iCAP An Innovative Device to Rapidly Resolve Microbial Keratitis

iCAP 一种快速解决微生物性角膜炎的创新设备

基本信息

批准号：
9135879
负责人：
ANJAL C SHARMA
金额：
$ 23.65万
依托单位：
LYNNTECH, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-30 至 2019-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9135879
关键词：
Accident and Emergency department Accounting Adhesions Ambulatory Care Facilities Amoeba genus Antibiotic Resistance Antibiotics Antimicrobial susceptibility Area Argon Bacteria Bacterial Model Blindness Cataract Cell Culture Techniques Cell Proliferation Chemical Exposure Cicatrix Clinical Coagulase Code Collaborations Cornea Corneal Ulcer Corneal edema Coupled DNA Damage Data Databases Defect Devices Diagnosis Disease Distress Edema Emergency Situation Emergency department visit Endophthalmitis Engineering Ensure Epidermal Growth Factor Receptor Expenditure Eye Focal Adhesions Future Gases Genus staphylococcus Healed Health Expenditures Healthcare Healthcare Systems Helium Hour Hydrogen Peroxide IL8 gene In Vitro Infection Inflammation Interleukin-6 Keratitis Keratoplasty Lead Legal Blindness Light Lipid Peroxidation Mammalian Cell Medical Medical center Membrane Lipids Methods Microbe Mississippi Modeling Natural regeneration Nitrogen Ophthalmologist Oryctolagus cuniculus Outcome Oxygen PTK2 gene Patients Penetrating Keratoplasty Perforation Performance Phase Physiologic Intraocular Pressure Plasma Population Pseudomonas aeruginosa Regulation Resolution Safety Signal Pathway Small Business Innovation Research Grant Staging Staphylococcus aureus Streptococcus Streptococcus pneumoniae Time Trauma Treatment Cost Universities Vinculin Virus Weight commercialization corneal repair cytokine design efficacy evaluation fungus healing improved in vivo in vivo Model innovation killings microbial migration pre-clinical prototype public health relevance regenerative repaired resistance mechanism technology development

项目摘要

DESCRIPTION (provided by applicant): Ulcerative keratitis caused by infectious microbes (bacteria, fungi, amoebae and viruses) represents a major area of medical concern. It is one of the most important causes of corneal opacifications, which is the second common cause of legal blindness world-wide after cataracts. In 2010, in the USA alone, 76.5% of the approximately 930,000 doctor's office and outpatient clinic and 58,000 emergency department visits related to ocular distress and emergencies, resulted in antibiotic prescriptions for microbil keratitis. The total annual financial burden on our healthcare system for keratitis cases was estimated to be $175 million in direct health care expenditures in 2010 and was also estimated to consume over 250,000 annual hours of clinician time. Bacterial keratitis manifests as corneal ulcer, corneal edema and/or hypopyon and can cause significant complications including corneal perforation, corneal thinning, elevated intraocular pressure and progression to endophthalmitis. This could lead to severe clinical outcomes including partial or complete vision loss, necessity for penetrating keratoplasty, corneal grafts, enucleation and evisceration. Although topical and systemic antibiotics are effective in reducing microbial loads in keratitis cases (unless the microbe is resistant to the antibiotic utilized), the time required to resolve th infection is generally quite lengthy. Furthermore, antibiotics are typically ineffective in reducin inflammation and evoking regenerative repair of corneal and/or scleral defects and scarring which may be induced by the infection. Lynntech, Inc. in collaboration with the University of Mississippi Medical Center proposes to develop an innovative, inexpensive and compact device, termed iCAP to effectively treat microbial keratitis at the point-of-diagnosis. This device will be engineered to rapidly and reagentlessly significantly reduce or totally eliminate bacterial loads regardless of antimicrobial susceptibility status of the infecting microbial species. Furthermore, iCAP has the potential to simultaneously trigger certain cellular signaling pathways which could result in improved regeneration of corneal and scleral defects induced by the infection. During this Phase I SBIR effort, our specific aims are to (1) design and fabricate prototype iCAP devices, (2) utilize in vitro microbial and mammalian cell culture techniques to obtain pilot ranges of iCAP device operating parameters likely to be effective in vivo and (3) demonstrate that iCAP can significantly reduce or eliminate bacterial loads and orchestrate healing of infection induced corneal/scleral defects in a relevant in vivo rabbit eye model of bacterial keratitis. The successful completion of these specific aims should demonstrate ample feasibility of this innovative new microbial keratitis treatment approach, and will enable us to execute more comprehensive technology development and commercialization thrusts in a future follow-on Phase II effort. The eventual commercial availability of iCAP devices is likely to sustai high positive impact for the patient populace suffering from microbial keratitis.

描述（由适用提供）：由传染性微生物（细菌，真菌，变形虫和病毒）引起的溃疡性角膜炎代表了医学上关注的主要领域。它是角膜无关的最重要原因之一，这是全世界在白内障之后造成法律失明的第二个共同原因。 2010年，仅在美国，大约930,000名医生办公室和门诊诊所中有76.5％以及与眼部困扰和紧急情况有关的58,000次紧急部门就诊，导致了微生物角膜炎的抗生素处方。 2010年，我们的直接医疗保健支出为1.75亿美元，估计我们的直接医疗保健案例的医疗保健系统每年的财务燃烧总数为1.75亿美元，估计还将消耗超过25万名临床时间。细菌性角膜炎表现为角膜溃疡，角膜水肿和/或炎症，可能会引起严重的并发症，包括角膜穿孔，角膜稀薄，眼内压升高以及向内咽炎的进展。这可能会导致严重的临床结果，包括部分或完全视力丧失，这对于穿透性角膜成形术，角膜移植物，枚举和鼻孔所必需。尽管局部和全身性抗生素可有效减少角膜炎病例中的微生物负荷（除非微生物对所使用的抗生素具有抗性），但是解决TH感染所需的时间通常很长。此外，抗生素通常在减少感染和诱发角膜和/或巩膜缺陷的再生修复方面无效，可能由感染引起。 Lynntech，Inc。在与密西西比大学医学中心的合作中合作开发一种创新，廉价和紧凑的装置，称为ICAP，以在诊断点上有效治疗微生物角膜炎。这个设备将设计以快速而显着减少或完全消除细菌载荷不管感染微生物物种的抗菌敏感性状态如何。此外，ICAP具有简单触发某些细胞信号通路的潜力，这可能会导致感染引起的角膜和巩膜缺陷的再生。 During this Phase I SBIR effort, our specific aims are to (1) design and fabricate prototype iCAP devices, (2) utilize in vitro microbial and mammalian cell culture techniques to obtain pilot ranges of iCAP device operating parameters likely to be effective in vivo and (3) demonstrate that iCAP can significantly reduce or eliminate bacteria loads and orchestrate healing of infection induced corneal/scleral defects in a相关的在体内兔眼睛炎的角质炎。这些特定目标的成功完成应证明这种创新的新微生物角膜炎治疗方法的足够可行性，并将使我们能够在未来的II阶段努力中执行更全面的技术开发和商业化势头。 ICAP设备的商业可用性可能会对患有微生物角膜炎的患者民众产生高积极影响。