Kartush J M
Department of Otology and Neurotology, Providence Hospital, Southfield, Michigan, USA.
Am J Otol. 2000 Sep;21(5):615-20.
To assess a new device intended to cover tympanic membrane (TM) perforations in an office setting.
Not all patients with TM perforations require or choose tympanoplasty surgery. Alternatives to surgery (e.g., paper and plastic onlay) have limitations that prompted a need for an alternative method. A new, simple device, designed to be inserted into the perforation, is made out of a very soft silicone in the shape of a sealed tympanostomy tube. The TM Patcher is self-stabilizing without adhesives.
An outpatient office.
Twenty-nine patients with 30 consecutive dry TM perforations, who volunteered to participate in the study. Patients with known cholesteatomas or persistent drainage were excluded.
In the office, patients had the Patcher inserted into their dry TM perforation. No anesthetics were needed.
Hearing was tested before and after patching by conventional audiometry. The ears were assessed for Patcher position, perforation status, and infection.
Patients with normal ossicular chains had immediate improvement of hearing. No patient experienced hearing loss. Twenty-six of 30 patients (87%) were free of infection. Two patients (7%) with persistent drainage were taken to surgery and were found to have mastoid disease (cholesteatoma or granulation tissue). Three patients (10%) had rare otorrhea after patching and were treated by drops or temporary removal of the Patcher. Two of these three ears subsequently became dry and then healed. Small perforations often healed or became smaller (46% of 3-mm perforations) despite failure of tympanoplasty or conventional office patching with a flat piece of paper or plastic. Perforations >5 mm did not heal; however, these patients simply continued wearing their Patcher and benefited by protection of their middle ear, typically with improved hearing and resolution of tinnitus. Occasional spontaneous lateralization was allowed to occur in the small perforations, which often later healed. In larger perforations, the Patcher was simply repositioned.
The Patcher is a safe and effective alternative for office patching of dry perforations when surgery is contraindicated or is refused by the patient. New materials should increase healing rates when applied to a Phase II Patcher.
评估一种旨在用于门诊环境覆盖鼓膜穿孔的新装置。
并非所有鼓膜穿孔患者都需要或选择鼓室成形术。手术替代方法（如纸片和塑料贴片）存在局限性，这促使需要一种替代方法。一种设计用于插入穿孔的新型简单装置由非常柔软的硅胶制成，呈密封鼓室造瘘管形状。鼓膜贴片器无需粘合剂即可自我稳定。
门诊办公室。
29例患者，连续30个干性鼓膜穿孔，自愿参与本研究。排除已知有胆脂瘤或持续性耳漏的患者。
在门诊，患者将贴片器插入干性鼓膜穿孔。无需麻醉。
通过传统听力测定法在贴片前后测试听力。评估耳朵的贴片器位置、穿孔状态和感染情况。
听骨链正常的患者听力立即改善。无患者出现听力损失。30例患者中有26例（87%）无感染。2例（7%）持续性耳漏患者接受手术，发现有乳突疾病（胆脂瘤或肉芽组织）。3例患者（10%）贴片后有罕见耳漏，通过滴耳剂或临时取出贴片器进行治疗。这三只耳朵中有两只随后变干并愈合。尽管鼓室成形术或用平纸片或塑料进行传统门诊贴片失败，但小穿孔通常愈合或变小（3毫米穿孔的46%）。大于5毫米的穿孔未愈合；然而，这些患者只需继续佩戴贴片器，中耳得到保护通常会受益，典型表现为听力改善和耳鸣缓解。小穿孔偶尔会出现自发偏向，之后通常会愈合。在较大穿孔中，只需重新调整贴片器位置。
当手术禁忌或患者拒绝手术时，贴片器是门诊干性穿孔贴片的一种安全有效的替代方法。应用于II期贴片器的新材料应能提高愈合率。
