CN1622792A - 采用具有内部限制件的可膨胀本体来压缩松质骨的装置和方法 - Google Patents

采用具有内部限制件的可膨胀本体来压缩松质骨的装置和方法 Download PDF

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Publication number
CN1622792A
CN1622792A CNA028285018A CN02828501A CN1622792A CN 1622792 A CN1622792 A CN 1622792A CN A028285018 A CNA028285018 A CN A028285018A CN 02828501 A CN02828501 A CN 02828501A CN 1622792 A CN1622792 A CN 1622792A
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Prior art keywords
sacculus
bone
expansion
elongated axis
along
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CNA028285018A
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CN100464723C (zh
Inventor
保罗·雷斯
塞萨尔·伊乔
卡伦·D·塔尔梅奇
马克·A·赖利
阿里·斯科尔滕
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Medtronic Spear LLC
Medtronic Spine LLC
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Kyphon Inc
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Abstract

挤压松质骨的装置和方法。在一个布置中，这些装置和方法使用了一种可膨胀本体，它包括与该本体连接的内部限制件。该内部限制件引导了本体的膨胀。在一个布置中，用于治疗骨头的方法包括将具有内部限制件的装置插入在骨头内部并且使得该本体在松质骨内定向膨胀。通过该定向膨胀来压实松质骨。

Description

采用具有内部限制件的可膨胀 本体来压缩松质骨的装置和方法
技术领域
本发明涉及对人类和其它动物中的骨病的治疗。
背景技术
当松质骨由于诸如骨质疏松、无血管形成性坏死或癌症而病变时，周围的皮质骨变得更容易出现压缩骨折或塌陷。这至少部分是因为松质骨不再给周围的皮质骨提供内部支撑。骨病还会影响周围皮质骨的强度和完整性，从而进一步使得该骨头容易骨折和/或塌陷。
在美国每年有两百万例骨折，其中大约130万例仅是由骨质疏松引起。还有其它骨病，包括感染的骨、愈合不好的骨或由于严重外伤导致骨折的骨。而且，使用各种药品例如类固醇、烟草和/或过度饮酒会使骨质明显变差。这些情况如果没有成功解决的话会导致骨折和/或骨塌陷，从而造成残废、慢性并发症，并且对生活质量造成全面的负面影响。
美国专利Nos.4969888和5108404披露了用于固接由骨质疏松和非骨质疏松引起的人类和其它动物骨骼系统的骨折或其它病况的设备和方法。与其它发明一起，这些专利披露了采用可膨胀本体来压缩松质骨和/或在目标骨内形成内部空腔的装置和方法。该空腔接纳填充材料，该材料硬化并且为皮质骨提供更新的内部结构支撑。
可以利用用于制作可膨胀本体并且使之在骨头中展开的改进系统和方法来更加全面地实现这些专利所希望的对骨病进行更好并且更有效的治疗。
发明内容
本发明的一个方面提供用于压缩松质骨的装置和方法。在一个布置方案中，这些装置和方法使用了一种包括与之连接的内部限制件的可膨胀本体。内部限制件引导了该可膨胀本体的膨胀。在一个布置方案中，治疗骨头的方法包括将这个具有内部限制件的装置插入在骨头内并且使该可膨胀本体在松质骨内定向膨胀。通过该定向膨胀来压实松质骨。
本发明的另一个方面提供了用于压实松质骨的装置和方法。在一个布置方案中，这些装置和方法使用了一种用来插入到骨头中并且在松质骨内进行膨胀以压实松质骨的本体。该本体包括在松质骨内膨胀的期间施加能够使断裂的皮质骨移动的力的材料，并且还包括用来约束在松质骨内的膨胀的内部薄膜。在一个布置方案中，一种治疗骨头的方法包括将这个具有内部薄膜的装置插入在骨头内并且使得该本体在松质骨内进行受约束膨胀。通过该受约束膨胀来压实松质骨。
在下面的说明和附图中以及在所附权利要求中给出了本发明的特征和优点。
附图说明
图1为根据本发明的教导构成的球囊的第一实施方案的透视图，该实施方案呈层叠的圆环形组件形状。
图2为贯穿图1的球囊的垂直剖面，显示出将图1的球囊的圆环形部分装配进椎体空腔中的方式。
图3为本发明球囊的另一个实施方案的示意图，显示出三个层叠的球囊和用于限制球囊沿着膨胀的各个方向膨胀的细绳状限制件。
图4为具有围绕着球囊的圆柱形环的球形球囊的俯视图。
图5为贯穿图4的球形球囊和环的垂直剖面。
图6显示出具有延伸进球囊的中央部分中的导管的椭圆形球囊。
图6A为其中可以将导管相对于用于使图6的球囊膨胀的内管布置的一种方式的透视图。
图7为用于进行使球囊膨胀和将由球囊自身膨胀所产生的碎片去除的吸管和造影剂注射管。
图8为在球囊已经变瘪之后并且在正在将它插入到人的椎体中时贯穿该球囊的垂直剖面。
图9、9A和9B为插管的侧视图，显示出在留下插管时保护套或引导件可以如何膨胀。
图10为形成为菜豆形状的本发明球囊的另一个实施方案的透视图。
图11为椎骨的透视图，显示出插入在骨头中并且膨胀的图10的菜豆形球囊。
图12为通过加热元件或烙印工具用几个隔室形成的菜豆形球囊的顶视图。
图13为沿着图12的13-13线剖开的剖视图，但是具有两个已经层叠在一起的菜豆形球囊。
图14为类似于图11的剖视图，但是显示出处于椎骨中的图13的层叠菜豆形球囊。
图15为菜豆形球囊的顶视图，显示出将球囊的顶壁和底壁相互连接的用来将内部细绳保持不动的外部线束。
图16为沿着图15的16-16线剖开的剖视图。
图17A为在右远端桡骨中的拱形香蕉状球囊的背视图。
图17B为沿着图17A的17B-17B线剖开的图17A的剖视图。
图18为从左近端肱骨的前面(前方)看在近端肱骨中具有底座的球形球囊。
图19A为近端胫骨的前(前方)视图，其中椭圆形柱状球囊插入在中间胫骨平台下面。
图19B为图19A的球囊的四分之三视图。
图19C为图19A的球囊的侧视图。
图19D为图19A的球囊的俯视图。
图20为从左髋骨的前面(前方)看用于治疗股骨(或肱骨)头部的无血管形成性坏死的球形球囊。
图20A为用于治疗股骨(或肱骨)的头部的无血管形成性坏死的半球形球囊的侧视图。
图21为从左髋骨的前面(前方)看用于防止和/或治疗髋骨骨折的球囊。
图22A-C为根据本发明用于给骨头输送治疗物质的示例性方法和系统的示意图。
图23为设有内部膨胀限制件的可膨胀结构的另一个实施方案。
图24A-C为在空气中膨胀的图23的可膨胀结构的剖视图。
图25A为用于压缩松质骨和/或使皮质骨移动的可膨胀结构的另一个实施方案的前视图。
图25B为图25A的结构的侧视图。
图25C为图25A的结构的透视图。
图26A为带有在图23和24A至24C中所示的那种可膨胀结构的空腔形成装置的侧视图。
图26B为在图26A中所示的空腔形成装置的远端的透视图，显示出将可膨胀结构的近端装配在该装置的外部导管本体的远端上。
图26C为在已经将可膨胀结构的近端和远端分别固定至外部导管本体的远端和该装置的内部导管本体的远端上之后在图26A中所示的空腔形成装置的远端的透视图。
图27为可膨胀结构的另一个实施方案。
图28为空腔形成装置的远端的侧视图。
具体实施方式
I.用于解剖结构的球囊
本发明涉及一种可以用来治疗易于骨折或塌陷的骨头的球囊。这些球囊包括一个或多个用于插入到所述骨头中的可膨胀球囊体。该球囊体在基本充分膨胀时具有优选的形状和尺寸，从而在出现骨折或塌陷的情况下压缩至少一部分内部松质骨以便在松质骨中形成一空腔和/或使外部皮质骨恢复到原始位置。在各个实施方案中，对球囊体进行约束以形成所述优选形状和尺寸，从而如果所述骨头没有骨折或塌陷的话理想地抑制完全膨胀的球囊体向外部皮质骨的内表面上的单个点上施加很大压力。
除了可膨胀装置本身的形状之外，另一个重要方面是球囊壁的结构，由此可以实现使球囊体正确膨胀以使松质骨进行最优的压缩。球囊的材料也优选如此选择，从而可以迅速而容易地通过插管将球囊插入到骨头中，并且该球囊还可以在膨胀时承受高压。例如，可以选择材料以便于折叠该球囊。或者，该材料优选可以使得球囊在膨胀期间能够进行塑性、弹性和/或半弹性变形。该材料最好还能够当在球囊的插入和膨胀期间与皮质骨和/或松质骨接触时抵抗球囊的磨损和/或刺破。该球囊还可以包括设在空腔上的可选脊部或凹槽，它们优选在已经拆除球囊之后保留在空腔壁中以提高骨隙填充物的稳定性。还有，可以使可膨胀装置具有可选的内部抽吸导管。这可以用来除去在球囊在骨头中膨胀期间从骨头中挤出的任何脂肪或流体。还有，通过在处于插管和/或骨头内期间用由适当材料例如Kevlar纤维产品或聚对苯二甲酸乙二醇酯(PET)或其它可以保护该球囊的聚合物或物质形成的可选保护套罩住该球囊体，从而可以保护球囊体免于被刺破(被周围的骨头或插管刺破)。该覆盖材料还具有降低球囊和插管间摩擦的额外优点，或者可以结合润滑材料例如硅酮来降低摩擦。因此，可膨胀装置的一个重要目的在于在骨头中尤其但不限于在椎体中形成或扩大空腔或通道。
在一个方面中，本发明提供一种改进的球囊状可膨胀装置，它用于在骨头中进行空腔成形外科手术流程以便提高该流程的效率、减少进行该流程所设计用于的外科手术所需要的时间并且提高临床效果。必要时，这些球囊可以接近它们所处的骨头内部形状以便最大地压缩松质骨。它们还可以具有额外的设计要素以实现专门的临床目标。在各个实施方案中，它们由无弹性的、半弹性的、弹性的或可塑性变形的材料制成，并且在膨胀时通过各种限制件保持在其限定的结构中，这些限制件包括但不限于使用与球囊体结合的无弹性的、半弹性的、弹性的或可塑性变形材料、通过将单独的材料片粘接或熔接在一起或者通过将球囊体的相对侧边熔接或粘接在一起形成的在球囊体中的接缝、粘接在球囊体的内侧或外侧上的纺织材料、设置在球囊体中的选定位置处的细绳或条带、通过胶粘或者通过将它们热熔接在一起将具有类似或不同尺寸或形状的球囊相互层叠。由上面的结构形成的或通过粘接附加材料增加的可选脊部或凹槽可以提高骨隙填充物的稳定性。这些脊部或凹槽也可以在随后受治疗骨头的承载和/或愈合期间帮助骨头填充材料保持在所要求的位置中。可选的抽吸装置优选如此设置，从而如果至少一个这种装置位于所形成的空腔的大致最低位置处，则这些抽吸装置最好允许该空腔能够被清洁和/或允许能够在填充之前从空腔中将流体或固体除去和/或将它们导入到其中。
本发明的各个实施方案如下：
1.一种圆环形(或环形)球囊，具有用来除去在球囊膨胀期间挤出的脂肪和其它产物的可选内部抽吸导管。
2.一种用来进行体腔形成的具有由环形球囊段包围的球形外形的球囊。
3.一种具有菜豆形结构的球囊。这种球囊可以构成为单层或者彼此层叠的几层。代替菜豆形，该实施方案也可以是方形或矩形。
4.一种近似股骨头部尺寸的球形球囊(即，近端股骨骨骺)。这种球囊也可以是半球形。
5.一种成近似桡骨远端(远端桡骨骨骺和干骺端)结构的拱形香蕉状或变化的金字塔形状的球囊。
6.一种球囊，它成圆柱形椭圆形状的，从而近似近端胫骨骨骺的中间半部或侧面半部的结构。这种球囊也可以构成为近似近端胫骨骨骺的两个半部的结构。
7.一种球囊，它在一底座上成球形形状，从而近似于近端肱骨骨骺和干骺端的形状，并且具有一插塞，用于将松质骨压缩进骨干，从而将它密封。这个实施方案也可以为圆柱形。
8.一种呈飞旋镖形状的球囊，它近似股骨头部、颈部和较小的转子的内部，从而使得能够进行防止髋骨骨折的手术。
9.一种球囊，它呈圆柱形形状，从而近似近端肱骨内部或远端桡骨的形状和尺寸。
10.一种呈花生或沙漏形状的具有内部薄膜的球囊，用来约束择优地沿着一个或多个轴线的膨胀。
11.一种呈圆盘形状的球囊。
12.一种具有可选抽吸装置的球囊装置。
13.用作防刺破部件的保护套，它可选地将每个球囊覆盖在其导管内部。
因此，本发明提供了用于在骨中形成或扩大空腔或通道的改进可膨胀装置，其中将这些装置插入到骨头中。虽然小至约40％(或更小)并且大至约99％的球囊对于骨折是可用的，但是在各个实施方案中每个装置的结构可以由周围的皮质骨和附近内部结构所限定，并且设计成占据骨内部的体积的70-90％。在各个其它实施方案中，例如对于治疗无血管形成性坏死和/或癌而言，由于骨折、塌陷和/或治疗区域的局部特性，膨胀球囊尺寸可以为所要治疗的骨头区域的松质骨体积的10％。球囊的完全膨胀尺寸和形状最好由在球囊体的选定部分中的其对膨胀的阻力形成约束的材料来调节，也可以通过以下方法来调节，通过形成在该装置中的内部或外部限制件包括但不限于网状物、带状织物、薄膜、隔板或挡板、线圈、缠线或其它层叠在球囊体的各个部分上的材料、通过粘接在球囊内侧(通过胶粘、焊接等)或者通过将这些细绳穿到外面而在特定位置处保持不动的穿越球囊内部的连续或非连续细绳、以及通过将本体的两个部分粘接在一起或通过利用胶水或热将本体的相对侧面粘接而在球囊体中形成的接缝。除了采用不同材料之外，本发明的目的同样可以通过利用不同厚度的材料来调节球囊体的膨胀来实现。而且，使用具有不同弹性的类似材料例如具有通过γ射线照射交联并且因此更不容易膨胀的分散部分的聚氨基甲酸乙酯塑料球囊同样可以实现本发明的目的。
球囊的球形部分可以通过在球囊体的结构中采用无弹性、半弹性、弹性或弹性体材料来限制或者可以如刚才所述一样进行进一步限制。球囊的材料可以为非弹性材料，例如聚对苯二甲酸乙二醇酯(PET)、尼龙、Kevlar或其它专利或非专利医用球囊材料。如果设有适当的限制件，则它还可以由半弹性材料例如硅酮、橡胶、热塑性橡胶以及弹性体或弹性材料例如胶乳或聚氨基甲酸乙酯制成。这些限制件可以是连续的或由柔性无弹性高拉伸强度材料分散元件制成，这些材料包括但不限于在这里被引用作为参考的美国专利No.4706670中所披露的材料。球囊壁的厚度通常为0.002至0.025英寸，但是也可以采用其它可以承受高压例如250-400psi或更大甚至高达500、1000或2000psi压力的厚度。
本发明的经皮椎体扩张的一个重要目的在于提供一种球囊，该球囊可以在椎体内部形成其结构对于支撑骨头而言是最优的空腔。另一个重要目的在于使椎体的顶部和底部(或者被称为上下终板)朝着更正常的解剖位置运动以恢复可能的高度。但是最好在不会由于使椎体的皮质骨侧壁断裂或由于使已经断裂的骨头在侧壁中的运动而明显改变椎体侧面的外部尺寸的情况下实现这两个目的。
本发明通过将要说明的可膨胀装置的设计结构来满足这些目的。使这种装置膨胀而在含钙的柔软松质骨内形成空腔(例如通过压缩该松质骨)和/或使周围的皮质骨朝着更正常的解剖位置移动。
在一个实施方案中，球囊体最好再造了未断裂椎体的内部形状，并且优选长大最大不超过内部容积的70-90％。这些实施方案的球囊如此设计，从而使它们最大程度地膨胀而优选将再造预定形状和尺寸。但是，传统的球囊在膨胀时变为球形。球形形状通常使得硬化的骨隙填充物不能够充分地支撑脊骨，因为它们会形成大体上为球形的空腔，该空腔在填充有填充材料时与椎体表面形成单点接触(等同于在方形内的圆形或在圆筒内的球体)。相反，本发明的球囊的各个实施方案通过结合有使球囊保持所期望形状的限制件从而更能再造椎体的平面。这些所期望的形状形成空腔，这些空腔在填充有填充材料时将从椎体表面传递来的载荷理想地分配给这些骨隙填充物，这最终加强了该脊骨。另外，填充这些空腔的骨隙填充物的体积理想地形成较厚的接合剂皮层(例如4mm或更大的厚度)，这提高了填充材料的压缩强度。各个实施方案的另一个有用特征在于在球囊中形成有脊部，这些脊部可以在压缩的松质骨内形成的空腔壁中留下一个或多个印痕。将最终填充这些印痕的所得到的骨隙填充物“指状物”可以提供更高的稳定性，并且降低了填充材料在脊骨的压缩载荷下在椎体内偏移或移动的可能性。
可以最优地挤压在椎体中的松质骨的球囊包括如上面球囊类型1-3、10和12所列出的球囊。其中一些球囊优选构成为近似椎体的形状。由于可以将该球囊选择为占据比目标椎体的总内部容积(在骨折之前)更小的容积，所以球囊的膨胀将不会在椎体的周围皮层侧壁上施加过大的压力(椎体的侧壁将不会膨胀超过其现有的尺寸—骨折的或未骨折的)。但是，由于椎体的上下终板通常在压缩骨折中塌陷，并且球囊可以接近未骨折椎体的高度，所以球囊的膨胀可以使顶部和底部终板朝着其骨折前位置和/或取向往回运动。而且，可以在椎体内使用多个单独球囊，例如通过层叠多个球囊，并且包含任意所披露的球囊类型的层叠体可以在形状和/或尺寸上混合以提供更大的灵活性和/或控制。
经皮股骨(或肱骨)头部扩张(球囊类型4)、经皮远端桡骨扩张(球囊类型5)、经皮近端胫骨扩张(球囊类型6)以及经皮近端肱骨扩张(球囊类型7)的主要目的在于形成其结构对于支撑所要治疗的骨头而言是最优的空腔。另一个重要目的在于压缩无血管形成性(无菌)坏死骨或支撑无血管形成性坏死骨。还有一个重要目的在于帮助将骨折碎片重新对准。这些目的通常通过主要在松质骨上施加可以传递给周围的皮质骨的压力来实现。可以想到直接作用在一小段皮质骨上的压力会引起骨折恶化，虽然不能排除，但是最好要避免这种情况出现。可膨胀装置的各个实施方案的结构近似于所要治疗的骨头形状。由可膨胀装置形成的空腔的大致容积可以为所要治疗的骨头体积的70％-90％。在无血管形成性坏死的情况中，根据无血管形成性坏死的程度，可以在骨内部形成更小或更大的空腔。在一些情况中，如果无血管形成性坏死的面积较小，则可以使用形成其体积只有总体积的10-15％的空腔的小球囊。如果无血管形成性坏死涉及更大的面积，则可以使用一个或更多更大的球囊，它们形成更大的空腔，包括为骨体积的80-90％的空腔(或更大)。本发明通过所述的可膨胀装置的结构来满足这些目标。
例如，经皮髋骨扩张(如结合球囊类型8所示一样)设计成通过压缩在其中出现髋骨骨折的股骨中的弱松质骨并且用适当的支撑材料代替它来防止和/或治疗髋骨骨折。本发明通过所述的可膨胀装置的设计结构来满足这个目的。
本发明披露了用于在骨头中展开的改进系统，它包括用来在使用时调整以呈现出具有所要求结构的膨胀几何形状的结构。这些可膨胀结构包括使得该结构能够在受到内压时有差别地膨胀的材料。这些结构在使用时能够择优地沿着一个或多个轴线膨胀以便朝着一个方向比向另一个方向输送更大的力和/或使松质骨进行更大的移动。另外，必要时，这种结构在膨胀时可以大体上与该结构在其中展开的内部骨空间的几何形状相配。例如，这些结构可以优选朝着所要求的形状膨胀而不是简单地朝着骨密度最低的区域膨胀，也就是说，即使在碰到骨头中具有不同阻力的区域时也可以控制该结构的膨胀。
而且，该膨胀结构与松质骨接触还通常需要具有对表面磨损、刺破和/或拉伸应力具有相当大的抵抗力的材料。例如，已经通过加热加压预成形为所要求形状的结合有弹性材料的结构可以在松质骨中进行受控膨胀并进一步扩展，而不会失效，同时在与松质骨接触时对表面摩擦和刺破具有抵抗力。
本发明还披露了具有一个或多个偏向的膨胀方向的可膨胀装置。例如，具有更小的侧向生长的可膨胀装置可以提供改善的降低骨折效果，因为这些装置可以在所治疗的骨头内施加更大的垂直力和/或偏移。这些可膨胀装置还可以通过使朝着这些侧壁的膨胀最小并且使膨胀沿着脊骨的纵向轴线方向的程度更大来保护椎体的外侧和前/后侧壁。在其中当可膨胀装置接触着目标骨头的侧面皮层壁时结束外科手术的情况中，这种偏向的膨胀将能够提高在到达这个手术结束点之前的骨折降低效果。
由于损伤、病变或其它治疗的特性以及患有这些损伤病人的健康程度和年龄，可以优选在打开或半打开手术期间使用本发明的装置来治疗骨头。另外，手术的目的可以是用不会流动的并且因此不适用于最小创伤手术的材料(例如骨填充物或某些药物)来更换患病或受损伤骨。
A.用于椎体的球囊
根据本发明的教导构成的球囊的第一实施方案(图1)大体上由标号10表示，并且包括一球囊体11，它具有一对由柔性材料构成的中空可膨胀部分12和14，该材料包括(但不限于)非弹性材料例如PET、聚酯薄膜或Kevlar，弹性材料例如聚氨基甲酸乙酯、胶乳或橡胶，半弹性材料例如硅酮，或者其它材料。部分12和14在它们之间具有一吸管16，用来通过吸进该管子16中来抽出脂肪和其它碎片以便传送给远处的丢弃位置。导管16具有一个或多个抽吸孔，从而可以从抽吸源(未示出)向管子16的开口端施加吸力。
在该实施方案中，部分12和14通过任意适当类型的能够粘接这种材料的粘接剂以及通过粘合即热粘合(激光、射频(RF)/感应、热模)、超声波焊接、溶剂粘合等方法连接在一起。部分12和14为如图1中所示一样的圆环形，并且具有管子18和20，这些管子分别与部分12和14连通并且从中分别延伸至高压膨胀流体源(未示出)。膨胀流体优选为液体。该液体在已经将处于塌陷状态(图8)的球囊插入到所要治疗的骨头例如在图2中的椎骨22中之后使球囊10尤其是其部分12和14膨胀。在这里被结合作为参考的上述美国专利US4969888和US5108404披露了在球囊为瘪的而且已经插入进管子中并由导管驱动进入该球囊要膨胀的皮质骨中时使用导针和插管来将球囊插入进所要治疗的骨头中。
图8显示出通过插管26插入到骨头中的瘪球囊10。在插管26中的球囊是瘪的并且通过在延伸进入到通入至骨头内部的通道28的导管21上施加手动力来将它推压穿过插管。插管具有轻微的柔性，但是具有足够的刚度以使得球囊能够被推压进骨头内部中，然后通过将流体导入进其出口端与相应部分12和14连接的管子88中来使球囊在该骨头内部膨胀。
在使用中，球囊10一开始是瘪的，并且在将要填充该球囊的骨头已经准备好接收该球囊(例如通过冲孔、钻孔或以其它方式直接在插管开口外边除去少量松质骨)之后，使瘪球囊在塌陷的状态中穿过插管26进入到骨头中。(在图2中显示出该骨头)。在该实施方案中，该球囊优选在骨头中如此取向，从而球囊的膨胀使得能够在没有出现任何骨折或骨塌陷的皮质骨上施加最小的压力。在没有出现这种骨折或塌陷的情况下，这种压力优选将骨髓和/或松质骨挤压在皮质骨的内壁上，由此压实所要治疗的骨头的骨髓并且进一步扩大其中骨髓将要由生物兼容可流动骨材料替换的空腔。
使球囊膨胀以压实在空腔中的骨髓和/或松质骨，并且在骨髓和/或松质骨压实之后，使球囊变瘪并且从空腔中取出。在进行使球囊膨胀和压实的同时，必要时可以通过向导管16施加吸力从部分12和14之间和周围将脂肪和其它碎片抽出。之后并且在骨髓压实之后，使球囊变瘪，并且通过向导管21施加手动拉力将它从空腔中拉出。
根据本发明的教导构成的可膨胀装置的另一个实施方案在图4和5中显示出并且大体上由标号60表示。该球囊60包括一中央球形部分62，该部分是中空的并且用于通过管子64接收高压膨胀流体。球形部分具有一球形外表面66，并且具有基本上由环形部分68包围的外周表面，该环形部分68具有用来给部分68充流体的管段70。一对通道69将部分62和68相互连接在一起。吸管段72从由球囊60形成的骨腔中抽出液体和碎片。
可以为球囊60以及在这里所披露的所有球囊设置一球囊套71。球囊套71(图9)可拆换地安装在外管71a中，并且可以用来将瘪球囊60插入到皮质骨中。该套71具有压靠在椎骨22的入口71c内部上的弹性指状部分71b(图9A和9B)，用来防止球囊60翘起或隆起。一旦拆掉球囊套，高压流体将导入进管子64中，这将使部分62和68膨胀，从而压实在皮质骨内的骨髓。之后，使球囊60变瘪并且从骨腔中取出。
图6和6A显示出改进的在图1和2中所示的这种圆环形球囊80，其中一个差别在于球囊80的圆环形状没有缝在一起。在图6中，球囊80具有由第一中空部分84和第二中空部分85构成的梨形外凸形表面82。管子88设置用来沿着两个支管90和92将液体导入进两个部分以在已经将这些部分插入到骨头的髓腔中之后使这些部分膨胀。将导管16插入到球囊80的两个部分之间的空间96中。粘接剂将这两个部分84和85在其界面处粘接在一起。
图6A显示出将导管16插入到球囊80的两个部分之间的空间或开口96中的一种方法。
图7显示出管子88，它在将膨胀流体引导进球囊80中之后可以将造影材料注入进球囊80中，从而可以为在其中具有膨胀材料的球囊拍X-光照片以确定球囊的正确位置。或者，膨胀液体可以包括不透射线的膨胀液体例如碘酞葡胺造影介质(在市场上可以从Mallinckrodt Inc.of St.Louis，Mo.中买到)，从而膨胀和造影可以同时进行，从而使得在膨胀步骤中能够监测球囊位置和状态。在图6中还显示出管16，它以适当的方式安装在管88的外侧壁表面上。
在图3中显示出本发明的再一个实施方案，该实施方案类似于图1(但是一个差别在于它不是圆环形)并且包括具有三个球囊单元110、112和114的可膨胀装置109，这些球囊单元是可膨胀的并且具有限制了球囊单元沿着与球囊单元的纵向轴线垂直的方向的膨胀的细绳状限制件117。必要时，这些限制件可以包括与球囊相同或相似的材料，或者这些限制件可以包括具有更小、很小或基本上没有膨胀能力的材料。
管系统115可以设置用来将高压液体引导进球囊单元110、112和114，从而球囊单元在以瘪的状态安置在骨头内时可以使用液体来使这些球囊单元膨胀。在适当膨胀并且压实骨髓之后，可以通过使它/它们变瘪并且从正在治疗的骨头中将它/它们向外拉出来除去这些球囊。这些限制件最好使相对侧边77和79保持基本上平坦并且彼此平行。
在图10中，显示出可膨胀球囊的另一个实施方案。该装置包括具有一对相对菜豆形侧壁132的菜豆形球囊体130，这些侧壁适于塌陷并且与连续端壁134合作，从而可以将该球囊130推压进在图11中所示的骨头136中。管子138用来将膨胀液体引导进球囊中以使球囊膨胀并且使之呈现出在图11中的椎体136中所示的尺寸和位置。如果皮质骨没有骨折或塌陷的话，该球囊130将令人满意地挤压松质骨。对于这个动作的限制件主要依靠球囊的侧壁和端壁。
图12显示出一球囊140，它也是菜豆形并且具有用于将可膨胀液体引导进管子中以便使该球囊膨胀的管子142。球囊一开始形成为单腔室囊状件，但是该囊状件可以随后沿着弯曲线或条带141烙印和/或熔融以便形成连接线144，它们采取如图13中所示的菜豆形的并排腔室146的形状。烙印最好使得囊状件的两个侧边焊接和/或粘合在一起-该材料可以为标准的医用球囊材料，通常为可以采用热形成和/或粘合的塑料。
图14为包含图12的球囊的椎体147的透视图，显示出在插入在椎骨147中时的双层叠球囊140。
图15为除了线束155之外与图10类似的视图，这些线束可以为细绳状限制件或在球囊的相对内壁之间的其它结构，它们在可膨胀装置150的侧壁152之间延伸并且与之连接，并且限制了这些侧壁相对于彼此的膨胀。在该实施方案中，这些线束最好使得这些侧壁大体上相互平行。当然，仅用来限制和/或降低在球囊的相对侧壁之间的位移的线束将同样在一定程度上实现本发明的各个目的。管子88用来按照上述方式给菜豆形球囊填充膨胀液体。
椎体球囊的尺寸可以根据目标椎体的尺寸、位置和状况以及治疗的目的在大范围上变化。例如，用于腰椎体和胸椎体的椎体球囊的高度(H，图11)通常可以为0.5cm至3.5cm。腰椎体和胸椎体这两者的前后(A，图11)椎体球囊尺寸通常可以为0.5至3.5cm。胸椎体的左右(L，图11)椎体尺寸将通常为0.5cm至3.5cm。腰椎体的左右椎体尺寸通常将为0.5cm至5.0cm。当然，根据治疗目的和病人骨头的实际尺寸，可以适当使用其尺寸比所披露的范围更大或更小的球囊。
根据以下几个因素来最终选择例如用于给定椎体的适当球囊。影响球囊尺寸选择的一个主要因素为治疗的目的。例如，如果主要治疗目的仅仅是修复和/或扩张塌陷的椎体，则适当的球囊尺寸(以及所要求的空腔尺寸)可以为接近椎体内部在未骨折和/或未塌陷状态中的尺寸的球囊。或者，在单个椎体中可以同时使用两个或多个球囊，它们一起在椎体内形成所要求尺寸的空腔。作为另一个可选方案，如果治疗的目的在骨头内更加局部化例如形成更小的空腔以扩张和/或修复更小部分的骨头，则最好使用更小的球囊尺寸(以及所要求的空腔尺寸)。同样，在松质骨相对坚固和/或耐挤压的情况下，使用更小的球囊可以保证实现在不会明显压缩松质骨(因此形成更小的空腔)的情况下使皮质骨移动(以减小骨折)。而且，更小的球囊也可以适合用在治疗骨瘤等，其中可以使用该球囊来在肿瘤附近形成小空腔—这个小空腔将简化其它最小创伤工具的使用以直接造影治疗区域以及粉碎该肿瘤和/或从骨头中将它切除。
前后(A-P)球囊尺寸是从前皮层的内皮层壁到椎体的后皮层的内皮层壁测量出的。通常，对于扩张和/或加强塌陷的椎体而言，适当的A-P球囊尺寸通常比该测量值小大致为5至7毫米。
从CT扫描或从所要治疗的椎体的平片X光图像中选择对于给定椎体的适当的左右球囊尺寸。左右距离可以从椎骨侧面的内皮层壁中测量出。在一个实施方案中，适当的左右球囊尺寸可以比该测量值小5至7毫米。在可选实施方案中，适当的左右球囊尺寸可以明显更小，例如在将多个球囊插入到单个椎体中的情况下或在皮质骨的偏移是治疗的主要目的的情况下。通常，腰椎体的左右尺寸往往比其A-P尺寸宽得多。相反，胸椎体的左右尺寸和其A-P尺寸通常大致相等。
可以通过在所要治疗的椎体上方和下方对这些椎体进行CT扫描或X光成像来选择用于给定椎体的适当椎体球囊的高度尺寸。可以测量出在所要治疗椎体上方和下方的椎体高度，并且将它取平均值。可以使用该平均值来确定所选椎体球囊的适当高度尺寸。当然，如上所述，可以根据治疗目的以及实际病人的解剖组织来采取各种其它球囊尺寸。
B.用于长骨的球囊
可以使用本发明的球囊来治疗的长骨包括(但不限于)远端桡骨(在腕部处的更大的臂骨)、近端胫骨平台(正好在膝盖下面的腿骨)、近端肱骨(在肩部处的手臂上端)以及近端股骨头部(在髋部中的腿骨)。
C.远端桡骨球囊
对于远端桡骨而言，在远端桡骨152中显示出的球囊160的一个实施方案具有这样一个形状，该形状近似金字塔形，更准确的说可以认为是拱起的香蕉形，其中它基本上填充了远端桡骨的空间内部以将松质骨154推压在皮质骨158的内表面156上。
球囊160具有向下延伸进入远端桡骨152的中空空间中的下锥形部分159，该锥形部分159在接近中央远端部分161时其横截面增加。该球囊160的横截面在中央位置处显示出(图17B)，并且该位置靠近球囊的最宽位置。由标号162表示的球囊的上端与导管88连接以便将液体导入进球囊中，从而使之膨胀以挤压松质骨和/或将该松质骨推压在皮质骨的内表面上。球囊160的形状最好预先确定好，并且可以通过由细绳限制件165形成的线束以及在这里所述的各种其它类型的限制件来限制。这些限制件是可选的，并且为球囊体160提供额外的强度，但是对于实现所要求的结构而言不是绝对需要的。按照上面针对椎骨所述一样的方式将球囊安置进远端桡骨中并且从中取出。
该远端桡骨球囊的尺寸如下变化：
球囊的近端(即离肘部最近的部分)其形状为圆柱形，并且可以为0.5×0.5cm至1.8×1.8cm。
远端桡骨球囊的长度可以为1.0cm至12.0cm。
在远端桡骨-尺骨关节处或附近出现的该远端桡骨球囊的最宽内侧到外侧尺寸其测量值为1.0cm至2.5cm。
远端桡骨球囊的远端前后尺寸可以为0.5cm至3.0cm。
在同样适用于治疗远端桡骨断裂的可选实施方案中，球囊可以采取例如在图25A-25C中所示的环形或圆盘形形状。
D.近端肱骨骨折球囊
通常根据远端桡骨的放射尺寸和骨折位置以及治疗目标来选择治疗给定远端桡骨骨折的适当球囊尺寸。
在近端肱骨169的情况中，在图18中所示的球囊166的一个实施方案为球形，并且具有底座设计。它可以最佳地压实近端肱骨169中的松质骨168。可以采用嵌入的、层叠的和/或缠绕的网170来在球囊166上形成颈部172，并且可以使用第二网170a来使底座172a的底部与内皮层壁在骨体的开始处的形状相符。这些限制件为球囊体提供了额外的强度，但是该结构也可以通过各种方法来实现，包括在这里所述的球囊体或各种其它限制件的模制。该实施方案令人满意地挤压松质骨以形成如图18所示的包围着球囊166的压实区域。皮质骨173最好在底座174处相对较宽并且在上端175处为薄壁。该球囊166具有一输送管177，通过它将高压液体推压进球囊中以使之膨胀，从而压实在近端肱骨中的松质骨。按照与上面参照椎骨所述相同的方式将球囊插入到近端肱骨中并且从中取出。
在该实施方案中，近端肱骨骨折球囊的尺寸如下变化：
球囊的球形端部可以为1.0×1.0至3.0×3.0cm。
近端肱骨骨折球囊的颈部可以为0.8×0.8cm至3.0×3.0cm。
近端肱骨骨折球囊的底座部分或远端部分的宽度可以为0.5×0.5cm至2.5×2.5cm。
球囊的长度可以为4.0cm至14.0cm。
根据近端肱骨的放射尺寸和断裂位置以及治疗目标来选择治疗给定近端肱骨的断裂的适当球囊。
E.近端胫骨平台骨折球囊
在图19A中显示出胫骨骨折，其中将球囊180的一个实施方案安置在胫骨183的一侧182中。优选的是，该球囊在膨胀时压实了在包围着球囊180的层184中的松质骨。在图19C中显示出球囊的这个实施方案的横断面，其中该球囊具有一对相对的侧面185和187，它们由可以采取任意适当结构的细绳或柔性部件形式的限制件188相互连接。在该实施方案中，这些限制件优选使侧面185和187保持基本上相互平行并且为非球形。管子190与球囊180连接以将膨胀液体导入和导出球囊。这些限制件的端部在图19B和19D中显示出并且由标号191表示。按照与上面参照椎骨所述一样的方式将球囊插入到胫骨中并且从中取出。图19B显示出球囊的基本上为圆形的结构；而图19D显示出球囊的基本上为椭圆形的形式。
近端胫骨平台骨折球囊的这个实施方案的尺寸如下变化：
球囊的厚度或高度为0.5cm至5.0cm。
前后(前面到后面)尺寸为1.0cm至6.0cm。
左右(内侧到外侧)尺寸为1.0cm至6.0cm。
根据近端胫骨的放射尺寸和骨折位置以及治疗目标来选择治疗给定近端胫骨平台骨折的适当球囊。
F.股骨头部球囊
在股骨头部的情况中，球囊200的一个实施方案显示为已经插入在股骨头部的皮质骨202内部，该股骨头部在股骨的外端204处较薄并且在股骨的下端206处厚度会增加。该皮质骨包围着松质骨207，并且优选利用球囊200的膨胀来压实该骨。将用于进行膨胀的液体引导进球囊的管子由标号209表示。它沿着股骨颈部延伸并且导入进其结构大体上为球形的股骨头部。图20A显示出由标号200a表示的球囊可以为半球形以及如图20所示的球形。按照与上面参照椎骨所述相同的方式将球囊200插入到股骨头部中并且从中取出。通过粘接底部的重叠部分来在该实施例中保持该半球形形状，从而形成如图20A中所示的褶200b。
股骨头部球囊的尺寸可以如下改变—股骨头部球囊的直径可以为1.0cm到4.5cm或更大。根据股骨头部的放射或CT扫描尺寸以及无血管性坏死骨的位置和尺寸来选择股骨头部球囊的适当尺寸。半球形球囊的尺寸与球形球囊的尺寸类似，除了设置为该球囊的大致一半。
G.防止髋骨骨折
图21显示出用于防止和/或治疗髋骨骨折的“飞旋镖形”球囊210的一个实施方案。在膨胀时，“飞旋镖形”球囊210为一圆柱体，它类似于飞旋镖在中间部分逐渐弯曲并且从离股骨头部211的端部大约0.5cm处延伸穿过股骨颈部212并且向下进入近端股骨骨干213中超过小转子214大约5-7cm。球囊210的这个实施方案优选通过非弹性材料环(215为其中一个)保持其形状，这些环通过连接至沿着球囊侧面长度延伸的较短非弹性条带216在一个侧面上更加靠近地保持在一起并且通过连接至粘接在相对侧面上的较长的非弹性条带217进一步分开，但是也可以采用在这里所披露的各种其它限制件。
在膨胀之后和之前，可以将球囊210相对于膨胀管219翻折(在218处以虚线所示)。在膨胀之前，也可以将球囊210卷起并且利用在球囊膨胀时断裂的松散连接件保持压靠在膨胀管上。为了将球囊在其膨胀管上插入到髋骨中，外科医生可以在放射引导下使用电钻来形成一空腔220，该空腔在外侧股骨皮层221处开始通常为4-6mm宽并且进入到股骨头部211中。球囊210膨胀进入更大的转子区域222代替沿着股骨骨干213向下更不理想，并且通常通过适当选择球囊的形状以及通过其设置和正确取向(瘪球囊最好面对着更小的转子)来避免。在已经使球囊210在空腔220内膨胀之后(参见在图21中的虚线)，球囊的预定尺寸和形状使球囊的近端部分向下偏转进更小的转子。可选的是，可以从相同的进入点或从另一侧将一第二空腔向下钻进骨干中。
髋骨中的骨密度低于界限的病人其髋骨断裂的危险程度更高，并且密度越低则危险越大。可以通过骨密度扫描或其它本领域所公知的确定骨质的方法来进行病人选择。这种选择也可以从另一个髋骨的以前和/或当前断裂或骨质疏松断裂的一些其它类型和/或位置来得出。外科医生可以将球囊长度选择为从股骨头部的端部延伸大约0.5cm，穿过股骨颈部并且进入近端股骨骨干，通常在更小的转子下面大约4-8cm处。可以通过测量股骨颈部(最窄区域)的内部皮层直径并且减去0.5cm来选择球囊直径。“飞旋镖形”球囊的优选尺寸为10-20cm的总长并且1.0-2.5cm的直径。(具有适当长度的“拱形香蕉形”球囊也可以用于防止髋骨骨折，其中“拱形”宽度不超过所要求的股骨颈部尺寸。)
在股骨头部中具有最低骨密度的病人需要在股骨头部中进行更大的压实，这例如可以通过一个接着一个使用两个球囊来实现：“飞旋镖形”之后为股骨头部球囊(在相同位置处插入并且在插入任意支撑材料之前膨胀)。或者，“飞旋镖形”球囊可以具有接近股骨头部球囊的形状的远端部分。
在这里所述的各种球囊也可以与在人类和动物身体内各种结构的替代物结合使用。例如，在这里所述的球囊可以用来在移植人造髋骨骨干的准备中挤压在股骨中的松质骨。同样，在这里所述的球囊可以与各种其它关节包括人造膝盖和踝关节更换手术结合使用。
H.所有球囊
应该理解的是，在这里所披露的球囊的各种实施方案决不局限于应用在身体内的单个治疗位置。相反，虽然每个实施方案可以结合一示例性治疗位置披露，但是根据治疗目的以及目标骨头的解剖结构，这些实施方案可以用在人体内的各个位置中。例如，前面所披露的用在治疗远端桡骨断裂的球囊的实施方案同样可以用于治疗在身体内各个其它区域中的断裂，包括但不限于股骨、桡骨、尺骨、胫骨、肱骨、跟骨或脊骨的断裂和/或将要断裂。同样，各个其它所披露的实施方案可以在整个身体上使用，并且根据目标骨头的治疗目的和/或解剖结构具有不同的结果。
II.可膨胀装置
A.复杂的可膨胀结构
有时难以使用具有单个膨胀区域的可膨胀本体在给定的松质骨区域内实现所要求的压实均匀度和面积。图27显示出包括沿着其长度间隔开的膨胀分段区域282和284的复杂预成形结构280。该结构280形成一更长的外形，由此可以提高体积。
通过挤出成形或模制成形塑料或其它弹性材料管286来形成复杂的可膨胀结构。在优选实施方案中，该管子由塑料材料构成。该管子具有正常挤出的壁厚(T5)和正常挤出的外径(D5)(如图27所示)。
通过向管子的中间区域施加热量、正内压和/或在夹具或模具(未示出)内拉伸来形成分段成形区域282和284。在一个实施方案中，夹具可以具有两个由直径更小区域或中间通道分开的空腔区域。这些空腔区域或通道受到加热以使该区域的材料软化。当受热软化(按照前面所述的方式)时，管子286的内部拉伸并且受到来自压力源的正压。在该区域288中的材料将在空腔和通道内理想地膨胀或延伸。
一旦冷却并且从夹具中取出，可以将该结构280安装在外导管250的远端上(参见图28)。外导管250(以及内导管258)的结构可以改变，并且外导管250可以由各种柔性材料包括医用级塑料材料如乙烯、聚乙烯、离聚物、聚氨基甲酸乙酯和聚对苯二甲酸乙二醇酯(PET)以及次柔性材料例如Kevlar、PEBAXTM、不锈钢、钛镍合金和其它金属和/或陶瓷材料构成。外导管250最好结合有一内孔260，内导管258延伸进入该内孔。应该注意到的是，外导管250可以具有一个或多个内部管腔。在所示的实施方案中，内导管258延伸穿过内孔260并且越过导管250的远端254。该结构280的远端区域固定在外导管250的远端区域254上，而该结构280的近端区域固定在内导管258的远端区域262上。例如可以采用粘接剂或热粘合等方法来固定这些端部区域。
该结构280在露天环境中具有正常的膨胀形状，具有直径D7(在图27的假想线中所示)。这些区域282和284的正常形状和直径D7通常分别与这些空腔的形状和尺寸相对应。
当抽内部真空从而从结构280中除去气体和/或流体时，该结构280呈现出如在图27中的线D6所示的基本上塌陷并且没有膨胀的几何形状。由于在中间区域288上施加了热量和压力，所以每个区域282和284的直径D6大于原始挤出管的正常挤出或模制成的外径D5。
这些区域282和284由管状颈部298分开，该颈部将该结构280分成两个可膨胀区域282和284。当在真空作用下基本上塌陷或没有膨胀时，该结构280具有较低的轮廓，这对于插入到目标松质骨区域中和/或从中取出是理想的。
将流体体积导入回管子286中将使得每个区域282和284从塌陷的直径D6恢复到正常扩大的但没有膨胀的几何形状，它具有在图27中的假想线D7中所示的形状和直径。
在所示的实施方案中，第一和第二成形区域282和284具有大体上相同的膨胀半径，因此具有相同的未膨胀形状和直径D7。或者，每个区域282和284可以具有不同的膨胀半径，因此具有不同的非膨胀形状和直径。然而当处于正常非膨胀直径D7中时该结构280在区域288中的材料没有明显拉伸或受到应力，因为这些区域282和284已经在消除应力的状态中膨胀为在这些空腔中的这些几何形状。
如前面结合该结构所述一样，可以通过在不同空腔内加热和/或内压来使这些区域282和284成形以呈现出不同的几何形状例如圆柱形或椭圆形几何形状或非球形、非圆柱形或非椭圆形几何形状，并且具有均匀或复杂的曲面，而且呈对称或不对称形式。当然，可以沿着管子的长度形成两个以上的分段区域282和284。另外，可以通过其它技术来实现该结构的正常膨胀形状特性。例如并且以不是以限定性的方式，可以通过浸渍、失蜡铸造或注射模塑来形成该结构。
每个成形区域282和284在处于正常扩大但没有膨胀的几何形状D7中时具有最小的壁厚(在图27中由T7表示)。由于受热软化材料在这些空腔中在压力作用下膨胀，所以该壁厚不均匀，即T7小于管子的正常挤出或模制的壁厚T5。这些区域282和284的最小壁厚T7可以是相同的或不同的。
当处于扩大但没有膨胀的几何形状中时，颈部区域298具有一外径(在图27中由D9表示)，这等于或大于管子的正常挤出或模制直径D5。在夹具中的通道尺寸确定了直径D9的大小。由于在相邻区域282和284中的受热软化材料在这些空腔中在压力作用下膨胀，所以该颈部区域298(它在通道中在压力作用下膨胀)的壁厚(在图27中用T9表示)小于或等于管子286的正常挤出或模制壁厚T5，但是仍然大于完全成形区域282或284的最小壁厚T7。
所形成的复杂结构280因此具有其最小壁厚沿着其长度不均匀的区域，即T5≥T9≥T7。所形成的复杂结构280还形成由颈部区域298分开的具有相同或不同扩大外径(D7)的多个可膨胀区域282和284，其中D6＞D5；D7＞D6；并且D7＞D9。
通过继续以在界限量P(t)处的恒定压力施加流体体积并且由此提高在结构280内的体积，从而该结构280的成形区域282和284将继续扩大超过直径D7至在图27中由D8表示的膨胀形状和几何形状。壁厚T7进一步减小并且接近T8。在区域282和284接近直径D8时，如图27所示，颈部区域298的直径D9同样朝着直径D10增加，从而与松质骨形成更加均匀细长的表面接触。
该结构280扩大超过直径D7使在区域282、284和298中的材料拉伸超过其消除应力状态，但是这些区域282和284的膨胀几何形状在重要的方面中将保持由这些空腔所规定的预成形形状。
可以调节在基本上恒定的增压状态下的拉伸程度以实现所要求的完全膨胀直径D8。最终完全膨胀直径D8可以选择为与目标松质骨区域的尺寸相配。这些分段区域282和284协调的受控拉伸可以使其主要直径小于单个非分段区域(即没有颈部区域298的区域)的松质骨受到等容压缩。换句话说，分段区域282和284在膨胀至给定膨胀体积时其直径小于膨胀至相等膨胀体积的球体。
在在D7和D8之间的区域中扩展的同时，该结构280当位于骨头内部时呈现出不断增大的表面积和体积，由此压实周围的松质骨。在松质骨中的膨胀与外面骨头一样可以在相同的界限压力P(t)下出现。但是，由于松质骨的密度和松质骨对压实的阻力，通常需要增加在骨头内部的界限压力P(t)。
B.具有内部薄膜的可膨胀球囊装置的组装
图23和24A-24C显示出根据本发明教导构成的空腔形成装置的另一个可选实施方案的剖视图。因为该实施方案的许多特征与结合前面实施方案所述的那些类似，所以将使用相同的参考标号来描述类似的部件。
在该实施方案中，空腔形成装置装有一球囊300，该球囊包括一段具有外壁310和内部薄膜320的双管腔管道。该球囊300最好由通常用于球囊导管的材料包括但不限于聚乙烯、聚酯薄膜、橡胶或聚氨基甲酸乙酯构成。更优选的是，该球囊300由弹性材料构成，该材料还具有预成形的能力，即例如通过利用诸如传统的热成形、吹塑成形和/或浸涂技术进行加热加压来获得所要求的形状。符合这个标准的代表性材料包括聚氨基甲酸乙酯、硅酮、热塑性橡胶、尼龙和热塑性弹性材料。
在所示的实施方案中，球囊300由塑料材料构成。该材料可以加工并且挤出成形为管状，然后将它切割成单独的长度以便进行进一步加工。可以通过对切割的管长加热然后将受热的管子封装在模具内同时向该管长施加正内压来形成球囊300。该模具当然可以是传统球囊成型机的一部分。
在当前实施方案中，在形成球囊之后，可以将该球囊300的近端安装在外部导管本体250的远端上并且可以将该球囊300的远端安装在内部导管本体258的远端上。外部和内部导管每个都可以包括由例如塑料材料制成的挤出成形管道，并且每个都可以挤出成形为管状。
在装配空腔形成装置中，如图26A所示，球囊300的近端优选粘接在外部导管本体250的远端上。在一个优选实施方案(如图26B所示)中，可以使用刀片或其它切割器具来将外部导管本体250的大约为5mm的远端切开，从而形成一对狭缝360，如由在图26B中的“A”最清楚地所示一样。然后可以使球囊300的近端在外部导管本体250的远端上滑动，其中外壁310设置在外部导管本体250的远端周围并且内部薄膜320设置在狭缝360内(如图26C所示)。为了使流动通道(用于膨胀流体)穿过外部导管本体250并且进入球囊300，可以按照本领域所公知的方式将一对芯棒或插入件(未示出)插入到外部导管本体和球囊中。然后可以使用包括热粘合、粘接剂或类似的各种手段将外部导管本体250的远端和球囊300的近端粘接在一起。在形成粘合之后，可以除去这些芯棒。优选的是，将外部导管本体250切开增加了在导管本体250和球囊300之间的粘接机械强度，并且使得球囊能够更加牢固地粘接在外部导管本体250上，从而降低了球囊300的近端粘接失效的机会。
球囊300的远端也粘接在内部导管本体258的远端上。必要时，内部导管本体258的远端可以按照类似的方式切开以提高远端粘接的机械强度。优选的是，内部导管本体258将沿着内部薄膜320的一侧延伸穿过外部导管本体250以及球囊300。
如图26A所示，外部导管本体250的近端可以固定在Y形路厄接头400的远端上。内部导管本体258最好延伸穿过路厄接头400的内管腔，并且可以粘接在接头400的近端上。优选的是，该Y形路厄接头400的膨胀接头402可以与形成在内外部导管本体250和258之间的管腔404流体连通(参见图26C)，它们反过来与球囊300的内部流体连通，从而导入进膨胀接头402中的膨胀流体将使该球囊300膨胀。
优选的是(如图26A至26C所示)，外部导管本体250和/或Y形路厄接头400将设有一标识器406或其它可从外面看到的标记，它在球囊300处于病人体内的所要求位置中时给外科医生显示出内部薄膜320的取向。这种标记可以包括在外部导管本体250或Y形路厄接头400上的彩色标识器或条纹406、凹痕和/或凸起以及路厄接头自身的取向。通过利用这种标记406，从而外科医生可以很容易使球囊300转动到在椎体内的所要求取向。因为用来构成医用球囊的材料通常为透辐射的，所以一旦球囊300在目标骨头内处于适当位置中就难以测定内部薄膜320的取向。或者，与外部标记406结合，内部薄膜320可以形成有一个或多个标识器条带或其它不透射线的物质408(参见图26C)以描绘出该薄膜320在目标椎体内的取向。
可以为空腔形成装置的零部件选择各种材料。另外，空腔形成装置的零部件的尺寸也可以根据其所打算的用途来改变。应该理解的是，虽然一个上述实施方案设有双管腔管道，其它各个实施方案可以设有其它形式的多管腔管道(包括但不限于三个、四个等管腔管道)，还可以设有在管道内具有变化的取向和/或位置的薄膜(例如，对称或不对称)。
C.可膨胀球囊的示例性性能特性
图24A、24B和24C显示出球囊300的上述实施方案在其在空气中展开期间的剖视图。优选的是，球囊300将在目标骨头例如椎体内按照类似的方式膨胀。
图24A显示出球囊300在充有少量膨胀流体时的剖视图，从而该球囊理想地呈现出模具的大致尺寸和形状，之前在该模具中形成该球囊，并且内部薄膜320受到最小的应力。在该情况下，球囊的膨胀在横断面上基本上为圆形。因此，膨胀球囊300的横断面的垂直和水平尺寸大致相等，或DX1＝DY1。
图24B显示出在进一步填充有加压膨胀流体的图24A的球囊300。在该图中，球囊300呈现出进一步膨胀的形状，并且该球囊300的壁材料通常承受着弹性和/或塑性变形以呈现出该扩大的几何形状。球囊300优选不呈现完全为圆形的横断面形状，这主要是因为内部薄膜抵抗了外壁310的横向膨胀。虽然内部薄膜320通常会出现一些拉伸(由于该薄膜的弹性和/或塑性变形)，但是所得到的横断面形状通常为卵形或在一定程度上类似于8字形。但是，没有明显限制球囊300沿着垂直方向长大。限制件的这种组合导致沿着垂直方向比沿着水平方向基本上膨胀或成长更大的球囊。因此，膨胀球囊300的垂直尺寸大于球囊300的水平尺寸，或DX2＞DY2。
图24C显示出在进一步填充有加压膨胀液体时图24A和24B的球囊300。在该图中，球囊300已经呈现出更加膨胀的形状，并且壁材料通常承受着弹性和明显的塑性变形以便呈现出这种扩大的几何形状。在这一点上，球囊300明显处于非圆形形状，其中内部薄膜320明显阻止了球囊的横向生长(但是薄膜320看起来已经出现一些额外的弹性拉伸和/或塑性变形)。因此，膨胀球囊300的垂直尺寸明显大于球囊300的水平尺寸，或DX3＞＞DY3。
对于上述实施方案而言，利用体积为0cc至2cc以及2cc至4cc的膨胀流体对球囊进行膨胀试验，其结果如下：
0cc：
球囊小直径(DX1-宽度)：7.7mm
球囊大直径(DY1-高度)：7.7mm
膨胀至2cc(流体)：
球囊小直径(DX2-宽度)：9.2mm
小(水平)直径增加：1.5mm(宽度)-[总增加19.5％]
球囊大直径(DY2-高度)：10.9mm
大(垂直)直径增加：2.2mm(高度)-[总增加28.6％]
膨胀至4cc(流体)：
球囊小直径(DX3-宽度)：12.7mm
小(水平)直径增加：5mm(宽度)-[总增加65％]
球囊大直径(DY3-高度)：15.4mm
大(垂直)直径增加：7.7mm(高度)-[总增加100％]
除了球囊300随着球囊膨胀而轴向长大(如前面所述一样)，球囊的纵向长度在膨胀期间也将增加。这是因为球囊材料受到的应力通常沿着一个以上的尺寸作用(从而导致沿着一个以上的轴线出现材料变形)，从而引起球囊300的整个纵向长度响应于内压增加而扩展。但是，在当前实施方案中，内部薄膜320也将降低球囊在膨胀期间的纵向长大。例如，对于球囊300的前面所述的实施方案而言，从2cc到4cc的体积增加导致球囊纵向长度只增加27.1％。对于没有设置内部薄膜的类似构成的球囊而言，从2cc到4cc的体积增加导致纵向长度增加37.1％。因此，本发明的内部薄膜320不仅限制了圆周膨胀的特定方面，而且还限制了纵向膨胀的方面。
当前实施方案的内部薄膜320也明显降低了球囊300在病人体内出现完全径向失效和/或破裂的几率。在外科手术过程中，如果球囊被刺破或撕裂，则球囊失效会传播穿过相当多的球囊材料。如果这个失效围绕着整个球囊半径传播，则球囊的远端部分存在与球囊近端完全分离的危险，并且仅仅内部导管本体258将球囊的远端部分与空腔形成装置连接。在这种情况中，一旦从病人身上将空腔形成装置取出，则内部导管本体258就可能失效，从而在病人体内留下远端部分和任意球囊碎片。
当前实施方案的内部薄膜320理想地降低了球囊300完全径向失效的几率，并且还明显降低了球囊碎片与空腔形成装置分开的几率。在内部薄膜320连接着可膨胀壁的情况中，在该连接部分410(参见图26C)处的球囊材料的几何形状和/或附加厚度明显提高了球囊在该位置处对断裂的阻力。朝着这种连接部分410传播的断裂通常将由该连接部分重新引导-通常该断裂将中止，将从该连接部分处回弹和/或将沿着该连接部分重新引导。
在所披露的实施方案中，朝着连接部分410传播的径向断裂通常将朝着球囊300的纵向轴线重新引导。而且，内部薄膜320用来连接球囊300的近端和远端，这将在球囊完全径向失效的意外情况中加强内导管本体258。因此，因为当前实施方案设有至少两个纵向延伸连接部分(即，球囊300的内部薄膜320和其上固定着球囊300的远端的内部导管本体258)，所以这个实施方案的断裂不容易导致球囊材料完全径向撕裂和/或空腔形成装置破碎。
III.移植形成和性能
一旦球囊300处于目标骨头(在该实施方案中为椎体)内的所要求位置中，则可以将膨胀介质导入进该球囊中，这将使得球囊在目标骨头内优选地膨胀。该球囊将优选地在目标骨头内呈现出与它在空气中所呈现的形状类似的形状，由此在骨头内形成具有与膨胀球囊基本上相同的形状和尺寸的空腔。但是，必须理解的是，在松质骨密度和质量方面的变化会使膨胀球囊的最终膨胀尺寸和形状扭曲，从而该膨胀球囊在尺寸和形状上会与它在空气中膨胀时明显不同。
虽然在这里所述的限制件不能绝对保证球囊(因此该空腔)的最终形状和尺寸将等于该球囊在空气中的形状和尺寸，但是在这里所述的限制件明显提高了形成具有最优尺寸和形状的空腔以实现一个或多个所期望的治疗目的的可能性。例如，如果所期望的治疗目的是加强和/或修复目标椎体，则可以选择形成有用来使球囊的垂直长大最大(在这方面，垂直取向可以假设为与脊柱的纵向轴线平行)同时使球囊的水平和/或纵向长大最小的限制件的球囊。必要时，该球囊也可以形成有使沿着其纵向轴线的球囊膨胀减小和/或最小化的限制件。
或者，外科医生期望这样一种球囊，它形成有用来使球囊的水平长大最大(在这一点上，可以将水平长大假设为与脊柱的纵向轴线垂直)同时使球囊的垂直长大最小的限制件。这种球囊(这可以仅仅是将前面所述的实施方案在绕着其纵向轴线旋转90°所得到的球囊)可以用来首先形成在基本上整个椎体上延伸的空腔。在取出第一球囊之后，随后可以将第二球囊(具有相同或不同的设计)导入进水平空腔中并且膨胀。必要时，该第二球囊可以在膨胀之前基本上填充该水平空腔(由此使球囊面对着上下终板的表面积最大)，并且在膨胀时可以使最终作用在椎体的终板上的垂直力最大(在试图使周围皮质骨偏移中)。
必要时，选择用于治疗椎体的球囊还可以形成有使该球囊膨胀成不规则形状的限制件。在这里所披露的一个实施方案中，如在图23中最清楚地所示一样，从侧面看时该球囊优选地膨胀成“花生状”形状。该实施方案将形成类似于“花生状”的空腔，并且该空腔基本上包括一对由具有更小空腔尺寸的区域分开的扩大空腔凸起部，换句话说，该空腔为哑铃状。优选的是，占据该空腔的填充材料将硬化、凝固和/或固化成基本上具有它所导入进的空腔的形状的移植物。通过将该移植物形成为这种哑铃形状，从而该移植物的具有更小宽度的区域将理想地有助于将该移植物锚固在松质骨内，由此降低了移植物沿着移植物的纵向轴线偏移和/或在所治疗骨头里面或外面迁移的可能性。
另外，必要时用于治疗椎体的球囊可以设有额外的限制件，它们改变了膨胀球囊的外形以进一步降低移植物在所治疗骨头里面和/或外面迁移的几率和/或趋势。例如，在上述一个实施方案中，该球囊设有一内部薄膜，该薄膜优选地使得膨胀的球囊呈现出其横断面为凹入或细长的“8字形”形状(见图24c)。这个形状在形成进空腔壁并且最终由填充材料呈现的话将优选地形成具有类似横截面的移植物。通过将该移植物形成为这种8字形形状，从而该移植物将理想地锚固在松质骨内，由此降低了移植物绕着其纵向轴线旋转和/或在所治疗骨头里面或外面迁移的可能性。
除了使将要优选地用作模具以约束填充材料并且使之成形的空腔形成所要求的形状和尺寸之外，外科医生还可以按照各种方式定制移植入物的形状。例如，在初始空腔成形之后，但是在导入填充材料之前，外科医生可以使用其它外科器械来改变空腔的形状和/或尺寸，例如通过除去额外的松质骨和/或沿着空腔壁将压缩的松质骨刻痕。同样，在导入填充材料之前，外科医生可以将一个或多个附加的球囊导入进空腔中以改变现有的空腔尺寸和/或形成具有独特和/或所期望形状的附加空腔。或者必要时，外科医生可以选择将两种或多种不同骨填充材料导入进单个空腔，并且不同的材料占据着该空腔的不同部分和/或相互纠缠、混合或按照某种方式分开。另外，在填充材料已经填充了整个空腔之后，外科医生可以继续导入额外量的骨填充材料，这将优选地使得少量骨填充材料相互交错或流进在空腔壁中的各个间隙和/或裂缝中，由此进一步将所得到的移植物锚固在松质骨内。例如，注入额外的0.5cc、1cc或1.5cc骨填充材料(超过形成在松质骨内的空腔的体积)可以明显提高骨填充材料与周围松质骨基质相互交错。
IV.其它用途、方法和球囊
由球囊形成的空腔可以填充有具有药物或生长因子的适合医用的药剂。作为输送药物的一个示例，用于治疗局部骨髓炎(骨感染)的抗生素、庆大霉素的通常剂量为1克(但是庆大霉素的治疗剂量范围可以更大，例如可以为1毫微克至100克，这取决于所要治疗的病况和所要覆盖的区域的尺寸)。用适当的凝胶材料例如聚乙二醇配成的医用凝胶可以在凝胶的凝固体积中包含1克庆大霉素例如10cc。具有其形状和尺寸符合所要治疗的位置的这种体积的球囊(也就是说，该球囊优选地在所选位置处膨胀时不会破坏皮质骨)可以用来压实受感染的松质骨。这形成可以在打开或最小创伤手术中填充抗生素凝胶的空间。这使所要求量的药物正好位于并且保持在需要治疗的位置处，并且防止了该药物被血液或其它流体迅速冲掉。不仅可以优化剂量，而且在较晚的时候可以施加附加的剂量而不用开放式外科手术，增强了治疗成果。如果用于优化药物剂量的所需空腔削弱了骨头，可以采用管型或者采用常用的内部或者外部金属或者塑料固定装置来保护骨头将来不会骨折。放在骨头中的治疗物质也可以作用在骨头之外。含有化学治疗剂的配方可以用于治疗局部固相骨肉瘤或者靠近骨头的其它瘤。
作为一个替换实施方案，为了传送治疗物质，在将球囊插入到要治疗的骨头中之前，可以将球囊浸在含有医学有效量的任何所需的抗生素、骨生长因子或者其它治疗剂的医药配方(通常是干粉、液体或者凝胶)中以利用上述物质涂布该球囊。任选地，在进行涂布之前，利用空气或者液体使该球囊全部或者部分地膨胀。任选地，当所施加的配方是湿的时候，例如是液体或者凝胶的时候，可以利用空气或者其它方法使被涂布的球囊干燥。按照需要将球囊再折叠，并如果适当和需要，立刻使用或者存放。可以输送涂布在球囊上的治疗物质，同时松质骨受压，或者一旦空腔形成之后可以利用另外的球囊来进行输送。
上述方法也可以用于在使用之前在球囊上涂布Gelfoam可吸收的凝胶粉末或者其它试剂。这种试剂也可以包括能理想地促进体液凝固和/或增稠的物质。在骨头内膨胀涂布了Gelfoam的球囊还可以填充在骨折的骨头中的还没有被压缩的松质骨填充的任何裂缝。
图22A-C示意性地显示了根据本发明用于向骨头输送治疗物质的一个系统和方法。如图22A所示，连接至膨胀管230的膨胀的球囊229利用连接管230和线232的夹子231来稳定。如图22B所示，含有所需量物质233的凝胶配方的测量好的量被均匀地优选以细线235从容器234中分配到球囊236的外表面上。如图22C所示，然后将涂布的球囊23收缩，并使其干燥直至凝胶凝固。然后涂布的球囊237等待包装用于治疗。当然，可以不用先膨胀而涂布球囊。另外，涂布的物质可以仅是处于自然状态(固体、液体或气体)或者是一个适当的配方的所需化合物，包括干粉、气溶胶或者溶液。任选的干燥时间当然取决于化合物和其配方的性质。
在用于压缩骨头的球囊外侧上或者在骨头被压缩之后利用第二球囊(可以略大)输送治疗物质，与将配好的药物放在空腔内相比，从质量方面看是不同的。当压缩骨头的同时进行输送时，该物质开始引入到压实的骨头中。这可以作为一种方法来立即配制一种该物质的缓慢释放的方案。同时它允许外科医生以适当的支撑材料例如丙烯酸骨粘固粉或者生物兼容的骨替代物来填充空腔，因此不需要铸造或者金属固定件。这种组合使得外科医生例如能够经皮固定骨质疏松造成的骨折同时向该位置输送所要求的治疗物质(例如抗生素、骨生长因子或骨质疏松药物)。因此，在这些情况中可以不需要任何铸造或金属固定装置。
在医学上有效的治疗物质量通常由其制造商或保证人来限定并且通常为每个部位10毫微克至50毫克，但是在特定情况可能需要更多或更少的量。通常的抗生素包括庆大霉素和妥布霉素。通常的骨生长因子有骨形态发生因子、成骨蛋白、成纤维细胞生长因子、类胰岛素生长因子以及转化生长因子α和β家族。化学治疗和相关药物包括这些化合物例如顺铂、阿霉素、红柔霉素、氨甲蝶呤、紫杉醇和三苯氧胺。骨质疏松药物包括雌激素、降钙素、二磷酸盐和甲状旁腺激素拮抗剂。
在本发明中所述的球囊可以用在在上述部位处进行的打开外科手术中以便为插入整形移植物、移植骨、骨替代物、骨填充物或治疗物质提供更好的空间。所选球囊的尺寸和形状将根据所要治疗的部位以及外科医生想要插入到剩余骨中的材料尺寸、形状或量来确定。可以在任意部位处使用方形和矩形球囊以安置骨替代物例如可以以那些形状得到的羟磷灰石。球囊最好制成为与那些预定尺寸相配，并且外科医生将选择该球囊来配合所选材料的尺寸。
为了将没有流进球囊形成的空腔的材料例如羟磷灰石颗粒或骨无机盐基质插入，外科医生可以通过进行最小创伤手术的过程用其直径比插管内径稍窄的长针沿着管子将它们推压下。在打开手术期间，就如该手术是经皮的一样外科医生可以接近所要治疗的骨头，除了在外科医生和所要治疗的骨头之间没有任何皮肤和其它组织。这理想地尽可能保持皮质骨不被接触。如果所要插入的材料没有流动并且不应该通过插管推进到空腔中(如在羟磷灰石块的情况中一样，因为这会导致对病人造成明显损伤)，则外科医生可以采用“最小创伤”方法制作该空腔，然后采用标准工具(例如冲头、圆凿或锉刀)冲出通入进皮质骨的一侧中的孔以使得能够将该块插入。可以使用这个相同的方法来移植金属假体，例如整个膝盖更换系统的金属胫骨部件。
不同尺寸和/或形状的球囊可以用在上面没有指出的部位例如颚骨、臂骨和腿骨的中间骨体、颈椎体、足和踝骨、肋骨等类似部位。在治疗或防止骨折中选择球囊形状和尺寸的一个关键之处在于本申请的教导，即，优选地，在引起断裂(或断裂危险)的骨病为松质骨质量损失(如在骨质疏松中)的情况中可以压缩松质骨的70-90％(或更大)。在所要治疗的部位处压实小于70-90％的松质骨可能会在所治疗的部位处留下过多的患病松质骨。患病的松质骨会保持脆弱并且随后塌陷，从而尽管进行了治疗也会造成骨折。通过这个原理，将对任意所选的骨头的所允许形状和最小尺寸进行说明和限定。
当然，如在该说明书中所概述的一样，除了该70-90％空腔尺寸之外还有许多例外。一个例外是在所要治疗的骨病是局部的，例如在无血管形成性坏死中，在该情况中局部供血不足正在使在有限区域中的骨头坏死。在那个情况中，球囊可以更小，因为需要治疗的患病区域往往更小。第二个例外是使用改善将限定形状的固态材料例如羟磷灰石插入的装置和在全关节置换术中的部件。在这些情况中，球囊形状和尺寸通常由所插入的材料的形状和尺寸限定。另一个例外是输送治疗物质。在该情况中，松质骨可能或不会受到影响。如果不会受到影响，则可以通过压实它以改善具有重要治疗用途的药物或生长因子的输送，从而牺牲了一些松质骨。在该情况中，内部具有药物的骨头受到支撑同时药物起作用，然后通过铸造或当前固定装置来治愈该骨头。另一个例外可以涉及骨瘤的治疗，其中在靠近肿瘤的松质骨中形成小空腔便于最小创伤操作和/或除去该肿瘤。另一个例外可能是这样一种情况，其中松质骨的质量大体上较好，但是骨头已经断裂和/或以某种方式塌陷。在这种情况中，在更坚固的松质骨内形成小空腔会使皮质骨碎片偏移至这些碎片的正常解剖位置处或附近的位置，且不会明显挤压该松质骨。
选择球囊形状和尺寸的另一个关键之处在于本发明的一个教导，即可以利用无弹性、弹性和/或半弹性球囊限制件，并且无弹性或半弹性球囊材料通常是优选的。这些材料可以安全并且方便地防止球囊膨胀超过由松质骨外缘(为皮质骨的内侧)的标称尺寸的限制所限定的其预定形状和尺寸。例如过度膨胀的球囊会产生出立即断裂的危险，因此在一个实施方案中，这限定了在每个部位处球囊尺寸的上限。利用许多通常的血管成形球囊，外科医生通常依靠监测压力(代替本发明的球囊设计特征)来防止其球囊过度膨胀。这往往需要比本申请的教导更高的外科医生技能，本发明在于对所要治疗的部位拍X光并且测量出如在这里所述的重要尺寸。另外，在骨治疗中，依赖压力往往会导致较差的临床效果。外科医生通常事先不知道完全压实松质骨需要多大的压力，因为这根据松质骨的厚度和由于患病而丧失密度的程度而变化。外科医生往往容易使球囊膨胀少一些以避免过膨胀和/或皮质骨断裂的潜在结果。
该申请的另一个教导在于，尽管沿着所有方向同等施加的最大压力通常会挤压松质骨的最弱区域，但在球囊体中使用限制件将令人满意地将球囊膨胀限制在一定程度上。如果球囊设计没有设置限制件，它将不会以最优的方式挤压松质骨以便加强和/或修复断裂的椎骨。医学专业人员通常可以采用人体骨骼解剖学的教科书以及他们对该部位及其疾病或损伤的知识来了解所要压缩的松质骨的形状和在骨头不适当地运动的情况下会受到损伤的局部结构。形状和尺寸的范围由所要治疗的部位限定。可以通过对所要治疗的部位的X光片、治疗目的和在该部位处的安全约束条件来确定对于给定病人的精确尺寸。对于患病骨头而言，可能期望更换大部分松质骨，因此可以选择其形状和尺寸挤压了在治疗区域中的松质骨体积的大约70-90％(或更大)的球囊。但是，尤其在局部骨治疗和/或输送治疗物质是主要目的的情况下，如上所述可以适当选择更大或更小的球囊。必要时，考虑到球囊最好不应该使皮质骨偏移超过其正常未断裂的尺寸，所以可以通过所期望量的治疗物质来选择球囊尺寸。
虽然已经在人体椎骨的治疗方面对新的装置和方法进行了更具体的说明，但是应该理解的是，可以按照相同或等同的方式来治疗其它人类或动物骨骼类型。以示例的方式并且不是限定性的，当前的系统和方法可以用在其中具有骨髓的任意骨头中，包括桡骨、肱骨、椎骨、股骨、胫骨或跟骨。另外，本领域普通技术人员通过阅读在这里所披露本发明的说明书和实践将了解本发明的其它实施方案和用途。所有在这里所参照的文献全部被明确引用作为参考。该说明书和实施例应该被认为只是示例性的，并且本发明的真实范围和精神由下面的权利要求表示。本领域普通技术人员将容易理解的是，在由下面权利要求所限定的本发明的范围内将很容易作出每个所披露的实施方案的变体和变型。

Claims (37)

1.一种挤压松质骨的装置，它包括：
一可膨胀本体，它包括与本体连接的用来引导本体膨胀的内部限制件。
2.如权利要求1所述的装置，其中所述内部限制件包括一内部薄膜。
3.如权利要求1所述的装置，其中所述可膨胀本体包括一细长轴线，并且
其中所述内部限制件包括在可膨胀结构的相对内部侧面之间相对于细长轴线垂直地延伸的内部薄膜。
4.如权利要求1所述的装置，其中所述可膨胀本体包括一细长轴线，并且
其中所述内部限制件包括在可膨胀结构的相对端面之间沿着细长轴线延伸的内部薄膜。
5.如权利要求1所述的装置，其中所述可膨胀本体包括一细长轴线，并且
其中所述内部限制件包括在可膨胀结构的相对端面之间沿着细长轴线在一个方向延伸并且在可膨胀结构的相对内部侧面之间沿着与细长轴线垂直的第二方向延伸的内部薄膜。
6.如权利要求1所述的装置，其中所述内部限制件引导该可膨胀本体沿着一个方向比沿着与该一个方向垂直的另一个方向膨胀更大。
7.如权利要求1所述的装置，其中所述可膨胀本体包括一细长轴线，
其中所述内部限制件约束了该可膨胀本体沿着细长轴线的膨胀。
8.如权利要求1所述的装置，其中所述可膨胀本体包括一细长轴线，
其中所述内部限制件引导该可膨胀本体沿着从细长轴线的一个径向方向比沿着从细长轴线的另一个径向方向膨胀更大。
9.如权利要求8所述的装置，其中所述内部限制件约束了可膨胀本体沿着细长轴线的膨胀。
10.一种治疗骨头的方法，该方法包括以下步骤：
将如在权利要求1中所述的装置插入在骨头内部；
使得该本体在松质骨中定向膨胀；并且
通过该定向膨胀压实松质骨。
11.如权利要求10所述的方法，其中所述定向膨胀提升了椎骨终板。
12.如权利要求10所述的方法，其中所述定向膨胀提升了胫骨平台凹陷。
13.如权利要求10所述的方法，其中所述定向膨胀提升了近端肱骨凹陷。
14.如权利要求10所述的方法，其中所述定向膨胀提升了皮质骨。
15.如权利要求10所述的方法，其中所述压实步骤形成一空腔。
16.如权利要求15所述的方法，还包括用材料填充该空腔的步骤。
17.如权利要求16所述的方法，其中所述材料包括骨粘固粉。
18.如权利要求16所述的方法，其中所述材料包括合成骨替代物。
19.如权利要求16所述的方法，其中所述材料包括凝固成硬化状态的可流动材料。
20.一种压实松质骨的装置，它包括用来插入到骨头中并且在松质骨中承受膨胀以压实松质骨的本体，该本体包括在松质骨中膨胀期间施加能够使断裂的皮质骨移动的力的材料，并且该本体还包括用来约束在松质骨中的膨胀的内部薄膜。
21.如权利要求20所述的装置，其中所述可膨胀本体包括一细长轴线，并且
其中所述内部薄膜在可膨胀结构的相对内侧表面之间相对于细长轴线垂直地延伸。
22.如权利要求20所述的装置，其中所述可膨胀本体包括一细长轴线，并且
其中所述内部薄膜在可膨胀结构的相对端面之间沿着细长轴线延伸。
23.如权利要求20所述的装置，其中所述可膨胀本体包括一细长轴线，并且
其中所述内部薄膜在可膨胀结构的相对端面之间沿着细长轴线在一个方向延伸并且在可膨胀结构的相对内部侧面之间沿着与细长轴线垂直的第二方向延伸。
24.如权利要求20所述的装置，其中所述内部薄膜约束可膨胀本体沿着一个方向的膨胀比沿着与所述一个方向垂直的另一个方向的膨胀更大。
25.如权利要求20所述的装置，其中所述可膨胀本体包括一细长轴线，
其中该内部薄膜约束了可膨胀本体沿着细长轴线的膨胀。
26.如权利要求20所述的装置，其中
所述可膨胀本体包括一细长轴线，
其中所述内部薄膜约束可膨胀本体沿着从细长轴线的一个径向方向的膨胀比沿着从细长轴线的第二径向方向的膨胀更大。
27.如权利要求26所述的装置，其中所述内部薄膜约束了可膨胀本体沿着细长轴线的膨胀。
28.一种治疗骨头的方法，该方法包括以下步骤：
将如在权利要求20中所述的装置插入在骨头内部；
使得该本体在松质骨中受约束膨胀；并且
通过该受约束膨胀压实松质骨。
29.如权利要求28所述的方法，其中所述受约束膨胀提升了椎骨终板。
30.如权利要求28所述的方法，其中所述受约束膨胀提升了胫骨平台凹陷。
31.如权利要求28所述的方法，其中所述受约束膨胀提升了近端肱骨凹陷。
32.如权利要求28所述的方法，其中所述受约束膨胀提升了皮质骨。
33.如权利要求28所述的方法，其中所述压实步骤形成一空腔。
34.如权利要求33所述的方法，还包括用材料填充该空腔的步骤。
35.如权利要求33所述的方法，其中所述材料包括骨粘固粉。
36.如权利要求33所述的方法，其中所述材料包括合成骨替代物。
37.如权利要求33所述的方法，其中所述材料包括凝固成硬化状态的可流动材料。
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