Development and functional characterization of a novel respiratory mask with full accordion cushioning to prevent air leaks and pressure injuries during non-invasive ventilation,Critical Care

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Development and functional characterization of a novel respiratory mask with full accordion cushioning to prevent air leaks and pressure injuries during non-invasive ventilation
Critical Care ( IF 8.8 ) Pub Date : 2024-11-01 , DOI: 10.1186/s13054-024-05133-5
Masahiko Hara, Masatake Tamaki

Non-invasive ventilation (NIV) is critical in the treatment of several respiratory diseases [1, 2]. However, interface air leakage and resultant pressure injury from tight-fitting can lead to intolerance or unsuccessful implementation of NIV [3, 4]. In response to these challenges, we have developed a new type of oronasal mask with full accordion cushioning designed to achieve effective sealing at lower pressures (Fig. 1 and Video. S1). Our mask incorporates six innovations: full accordion cushioning, turtle shell cover, nasal groove, folding function, visual pressure indicator, and soft medical-grade silicone (Videos. S2, S3, and S4). The mask is tapered toward the face, and it also incorporates multiple elastic adjustment lines to improve adaptability and fit, allowing the mask to “fold” snugly around the face. These elements enhance the mask’s ability to evenly distribute pressure and conform to different facial shapes, providing a secure fit at low pressures. The thickness of the accordion cushion decreases toward the face side, providing a visual indication of pressure application through the compression of the accordion valleys.

To assess the mask’s performance, a mechanical bench test was conducted to evaluate sealing efficiency and to estimate skin pressure at various visual pressure indicator scenarios. Smoke leak tests were performed to visually confirm the seal (Video. S5). The mask conformed effectively to various mannequin head shapes, and achieved complete sealing at an estimated skin pressure of 2.2 mmHg. The outermost ridges were sequentially labelled from the facial side. Estimated skin pressures were 5.3 ± 0.4 mmHg when the first and second accordion lines adhered, 10.8 ± 0.6 mmHg when the first through third lines adhered, and 16.8 ± 0.7 mmHg when the first through fourth lines adhered. The Lin’s concordance correlation coefficient was 0.987 (95% confidence interval, 0.963–0.995), indicating a high degree of agreement between measurements by different observers. Based on these results, we developed a special strap (Fig. S1) that allows the mask to be held in place on the face with minimal pressure, thereby improving usability. The mask was registered as a medical device in Japan under the product name “javalla” (iDevice, Inc., Osaka, Japan), a term that reflects the accordion-like structure. The mask is designed for reuse, with durability guaranteed for up to 10 patients per mask.

Initial clinical feedback has been overwhelmingly positive, highlighting the mask’s ease of fit and comfort without the need for specific sizing. The one-size-fits-all design eliminates the need for sizing by conforming to a variety of facial shapes, including different nasal contours. Users reported fewer air leaks, less discomfort, and reduced ventilator alarms. The folding feature benefited patients with edentulous faces or sunken cheeks. During the trial sales phase, 33 out of 74 hospitals (44.6%) adopted our product, despite its price being more than double that of the most commonly used masks available to them. However, some users noted a learning curve for the placement method, concerns about the looser fit, and the importance of keeping the ventilator tube tension-free (gravity-free) to prevent dislodgement due to the soft wearing of the mask. It was also observed that some users tended to secure the mask too tightly, as with conventional masks, resulting in excessive tightening that caused the 1st through 4th accordion lines to adhere. This led to the loss of the cushion’s flexibility, paradoxically increasing air leaks rather than preventing it.

This novel mask addresses critical challenges in NIV, such as air leak and pressure injury, which are often associated with high morbidity and increased healthcare costs [3, 4]. Pressure injuries occur when the sustained external force exceeds tissue perfusion pressure, typically around 30–35 mmHg [4, 5]. Our mask’s ability to provide an effective seal at low pressures shows potential in reducing the occurrence of these injuries. Preliminary testing suggests that the mask achieves an optimal balance between comfort and sealing efficacy when fitted to engage the first two to three accordion lines, maintaining pressures well below the injury threshold [4, 5]. The mask’s ease of fitting and elimination of sizing requirements could also reduce the time needed to implement NIV, particularly in emergency settings. As with any novel device, widespread clinical use and further studies are necessary to determine the long-term impact of the mask on clinical outcomes, including the prevention of pressure injuries and improving patient tolerance during NIV. In conclusion, we have developed a novel oronasal mask with full accordion cushioning to address air leakage, pressure discomfort, and pressure injury during NIV. Bench testing demonstrated effective sealing at lower pressures. Clinical studies are warranted to evaluate the impact of the mask on clinical outcomes.

The data and materials used in this study are available from the corresponding author upon reasonable request.

NIV:: Non-invasive ventilation

Osadnik CR, Tee VS, Carson-Chahhoud KV, Picot J, Wedzicha JA, Smith BJ. Non-invasive ventilation for the management of acute hypercapnic respiratory failure due to exacerbation of chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2017;7:CD004104.
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Berbenetz N, Wang Y, Brown J, Godfrey C, Ahmad M, Vital FM, Lambiase P, Banerjee A, Bakhai A, Chong M. Non-invasive positive pressure ventilation (CPAP or bilevel NPPV) for cardiogenic pulmonary oedema. Cochrane Database Syst Rev. 2019;4:CD005351.
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Liesching T, Kwok H, Hill NS. Acute applications of noninvasive positive pressure ventilation. Chest. 2003;124:699–713.
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Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA. 2006;296:974–84.
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Thomas DR. Does pressure cause pressure ulcers? An inquiry into the etiology of pressure ulcers. J Am Med Dir Assoc. 2010;11:397–405.
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The authors thank the Japan Society of Clinical Research for their dedicated support.

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Authors and Affiliations

Department of Medical Device Development, iDevice, Inc., Osaka, Japan
Masahiko Hara & Masatake Tamaki
Center for Community-Based Healthcare Research and Education, Shimane University Faculty of Medicine, Izumo, Japan
Masahiko Hara

Authors

Masahiko HaraView author publications
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Masatake TamakiView author publications
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Contributions

MH and MT contributed to the conception and design of this manuscript, the acquisition and interpretation of data, and the drafting and revision of the manuscript for critical intellectual content.

Corresponding author

Correspondence to Masahiko Hara.

Ethics approval and consent to participate

The need for approval was waived because this is not an article of clinical study.

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Not applicable.

Competing interests

All authors are shareholders and serve as board members of iDevice, Inc.

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Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

We herewith state that (1) the paper is not under consideration elsewhere, (2) the paper’s contents have not been previously published in whole or in part, (3) all authors have read and approved the manuscript, and (4) all authors are shareholders and serve as board members of iDevice, Inc. Additionally, iDevice holds four patents related to the product discussed in this manuscript.

Additional file 1. Supplementary Figure 1. Demonstration of the Mask Fitting Process.

Additional file 2. Supplementary Video 1. Three-Dimensional Computer-Aided Design Visualization of Our Novel Respiratory Mask with Full Accordion Cushioning.

Additional file 3. Supplementary Video 2. How The Full Accordion Cushioning Conforms to The FACE.

Additional file 4. Supplementary Video 3. How The Nasal Groove Conforms to The FACE.

Additional file 5. Supplementary Video 4. The Folding Function in Action.

Additional file 6. Supplementary Video 5. Smoke-Based Air Leakage Assessment of The Mask.

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Hara, M., Tamaki, M. Development and functional characterization of a novel respiratory mask with full accordion cushioning to prevent air leaks and pressure injuries during non-invasive ventilation. Crit Care 28, 353 (2024). https://doi.org/10.1186/s13054-024-05133-5

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Received: 13 October 2024
Accepted: 15 October 2024
Published: 01 November 2024
DOI: https://doi.org/10.1186/s13054-024-05133-5

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中文翻译：

具有全手风琴缓冲的新型呼吸面罩的开发和功能表征，以防止无创通气期间的漏气和压力损伤

无创通气（NIV）在治疗多种呼吸系统疾病中至关重要 [1， 2]。然而，界面漏气和紧密贴合导致的压力损伤可导致 NIV 不耐受或实施不成功 [3， 4]。为了应对这些挑战，我们开发了一种新型的口鼻面罩，具有全手风琴缓冲，旨在在较低压力下实现有效密封（图 1 和视频）。S1）。我们的面罩融合了六项创新：全手风琴缓冲、龟壳罩、鼻槽、折叠功能、视觉压力指示器和柔软的医用级硅胶（视频.S2、S3 和 S4）。面膜向面部逐渐变细，还结合了多条弹性调节线以提高适应性和贴合性，使面膜可以“折叠”在脸上。这些元素增强了面罩均匀分布压力和贴合不同面部形状的能力，在低压下提供牢固贴合。手风琴垫的厚度向面部一侧减小，通过手风琴谷的压缩提供压力施加的视觉指示。

为了评估面罩的性能，进行了机械台架测试，以评估密封效率并估计各种视觉压力指示器情况下的皮肤压力。进行了烟雾泄漏测试以目视确认密封（视频。S5）。该面罩有效地贴合各种人体模型头型，并在估计 2.2 mmHg 的皮肤压力下实现完全密封。最外侧的脊从面部侧依次标记。当第一±第二条手风琴线粘附时，估计皮肤压力为 5.3 0.4 mmHg，当第一至第三条线粘附时，皮肤压力为 10.8 ± 0.6 mmHg，当第一至第四条线粘附时，皮肤压力为 16.8 ± 0.7 mmHg。Lin's 一致性相关系数为 0.987 （95% 置信区间，0.963-0.995），表明不同观察者的测量结果高度一致。基于这些结果，我们开发了一种特殊的带子（图 S1），它可以以最小的压力将口罩固定在脸上，从而提高可用性。该口罩在日本注册为医疗器械，产品名称为“javalla”（iDevice， Inc.，日本大阪），该术语反映了手风琴状结构。该面罩专为重复使用而设计，每个面罩最多可容纳 10 名患者。

最初的临床反馈非常积极，突出了口罩的易用性和舒适性，无需特定尺寸。一刀切的设计通过符合各种面部形状（包括不同的鼻部轮廓）来消除对尺寸的需求。用户报告说漏气更少，不适感更少，呼吸机警报也更少。折叠功能使面部无牙颌或脸颊凹陷的患者受益。在试销阶段，74 家医院中有 33 家（44.6%）采用了我们的产品，尽管其价格是他们最常用的口罩的两倍多。然而，一些用户注意到放置方法的学习曲线、对更宽松贴合的担忧以及保持呼吸机管无张力（无重力）以防止因面罩的柔软佩戴而移位的重要性。还观察到，一些用户倾向于像传统口罩一样将口罩固定得太紧，导致过度拧紧，导致第 1 至第 4 手风琴线粘附。这导致坐垫失去了柔韧性，自相矛盾的是，空气泄漏增加了而不是防止空气泄漏。

这种新型面罩解决了 NIV 中的关键挑战，例如漏气和压力性损伤，这些挑战通常与高发病率和医疗费用增加有关 [3， 4]。当持续的外力超过组织灌注压力时，通常会发生压力性损伤，通常约为 30-35 mmHg [4， 5]。我们的面罩在低压下提供有效密封的能力显示出减少这些伤害发生的潜力。初步测试表明，当面罩与前 2 到 3 条手风琴线啮合时，面罩在舒适度和密封效果之间实现了最佳平衡，将压力保持在远低于损伤阈值 [4， 5]。面罩易于佩戴且无需尺寸要求，还可以减少实施 NIV 所需的时间，尤其是在紧急情况下。与任何新设备一样，需要广泛的临床使用和进一步的研究来确定面罩对临床结果的长期影响，包括预防压力性损伤和提高 NIV 期间的患者耐受性。总之，我们开发了一种具有全手风琴缓冲的新型口鼻面罩，以解决 NIV 期间的漏气、压力不适和压力性损伤。台架测试表明，在较低压力下可实现有效密封。有必要进行临床研究以评估口罩对临床结果的影响。

本研究中使用的数据和材料可应合理要求从通讯作者处获得。

NIV：: 无创通气

Osadnik CR， Tee VS， Carson-Chahhoud KV， Picot J， Wedzicha JA， Smith BJ.无创通气用于治疗慢性阻塞性肺疾病恶化引起的急性高碳酸血症性呼吸衰竭。Cochrane 数据库系统修订版 2017;7：CD004104。
PubMed 谷歌学术
Berbenetz N， Wang Y， Brown J， Godfrey C， Ahmad M， Vital FM， Lambiase P， Banerjee A， Bakhai A， Chong M. 无创正压通气（CPAP 或双水平 NPPV）治疗心源性肺水肿。Cochrane 数据库系统修订版 2019;4：CD005351。
PubMed 谷歌学术
Liesching T， Kwok H， Hill NS.无创正压通气的急性应用。胸。2003;124:699–713.

文章 PubMed 谷歌学术
Reddy M、Gill SS、Rochon PA。预防压疮：系统评价。美国医学会。2006;296:974–84.

论文 CAS PubMed Google Scholar
托马斯博士。压力会导致压疮吗？对压疮病因的探究。J Am Med Dir Assoc. 2010 年;11:397–405.

文章 PubMed 谷歌学术

下载参考资料

作者感谢日本临床研究学会的大力支持。

没有。

作者和单位

日本大阪 iDevice， Inc. 医疗器械开发部
Masahiko Hara & Masatake Tamaki
岛根大学医学院社区医疗研究与教育中心，日本出云
Masahiko Hara

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原雅彦 Masahiko Hara查看作者出版物

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贡献

MH 和 MT 为这份手稿的构思和设计、数据的获取和解释以及关键知识内容的手稿的起草和修订做出了贡献。

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与 Masahiko Hara 的通信。

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无需批准，因为这不是一篇临床研究文章。

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不適用。

利益争夺

所有作者均为 iDevice， Inc. 的股东，并担任董事会成员。

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我们特此声明：（1）该论文未在其他地方被考虑，（2）该论文的内容之前未全部或部分发表，（3）所有作者均已阅读并批准该手稿，以及（4）所有作者都是 iDevice， Inc. 的股东并担任董事会成员。此外，iDevice 拥有与本手稿中讨论的产品相关的四项专利。

附加文件 1.补充图 1.面罩试配过程演示。

附加文件 2.补充视频 1.我们的新型呼吸面罩的三维计算机辅助设计可视化，具有全手风琴缓冲。

附加文件 3.补充视频 2.Full Accordion Cushioning 如何符合 The FACE。

附加文件 4.补充视频 3.鼻槽如何符合 FACE。

附加文件 5.补充视频 4.Folding 功能正在运行。

附加文件 6.补充视频 5.面罩的基于烟雾的漏气评估。

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