Micro-patterned surfaces for reducing the risk of catheter-associated UTI

微图案表面可降低导管相关尿路感染的风险

• 批准号: 7744454
• 负责人: Shravanthi Reddy
• 金额: $ 16.84万
• 依托单位: SHARKLET TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7744454
• 关键词: Accounting; Address; Adverse effects; Affect; Animal Model; Antibiotic Prophylaxis; Antibiotic Therapy; Antibiotics; Area; Bacteria; Bacteriocides; Biocompatible Materials; Biological; Biological Assay; Categories; Catheters; Cause of Death; Cell Survival; Cessation of life; Characteristics; Chemicals; Chemistry; Clinical; Culture Media; Data; Development; Devices; Effectiveness; Elastomers; Environment; Exhibits; Family suidae; Goals; Growth; Health Care Costs; Hospital Costs; Hospital Nursing; Hospitals; Housing; Human; Image; In Vitro; Indwelling Catheter; Infection; Interferometry; Knowledge; Length of Stay; Letters; Light; Marketing; Measures; Medical Device; Methods; Metric; Microbial Biofilms; Microscopic; Modeling; Multi-Drug Resistance; Nosocomial Infections; Nursing Homes; Organism; Patient Care; Patients; Pattern; Phase; Polymers; Private Sector; Property; Publishing; Relative (related person); Research; Resistance; Resistance to infection; Risk; Sampling; Scanning; Scanning Electron Microscopy; Shark; Simulate; Skin; Small Business Innovation Research Grant; Solutions; Specific qualifier value; Surface; Technology; Testing; Tube; Urinary tract; Urinary tract infection; Urine; Uropathogen; Uropathogenic E. coli; Validation; Veterans; Work; antimicrobial; antimicrobial drug; base; catheter associated UTI; commercialization; design; drug resistant bacteria; economic evaluation; experience; falls; improved; in vitro Assay; in vivo; interest; manufacturing process; meetings; microorganism; next generation; novel; pathogenic bacteria; polydimethylsiloxane; prevent; prophylactic; prototype; public health relevance; research and development; response; scale up; soy; success; urinary

DESCRIPTION (provided by applicant): In the U.S. alone, nearly two million patients acquire a nosocomial infection in the hospital each year, and approximately 100,000 of them die. Nosocomial infections are a leading cause of death in the U.S., and they result in major increases in hospital stays, human suffering, and healthcare costs. Nearly half of these infections are associated with the use of a medical device, and catheter-associated urinary tract infection (UTI) is the most common type of nosocomial infection, accounting for over 40% of infections in hospitals and nursing homes. Some 95% of UTIs are associated with urinary catheters, and these catheter-associated UTIs account for an estimated annual hospital cost of more than $400 million. The current paradigm for preventing bacterial UTIs has been to introduce antimicrobial agents to reduce the concentrations of bacteria associated with biofilm formation. However, use of antimicrobial agents leads to resistance patterns that make indwelling catheter infections more difficult to treat. By coating the catheter, the risk of infection is reduced; however, this strategy at best only delays the infection onset. Despite advances in prophylactic strategies, there are currently no definitive methods to prevent catheter-associated UTI. Sharklet Technologies therefore proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. Preliminary studies have shown that micro-patterns on polymer surfaces can be designed to inhibit bacterial biofilm growth-with the Sharklet" micro-pattern being the most effective. Therefore, the overall goal of this project is to develop, validate, and commercialize the use of the Sharklet microscopic pattern (based on the unique antifouling characteristics of shark skin) to inhibit bacterial biofilm formation on urinary catheters without the use of antimicrobial agents. The Specific Aims for proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. proposes development of a novel catheter design capable of sustained inhibition of bacterial biofilm formation that does not rely on traditional antimicrobial coatings or treatments. Phase I are 1) to validate the effectiveness of the Sharklet micro-patterned polymer surface for inhibiting biofilm formation with uropathogenic E. coli in growth media and artificial urine over the course of 14 days, and 2) to prove the feasibility of fabricating catheter-like prototypes that exhibit Sharklet-patterned extraluminal and intraluminal surfaces. Phase I success will validate the use of micro- patterned surfaces to prevent biofilm growth of a uropathogen and will demonstrate the feasibility of constructing a catheter-like prototype exhibiting the pattern. A follow-on Phase II project will be designed to develop manufacturing methods for the tube prototypes and to demonstrate efficacy with an in vivo pig model. The Phase I and Phase II SBIR data will be essential in attracting the types of "Phase III" private-sector investors and/or strategic partners with whom we are already discussing this technology. Phase III commercialization efforts will therefore be focused on establishing partnerships with medical device partners and distributors-particularly those in the urinary catheter markets. PUBLIC HEALTH RELEVANCE: Some 30 million urinary catheters are inserted into 5 million patients in the U.S. each year, and each one of those patients is at risk for acquiring a urinary tract infection due to the bacterial biofilms that form on the catheter surface. Current strategies for inhibiting biofilm formation on the catheter surfaces are expensive, ineffective, and give rise to serious complications such as toxic side-effects and multi-drug resistance. The overall goal of this project is to develop, validate, and commercialize the use of the Sharklet microscopic pattern (based on the unique antifouling characteristics of shark skin) to inhibit bacterial biofilm formation on urinary catheters without the use of antimicrobial agents.

描述（由申请人提供）：仅在美国，每年在医院就有近200万名患者在医院接受医院感染，其中约有100,000例死亡。医院感染是美国的主要死亡原因，它们导致住院，人类痛苦和医疗保健费用的重大增加。这些感染中的几乎一半与使用医疗装置有关，与导管相关的尿路感染（UTI）是最常见的医生感染类型，占医院和疗养院中感染的40％以上。约95％的UTI与尿导管有关，这些与导管相关的UTI估计估计的医院费用超过4亿美元。当前用于预防细菌UTI的范例是引入抗菌剂，以降低与生物膜形成相关的细菌的浓度。然而，使用抗菌剂会导致抗性模式，从而使留置导管感染更难以治疗。通过涂覆导管，感染的风险降低；但是，这种策略充其量只会延迟感染发作。尽管预防性策略取得了进步，但目前尚无预防导管相关的UTI的确切方法。因此，鲨鱼技术提出了一种能够持续抑制细菌生物膜形成的新型导管设计，该设计不依赖传统的抗菌涂层或处理。 Preliminary studies have shown that micro-patterns on polymer surfaces can be designed to inhibit bacterial biofilm growth-with the Sharklet" micro-pattern being the most effective. Therefore, the overall goal of this project is to develop, validate, and commercialize the use of the Sharklet microscopic pattern (based on the unique antifouling characteristics of shark skin) to inhibit bacterial biofilm formation on urinary catheters在不使用抗菌剂的情况下，特定的目的是开发一种能够抑制细菌生物膜形成的新型导管设计，该设计不依赖于传统的抗微生物涂层或处理能力抑制传统抗议的新型导管设计。不依赖传统抗菌涂层或治疗的细菌生物膜形成的持续抑制作用。第一阶段是1）在生长培养基和人工尿中抑制鲨鱼微图案的聚合物表面抑制生物膜形成的生物膜形成的有效性，以及2）证明了塑造类似导管的原型的可行性。第一阶段的成功将验证使用微型表面以防止尿道病生长生长，并将证明构建具有该模式的导管样原型的可行性。后来的II期项目将旨在开发用于管原型的制造方法，并通过体内猪模型证明功效。第一阶段和第二阶段SBIR数据对于吸引我们已经与我们已经讨论这项技术的“ III期”私营部门投资者和/或战略合作伙伴的类型至关重要。因此，第三阶段的商业化工作将集中在与医疗器械合作伙伴和分销商建立伙伴关系上，尤其是尿道导管市场中的伙伴关系。公共卫生相关性：每年在美国插入约3000万次尿导管，每个患者中的每名患者都有可能因在导管表面形成的细菌生物膜而产生尿路感染的风险。当前抑制导管表面生物膜形成的策略昂贵，无效，并引起严重的并发症，例如有毒副作用和多药耐药性。该项目的总体目标是开发，验证和商业化鲨鱼微观模式的使用（基于鲨鱼皮肤的独特防撞特征），以抑制在不使用抗菌剂的情况下对尿道导管的细菌生物膜形成。