Ramirez-Miranda Arturo, Haber-Olguin Alberto, Moya-Villamar Juan A, Pedro-Aguilar Lucero, Vera-Duarte Guillermo Raul, Ortiz-Morales Gustavo, Navas Alejandro, Loya-Garcia Denise, Graue-Hernandez Enrique O
Department of Cornea and Refractive Surgery, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Eye Bank, Instituto de Oftalmologia Fundacion Conde de Valenciana IAP, Mexico City, Mexico.
Med Hypothesis Discov Innov Ophthalmol. 2025 May 10;14(1):239-246. doi: 10.51329/mehdiophthal1515. eCollection 2025 Spring.
Corneal transplantation requires exquisite microsurgical precision, particularly during the suturing of donor and recipient tissues. In corneal transplantation procedures such as penetrating keratoplasty, the donor cornea is traditionally secured using ultrafine 10-0 nylon sutures, meticulously placed under an operating microscope to achieve precise tension and promote optimal wound healing. Although this technique remains the reference standard, it is inherently time-intensive and requires advanced microsurgical expertise. To enhance surgical efficiency and maintain clinical outcomes, recent innovations have proposed the use of a modified stapling device equipped with ultrafine nylon staples as an alternative to conventional suturing. Although experimental stapling systems have been engineered to facilitate graft fixation, widespread clinical adoption or regulatory approval has not yet been achieved, largely because of unresolved concerns regarding precision, stability, and long-term safety.
To address these challenges, we propose an adaptation of the skin stapler mechanism, employing nylon-based staples specifically engineered for corneal application. This study hypothesizes that the development of a specialized corneal stapler as a viable, time-efficient alternative to manual suturing in keratoplasty is feasible, contingent upon addressing critical challenges. These include replicating the biomechanical finesse and tension control of sutures, ensuring the biocompatibility of staple materials with ocular tissues, and minimizing the risk of postoperative complications such as astigmatism, wound dehiscence, and infection. The specialized corneal stapler utilizing ultrafine, biocompatible nylon staples can replicate the precision, tension control, and wound stability achieved by traditional 10-0 nylon suturing in penetrating keratoplasty, while significantly reducing operative time and technical demands. Rigorous preclinical testing and clinical validation are essential to evaluate whether stapling technology can match or exceed the standards established by traditional suturing techniques in corneal transplantation.
The conceptual model for a specialized corneal stapler presents a promising alternative to traditional suturing techniques. However, substantial technological innovation is necessary to meet the intricate anatomical and surgical requirements of the cornea. Further research, including iterative prototyping and preclinical validation, is essential before clinical applications can be realized. Moreover, further research and clinical validation are necessary to determine whether staplers can safely and effectively replace traditional sutures during corneal transplantation.
角膜移植需要精湛的显微手术精度,尤其是在缝合供体和受体组织时。在穿透性角膜移植等角膜移植手术中,传统上使用超精细的10-0尼龙缝线固定供体角膜,在手术显微镜下精心放置以实现精确的张力并促进最佳的伤口愈合。尽管该技术仍然是参考标准,但它本质上耗时且需要先进的显微手术专业知识。为了提高手术效率并维持临床效果,最近的创新提出使用配备超精细尼龙钉的改良吻合器装置作为传统缝合的替代方法。尽管已经设计了实验性吻合器系统以促进移植物固定,但尚未实现广泛的临床应用或监管批准,这主要是因为在精度、稳定性和长期安全性方面仍存在未解决的问题。
为应对这些挑战,我们提出对皮肤吻合器机制进行改进,采用专门为角膜应用设计的尼龙钉。本研究假设,开发一种专门的角膜吻合器作为角膜移植中手动缝合的可行、省时替代方法是可行的,但前提是要应对关键挑战。这些挑战包括复制缝线的生物力学精细度和张力控制,确保钉材料与眼组织的生物相容性,并将术后并发症如散光、伤口裂开和感染的风险降至最低。使用超精细、生物相容性尼龙钉的专门角膜吻合器可以复制传统10-0尼龙缝线在穿透性角膜移植中实现的精度、张力控制和伤口稳定性,同时显著减少手术时间和技术要求。严格的临床前测试和临床验证对于评估吻合器技术在角膜移植中是否能够达到或超过传统缝合技术所确立的标准至关重要。
专门角膜吻合器的概念模型为传统缝合技术提供了一个有前景的替代方案。然而,需要大量的技术创新来满足角膜复杂的解剖和手术要求。在实现临床应用之前,进一步的研究,包括迭代原型制作和临床前验证,是必不可少的。此外,还需要进一步的研究和临床验证来确定吻合器在角膜移植过程中是否能够安全有效地替代传统缝线。