女性盆底在体生物力学研究
摘要
目的：本研究拟自主设计研制操作性强、精确度高的数字化女性盆底生物力学在体拉伸测量系统,并建立实用可行的女性盆底支持结构在体生物力学性能的测量方法；进行盆底重建手术所涉及的盆底支持结构及骶前纵韧带的在体生物力学性能测定,为各种盆底重建手术的有效性提供生物力学依据；完成TVT-0及TVT-S在体生物力学性能的测定,为其术后短期有效性提供生物力学依据。
方法：在10具新鲜女性尸体上按照各种盆底重建手术操作方式缝合所涉及的宫骶韧带、宫颈周围环、盆筋膜腱弓、坐骨棘筋膜、骶棘韧带、骶前纵韧带,利用在体拉伸测量系统完成连续加载并同步记录载荷和位移参数,根据所得的载荷-变形曲线分析比较各组织结构的生物力学性能；运用随机数字表确定尸体标本的手术方式(TVT-05例和TVT-Secur H型5例),利用在体拉伸测量系统测量并比较两者的在体生物力学性能。
结果：
1.宫骶韧带、宫颈周围环、盆筋膜腱弓、坐骨棘筋膜、骶棘韧带的极限载荷分别为37.3±23.5N、49.3±28.4N、46.8±18.7N、42.2±19.8N、39.4±25.6N,各组韧带间无显著差异(P=0.462)；同时发现各组韧带的极限载荷个体差异大,但盆筋膜腱弓及坐骨棘筋膜极限载荷的变异系数分别为40.02%、46.99%,均明显小于其余三组的,说明前两者的极限载荷的变化范围相对较小
2.宫骶韧带、宫颈周围环、盆筋膜腱弓、坐骨棘筋膜、骶棘韧带的刚度分别为1.26±1.22 N/mm.1.45±0.92 N/mm.1.28±O.44 N/mm.1.47±O.40 N/mm、1.47±0.62 N/mm,各组间亦无显著差异(P=0.832),同样发现ATFP及坐骨棘筋膜刚度的变化范围明显小于其余三组的,前两者刚度的变异系数分别为34.12%、27.30%。
3.10具尸体中各水平骶前纵韧带的极限载荷由上到下依次递减,分别为129.55±64.07N.69.46±15.52N.18.90±7.52N,差异有统计学意义(P<0.01)。
4.骶岬、骶1、骶2水平前纵韧带的刚度依次为4.24±2.14N/mm.2.9l±1.54N/mm、2.14±0.79N/mm,亦呈现递减趋势,差异有统计学意义(P<0.01)。各水平骶前纵韧带两两相比,骶岬水平的刚度明显大于骶1(P=0.011)及骶2水平(P<0.01)的刚度,而骶1和骶2水平间无显著差异(P=0.117)。
5.TVT-O吊带置入尸体体内后的机械阻力为18.71±2.68N,大于TVT-SecurH型的12.30±9.70N,但差异无统计学意义(P=0.192)。
结论：
1.本研究自主设计了操作性强、精确度高的数字化女性盆底生物力学在体拉伸测量系统,能连续可调节地加载并同步提供载荷和位移参数,并可在水平面及矢状面调整加载方向,为后续的女性盆底支持结构在体生物力学性能测量方法的建立及盆底重建手术有效性的研究提供了有效的研究工具。
2.建立了实用可行的女性盆底支持结构及骶前纵韧带在体生物力学性能的测量方法；从缝线选择、加载速度、拉伸方向、缝合位点等方面优化试验方法,增加了试验的稳定性和可重复性。首次在在体生物力学性能测定中引入刚度这一力学参数,利用刚度变化准确判断极限载荷,从而获得更为全面准确的生物力学数据。
3.首次完成中国女性新鲜尸体标本盆底重要支持结构和骶前纵韧带的在体生物力学性能测定,为各种盆底重建手术的有效性提供生物力学数据。
4.本研究测量了宫颈周围环的生物力学性能,在国内尚属首次,发现其极限载荷明显大于阴道壁的,提出在中盆腔缺陷的重建手术中,要确保缝合阴道及阴道外的筋膜即宫颈周围环以提供足够的强度。
5.本研究首次测量了中国女性盆筋膜腱弓的极限载荷,缝合位点模拟协和式改良全盆底重建术前路深带的穿刺点,结果显示其可提供与Prolift前路深带悬吊点同样有力的支持,从而为协和式改良全盆底重建术手术的有效性提供了生物力学依据。
6.坐骨棘筋膜为坐骨棘盆面的肌肉筋膜组织,本研究测得的极限载荷与骶棘韧带相似,而刚度大于常用的聚丙烯网片,且其力学性能的个体差异小,稳定性好,结合应用解剖学,提出坐骨棘筋膜可以成为新的治疗阴道脱垂的安全有效且经济的悬吊点。
7.骶棘韧带是公认的强壮有力的韧带,本研究通过测量骶棘韧带的在体生物力学性能,指出离体生物力学研究难以真实反映其在体内的力学状态,同时发现其极限载荷和刚度的个体差异大。
8.骶前纵韧带的极限载荷及刚度均沿骶骨由上向下呈递减趋势。本研究首次同时从极限载荷和刚度两方面提供生物力学依据,建议骶骨阴道固定术应首选骶岬水平(即腰5骶1椎间盘水平)的前纵韧带作为缝合位点。
9.本研究首次对TVT-0和TVT-Secur两种吊带在新鲜尸体体内生物力学性能进行了深入研究,为今后优化网片在体生物力学性能的研究方法提出了建议。同时提出TVT-Secur-H型在术后短期的在体生物力学性能可与TVT-0相媲美,理论上在术后早期可达到与TVT-0相似的临床效果,为新术式的广泛开展提供生物力学依据。
Objects:To devise a special in vivo puller measuring instrument for female pelvic floor.To establish a reliable experimental protocol to characterize the in vivo biomechanical properties of female pelvic floor supporting structure. To mesure the in vivo biomechanical properties of several important supporting structure, the anterior longitudinal ligament(ALL) and the tensile free vaginal tape. Accordingly, to provide biomechanical evidence for the efficiency of reconstructive pelvic surgery.
Materials and Methods:Ten fresh cadavers were dissected to expose uterosacral Ligament(USL),the ring around cervix, arcus tendineus fascia pelvis(ATFP), fascia on the ischial spine, sacrospinous ligament(SSL) and ALL. After the fascia and ligaments were sewed according to the surgical technique, they were stretched at a steady rate until breakage while allowing constant electronic registration of load and displacement. Then to compare the in vivo biomechanical properties by analyzing the load-displacement curve.Ten fresh cadavers were randomized to (tension free vaginal tape—obturator)TVT-0 or the TVT-Secur group, each group had five bodies. After the surgical procedures was finished, tension tests were performed by the purpose-built puller system to prove the surgical efficiency.
Results:
1. The ultimate load of USL, the ring around cervix, ATFP, fascia on the ischinal spine and SSL was 37.3±23.5N,49.3±28.4N、46.8±18.7N、42.2±19.8N and 39.4±25.6N, respectively, and there was no significant difference among groups(P>0.05). The coefficient of variation(CV) of ATFP and fascia on the ischial spine were less than the others. That is to say, the individual differences of ultimate load among the first two groups were small.
2. The stiffness of USL, the ring around cervix, ATFP, fascia on the ischinal spine and SSL was 1.26±1.22 N/mm,1.45±0.92 N/mm,1.28±0.44 N/mm, 1.47±0.40 N/mm and 1.47±0.62 N/mm, respectively. There was also no significant difference among groups (P>0.05). There was a considerable variability for each value, but the CV of ATFP and fascia on the ischial spine were less than the other three groups.
3. The ultimate load of ALL at the sacral promontory, the first sacral vertebra and the second sacral vertebra were 129.55±64.07N、69.46±15.52N and 18.90±7.52N, respectively. It progressively decreased distally along the sacral vertebra, the differences between levels were significant(P<0.01).
4. The stiffness of ALL was 4.24±2.14N/mm at the sacral promontory,2.91±1.54N/mmat the first sacral vertebra and 2.14±0.79N/mm at the second sacral vertebra, which was declining(P<0.05). The stiffness of ALL at the sacral promontory was greater than the stiffness of other levels (P<0.01), but there was no significant difference between the lower two levels (P>0.05).
5. The mechanical resistance of TVT-0 was 18.71±2.68N, which was stronger than TVT-Secur, but no significant difference could be found(P>0.05).
Conclusions:
1. We devised a digital in vivo puller measuring instrument for female pelvic floor biomechanical study with high fidelity. The instrument can stretch samples at a continuous and adjustable rate until breakage while allowing constant electronic registration of load and displacement. It can enable orientation in a vertical and horizontal surface plane in order to guide traction.
2. We established a reliable experimental protocol to characterize the in vivo biomechanical properties of female pelvic floor supporting structure and ALL. We also optimize the protocol in details to guarantee good test repeatability. For the first time we introduce "stiffness" into the in vivo biomechanics,so as to get comprehensive and accurate biomechanical data.
3. This is the first report of the in vivo biomechanical properties of pelvic floor important support structure and ALL in fresh cadavers of Chinese women. We provided biomechanical evidence for the efficiency of reconstructive pelvis surgery.
4. This study measured the in vivo biomechanical properties of ring around cervix firstly at home and suggested to sew ring around cervix to provide sufficient strength in reconstructive pelvic surgery.
5. As we know, it was the first time that we survey the ultimate load of ATFP in fresh cadavers of Chinese women by simulating the Peking^Union-modified pelvic floor reconstruction surgery. The results showed that the Peking-Union-modified surgery could provide equal strength to the total pelvic floor reconstruction surgery(Prolift).
6. The fascia on the ischial spine had similar ultimate load value with SSL and greater stiffness than mesh, which is safe, strong and economical to be used as a new site for suspension in vaginal prolapse.
7. There was a considerable variability for the ultimate load value and stiffness index of SSL, which is recognized as a strong ligament.
8. The ultimate load and stiffness of ALL both decreased along the sacrum. It was the first time to recommend ALL at the sacral promontory as the best suture point of sacrocolpopexy from these two mechanical parameter.
9. It was the first time to compare the in vivo biomechanical properties of TVT-0 and TVT-Secur, furthermore making recommendations for optimizing the experimental protocol of mesh.The mechanical resistance of TVT-Secur-H-type was found to be comparable with that of TVT-0. Therefore, TVT-Secur-H-type could acquire similar clinical effect to TVT-0 in theory.
方法：在10具新鲜女性尸体上按照各种盆底重建手术操作方式缝合所涉及的宫骶韧带、宫颈周围环、盆筋膜腱弓、坐骨棘筋膜、骶棘韧带、骶前纵韧带,利用在体拉伸测量系统完成连续加载并同步记录载荷和位移参数,根据所得的载荷-变形曲线分析比较各组织结构的生物力学性能；运用随机数字表确定尸体标本的手术方式(TVT-05例和TVT-Secur H型5例),利用在体拉伸测量系统测量并比较两者的在体生物力学性能。
结果：
1.宫骶韧带、宫颈周围环、盆筋膜腱弓、坐骨棘筋膜、骶棘韧带的极限载荷分别为37.3±23.5N、49.3±28.4N、46.8±18.7N、42.2±19.8N、39.4±25.6N,各组韧带间无显著差异(P=0.462)；同时发现各组韧带的极限载荷个体差异大,但盆筋膜腱弓及坐骨棘筋膜极限载荷的变异系数分别为40.02%、46.99%,均明显小于其余三组的,说明前两者的极限载荷的变化范围相对较小
2.宫骶韧带、宫颈周围环、盆筋膜腱弓、坐骨棘筋膜、骶棘韧带的刚度分别为1.26±1.22 N/mm.1.45±0.92 N/mm.1.28±O.44 N/mm.1.47±O.40 N/mm、1.47±0.62 N/mm,各组间亦无显著差异(P=0.832),同样发现ATFP及坐骨棘筋膜刚度的变化范围明显小于其余三组的,前两者刚度的变异系数分别为34.12%、27.30%。
3.10具尸体中各水平骶前纵韧带的极限载荷由上到下依次递减,分别为129.55±64.07N.69.46±15.52N.18.90±7.52N,差异有统计学意义(P<0.01)。
4.骶岬、骶1、骶2水平前纵韧带的刚度依次为4.24±2.14N/mm.2.9l±1.54N/mm、2.14±0.79N/mm,亦呈现递减趋势,差异有统计学意义(P<0.01)。各水平骶前纵韧带两两相比,骶岬水平的刚度明显大于骶1(P=0.011)及骶2水平(P<0.01)的刚度,而骶1和骶2水平间无显著差异(P=0.117)。
5.TVT-O吊带置入尸体体内后的机械阻力为18.71±2.68N,大于TVT-SecurH型的12.30±9.70N,但差异无统计学意义(P=0.192)。
结论：
1.本研究自主设计了操作性强、精确度高的数字化女性盆底生物力学在体拉伸测量系统,能连续可调节地加载并同步提供载荷和位移参数,并可在水平面及矢状面调整加载方向,为后续的女性盆底支持结构在体生物力学性能测量方法的建立及盆底重建手术有效性的研究提供了有效的研究工具。
2.建立了实用可行的女性盆底支持结构及骶前纵韧带在体生物力学性能的测量方法；从缝线选择、加载速度、拉伸方向、缝合位点等方面优化试验方法,增加了试验的稳定性和可重复性。首次在在体生物力学性能测定中引入刚度这一力学参数,利用刚度变化准确判断极限载荷,从而获得更为全面准确的生物力学数据。
3.首次完成中国女性新鲜尸体标本盆底重要支持结构和骶前纵韧带的在体生物力学性能测定,为各种盆底重建手术的有效性提供生物力学数据。
4.本研究测量了宫颈周围环的生物力学性能,在国内尚属首次,发现其极限载荷明显大于阴道壁的,提出在中盆腔缺陷的重建手术中,要确保缝合阴道及阴道外的筋膜即宫颈周围环以提供足够的强度。
5.本研究首次测量了中国女性盆筋膜腱弓的极限载荷,缝合位点模拟协和式改良全盆底重建术前路深带的穿刺点,结果显示其可提供与Prolift前路深带悬吊点同样有力的支持,从而为协和式改良全盆底重建术手术的有效性提供了生物力学依据。
6.坐骨棘筋膜为坐骨棘盆面的肌肉筋膜组织,本研究测得的极限载荷与骶棘韧带相似,而刚度大于常用的聚丙烯网片,且其力学性能的个体差异小,稳定性好,结合应用解剖学,提出坐骨棘筋膜可以成为新的治疗阴道脱垂的安全有效且经济的悬吊点。
7.骶棘韧带是公认的强壮有力的韧带,本研究通过测量骶棘韧带的在体生物力学性能,指出离体生物力学研究难以真实反映其在体内的力学状态,同时发现其极限载荷和刚度的个体差异大。
8.骶前纵韧带的极限载荷及刚度均沿骶骨由上向下呈递减趋势。本研究首次同时从极限载荷和刚度两方面提供生物力学依据,建议骶骨阴道固定术应首选骶岬水平(即腰5骶1椎间盘水平)的前纵韧带作为缝合位点。
9.本研究首次对TVT-0和TVT-Secur两种吊带在新鲜尸体体内生物力学性能进行了深入研究,为今后优化网片在体生物力学性能的研究方法提出了建议。同时提出TVT-Secur-H型在术后短期的在体生物力学性能可与TVT-0相媲美,理论上在术后早期可达到与TVT-0相似的临床效果,为新术式的广泛开展提供生物力学依据。
Objects:To devise a special in vivo puller measuring instrument for female pelvic floor.To establish a reliable experimental protocol to characterize the in vivo biomechanical properties of female pelvic floor supporting structure. To mesure the in vivo biomechanical properties of several important supporting structure, the anterior longitudinal ligament(ALL) and the tensile free vaginal tape. Accordingly, to provide biomechanical evidence for the efficiency of reconstructive pelvic surgery.
Materials and Methods:Ten fresh cadavers were dissected to expose uterosacral Ligament(USL),the ring around cervix, arcus tendineus fascia pelvis(ATFP), fascia on the ischial spine, sacrospinous ligament(SSL) and ALL. After the fascia and ligaments were sewed according to the surgical technique, they were stretched at a steady rate until breakage while allowing constant electronic registration of load and displacement. Then to compare the in vivo biomechanical properties by analyzing the load-displacement curve.Ten fresh cadavers were randomized to (tension free vaginal tape—obturator)TVT-0 or the TVT-Secur group, each group had five bodies. After the surgical procedures was finished, tension tests were performed by the purpose-built puller system to prove the surgical efficiency.
Results:
1. The ultimate load of USL, the ring around cervix, ATFP, fascia on the ischinal spine and SSL was 37.3±23.5N,49.3±28.4N、46.8±18.7N、42.2±19.8N and 39.4±25.6N, respectively, and there was no significant difference among groups(P>0.05). The coefficient of variation(CV) of ATFP and fascia on the ischial spine were less than the others. That is to say, the individual differences of ultimate load among the first two groups were small.
2. The stiffness of USL, the ring around cervix, ATFP, fascia on the ischinal spine and SSL was 1.26±1.22 N/mm,1.45±0.92 N/mm,1.28±0.44 N/mm, 1.47±0.40 N/mm and 1.47±0.62 N/mm, respectively. There was also no significant difference among groups (P>0.05). There was a considerable variability for each value, but the CV of ATFP and fascia on the ischial spine were less than the other three groups.
3. The ultimate load of ALL at the sacral promontory, the first sacral vertebra and the second sacral vertebra were 129.55±64.07N、69.46±15.52N and 18.90±7.52N, respectively. It progressively decreased distally along the sacral vertebra, the differences between levels were significant(P<0.01).
4. The stiffness of ALL was 4.24±2.14N/mm at the sacral promontory,2.91±1.54N/mmat the first sacral vertebra and 2.14±0.79N/mm at the second sacral vertebra, which was declining(P<0.05). The stiffness of ALL at the sacral promontory was greater than the stiffness of other levels (P<0.01), but there was no significant difference between the lower two levels (P>0.05).
5. The mechanical resistance of TVT-0 was 18.71±2.68N, which was stronger than TVT-Secur, but no significant difference could be found(P>0.05).
Conclusions:
1. We devised a digital in vivo puller measuring instrument for female pelvic floor biomechanical study with high fidelity. The instrument can stretch samples at a continuous and adjustable rate until breakage while allowing constant electronic registration of load and displacement. It can enable orientation in a vertical and horizontal surface plane in order to guide traction.
2. We established a reliable experimental protocol to characterize the in vivo biomechanical properties of female pelvic floor supporting structure and ALL. We also optimize the protocol in details to guarantee good test repeatability. For the first time we introduce "stiffness" into the in vivo biomechanics,so as to get comprehensive and accurate biomechanical data.
3. This is the first report of the in vivo biomechanical properties of pelvic floor important support structure and ALL in fresh cadavers of Chinese women. We provided biomechanical evidence for the efficiency of reconstructive pelvis surgery.
4. This study measured the in vivo biomechanical properties of ring around cervix firstly at home and suggested to sew ring around cervix to provide sufficient strength in reconstructive pelvic surgery.
5. As we know, it was the first time that we survey the ultimate load of ATFP in fresh cadavers of Chinese women by simulating the Peking^Union-modified pelvic floor reconstruction surgery. The results showed that the Peking-Union-modified surgery could provide equal strength to the total pelvic floor reconstruction surgery(Prolift).
6. The fascia on the ischial spine had similar ultimate load value with SSL and greater stiffness than mesh, which is safe, strong and economical to be used as a new site for suspension in vaginal prolapse.
7. There was a considerable variability for the ultimate load value and stiffness index of SSL, which is recognized as a strong ligament.
8. The ultimate load and stiffness of ALL both decreased along the sacrum. It was the first time to recommend ALL at the sacral promontory as the best suture point of sacrocolpopexy from these two mechanical parameter.
9. It was the first time to compare the in vivo biomechanical properties of TVT-0 and TVT-Secur, furthermore making recommendations for optimizing the experimental protocol of mesh.The mechanical resistance of TVT-Secur-H-type was found to be comparable with that of TVT-0. Therefore, TVT-Secur-H-type could acquire similar clinical effect to TVT-0 in theory.
引文
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