CN103687645A - 用于骨重建及稳定的装置和方法 - Google Patents
用于骨重建及稳定的装置和方法 Download PDFInfo
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Abstract
文中公开了用于重建和稳定骨的骨折或弱化的头部的装置(100)和方法。装置(100)包括:输送导管(150),其具有近侧端部和远侧端部、用于供至少一种光敏液体(165)通过用的内空隙、以及内腔;可膨胀构件(170),其以可释放的方式接合输送导管(150)的远侧端部;以及光导纤维(140),其尺寸构造为穿过输送导管(150)的内腔并进入到可膨胀构件(170)中。可膨胀构件(170)在将光敏液体(165)通到可膨胀构件(170)时从收缩状态变为充胀状态。光导纤维(140)能够分散光能以使可膨胀构件(170)内的光敏液体(165)开始硬化,从而形成光动力学植入物(510)。
Description
相关申请
本申请要求于2011年7月19日提交的美国临时专利申请No.61/509,391、于2011年7月19日提交的美国临时专利申请No.61/509,314、于2011年7月19日提交的美国临时专利申请No.61/509,459、于2012年7月19日提交的美国专利申请No.13/553,247、于2012年7月19日提交的美国专利申请No.13/553,051以及于2012年7月19日提交的美国专利申请No.13/553,450的权益和优先权,这些申请的全部内容通过引用就此并入本文中。
技术领域
文中公开的实施方式涉及骨植入物,并且更特别地涉及用于骨重建及稳定的装置和方法。
背景技术
骨形成身体的骨架并且使被支承的身体能够抵抗重力并能够在地球上移动且发挥作用。骨折可以例如由于外力或受控的手术切割(截骨术)发生。就骨折碎片是移位了还是处于其正常解剖位置而论来描述“骨折的对位”。在某些情况下,可能需要手术来重新对位和稳定骨折的骨。但骨的正确定位和对位是难以实现的。希望有一种用于稳定、定位和修复骨折的骨或弱化的骨的改进的装置或方法。
发明内容
文中公开了一种用于骨重建及稳定的装置和方法。根据文中说明的方面,提供了一种用于重建或稳定骨的骨折或弱化的头部的装置,包括:输送导管,所述输送导管具有细长的轴部,所述轴部具有近侧端部、远侧端部、以及在所述近侧端部与所述远侧端部之间的纵轴,所述输送导管具有供至少一种光敏液体通过用的内空隙、以及内腔;可膨胀构件,所述可膨胀构件以可释放的方式接合所述输送导管的所述远侧端部,所述可膨胀构件在将所述至少一种光敏液体通到所述可膨胀构件时从收缩状态变为充胀状态,其中,所述可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中;以及光导纤维,所述光导纤维的尺寸构造为穿过所述输送导管的所述内腔并进入到所述可膨胀构件中,其中,当所述光导纤维处于所述可膨胀构件中时,所述光导纤维能够分散光能以使所述可膨胀构件内的所述至少一种光敏液体开始硬化,从而形成本公开的光动力学植入物。在实施方式中,可膨胀构件设计成足以容纳在骨的头部内。在实施方式中,可膨胀构件设计成足以使得可膨胀构件的头部部段位于骨的头部内并且可膨胀构件的轴部部段伸到骨的骨干中一定长度。
在实施方式中,本公开的光动力学植入物用作芯轴或模型,骨的头部的骨块可以在该芯轴或模型上布置成基本原始位置。在实施方式中,光动力学植入物用作填料以将骨的头部基本恢复至其在骨折或断裂之前的原始、解剖形状。在实施方式中,本公开的光动力学植入物用于重新附接骨头部的与骨分离的骨块。在实施方式中,本公开的光动力学植入物用于固定与骨分离的骨头部。在实施方式中,本公开的光动力学植入物用来重新对位断骨的骨块以促进骨折重建和稳定。在实施方式中,本公开的光动力学植入物在骨的自然愈合过程期间为骨折的骨或弱化的骨提供支承和稳定性。在实施方式中,本公开的光动力学植入物用来为弱化的骨提供增加的强度。
在实施方式中,本公开的光动力学植入物构造成与包括但不限于金属螺钉、棒、销或穿钉的其他植入物接合。在实施方式中,本公开的光动力学植入物提供了将骨折的骨块紧固、用螺栓固定和拉回到一起处于适当位置中的装置。在实施方式中,本公开的光动力学植入物用来填充骨折的骨内的空间以将骨折的骨恢复至其解剖形状并且接合至为所述形状提供强度和稳定性的其他植入物。在实施方式中,本公开的光动力学植入物构造成接纳骨螺钉使得压缩力施加在通过光动力学植入物支承的骨块上。
在实施方式中,本公开的光动力学植入物构造成填充骨固定植入物与皮质骨之间的孔隙空间以更均匀地将负载分布在整个骨界面上。即,本公开的光动力学植入物用作骨固定植入物与皮质骨界面之间的填料使得负载不经由骨固定装置与皮质骨之间的病灶接触点传输,而是遍及骨中的共形接触进行分布。
提供了一种用于重建或稳定骨的骨折或弱化的头部的装置。所述装置包括:输送导管,所述输送导管具有细长的轴部,所述轴部具有近侧端部、远侧端部、以及在所述近侧端部与所述远侧端部之间的纵轴,所述输送导管具有供至少一种光敏液体通过用的内空隙、以及内腔;可膨胀构件,所述可膨胀构件以可释放的方式接合所述输送导管的所述远侧端部;以及光导纤维,所述光导纤维的尺寸构造为穿过所述输送导管的所述内腔并进入到所述可膨胀构件中。所述可膨胀构件能够在将所述至少一种光敏液体通到所述可膨胀构件时从收缩状态变为充胀状态。所述可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中。当所述光导纤维处于所述可膨胀构件中时,所述光导纤维能够分散光能以使所述可膨胀构件内的所述至少一种光敏液体开始硬化,从而形成光动力学植入物。
在实施方式中,所述可膨胀构件呈梨形、球茎形、拱顶形、圆形或细长形。在实施方式中,所述可膨胀构件呈渐缩的细长形状。在实施方式中,所述可膨胀构件呈逆行形状(retrograde shape)或顺行形状(antegradeshape)。在实施方式中,所述可膨胀构件具有近侧端部和远侧端部,并且所述可膨胀构件的所述近侧端部的直径大于所述可膨胀构件的所述远侧端部的直径。在实施方式中,所述可膨胀构件具有近侧端部和远侧端部,并且所述可膨胀构件的所述远侧端部的直径大于所述可膨胀构件的所述近侧端部的直径。在实施方式中,所述可膨胀构件设计成足以容纳在骨的头部内。在实施方式中,所述可膨胀构件包括头部部段和轴部部段,并且,所述可膨胀构件设计成足以使得所述头部部段能够放置在骨的头部内且所述轴部部段能够伸到所述骨的骨干中一定长度。
在实施方式中,所述光动力学植入物构造成与至少一个骨固定植入物接合。在实施方式中,所述至少一个骨固定植入物为螺钉、棒、销、穿钉或其组合。在实施方式中,所述光导纤维包括纤芯以及设置在所述纤芯上的包层,并且,所述包层在其中具有至少一个切口以露出所述纤芯,所述包层构造成改变从所述光导纤维发散的光。
在一方面中,一种用于修复或稳定骨的骨折或弱化的头部的成套工具包括:光导纤维;至少一种光敏液体;输送导管,所述输送导管具有细长的轴部,所述轴部具有近侧端部、远侧端部以及在所述近侧端部与所述远侧端部之间的纵轴,所述输送导管具有内空隙以及内腔;以及可膨胀构件,所述可膨胀构件以可释放的方式接合所述输送导管的所述远侧端部。所述可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中。所述输送导管的内空隙用于将所述至少一种光敏液体通到所述可膨胀构件中,所述输送导管的内腔用于将所述光导纤维通到所述可膨胀构件中。在实施方式中,所述成套工具包括具有不同尺寸或形状的多个可膨胀构件。在实施方式中,所述成套工具包括光源。
在一方面中,一种用于修复或稳定骨的骨折或弱化的头部的方法包括:将以可拆卸的方式附接至输送导管的远侧端部的可膨胀构件至少部分地放置到骨的头部内的空间中;将光敏液体经由所述输送导管的内腔注入到所述可膨胀构件中;将光导纤维经由所述输送导管的内空隙插入到所述可膨胀构件中;以及激活所述光导纤维以使所述可膨胀构件内的所述光敏液体固化,从而在所述骨的所述头部内形成光动力学植入物。在实施方式中,所述可膨胀构件呈渐缩的细长形状。
在实施方式中,所述方法包括将所述可膨胀构件的头部部段设置在骨的头部内并且将所述可膨胀构件的轴部部段伸到所述骨的骨干中一定长度。在实施方式中,所述方法包括将所述光动力学植入物与至少一个骨固定植入物接合。在实施方式中,所述至少一个骨固定植入物为螺钉、棒、销、穿钉或其组合。在实施方式中,所述骨为股骨或肱骨。
附图说明
将参照附图对目前公开的实施方式进行进一步描述,在附图中,贯穿若干视图,相同的结构由相同的附图标记标示。所示的附图并非一定按比例绘制,而是通常着重于说明目前公开的实施方式的原理。
图1A示出了本公开的骨植入系统的实施方式的示意图。该系统包括光源、光管、附接系统、光导纤维、光敏液体、输送导管以及形状构造成足以配装在骨折的骨中的空间或间隙内的可膨胀构件。
图1B和图1C示出了骨植入装置的实施方式的示意图,其中,骨植入装置包括输送导管以及形状构造成足以配装在骨折的骨中的空间或间隙内的可膨胀构件。
图2A和图2B示出了图1A中圈出的区域的特写截面图。图2A示出了在装置注入有光敏液体之前的可膨胀构件以及输送导管的远侧端部的截面图。图2B示出了在装置已经注入有光敏液体并且来自光导纤维的光能被引入到输送导管以及可膨胀构件的内腔中从而使光敏液体固化之后的可膨胀构件以及输送导管的远侧端部的截面图。
图2C和图2D分别示出了图1B和图1C中圈出的区域的特写截面图。图2C和图2D示出了输送导管的远侧端部和可膨胀构件和输送导管中的光导纤维和可膨胀构件的内腔的截面图。
图3A示出了可膨胀构件充胀之前骨腔中的装置的实施方式的截面图。
图3B示出了可膨胀构件充胀之后骨腔中的装置的实施方式的截面图。
图4A和图4B示出了可膨胀构件的实施方式的示意图。
图5为本公开的光动力学植入物的实施方式的示意图。
图6示出了利用所公开的装置和方法插入到骨腔中的装置的实施方式的截面图。
图7示出了用于利用所公开的方法治疗股骨的骨折的或弱化的头部的装置的实施方式的截面图。
尽管上述附图提出了目前公开的实施方式,但正如论述中所指出的,还可以考虑其他实施方式。本公开通过代表性而非限制性的方式呈现了说明性实施方式。本领域技术人员可以设计出落入当前所公开实施方式的原理的范围和精神内的许多其他改型和实施方式。
具体实施方式
文中公开了用于骨重建和骨稳定的装置和方法。在一种实施方式中,本公开针对用于骨骨折的人类治疗的装置和方法。在一种实施方式中,本公开针对用于骨折或弱化的骨的兽医治疗。在一种实施方式中,提供用于重建、对位和稳定具有圆头的骨的装置和方法。本公开的装置适于治疗任何骨折的或弱化的骨,所述骨包括但不限于胫骨、股骨、腓骨、肱骨、尺骨、桡骨、跖骨、掌骨、趾骨、指骨、肋骨、脊骨、椎骨、锁骨、骨盆、腕骨、下颌骨以及其他骨。在一种实施方式中,本公开的骨植入系统用来治疗骨折的或弱化的肱骨近侧端部。在一种实施方式中,本公开的骨植入系统用来治疗骨折的或弱化的股骨头。
如文中所使用的,术语“骨折”或“骨折的骨”指骨的连续性被部分地或完全地破坏。骨折可以例如由于外力或由于受控的手术切割(截骨术)而发生。目前公开的实施方式可以用来治疗任何类型的骨折,包括但不限于移位性骨折、未移位性骨折、开放性骨折、闭合性骨折、骨裂、复合性骨折、单纯性骨折、多段骨折、粉碎性骨折、撕脱性骨折、弯曲骨折、嵌插骨折、应力性骨折、压缩性骨折、螺旋骨折、蝶形骨折、如通过AO组织编码描述的其他骨折、骨中的多处骨折以及其他类型的骨折。
如文中所使用的,术语“弱化的骨”指由于疾病或创伤引起的强度或稳定性减小而倾向于骨折的骨。弱化骨的一些骨病包括但不限于骨质疏松、软骨发育不全、骨癌、进行性肌肉骨化症、骨纤维异常增殖症、股骨头缺血坏死、骨髓瘤、成骨不全、骨髓炎、骨质减少、骨质疏松、佩吉特氏病和脊柱侧凸。弱化的骨更容易骨折,并且可能需要用于防止骨折的治疗。
如文中所使用的,术语“光动力学植入物”指本公开的可膨胀构件,该可膨胀构件注入有光动力学(光可固化)材料并暴露于适当频率的光和强度,以固化可膨胀构件内的材料并形成刚性结构。
如文中所使用的,术语“骨重建”或“重建”指将骨折的骨定位回基本正常、符合解剖学的正确位置(骨块的分离)和/或形状以及支承或稳定弱化的骨。在实施方式中,本公开的光动力学植入物提供用于重建骨折的骨或弱化的骨的模板、芯轴或模型。即,本公开的光动力学植入物用作模板、芯轴或模型,骨折的骨的骨块可以在所述模板、芯轴或模型上设置至基本原始位置和/或骨块可以在基本原始位置中紧固至所述模板、芯轴或模型。在实施方式中,本公开的光动力学植入物用作模板、芯轴或模型以使断骨恢复到其基本正常、符合解剖学的正确形状。在实施方式中,本公开的光动力学植入物用作模板、芯轴或模型以将弱化的骨支承或稳定在其基本正常、符合解剖学的正确形状。在实施方式中,本公开的光动力学植入物用来通过帮助将骨的断开部分附接至骨的未受损部分来重建骨折的骨。在实施方式中,本公开的光动力学植入物用来增加弱化的骨的强度以防止进一步弱化或潜在的骨折。
在实施方式中,本装置在微创手术中使用。该装置可以进入微创切口或任何合适尺寸的进入孔。例如,进入孔的直径为约5mm至约6mm或任何其他合适的尺寸。在实施方式中,扩孔器或骨钻用来穿过小的进入孔。当插入时,扩孔器打开直至骨中形成较大的孔。
图1A示出了骨植入系统100的实施方式的示意图。如图1A所示,系统100包括光源110、光管120、附接系统130和光导纤维140。附接系统130将来自光源110的光能传送至光导纤维140。在实施方式中,光源110发出与390nm至770nm附近的波带——即,可见光谱——对应的频率。在实施方式中,光源110发出与410nm至500nm附近的波带对应的频率。在实施方式中,光源110发出与430nm至450nm附近的波带对应的频率。系统100还包括挠性输送导管150,该挠性输送导管150具有包括至少两个端口的近侧端部以及终止于可膨胀构件170的远侧端部。图1A的可膨胀构件170呈球茎状,但还可以呈任何其他合适的形状。
图1B和图1C示出了骨植入装置的实施方式的示意图。该装置包括输送导管150以及形状构造成足以配装在骨折的骨中的空间和间隙内的可膨胀构件170。图1B和图1C的可膨胀构件170呈渐缩的细长形状,以填充要进行修复或稳定的特定的骨折的骨或弱化的骨中的空间或间隙。在实施方式中,可膨胀构件170具有如图1B所示的顺行形状。在实施方式中,可膨胀构件170具有如图1C所示的逆行形状。在图1B中,可膨胀构件170在其远侧端部处比其近侧端部处具有更大的直径。在图1C中,可膨胀构件170在其近侧端部处比其远侧端部处具有更大的直径。
在实施方式中,可膨胀构件170的较大部分的最大直径为可膨胀构件170的较小部分的最大直径的至少1.5倍。在实施方式中,可膨胀构件170的较大部分的最大直径为可膨胀构件170的较小部分的最大直径的至少两倍。
在图1B所示的实施方式中,可膨胀构件170的近侧部分的最大直径是可膨胀构件170的远侧部分的最大直径的至少1.5倍。在实施方式中,可膨胀构件170的近侧部分的最大直径是可膨胀构件170的远侧部分的最大直径的至少两倍。
在图1C所示的实施方式中,可膨胀构件170的远侧部分的最大直径是可膨胀构件170的近侧部分的最大直径的至少1.5倍。在实施方式中,可膨胀构件170的远侧部分的最大直径是可膨胀构件170的近侧部分的最大直径的至少两倍。
可膨胀构件170的各种形状允许在弱化的或骨折的骨的微创手术治疗期间使用不同的方法。例如,具有逆行形状或顺行形状的可膨胀构件170可以用于修复弱化的或骨折的肱骨近侧端部。顺行形状允许将可膨胀构件170的具有最大直径的部分放置在最需要修复或稳定的骨位置处,包括外科颈区域的上方和下方。例如,在肱骨近侧端部的情况下,顺行形状允许穿过肩袖或恰于肩袖的外侧进入到肱骨头中的切口和进入点。逆行形状的几何形状与顺行形状相反。在逆行形状的情况下,可膨胀构件170的具有最大直径的部分放置在导管150的远侧端部处。具有最大直径的逆行形状可膨胀构件170可以放置在最需要修复或稳定的骨位置处,包括外科颈区域的上方和下方。当修复肱骨近侧端部时,逆行形状允许在以下位置处通过切口和骨进入点的远侧放置:(1)内上髁或外上髁处;或者(2)鹰嘴窝顶部处的这些髁之间。在实施方式中,装置包括逆行形状的可膨胀构件170,并且由于从骨进入孔至外科颈的距离的增加而具有较长的导管150(例如,长出约3-4英寸)。
在实施方式中,可膨胀构件170形状构造成足以配装在骨折的骨或弱化的骨中的空间或间隙内。一个或更多个不透射线的标记物、带或珠可以沿着可膨胀构件170和/或挠性输送导管150放置在不同位置处,使得系统100的部件可以利用透视来观察。
在图1A、图1B和图1C中示出的实施方式中,输送导管150的近侧端部包括第一端口162和第二端口164。第一端口162可以接纳例如光导纤维140。第二端口164可以接纳例如容纳光敏液体165的注射器160。在实施方式中,注射器160在注入和抽吸光敏液体165期间保持低压。在实施方式中,注射器160在注入和抽吸光敏液体165期间保持约10个大气压或更小的低压。在实施方式中,注射器160在注入和抽吸光敏液体165期间保持小于约5个大气压的低压。在实施方式中,注射器160在注入和抽吸光敏液体165期间保持约4个大气压或更小的低压。在实施方式中,光敏液体165是一种光动力学(光可固化)单体。在实施方式中,光动力学(光可固化)单体暴露于适当的光频率和强度,以固化可膨胀构件170内的单体并且形成刚性结构。在实施方式中,光动力学(光可固化)单体165暴露于可见的电磁频谱(与390nm至770nm附近的波带对应的频率)。在实施方式中,光动力学(光可固化)单体165是可透过射线的,其允许x射线穿过光动力学(光可固化)单体165。在实施方式中,输送导管150具有一个或更多个端口。
图2A和图2B示出了图1中圈出的区域的特写截面图。图2A示出了在装置注入有光敏液体之前的可膨胀构件170以及输送导管150的远侧端部的截面图。图2B示出了在装置已经注入有光敏液体并且来自光导纤维光能被引入到输送导管150以及可膨胀构件170的内腔中而固化光敏液体之后的可膨胀构件170以及输送导管150的远侧端部的截面图。
如图2A和图2B所示,挠性输送导管150包括:供光敏液体165通过的内空隙152以及供光导纤维140通过的内腔154。在图2A和图2B所示的实施方式中,内腔154与内空隙152是彼此同心的。光敏液体165具有低的粘度或低的流动阻力,以利于通过内空隙152输送光敏液体165。在实施方式中,光敏液体165具有约1000cP或更小的粘度。在实施方式中,光敏液体165具有在从约650cP至约450cP的范围中变化的粘度。可膨胀构件170可以用光敏液体165充胀、试配装并进行调整使用者想要的多次,直到光源110被开启,聚合过程开始时为止。由于光敏液体165具有液体稠度并且是粘性的,因此可以利用低压输送来输送光敏液体165而不需要高压输送,但可以使用高压输送。
图2C和图2D分别示出了图1B和图1C中圈出的区域的特写截面图。图2C和图2D示出了输送导管150的远侧端部和可膨胀构件170和输送导管150中的光导纤维140以及可膨胀构件170的内腔的截面图。该装置还在输送导管150和可膨胀构件170的接合部处具有分离区域172,在此处,输送导管150可以与可膨胀构件170分离。
在实施方式中,造影剂在不显著增加粘度的情况下可以添加至光敏液体165。造影剂包括但不限于硫酸钡、钽、或本领域已知的其他造影剂。光敏液体165可以引入到挠性输送导管150的近侧端部中并且在挠性输送导管150的内空隙152内行进直到可膨胀构件170的内腔172中,以改变可膨胀构件170的厚度而不改变可膨胀构件170的宽度或深度。在实施方式中,光敏液体165在低压下经由附接至第二端口164的注射器160被输送。光敏液体165根据需要可以被抽吸和再注入,从而允许在开启光源110并且将液态单体165转变成硬聚合物之前对可膨胀构件170的厚度进行调整。
在实施方式中,光敏液体可以以单位剂量提供。如文中所使用的,术语“单位剂量”意指足够用于单个阶段或治疗的有效的光敏液体量。作为非限制性示例,本公开的用于使可膨胀构件170膨胀的单位剂量的光敏液体可以被定义为足以使可膨胀构件170膨胀至期望的形状和尺寸的光敏液体。在实施方式中,可膨胀构件170的形状和尺寸构造成足以配装在骨折的骨中的空间或间隙内。可膨胀构件170的期望的形状和尺寸在患者之间可以略有不同。因此,使用单位剂量的使用者在术后可能遗留有过量的光敏液体。理想的是,提供足够量的光敏液体以适应甚至高于平均水平的患者。在实施方式中,本公开的单位剂量的光敏液体容纳在插口内。
在实施方式中,本公开的单位剂量的光敏液体容纳在安瓿中。在实施方式中,光敏液体可以在低压下经由附接至第二端口164的标准注射器输送。在实施方式中,光敏液体可以在不使用泵的情况下输送。
如结合图2B在图1A中所示,光导纤维140可以经由第一端口162被引入到挠性输送导管150的近侧端部中并且在挠性输送导管150的内腔154内行进直到可膨胀构件170中。光导纤维140根据将光形式的能量从光源110传送至远处的需要来使用。光敏液体165保持液态单体直到被光导纤维140激活(根据需要固化)为止。来自光源110的辐射能被吸收并且转换为化学能以使单体聚合。一旦暴露于正确频率的光和强度,光敏液体165就转变成硬聚合物,从而得到本公开的刚性结构或光动力学植入物。单体可以以任何时间量固化。在实施方式中,光敏液体165中的单体以约五秒至约五分钟固化。这种固化将处于膨胀形状的可膨胀构件170固定以形成本公开的光动力学植入物。固化可以指允许合成物从使其能够通过挠性输送导管150中的内空隙162输送的形式(例如,可流动的形式)发展到用于最终在体内使用的更永久的(例如,固化的)形式的任何化学、物理和/或机械转化。例如,“可固化”可以指有可能在体内(如通过催化或应用适当的能源)被固化的未固化的光敏液体165,以及处于固化过程中的光敏液体165(例如,在输送时通过多个合成物组分的同时发生的混合形成的合成物)。
光导纤维为了光学优点和机械优点而使用同心层的构造。适合的光导纤维140可以由任何材料制成并且可以具有任何直径,所述任何材料包括但不局限于玻璃、硅、硅玻璃、石英、蓝宝石、塑料、材料的组合、或任何其他材料。在实施方式中,光导纤维可以由具有透明聚合物包层的聚甲基丙烯酸甲酯纤芯制成。该光导纤维140具有任何合适的直径。在实施方式中,光导纤维具有在大约0.75mm与大约2.0mm之间的直径。在一些实施方式中,光导纤维可以具有约0.75mm、约1mm、约1.5mm、约2mm、小于约0.75mm或大于约2mm的直径。
在实施方式中,使用一个或更多个光导纤维140。使用多于一个光导纤维140可以减小光敏液体的固化时间,在使用较大的可膨胀构件170时尤其如此。在实施方式中,多个光导纤维140并排或并联地定位在可膨胀构件170中。在实施方式中,多个光导纤维140串联地定位,其中相邻光导纤维140的端部以端部对端部的方式彼此对准或邻接。例如,一个光导纤维可以定位在可膨胀构件的远侧部分中,并且另一光导纤维可以定位在可膨胀构件170的近侧部分中。在实施方式中,多个光导纤维以并联位置和串联位置的组合——比如,部分地交叠——或任何其他合适的构型定位。在实施方式中,多个光导纤维可以附接至具有光分路器的单个光源,或可以附接至多个光源。
在实施方式中,当使用多个光导纤维140时,输送导管150的内腔具有较大的内径。在实施方式中,输送导管150的内腔具有约1.8mm的内径。在实施方式中,输送导管的内腔定尺寸为容纳多个光导纤维140。在实施方式中,尺寸定为容纳多个光导纤维140的输送导管具有约2.3mm至约3.0mm的内径。
在实施方式中,光导纤维140由具有透明聚合物包层的聚甲基丙烯酸甲酯纤芯制成。应当理解的是,光导纤维140的上述特征和性能是示例性的,并且并非本公开的所有实施方式都要在这些方面进行限制。来自可见发光光源的光能可以通过光导纤维140来传输。在实施方式中,具有在约380nm至约780nm之间、约400nm至约600nm之间、约420nm至约500nm之间、约430nm至约440nm之间或任何其他合适的波长的波长谱的可见光被用来固化光敏液体。
纤维的最基本的功能是引导光,即,不管光束发散的自然趋势如何并且甚至可能在强弯曲条件下都使光保持集中于更长的传播距离上。在简单的阶跃型光纤的情况下,该引导通过围绕由包层包围的称为纤芯的光纤轴形成具有增加的折射率的区域来实现。该包层可以利用聚合物涂层来保护。光通过全内反射保持在光导纤维的“纤芯”中。包层保持光沿着光纤的长度行至目的地。在某些情况下,希望沿着单个导引件传导电磁波并且沿着导引件的远侧端部的给定长度而不仅在导引件的端接面上提取光。
在本公开的一些实施方式中,光导纤维的长度的至少一部分例如通过去除包层来改造,以改变从光导纤维发散出的光的轮廓。术语“光的轮廓”在无限制性的情况下指方向、传播、量、强度、入射角、均匀性、光的分布及其组合。在实施方式中,光导纤维除从其终端/末端发射光之外或者替代从其终端/末端发射光沿着光导纤维的长度以例如具有均匀的强度的均匀的方式径向地发射光。为此,可以去除沿着光导纤维的长度的全部或部分包层。应当指出的是,术语“去除包层”包括取走整个包层以露出光导纤维以及减小包层的厚度。另外,术语“去除包层”包括形成贯穿包层的诸如切口、凹口、或孔之类的开口。在实施方式中,去除全部或部分包层可以改变光沿着光导纤维的传播。在另一实施方式中,去除全部或部分包层可以改变从光导纤维发散出的光的入射方向和入射角。
图1B、图1C、图2C和图2D示出了在包层中具有沿着光导纤维的长度的切口141以修改从光导纤维发散出的光线的光导纤维的示例。
图3A示出了在可膨胀构件170充胀之前骨314的空腔中的装置的实施方式。在实施方式中,如图3A所示,光导纤维140的包层通过在包层中制出切口141而被去除以露出光导纤维140的纤芯。在实施方式中,切口141为延伸了改造部段的整个长度的连续切口。在实施方式中,切口141包括多个不连续的切口。在实施方式中,包层以类似光量沿光导纤维的改造部段发散的方式被去除。在另一实施方式中,包层以不同光量沿光导纤维的改造部段发散的方式被去除。在另一实施方式中,包层以沿着光导纤维的改造部段发散的光的量从光导纤维的改造部段的远侧端部朝向其近侧端部减少的方式被去除。在实施方式中,为了改变从改造部段发散的光的轮廓,包层中的切口沿着纤维的长度以螺旋的方式定位,如图3A所示。在实施方式中,切口之间的节距或间隔沿着光导纤维的改造部段的长度改变。在实施方式中,切口之间的间隔从光导纤维140的改造部段的近侧端部至其远侧端部增大,使得从光导纤维140的改造部段发散的光量朝向光导纤维140的改造部段的远侧端部逐渐增加。
图3B为示出了骨314的空腔中的处于膨胀状态的可膨胀构件170的实施方式的示意图。如图3B所示,可膨胀构件170设计成足以放置到包括但不限于肱骨或股骨的骨314的头部312内的空间310中。在实施方式中,可膨胀构件170近似头部312的形状并且构造成放置在头部312内。在实施方式中,可膨胀构件170设置有使得能够重建头部312的形状和尺寸。在实施方式中,可膨胀构件170可以是梨形的、灯泡形的或细长的。图3B示出了细长的可膨胀构件170的示例。
在实施方式中,可膨胀构件170包括并入到轴部部段304(即,渐缩的或截头圆锥形的下部段)中的头部部段302,即,扩大的上部段。在实施方式中,头部部段302逐渐变窄以形成轴部部段304,该轴部部段304可以从头部312延伸到骨314的骨干316中。在实施方式中,包括头部部段302和轴部部段304的可膨胀构件170构造成容纳在头部312内的空间310中。在实施方式中,可膨胀构件170的轴部部段304延伸到骨314的骨干316中任何期望的距离。在实施方式中,可膨胀构件170的轴部部段304延伸到骨314的骨干316中约50mm至约300mm。
图4A和图4B示出了可膨胀构件170的实施方式的示意图。如图4A所示,在实施方式中,头部部段402为拱顶形或圆形的。头部412的球茎形状具有比植入物的轴部部段的直径D2更大的直径D1。在实施方式中,头部部段402的直径D1是轴部部段404的直径D2的至少两倍。在实施方式中,头部部段402的直径D1是轴部部段404的直径D2的至少三倍。在各种实施方式中,头部部段402的直径D1是轴部部段404的直径D2的2.5倍、3.5倍、4倍、5倍、10倍或更大。在实施方式中,在植入物的远侧部(例如,解剖学上的肱骨头近端)处头部部段的直径可以为约20mm至35mm,在截头圆锥形的轴部部段中渐缩到10mm至15mm。在实施方式中,轴部部段404通常为三角形的或渐缩的。在实施方式中,轴部部段404通常为截头圆锥形的。包括头部部段402和轴部部段404的可膨胀构件170可以形成为一体,或替代性地,这些部段可以经由拧紧部段、通孔、或任何其他合适的机构来彼此配合。
如图4B所示,在实施方式中,可膨胀构件170的轴部部段404可以包括从头部部段402延伸的过渡部分404a以及远离头部412从渐缩的部分404a延伸到髓内空腔中的延伸部分404b。过渡部分404a可以是渐缩的或呈截头圆锥形的并且延伸部分可以是均匀的或者是渐缩的。在实施方式中,过渡部分404的直径D2与延伸部分404b的直径D3基本相等。在实施方式中,过渡部分404a的直径D2是延伸部分404b的直径D3的1.5倍、2倍、3倍或更大。在实施方式中,头部部段402的直径D1是轴部部段404的延伸部分404b的直径D3的至少两倍。在实施方式中,头部部段402的直径D1是轴部部段404的延伸部分404b的直径D3的至少三倍。在各种实施方式中,头部部段402的直径D1是轴部部段404的延伸部分404b的直径D3的2.5倍、3.5倍、4倍、5倍、10倍或更大。
在实施方式中,可膨胀构件170可以是圆形的或卵形的以便放置到骨414的头部412内的空间410中。应当指出的是,可膨胀构件170可以具有适于放置到骨的头部中的任何其他形状。合适的另外的形状包括但不限于球形、卵球形、渐缩的圆锥形、三维楔形——由此一个轴线明显地宽于另一个轴线,两者都从较大的尺寸渐缩至较小的尺寸——以及类似形状。如上所讨论的,可膨胀构件170可以为诸如分别如图1B和图1C所示的顺行形状或逆行形状的渐缩的细长形状。
在实施方式中,可膨胀构件170的外表面是有弹性的和耐穿刺的。在实施方式中,可膨胀构件170由不柔顺(无拉伸/无扩展)的适型材料制成,所述适型材料包括但不限于聚氨酯、聚对苯二甲酸乙二醇酯(PET)、尼龙弹性体及其他类似的聚合物。在实施方式中,可膨胀构件170由聚对苯二甲酸乙二醇酯(PET)制成。在实施方式中,可膨胀构件170由允许x射线穿过可膨胀构件170的射线可透过的材料制成。在实施方式中,可膨胀构件170由射线可透过的聚对苯二甲酸乙二醇酯(PET)制成。在实施方式中,可膨胀构件170由通过嵌入光纤限制尺寸变化的适型柔顺的材料制成。在实施方式中,可膨胀构件170的外表面174的至少一部分大致平坦且光滑。在实施方式中,可膨胀构件170的外表面的至少一部分包括诸如凸起、脊、肋、凹陷或任何其他形状的至少一个纹理元件。在实施方式中,可膨胀构件170的外表面的至少一部分突出来以形成纹理元件。在实施方式中,可膨胀构件170的外表面的至少一部分内陷以形成纹理元件。在实施方式中,纹理元件在可膨胀构件170插入到骨折位置中之后增大摩擦并且提高可膨胀构件170的抓牢力和稳定性。在实施方式中,与无纹理元件的可膨胀构件相比较,纹理元件导致骨—装置界面的交错接合增大。在实施方式中,纹理元件可以呈凸形形状。在实施方式中,纹理元件可以呈凹形形状。在实施方式中,纹理元件可以完全地或者部分地周向围绕可膨胀构件170的宽度。
通常,骨移植物或骨移植物替代品可以结合本公开的可膨胀构件170来使用。在实施方式中,骨移植物为同种异体骨移植物。在实施方式中,骨移植物为自体骨移植物。在实施方式中,骨移植物替代品为羟基磷灰石骨替代品。在实施方式中,骨移植物或骨移植物替代品用来填充在例如可能存在于可膨胀构件170的外表面与骨块的表面之间的任何间隙中。在实施方式中,骨移植物或骨移植物替代品用来填充例如可能存在于可膨胀构件170的纹理元件与骨块的表面之间的任何间隙。
通常,可膨胀构件170可以包括外表面,该外表面可以用包括但不限于药物(例如,抗生素)、蛋白质(例如,生长因子)或其他天然或合成添加剂(例如,不透射线的活性材料或超声活性材料)的材料覆盖。例如,在微创手术过程后患者可能发生感染,需要患者进行抗生素治疗。抗生素药物可以添加至可膨胀构件170的外表面以预防或对抗可能的感染。例如诸如成骨蛋白或其他生长因子之类的蛋白质已经显出用以诱导软骨和骨的形成。生长因子可以添加至可膨胀构件170的外表面以利于诱导新骨的形成。由于不存在可膨胀构件170中的光敏液体165的热输出,因此涂层的有效性和稳定性得以保持。
在实施方式中,可膨胀构件170不具有任何阀。没有阀的一个益处在于可膨胀构件170的尺寸可以根据需要被膨大或缩小多次以利于骨折复位和放置。不具有阀的可膨胀构件170的另一益处在于系统100的功效和安全性。因为所有的液体165容纳在可膨胀构件170中,由于不存在光敏液体165至人体的连通通道,所以不会存在液体165的任何泄漏。在实施方式中,可膨胀构件170与输送导管150之间形成永久密封,该密封在输送导管150被去除之前被硬化和固定。
在实施方式中,例如通过化学蚀刻或空气推动的研磨介质来研磨处理可膨胀构件170的外表面改善了可膨胀构件170的外表面与骨表面之间的连接和附着。表面修整显著增加了与骨接触的表面积的量,这可导致更强的抓牢。
可膨胀构件170可以注入有光敏液体165并且光敏液体165可以被固化以形成光动力学植入物。该光动力学植入物可以与输送导管150分离。如图3A和图3B所示,分离区域142位于固化的可膨胀构件170(或光动力学植入物)的远侧端部与输送导管150之间的接合部处以利于光动力学植入物从输送导管150的脱除。分离区域142确保不存在来自输送导管的细长轴部和/或光动力学植入物的加强材料的泄漏。该分离区域密封光动力学植入物并且通过使在已知的或预定的部位(例如,分离区域)处发生断裂来移除输送导管的细长轴部。该分离区域142可以是不同的长度并且多达约一英寸长。分离区域142还可以包括使分离区域142中的应力集中的应力集中部,诸如凹口、凹槽、沟道或类似结构。该应力集中部也可以是连续横截面导管内部的固化的光敏液体的径向横截面减小的区域,以利于通过施加纵向力来分离。应力集中部被设计成确保将光动力学植入物与输送导管150在分离区域142处分离。当将拉力施加到输送导管150时,光动力学植入物与输送导管150的轴部大致在应力集中部的位置处分离。拉力产生足够的机械力以优先破坏固化的材料和导管复合材料并产生光动力学植入物/轴部界面的完全分离。可以通过包括但不局限于径向扭曲、剪切冲击和横截面切割的任何其他合适的方式将光动力学植入物与输送导管150分离。
在实施方式中,光动力学植入物的形状对应于可膨胀构件170的形状。在各种实施方式中,光动力学植入物可以呈梨形、卵形、圆形、细长形、渐缩的形状等。对光敏液体165注入的修改允许使用者调节可膨胀构件170的跨距或厚度以给每个对象提供特定的光动力学植入物的尺寸和形状。可膨胀构件170能够由使用者在光固化可膨胀构件170中的光敏液体165之前形成和成形,光动力学植入物最佳地反映植入可膨胀构件170的区域的尺寸和形状。在实施方式中,光动力学植入物构造成至少部分地放置到骨的头部内的空间中。在实施方式中,光动力学植入物构造成容纳在骨的头部内。在实施方式中,光动力学植入物构造成使得植入物的远侧部段延伸到骨的骨干中一定长度。
在实施方式中,通过将光敏液体165注入到可膨胀构件170中并将其固化而形成的光动力学植入物用于重建、对位和/或稳定骨。在实施方式中,可膨胀构件170可以注入有一定量的光敏液体165,使得最终固化的光动力学植入物具有以使骨的断裂的头部基本恢复到其解剖形状的尺寸和形状。在实施方式中,可膨胀构件170可以注入有一定量的光敏液体165,使得光动力学植入物具有使得骨的头部可以围绕最终固化的光动力学植入物被重建至基本原始的尺寸和形状的尺寸和形状。在实施方式中,可膨胀构件170可以注入有一定量的光敏液体165,使得光动力学植入物有利于减少骨折的骨。在实施方式中,该光动力学植入物510的尺寸和形状试图使与周围的骨的表面接触面积最大化,从而使特定的压力集中点最小化。该光动力学植入物可以设计成足以提供高压缩强度,因此使动态负载条件下的变形最小化。
在实施方式中,可膨胀构件在骨折的骨或弱化的骨的区域处被定位和充胀成足以提供对骨腔——如髓内腔——的最大填充的尺寸。可膨胀构件充胀到任何合适的尺寸。在实施方式中,可膨胀构件被充胀到直径达到约20mm。
图5示出了光动力学植入物510的实施方式,该光动力学植入物510设计成接合包括但不限于尤其是骨螺钉、穿钉、销和棒的其他骨固定植入物520。骨固定植入物可以在沿着光动力学植入物的任何使用者选择的位置处接合最终固化的光动力学植入物。例如,图5示出了在使用者选择的位置525处与光动力学植入物510接合的多个骨固定植入物520。在实施方式中,可以通过将骨块利用骨固定植入物附接至最终固化的光动力学植入物来将骨块紧固在大体原始位置中。在实施方式中,光动力学植入物510可以放置到骨的头部内的空间中并且一个或更多个骨固定植入物可以穿过骨插入到光动力学植入物510中,以将头部固定至骨的其余部分。参照图5,在实施方式中,光动力学植入物510可以包括用于接纳标准金属植入物的一个或更多个插口530。在一个实施方式中,该光动力学植入物510可以包括一个或更多个插口530以接合髓内钉或棒550。该钉或棒550可以通过诸如例如锁定、卡扣配合、摩擦配合或螺纹连接或类似方式的任何适合的手段来紧固至光动力学植入物510。
在实施方式中,包括但不限于螺钉和其他合适的机构的骨固定植入物在基于骨折病理学的手术期望的位置处而非预定的锁定孔的位置处锚定到固化的可膨胀构件或光动力学植入物中。在实施方式中,光动力学植入物具有足够大的尺寸以在骨折部位上方和下方提供明显的锚点和目标,用于安置包括支承横向锁定螺钉和任何其他合适的机构的多个骨固定植入物。
图6示出了使用本发明的系统和方法插入到骨的空腔中的装置。首先,穿过患者身体的皮肤制成微创切口(未图示)以露出骨折的骨。切口可以在骨折的骨的近侧端部或远侧端部处形成以露出骨表面。骨一旦被露出,则可能需要收缩在看得见骨的范围内的一些肌肉和组织。如图6所示,通过钻孔或本领域已知的其他方法在骨605中形成进入孔610。进入孔延伸穿过骨的硬紧致外层进入到相对多孔的内部或松质骨的组织中。对于具有骨髓的骨而言,在系统100插入之前应当从髓腔清除髓质。骨髓主要见于诸如髋骨、胸骨、颅骨、肋骨、椎骨和肩胛骨之类的扁骨中,以及比如股骨和肱骨的骨的近侧端部处的松质材料中。一旦到达髓腔,包括空气、血液、流体、脂肪、骨髓、组织和骨头碎片的髓质应当被去除以形成空腔。空腔被定义为中空空间,其中,第一位置相对于骨上的穿刺点限定了空腔的最远边缘,并且第二位置相对于骨上的穿刺部位限定了空腔的最近边缘。骨可以被挖空成足以使髓腔的髓质直到皮质骨被去除。可以使用用于去除髓质的任何合适的方法。合适的方法包括但不限于以下专利文献中描述的方法:名为“Method of SuctionLavage”(抽吸灌洗方法)的美国专利No.4,294,251、名为“Bone Cleaningand Drying system”(骨清洁和干燥系统)的美国专利No.5,554,111、名为“Apparatus for Preparing the Medullary Cavity”(用于制备髓腔的装置)的美国专利No.5,707,374、名为“Bone Marrow Aspiration Needle”的美国专利No.6,478,751(骨髓抽吸针)以及名为“Apparatus for ExtractingBone Marrow”(用于抽取骨髓的装置)的美国专利No.6,358,252。
导丝608经由进入孔610可以被引入到骨605中并且通过骨602的髓内腔615前进至骨602的圆形头部609。然后系统100的可膨胀构件170通过导丝608进行输送而被放置在骨602的头部609内。可膨胀构件170的位置可以使用至少一个不透射线的标记物615来确定,该不透射线的标记物615能够从骨602的外部或内部检测到。一旦可膨胀构件170处于头部609内的正确位置中,然后就将光敏液体165注入到可膨胀构件170中以使可膨胀构件170膨胀到期望的尺寸和形状,如上所述。
如图3A所示,光敏液体165可以利用光导纤维140固化在可膨胀构件170内。在光敏液体165被硬化之后,可以将光导纤维140从系统100中移除。
在实施方式中,如图3B所示,可膨胀构件170填充有从输送导管150释放的固化的光敏液体165以在骨602的头部609内形成光动力学植入物。在实施方式中,本公开的光动力学植入物用来使断骨基本恢复至其原始的、解剖学的形状。在实施方式中,本公开的光动力学植入物用作芯轴,断骨的骨块可以在该芯轴上布置至基本原始位置,并且骨块可以通过利用包括但不限于尤其是骨螺钉、穿钉、销和棒等的骨固定植入物附接至该芯轴。骨固定植入物可以在光动力学植入物上的任何使用者选择的位置处被放置到本公开的光动力学植入物中。在实施方式中,本公开的光动力学植入物用于重新附接与断骨分离的骨块。在实施方式中,本公开的光动力学植入物用来重新对位断骨的骨块。在实施方式中,本公开的光动力学植入物在骨的自然愈合过程期间为骨折的骨提供支承和稳定性。在实施方式中,本公开的光动力学植入物可以用来稳定弱化的骨或为弱化的骨增加强度。
在实施方式中,尽管可以使用大量的锁定螺钉或其他骨固定机构,但光动力学植入物在不需要这种机构的情况下通过成型为骨空腔的轮廓来提供旋转稳定性。另外,可膨胀构件具有足够的尺寸以提供弯曲稳定性。
在实施方式中,本公开的骨植入系统100用来治疗骨折的或弱化的肱骨近端。通常,肱骨近端骨折基于主要骨块的数目和类型来分类。例如,两部分骨折通常为将肱骨头与肱骨干分离的肱骨颈骨折。更复杂的骨折为三部分骨折和四部分骨折。三部分肱骨近端骨折可以涉及例如更大的结节和肱骨颈的分离。四部分骨折通常涉及头部的关节面以及头部劈裂骨折。在实施方式中,本公开的光动力学植入物可以用来治疗肱骨近端的两部分骨折、三部分骨折或四部分骨折。在实施方式中,本公开的光动力学植入物可以用来重新对位、重建、稳定或支承肱骨的干部、更大的结节、肱骨颈、头部的关节面以及头部劈裂骨折。在实施方式中,本公开的光动力学植入物可以用来稳定弱化的肱骨头部、颈部、干部或肱骨的其他部分。
在实施方式中,进入肱骨的髓内腔可以通过如上所述的逆行方法或者顺行方法来获得。应当指出的是,可膨胀构件相对于输送导管的定向将根据选择的方法来改变。可膨胀构件107放置在肱骨头的顶部附近的松质骨的空间内。一旦可膨胀部分107处于肱骨内的正确位置中,则用光敏液体165填充可膨胀部分107,然后光敏液体165被固化从而形成光动力学植入物510。在实施方式中,骨植入系统100用来治疗将肱骨的头部与肱骨的干部分离的肱骨颈骨折。将光敏液体165添加至可膨胀构件170使可膨胀构件膨胀。当可膨胀构件170通过使光敏液体165进入而膨胀时,肱骨颈的骨折被减小。一旦骨块的方位被确认为处于期望的位置中,则光敏液体165可以被固化以形成光动力学植入物510,该光动力学植入物510然后可以与输送导管分离。在实施方式中,光动力学植入物510用来治疗肱骨头的三部分骨折或四部分骨折。在实施方式中,光动力学植入物510用作用于肱骨头的骨块的填料、芯轴或支承元件。在实施方式中,光动力学植入物510填充肱骨头内的空间以使肱骨头基本恢复至其解剖形状。在实施方式中,骨折的骨块可以放置在光动力学植入物510上以将骨块恢复至其相应的基本原始的、解剖位置。在实施方式中,可以通过将断裂的骨块借助于诸如尤其是骨螺钉、穿钉、销和棒等的骨固定植入物附接至光动力学植入物来将断裂的骨块紧固在其相应的基本原始的位置中。在实施方式中,光动力学植入物510延伸到肱骨的干部中或者附接至延伸到肱骨的干部中的另一植入物以在愈合过程期间为骨提供额外的稳定性。
在实施方式中,本公开的骨植入系统100用来治疗肱骨近端骨折,比如肱骨颈骨折。在实施方式中,本公开的骨植入系统100用来治疗或稳定弱化的股骨头。
如图7所示,在实施方式中,如上所述,光动力学植入物710形成在股骨702的头部706内的髓内空间704内。然后可以通过将金属螺钉708或其他骨固定植入物穿过股骨702的骨块或侧部放置到股骨头706中的光动力学植入物710中来将股骨702的断裂骨块对位并且压缩在一起。骨块上的压缩力可以通过控制螺钉708被钉入到光动力学植入物710中的距离来控制。光动力学植入物710和辅助植入物(即,螺钉708)的组合为股骨702提供强度和稳定性。替代性地或另外地,光动力学植入物710可以构造成填充骨固定植入物708与髓内腔704内的皮质骨表面之间的孔隙空间以更均匀地将负载分布在整个骨表面上。即,光动力学植入物710用作骨固定植入物708与皮质骨表面之间的填料使得负载不在骨固定植入物708与皮质骨之间经由骨固定植入物708与皮质骨之间的病灶接触点传输,而是遍及通过光动力学植入物710形成的共形接触进行分布。
在实施方式中,本装置包括插入到骨的空腔——比如髓管——中的一系列小互锁金属管或塑料管。在实施方式中,替代导管的使用或除使用导管之外,使用所述一系列管。管由包括但不限于金属或塑料的任何合适的材料制成。管被顺序地互锁至相邻管,使得每个增加的管的添加使整个管加长。
在实施方式中,管在芯轴上滑动,并且然后以首尾相连的方式锁定或接合到相邻的管。连续管的联锁机构是挠性的,使得管可以适应骨的空腔内的弯曲和偏转。由于一系列管是挠性的,因此所述一系列管能够穿越一段骨腔,而不会像一段刚性管那样在髓管内受阻。另外,由于管是挠性的,因此较大直径的管或一系列管可以在骨腔内联锁和使用。刚性管需要具有较小的直径来通过骨腔内的偏转和弯曲。联锁管可以具有不同的直径,使得管可以适应骨的空腔内的不同直径和锥度。
在实施方式中,一旦管都互锁上之后,将光动力学单体和可膨胀构件插入到管中并穿过管,可膨胀构件被充胀,并且光动力学单体在管的界限内固化。在实施方式中,所述一系列管以及设置在所述一系列管内的单体的使用提供了更强的光动力学植入物。
应当指出的是,尽管已经关于治疗肱骨和股骨的骨折描述了本公开,但是本领域的技术人员将认识到目前公开的实施方式和方法可以用于治疗体内的其他骨,包括但不限于骨折或弱化的胫骨、腓骨、尺骨、桡骨、跖骨、掌骨、指骨、趾骨、肋骨、脊骨、椎骨、锁骨和其他骨头。
在实施方式中,用于对骨折的或弱化的骨的头部进行重建或稳定的装置包括:输送导管,该输送导管具有带有近侧端部、远侧端部以及在近侧端部与远侧端部之间的纵轴的细长轴部,该输送导管具有用于使至少一种光敏液体通过的内空隙以及内腔;可膨胀构件,该可膨胀构件以可释放的方式接合输送导管的远侧端部,该可膨胀构件在使所述至少一种光敏液体进至可膨胀构件时从收缩状态变为充胀状态;其中,可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中;以及光导纤维,该光导纤维定尺寸为能够穿过输送导管的内腔并进入到可膨胀构件中,其中,当光导纤维位于可膨胀构件中时,光导纤维能够分散光能以开始硬化可膨胀构件内的所述至少一种光敏液体,从而形成光动力学植入物。
在实施方式中,用于对骨折的或弱化的骨的头部进行修复或稳定的方法包括:将以可拆卸的方式附接至输送导管的远侧端部的可膨胀构件至少部分地放置到骨的头部内的空间中;将光敏液体通过输送导管的内腔注入到可膨胀构件中;将光导纤维通过输送导管的内空隙插入到可膨胀构件中;以及激活光导纤维以固化可膨胀构件内的光敏液体,从而在骨的头部内形成用作芯轴或模型的光动力学植入物以修复和稳定骨的头部。
在实施方式中,用于对骨折的或弱化的骨的头部进行修复或稳定的成套工具包括:光导纤维;单位剂量的至少一种光敏液体;以及输送导管,该输送导管具有带有近侧端部、远侧端部以及在近侧端部与远侧端部之间的纵轴的细长轴部,其中,输送导管具有用于将至少一种光敏液体通到以可释放的方式接合输送导管的远侧端部的可膨胀构件中的内空隙以及用于将光导纤维通到可膨胀构件中的内腔,其中,可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中。在实施方式中,成套工具包括不同尺寸或形状的多个可膨胀构件。在实施方式中,成套工具包括光源。
在一方面中,用于对骨折的或弱化的骨的头部进行重建或稳定的装置包括:输送导管,该输送导管具有带有近侧端部、远侧端部以及在近侧端部与远侧端部之间的纵轴的细长轴部、用于使至少一种光敏液体通过的内空隙、以及内腔;可膨胀构件,该可膨胀构件以可释放的方式接合输送导管的远侧端部;以及光导纤维,该光导纤维定尺寸为穿过输送导管的内腔并进入到可膨胀构件中。可膨胀构件能够在所述至少一种光敏液体被输送到可膨胀构件时从收缩状态变为充胀状态。可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中。当光导纤维位于可膨胀构件中时,该光导纤维能够分散光能以开始硬化可膨胀构件内的所述至少一种光敏液体,从而形成光动力学植入物。
在一方面中,用于对骨折的或弱化的骨的头部进行修复或稳定的方法包括:将以可拆卸的方式附接至输送导管的远侧端部的可膨胀构件至少部分地放置到骨的头部内的空间中;将光敏液体通过输送导管的内腔注入到可膨胀构件中;将光导纤维通过输送导管的内空隙插入到可膨胀构件中;以及激活光导纤维以固化可膨胀构件内的光敏液体,从而在骨的头部内形成光动力学植入物。在实施方式中,可膨胀构件具有渐缩的细长形状。
在一方面中,用于对骨折的或弱化的骨的头部进行修复或稳定的成套工具包括:光导纤维;至少一种光敏液体;输送导管,该输送导管具有带有近侧端部、远侧端部以及在近侧端部与远侧端部之间的纵轴的细长轴部、内空隙以及内腔;以及可膨胀构件,该可膨胀构件以可释放的方式接合输送导管的远侧端部。可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中。输送导管具有用于将所述至少一种光敏液体通到可膨胀构件中的内空隙以及用于将光导纤维通到可膨胀构件中的内腔。在实施方式中,成套工具包括不同尺寸或形状的多个可膨胀构件。在实施方式中,成套工具包括光源。
文中所引用的所有专利、专利申请和出版文献的全部内容在此通过引用并入本文。应理解的是,以上公开的若干特征和功能以及其他特征和功能、或其替代方案可以按期望组合到许多其他不同的系统或应用中。本领域技术人员因此可以对其做出各种目前未预见或未预期的替代方案、改型、变型或改进。
Claims (20)
1.一种用于重建或稳定骨的骨折或弱化的头部的装置,包括:
输送导管,所述输送导管具有细长的轴部,所述轴部具有近侧端部、远侧端部、以及在所述近侧端部与所述远侧端部之间的纵轴,所述输送导管具有供至少一种光敏液体通过用的内空隙、以及内腔;
可膨胀构件,所述可膨胀构件以可释放的方式接合所述输送导管的所述远侧端部,所述可膨胀构件能够在将所述至少一种光敏液体通到所述可膨胀构件时从收缩状态变为充胀状态,其中,所述可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中;以及
光导纤维,所述光导纤维的尺寸构造为穿过所述输送导管的所述内腔并进入到所述可膨胀构件中,其中,当所述光导纤维处于所述可膨胀构件中时,所述光导纤维能够分散光能以使所述可膨胀构件内的所述至少一种光敏液体开始硬化,从而形成光动力学植入物。
2.根据权利要求1所述的装置,其中,所述可膨胀构件呈梨形、球茎形、拱顶形、圆形或细长形。
3.根据权利要求1所述的装置,其中,所述可膨胀构件呈渐缩的细长形状。
4.根据权利要求1所述的装置,其中,所述可膨胀构件呈逆行形状或顺行形状。
5.根据权利要求1所述的装置,其中,所述可膨胀构件具有近侧端部和远侧端部,并且所述可膨胀构件的所述近侧端部的直径大于所述可膨胀构件的所述远侧端部的直径。
6.根据权利要求1所述的装置,其中,所述可膨胀构件具有近侧端部和远侧端部,并且所述可膨胀构件的所述远侧端部的直径大于所述可膨胀构件的所述近侧端部的直径。
7.根据权利要求1所述的装置,其中,所述可膨胀构件设计成足以容纳在骨的头部内。
8.根据权利要求1所述的装置,其中,所述可膨胀构件包括头部部段和轴部部段,并且,所述可膨胀构件设计成足以使得所述头部部段能够放置在骨的头部内且所述轴部部段能够伸到所述骨的骨干中一定长度。
9.根据权利要求1所述的装置,其中,所述光动力学植入物构造成与至少一个骨固定植入物接合。
10.根据权利要求9所述的装置,其中,所述至少一个骨固定植入物为螺钉、棒、销、穿钉或其组合。
11.根据权利要求1所述的装置,其中,所述光导纤维包括纤芯以及设置在所述纤芯上的包层,并且,所述包层在其中具有至少一个切口以露出所述纤芯,所述包层构造成改变从所述光导纤维发散的光。
12.一种用于修复或稳定骨的骨折或弱化的头部的成套工具,包括:
光导纤维;
至少一种光敏液体;
输送导管,所述输送导管具有细长的轴部,所述轴部具有近侧端部、远侧端部以及在所述近侧端部与所述远侧端部之间的纵轴,所述输送导管具有内空隙和内腔;以及
可膨胀构件,所述可膨胀构件以可释放的方式接合所述输送导管的所述远侧端部,其中,所述可膨胀构件设计成足以至少部分地放置到骨的头部内的空间中,并且其中,所述输送导管的内空隙用于将所述至少一种光敏液体通到所述可膨胀构件中,所述输送导管的内腔用于将所述光导纤维通到所述可膨胀构件中。
13.根据权利要求12所述的成套工具,还包括具有不同尺寸或形状的多个可膨胀构件。
14.根据权利要求12所述的成套工具,还包括光源。
15.一种用于修复或稳定骨的骨折或弱化的头部的方法,包括:
将以可拆卸的方式附接至输送导管的远侧端部的可膨胀构件至少部分地放置到骨的头部内的空间中;
将光敏液体经由所述输送导管的内腔注入到所述可膨胀构件中;
将光导纤维经由所述输送导管的内空隙插入到所述可膨胀构件中;以及
激活所述光导纤维以使所述可膨胀构件内的所述光敏液体固化,从而在所述骨的所述头部内形成光动力学植入物。
16.根据权利要求15所述的方法,其中,所述可膨胀构件呈渐缩的细长形状。
17.根据权利要求15所述的方法,还包括将所述可膨胀构件的头部部段设置在骨的头部内并且将所述可膨胀构件的轴部部段伸到所述骨的骨干中一定长度。
18.根据权利要求15所述的方法,还包括将所述光动力学植入物与至少一个骨固定植入物接合。
19.根据权利要求15所述的方法,其中,所述至少一个骨固定植入物为螺钉、棒、销、穿钉或其组合。
20.根据权利要求15所述的方法,其中,所述骨为股骨或肱骨。
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US20130023876A1 (en) | 2013-01-24 |
GB2493100B (en) | 2014-08-20 |
US20220133377A1 (en) | 2022-05-05 |
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