CN116531072A - 钛涂层椎体桥接增强*** - Google Patents
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Abstract
本发明公开了一种钛涂层椎体桥接增强***,其包括螺钉本体,螺钉本体的两端分别为头端和尾端,螺钉本体内设有骨水泥通道,骨水泥通道沿螺钉本体的轴向布置,螺钉本体的外周壁上设有与骨水泥通道连通的侧孔,螺钉本体的外周壁上设有外螺纹,螺钉本体头端上的外螺纹间距要小于其余部分的外螺纹间距,螺钉本体的头端喷涂有钛粉,侧孔朝螺钉本体的尾端方向倾斜布置。其目的是为了提供一种钛涂层椎体桥接增强***,其能够完全没入椎体,并且与椎体保持稳固连接,不会出现松脱情况,除此之外,上述钛涂层椎体桥接增强***在植入椎弓根后,其侧孔方向不再朝向椎孔,从而大大降低了骨水泥渗入椎孔的风险。
Description
技术领域
本发明涉及医疗器械领域,特别是涉及一种用于治疗椎体压缩性骨折的装置。
背景技术
近年来,随着人口老龄化趋势增加,骨质疏松症患者的数量越来越多,当患者经历轻微外伤后,表现为几月甚至几年无明显症状期,但之后出现疼痛、后凸畸形等症状,这一类骨质疏松胸腰椎骨折称之为kummell病,影像学上表现为脊柱椎体内出现骨缺损。kummell病主要临床表现为疼痛较前期明显加重,以翻身起床、站立、行走活动时为甚,并出现椎体塌陷及进行性的后凸畸形,甚至出现神经功能损害,严重影响患者生活质量。随着目前我国老龄化的持续加剧,kummell病患者亦逐年增多,目前最主要、也是最有效的kummell病治疗方式为pvp或pkp,二者均使用骨水泥对病椎进行填充,以填补骨缺损、稳定脊柱,达到缓解患者疼痛、纠正脊柱后凸畸形的治疗作用。
然而,临床上使用骨水泥对病椎进行填充后,时常出现骨水泥移位情况,导致手术治疗失败,患者不得不接受开放式的翻修手术,同时kummell病患者多为高龄患者,其往往难以承受二次翻修手术。
目前市面上已经出现了一些骨水泥螺钉,通过螺钉、椎体以及骨水泥三者之间的机械结合使得骨水泥固定在椎体中的特定位置,防止骨水泥发生移位。但是在患者活动的过程中,螺钉与椎体的连接处会变得不稳定,可能会出现螺钉松脱的情况。
大部分脊柱螺钉并不会完全没入椎体,这种结构可能会损伤植入物周围的人体组织,同时患者容易出现异物感或疼痛感。
如图1所示,现有的螺钉1’内部设有骨水泥通道2’,骨水泥通道2’沿螺钉1’的轴向布置并且贯穿螺钉1’的两端,螺钉1’的外周壁上设有与骨水泥通道2’连通的侧孔3’,侧孔3’垂直于骨水泥通道2’。如图2所示,椎弓根与人体矢状面之间有15°~20°的夹角a,因此当螺钉1’沿着椎弓根方向植入椎体4’时,会向椎孔方向偏转15°~20°,此时侧孔3’方向便会朝向椎孔,也就是从侧孔3’出来的骨水泥是朝向椎孔流动的(骨水泥经骨水泥通道2’流入椎体4’内,同时骨水泥通道2’内的部分骨水泥从侧孔3’流入到椎体4’内),图中箭头所示即为从侧孔3’出来的骨水泥的流动方向。椎体压缩性骨折的患病椎体4’表面和椎孔内壁会有很多裂纹或断裂破碎,如果从侧孔3’出来的骨水泥朝向椎孔流动,可能会导致骨水泥沿椎孔内壁断裂处渗出,进入椎孔。椎孔内为人体中枢神经,一旦骨水泥渗入,将会导致患者瘫痪。
发明内容
本发明要解决的技术问题是提供一种钛涂层椎体桥接增强***,其能够完全没入椎体,并且与椎体保持稳固连接,不会出现松脱情况,除此之外,上述钛涂层椎体桥接增强***在植入椎弓根后,其侧孔方向不再朝向椎孔,从而大大降低了骨水泥渗入椎孔的风险。
本发明钛涂层椎体桥接增强***,包括螺钉本体,所述螺钉本体的两端分别为头端和尾端,所述螺钉本体内设有骨水泥通道,所述骨水泥通道沿螺钉本体的轴向布置,所述骨水泥通道贯穿螺钉本体的头端和尾端,所述螺钉本体的外周壁上设有与骨水泥通道连通的侧孔,所述螺钉本体的外周壁上设有外螺纹,所述螺钉本体外周壁上的外螺纹沿头端至尾端布置,所述螺钉本体头端上的外螺纹间距要小于其余部分的外螺纹间距,所述螺钉本体的头端喷涂有钛粉,所述侧孔朝螺钉本体的尾端方向倾斜布置。
本发明钛涂层椎体桥接增强***,其中所述螺钉本体头端上的外螺纹为双线螺纹,所述螺钉本体的除头端以外的其余部分的外螺纹为单线螺纹。
本发明钛涂层椎体桥接增强***,其中所述侧孔设在螺钉本体的除头端以外的其余部分上,所述侧孔设为多组,每组侧孔设有多个侧孔,多组侧孔沿螺钉本体的周向布置,每组侧孔的多个侧孔沿螺钉本体的轴向布置,所述侧孔的孔径沿螺钉本体头端至尾端的方向逐渐变大。
本发明钛涂层椎体桥接增强***,其中所述侧孔的轴线与螺钉本体的轴线之间的夹角为70°。
本发明钛涂层椎体桥接增强***,其中所述螺钉本体头端的端面上设有与骨水泥通道连通的对接槽,所述对接槽的槽壁上设有多个U型槽口,多个所述U型槽口沿螺钉本体的周向布置,所述对接槽的内槽壁上设有内螺纹。
本发明钛涂层椎体桥接增强***与现有技术不同之处在于本发明钛涂层椎体桥接增强***的螺钉本体的外周壁上沿头端至尾端布置有外螺纹,也就是说,螺钉本体通体遍布外螺纹,并且螺钉本体头端上的外螺纹间距要小于其余部分的外螺纹间距,即头端上的外螺纹较为密集,而其余部分的外螺纹较为稀疏,并且在头端喷涂钛粉以形成钛涂层,这样螺钉本体在植入椎体时,螺钉本体的头端与椎体皮质骨具有更好的结合强度,从而能够使螺钉本体与椎体保持稳固连接,不会出现松脱情况。除此之外,螺钉本体上的侧孔并未像现有技术那样垂直于骨水泥通道布置,而是朝螺钉本体的尾端方向倾斜布置,这样,当螺钉本体在植入椎体后,骨水泥在从侧孔流出时,不会朝椎孔流动,从而大大降低了骨水泥渗入椎孔的风险。
下面结合附图对本发明作进一步说明。
附图说明
图1为现有技术中螺钉的结构示意图;
图2为现有技术中螺钉的使用状态图;
图3为本发明钛涂层椎体桥接增强***的主视图;
图4为沿图3中A-A线的剖视图;
图5为本发明钛涂层椎体桥接增强***的左视图;
图6为本发明钛涂层椎体桥接增强***的右视图;
图7为本发明钛涂层椎体桥接增强***的后视图;
图8为本发明钛涂层椎体桥接增强***的立体图一;
图9为本发明钛涂层椎体桥接增强***的立体图二;
图10为本发明钛涂层椎体桥接增强***的立体图三;
图11为本发明钛涂层椎体桥接增强***的使用状态图。
具体实施方式
如图3所示,并结合图4-11所示,本发明钛涂层椎体桥接增强***,包括螺钉本体1,所述螺钉本体1的两端分别为头端7和尾端,头端7用来与骨水泥注射装置连接,尾端为钉尖,用来旋入椎体4。骨水泥注射装置能够将螺钉本体1拧入到椎体4内并注射骨水泥,骨水泥注射装置为现有技术,在此对其具体结构以及工作原理不再予以赘述。
螺钉本体1呈柱状,其头端7的直径要大于其余部分8的直径。
如图3所示,并结合图4-10所示,所述螺钉本体1内设有骨水泥通道2,所述骨水泥通道2沿螺钉本体1的轴向布置,所述骨水泥通道2贯穿螺钉本体1的头端7和尾端,所述螺钉本体1的外周壁上设有与骨水泥通道2连通的侧孔3,所述螺钉本体1的外周壁上设有外螺纹6,所述螺钉本体1外周壁上的外螺纹6沿头端7至尾端布置,所述螺钉本体1头端7上的外螺纹6间距要小于其余部分8(即螺钉本体1上除头端7以外的其余部分8)的外螺纹6间距,所述侧孔3朝螺钉本体1的尾端方向倾斜布置,具体为:所述侧孔3的轴线与螺钉本体1的轴线之间的夹角为70°。
如图4所示,骨水泥通道2与螺钉本体1同轴布置,侧孔3的轴线与螺钉本体1的轴线之间的夹角为70°,即侧孔3的轴线与骨水泥通道2的轴线之间的夹角为70°。由于此种设置,如图11所示,当螺钉本体1沿着椎弓根方向植入椎体4时,侧孔3的布置方向并未朝向椎孔,这样在注入骨水泥时,从侧孔3出来的骨水泥并不会朝椎孔方向流动(图11中的箭头所示即为从侧孔3出来的骨水泥的流动方向),因此,大大降低了骨水泥渗入椎孔的风险。
需要说明的是,在向螺钉本体1注入骨水泥时,骨水泥从螺钉本体1的两个部位注入到椎体4内:一是由于骨水泥通道2贯穿螺钉本体1的头端7和尾端,因此,一部分骨水泥会沿着骨水泥通道2从螺钉本体1的尾端注入到椎体4内;二是另一部分骨水泥会依次经骨水泥通道2、侧孔3注入到椎体4内。由于从螺钉本体1尾端流出的骨水泥背向椎孔流动,因此,只要使侧孔3流出的骨水泥不朝椎孔方向流动,即可达到降低骨水泥渗入椎孔的风险。
本发明钛涂层椎体桥接增强***,其中所述螺钉本体1的头端7喷涂有钛粉,使得头端7能够被骨长入,结合强度更高。
本发明钛涂层椎体桥接增强***,其中所述螺钉本体1头端7上的外螺纹6为双线螺纹,所述螺钉本体1的除头端7以外的其余部分8的外螺纹6为单线螺纹。双线螺纹用来与椎体4的皮质骨部位结合,单线螺纹用来与椎体4的松质骨部位结合,这种螺纹设计能够提高螺钉本体1在椎体4内的把持力,防止螺钉移位。如上所述,由于螺钉本体1的头端7喷涂有钛粉,即双线螺纹上喷涂有钛涂层,更进一步增强了螺钉本体1的把持力。
如图3所示,并结合图4-10所示,本发明钛涂层椎体桥接增强***,其中所述侧孔3设在螺钉本体1的除头端7以外的其余部分8上,所述侧孔3设为多组,每组侧孔3设有多个侧孔3,多组侧孔3沿螺钉本体1的周向布置,每组侧孔3的多个侧孔3沿螺钉本体1的轴向布置,所述侧孔3的孔径沿螺钉本体1头端7至尾端的方向逐渐变大。
在本实施例中,侧孔3设为四组,四组侧孔3沿螺钉本体1的周向均匀布置,每组侧孔3设有三个侧孔3,三个侧孔3的孔径沿螺钉本体1头端7至尾端的方向逐渐变大。上述设计能够使骨水泥在椎体4内扩散得更加均匀。
如图3所示,并结合图4-10所示,本发明钛涂层椎体桥接增强***,其中所述螺钉本体1头端7的端面上设有与骨水泥通道2连通的对接槽9,可以视为骨水泥通道2通过对接槽9贯穿螺钉本体1的头端7。所述对接槽9的槽壁上设有多个U型槽口5,多个所述U型槽口5沿螺钉本体1的周向布置,所述对接槽9的内槽壁上设有内螺纹10。U型槽口5设为三个,三个U型槽口5沿螺钉本体1的周向均匀布置。螺钉本体1的头端7通过对接槽9与骨水泥注射装置连接,U型槽口5和内螺纹10均是实现对接槽9与骨水泥注射装置相连接的具体结构。
本发明钛涂层椎体桥接增强***与现有技术不同之处在于本发明钛涂层椎体桥接增强***的螺钉本体1的外周壁上沿头端7至尾端布置有外螺纹6,也就是说,螺钉本体1通体遍布外螺纹6,并且螺钉本体1头端7上的外螺纹6间距要小于其余部分8的外螺纹6间距,即头端7上的外螺纹6较为密集,而其余部分8的外螺纹6较为稀疏,并且在头端7喷涂钛粉以形成钛涂层,这样螺钉本体1在植入椎体4时,螺钉本体1的头端7与椎体4皮质骨具有更好的结合强度,从而能够使螺钉本体1与椎体4保持稳固连接,不会出现松脱情况。除此之外,螺钉本体1上的侧孔3并未像现有技术那样垂直于骨水泥通道2布置,而是朝螺钉本体1的尾端方向倾斜布置,这样,当螺钉本体1在植入椎体4后,骨水泥在从侧孔3流出时,不会朝椎孔流动,从而大大降低了骨水泥渗入椎孔的风险。
本发明由钛合金材料制作,适应症为椎体压缩性骨折,配合骨水泥以及骨水泥注射装置使用。
本发明的工作原理主要是:通过钛涂层椎体桥接增强***、椎体4以及骨水泥三者之间的机械结合使得骨水泥固定在椎体4中的特定位置,防止骨水泥发生移位。
本发明具有以下优点:
(1)本发明可完全没入椎体4,达到“零切迹”的效果,不会损伤螺钉本体1的周边组织,同时也不会使患者出现明显的异物感;
(2)本发明可在植入椎体4后进行骨水泥注射,骨水泥与钉体的结合强度更高,能够在很大程度上减少二次手术翻修的概率;
(3)本发明通过增加头端7螺纹密集程度以及喷涂钛粉两种方式,使得螺钉本体1与椎体4的结合强度非常高,不会出现螺钉本体1松脱的情况;
(4)本发明侧孔3结构的优化,极大地降低了骨水泥渗入椎孔的风险。
需要说明的是,术语“中心”、“上”、“下”、“前”、“后”、“左”、“右”、“中”等指示的方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述本发明和简化描述,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。
在本发明的描述中,需要说明的是,除非另有明确的规定和限定,术语“相连”、“连接”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或一体地连接;可以是机械连接,也可以是电连接;可以是直接相连,也可以通过中间媒介间接相连。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本发明中的具体含义。
以上所述的实施例仅仅是对本发明的优选实施方式进行描述,并非对本发明的范围进行限定,在不脱离本发明设计精神的前提下,本领域普通技术人员对本发明的技术方案作出的各种变形和改进,均应落入本发明权利要求书确定的保护范围内。
Claims (5)
1.一种钛涂层椎体桥接增强***,包括螺钉本体,所述螺钉本体的两端分别为头端和尾端,所述螺钉本体内设有骨水泥通道,所述骨水泥通道沿螺钉本体的轴向布置,所述骨水泥通道贯穿螺钉本体的头端和尾端,所述螺钉本体的外周壁上设有与骨水泥通道连通的侧孔,所述螺钉本体的外周壁上设有外螺纹,其特征在于:所述螺钉本体外周壁上的外螺纹沿头端至尾端布置,所述螺钉本体头端上的外螺纹间距要小于其余部分的外螺纹间距,所述螺钉本体的头端喷涂有钛粉,所述侧孔朝螺钉本体的尾端方向倾斜布置。
2.根据权利要求1所述的钛涂层椎体桥接增强***,其特征在于:所述螺钉本体头端上的外螺纹为双线螺纹,所述螺钉本体的除头端以外的其余部分的外螺纹为单线螺纹。
3.根据权利要求2所述的钛涂层椎体桥接增强***,其特征在于:所述侧孔设在螺钉本体的除头端以外的其余部分上,所述侧孔设为多组,每组侧孔设有多个侧孔,多组侧孔沿螺钉本体的周向布置,每组侧孔的多个侧孔沿螺钉本体的轴向布置,所述侧孔的孔径沿螺钉本体头端至尾端的方向逐渐变大。
4.根据权利要求3所述的钛涂层椎体桥接增强***,其特征在于:所述侧孔的轴线与螺钉本体的轴线之间的夹角为70°。
5.根据权利要求4所述的钛涂层椎体桥接增强***,其特征在于:所述螺钉本体头端的端面上设有与骨水泥通道连通的对接槽,所述对接槽的槽壁上设有多个U型槽口,多个所述U型槽口沿螺钉本体的周向布置,所述对接槽的内槽壁上设有内螺纹。
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