The aim of this study was to evaluate the effectiveness of BM (basement membrane) and SIS (small intestine submucosa) composite extracellular matrix staple line reinforcement in surgical procedures through finite element modelling simulations and leak-proof performance experiments. The mechanical analyses of soft tissues with and without staple line reinforcement were performed by establishing finite element models of three tissues, namely, stomach, intestine and lungs, under the use scenarios of different anastomosis staple models; and the leak-proof performance of the staple line reinforcement was evaluated by simulating leak-proof experiments of gastric incision margins, intestinal sections, and lung incision margins in vitro. The results showed that the equivalent average stresses of the staple line reinforcement were increased by 20 kPa-68 kPa in gastric and intestinal tissues, and 8 kPa-22 kPa in lung tissues. and that the BM and SIS composite extracellular matrix staple line reinforcement could strengthen the anastomotic structure, and at the same time disperse the high stresses of the anastomosed tissues, which could effectively reduce the postoperative complications such as anastomotic bleeding and anastomotic leakage, and provide a safer and more effective optimized design for surgical mechanical anastomosis. It can effectively reduce postoperative complications such as anastomotic bleeding and anastomotic leakage, and provide a safer and more effective optimized design for surgical mechanical anastomosis.
References
[1]
Reddy, B.N., Subhash, M., Vangel, M., Markowiak, S., Delvadia, D., Razdan, S., et al. (2023) Mortality Related to the Use of Stapler Devices and Clip Appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database. Surgery, 173, 1184-1190. https://doi.org/10.1016/j.surg.2022.11.013
[2]
Betzold, R. and Laryea, J.A. (2014) Staple Line/Anastomotic Reinforcement and Other Adjuncts: Do They Make a Difference? Clinics in Colon and Rectal Surgery, 27, 156-161. https://doi.org/10.1055/s-0034-1394089
[3]
Ghosh, S., More, N. and Kapusetti, G. (2022) Surgical Staples: Current State-of-the-Art and Future Prospective. Medicine in Novel Technology and Devices, 16, Article ID: 100166. https://doi.org/10.1016/j.medntd.2022.100166
[4]
Myers, S.R., Rothermel, W.S. and Shaffer, L. (2011) The Effect of Tissue Compression on Circular Stapler Line Failure. Surgical Endoscopy and Other Interventional Techniques, 25, 3043-3049. https://doi.org/10.1007/s00464-011-1667-4
[5]
Amani, H., Habibey, R., Hajmiresmail, S., Latifi, S., Pazoki-Toroudi, H. and Akhavan, O. (2017) Antioxidant Nanomaterials in Advanced Diagnoses and Treatments of Ischemia Reperfusion Injuries. Journal of Materials Chemistry B, 5, 9452-9476. https://doi.org/10.1039/C7TB01689A
[6]
Shikora, S.A. and Mahoney, C.B. (2015) Clinical Benefit of Gastric Staple Line Reinforcement (SLR) in Gastrointestinal Surgery: A Meta-Analysis. Obesity Surgery, 25, 1133-1141. https://doi.org/10.1007/s11695-015-1703-x
[7]
Lin, X.X., Wang, W.B., Zhang, W.J., Zhang, Z.Y., Zhou, G.D., Cao, Y.L., et al. (2017) Hyaluronic Acid Coating Enhances Biocompatibility of Nonwoven PGA Scaffold and Cartilage Formation. Tissue Engineering Part C-Methods, 23, 86-97. https://doi.org/10.1089/ten.tec.2016.0373
[8]
Wood, A.J., Cozad, M.J., Grant, D.A., Ostdiek, A.M., Bachman, S.L. and Grant, S.A. (2013) Materials Characterization and Histological Analysis of Explanted Polypropylene, PTFE, and PET Hernia Meshes from an Individual Patient. Journal of Materials Science-Materials in Medicine, 24, 1113-1122. https://doi.org/10.1007/s10856-013-4872-y
[9]
Angrisani, L., Lorenzo, M., Borrelli, V., Ciannella, M., Bassi, U.A. and Scarano, P. (2004) The Use of Bovine Pericardial Strips on Linear Stapler to Reduce Extraluminal Bleeding during Laparoscopic Gastric Bypass: Prospective Randomized Clinical Trial. Obesity Surgery, 14, 1198-1202. https://doi.org/10.1381/0960892042387075
[10]
Downey, D.M., Harre, J.G. and Dolan, J.R. (2005) Increased Burst Pressure in Gastrointestinal Staple-Lines Using Reinforcement with a Bioprosthetic Material. Obesity Surgery, 15, 1379-1383. https://doi.org/10.1381/096089205774859254
[11]
Badylak, S., Kokini, K., Tullius, B., Simmons-Byrd, A. and Morff, R. (2002) Morphologic Study of Small Intestinal Submucosa as a Body Wall Repair Device. Journal of Surgical Research, 103, 190-202. https://doi.org/10.1006/jsre.2001.6349
[12]
Wong, J.B., Henninger, D.D., Clymer, J.W., Ricketts, C.D. and Fryrear II, R.S. (2020) A Novel, Easy-to-Use Staple Line Reinforcement for Surgical Staplers. Medical Devices-Evidence and Research, 13, 23-29. https://doi.org/10.2147/MDER.S234156
[13]
Cheng, W.Y., Yang, X.X., Chen, S.S., Zhao, M.B., Zhang, J.P., et al. (2021) Comparative Study on the in Vivo and in Vitro Degradation Process of Biological Grafts Derived from Different Tissues. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 15, 97-101.
[14]
Cheng, W.Y., Chen, J.S., Liu, Y.T., Zhao, M.B., Wang, Q., et al. (2019) Experimental Assessment of Tissue Repair of Basement Membrane in Partial Thickness Defect in Abdominal Wall of Rats. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 13, 198-203.
[15]
Baker, R.S., Foote, J., Kemmeter, P., Brady, R., Vroegop, T. and Serveld, M. (2004) The Science of Stapling and Leaks. Obesity Surgery, 14, 1290-1298. https://doi.org/10.1381/0960892042583888
[16]
Simone, C. and Okamura, A.M. (2002) Modeling of Needle Insertion Forces for Robot-Assisted Percutaneous Therapy. 19th IEEE International Conference on Robotics and Automation (ICRA), Washington DC, 11-15 May 2002, 2085-2091.
[17]
Egorov, V.I., Schastlivtsev, I.V., Prut, E.V., Baranov, A.O. and Turusov, R.A. (2002) Mechanical Properties of the Human Gastrointestinal Tract. Journal of Biomechanics, 35, 1417-1425. https://doi.org/10.1016/S0021-9290(02)00084-2
[18]
Haber, H.P. and Stern, M. (2000) Intestinal Ultrasonography in Children and Young Adults: Bowel Wall Thickness Is Age Dependent. Journal of Ultrasound in Medicine, 19, 315-321. https://doi.org/10.7863/jum.2000.19.5.315
[19]
Rawlins, L., Rawlins, M.P. and Teel II, D. (2014) Human Tissue Thickness Measurements from Excised Sleeve Gastrectomy Specimens. Surgical Endoscopy and Other Interventional Techniques, 28, 811-814. https://doi.org/10.1007/s00464-013-3264-1
[20]
Wang, S.X., Wang, J.C. and Li, J.M. (2015) Modelling and Quality Control of Robot-Assisted Gastrointestinal Assembly. Cirp Annals-Manufacturing Technology, 64, 21-24. https://doi.org/10.1016/j.cirp.2015.04.050
[21]
Trân, T., Novacek, V., Tolba, R., Klinge, U., Turquier, F. and Staat, M. (2011) Experimental and Computational Approach to Study Stapled Colorectal Anastomosis. Proceedings of the International Society of Biomechanics, Brussels, 3-7 July 2011.
[22]
Gao, F., Liao, D.H., Zhao, J.B., Drewes, A.M. and Gregersen, H. (2008) Numerical Analysis of Pouch Filling and Emptying after Laparoscopic Gastric Banding Surgery. Obesity Surgery, 18, 243-250. https://doi.org/10.1007/s11695-007-9314-9
[23]
Hampton, C.E. and Kleinberger, M. (2018) Material Models for the Human Torso Finite Element Model. US Army Research Laboratory (ARL), Aberdeen Proving Ground.
[24]
Naini, A.S., Patel, R.V. and Samani, A. (2011) Measurement of Lung Hyperelastic Properties Using Inverse Finite Element Approach. IEEE Transactions on Biomedical Engineering, 58, 2852-2859. https://doi.org/10.1109/TBME.2011.2160637
[25]
Saraf, H., Ramesh, K.T., Lennon, A.M., Merkle, A.C. and Roberts, J.C. (2007) Mechanical Properties of Soft Human Tissues under Dynamic Loading. Journal of Biomechanics, 40, 1960-1967. https://doi.org/10.1016/j.jbiomech.2006.09.021
[26]
De, S., Rosen, J., Dagan, A., Hannaford, B., Swanson, P. and Sinanan, M. (2007) Assessment of Tissue Damage Due to Mechanical Stresses. International Journal of Robotics Research, 26, 1159-1171. https://doi.org/10.1177/0278364907082847
[27]
NovÁCek, V., Trân, T.N., Klinge, U., Tolba, R.H., Staat, M., Bronson, D.G., et al. (2012) Finite Element Modelling of Stapled Colorectal End-to-End Anastomosis: Advantages of Variable Height Stapler Design. Journal of Biomechanics, 45, 2693-2697. https://doi.org/10.1016/j.jbiomech.2012.07.021
