胸锁关节解剖型锁定钢板的研制及生物力学研究

发布时间：2018-08-26 16:50

【摘要】：第一部分胸锁关节的解剖学及生物力学研究目的:(1)测量胸锁关节周围骨性结构与韧带的解剖学数据,观察其形态学特点,为胸锁关节脱位及周围骨折解剖锁定钢板的研制提供解剖学参数与理论依据。(2)对胸锁关节及周围韧带进行生物力学测试,探讨其生物力学特点,为设计用于胸锁关节脱位及周围骨折的内固定钢板提供生物力学依据,也为临床手术提供生物学参考。方法:(1)选取8具成人防腐、湿润尸体标本(6男、2女),死亡年龄32-58岁,平均46.5岁。解剖分离出完整的胸骨柄、双侧锁骨及胸锁关节周围组织。剥除标本上附着的肌肉及无关软组织,完整保留双侧胸锁关节、周围韧带及关节囊结构,修整成骨-韧带-骨标本模型。用墨迹图及网格计数法测量本组胸锁关节标本的胸骨柄与锁骨端关节面积,并进行统计学分析。对所有标本进行CT三维重建,用影像学和解剖学两种方法测量本组标本以下解剖参数:参考董加纯等提供的方法测量胸骨柄厚度,同时测量胸骨切迹宽度,双侧锁骨近端三分之一的前后径、上下径,锁骨与胸骨柄在冠状面所成夹角,胸锁关节在解剖位向前的成角,对两种方法测得的每组数据进行统计学分析。(2)观察本组标本胸锁前、后韧带的形态学特点,分别测量长、宽及厚度,并进行统计学分析。(3)将每副标本的左、右侧胸锁关节随机配对分组:A组测试单纯切断胸锁前韧带前后在锁骨远端加载0-10N负荷下负载点的位移及角度变化,B组测试单纯切断胸锁后韧带前后在锁骨远端加载0-10N负荷下负载点的位移及角度变化。参考Spencer的力学实验研究,操作如下:分别用特制夹具固定标本的胸骨柄端,在解剖位垂直于锁骨远端进行前、后方向负载实验(匀速加载0-10N,加载速度2mm/min)。力学试验机相连接的终端计算机采集实验数据,并绘制负荷-位移曲线。所得位移值根据正弦三角函数关系计算出胸锁关节向前、后方向所成角度。比较两组在前、后方向负载下关节所成的角度及负载-成角回归直线斜率。实验数据应用SPSS19.0统计学软件进行分析,P0.05认为具有统计学差异。结果:(1)本组测量的胸骨柄关节面积(239.00±28.78mm2)小于锁骨内侧端关节面积(482.56±44.89mm2),有显著性差异(t=-40.105,P0.001)。胸骨柄厚度,胸骨切迹宽度,双侧锁骨近端三分之一的前后径、上下径,锁骨与胸骨柄在冠状面所成夹角,胸锁关节在解剖位向前的成角,在标本大体与CT两种方法上测量的数据结果均无统计学差异(P0.05)。(2)本组测量的胸锁前韧带长度为17.56±1.94mm,宽度为15.54±1.42mm,厚度为1.93±0.32 mm。后韧带长度为17.21±1.86 mm,宽度为15.97±1.17 mm,厚度为2.07±0.29 mm。胸锁前韧带长度相较于后韧带略长,形态学表现更为松弛,分别比较两者的长、宽、厚度均无统计学差异(P0.05)。(3)两组标本在切断胸锁韧带前后,负载0-10N范围内,随着负荷的增加,关节向前、后方向所成的角度逐渐增大,两者呈线性关系。切断韧带之前,在负荷为2、4、6、8、10N时,负载向前导致关节向后的成角均小于负载向后导致关节向前的成角,但仅在负荷为6、8、10N时,差异有统计学意义(P0.05)。负载向前的负载-成角回归直线斜率小于负载向后的负载-成角回归直线斜率,差异有统计学意义(F=31.413,P=0.001)。切断韧带后,A组与B组在向前负载2、4、6、8、10N时,A组关节向后的成角均小于B组,差异均有统计学意义(P0.05),A组负载-成角回归直线斜率小于B组,差异有统计学意义(F=52.224,P0.001)。两组在向后负载2、4、6、8、10N时,A组关节向前的成角均大于B组,差异均有统计学意义(P0.05),A组负载-成角回归直线斜率大于B组,差异有统计学意义(F=12.503,P=0.008)。结论:解剖学和影像学两种方法测量胸锁关节及周围骨性结构无统计学差异,CT三维重建不仅能对胸锁关节脱位进行准确的诊断,也能对胸锁关节及周围骨性结构进行较精确的测量,有助于内固定方案的选择。锁骨内侧端关节面与胸骨柄关节面的接触面狭小,关节本身不稳定,胸锁韧带对于维持关节稳定性的作用极为重要。力学实验表明胸锁前韧带主要限制关节向前成角,胸锁后韧带主要限制关节向后成角,胸锁韧带限制关节向前成角的作用弱于向后成角,又因关节在解剖位时向前自然成角,胸锁关节易发生前脱位。在手术治疗胸锁关节脱位及周围骨折时应重视胸锁韧带的修复与重建。第二部分胸锁关节解剖锁定钢板的研制及生物力学测试目的:研制符合胸锁关节解剖学特点,固定可靠,手术操作简便的解剖锁定钢板,为治疗胸锁关节脱位或周围骨折提供一种理想的内固定器械。通过生物力学实验对比分析,对胸锁关节解剖锁定钢板固定胸锁关节脱位的生物力学性能进行评价,为进一步临床应用提供实验依据。方法:根据本组胸锁关节标本的解剖学测量参数及生物力学特性,设计并研制出胸锁关节解剖锁定钢板。将研制的解剖锁定钢板与目前常用的斜“T”形锁定钢板进行生物力学对比。本组8具胸锁关节骨-韧带-骨结构标本,均用手术刀完全切断胸锁韧带及关节囊,造成胸锁关节完全脱位模型。将每副标本的左、右侧胸锁关节进行随机配对分组:实验组ALCP(解剖型锁定钢板),对照组OTLCP(斜“T”形锁定钢板)。在万能生物材料试验机(四川大学生物力学重点实验室)上模拟胸锁关节脱位常见受力机制,分别进行锁骨远端负载、胸锁关节扭转、钢板胸骨柄部抗拔出三项生物力学性能测试。生物力学试验机的终端计算机采集实验数据并绘制应力-变形曲线。实验数据应用SPSS19.0统计学软件进行分析,P0.05认为具有统计学差异。结果:(1)依据胸锁关节形态学特点及解剖学测量的参数,研制出解剖锁定钢板,并委托具有临床医疗器械生产许可的厂家生产。获得国家实用新型专利及外观专利,同时申请发明专利。(2)锁骨远端负载实验中,负载0~20N范围内,加载点的负荷与位移呈线性关系。在解剖位垂直于锁骨远端向后加载,最大负荷为20N时,ALCP组加载点的位移为8.455±0.981mm,OTLCP组加载点的位移为10.163±1.379 mm,两组之间有统计学差异(t=-3.012,P=0.020)。在解剖位垂直于锁骨远端向上加载,最大负荷为20N时,ALCP组加载点的位移为5.427±1.154mm,OTLCP组加载点的位移为6.393±1.040mm,两组间无统计学差异(t=-1.459,P=0.188)。ALCP组抗胸锁关节锁骨端向后负载变形的性能更强,抗胸锁关节锁骨端向上负载变形与OTLCP组无明显差异。(3)胸锁关节扭转实验中,两组标本在顺、逆时针扭转角度0~10°范围内,扭矩与扭角之间呈线性关系,随着扭转角度的增加,扭矩逐渐增大。两组顺时针扭转角为2、4、6、8、10°时,ALCP组扭矩均大于OTLCP组,两组差异均有统计学意义(P0.05)。两组逆时针扭转角为2、4、6、8、10°时,ALCP组扭矩均大于OTLCP组,但仅扭角为4、6、8、10°时,两组差异有统计学意义(P0.05)。两组扭矩-扭角回归直线的斜率即扭转刚度,在顺时针扭转实验中,ALCP组扭转刚度为0.122 N.m/°,OTLCP组扭转刚度为0.083 N.m/°,两组有显著性差异(F=67.824,P0.001)。逆时针扭转实验中,ALCP组扭转刚度为0.108 N.m/°,OTLCP组扭转刚度为0.078 N.m/°,两组有显著性差异(F=20.992,P=0.002)。ALCP组抗扭转变形的能力优于OTLCP组。(4)ALCP组最大抗拔力为225.24±16.02N,OTLCP组最大抗拔力为174.40±21.90N,两组有显著性差异(t=5.785,P=0.001),ALCP组固定胸骨柄的抗拔出性能更为优越。结论:本课题研制的胸锁关节解剖锁定钢板是一种依据胸锁关节解剖学特点及生物力学特性设计而成,具有三维固定模式的新型内固定器械。其固定可靠、手术操作简便、创伤小、生物力学性能优越,利于早期功能锻练,为临床治疗胸锁关节脱位及周围骨折提供了一种较理想的内固定器械。
[Abstract]:Part I Anatomical and biomechanical study of the sternoclavicular joint Objective: (1) To measure the anatomical data of the osseous structures and ligaments around the sternoclavicular joint and observe their morphological characteristics, so as to provide anatomical parameters and theoretical basis for the development of the anatomical locking plate for the dislocation of the sternoclavicular joint and peripheral fractures. (2) To biologize the sternoclavicular joint and its surrounding ligaments. Methods: (1) Eight adult cadavers (6 males and 2 females) aged 32-58 with a mean age of 46.5 years were dissected and separated completely. Sternal stalk, bilateral clavicle and surrounding tissue of sternoclavicular joint. The attached muscles and unrelated soft tissues were stripped off, the bilateral sternoclavicular joint, surrounding ligaments and joint capsule were completely preserved, and the bone-ligament-bone specimen model was reconstructed. All specimens were reconstructed by CT. The following anatomical parameters were measured by imaging and anatomy: sternal stalk thickness, sternal notch width, anterior and posterior diameters of one third of proximal clavicle, upper and lower diameters, clavicle and sternal stalk in coronal shape, with reference to Dong Jiachun et al. (2) To observe the morphological characteristics of the anterior and posterior ligaments of the sternoclavicle, and measure the length, width and thickness of the anterior and posterior ligaments respectively, and make statistical analysis. (3) The left and right sternoclavicular joints of each pair of specimens were randomly divided into two groups: group A test. The displacement and angle of the loading point were measured before and after the simple transection of the anterior clavicular ligament under 0-10N loading at the distal end of the clavicle. The displacement and angle of the loading point were measured before and after the simple transection of the posterior clavicular ligament under 0-10N loading at the distal end of the clavicle. At the end of sternal stalk, the load experiment was carried out before and after the anatomical position was perpendicular to the distal clavicle (loading 0-10N at a constant speed, loading speed 2mm/min). The experimental data were collected by the computer connected with the mechanical testing machine, and the load-displacement curve was drawn. The displacement values were calculated according to the sinusoidal trigonometric function. Results: (1) The area of sternal stalk joint (239.00 65507 There were significant differences (t = - 40.105, P 0.001). Sternal stalk thickness, sternal notch width, bilateral proximal clavicle one third of the anterior and posterior diameters, upper and lower diameters, clavicle and sternal stalk in the coronal angle, sternoclavicular joint in the anatomical position of the anterior angle, there was no significant difference between the specimen and CT measurement of the two methods (P 0.05). (2) The length, width and thickness of the anterior sternoclavicular ligament were 17.56 (+ 1.94 mm), 15.54 (+ 1.42 mm) and 1.93 (+ 0.32 mm). The length, width and thickness of the posterior ligament were 17.21 (+ 1.86 mm), 15.97 (+ 1.17 mm) and 2.07 (+ 0.29 mm). The length of the anterior sternoclavicular ligament was slightly longer and more relaxed than that of the posterior ligament. There was a linear relationship between the two groups (P 0.05). (3) In the range of 0-10N, the angle of the joint in the forward and backward directions increased with the increase of the load. Before the ligament was cut off, when the load was 2,4,6,8,10N, the angle of the joint in the forward direction was less than that in the backward direction. The linear slope of load-angular regression was less than that of load-angular regression (F = 31.413, P = 0.001). After ligament amputation, the joint of group A and group B angled backward when the load was 2, 4, 6, 8, 10N forward. The linear slope of load-angular regression in group A was significantly lower than that in group B (P 0.05). The linear slope of load-angular regression in group A was significantly lower than that in group B (F = 52.224, P 0.001). The forward angle of joint in group A was greater than that in group B at 2, 4, 6, 8, and 10 N of backward load (P 0.05). The linear slope of load-angular regression in group A was significantly higher than that in group B (P 0.05). Conclusion: There is no significant difference between anatomy and imaging in the measurement of sternoclavicular joint and peripheral bone structure. CT three-dimensional reconstruction can not only diagnose sternoclavicular joint dislocation accurately, but also measure sternoclavicular joint and peripheral bone structure accurately, which is helpful to the selection of internal fixation scheme. The contact surface between the medial clavicle and the sternal stalk is narrow, and the joint itself is unstable. The sternoclavicular ligament plays an important role in maintaining the stability of the joint. Anterior dislocation of the sternoclavicular joint is easy to occur because of the natural angulation of the joint forward in the anatomical position. The repair and reconstruction of the sternoclavicular ligament should be emphasized in the surgical treatment of the dislocation of the sternoclavicular joint and peripheral fractures. Anatomical locking plate is an ideal internal fixator for the treatment of thoracoclavicular joint dislocation or peripheral fracture. The biomechanical properties of the anatomical locking plate for the treatment of thoracoclavicular joint dislocation were evaluated by biomechanical experiments. Methods: According to the anatomical measurement parameters and biomechanical characteristics of the sternoclavicular joint specimens, an anatomical locking plate for the sternoclavicular joint was designed and manufactured. The left and right sternoclavicular joints of each pair of specimens were randomly divided into two groups: the experimental group (ALCP) and the control group (OTLCP). Laboratory) Simulating the common stress mechanism of sternoclavicular dislocation, three biomechanical tests were carried out, including distal clavicular load, sternoclavicular torsion, steel plate sternal handle pull-out resistance. Results: (1) According to the morphological characteristics of the sternoclavicular joint and the parameters of anatomical measurement, an anatomical locking plate was developed and manufactured by a manufacturer licensed for the manufacture of clinical medical instruments. In the ALCP group, the displacement of the loading point was 8.455 65507 The displacement of loading point in ALCP group was 5.427 (+ 1.154 mm) and that in OTLCP group was 6.393 (+ 1.040 mm). There was no significant difference between the two groups (t = - 1.459, P = 0.188). The ALCP group had stronger anti-sternoclavicular end load deformation, and no anti-sternoclavicular end load deformation compared with OTLCP group. (3) In the experiment of sternoclavicular joint torsion, there was a linear relationship between torque and torsion angle in the range of 0-10 degrees clockwise and counter-clockwise, and the torque increased gradually with the increase of torsion angle. The torque in ALCP group was higher than that in OTLCP group at 2,4,6,8,10 degrees, but only at 4,6,8,10 degrees, there was significant difference between the two groups (P 0.05). In counterclockwise torsion test, the torsional stiffness of ALCP group was 0.108 N.m /degrees, and that of OTLCP group was 0.078 N.m /degrees. There was significant difference between the two groups (F = 20.992, P = 0.002). The torsional deformation resistance of ALCP group was better than that of OTLCP group. (4) The maximum pull-out resistance of ALCP group was 225.24 [16.02N] and that of OTLCP group was 174.40. There was a significant difference between the two groups (t = 5.785, P = 0.001). The pullout resistance of sternal stalk fixation in ALCP group was better than that in ALCP group. It has the advantages of simple operation, less trauma, superior biomechanical properties and early functional training. It provides an ideal internal fixation instrument for the treatment of thoracoclavicular dislocation and peripheral fractures.
【学位授予单位】：西南医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R687;R318.01

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