A novel shape-memory Bi-hook device for nasolacrimal duct stent implantation in canalicular laceration repair
摘要
To evaluate the clinical efficacy and safety of a novel shape-memory Bi-hook device in facilitating antegrade stent implantation for canalicular laceration repair.
MethodsIn this retrospective comparative study, 76 patients (76 eyes) with canalicular laceration were enrolled: 39 patients (39 eyes) underwent Bi-hook-assisted stent implantation (Bi-hook group) and 37 patients received conventional Ritleng stent intubation (control group). The Bi-hook device was fabricated using a thermally shaped 0.2-mm nitinol (nickel-titanium shape-memory alloy) wire within a stainless-steel bending needle to exploit its shape-memory properties. It was utilized to perform canalicular probing, advancing the nitinol wire until it spontaneously emerged from the nasal vestibule, which then guided the retrograde passage of a 5 − 0 silk thread through the lacrimal punctum, ultimately facilitating antegrade placement of the lacrimal stent. All patients were followed up for at least 6 months. The silicone stents were removed at three months postoperatively. Primary outcome measures included the success rates of nasal vestibule spontaneous emergence (nitinol wire/ prolene guidewire), the number of lacrimal duct probing attempts, stent intubation time, and postoperative complications. Secondary outcomes encompassed lacrimal irrigation patency rate, tear meniscus height (TMH) via anterior segment optical coherence tomography (AS-OCT), and Munk scores.
ResultsThe success rates of nasal vestibule spontaneous emergence (nitinol wire/ prolene guidewire) significantly differed between the groups, with 38 cases (97.44%) achieving spontaneous emergence in the Bi-hook group, compared to only 6 cases (16.22%) in the control group, (p < 0.001) with nasal endoscopy assisting retrieval in cases of failed wire emergence. Although the number of probing attempts showed comparable results between the groups (Bi-hook: 2.68 ± 2.56; control: 3.57 ± 4.13, p = 0.064), stent insertion time was 18.93 ± 7.19 min in Bi-hook group and 32.02 ± 10.25 min in the control group (p < 0.001). The Bi-hook group showed a significantly lower incidence of immediate postoperative complications. Nasal hemorrhage occurred in 5.13% of the Bi-hook cases compared to 21.6% in the control group (p = 0.033), and eyelid edema was observed in 12.82% versus 29.73% of cases respectively (p = 0.022). However, assessments conducted postoperatively revealed no statistically significant differences between the groups in terms of lacrimal duct patency, TMH, or Munk scores (all p > 0.05).
ConclusionThe self-made Bi-hook device, featuring a memory-shaped nitinol wire tip, effectively facilitates lacrimal stent intubation in patients with canalicular lacerations. The Bi-hook demonstrated procedural advantages in surgical efficiency and immediate postoperative safety, though long-term functional outcomes were comparable between groups.