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CN108348227B - 可植入的核假体 - Google Patents

可植入的核假体 Download PDF

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CN108348227B
CN108348227B CN201680058105.XA CN201680058105A CN108348227B CN 108348227 B CN108348227 B CN 108348227B CN 201680058105 A CN201680058105 A CN 201680058105A CN 108348227 B CN108348227 B CN 108348227B
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proximal
implant device
fillable enclosure
spinal implant
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CN108348227A (zh
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詹姆斯·D·卢茨
洛伦·W·弗朗西斯
马克·诺沃特尼
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Spinal Stabilization Technologies LLC
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    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30581—Special structural features of bone or joint prostheses not otherwise provided for having a pocket filled with fluid, e.g. liquid
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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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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
    • 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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    • 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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Abstract

核椎间盘植入物包括可填充内壳体和可填充外壳体。在插入无核的椎间盘腔之后，内壳体填充有流体，可填充外壳体填充有可固化材料。使可固化材料固化，将流体从内壳体去除以保留被固化的外壳体包围的内壳体。可以在核椎间盘植入物周围设置增强带。提供填充核椎间盘植入物的填充工具。

Description

可植入的核假体
相关申请的交叉引用
本申请要求于2015年9月1日提交的美国临时申请第62/212950号的优先权，其全部内容通过引用明确地并入本文而没有放弃的内容。
背景
1.发明领域
本申请一般涉及用于置换椎间盘的方法和装置。更具体地，本申请涉及可以使用微创手术技术或经皮植入的可植入椎间盘置换物，以及用于制造这种椎间盘置换物/假体的方法。
2.相关技术的描述
常见的医疗问题是由于创伤、衰老过程或其他病症引起的椎间盘损伤导致的背痛。已经提出的一种治疗方法是去除现有的髓核，并使用开放手术或微创手术技术用原位形成的核假体置换它。提出的一种方法包括以下步骤：(i)提供例如气囊的模具以容纳可以在椎间盘隙内原位固化的可流动的可固化材料，(ii)提供导管以将模具腔体连接到可流动的可固化材料源，(iii)将可流动的可固化材料输送到模具中以填充腔体，以及(iv)使可固化材料固化。
原位形成核假体的现有技术尚未取得令人信服的临床认可或商业成功。本发明人发现的一个问题是包括椎骨终板和纤维环的椎骨部分与植入元件之间的弹性模量的显著差异。植入材料的高弹性模量是不利的，因为它不会抑制极端弯曲或扭曲时的冲击或椎间盘内压力的突然增加，特别是在负载高峰期间。植入的椎间盘材料与邻近组织之间弹性模量的巨大差异也可以导致椎骨终板和邻近骨(海绵体)的软化，导致核植入物的沉降。也可以发生植入物的迁移和排出。
因此，需要改进的核植入物。
概要
根据另一个示例性实施方案，用于植入核置换装置的套件包括脊柱植入装置和填充针。可填充内壳体具有带近端开口的近端和带远端开口的远端。可填充外壳体具有近端和远端，可填充内壳体和可填充外壳体的近端和远端联接在一起，使得可填充外壳体包封可填充内壳体。远端塞密封可填充内壳体的远端的远端开口，近端塞密封可填充内壳体的近端的近端开口。近端塞具有用于提供通往内壳体的通道的第一腔和用于提供通往外壳体的通道的第二腔。填充针适于与近端塞匹配，填充针包括用于将流体输送到内壳体的第一腔和用于将流体输送到外壳体的第二腔。
在一些实施方案中，增强带包围可填充外壳体的外周。增强带可以包括织物。控制部件可以联接到环形增强带的中心区域。至少一根拉线可以联接到环形增强带的边缘。
在一些实施方案中，输送套管包围填充针，其中输送套管可从输送位置移动到展开位置。控制部件和至少一根拉线位于输送套管和填充针之间。
根据示例性实施方案，脊柱植入装置包括可填充内壳体和可填充外壳体。可填充内壳体具有带近端开口的近端和带远端开口的远端。可填充外壳体具有近端和远端，可填充内壳体和可填充外壳体的近端和远端联接在一起，使得可填充外壳体基本上包封可填充内壳体。远端塞密封可填充内壳体的远端的远端开口，近端塞密封可填充内壳体的近端的近端开口。近端塞密封可填充内壳体的近端的近端开口。近端塞具有用于提供通往内壳体的通道的第一腔和用于提供通往外壳体的通道的第二腔。在一些实施方案中，用于提供通往内壳体的通道的第一腔在植入后保持打开。
在一些实施方案中，可填充内壳体和可填充外壳体包括整块材料。
在一些实施方案中，近端塞适于容纳填充针，所述填充针包括分别用于将流体输送至内壳体和外壳体的第一腔和第二腔。
在一些实施方案中，增强带包围可填充外壳体的外周。增强带可以包括织物。控制部件可以联接到环形增强带的中心区域。至少一根拉线可以联接到环形增强带的边缘。
在一些实施方案中，外壳体填充有可固化的硅酮材料。
根据另一个示例性实施方案，将假体装置植入具有被纤维环包围的髓核的椎间隙的方法包括：穿透纤维环；去除髓核以产生无核的椎间盘腔；将可填充的椎间盘植入装置插入到无核的椎间盘腔中，所述可填充的椎间盘植入装置具有形成内壳体的可填充内壳体和联接到可填充内壳体的可填充外壳体，使得可填充外壳体基本上完全包围可填充内壳体；用流体介质填充可填充内壳体；用可固化介质填充可填充外壳体；使可固化介质固化；从可填充内壳体去除流体介质；使可填充内壳体保持开口以使流体能够进入和离开可填充内壳体。
在一些实施方案中，流体介质包括基本上不可压缩的流体，例如造影剂。
在一些实施方案中，提供了用于增强可填充椎间盘植入物的外周的增强带。将增强带插入无核的椎间盘腔并操控增强带以形成用于容纳可填充椎间盘植入物的袋。可以通过拉动增强带的下边缘和增强带的上边缘来将边缘拉向无核的椎间盘腔的内部来操控增强带；激活增强带的中心部分中的控制部件以在中心部分向外朝向无核的椎间盘腔的纤维环按压环形增强带。增强带的下边缘和上边缘可以通过使用设置在增强带的下边缘和上边缘的下拉线和上拉线来拉动。可以通过使用柔性带激活控制部件以将环形增强带向外朝向纤维环按压。在可填充外壳体被填充后，可以去除拉线和柔性带。
根据又一个实施方案，用于椎间盘植入物的增强带包括织物带，所述织物带具有上边缘、下边缘以及上边缘和下边缘之间的中心区域。在织物带的上边缘设置有上拉线，其用于当拉动时使织物带的上边缘张紧，在织物带的下边缘设置有下拉线，其用于当拉动时使织物带的下边缘张紧。控制部件设置在中心区域中用于使中心区域膨胀。控制部件可以包括金属带。
术语“联结”定义为连接，尽管不一定直接连接。指示词前没有数量词定义为一个或超过一个，除非本公开明确另外要求。术语“基本上”、“大约”和“约”定义为很大程度上但不一定完全是如本领域普通技术人员理解的指定项目(并且包括指定项目；例如，基本上90度包括90度，基本上平行包括平行)。在任何公开的实施方案中，术语“基本上”、“大约”和“约”可以用在指定项目的“[百分比]以内”代替，其中百分比包括0.1％、1％、5％和10％。
术语“包含”、“具有”、“包括”和“含有”都是开放式连接动词。因此，“包含”、“具有”、“包括”或“含有”一个或超过一个的部件或特征的系统或系统的部件具有那些一个或超过一个的部分或特征，但不限于仅具有那些部件或特征。同样地，“包含”、“具有”、“包括”或“含有”一个或超过一个的步骤的方法具有那些一个或超过一个的步骤，但不限于仅具有那些一个或超过一个的步骤。另外，例如“第一”和“第二”的术语仅用于区分结构或特征，而不是将不同的结构或特征限制为特定的顺序。
以某种方式配置的装置、系统或部件至少以这种方式配置，但它也可以以除了具体描述的那些方式以外的其他方式配置。
任何系统和方法的任何实施方案可以由或基本上由任何所描述的部件、特征和/或步骤组成，而不是包括/包含/含有/具有任何所描述的部件、特征和/或步骤。因此，在任何权利要求中，术语“由……组成”或“基本上由……组成”可以代替上述任何开放式连接动词，以改变使用开放式连接动词时的给定权利要求的范围。
即使未描述或示出，一个实施方案的特征可以应用于其他实施方案，除非由本公开或实施方案的性质明确禁止。
以下给出与上述实施方案等有关的细节。
附图说明
图1是根据本公开的实施方案的植入物的俯视图；
图2是图1的植入物的左视图；
图3是图1的植入物的右视图；
图4是图1的植入物的侧视图；
图5是沿图4中的线5-5截取的截面图；
图6是图1的植入物的远端塞的放大图；
图7是图1的植入物的近端塞的放大图；
图8是用于形成图1的植入物的植入物坯件的透视图；
图9是在植入物坯件部分翻转之后的图8的植入物坯件的剖视图；
图10是插入到图1的植入物的远端塞中的填充针；
图11是图10的填充针的远端的平面图；
图12是图10的填充针的近端的平面图；
图13是另一填充针的远端的截面图；
图14示出与图1的植入物一起使用的环形增强带，其中未填充的植入物位于带内部；
图15示出带有填充的植入物的图14的环形增强带；
图16示出在展开期间的图14的环形增强带；
图17是图13的织物带的截面图；
图18示出植入图1的植入物组装件的第一步骤；
图19示出植入图1的植入物组装件的第二步骤；
图20示出植入图1的植入物组装件的第三步骤；
图21示出植入图1的植入物组装件的第四步骤；
图22示出植入图1的植入物组装件的第五步骤；和
图23示出植入图1的植入物组装件的第六步骤。
具体实施方式
在以下详细描述中参考了附图，其中示出了本发明的示例性但非限制性和非全部的实施方案。足够详细地描述这些实施方案以使本领域技术人员能够实践本发明，并且应该理解，可以使用其他实施方案，可以做出其他变化而不偏离本发明的精神或范围。因此，以下详细描述不应被视为具有限制意义，本发明的范围仅由所附权利要求限定。在附图中，除非另有说明，否则相同的附图标记在各个附图中表示相同的部分。
核植入物
参照图1至图8，微创或经皮递送的脊柱植入物100的实施方案包括可填充外壳体102和可填充内壳体104。可填充外壳体102形成外室106，可填充内壳体104形成内室108。内室108被包封在外室102内。如本文所使用的，包封指内室108基本上容纳在外室106内，使得内室108各处基本上被外室106包围。可填充外壳体102和可填充内壳体104可以形成为例如硅橡胶的弹性体材料的无缝整块件。使用弹性体材料产生柔性外壳体102和内壳体104。也就是说，当填充可固化材料时，外壳体102和内壳体104随着内部压力的增加而膨胀。使用柔性壳体提供一定优势。柔性壳体适应核空间的不规则、扁平或盘状结构。此外，柔性壳体可以在弹性体固化之后有助于保持核植入物的合适弹性模量，并且有助于保持椎骨节段的生物机械移动性，并且有助于允许固化的硅酮组分顺利变形并进入到中心空隙中。可填充内壳体104和可填充外壳体102的物理特性可以被调整以提供期望的物理结果。例如，在一些实施方案中，壳体102和壳体104优选地沿横向平面膨胀。在一些实施方案中，可填充内壳体104和可填充外壳体102可以是完全或部分半柔性或非柔性的(即随着内部压力增加，不会膨胀或极小程度地膨胀)。在一些实施方案中，可填充内壳体104和可填充外壳体102的不同部分可以由不同材料形成以向壳体102和壳体104提供不同特性。
植入物100的尺寸优选为使得它能够经皮插入到或使用微创手术插入到无核的椎间盘腔中，同时排气然后被填充以填充无核的腔。在一个实施方案中，填充的植入物100外部的长度大约为30mm，宽度为20mm，高度为10mm，并且可填充内壳体104外部的长度大约为9mm，宽度为6mm，厚度为6mm。在一些实施方案中，壳体在填充时不会显著膨胀(即它是非柔性或半柔性的)。在其它实施方案中，植入物被填充以使植入物在植入时膨胀大约100％(即尺寸加倍)。在其他实施方案中，植入物被填充以使植入物在植入时膨胀超过100％。
可填充外壳体102具有第一端(或近端)110和第二端(或远端)112。可填充内壳体104具有联接到近端颈部116的第一端(或近端)114。可填充内壳体104的第二端(或远端)118联接到远端颈部120。远端颈部部分120的端部部分122联接到可填充外壳体102的远端112，近端颈部116的端部部分124联接到可填充外壳体102的近端110。在所示实施方案中，如下文将更详细描述的那样，通过将近端颈部124的端部部分124和可填充外壳体102的近端110形成整块件而将近端颈部124的端部部分124联接到可填充外壳体102的近端110。可填充外壳体102的远端112被反转并结合到远端颈部部分的端部122以形成基本上对流体的密封。以这种方式将壳体联接在一起形成基本上对流体密封的外室106。
近端塞126位于由近端颈部116形成的开口中。近端颈部116可以具有用于与近端塞126的匹配特征部相配合的特征部，例如凹槽148，以辅助定位近端塞126。近端塞126可以插入到近端颈部116并与之结合。近端塞126适于与填充针130的填充尖端192匹配。容纳部132容纳填充尖端192的第一腔186，以通过孔134将材料输送到外室106中。孔134可以是将材料输送到外室106的瓶颈，并且可以形成为切割孔以最大化孔134的尺寸。近端塞126可以由硅酮或与壳体102、104相容的其他材料制成，并且可以使用常规制造技术例如注塑成型来制造。
在一些实施方案中，设置有助于防止填充针130从近端塞126意外脱落的锁定特征部。例如，可以在近端塞126中设置凹部136，并且可以在填充尖端192上设置匹配特征部(例如图13中的珠状物152)。
通道腔138穿过近端塞126延伸以提供通往内室108的通道。从图3可以看出，容纳部132和通道腔138可以被布置成防止填充针130的不适当安装。在一些实施方案中(如图10所示)，设置键214以物理地防止填充针130的不适当安装。键214可以用于控制填充尖端130的插入深度。或者，在其他实施方案中，定位套环190可以用于控制填充尖端130的插入深度。通道腔138被配置成在植入后保持打开以作为内室108的通气孔。
远端塞140设置在远端颈部120中以密封远端颈部。远端塞140可以在内侧具有圆柱形凹部142，用于容纳填充针130的造影腔188的远端200。另一个圆柱形凹部146可以设置在远端塞140上。远端塞140可以由硅酮或与壳体102、104相容的其他材料制成，并且可以使用常规制造技术例如注塑成型来制造。
织物带
参照图14至图17，可以设置任选的环形增强带160以增强植入物100。当患者的纤维环受损时，环形增强带160是有用的。在一个实施方案中，环形增强带160包括管状织物材料。环形增强带160被设置为包围植入物100的侧边缘的外周，以最小化或防止外部气囊102和内部气囊104的周向膨胀过度。控制周向膨胀还促使气囊102和气囊104的垂直膨胀以分散相邻的椎骨并拓宽椎间盘空间。椎骨上终板和下终板约束植入物100的垂直膨胀。在一些实施方案中，环形增强带160由编织材料形成。在一个实施方案中，环形增强带160使用轴向编织，这最小化或基本上防止带在膨胀时缩短。标题为Percutaneous ImplantableNuclear Implant的美国专利第8636803号公开了环形增强带160的其他合适构造，出于所有目的通过引用将其全部内容并入本文。用于环形增强带160的一种合适材料是超高分子量聚乙烯纤维，例如可从荷兰海尔伦的Koninklijke DSM N.V.购买的
Figure BDA0001618626130000081
纤维。
环形增强带160具有上边缘162、下边缘164以及上边缘162和下边缘164之间的中心区域166。设置一根或更多根拉线和控制部件以在展开植入物100时帮助放置环形增强带。在一个实施方案中，设置下拉线168、上拉线170和控制部件172。上拉线被放置在袋176中或以其他方式联接到环形增强带160的上边缘162。类似地，下拉线168被放置在袋176中或以其他方式联接到环形增强带160的下边缘164。在展开过程中，可以使用下拉线和上拉线作为牵引线(即拉线)以将环形增强带160的边缘向内拉动，从而有助于约束和定位植入物100。控制部件172设置在环形带160的中心区域166中。如果环形带160包括管状材料，则控制部件172被放置在管状材料内部。在其他实施方案中，控制部件172被放置在环形增强带160上形成的袋中。控制部件172可以是围绕环形增强带160的外周的金属丝，例如镍钛诺扁平带。控制部件172可以用于将环形增强带160向外按压至纤维环。下文将讨论控制部件172和拉线168和拉线170的操作的进一步细节。
填充针和输送套管
参考图10至图13，填充针130可以与输送套管结合使用以输送植入物100和环形增强带160。填充针130包括具有近端182和远端184的杆180。第一腔186和第二腔188延伸穿过轴180。设置定位套环190以将第一内腔186和第二腔188保持在期望的位置。第一腔186和第二腔188的远端形成填充尖端192，其被配置成与近端塞126匹配。
第一(或硅酮)腔186从填充针130的近端182延伸到填充针130的远端184。当填充针130与近端塞126匹配时，第一腔186的远端的孔194与近端塞126的孔134重合，以允许外室106与第一腔186之间流体连通。腔186的近端设置连接件196，其用于连接到本领域技术人员已知的常规填充工具(例如注射器)。
在某些实施方案中，例如图13所示的实施方案，可以设置通气孔198以当硅酮或其他合适的材料被输送到外室106时允许空气离开硅酮腔186。通风孔198可以足够大以允许空气自由地穿过它运动，同时抵抗更黏性的流体如可固化硅酮。应该理解的是，如本文所使用的，“硅酮腔”指用于将任何期望的流体输送到外室106的腔，并且可以包括除硅酮之外的材料。通气孔198优选地穿过杆180延伸以在填充针130的近端与大气连通。
第二(或造影)腔188从填充针130的近端182延伸到填充针130的远端184。造影腔188延伸至填充针130的近端之外。优选地，造影腔188可相对于填充针130独立地移动，使得造影腔188的远端200的位置可相对于填充针130的远端184伸出和缩回。为了在植入之前输送，造影腔188可以穿过通道腔138延伸，并且造影腔188的远尖端可以被定位在远端塞140的凹槽142内以将其保持就位。造影腔188可以用于从内室108输送和去除流体。在一些实施方案中，造影腔188的远端200被预成形为允许更容易地从内室108去除流体的形状。在一个具体实施方案中，造影腔188被预成形为弯曲形状，其允许更容易地到达内室108的底部。与伸出和缩回造影腔188的能力相结合的弯曲形状允许其在用于从内室108收回流体时进行调整。应该理解的是，如本文所使用的，“造影腔”应理解为指用于将任何期望的流体输送至内室108的腔，并且可包括除造影剂以外的材料。可以使用造影剂来确保成像、例如荧光透视下的可见性。
参考图16，输送套管174包括腔，其尺寸为配合填充针130的杆180外部。为了输送植入物100，植入物100被放置在填充尖端192上，该组合体被收回到输送套管174的远端中。如果使用拉线168和拉线170以及控制部件172，则它们可以穿过输送套管的腔放置。
制造植入物的方法
参考图8至图9，植入物100可以通过形成植入物坯件150来形成，所述植入物坯件150包括联接到可填充内壳体104的可填充外壳体102。植入物坯件150可以使用常规制造技术制造，例如注塑成型或浸渍模塑成型。在植入物坯件150形成之后，植入物坯件150被部分地翻转以将可填充内壳体104放入可填充外壳体102的内部。远端塞140被插入到远端颈部120中，并且近端塞126被插入到近端颈部116中。关于一种合适的制造技术的其他细节在2014年11月4日提交的标题为“Percutaneous Implantable Nuclear Prosthesis”的待审申请62/074295中公开，其全部内容通过引用并入本文中。
展开植入物的方法
参照图18至图23，可填充的植入物100特别良好地适合于使用微创或经皮手术技术进行展开。
为了植入可填充的植入物100，通过进行椎间盘切除术而将现有的髓核去除，同时使纤维环202基本上完整地保留。优选地，使用微创手术技术、例如经皮技术进行椎间盘切除术，该技术使用插管208通过纤维环202中的小开口进入椎间盘腔206。在一个实施方案中，通过Kambin三角使用后外侧路径进入椎间盘腔。也可以使用前路手术。为了尽可能地保持纤维环的完整性，纤维环中的纤维环切开术可以通过用导销(例如K线)和放置在导销上的一系列直径递增的膨胀器穿透纤维环来进行。一旦获得期望的直径，将进入插管208放置在最大直径上，并且将膨胀器组去除。该过程将纤维环的纤维带展开以进行纤维环切开术而不切除(即去除)任何组织，这有助于愈合过程。或者，纤维可以用手术刀刺穿以产生垂直狭缝以进入核空间。
一旦插管208就位，医生可以使用任何合适的器械(例如咬骨钳)去除现有的椎间盘。医生应该避免破坏周围瓣环或穿透上下椎骨终板。医生可以通过将柔性成像气囊插入椎间盘空间并用造影剂填充成像气囊来监测椎间盘切除术的进展。在一些实施方案中，成像气囊包括变形的植入物，其包括可填充外壳体102而没有可填充内壳体。成像气囊还可作为试验植入物来预测最终植入物的体积、形状和位置。
一旦现有的髓核已被去除到医生满意的程度，纤维环202和椎骨终板204形成基本上空的无核椎间盘腔206(图18)。
装载到输送套管174中的植入物100通过插管208放入无核椎间盘腔206中。通常，植入物将被输送到椎间盘腔的远端。然后抽出输送套管174以在无核椎间盘腔内暴露植入物100。
如果提供任选的环形增强带，则操控控制部件172以按压环形增强带160的中心区域166以使其基本上平齐地抵靠在纤维环202的内表面。拉线168和拉线170可以被拉动以使环形增强带160的边缘162和边缘164张紧并形成用于容纳植入物100的袋。控制部件172以及拉线168和拉线170可以包括不透射线的特征部(例如铂或镍钛诺涂层)以有助于在荧光透视下可视化。
在一些实施方案中，首先用流体将内室108填充至期望的尺寸。在一个具体实施方案中，使用基本上不可压缩的流体210，例如造影剂。在填充内室之前，应该使用例如真空锁定注射器从系统排出空气。使用填充针130的造影腔188输送流体210。选择内室108的填充压力以将可填充内壳体104填充到期望的尺寸。
填充针130用于将可固化材料212输送到外室106。可固化材料212优选是弹性体材料，例如含有不透射线材料(例如硫酸钡)的硅橡胶。由于所包括的通气孔，因此在填充之前不需要从外室排出空气。可以选择可固化材料212以使其与可填充内壳体104和可填充外壳体102的材料聚合以形成整块构件。可固化材料212的弹性模量和其他特性可以基于患者特定参数来选择。例如，与较少运动的老年患者相比，更年轻、更有活力的患者可能需要更坚固的材料。一旦外室106被填充至期望的压力，则使可固化材料212固化。在一些实施方案中，可固化材料包含在短时间内、例如少于10分钟或少于5分钟内固化的可固化硅酮。使用较短的固化时间可以帮助防止溶剂从可固化介质溶解到可填充壳体中，这可能在较长的固化介质中发生。溶剂的这种浸出可能会不利地影响可填充壳体的结构完整性。
在使可固化材料212固化之后，使用造影腔188去除基本上不可压缩的流体210。如前文所讨论的，造影腔188可以被移动和操控以根据期望去除尽可能多的不可压缩的流体210。优选地，基本上全部的流体210被去除；但是，可以保留一些流体，不必去除所有流体。
一旦流体210已经被去除并且可固化材料212被充分固化，填充针130可以通过插管208被全部收回，并且插管208可以被移除。如果使用任选的环形增强带，拉线168、拉线170和控制部件172也通过插管208被收回。
因此，植入物100包括围绕中空内室108的固化材料212的环。内室108保持打开以允许流体进入和离开，从而用作缓冲部。该结构允许位于椎间盘空间的垂直和水平负载应力重新向内定向，集中朝向内室108(参见图23的箭头方向)而不是朝外。此外，环形增强带160促使天然纤维环202的组织生长，从而为天然纤维环202提供强化。
以上说明书和实施例提供了示例性实施方案的结构和使用的完整描述。虽然以上已经以某种具体程度或者参照一个或更多个单独的实施方案描述了某些实施方案，但是本领域技术人员可以对所公开的实施方案进行多种改变而不脱离本发明的范围。如此，本发明装置的各种说明性实施方案并非旨在被限制为所公开的具体形式。而是，它们包括落入权利要求范围内的所有修改方案和替换方案，并且除了所示出的实施方案之外的实施方案可以包括所示实施方案的一些或全部特征。例如，部件可以组合为整体结构，和/或连接方式可以被替换(例如螺纹可以用压装或焊接代替)。此外，在适当的情况下，上述任何实施例的方面可以与所描述的任何其他实施例的方面组合以形成具有相当或不同特性并解决相同或不同问题的其他实施例。类似地，应该理解的是，上述益处和优点可以涉及一个实施方案或可以涉及几个实施方案。
权利要求不旨在包括并且不应被解释为包括装置和功能或步骤和功能限定，除非这种限定在给定权利要求中分别使用短语“用于……的装置”或“用于……的步骤”明确地记载。

Claims (30)

1.一种用于植入核置换装置的套件，其包括：
脊柱植入装置，其包括：
可填充内壳体，其具有带近端开口的近端和带远端开口的远端；
具有近端和远端的可填充外壳体，其中所述可填充内壳体和可填充外壳体的近端联接在一起，所述可填充内壳体和可填充外壳体的远端联接在一起，使得所述可填充外壳体基本上包封所述可填充内壳体；
设置成密封所述可填充内壳体的远端的远端开口的远端塞；和
设置成密封所述可填充内壳体的近端的近端开口的近端塞，所述近端塞具有用于提供通往所述可填充内壳体的通道的通道腔以及具有孔的容纳部，所述孔用于提供通往所述可填充外壳体的通道，其中用于提供通往所述可填充内壳体的通道的通道腔被配置为在植入后保持打开；和
填充针，其适于与所述近端塞匹配，其中所述填充针包括：
第一腔，其设置成延伸穿过所述近端塞的通道腔以将流体输送至内壳体并且从内壳体去除；和
用于将流体输送至外壳体的第二腔。
2.根据权利要求1所述的套件，其还包括包围所述可填充外壳体的外周的增强带。
3.根据权利要求2所述的套件，其中所述增强带包括织物。
4.根据权利要求2所述的套件，其还包括联接到环形增强带的控制部件。
5.根据权利要求4所述的套件，其还包括联接到所述环形增强带的边缘的至少一根拉线。
6.根据权利要求5所述的套件，其中所述至少一根拉线被缝合到所述增强带内的通道中。
7.根据权利要求5所述的套件，其还包括包围所述填充针的输送套管，其中所述输送套管能够从输送位置移动到展开位置。
8.根据权利要求7所述的套件，其中所述控制部件和至少一根拉线位于所述输送套管和所述填充针之间。
9.根据权利要求1所述的套件，其还包括用于注入到所述可填充外壳体中的可固化硅酮材料。
10.根据权利要求9所述的套件，其中所述可固化硅酮材料在五分钟内基本固化。
11.一种脊柱植入装置，其包括：
可填充内壳体，其具有带近端开口的近端和带远端开口的远端；
具有近端和远端的可填充外壳体，其中所述可填充内壳体和可填充外壳体的近端联接在一起，所述可填充内壳体和可填充外壳体的远端联接在一起，使得所述可填充外壳体基本上包封所述可填充内壳体；
设置成密封所述可填充内壳体的远端的远端开口的远端塞；和
设置成密封所述可填充内壳体的近端的近端开口的近端塞，所述近端塞具有用于提供通往所述可填充内壳体的通道的通道腔以及具有孔的容纳部，所述孔用于提供通往所述可填充外壳体的通道，其中用于提供通往所述可填充内壳体的通道的通道腔被配置为在植入后保持打开。
12.根据权利要求11所述的脊柱植入装置，其中所述可填充内壳体和可填充外壳体包括整块材料，并且其中，所述近端塞结合到所述近端开口并适于容纳填充针，所述填充针包括从所述近端塞的近端基本纵向地延伸穿过所述近端塞的远端的至少一个腔。
13.根据权利要求11所述的脊柱植入装置，其中所述近端塞适于容纳填充针，所述填充针包括分别用于将流体输送到内壳体和外壳体的第一腔和第二腔。
14.根据权利要求13所述的脊柱植入装置，其中所述近端塞设置成具有辅助将所述近端塞定位在所述可填充内壳体的近端颈部的一个或多于一个特征。
15.根据权利要求14所述的脊柱植入装置，其中所述通道腔设置成防止所述填充针的不适当安装。
16.根据权利要求15所述的脊柱植入装置，其中所述通道腔设置成与内室通气。
17.根据权利要求11所述的脊柱植入装置，其还包括包围所述可填充外壳体的外周的增强带。
18.根据权利要求17所述的脊柱植入装置，其中所述增强带包括织物。
19.根据权利要求17所述的脊柱植入装置，其还包括可移除的控制部件，所述可移除的控制部件在所述增强带的中心区域联接到所述增强带。
20.根据权利要求19所述的脊柱植入装置，其中所述控制部件位于输送套管和所述填充针之间。
21.根据权利要求17所述的脊柱植入装置，其还包括联接到环形增强带的边缘的至少一根可移除的拉线。
22.根据权利要求21所述的脊柱植入装置，其中至少一根可移除的拉线位于位于输送套管和所述填充针之间。
23.根据权利要求11所述的脊柱植入装置，其中所述外壳体能够填充有可固化硅酮材料。
24.根据权利要求11所述的脊柱植入装置，其还包括用于将装置固定在填充针上的固定部件。
25.根据权利要求24所述的脊柱植入装置，其还包括设置成包围所述填充针的输送套管。
26.根据权利要求11所述的脊柱植入装置，其中所述远端塞具有圆柱形凹部，所述圆柱形凹部用于容纳填充针的远端。
27.根据权利要求26所述的脊柱植入装置，其中所述远端塞具有与所述圆柱形凹部相对的第二凹部，所述第二凹部用于容纳填充针的远端。
28.根据权利要求11所述的脊柱植入装置，其中所述填充的植入装置的外部尺寸的长度为30mm，宽度为20mm，高度为10mm。
29.根据权利要求28所述的脊柱植入装置，其中所述可填充内壳体的外部尺寸的长度为9mm，宽度为6mm，厚度为6mm。
30.根据权利要求11所述的脊柱植入装置，其中所述植入装置设置成其原始尺寸膨胀至少100％。
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JP2018527145A (ja) 2018-09-20
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US20200229947A1 (en) 2020-07-23
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CA2997117A1 (en) 2017-03-09
CN108348227A (zh) 2018-07-31
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JP6891176B2 (ja) 2021-06-18
US10575967B2 (en) 2020-03-03
US20170056195A1 (en) 2017-03-02
EP3344156A4 (en) 2018-08-08
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US11576793B2 (en) 2023-02-14
EP3344156A1 (en) 2018-07-11
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