Lee Taya, Richardson-Powell Vené, Chen Jason, Garvey David, Sarojasamhita Venkata, Aroom Kevin, Wang Martha O, Crouch Brian, Ramanujam Nimmi, Hurvitz Julie, Mueller Jenna
Department of Bioengineering, University of Maryland, College Park, MD, USA.
Robert E. Fishell Institute for Biomedical Devices, University of Maryland, College Park, MD, USA.
Ann Biomed Eng. 2025 Jul 21. doi: 10.1007/s10439-025-03799-8.
Current treatments for cervical neoplasia are often inaccessible in low- and middle-income countries (LMICs), which contributes to high cervical cancer mortality. We previously developed a low-cost ablative therapy using ethanol mixed with ethyl cellulose (EC) to a form an ethanol-retaining gel that reduces injection leakage. To optimize delivery of EC-ethanol into the cervix, we developed and compared three speculum-compatible injectors that each address clinical challenges: 1) a single needle injector, which contained an adjustable depth stop to control the depth of injection, 2) a multi needle injector, which injected three locations in the cervix simultaneously, and 3) an extender injector, which included a needle extender.
The variability in EC-ethanol injections was evaluated through bench top and ex vivo swine testing. Usability testing was performed by gynecology (GYN) providers who used each device in a custom pelvic model.
Both the extender and single needle devices led to consistent ejection volumes in benchtop tests with no variability between injections. All devices achieved spherical depots with minimal leakage in ex vivo tests. In usability testing, 65% of GYN providers preferred the extender device, which achieved significantly shorter injection times in the custom pelvic model compared to other injectors.
While all devices met clinical constraints, the extender device was preferred by clinicians and achieved repeatable injection distributions. This work presents a clinically informed low-cost intracervical delivery method for LMICs. Future work will include validating performance in clinical trials and assessing feasibility in clinical settings to advance global cervical neoplasia treatment.
在低收入和中等收入国家（LMICs），目前用于宫颈肿瘤的治疗方法往往难以获得，这导致宫颈癌死亡率居高不下。我们之前开发了一种低成本的消融疗法，使用乙醇与乙基纤维素（EC）混合形成一种能减少注射渗漏的乙醇保留凝胶。为了优化EC - 乙醇向宫颈的递送，我们开发并比较了三种与窥器兼容的注射器，每种都针对临床挑战：1）单针注射器，其包含一个可调节的深度限位器以控制注射深度；2）多针注射器，其能同时在宫颈的三个位置进行注射；3）延长器注射器，其包括一个针头延长器。
通过台式试验和离体猪测试评估EC - 乙醇注射的变异性。由妇科（GYN）医护人员在定制盆腔模型中使用每种设备进行可用性测试。
在台式试验中，延长器和单针设备都能实现一致的喷射体积，注射之间没有变异性。在离体测试中，所有设备都实现了球形储库且渗漏最小。在可用性测试中，65%的妇科医护人员更喜欢延长器设备，与其他注射器相比，它在定制盆腔模型中的注射时间明显更短。
虽然所有设备都满足临床限制，但延长器设备更受临床医生青睐，并且实现了可重复的注射分布。这项工作为LMICs提出了一种基于临床经验的低成本宫颈内递送方法。未来的工作将包括在临床试验中验证性能以及评估在临床环境中的可行性，以推进全球宫颈肿瘤的治疗。
