CN1427700B - 治疗骨折和/或病骨的方法和装置 - Google Patents

治疗骨折和/或病骨的方法和装置 Download PDF

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CN1427700B
CN1427700B CN018090974A CN01809097A CN1427700B CN 1427700 B CN1427700 B CN 1427700B CN 018090974 A CN018090974 A CN 018090974A CN 01809097 A CN01809097 A CN 01809097A CN 1427700 B CN1427700 B CN 1427700B
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cavity
bone
bar
vertebral body
expansible structure
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CN1427700A (zh
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雷纳尔多·A·奥索里奥
玛利亚露露·福尔默
理查德·W·莱恩
瑞安·P·鲍彻
卡伦·D·塔尔梅奇
约瑟夫·J·巴西斯塔
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Medtronic Spine LLC
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Kyphon Inc
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Abstract

本发明涉及治疗骨折和/或病骨的装置和方法。更具体地，本发明涉及修复、增强和/或治疗骨折和/或病骨的装置以及使用不同装置，包括空腔形成装置，修复、增强和/或治疗骨折和/或病骨的方法。

Description

治疗骨折和/或病骨的方法和装置
技术领域
本发明涉及治疗骨折和/或病骨的装置和方法。更具体地，本发明涉及修复、增强和/或治疗骨折和/或病骨的装置以及使用不同装置，包括使用空腔形成装置，修复、增强和/或治疗骨折和/或病骨的方法。
背景技术
正常的健康骨由蛋白质、胶原质和钙盐形成的构架所构成的。健康骨通常足够强壮，能经受个体在他或她的正常日常活动中遇到的各种应力，并能在精疲力竭之前在更大的应力下经受不同长度的时间。但是，骨质疏松症或其它疾病病灶，包括像乳癌、血管瘤、溶骨性转移瘤或脊髓瘤变变这样的疾病，以及长期过量饮酒、吸烟和/或吸各种毒品，能一天天地影响和显著弱化健康骨。如果不检查的话，这些因素能将骨的强度降低到特别容易骨折、塌陷和/或不能承受平均的正常日常应力的程度。
不幸的是，不到骨的完整性已经严重损害骨强度的减弱常常难以发现。例如，通常直到骨折已经发现后才能发现骨质疏松症的影响，此时大多数病人整体骨强度通常减弱到危险的程度。并且，由于大多数骨的发育主要在儿童时期和成熟期的早期，因此骨强度的长期减弱通常是不可逆的。另外，很多骨的疾病，包括骨质疏松症、癌症和其它与骨相关的疾病，在我们医学发展的当前阶段按常规是不能治愈的。
对于我们老年人群中的很多个体，不能诊断和/或不能治愈的骨强度损失已经将这些个体的骨强度减弱到平均正常日常活动可产生明显骨折危胁的程度。例如，当脊柱骨骼弱化到一定程度时，脊柱内的压力常常引起椎体的骨折和/或变形。对于弱化到一定程度的骨骼，即使正常日常活动，像步行下台阶或携带采购的物品，能引起一块或多块脊柱骨骼的塌陷，就像一支粉笔在人脚的压力下塌陷。椎体以这种方式骨折通常是指脊椎压缩骨折。研究者估计，在超过50岁的人中，至少所有女性中的25％，以及百分数略低的男性，仅仅由于骨质疏松症就受到一次或两次脊椎压缩骨折。在美国，据估计，每年出现超过700000次脊椎压缩骨折，其中超过200000次需要某种形式的住院治疗。其它通常发生的由骨弱化引起的骨折，举几个例子来说，可包括髋、腰、膝和踝骨折。
骨折，诸如脊椎压缩骨折，常常引起一阵的疼痛，这是慢性的和剧烈的。除了骨折本身引起的疼痛外，脊柱的损伤能引起神经萎缩和/或损坏，导致瘫痪、丧失功能以及波及病人全身的剧烈疼痛。即使没有影响神经，但是，与所有类型骨折有关的剧痛减轻，导致大量应力，减弱运动能力和其它慢性结果。例如，随着时间逐渐发生的脊柱骨折能引起脊柱严重变形(“驼背”)，使个人产生驼背的外观，也能引起肺活量的明显降低以及死亡率增大。
直到最近，脊椎压缩骨折以及其它严重骨折和/或骨强度减弱的治疗选择受到极大限制，主要用强的口服或静脉内药物治疗缓解疼痛，减少活动，加支架和/或放射治疗，所有这些都具有普通的效果。因为具有这些问题的病人通常是老人，常常受到多种其它明显的健康并发症，这些个体中的很多人不能忍受有创的外科手术。另外，为进一步治疗骨强度损失，很多病人被给予激素和/或维生素/无机盐补充，这些具有普通的效果并常常有明显的副作用。
在过去的十年中，一种称为脊柱整形术的技术已经进入美国。脊柱整形术包括将可流动的增强材料，通常是聚甲基丙烯酸甲酯(PMMA，常称为骨水泥)，注射到骨折的、弱化的或患病的脊椎骨内。注射后不久，液态填充的材料硬化并聚合，根据需要在内部支撑脊椎骨，减轻疼痛并防止被注射脊椎骨的进一步塌陷。
虽然已经证明脊柱整形术能缓解与脊椎压缩骨折相关的一些疼痛，但此技术具有某些内在的缺点。与脊柱整形术有关的最明显的危险是医师在将液体骨水泥注射到脊椎的过程中不能控制其流动。尽管通过CT扫描或X光透视检查能监视水泥的定位与流动，但一旦液体水泥流出针头，它自然沿着骨内较小阻力的路径流动，这常常是流过松质骨和/或皮质骨中的裂缝和/或间隙。而且，因为松质骨对骨水泥的注射有阻力，在脊柱整形术过程中通常使用小直径的针头，需要极高的压力迫使骨水泥通过针头并进入椎体。骨水泥具有粘性，难以通过小直径针头注射，因此很多医师选择“稀释”水泥混合物以改善水泥的注射，但最终加剧泄露的问题。在最近的研究中，有37个具有骨转移或多发性骨髓瘤的病人接受脊柱整形术治疗，72.5％的治疗导致水泥泄露到椎体以外。Cortet B.等人：“Percutaneous Vertebroplasty inPatients with Osteolytic Metastases or Multiple Mgebma(骨转移或多发性骨髓瘤病人中经皮脊柱整形术)(1998)”。并且，当医师通过在水泥混合物中添加额外的液体单体试图“稀释”水泥时，未聚合的或“游离”单体的数量增加，这最终对病人是有毒的。
脊柱整形术的另一个缺点是因为不能看到(利用CT扫描或X光透视检查)存在于脊椎骨内的各种静脉和其它软组织结构。虽然针在椎体内的位置通常是可见的，但看不到椎体内的静脉组织的位置。因此，小直径的脊柱整形术能容易地偶然定位在椎体的静脉内，并将液体水泥直接抽送到静脉系统内，此时水泥容易通过前外静脉丛或椎体静脉越过椎体的前和/或后壁
脊柱整形术的另一个明显的内在缺点是，这种治疗不能将椎体恢复到注射增强材料之前的骨折前状态。因为发生了骨折和/或变形，在注射水泥之前没有复位，脊柱整形术完全将骨“冻结”在骨折的状态。并且，传统脊柱整形术治疗能明显恢复到骨折前解剖状态是很不可能的，因为骨水泥沿较小阻力的路径流动，任何皮质骨的整体移动将可能在椎体的内部和/或壁中产生间隙，骨水泥通过它将很快流走。
一种最近发展的治疗如脊椎压缩骨折的骨折和其它相关骨病的手术被称为KyphoplastyTM。例如，参见美国专利4969888和5108404。在Kyphoplasty中，将可膨胀体通过一个小口插入断骨或弱骨中。这种治疗压缩松质骨，并希望将断骨移动到其骨折前的方位，并在骨内产生空腔以便在其中填充固定材料，例如水泥或任何数量的合成骨替代物。实际上，这种治疗将骨“调整”到其骨折前的位置或此位置附近并形成内部“铸造”，防止骨进一步骨折和/或塌陷。这种治疗当然也适合应用于各种其它的骨。
虽然Kyphoplasty能将骨恢复到骨折前的状态，并在Kyphoplasty过程中注射的骨填充剂不易泄露出脊椎骨以外，但Kyphoplasty比脊柱整形术需要更多的外科工具，增加了成本。同时，Kyphoplasty工具通常比脊柱整形术工具具有较大的直径，从而需要较大的切口并且一般更具创伤。
发明内容
本发明克服了许多与当前修复、增强和/或治疗弱化、患病和/或断裂骨的医疗方法中的方案与设计有关的问题和缺点。在一个优选实施例中，本发明涉及改进的脊柱整形术疗法以及应用于这种疗法的外科器械。
本发明提供了一种球囊导管，包括：
管，该管包括近端和封闭的远端；
位于所述管内的管腔，用于输送膨胀介质；
形成在所述管的侧壁中的开口；
在所述管的近端处或附近的管接头，该管接头适于可松开地联接到膨胀介质源，所述管接头具有与所述管腔连通的一个或多个膨胀口；以及
可扩张结构，该可扩张结构由管承载并至少部分地位于所述管内，并且该可扩张结构与所述管腔连通，响应于膨胀介质穿过所述一个或多个膨胀口和所述管腔而引入，所述可扩张结构的至少一部分能够扩张穿过所述开口。
在本发明方法的一个一般性实施例中，将一种插入装置，优选的是11标准脊柱针组件，插入目标椎体中，并使用X光透视检查监视针的定位。通过针将空腔形成装置插入椎体中。空腔形成装置压缩针远端尖附近的松质骨，在骨中形成小的空腔。取出空腔形成装置并通过脊柱针将水泥输入。将骨填充剂，例如混有造影剂的骨水泥，注入空腔中，并使用X光透视检查监视骨填充剂在椎体内的流动。当达到所需的填充数量时、椎体骨折部分达到时和/或返回到其骨折前的位置时，或者骨填充剂泄露即将发生时停止注入骨填充剂。因为空腔在椎体内的形成先于骨填充剂的注入，所以所用的注入压力非常低，明显减小了水泥泄露的可能性。另外，所需流动通道的形成使骨填充剂材料在椎体内的布置得到较大的控制。
在另一个一般性的本发明方法的实施例中，将一种插入装置，例如商用的脊柱针组件，通过皮质骨区插入目标骨的松质骨区，并使用X光透视检查监视针的定位。将第一材料，例如骨填充剂，通过插入装置输入松质骨区。接着将可扩张结构通过插入装置插入并在骨内扩张，压缩第一材料和/或松质骨，从而形成空腔和/或基本上围绕空腔的压缩松质骨的屏障区。接着将第二材料，可以是与第一材料相同的材料，通过插入装置输入骨内。如果需要，第一材料可包括强度足够在外科手术过程中支撑空腔的材料，从而在可扩张结构缩小和取出时防止空腔的塌陷。这种第一材料可包括：骨水泥、骨移植材料或金属和非金属斯腾特式模件。
在另一个实施例中，本发明的方法应用于压缩和/或骨折的椎骨，用以增强椎骨，将其返回，至少是部分返回，其骨折前的位置，防止椎骨进一步骨折或塌陷，和/或缓解与脊柱骨折和压缩有关的疼痛。
在本发明的一个实施例中，空腔形成装置包括球囊导管。球囊导管具有穿过球囊材料的中空管。在导管的近端，管和可扩张结构连接到管接头。在远端，可扩张结构直接固定到和/或围绕着中空管。可扩张结构的远端及中空管的远端是密封的。在中空管的远端附近有一个或多个开口，通过开口膨胀介质流入和流出中空管并且扩张和缩小可扩张结构。
本发明的球囊导管可通过插入装置，例如11标准针组件，插入骨内，例如椎体，导管的远端伸出针以外，伸出的长度由医师确定。当导管充满膨胀介质时，导管伸出针的部分向外扩张，压缩松质骨并在椎体形成所需的空腔。
在本发明的另一个实施例中，空腔形成装置包括杆，杆的远端具有一根或多根线或“刚毛”。空腔形成装置通过插入装置，例如脊柱针，插入骨的松质区，例如椎体。当刚毛进入椎体时，它们在受控的状态下推移松质骨，在松质骨内形成一个或多个小的通道或空腔。从椎体和针中取出空腔形成装置，将骨填充剂输入椎体。骨填充剂，正常情况下沿最小阻力的通道流动，最初流过小空腔。如果需要，医师能中断骨填充剂的输入并通过重新插入空腔形成装置形成额外的空腔。通过在松质骨中形成所需的通道，本发明减小了水泥泄露出椎体的机率和/或改善骨填充剂在椎体大部分区域内的分布。
本发明的其它目标、优点和实施例，一部分将在下面的描述中给出，而一部分在此描述中清楚地显示出，或者可以从本发明的实践中领会。
附图说明
图1是一根脊柱的图，其中在一节脊椎骨中有压缩骨折；
图2是一位要进行外科手术的病人的图；
图3是侧视图，部分去除并剖视，表示压缩骨折的腰椎；
图4是腰椎的冠状图；
图5A是腰椎的侧视图，表示插入椎体内的脊柱针；
图5B是图5A腰椎的侧视图，其中从脊柱针中取下了管心针；
图5C是图5B腰椎的侧视图，其中将根据本发明一个实施例制造的空腔形成装置插入椎体内；
图5D是图5C腰椎的侧视图，其中空腔形成装置膨胀；
图5E是图5D腰椎的侧视图，其中空腔形成装置缩小；
图5F是图5E腰椎的侧视图，其中从椎体中取下空腔形成装置；
图5G是图5F腰椎的侧视图，其中骨填充剂注射到椎体内；
图5H是图5G腰椎的侧视图，其中将脊柱针刺入空腔；
图5I是图5H腰椎的侧视图，其中将第二骨填充剂注射到椎体内；
图5J是图5I腰椎的侧视图，其中将另外的骨填充剂注射到椎体内；
图5K是图5J腰椎的侧视图，其中将另外的骨填充剂注射到椎体内；
图5L是图5K腰椎的侧视图，其中从椎体中取下脊柱针；
图6A是根据本发明另一个实施例制造的空腔形成装置的侧视图；
图6B是图6A空腔形成装置远端的放大图；
图7A是腰椎的侧视图，表示图6A的空腔形成装置插入脊椎骨内；
图7B是图7A腰椎的侧视图，其中空腔形成装置在脊椎骨内展开；
图7C是图7B腰椎的侧视图，其中从脊椎骨内抽出空腔形成装置；
图8A是腰椎的侧视图，表示根据本发明的原理治疗椎体的另一种疗法；
图8B是图8A腰椎的侧视图，其中空腔形成装置插入骨填充剂内；
图8C是图8B腰椎的侧视图，其中空腔形成装置在空腔内扩张；
图9是根据本发明一个实施例制造的空腔形成装置的侧视图；
图10是图9空腔形成装置远端的放大图；
图11是从针远端伸出的球囊导管远端的放大图，表示用膨胀介质膨胀球囊材料；
图12是根据本发明另一个实施例制造的空腔形成装置的侧视图；
图13是根据本发明另一个实施例制造的空腔形成装置的侧视图；
图14是根据本发明另一个实施例制造的空腔形成装置的侧视图；
图15是根据本发明另一个实施例制造的空腔形成装置的侧视图；
图16A是腰椎的侧视图，表示根据本发明的原理治疗椎体的另一种疗法；
图16B是图16A腰椎的侧视图，其中骨填充剂注射到脊椎骨内；
图16C是图16B腰椎的侧视图，其中空腔形成装置插入脊椎骨内；
图16D是图16C腰椎的侧视图，其中空腔形成装置在空腔内扩张；
图17是根据本发明另一个实施例制造的空腔形成装置的侧视图；
图18是根据本发明另一个实施例制造的空腔形成装置的侧视图；
图19是图18的空腔形成装置沿线19-19的剖视图；
图20是图18的空腔形成装置沿线20-20的剖视图。
具体实施方式
如同这里具体表达和广义描述地，本发明涉及用于修复、增强和/或治疗、患病和/或断裂骨的外科手术方法。本发明还涉及应用于这些外科手术方法的装置。
图1表示典型的人类脊柱1，其中压缩骨折10出现在腰椎100中。如图3的详细表示，脊椎骨100已经骨折，其中顶和底板103和104一般是压向脊椎骨100的前壁10并离开其骨折前的位置，通常是平行取向(大体如平行线90所示)。
图4表示图3脊椎骨的冠状面(顶视)图。脊椎骨100包括椎体105，在椎骨100的前(即面或胸)侧延伸。椎体105大致具有椭圆形盘的形状，并具有前壁10和后壁261。椎体105的几何形状一般是对称的。椎体105包括由紧密的皮质骨110形成的外层。皮质骨110封闭形成内部的网状松质骨115，或海绵状骨(也称为髓质骨或小梁骨)。
椎孔150位于每块椎骨100的后(即背)侧。脊髓151通过椎孔150。椎弓135环绕着椎管150。椎弓135的左右椎弓板120与椎体105毗连。棘突130从椎弓135的后面伸出，左右横突125和乳突126也是如此。
图2表示准备实施本发明方法的病人50。恰当培训并获得执行本发明治疗的医学专家能为门诊病人或住院病人实施这些治疗。所希望的是，病人在外科手术期间处于全身麻醉或局部麻醉。
在本发明的一个实施例中，外科手术方法包括，在优选的背部目标区域(图2中示为60)将插入装置350(图5A)经皮插入到骨骼内，例如骨折的椎体105。插入装置350可以是任何类型和大小的中空器械，优选地具有一个尖端。在一个优选的实施例中，插入装置350包括约为11号直径的中空针头。11号针头在治疗中是优选的，因为它具有足够大小的中空管腔，便于通过多种器械和材料，并且针头的总尺寸足够小以便对病人的骨和组织损伤降低到最低程度。但是，也应理解的是，各种其它尺寸的针头，包括6号到14号标准针头，也可用在本发明的装置和方法中，得到不同的效果。另外，不同的其它插入器械，例如那些在美国专利4969888、5108404、4827289、5972015、6048346和6066154中所描述的，也可根据本发明的原理使用，得到不同的效果。上述每个专利在此都引用为参考文献。
插入装置350优选地由高强度、非反应性和医疗等级的材料构成，例如外科钢。如果需要，插入装置350装在操作装置上，操作装置由非反应性和医疗等级的材料构成，包括，塑料、陶瓷、金属、复合材料、丙烯腈-丁二烯-苯乙烯(ABS)、聚乙烯、聚丙烯、聚氨酯、或外科钢，但不限于此。图5A表示市售针头组件，通常用于本发明的不同实施例中，这在下面进一步描述。
如图5A所示，插入装置350，例如11号活组织检查针头(从新泽西州Franklin Lakes的Becton Dickinson公司购买)，能穿过背部的软组织并插入椎体105中。一般地，这种手术的插入方法是经椎弓板的，但根据治疗的水平和/或介入解剖特征，可以使用各种其它方法，包括侧面的、椎弓板外的和/或前面的插入，这对本领域普通熟知人员也是公知的。在一个实施例中，装置350包括针体348和管心针349，这在本领域内是熟知的。在装置350的插入过程中，装置350的定位使用视像设备进行监视，如实时X射线、CT扫描设备70(见图2)、MRI或其它任何本领域内熟知人员通用的监视设备，包括计算机辅助导向和绘图设备，如BrainLab公司或通用电气公司销售的系统。
在一个优选实施例中，插入装置350的远端351定位于椎体105内，优选地在朝向椎体105后侧的位置。如果需要，远端351可定位于整椎体105内的各个位置，包括朝向前侧。一旦定位，可以抽出插入装置350的管心针349，见图5B，并且可以通过杆348插入空腔形成装置200并插到椎体105内，见图5C。空腔形成装置200，由生物相容性和医疗可接受性材料制成，可以是小的机械捣打工具、铰刀、冲孔器、球囊导管(见下面的描述)或任何适当的能转移松质骨的装置。一旦空腔形成装置定位在椎体105内，就用于转移松质骨115，从而形成空腔170，见图5F。
在一个实施例中，如图9和图10所示，空腔形成装置包括球囊导管200。球囊导管200伸过至少20％的椎体，但可以根据所产生的空腔尺寸，延伸更远或更近。在此实施例中，随着球囊导管201的扩张，在一个受控的状态下从空腔170中将松质骨转移出来，形成压缩骨区域172围绕着空腔170外围的基质部分。
球囊导管200将在下面详细描述，其尺寸加工成或折叠成适合穿过杆348的中空内部并进入椎体105内。一旦定位于椎体105内所需的位置，球囊导管190被适合于医疗应用的加压填充介质275所填充，加压填充介质包括空气、氮气、盐水或水，但不限于此，参见图5D和11。在一个优选的实施例中，填充介质275是辐射透不过的流体(如流体，密苏里州St.Louis的Mallinkrodt公司销售)，使医师在膨胀期间能看到导管190。如果需要，可以使用其它扩张导管的方法，包括机械扩张、折叠刀、扩张弹簧和/或扩张/发泡剂，得到不同的效果。
在一个实施例中，导管201扩张到任何适合的体积，在椎体105内产生空腔170。在一个优选的实施例中，导管201的体积至少扩张到0.2cc，但可以扩张到明显大于此尺寸，例如1、2、4、6或8cc，这取决于骨的质量和密度。形成空腔后，导管201缩小(见图5E)并从椎体105和杆348中取出(见图5F)。使用与针体348兼容的任何类型的柱塞、挤压器和/或加料装置349，将骨填充剂180通过杆348输送并送入椎体105内。一旦骨填充剂注射完，就可以抽出杆348。
如果需要，球囊导管201的部分可以临时地或永久地留在椎体105内。例如，在形成空腔并取出膨胀介质后，球囊导管201缩小的膨胀部分可以用骨填充剂180重新填充并留在椎体105内。另外，膨胀介质180可以包括骨填充剂180。当球囊导管201被这种膨胀介质填充后，至少一部分的球囊导管201可以永久地留在空腔170内。在另外的实施例中，想要留在空腔170内的导管201可以包括生物可吸收性材料和/或织物/网孔材料作为可扩张结构。
在形成空腔170时，导管201的膨胀使可扩张材料210压向松质骨115，这可以沿空腔170的大部分周边形成压缩骨区或“壳”172。壳172将阻碍或防止骨填充剂180流出空腔170，从而阻止空腔内骨填充剂的溢出和/或促进空腔内骨填充剂180的加压，如果需要的话。随着空腔170内的压力增大，骨填充剂180可以进一步向外压迫空腔170的壁，进一步压缩椎体105内的松质骨和/或增大空腔170的尺寸。如果达到足够的压力，能维持壳172的完整性而不明显泄露骨填充剂180，可以达到能移动骨折的皮质骨的压力。
在本发明的一个实施例中，形成空腔后，在低压下将一定量的材料，例如骨填充剂180，通过杆348送入椎体105中。骨填充剂的数量应超过空腔170的体积，但是，送入较少的骨填充剂将得到不同的结果。一旦完全充满空腔170，继续送入骨填充剂180可以增大空腔170内骨填充剂180的压力，压力的增大将导致至少一部分空腔170的壁向外移动，从而扩大空腔170并进一步压缩松质骨和/或移动皮质骨。所希望的是，继续输入骨填充剂180直到骨填充剂从椎体的泄露即将出现，皮质骨恢复到其骨折前的位置和/或医师确定输入骨内的骨填充剂180已经足够。如果需要，医师可以利用空腔形成装置形成额外的空腔用于骨填充剂，或者从椎体中取出杆348以结束治疗。
骨填充剂180可以是任何一种适合的、可用于整形外科的填充材料，包括同种异体移植或自体移植组织、羟基磷灰石、环氧、PMMA骨水泥或合成骨替代物如Wright医学技术公司的医疗等级的石膏、Norian公司的骨骼修复系统或Zimmer公司的Collagraft，但不限于此。当骨填充剂180输入椎体105时，可以用X光透视检查监视输入过程，或者用任何其它适合的监视设备或方法，以保证骨填充剂180不流出椎体105之外。为了易于显像，骨填充剂180可以混入造影剂，例如辐射性不透明的硫酸钡。在另一个实施例中，骨填充剂180可以包括骨水泥的混合物和触变材料，用于限制和/或防止骨水泥的溢出。
在本发明方法的另一个实施例中，如图5G到5L所示，将第一骨填充剂180输入空腔170，第一骨填充剂180的数量优选地小于或约等于空腔170的体积。例如，如果用于形成空腔170的球囊导管200用膨胀流体膨胀1.0cc，那么开始输入空腔170的骨填充剂180小于或约等于1.0cc。当然，如果需要，可以将大于空腔体积的第一骨填充剂180输入空腔。接着，将杆348在椎体105中重新定位，见图5H，装置350的远端351定位于空腔170中含有的第一骨填充剂180的团块400中。如图5I的详细描述，接着将第二数量的骨填充剂182注入椎体105，迫使第一数量的骨填充剂180向外压空腔170的壁。所希望的是，第一数量的骨填充剂180抵抗溢出空腔170并向外推向空腔170的壁，进一步压缩松质骨115和/或增大空腔170的尺寸。继续输入第二数量的骨填充剂182直到骨填充剂有苗头从椎体泄露出、皮质骨恢复到其骨折前的位置和/或医师确定已经将足够量的骨填充剂180输入到骨内。如果需要，医师重新插入导管200，以形成额外的空腔，或者取出杆348以完成治疗。
图8A到8C表示本发明方法的另一个实施例，其中医师输入第一材料，例如骨填充剂180，到空腔170中，并且随后将空腔形成装置200插入骨内。接着扩张空腔形成装置200，并将骨填充剂180向空腔壁压缩，密封水泥流过的任何明显的裂纹和/或静脉通道。在另一个实施例中，医师可以在取出空腔形成装置之前和/或输入第二材料如骨填充剂之前等待第一骨填充剂部分硬化或全部硬化。第二材料(未示出)可以随后注入椎体内，泄露的危险很小。如果需要，每当有水泥泄露的苗头时就使用此方法，并重复多次直到医师确定已经足够量的骨填充剂180已经注入骨内。另外，医师可以重复此治疗直到皮质骨恢复到其骨折前的位置。在另一个实施例中，医师在输入第一骨填充剂之前使用空腔形成装置，接着将第一骨填充剂输入空腔，随后进行一个或多个所述的方法。
第一骨填充剂可包括一种能够被输入空腔的材料，但当第二骨填充剂输入空腔时还要能抵抗溢出空腔和/或椎体。在本发明的一个实施例中，第一和第二骨填充剂包括骨水泥，第一骨水泥比第二骨水泥更能抵抗溢出。例如，第一骨水泥的成分可以特别挑选，以使第一骨水泥比第二骨水泥固化快。另外，第一骨水泥在第二骨水泥之前准备和/或输入到椎体内，使第一骨水泥在第二水泥之前部分或全部固化。另外，可以加速(例如通过加热)第一骨水泥的固化和/或硬化，或者推迟(例如通过冷却)第二骨水泥的固化和/或硬化。在另一个实施例中，第一和第二骨填充剂包括骨水泥，第一骨水泥比第二骨水泥粘度大。在另一个实施例中，第一骨填充剂包括扩张结构，例如斯腾氏模件。
在另一个实施例中，第一骨填充剂包括粘度大于第二骨填充剂的材料，第一和第二骨填充剂包括不同材料。在另一个实施例中，第一骨填充剂包括比第二骨填充剂更能抵抗溢出到松质骨的材料。在另一个实施例中，第一骨填充剂包括具有颗粒大于第二骨填充剂中颗粒的材料。在另一个实施例中，第一骨填充剂包括可固化的材料，例如两部分可塑性材料或者其它可固化的生物材料。
图16A到16D表示本发明方法的另一个实施例，其中第一材料，例如骨填充剂180，最初输入到人骨的松质骨115中，例如椎体105中。随后将扩张结构210，例如存在于球囊导管200的远端，插入椎体105中。可扩张结构210，例如存在于球囊导管200的远端，随后插入到椎体105。接着扩张可扩张结构210，移动骨填充剂180和/或松质骨115，在椎体105中形成空腔170。在一个实施例中，可扩张结构210的扩张进一步将骨填充剂180压入松质骨115，和/或进一步压缩松质骨。为了使骨填充剂180的泄露最小，骨填充剂可以在可扩张结构210扩张之前部分或全部硬化。在另一个实施例中，可以将第二材料输入空腔170中，第二材料可以选择额外的骨填充剂。在一个实施例中，第二材料是将骨支撑在静止位置的材料。每当水泥有泄露的苗头时就使用此方法，并重复多次直到医师确定足够数量和种类的材料已经注入骨内为止。另外，当皮质骨恢复或基本恢复到其骨折前的位置时医师也可以中止输入填充剂材料。
通过在松质骨内形成空腔和/或优选的流动通道，本发明避免了需要极高压力将骨填充剂注入松质骨内。如果需要，可以在大气压和/或环境压力下或此压力附近，或者在低于400磅每平方英寸的压力下，使用骨填充剂输送系统，例如PCT专利号WO 00/09024中描述地，将骨填充剂注入骨内。上述专利在此作为参考文献。这样，可以在低压力下(例如，在大气压或环境压力或者此压力附近的输送压力下流出输送装置)将粘度较大的骨填充剂(例如，稠的骨水泥)注入骨内，降低水泥泄露和/或溢出骨以外的机率。
空腔形成装置
本发明还包括根据本发明原理制造的空腔形成装置。在一个实施例中，空腔形成装置包括球囊导管201，如图9、10和11所示。导管包括中空管205，优选地由医疗等级的材料如塑料或不锈钢制成。中空管205的远端206被可扩张材料210包围，可扩张材料210由可变形材料制成，例如通常在球囊导管中使用的，包括金属、塑料、复合材料、聚乙烯、聚酯薄膜、橡胶或聚氨酯。在管205的远端206附近有一个或多个开口250，可以使管205的中空内部与管205和可扩张结构210之间形成的管腔之间实现流体流动。具有一个或多个膨胀口222、224的管接头220固定在管205的近端207。在此实施例中，一旦导管201定位于椎体105内的所需位置，则通过膨胀口222将膨胀介质275输入管接头220，膨胀介质275通过管接头220，通过中空管205，通过开口250，进入可扩张结构210与中空管205之间的管腔274。随着继续注入膨胀介质275，膨胀介质275的压力迫使可扩张结构210离开中空管205，向外膨胀，从而压缩松质骨115并形成空腔170。一旦达到所需尺寸的空腔，从导管200中取出膨胀介质275，可扩张结构在空腔170中塌陷，这时可以取出导管200。
例如，根据本发明一个优选实施例制造的球囊导管201，适合使用11号针，包括中空的不锈钢皮下管205，其外径为0.035英寸，长度为10.75英寸。在离开管205的远端约0.25英寸处具有一个或多个开口250。在一个优选的实施例中，使用本领域中任何公知的方法包括粘结剂，将中空管205的远端206封闭。
在一个实施例中，中空管205基本上被可扩张结构210所包围，可扩张结构210包括挤压的塑料管。在一个实施例中，塑料管的内径为0.046英寸，外径为0.082英寸，长度为91/2英寸。用本领域内公知的方法，例如通过合适的粘结剂，将塑料管的远端与中空管205的远端206结合在一起。另外，通过本领域内公知的方法，可以将塑料管加热密封到中空管205的远端206上。一根外径3/16英寸，长度为3/4英寸的热缩管215可固定于塑料管的近端。在一个实施例中，中空管205的近端插入管接头220中，使用本领域中公知的适合的粘结剂将热缩管215结合到管接头220上。管接头220，可以是从很多零件供应商处得到的路厄氏三通管接头，可以用本领域熟知人员公知的任何合适材料制成。管接头220包括一个或多个用于装另外器械的口222、224，例如泵和注射器(未示出)。如果需要，使用合适的粘结剂将中空管205同样结合到管接头220上。另外，如图12所示，可扩张结构210可明显短于中空管205，并在其远端206和其近端209结合到中空管205上。
在本发明的治疗过程中，中空管205和一个或多个开口250使之易于从导管中取出膨胀介质。当导管缩小时，可扩张结构210通常向管205塌陷，这常常密封闭合的管腔(在缺少至少一个第二取出通道的情况下)并阻止从导管可扩张结构210中进一步取出膨胀介质。但是，在本发明的实施例中，管205远端206附近的一个或多个开口250使膨胀介质275从中空的皮下管205中取出，进一步缩小可扩张结构210。中空皮下管205的高强度壁抵抗在排出膨胀介质的真空下的塌陷，保持膨胀介质的流动通道，使膨胀介质快速地从导管中取出，导管缩小仅在几秒内完成。
在本发明实施例中，当导管201膨胀时，膨胀介质275通常能充满整个可扩张结构210和中空管205之间的管腔，从而沿可扩张结构210的整个长度扩张导管201。但是，由于大部分导管201位于杆348的管腔内，导管201的远端206伸入椎体105内，杆348限制可扩张结构210的扩张，使可扩张结构210初期在导管200的远端206扩张。所希望的是，进一步插入或抽出导管201改变可扩张结构210从杆348远端的伸出量，从而增大或减小可扩张结构210在椎体105内不扩张的长度。在外科手术过程中，通过选择导管201插入椎体105内的长度，医师能改变可扩张结构的长度，最终改变由导管201形成的空腔大小。因此，本发明的实施例能避免和/或减少对不同长度的多个导管的需求。如果需要，标记269(见图9)刻在导管的近端，与导管201伸出杆348的长度对应，使医师校准导管200的可扩张结构210在椎体105内的尺寸。同样地，在下面的本发明实施例中，空腔形成装置201具有与刚毛伸出杆348尖端的长度对应的标记。
在另一个实施例中，如图13所示，通过将可扩张结构210固定和/或粘结到沿中空管205的第二位置214，能进一步限制导管可扩张部分211的长度。例如，如果所需的可扩张部分211的最大长度是3英寸，则将可扩张结构210固定到中空管205的第二位置214上，离开中空管205远端206约3英寸。这种结构使医师能够选择可扩张部分211的扩张长度高达3英寸，同时限制和/或防止导管201其余部分203的扩张。这种结构还防止导管伸出杆体348近端191的部分202的不想要扩张(见图5C)。
如前所述，在本发明的实施例中，可扩张结构可固定在中空管的远端，如果可扩张结构210受到撕裂或损坏，例如完全径向撕裂，则可扩张结构210的碎片易于恢复。由于中空管205可保持与可扩张结构210的碎片连结，这些碎片能用中空管205从椎体105中取出。另外，远端连结可防止和/或减小扩张结构210沿中空管205纵轴的明显扩张。
图17表示根据本发明另一个实施例制造的空腔形成装置300。由于此实施例的很多特征与前述的实施例相似，因此相似的标号用于指示相似的元件。在此实施例中，中空管205穿过管接头220，例如三通管接头，并固定在帽310上。在一个优选的实施例中，中空管205能相对管接头220旋转。如果需要，密封(未示出)，例如硅酮或O形密封圈，用于管接头222的近端以限制和/或防止膨胀介质泄露出中空管205。
在使用中，空腔形成装置300压缩松质骨和/或形成空腔，方式与前述的实施例相似。但是，一旦空腔形成并需要取出装置300，帽310能旋转，相对管接头220扭转可扩张材料210并将可扩张结构210拉向中空管205，可将装置300可扩张部分的总外径减小到最低程度。装置300能容易地从杆348中取出。即使可扩张结构210塑性变形，或者在某些情况下失效，本发明的实施例也使可扩张结构210卷绕在中空管205上，从而容易取出和/或插入。另外，中空管205可相对管接头220的纵轴移动，可进一步相对中空管205伸展和/或收缩可扩张结构210。
图6A和6B表示根据本发明另一个实施例制造的空腔形成装置410。空腔形成装置410包括杆420，其尺寸能穿过插入装置350的杆348。便于操纵空腔形成装置410的把手415固定在杆420的近端412。一根或多根线或“刚毛”425固定在杆420的远端423。刚毛425通过焊接、锡焊、粘接或其它本领域内公知固定方法固定在杆420上。另外，刚毛425可以整体与杆420形成在一起，或者使用激光或其它本领域内公知的方法从杆上蚀刻而成。刚毛和杆可以由高强度的、非反应性的和医疗等级的材料制成，例如外科级不锈钢。在一个实施例中，刚毛425沿杆425的纵轴延伸，但在径向略微向外偏离杆的轴线。按这种方式，能收集或“束缚”刚毛425通过杆348，但在伸出杆348后能扩展或“展开成扇形”。如果需要，刚毛可以是直的或弯曲的，以便于通过松质骨115。另外，如果需要，一根或多根刚毛425可以是中空的，使医师能够在插入装置410过程中取出松质骨的活体组织检查样本。
如图7所示，空腔形成装置410可以通过杆348插入并定位在目标骨中，例如椎体105。随着刚毛425进入松质骨115，刚毛425将推移骨115并在椎体内形成一个或多个空腔426或者优选的形成流动通道。如果需要，医师可将刚毛425抽回杆348，重新定位空腔形成装置410(例如通过旋转装置410)，并重新插入刚毛425，从而在松质骨115内形成额外的空腔。
当取出空腔形成装置410后，可以将材料，例如骨填充剂(未示出)，通过杆348输入。骨填充剂初始穿过刚毛425形成的空腔426。如果需要，医师可中断骨填充剂的输入并通过重新插入空腔形成装置410以形成另外的空腔。另外，当骨填充剂有泄露发生时或者即将发生时，医师能中断骨填充剂的注入，如上所述形成另外的空腔，等待输入/泄露的骨填充剂硬化到足够的程度以抵抗进一步的溢出，接着继续输入骨填充剂。如前所述，骨填充剂可包括很多不同的材料，或者材料的复合，得到不同的效果。
图14表示根据本发明另一个实施例制造的空腔形成装置500。空腔形成装置500包括杆520，其尺寸能穿过插入装置350的杆348。便于操纵空腔形成装置500的把手组件515固定在杆520的近端512。空腔形成装置500的杆520最好长于插入装置350的杆348。杆520的远端525可以是斜的(未示出)，便于通过松质骨115，或者倒圆角或倒平以使穿透椎体105前壁10的机率降到最低。另外，如果需要，杆520的远端525可以是中空的(未示出)，使医师能够在插入装置500的过程中提取松质骨115的活体组织检查样本。
图15表示根据本发明另一个实施例制造的空腔形成装置600。空腔形成装置600包括杆620，其尺寸能穿过插入装置350的杆348。便于操纵空腔形成装置600的把手615固定在杆620的近端612。杆620可长于插入装置350的杆348。杆620的远端625可以是斜的(未示出)，便于通过松质骨115，或者倒圆角或倒平以使穿透椎体105前壁10的机率降到最低。在此实施例中，装置600的远端625设有钻头螺纹627，以便于装置600在松质骨115内推进。另外，如果需要，杆620的远端625可以是中空的，使医师在插入装置600的过程中提取松质骨115的活体组织检查样本。
当取出装置后，可以通过杆348输入骨填充剂(未示出)。所希望的是，骨填充剂初始穿过装置形成的空腔。如果需要，医师可中断骨填充剂的输入并通过重新插入装置形成另外的空腔。另外，当骨填充剂泄露发生或者即将发生时，医师能中断骨填充剂的注入，如上所述形成另外的空腔，等待输入/泄露的骨填充剂足够硬化，接着继续输入骨填充剂。如前所述，骨填充剂可包括很多不同的材料，或者材料的复合，得到不同的效果。
图18-20表示根据本发明另一个实施例制造的空腔形成装置600a。由于此装置的很多元件与那些前面描述的相似，相似的标号用于指示相似的元件。空腔形成装置600a包括杆620，其尺寸能穿过插入装置350的杆348。便于操纵空腔形成装置600a的把手组件615a固定在杆620a的近端612a。杆620a可长于插入装置350的杆348。杆620a的远端625a可以是倒圆角或斜的(未示出)，便于通过松质骨115，或者倒平以使穿透椎体105前壁10的机率降到最低。
在杆620a上具有开口或窗口700。如图19和20所示，可扩张结构710至少部分位于于杆620a中，优选的位于窗口700附近的位置。当通过沿杆620a延伸的管腔输入膨胀流体时，可扩张结构710扩张并可扩张结构710至少一部分穿过窗口700伸出杆620a之外。所希望的是，随着结构的继续扩张，可扩张结构710穿过窗口700“增长”(图20中P1到P2到P3)，从而压缩松质骨，形成空腔和/或移动皮质骨。当缩小可扩张结构710时，大部分可扩张结构710抽回到杆620a中，以将工具从椎体中取出。在一个实施例中，至少一部分构成可扩张结构710的材料在其扩张时产生塑性变形。
可扩张结构710可以包括通常应用于医疗装置中的柔性材料，包括塑料、聚乙烯、聚酯薄膜、橡胶、尼龙、聚氨酯、金属、陶瓷或复合材料，但不限于此。所希望的是，杆620a包括与可扩张结构710的材料相比对扩张有更大抵抗作用的材料，包括不锈钢、陶瓷、复合材料和/或刚性塑料，但不限于此。在另一个实施例中，相似的材料可应用可扩张结构710和杆620a，但厚度和/或数量不同，从而使可扩张结构比杆620a的材料更易于扩张。可扩张结构710可以通过各种本领域内公知的方法直接结合到杆620a上，包括像焊接、熔化、粘结或类似的方法，但不限于此。在另一个实施例中，可扩张结构可以固定在杆620a的内部或外部，或者二者的结合。
如前所述，任何空腔形成装置500、600和600a可以通过定位于目标骨内的杆348插入，例如定位于椎体105中的杆348插入。当装置进入松质骨115时，它们移出骨115并在椎体内形成一个或多个空腔。如果需要，医师能将装置抽回到杆348中并根据需要重新插入，以在松质骨115中形成所需的空腔。
在图18-20空腔形成装置的实施例中，可以使用空腔形成装置600a而不用相关的插入装置。在这种情况下，空腔形成装置具有穿透软组织及椎体皮质/松质骨的尖锐远端尖。如果需要，远端尖可以是中空的或实心的结构。相似地，根据可扩张结构的尺寸和结构以及空腔形成装置所需的强度，所述窗口可以或的或少地绕杆620a周边延伸。
通过在松质骨115中形成一个或多个空腔，本发明的空腔形成装置形成优选的骨填充剂180的流动通道。另外，空腔形成装置也可闭合和/或阻塞通往空腔之外的其它天然流动通道，例如松质骨中的静脉和/或裂纹。并且，本发明的方法和装置能用于操纵已经输入到骨内的骨填充剂。这样，本发明减小水泥泄露出椎体的机率和/或提高骨填充剂在大部分椎体内的分布。另外，本发明中描述的空腔以及所需的流动通道的形成使生物材料的放置在更加安全、较高的控制性和较低的压力下进行。
除了上述的具体应用外，这里描述的空腔形成装置和方法也很适合应用于治疗和/或增强弱化的、患病的和/或骨折的骨以及全身不同部位的其它器官。例如，本发明的装置和方法可用于将增强材料和/或药物，例如癌症药、置换骨细胞、胶原质、骨基体、去矿化的钙及其它材料/药物，直接输送到骨折的、弱化的和/或患病的骨，从而增大材料的效用，增强弱化的骨和/或加速治愈。并且，将这种材料注入体内的一种骨使药物/材料迁移和/或输送到体内的其它骨和/或器官，从而提高没有直接注入材料和/或药物的骨和/或其它器官的质量。
对于本领域内一般技术人员来说，当考虑这些描述的本发明的说明书和实际应用时，本发明的其它实施例和应用是显而易见的。所有这里引用的文献都被具体地和全部地作为参考文献。说明书和实施例认为是仅具有所附权利要求指示的本发明真实范围和精神的典范。那些本领域一般技术人员能容易地理解到，在所附权利要求限定的本发明范围内能容易地做出对每个所述实施例的变化和修改。

Claims (11)

1.一种空腔形成装置(600a)，包括：
杆(620a)，该杆(620a)包括近端(612a)和封闭的远端(625a)；
位于所述杆(620a)内的管腔，用于输送膨胀介质：
形成在所述杆(620a)的侧壁中的开口(700)；
在所述杆(620a)的近端(612a)处或附近的管接头(220)，该管接头适于可松开地联接到膨胀介质源，所述管接头具有与所述管腔连通的一个或多个膨胀口(222、224)；以及
可扩张结构(710)，该可扩张结构由杆(620a)承载并至少部分地位于所述杆(620a)内，并且该可扩张结构与所述管腔连通，响应于膨胀介质穿过所述一个或多个膨胀口(222、224)和所述管腔而引入，所述可扩张结构的至少一部分能够扩张穿过所述开口。
2.如权利要求1所述的空腔形成装置(600a)，其中，所述可扩张结构(710)是聚氨酯。
3.如权利要求1所述的空腔形成装置(600a)，其中，所述可扩张结构(710)结合到所述杆的管腔。
4.如权利要求3所述的空腔形成装置(600a)，其中，所述可扩张结构通过焊接进行结合。
5.如权利要求3所述的空腔形成装置(600a)，其中，所述可扩张结构通过熔化进行结合。
6.如权利要求3所述的空腔形成装置(600a)，其中，所述可扩张结构通过粘结进行结合。
7.如权利要求1所述的空腔形成装置(600a)，其中，所述远端(625a)是倒圆角的。
8.如权利要求1所述的空腔形成装置(600a)，其中，所述远端(625a)是倒平的。
9.如权利要求1所述的空腔形成装置(600a)，其中，所述远端(625a)是尖锐的。
10.如权利要求1所述的空腔形成装置(600a)，还包括插入装置(350)，该插入装置(350)的尺寸和结构允许经皮通过所述杆(620a)。
11.如权利要求10所述的空腔形成装置(600a)，其中所述插入装置(350)是针。
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US8246681B2 (en) 2012-08-21
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