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Implantable multi-analyte sensors for the continuous monitoring of body chemistri

用于连续监测身体化学物质的植入式多分析物传感器

基本信息

批准号：
8883528
负责人：
Mike McShane
金额：
$ 114.75万
依托单位：
PROFUSA, INC.
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-09-15 至 2017-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8883528
关键词：
Achievement Address Adoption Biochemical Biocompatible Materials Biological Assay Biological Markers Biomimetics Biosensing Techniques Biosensor Blood capillaries Cellular Phone Chemicals Chemistry Clinical Creatinine Data Decentralization Decision Making Development Diagnosis Diagnostic tests Disease Eating Electrolytes Evaluation Event Failure Family suidae Foreign Bodies Frequencies Glucose Goals Growth Hand Health Health Personnel Health Status Health Status Indicators Health care facility Healthcare Healthcare Systems Human Hydrogels In Vitro Individual Injectable Intervention Knowledge Longevity Maintenance Measurement Measures Medical Metabolic Marker Metabolism Modeling Monitor Nanosphere Nanotechnology Optics Outcome Pathway interactions Patient Care Patients Performance Physicians Physiological Play Polymers Population Production Reader Renal function Role Skin Solid System Technology Testing Texas Time Tissue Engineering Tissues Vascularization Vertebral column Visit Wireless Technology Work accurate diagnosis capillary capsule cost design empowered empowerment glucose sensor health care delivery high risk implantable device implantation implanted sensor improved in vivo innovation interest luminescence meetings miniaturize model design novel porous hydrogel product development prototype radio frequency receptor response scaffold sensor success

项目摘要

DESCRIPTION (provided by applicant): The existing health care system requires an individual to visit a health care facility to conduct point-in-time tests to monitor even the most basic healt status markers, which can miss fluctuations in body chemistries that are vital to accurate diagnoses, particularly in high-risk populations. Continuous multi-analyte health sensors have the potential to dramatically change health care by paving the way for decentralization of health care delivery and shifting the focus away from reactive treatment to preventative maintenance. PROFUSA, Inc. proposes to transform current biosensing paradigms by developing highly miniaturized, implantable, multi-analyte sensors composed of luminescent tissue integrating materials for continuous monitoring of body chemistries. The largest hurdle in developing implantable sensors is the foreign body response (FBR). Through the use of unique tissue integrating scaffolds, which are a major innovative improvement compared to current implantable sensors in that they induce capillary formation and in-growth rather than the typical FBR fibrous capsule formation, intimate access to metabolic markers and other analytes of interest is achieved. Analyte-specific luminescent sensing chemistries, are embedded in these hydrogel scaffolds. The resultant sensors are injected under the skin and monitored optically using a miniaturized, wireless, Band-Aid-like reader for continuous measurement or a hand-held wand for periodic self-measurement, depending on the clinical need. The proposed monitoring system is inconspicuously small and the form factor meets patient demands for widespread adoption of real-time, long-term monitoring body chemistries. Additionally, viewing of the collected data can be done remotely, allowing the physician access to medical data without the need for the patient to be present until a critical threshold is met. Past efforts by PROFUSA and collaborators have resulted in the successful development of prototype glucose sensors using this technology. Here, the development of a multi-analyte continuous monitor using the same platform is proposed with extended longevity. Glucose and creatinine are proposed to demonstrate the multi-analyte concept due to their importance as markers of food intake, metabolism and kidney function. Glucose and creatinine sensing nanospheres will be developed and optimized individually and incorporated into the tissue-integrating scaffolds to generate prototype sensors. Sensor longevity and accuracy will be enhanced to attain the desired 90-day functionality in vivo, with an ultimate goal of one year functionality. The development of PROFUSA's multi-analyte sensor platform, which has the potential for being customized to various disease states by integrating sensing nanospheres specific to analytes of interest, could potentially transform health care. Clinical adoption of a continuous multi-anlayte sensor will empower patients to take control of their own health, helping them to make decisions to maintain their health, while at the same time enabling physicians to more accurately reach a diagnosis and prescribe treatment.

描述（由申请人提供）：现有的医疗保健系统要求个人前往医疗保健机构进行时间点测试，以监测最基本的健康状态标志物，这可能会错过对准确诊断至关重要的身体化学波动，尤其是在高危人群中。连续多分析健康传感器有可能为医疗保健服务的分散化铺平道路，并将重点从反应性治疗转移到预防性维护，从而显着改变医疗保健。 PROFUSA, Inc. 提议通过开发高度小型化、可植入、多分析物传感器来改变当前的生物传感范例，该传感器由发光组织集成材料组成，用于连续监测身体化学成分。开发植入式传感器的最大障碍是异物反应（FBR）。通过使用独特的组织整合支架，与当前的植入式传感器相比，这是一项重大创新改进，因为它们诱导毛细血管形成和向内生长，而不是典型的 FBR 纤维囊形成，从而实现了对代谢标记物和其他感兴趣分析物的密切接触。分析物特异性发光传感化学物质嵌入这些水凝胶支架中。将所得传感器注入皮下，并根据临床需要，使用微型无线创可贴式读取器进行连续测量或使用手持棒进行定期自我测量进行光学监控。所提出的监测系统体积小得不显眼，其外形满足患者广泛采用实时、长期监测身体化学物质的需求。此外，可以远程查看收集的数据，从而允许医生访问医疗数据，而无需患者在场，直到达到关键阈值。 PROFUSA 和合作者过去的努力已经成功开发了使用该技术的原型葡萄糖传感器。在此，建议开发使用同一平台的多分析物连续监测仪，以延长使用寿命。葡萄糖和肌酐被提议用来证明多分析物概念，因为它们作为食物摄入、代谢和肾功能标志物的重要性。葡萄糖和肌酐传感纳米球将单独开发和优化，并整合到组织整合支架中以生成原型传感器。传感器的寿命和准确性将得到增强，以实现所需的 90 天体内功能，最终目标是一年的功能。 PROFUSA 的多分析物传感器平台的开发有可能通过集成针对感兴趣分析物的传感纳米球来针对各种疾病状态进行定制，这可能会改变医疗保健。临床上采用连续多分析传感器将使患者能够掌控自己的健康，帮助他们做出维护健康的决定，同时使医生能够更准确地做出诊断并开出治疗处方。

项目成果

期刊论文数量（14）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Tissue-Integrating Oxygen Sensors: Continuous Tracking of Tissue Hypoxia.

组织集成氧传感器：连续跟踪组织缺氧。

DOI：
10.1007/978-3-319-55231-6_49
发表时间：
2017
期刊：
Advances in experimental medicine and biology
影响因子：
0
作者：
Wisniewski,NatalieA;Nichols,ScottP;Gamsey,SoyaJ;Pullins,Steve;Au-Yeung,KitY;Klitzman,Bruce;Helton,KristenL
通讯作者：
Helton,KristenL

Inorganic-Organic Interpenetrating Network Hydrogels as Tissue-Integrating Luminescent Implants: Physicochemical Characterization and Preclinical Evaluation.