CN1662193A - 可膨胀的气囊植入体 - Google Patents

可膨胀的气囊植入体 Download PDF

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Publication number
CN1662193A
CN1662193A CN038148358A CN03814835A CN1662193A CN 1662193 A CN1662193 A CN 1662193A CN 038148358 A CN038148358 A CN 038148358A CN 03814835 A CN03814835 A CN 03814835A CN 1662193 A CN1662193 A CN 1662193A
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China
Prior art keywords
implant
air bag
importing
sleeve
vertebra
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Granted
Application number
CN038148358A
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CN100425213C (zh
Inventor
迪特里希·格勒内迈尔
马丁·德利
于尔根·斯佩达
约恩·里克特
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EFMT ENTWICKLUNGS und FORSCHUN
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EFMT ENTWICKLUNGS und FORSCHUN
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    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA

Abstract

本发明涉及一种可膨胀的气囊植入体(3)，该植入体具有有限的液体渗透性。本发明也涉及一种椎体成形装置，该装置包括具有有限液体渗透性的气囊植入体(3)，该植入体连接到导入套筒(2)的末端，以使所述植入体的内部与所述导入套筒相通。

Description

可膨胀的气囊植入体
技术领域
本发明涉及一种可膨胀的气囊植入体。本发明也涉及将这样一种植入体放置于骨腔中的装置。
背景技术
已知的治疗椎骨骨折(尤其是由骨组织中的骨质疏松引起的椎骨骨折)的方法，在于直接将骨水泥或其它的填充物通过经皮通道填入椎骨并以此来稳固椎骨(椎体成形术)。这种方法的缺陷在于椎骨不能在稳固之前直立。而且，这种方法存在填充物从椎骨腔内部流出并进入到身体内的危险。
此外，填充物也可能进入到脊椎管、椎间孔或椎骨的静脉丛并阻塞它们或被血流带走，从而引起栓子或梗死。这种方法还具有一个特殊的问题：如果填充物的粘度太低，填充物从椎骨腔流出的危险就会增大，而当粘度太高时，该填充物硬化太快，又会导致填充不充分。
根据另一种现有的治疗方法，在椎骨腔被填充物充满之前，可采用一个或多个气囊导管，使椎骨松质被压缩并因此扩展(cyphoplasty：脊柱后凸成形术)。这种方法，一方面可用来密封裂缝以防止填充物的可能泄漏，另一方面，该方法在导入填充物之前有可能使椎骨直立。该方法需要去除气囊导管从而延长了外科手术的时间，还有一个风险则是背部肌肉的紧张会使先前完成的直立失效。此外，脊柱后凸成形术不能彻底防止填充物进入到脊椎管、椎间孔或静脉丛。
发明内容
考虑到椎骨骨折的现有治疗方法所存在的问题，本发明的目的在于提供一种植入体，该植入体使进行椎体成形术时填充物泄漏的风险达到最小，同时使外科手术时间尽可能地短，并且使椎骨得以直立。
根据本发明，通过使用一种如前所述类型的提供有限液体渗透性的气囊植入体来实现上述目的。
使用管状导入套筒将本发明的气囊植入体在放完气的状态下通过经皮通道植入准备好的(即打开的)椎骨。一旦将气囊植入体放入椎骨内，优选通过所述导入套筒导入填充物，以使所述气囊植入体膨胀。有限的液体渗透性，一方面确保了填充物进入到脊椎管的风险为最小，另一方面确保了植入体和椎骨之间的安全连接。这使得可以使用粘度比现有治疗方法中所用的填充物的粘度更低的填充物，从而也消除了填充物在椎骨腔被完全充满之前就硬化的风险。此外，如果需要的话，随着气囊膨胀而施加的压力可以使椎骨直立。
当脊椎腔被填充后，将植入体的近端流入口闭合，并将植入体与导入套筒分开。
使用本发明所述的植入体能得到比现有的操作方法更好的治疗效果，因为它可以使涉及填充物过度泄漏以及手术时间过长的并发症达到最少化。
在最简单的实施方案中，所述植入体仅仅由气囊本身组成，尽管该植入体也可以具有更多的部件(如接合部件)。在这种情况下，只有气囊本身需要具有有限液体渗透性。
组成气囊的可以是具有有限液体渗透性的材料，或者是带有小孔的不可渗透的材料，所述的小孔可以使该气囊具有有限液体渗透性。
所述材料可以是有弹性的或者是没有弹性的，前提是在生理相容性和抗撕裂性方面须符合医用材料的要求。在一个优选的实施方案中，采用了塑性材料，它可被压缩至特别小以便植入到椎骨腔内，因此它们可以与例如横截面特别小的导管一起使用。
在一个优选的实施方案中，所述的液体渗透性材料是织物包装纸(textile tissue)或织物，特别是尼龙织物(nylon tissue)。满足DIN标准53861-3要求的材料尤其适合。所用的气囊材料的密度必须允许有限量的液体在填充物硬化之前可以渗出。一个称职的本领域技术人员可以很容易地针对所用的特定填充物选择合适的气囊材料。
一种特别适合用作带小孔的不可渗液性物质的材料是穿孔或有点(stippled)乳胶，因为这种材料一般是生理可容许的并且是弹性的。
具有固有的不可渗液性的物质所带的孔的尺寸和数量(即孔的密度)取决于所用的填充物(例如常规的骨水泥或聚合填充物)，并且可以由本领域技术人员很容易地确定适用于给定的填充物的孔密度。特别适合于通常的填充物的孔密度是，相对于材料表面最多为5％，优选1％到3％。
可按以下条件设定孔的尺寸：治疗期间骨填充物的泄漏量是0.05％到6％，优选是1％到4％，特别优选是2％到3％，于是大量的孔确保了该植入体的正确固定。
如果材料(具有固有的可渗水性或固有的非渗水性但具有小孔)能够保证气囊对医用骨填充物的渗透性在0.05％到6％的范围内，优选是1％到4％的范围内，特别优选的是2％到3％的范围内，则该材料特别适合于充当气囊材料。
这些渗透能力大小指的是以液态导入的填充物在椎骨腔内硬化之前的泄漏量，其中导入气囊内的填充物总量设为100％。于是本领域技术人员所选的材料取决于使用的填充物和它的粘度。对本领域技术人员来说根据所用的填充物确定最合适的气囊材料是毫无问题的(粘度越低或硬化速率越低——材料密度越高)。
本发明的植入体允许使用粘度特别低的填充物(这种情况下必须使用更致密的材料，以达到上述的合适的渗透能力大小)，这有效降低了填充物在手术完成前硬化的风险，同时也使得可以使用小口径导入套筒和其它小口径设备。这种低渗透能力将与填充物过度泄漏有关的手术风险降至最小，同时使该植入体得以安全地固定在椎骨腔内部。
在非膨胀的条件下，所述气囊呈袋式形状。在一个有利的实施方案中，在膨胀条件下且没有外部约束(如椎骨腔的形状)的作用时，该气囊呈预定的形态，该预定形态可以是近似的球状或长方体状或者甚至更复杂的形状。于是，对任何椎骨构造，可以选择一特别合适的植入体，以安全地确保该椎骨腔被完全填充。通过使用弹性气囊材料，可以进一步增强这种安全性，以确保膨胀后的气囊形状对椎骨腔形状有特别好的适应性。
在另一个有利的实施方案中，为了与导入设备分离，该植入体在其近侧的开口端具有较薄的壁部，该壁部可作为预设的断裂点。这种成本很低的变型使得在填充椎骨腔后可通过旋转/轻拉动作的组合，将气囊关闭并使该植入体与导入设备相分离，因此植入体由于其拉力反应可以很容易地被分离。(在这种情况下，通往椎骨腔的通道的横截面要比腔体本身小，因此植入体在被填入后通过机械夹紧作用即使在填充物硬化前也可以安全地保持在原位置)。
在另一个有利的实施方案中，植入体在其近侧区域具有一个接合部件，该部件使该植入体和其导入套筒之间可形成一个可分离并可传导的连接点。取决于所用的接合部件的类型，将该植入体与外部的导入套筒从外部相分离的方法可以是，例如通过机械作用、电解分离(electrolyticdetachment)或者通过激光闪光(laser flashes)等。这些接合部件和制造它们所需的材料对称职的本领域技术人员来说都是已知的。
另一个有利的实施方案是以下的设计：其中，该植入体具有用于闭合近侧开口的一个闭合装置，外科医生可以在外部操作该装置(例如可通过施加牵拉作用来关闭的插栓或者环)。
本发明也涉及一种椎体成形装置，该装置装有上述任何一种气囊植入体，该气囊植入体与导入套筒末端相连接，由此，该植入体内部可以与所述导入套筒内腔相通。(这里的术语“末端”并不一定意味着导入套筒的末梢，而是指末端区域)。
该植入体基本上可以采用任何已知的适宜技术与所述导入套筒接合一于是该植入体可以在所述导入套筒的外部的或内部的周边与之接合，或者该连接点可以采用从该植入体到所述导入套筒的连续过渡的形式。
一种有利的解决方案是如下装置：其中，所述气囊通过例如粘合、夹紧、扩张或者螺栓连接等形状配合(form-fit)接合方法，与所述导入套筒接合。如果需要的话，可使该气囊和/或导入套筒具有合适的保持部件。
该植入体和导入套筒之间的可分离性，是通过所述气囊和导入套筒之间的连接本身的可分离性来确保(例如前面所述的螺栓连接法或夹紧法，或者一个或多个接合部件的可电解分离性)，或者通过以下方式来确保：所述气囊和导入套筒之间的连接不可分离，但该气囊具有预设的断裂点(如前所述)。
一种有利的装置是如下这种装置：其中，所述气囊的开口端固定在所述导入套筒的内周边。
根据另一个特别有利的实施方案，牵拉所述气囊的开口端使其套在所述导入套筒的末端并固定在导入套筒的外周边。
在所述装置的一个特别有利的实施方案中，所述导入套筒在其末端具有一个加固部件，该部件用于加强该导入套筒末端与所述植入体近侧端之间的连接。它可以是所述导入套筒的壁的一部分(翻转的末端)，或者是呈额外部件(例如环)的形式，该额外部件通过通常的方式与该导入套筒牢固连接。
该部件优选设计成一个夹圈或压紧圈，作为一个闭塞圈，牢固地将该气囊的近侧端夹紧到导入套筒(于是提供一个到外壁的额外连接)或者把它牢固地锁定在原位置(通过把它压在内壁上)。
所述导入套筒优选是由医用等级的钢制成。所有生理可容许的高强度且耐磨损的材料，一般都适用于这个目的。
在一个特别优选的实施方案中，所述导入套筒通过医用套管针的中空针的引导来方便导入。
以下基于如图所示的示范性实施方案对本发明作更详细的解释。
附图说明
参考下列示意图：
图1a是在导入椎骨腔前的带导管2的椎体成形装置1的非真实比例的示意图。
图1b是带球形的膨胀气囊植入体3的椎体成形装置1的非真实比例的示意图。
图1c是带长方体形的膨胀气囊植入体3的椎体成形装置1的非真实比例的示意图。
具体实施方式
图1a所示的椎体成形装置1包括导入套筒2和可膨胀气囊植入体3。在导入套筒2的末端，气囊植入体3通过热成形以形状配合的方式连接到导入套筒2的外壁。为提供额外的安全性，该连接通过一个夹圈进行加强，该夹圈设计成闭塞圈4，作用于导入套筒2的外周边，以阻止任何朝所述末端方向的运动。
在使用已知技术如套管针来建立经皮通道并打开椎骨后，将导入辅助器5例如套管针的中空针，上移至椎骨开口处，并将气囊植入体3在放完气的状态下导入椎骨腔。
在这个X射线控制下的手术中，将导入套筒2首先上移到椎骨开口。然后通过前移导入套筒2将气囊导入腔内，此时要确定导入套筒2的末端也已导入以便确保完全导入。该手术是在X射线控制下的，导入辅助器或导管5和导入套筒2的位置由于使用了标记物因此是可控制的。
随后将合适的填充物(聚甲基丙烯酸甲酯、骨水泥或其它合适的优选抗X射线的物质)通过导入套筒2从外部导入气囊植入体3，放置在椎骨腔内，直到该植入体填满腔体。
图1b和图1c显示了植入体的两个不同的实施方案3’/3”，它们在膨胀状态下可呈不同的形状(球3’或长方体3”)。于是，取决于腔体的形状，可以选择其呈现的形状已设计为特别适合于腔体形态的植入体3。此外，由于尼龙材料的弹性，植入体3在膨胀时将扩展而超出预定的形状，进一步推进到腔体内，于是特别充分地填满腔体。
在这个例子里，植入体3由气囊本身组成。该气囊经过预成形，因而在膨胀状态下它具有颈部6(其外周边比本体部7更小)和本体部7。在颈部6区域，该植入体3具有更薄的壁部，该壁部使得在填充完填充物后，可以通过旋转导入套筒2至一定的角度同时稍加牵拉，从外部将植入体3与导入套筒2分离。
所述的旋转动作与用于植入体3的尼龙材料8的弹性相结合，可使植入体3的颈部6闭合，由此使得大部分填充物都不能向近侧端方向漏出。
此外，在填满腔体后，可以使用合适的闭合装置(如插栓或螺栓)来封闭腔体。或者，可使用本身配置了闭合部件(图中未显示)的植入体。
另外，在完成旋转动作使颈部6闭合并使植入体3分离(通过拉力作用和进一步的旋转动作)后，外科医生可以例如等待直至填充物硬化。此时必须确保导入套筒2的末端已在硬化过程完成前脱离了椎骨并放置在腔体开口处。以此确保在导入套筒2和椎骨之间不会形成意外的连接。
在这些实施方案中，导入辅助器5设计为医用套管针的中空针。导入套筒2和植入体3一起穿过导入辅助器5移动到治疗部位。
首先，在由X射线控制的过程中，将由导入辅助器和充填器(套管针)组成的全套装置穿过皮肤导入到骨头中。一旦到达目标部位，就将充填器拔出。此时中空针构成了通往目标部位的工作通道。可以使软气囊穿过中空针推进至治疗部位，而不会有推进时粘在骨头表面的风险。(以上的图1a显示了导入辅助器推动中空针和气囊)。一旦气囊在其目标部位，将导入辅助器向后拉至一定程度以便通过注入骨水泥使气囊膨胀。
选择填充物和气囊材料以确保填充物在硬化之前只有2％-3％的物质漏进腔内。这确保了该植入体可安全地放置在腔内，而不存在填充物进入椎骨的后四分之一部并且填充该区域中的静脉血管的风险(或者由自由飘浮的硬化填充物引起的拴子和梗死的风险)。
取决于腔体的构造，也许导入几个植入体是有利的，如果合适的话可使用不同的通道。

Claims (22)

1.可膨胀的气囊植入体，其特征在于，该气囊植入体具有有限的液体渗透性。
2.如权利要求1所述的植入体，其特征在于，所述气囊(3)由具有有限液体渗透性的材料制成。
3.如权利要求2所述的植入体，其特征在于，所述材料是织物包装纸或织物。
4.如权利要求3所述的植入体，其特征在于，所述材料是弹性的。
5.如权利要求4所述的植入体，其特征在于，所述材料是尼龙织物。
6.如权利要求5所述的植入体，其特征在于，所述纺织材料符合DIN标准53861-3。
7.如权利要求1或2所述的植入体，其特征在于，所述材料具有固有的不可渗液性并具有小孔。
8.如权利要求7所述的植入体，其特征在于，所述小孔最多占所述气囊表面的5％。
9.如权利要求7或8所述的植入体，其特征在于，所述材料是有孔的乳胶。
10.如以上权利要求任一项所述的植入体，其特征在于，用于气囊(3)的材料对于医用骨填充物的渗透能力大小为0.05％到6％，优选是1％到4％，特别优选是2％到3％。
11.如以上权利要求任一项所述的植入体，其特征在于，所述气囊植入体(3)经过预成形而在膨胀时呈预定的形状。
12.如以上权利要求任一项所述的植入体，其特征在于，所述植入体具有用于以可分离且可传导的方式使该植入体与导入套筒(2)连接的装置。
13.如以上权利要求任一项所述的植入体，其特征在于，所述植入体在其近侧开口端具有一个较薄的壁区，该壁区用作预设的断裂点。
14.如以上权利要求任一项所述的植入体，其特征在于，所述植入体在其近侧开口端具有用于封闭所述气囊内腔的闭合装置。
15.配置了以上权利要求任一项所述的气囊植入体(3)的椎体成形装置，所述气囊植入体(3)与导入套筒(2)的末端相连接，以使所述植入体的内部与所述导入套筒的内腔相通。
16.如权利要求15所述的装置，其特征在于，所述植入体(3)通过例如粘合、夹紧、扩张或者螺栓连接的形状配合接合技术与导入套筒(2)接合。
17.如权利要求15或16所述的装置，其特征在于，所述导入套筒(2)与气囊植入体(3)之间的连接是可分离的。
18.如权利要求15或16所述的装置，其特征在于，所述导入套筒(2)与气囊植入体(3)之间的连接是不可分离的，并且气囊植入体(3)具有预设的断裂点。
19.如权利要求15至18中任一项所述的装置，其特征在于，所述气囊植入体(3)的开口端连接到导入套筒(2)的内周边。
20.如权利要求15至19中任一项所述的装置，其特征在于，所述气囊植入体(3)的开口端套在所述导入套筒的末端上并连接于该导入套筒的外周边。
21.如权利要求15至20中任一项所述的装置，其特征在于，所述导入套筒(2)在其末端具有一个额外部件(4)，该部件用于将气囊植入体(3)固定在原位置。
22.如权利要求15至21中任一项所述的装置，其特征在于，所述导入套筒(2)由医用等级的钢制成。
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