纺织学报 ›› 2022, Vol. 43 ›› Issue (03): 38-43.doi: 10.13475/j.fzxb.20211109806

• 特约专栏:生物医用纺织品 • 上一篇    下一篇

女性压力性尿失禁吊带的设计及其体外力学性能评价

方镁淇1,2, 王茜1,2, 李彦1,2,3, 李超婧1,2,3(), 黎昊4, 王璐1,2,3   

  1. 1.东华大学 纺织学院, 上海 201620
    2.东华大学 纺织面料技术教育部重点实验室, 上海 201620
    3.东华大学 纺织行业生物医用纺织材料与技术重点实验室, 上海 201620
    4.上海宏钰医疗科技有限公司, 上海 201400
  • 收稿日期:2021-11-24 修回日期:2022-01-04 出版日期:2022-03-15 发布日期:2022-03-29
  • 通讯作者: 李超婧
  • 作者简介:方镁淇(1998—),女,硕士生。主要研究方向为女性压力性尿失禁吊带。
  • 基金资助:
    中央高校基本科研业务费专项资金资助项目(2232020G-01);高等学校学科创新引智计划2.0项目(BP0719035)

Design and in-vitro mechanical property analyses of sling for female stress urinary incontinence

FANG Meiqi1,2, WANG Qian1,2, LI Yan1,2,3, LI Chaojing1,2,3(), LI Hao4, WANG Lu1,2,3   

  1. 1. College of Textiles, Donghua University, Shanghai 201620, China
    2. Key Laboratory of Textile Science & Technology, Ministry of Education, Donghua University, Shanghai 201620, China
    3. Key Laboratory of Textile Industry for Biomedical Textile Materials and Technology, Donghua University, Shanghai 201620, China
    4. Shanghai Hongyu Medical Tech Co., Ltd., Shanghai 201400, China
  • Received:2021-11-24 Revised:2022-01-04 Published:2022-03-15 Online:2022-03-29
  • Contact: LI Chaojing

摘要:

为改善女性压力性尿失禁吊带术后侵蚀并发症,制备了菱形网孔激光切割边缘吊带和矩形网孔自锁成边吊带,分别测试了吊带网片宽度、厚度、面密度、线圈密度、密度对比系数、孔径尺寸、孔隙率和有效孔隙率,并且进行了单轴向拉伸测试与定负荷反复拉伸测试,初步分析了2款吊带的长期有效性与抗皱缩变形能力。结果表明:2款吊带均满足轻质大孔、高有效孔隙率的需求,断裂强度与断裂伸长率均无显著差异;矩形网眼吊带的弹性模量与抗弯刚度明显大于菱形网眼吊带,在2.5和16 N/cm定负荷拉伸下都具有更高的有效孔隙率和更优异的尺寸稳定性,同时具有更显著的尿道壁支撑作用,但吊带的柔软度仍需进一步改进。

关键词: 女性压力性尿失禁吊带, 无张力尿道中段悬吊术, 医用纺织品, 织物结构, 体外力学性能

Abstract:

To improve the postoperative erosion of female stress urinary incontinence, a sling with laser-cut diamond-shaped pores and a sling with rectangular pore shapes and self-locking edge were designed. The mesh width, thickness, density, ratio of course density to wale density, pore size, porosity, and effective porosity were characterized and analyzed. The test results of the uniaxial tension and constant load tension test, and the long-term effectiveness and the shrinkage of the two types of slings were discussed and studied. The results show that the two slings are light-weight with large pores, meeting the requirements of high effective porosity, and there is no significant difference between the two in breaking strength and elongation. However, the elastic modulus and flexural stiffness of rectangular mesh sling are obviously larger than that of diamond mesh sling, having higher effective porosity, better dimensional stability and more significant supporting effect of urethral wall under both 2.5 and 16 N/cm loading. The flexibility of the slings would need further improvement.

Key words: sling for female stress urinary incontinence, tension-free mid-urethral sling procedure, medical textiles, fabric structure, mechanical property in-vitro

中图分类号: 

  • TS181

图1

吊带A和吊带B经编结构和垫纱运动图"

图2

吊带A和吊带B网孔选区和网孔间距测量实例"

表1

网孔参数测试结果 (P<0.05)"

样品 最大网孔间距/mm 孔隙率/% 有效孔隙率/%
吊带A 1.55±0.08 67.82±0.70 55.62±0.12
吊带B 1.88±0.06 73.55±2.50 57.17±1.00

表2

吊带结构参数测试结果"

样品 宽度/cm 厚度/mm 面密度/
(g·m-2)
横密/
(纵行·cm-1)
纵密/
(横列·cm-1)
线圈密度/
(个·cm-2)
密度对比
系数K
吊带A 1.29±0.10 0.369±0.001 46.4 9 9 81 1
吊带B 1.69±0.10 0.497±0.010 40.0 7 18 126 0.39

图3

吊带A和吊带B的应力-应变代表性曲线"

图4

吊带A和吊带B的轴向拉伸性能对比"

图5

吊带A和吊带B的定负荷拉伸宏观图像"

表3

吊带A和吊带B的定负荷拉伸性能对比"

负荷/
(N·cm-1)
孔隙率/% 有效孔隙率/% 横向皱缩率/% 塑性变形率/% 弹性回复率/%
吊带A 吊带B 吊带A 吊带B 吊带A 吊带B 吊带A 吊带B 吊带A 吊带B
0 67.82±0.7 73.55±2.5* 55.62±0.1 57.17±1.0*
2.5 57.67±1.8 67.38±1.2* 38.80±2.7 47.87±2.7* 9.44±0.4 4.97±2.2* 1.57±0.2 0.10±0.1* 73.94±5.0 77.87±7.0
16 45.85±0.5 59.68±1.1* 14.23±2.3 43.46±1.1* 35.56±1.5 37.28±2.1 10.06±0.5 11.79±1.9 56.25±2.0 57.30±3.0

表4

L929培养72 h的CCK-8测试结果 (P>0.05)"

样品 OD值 相对细胞活力/%
空白对照 1.61±0.03
吊带A 1.50±0.03 93.21±0.04
吊带B 1.47±0.04 91.52±0.04
[1] ZHANG R Q, XIA M C, CUI F, et al. Epidemiological survey of adult female stress urinary incontinence[J]. BMC Women's Health, 2021,21(1):172.
doi: 10.1186/s12905-021-01319-z
[2] GOMES C M, CARVALHO F L, BELLUCCI C H S, et al. Update on complications of synthetic suburethral slings[J]. Int Braz J Urol, 2017,43(5):822-834.
doi: 10.1590/s1677-5538.ibju.2016.0250
[3] KLINGE U, BINNEBOESEL M, KUSCHEL S, et al. Demands and properties of alloplastic implants for the treatment of stress urinary incontinence[J]. Expert Review of Medical Devices, 2007,4(3):349-359.
doi: 10.1586/17434440.4.3.349
[4] WILLIAMS E R, KLUTKE C G. Stress urinary incontinence: the evolution of the sling[J]. Expert Review of Medical Devices, 2008,5(4):507-523.
doi: 10.1586/17434440.5.4.507
[5] RUSAVY Z, MASATA J, SVABIK K, et al. Are the same tapes really the same? Ultrasound study of laser-cut and mechanically cut TVT-O post-operative behavior[J]. International Urogynecology Journal, 2018,29(9):1335-1340.
doi: 10.1007/s00192-017-3516-z
[6] DIETZ H P, VANCAILLIE P, SVEHLA M, et al. Mechanical properties of urogynecologic implant materials[J]. International Urogynecology Journal, 2003,14(4):239-243.
doi: 10.1007/s00192-003-1041-8
[7] MÜHL T, BINNEBÖSEL M, KLINGE U, et al. New objective measurement to characterize the porosity of textile implants[J]. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 2008,84B(1):176-183.
doi: 10.1002/(ISSN)1552-4981
[8] EDWARDS S L, WERKMEISTER J A, ROSAMILIA A, et al. Characterisation of clinical and newly fabricated meshes for pelvic organ prolapse repair[J]. Journal of the Mechanical Behavior of Biomedical Materials, 2013,23:53-61.
doi: 10.1016/j.jmbbm.2013.04.002
[9] LIN A T L, WANG S J, KUANG K C, et al. In vivo tension sustained by fascial sling in pubovaginal sling surgery for female stress urinary incontinence[J]. Journal of Urology, 2005,173(3):894-897.
doi: 10.1097/01.ju.0000153694.49749.73
[10] AFONSO J S. Estudo comparativo das propriedades fundamentais das redes de polipropileno usadas no tratamento da incontinência urinária de esforço[D]. Sao Paulo: Universidade Federal de São Paulo, 2014: 26-30.
[11] 宋晓晨. 阴道前壁膨出女性的阴道壁生物力学特性研究及三种合成网片植入兔腹壁及阴道后组织相容性及生物力学特性变化的研究[D]. 北京:中国医学科学院北京协和医学院, 2016: 20-24.
SONG Xiaochen. Biomechanical properties of prolapsed anterior vaginal tissue in anterior vaginal prolapse patients and histoligic response and changes in mechanical properties of three synthetic prolapse meshes following implanted in the abdomen and vagina of rabbits[D]. Beijing: Chinese Academy of Medical Sciences & Peking Union Medical College, 2016: 20-24.
[12] 苗琳莉. 经缎组织疝修复平片与三维补片的结构及力学性能[D]. 上海:东华大学, 2016: 11-12.
MIAO Linli. Strucyure and mechanical property of flat and three dimensional hernia mesh with atlas structure[D]. Shanghai: Donghua University, 2016: 11-12.
[13] PRZYDACZ M, ADLI O E Y, MAHFOUZ W, et al. Structural differences and architectural features of two different polypropylene slings (TVT-O and I-STOP) have no impact on biocompatibility and tissue reactions[J]. Cent European J Urol, 2017,70(2):154-162.
[14] MOSTAFA A, AGUR W, ABDEL-ALL M, et al. A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-OTM) in the management of female stress urinary incontinence: pain profile and short-term outcomes[J]. European Journal of Obstetrics & Gynecology and Reproductive Biology, 2012,165(1):115-121.
[15] CHAPIN K, KHALIFA A, MBIMBA T, et al. In vivo biocompatibility and time-dependent changes in mechanical properties of woven collagen meshes: A comparison to xenograft and synthetic mid-urethral sling materials[J]. Journal of Biomedical Materials Research Part B: Applied Biomaterials, 2019,107(3):479-489.
doi: 10.1002/jbm.b.v107.3
[16] 周围, 丁祖泉, 童晓文. 女性压力性尿失禁尿道下吊带术后尿道壁的力学分析[J]. 第三军医大学学报, 2009,31(19):1843-1846.
ZHOU Wei, DING Zuquan, TONG Xiaowen. Mechanical analyses on urethra wall after suburethrai slings for female pig stress urinary incontinence[J]. Acta Academiae Medicinae Militaris Tertiae, 2009,31(19):1843-1846.
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