Stapler for corneal transplantation: a hypothesis.

Abstract

Background: 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.

Hypothesis: 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.

Conclusions: 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.