和5304。使用这种构造,非常小的加强和固定装置可被原位构造。
在类似构造中,可以设计如图54所示的可膨胀装置5401,从而与骨的交错接合位于多个棒、杆或者将两端连接在一起的其它元件的近端和远端。
在另一个例子中,骨的上转节区域或者肌骨骼系统的其它区域可被暴露并且可在股骨颈5501钻出孔,如图55中所示。加强装置(例如由镍钛诺制成)然后可被输送到腔并被膨胀以填无孔5601的外径,如图56中所示。加强装置的内径可用骨粘接剂填充和加压。作为替代,加强装置的内径可被填充有分割骨、骨堵塞物或者异形骨5602。
前述领域的配套实施方式包括从装置的远端向近端轴向平移,从而将骨和组织拉到一起,缩短从远端到近端的轴向距离。这些实施方式在非联合骨折、关节融合术和某些骨折中具有特别的应用。
如同本领域技术人员所理解的那样,在本文中公开的装置可以各种合适的方式展开。例如,可以执行骨折的临时封闭复原,其中1.5到2英寸的切口在骨的干骺端突出物上被形成。然后可对筋膜实施钝解剖,于是筋膜被切开。外科接近中间面(前-后)通过纵向分开腱或者韧带或者肌肉或者通过以骨膜下的方式升高骨的结构来进行。特定方法的选择根据待治疗的骨折骨而变化。专门的软组织牵引器被设置在骨上,以回缩软组织离开骨的进入点。
导丝然后可沿着干骺端突出物以一定角度钻入插入点中。导丝沿着骨的纵向轴线定位的角度取决于骨折解剖和待治疗的特定骨。导丝然后可在荧光镜引导下设置。沿着导丝引入最优选择的铰刀,以打开干骺端进入点。然后,两种装置都被移除。
弯曲的导丝被引入穿过干骺端的开口通道并行进穿过骨折部位进入骨干。适用于特定装置的顺序铰除动作被执行以准备用于骨干。在荧光镜下估计从骨折部位到进入点的距离,并且选择合适的装置。铰刀被退出并且装置穿过导丝被引入到干骺端并穿过骨折进入骨干。荧光镜确保万向接头在干骺端/骨干骨折部位的位置。
装置的骨干齿被展开并且装置刚性固定到骨折骨的远离骨折部位的骨干。任何延伸到接头中的骨折现在可以以封闭形式被复原并用K-线保持,或者以开口形式经背向接近骨折的关节内部分。具有连接的目标支架的干骺端锁定凸缘现在穿过干骺端轴行进(进入干骺端骨)。使用连接的目标支架,导丝现在经过干骺端锁定凸缘被设置。导丝在荧光镜下定向以牢固地固定骨折的关节内部分和/或固定干骺端骨折。沿着导丝用套管插入钻头钻孔。然后,自旋塞螺钉沿着导丝行进以将骨锁定到轴和干骺端锁定凸缘。装置现在被锁定在近端和远端骨折(干骺端或者骨干)和远端(骨干)骨中。这提供了粉碎性关节内碎片彼此的刚性固定,并且同时互锁在干骺端凸缘元件中的这些螺钉之间的固定提供了干骺端区域中的这些关节内碎片与骨干轴的刚性固定。末端和骨折现在被操作直到在荧光镜下观察时达到了满意的复原。此后,骨折在荧光镜引导下被操作以便实现骨碎片的解剖学对准。一旦达到了最佳骨髓内复原,万向接头就被锁定。骨折现在被牢固固定。导丝被除去并且伤口被封闭,以修复干骺端进入点上的骨膜并修复韧带和封闭皮肤。可以施加夹板。
虽然在本文中已经显示和描述了本发明的优选实施方式,本领域技术人员应当理解,这些实施方式仅仅作为例子而提供。现在本领域技术人员可进行许多变化、改变和替代,都不脱离本发明。应当理解,在本文中描述的本发明的实施方式的各种替代可在实践本发明时采用。下面的权利要求书限定了本发明的范围,并且这些权利要求中的方法和结构以及它们的等同物由此而被覆盖。
Claims (55)
1.一种可锁定骨固定装置,包括:
a、能够被定位在骨中形成的空间中的套筒;
b、能够导引套筒的运动的导丝;和
c、能够将套筒从装置的末端固定在骨内空间中的可致动锁。
2.如权利要求1所述的可锁定骨固定装置,其中套筒是柔性的。
3.如权利要求1所述的可锁定骨固定装置,其中套筒具有窗。
4.如权利要求1所述的可锁定骨固定装置,其中套筒是可膨胀的。
5.如权利要求1所述的可锁定骨固定装置,其中套筒是生物可吸收的。
6.如权利要求1所述的可锁定骨固定装置,其中套筒可从骨内空间中移除。
7.如权利要求1所述的可锁定骨固定装置,其中套筒能够经过在骨的骨隆突处形成的进入窗进入骨内空间。
8.如权利要求1所述的可锁定骨固定装置,还包括能够配合在第一套筒中的第二套筒。
9.如权利要求8所述的可锁定骨固定装置,其中第二套筒具有可伸缩交错接合突。
10.如权利要求9所述的可锁定骨固定装置,其中套筒具有沿着其长度的窗,可伸缩交错接合突能够经过该窗接合骨。
11.如权利要求9所述的可锁定骨固定装置,其中当由套筒致动时可伸缩交错接合突能够接合骨。
12.如权利要求1所述的可锁定骨固定装置,还包括能够将可锁定骨固定装置保持在空间中的悬臂。
13.如权利要求1所述的可锁定骨固定装置,其中套筒能够由用户在空间中膨胀和收缩。
14.如权利要求1所述的可锁定骨固定装置,其中装置能够通过导管输送。
15.如权利要求1所述的可锁定骨固定装置,其中装置的远端具有钝套管表面。
16.如权利要求1所述的可锁定骨固定装置,其中装置的远端具有导引尖。
17.如权利要求1所述的可锁定骨固定装置,其中装置能够接受外来刺激以提供对骨的治疗。
18.如权利要求1所述的可锁定骨固定装置,其中当装置设置在内腔中时,装置能够接收合成材料。
19.一种骨固定装置,包括:
a、在沿着其长度的位置处具有能够接合骨的可伸缩交错接合突的第一套筒;
b、尺寸能够致动第一套筒的交错接合突的第二套筒。
20.如权利要求19所述的骨固定装置,其中第一套筒或第二套筒是柔性的。
21.如权利要求19所述的骨固定装置,其中第一套筒或第二套筒具有窗。
22.如权利要求19所述的骨固定装置,其中第一套筒或第二套筒是可膨胀的。
23.如权利要求19所述的骨固定装置,其中第一套筒或第二套筒是生物可吸收的。
24.如权利要求19所述的骨固定装置,其中第一套筒或第二套筒是可移除的。
25.如权利要求19所述的骨固定装置,其中第一套筒或第二套筒能够经过在骨的骨隆突处形成的进入窗进入骨内空间。
26.如权利要求19所述的骨固定装置,其中第二套筒具有可伸缩交错接合突。
27.如权利要求19所述的骨固定装置,其中第二套筒具有沿着其长度的窗,可伸缩交错接合突能够经过该窗接合骨。
28.如权利要求19所述的骨固定装置,其中当由第二套筒致动时,可伸缩交错接合突能够接合骨。
29.如权利要求19所述的骨固定装置,其中悬臂将骨固定装置保持在骨的空间中。
30.如权利要求19所述的骨固定装置,其中第一套筒或第二套筒能够由用户在骨空间中膨胀和收缩。
31.如权利要求19所述的骨固定装置,其中装置能够通过导管输送。
32.如权利要求19所述的骨固定装置,其中装置的远端具有钝套管表面。
33.如权利要求19所述的骨固定装置,其中装置的远端具有导引尖。
34.如权利要求19所述的骨固定装置,其中装置能够向骨输送治疗刺激。
35.如权利要求19所述的骨固定装置,其中当装置设置在内腔中时,装置能够接收合成材料。
36.一种修复骨折的方法,包括:
a、沿着骨的长度经过在骨末端的进入点处的骨隆突进入骨折部;
b、经过骨末端的进入点将骨固定装置推进到空间中;
c、沿着其长度弯曲一部分骨固定装置以横过骨折部;和
d、将骨固定装置锁定在骨空间内的位置中。
37.如权利要求36所述的方法,还包括在将骨固定装置推进到空间中之前,经过骨隆突推进套管并穿过骨折部的步骤。
38.如权利要求36所述的方法,还包括将骨固定装置锚定在所述空间中的步骤。
39.如权利要求36所述的方法,其中骨固定装置的第一套筒和第二套筒被接合以将交错接合突膨胀到骨中。
40.一种修复骨折的方法,包括:
a、沿着骨的长度经过进入口处的骨隆突进入骨折部;
b、经过进入口将骨固定装置引入到髓管中;
c、沿着其长度弯曲骨固定装置以将骨固定装置推进到骨中的骨髓空间中;
e、将柔性肘设置在骨折部位的髓管中;
f、硬化骨固定装置;
g、将骨固定装置锁定在骨中。
h、使用骨固定装置复原骨折;
i、锁定柔性肘以实现骨折部的骨髓内复原。
41.如权利要求40所述的方法,还包括沿着其长度弯曲骨固定装置以横过骨折部位的步骤。
42.如权利要求40所述的方法,还包括经过进入口处的骨隆突将导丝引入骨髓内空间。
43.如权利要求40所述的方法,还包括经过进入口处的骨隆突铰扩导丝。
44.如权利要求43所述的方法,其中被铰扩的管的位置由骨折解剖和骨解剖来确定。
45.如权利要求40所述的方法,还包括沿着骨固定装置推进套筒。
46.如权利要求45所述的方法,其中套筒从固定装置打开长钉。
47.如权利要求46所述的方法,其中长钉将骨固定装置锁定到骨。
48.如权利要求47所述的方法,还包括将蝴蝶环锁定到骨。
49.如权利要求47所述的方法,还包括将蝴蝶环锁定到骨固定装置。
50.如权利要求47所述的方法,其中蝴蝶环螺旋连接在骨固定装置上。
51.如权利要求46和47所述的方法,其中导引夹具导引螺钉经过蝴蝶环。
52.如权利要求46和47所述的方法,其中自攻螺钉将蝴蝶环锁定到骨和骨固定装置。
53.如权利要求45所述的方法,其中骨固定装置被硬化。
54.如权利要求40所述的方法,还包括使用锁定在骨上的骨固定装置复原骨折碎片。
55.如权利要求40所述的方法,还包括推进定位螺钉以将所述肘锁定在骨折部位。
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2006
- 2006-05-15 JP JP2008512398A patent/JP2008540037A/ja active Pending
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- 2006-05-15 CN CNA200680023333XA patent/CN101208053A/zh active Pending
- 2006-05-15 US US11/383,275 patent/US20060264951A1/en not_active Abandoned
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Also Published As
Publication number | Publication date |
---|---|
WO2006124764A1 (en) | 2006-11-23 |
US7942875B2 (en) | 2011-05-17 |
CA2608693A1 (en) | 2006-11-23 |
US20070233105A1 (en) | 2007-10-04 |
JP2008540037A (ja) | 2008-11-20 |
US20060264951A1 (en) | 2006-11-23 |
US7846162B2 (en) | 2010-12-07 |
EP1885263A1 (en) | 2008-02-13 |
US20060264952A1 (en) | 2006-11-23 |
US20060264950A1 (en) | 2006-11-23 |
US7914533B2 (en) | 2011-03-29 |
AU2006247498A1 (en) | 2006-11-23 |
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