CN100369582C - 对孔的扩张进行定位、测量和估计的系统和装置 - Google Patents

对孔的扩张进行定位、测量和估计的系统和装置 Download PDF

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CN100369582C
CN100369582C CNB2003801037179A CN200380103717A CN100369582C CN 100369582 C CN100369582 C CN 100369582C CN B2003801037179 A CNB2003801037179 A CN B2003801037179A CN 200380103717 A CN200380103717 A CN 200380103717A CN 100369582 C CN100369582 C CN 100369582C
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CN1713852A (zh
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L·默瑟·麦金利
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4504—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61B2017/564—Methods for bone or joint treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6877—Nerve

Abstract

提供一种用于对孔的扩张进行定位、测量和估计的系统、装置和方法。一种器械具有把手、成角度的区域和被插入孔的端部。一种器械可被按压在孔上以确定其位置和孔内的空余空间是否足够大，以使端部的最大宽度可被插入。如果端部不能插入，对孔进行切割，将其扩张至足以使端部插入。本发明还公开了一套工具，包括多个器械或具有不同最大宽度的多个端部的单一器械，用于在扩张过程中确定孔内空余空间的量。

Description

对孔的扩张进行定位、测量和估计的系统和装置
技术领域
本发明涉及手术器械和方法，特别是涉及一种用于对孔的扩张进行定位、测量和/或估计的系统、方法和装置。
背景技术
脊椎手术往往必须通过体内被称为“孔“的开口施行。例如，在手术中，或当孔非常小时，可能很难看到这些孔或估计其大小或直径。在这种情况下，难以对孔的扩张进行定位、测量或估计。例如，在脊柱侧神经出口处的开口，称为“神经孔”，通常非常狭窄。患有“椎管狭窄(spinal stenosis)”的病人的神经孔尤其狭窄，此处的脊椎神经被扩大的、有关节炎的关节面所压迫。如果无法减轻这种狭窄，往往造成背脊手术“失败”，尤其是当手术需要对椎管和孔“减压”或开口以减轻脊髓压力时更易造成手术失败。
对于某些神经孔非常小的病人，必须在试图扩张神经孔之前通过搜索发现神经孔的位置。一旦发现神经孔的位置，外科医生使用诸如“Kerrison”骨钳之类的手术器械切除孔四周的一些骨头，直到医生确信环绕出椎管神经(existing nerve)的孔已经被充分扩张。这种对孔何时已充分扩张的不确定性将导致外科医生高估孔的大小，以至于过早中断了对孔的扩张。在椎管狭窄减压手术中发生最多数量的失败是因为外科医生未对孔进行充分扩张，以至于无法为出椎管的神经留出足够的空间。
因此，需要一种对病人在手术进行中探测孔并对孔的扩张进行准确估计的系统和方法。
发明内容
本发明的目的在于提供一种用于对孔的扩张进行定位、测量和/或估计的系统、方法和装置。
本发明的一个实施例包括一种孔器械，该器械包括把手、成角度的区域和端部。对于此公开，术语“把手”指器械上可抓握的区域。在此实施例中，端部可以为任意形状，只要允许其最大宽度处可插入孔中的开放空间，例如，在出椎管的神经和神经孔的边缘之间的开放空间。在一个优选实施例中，端部大致呈圆形或球形。在此实施例中，该孔器械的端部的最大宽度介于比未扩张孔内的开放空间略小到所需的扩张的孔内开放空间之间的尺寸。例如，在神经孔中，此优选的范围约为0.5毫米至8毫米。在另一个实施例中，成角度的区域与把手之间呈一角度，优选该角度约为60度至80度，更优选地，约为70度至78度，最优选地，约为76度。在此实施例中，该成角度的区域可大致是弯曲的或直线的。
本发明还涉及一种孔开口系统，该系统包括多个如上所述的器械，每个器械的端部具有不同的最大宽度。在另一实施例中，该成套工具包括具有不同最大宽度的多个端部的单一器械。通过在手术中用不同最大宽度的端部插入孔中，外科医生能够确定孔内当前开放空间的尺寸或位置，以及还需要多大的扩张量。
本发明还涉及一种估计孔扩张的方法，该方法包括定位处于未扩张状态的孔；将具有一定最大宽度的端部的器械按压在孔上；确定该端部是否插入孔中，以及如果该端部未插入孔中，则切除孔边缘的部分。重复此过程直至器械的端部插入被扩张的孔中。
另一个实施例还包括用最大宽度大于第一器械的第二器械重复此方法。这使得孔在不同的阶段被扩张，以在手术过程中，向外科医生提供孔内开放空间的大小，以及还需要多少扩张量。最后，在另一个实施例中，将端部的最大宽度较小的器械在孔附近区域按压，直至其插入孔中。这可对被扩张之前的孔进行定位。
附图说明
通过结合附图，并参考下文的详细说明可对本发明的这些和其它特征，以及优点有更好的了解。附图是：
图1示出了根据本发明一个实施例的孔器械示例的侧面透视图；
图2示出了图1所示实施例的端部插入神经孔时的平面放大图；
图3示出了根据本发明实施例的系统的另一个实施例的侧视图；和
图4示出了根据本发明的方法的另一个实施例的流程图。
具体实施方式
本发明涉及一种用于对孔的扩张进行定位、测量和估计的装置、系统和方法，以确保得到理想的手术结果。对于此应用来说，术语“孔”指身体内的开口或通口，尤其指脊椎上的开口，术语“端部”是指一个突出物的末端区域。术语孔的“未扩张状态”指在进行任何扩张前孔开口的大小，而孔的“扩张状态”指已经经过至少一定程度扩张的孔开口的大小。
如图1所示，本发明的一个实施例包括一个孔器械，该孔器械具有把手10、成角度的区域12和端部14。把手10优选约为7.5-8厘米长，但是本领域普通技术人员应该认识到，也可采用任何长度的把手，只要把手可被单手方便地抓握，并且具有能延伸到孔附近(未示出)区域的足够的长度。把手10可以是有织纹的或对称的，以使器械可被更好地抓握，并且把手10还可包括凹槽16，以在上面粘贴标签(未示出)等。
成角度的区域12从把手10处以一定的角度18向外伸出。在此实施例中，该成角度的区域12是弯曲的。本发明也包括该成角度的区域12以给定的角度呈直线的从把手处伸出。优选地，成角度的区域12从把手处伸出的角度18在60度到80度之间；更优选地，在70度到78度之间；最优选地，约呈76度角。在图1示出的实施例中，邻近端部14处成角度的区域12的厚度比端部14的最大宽度20要窄，以使至少部分成角度的区域12能和端部14一起插入孔(未示出)中。然而，在其它实施例中，成角度的区域12并不部分地插入孔(未示出)中，就可以为任意厚度，只要端部14的最大宽度20足够窄以插入到孔中理想的开放空间中。
虽然图1中示出的本发明一个实施例的端部14大致为球形，本发明也包括呈任何形状的端部，只要该端部可插入孔的开放空间中，如神经孔内的未被出椎管的神经占据的空间。例如，端部也可以是圆形的，不管端部插入方位上的微小变化，使得孔内几乎同样大小的空余空间可被确定。然而，本发明也包括手术所需的任何形状的端部。
图2更详细地示出了图1所示实施例的器械的成角度的区域12和端部14。其中显示端部14插入了神经孔100的位于出椎管的神经102和孔100边缘之间的空间106内。在一些优选实施例中，端部的最大宽度104包括：与理想的扩大的空间相同的宽度[扩孔宽度](优选约为5到8毫米，对于神经孔，更优选约为6毫米)；足够小以在进行任何扩张前即可插入空间106的宽度[插入宽度](优选约为0.5到2毫米，对于神经孔，更优选约为1.2毫米)；以及任何介于扩孔宽度和插入宽度之间的中间宽度，以确定空间106的中间尺寸和另外扩孔所需的程度。
本发明还涉及一种如图3所示的孔开口系统。在此系统中，手术的成套工具中包括四个器械300、302、304和306，它们分别具有四个端部310、312、314和316，该四个端部分别具有不同的最大宽度320、322、324和326。第一器械300的最大宽度320足够小以至于可插入未经外科医生扩张的狭窄的神经孔(未示出)中。优选地，端部310的最大宽度320约为0.5毫米至2毫米，更优选地，对于神经孔器械，约为1.2毫米。第二器械(可有多个)的端部312和第三器械(可有多个)的端部314具有中等最大宽度322和324，以对孔开口的程度进行测量。对于神经孔器械，优选的最大宽度322和324分别约为2毫米至4毫米(更优选为3毫米)，以及4毫米至5毫米(更优选约为4.5毫米)。第四器械(可有多个)的端部316的最大宽度326等于出椎管的神经和孔边缘之间的理想空间(图2中示出)，优选约为5毫米至8毫米，更优选地，对于神经孔器械，为6毫米。虽然图3仅示出了四个器械300、302、304和306，根据手术的需要，成套工具中可包括数量更多或更少的器械，以对孔进行定位和测量(图2中示出)。
另一个孔开口系统的实施例(未示出)包括单一的把手和成角度的区域，如图1中实施例所示。然而，此实施例还包括几个可更换的端部(未示出)。每个端部可拆卸地与成角度的区域连接，并且如上述图4所示的实施例一样具有一个选择的最大宽度。端部可通过任何使其保持在固定位置的方式与成角度的区域连接，例如，成角度的区域带有外螺纹，端部带有内螺纹，等等。
再一个实施例(未示出)包括与把手的每一端固定连接的两个成角度的区域。每个成角度的区域分别与一个具有不同最大宽度的端部固定连接。此实施例使外科医生用同一个器械即可在两个不同的扩张阶段确定孔的位置和/或孔的大小。
本发明进一步包括一种估计神经孔的扩张的方法。参见图4，该方法包括对孔进行定位(400)、在孔上按压器械(402)、确定是否该器械插入孔中(404)和如果该器械不能插入(412)，则切除孔的边缘(414)。重复按压(402)、确定是否插入(404)和切除(414)步骤直至器械插入孔中(406)。
在一个实施例中，插入孔的器械的端部其最大宽度等于出椎管的神经和孔边缘之间的理想空间。因此，当能将该最大宽度插入该空间时，外科医生可确信该孔是足够大的，从而结束手术(408)。
在另一个实施例中，外科医生用具有最大宽度逐渐增加的多个端部的多个器械重复步骤410，以在扩张过程中确定孔内开放空间的当前尺寸。如上所讨论的，该方法也可使用一个器械和多个固定的或可更换的端部。
在另一个实施例(未示出)中，定位孔的步骤(400)包括在邻近孔的区域内将孔定位器械的端部向脊椎拖动。优选地，器械的端部的最大宽度约为0.5毫米至2毫米，更优选地，约为1.2毫米，以保证端部可插入孔中。当端部插入孔中时，外科医生可以确定其位置。然后，外科医生可通过切除孔边缘(414)开始进行扩孔。
虽然在此公开了几个特定实施例，但可以预见，本领域普通技术人员在形式上或是根据等同替代原则，能够并将设计出替代的器械和方法，执行器械和方法均所附在权利要求的范围之内。

Claims (22)

1.一种用于定位和测量神经孔内出椎管神经的可用开放空间的器械，包括：
把手；
大体刚性的端部，其具有由该刚性端部的最大宽度限定的预定测量尺寸；和
连接该把手和该端部的大体刚性的成角度的区域，所述成角度的区域从末梢处该端部至所述把手的轴线形成的角度为60°至80°，
其中该端部和成角度的区域具有的尺寸使得在所述神经孔处于未扩张状态和扩张状态中的至少一种状态时所述端部的最大宽度可插入所述神经孔中，以便准确测量所述神经孔的尺寸。
2.如权利要求1所述的器械，其中该端部大致呈圆形。
3.如权利要求1所述的器械，其中该端部大致呈球形。
4.如权利要求1所述的器械，其中所述成角度的区域从末梢处该端部至所述把手的轴线形成的角度约为70°至78°。
5.如权利要求1所述的器械，其中所述成角度的区域从所述端部至所述把手的轴线形成的角度约为76°。
6.如权利要求1所述的器械，其中所述成角度的区域是弯曲的，并且具有小于所述测量尺寸的直径。
7.如权利要求1所述的器械，其中所述端部的最大宽度在约0.5毫米至8毫米的范围之内。
8.如权利要求1所述的器械，进一步包括至少一个大体刚性的替换的端部，其中该端部和该替换的端部可拆卸地连接至该成角度的区域。
9.如权利要求1所述的器械，进一步包括具有大体刚性的第二端部的大体刚性的第二成角度的区域，所述第二成角度的区域在前述成角度的区域的反方向连接到所述把手，其中该第二端部和第二成角度的区域所具有的尺寸使得在所述神经孔处于未扩张状态和扩张状态中的至少一种状态时所述第二端部可插入所述神经孔中。
10.一种用于探测和估计神经孔内出椎管神经的可用开放空间的系统，包括：
多个器械，每个器械具有把手、具有由其最大宽度限定的预定测量尺寸的大体刚性的端部，和位于该把手和该端部之间的大体刚性的成角度的区域，所述成角度的区域从末梢处该端部至所述把手的轴线形成的角度为60°至80°，
其中每个端部和每个成角度的区域具有的尺寸使得在所述神经孔处于未扩张状态和扩张状态中的至少一种状态时每个端部的最大宽度可插入所述神经孔中，和
其中该多个器械中每个端部具有与该多个器械的其它端部不同的最大宽度。
11.如权利要求10所述的系统，其中每个端部大致呈圆形。
12.如权利要求10所述的系统，其中每个端部大致呈球形。
13.如权利要求10所述的系统，其中每个成角度的区域与和其相关把手之间的角度约为60°至80°。
14.如权利要求10所述的系统，其中每个成角度的区域从末梢处该端部至与其相关把手的轴线形成的角度约为70°至78°。
15.如权利要求10所述的系统，其中每个成角度的区域从所述端部至与其相关把手的轴线形成的角度约为76°。
16.如权利要求10所述的系统，其中每个成角度的区域是弯曲的，并且具有小于所述测量尺寸的直径。
17.如权利要求10所述的系统，其中该多个器械包括四个器械。
18.如权利要求10所述的系统，其中该多个器械中至少一个器械的端部的最大宽度在约为0.5毫米至8毫米之间的范围内。
19.一种用于定位和测量神经孔内出椎管神经的可用开放空间的器械，包括：
把手；
大体刚性的端部，其具有由该刚性端部的最大宽度限定的预定测量尺寸；和
连接该把手和该端部的大体刚性的成角度的区域，所述成角度的区域从末梢处该端部至所述把手的轴线形成的角度为60°至80°，并且具有小于所述测量尺寸的直径，
其中该端部和成角度的区域具有的尺寸使得在所述神经孔处于未扩张状态和扩张状态中的至少一种状态时所述端部的最大宽度可插入所述神经孔中，并且其中该端部具有的形状使得无论插入角度如何，均可准确测量神经孔的尺寸。
20.一种用于定位和测量神经孔内出椎管神经的可用开放空间的器械，包括：
把手；
大体刚性的端部，其具有由该刚性端部的最大宽度限定的预定测量尺寸；和
连接该把手和该端部的大体刚性的成角度的区域，所述成角度的区域从末梢处该端部至所述把手的轴线形成的角度为60°至80°，并且具有小于所述测量尺寸的直径，
其中该端部和成角度的区域具有的尺寸使得在所述神经孔处于未扩张状态和扩张状态中的至少一种状态时所述端部的最大宽度可插入所述神经孔中，并且其中该端部具有的形状使该端部在插入孔中时不会干扰出椎管神经。
21.一种用于探测和测量孔神经内出椎管神经的可用开放空间的系统，包括：
多个器械，每个器械具有把手、具有由其最大宽度限定的预定测量尺寸的大体刚性的端部，和位于该把手和该端部之间的大体刚性的成角度的区域，所述成角度的区域从末梢处该端部至所述把手的轴线形成的角度为60°至80°，
其中该多个器械中每个端部具有与该多个器械中其它的端部不同的最大宽度，
其中至少一个器械的端部具有足够小的尺寸，以确保在所述神经孔处于未扩张状态时插入所述神经孔中，和
其中至少一个器械的端部具有足够大的尺寸，以确保所述神经孔可被充分扩张。
22.一种用于探测和测量神经孔内出椎管神经的可用开放空间的系统，其包括：
多个器械，每个器械具有把手、具有由其最大宽度限定的预定测量尺寸的大体刚性的端部，和位于该把手和该端部之间的大体刚性的成角度的区域，所述成角度的区域从末梢处该端部至所述把手的轴线形成的角度为60°至80°，
其中该多个器械中每个端部具有与该多个器械中其它端部不同的最大宽度，
其中至少一个器械的探测端部具有足够小的尺寸，以确保在所述神经孔处于未扩张状态时插入所述神经孔中，
其中至少一个器械的扩张端部具有足够大的尺寸，以确保所述神经孔可被充分扩张，和
进一步包括至少一个器械，其测量端部具有的尺寸介于该探测端部和该扩张端部之间，以使在扩张过程中提供对所述神经孔的准确测量。
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