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

• 批准号: 8542847
• 负责人: Mike McShane
• 金额: $ 102.76万
• 依托单位: PROFUSA, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-15 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8542847
• 关键词: Achievement; Address; Adoption; Biochemical; Biocompatible Materials; Biological Assay; Biological Markers; Biomimetics; Biosensing Techniques; Biosensor; Blood capillaries; 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; Radio; Reader; Renal function; Role; Skin; Solid; System; Technology; Testing; Texas; Time; Tissue Engineering; Tissues; Vascularization; Vertebral column; Visit; Wireless Technology; Work; 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; receptor; response; scaffold; sensor; success

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访问医疗机构以进行点数测试，以监视甚至最基本的治疗状态标记，这可能会错过对准确诊断至关重要的人体化学体波动，尤其是在高风险人群中。连续的多分析型健康传感器有可能通过为医疗保健提供的分散途径铺平道路，并将重点从反应性治疗转移到预防性维护中，从而极大地改变医疗保健。 Profusa，Inc。提议通过开发高度微型，可植入的，多分析的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，以连续监测人体化学。开发植入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，这是与当前可植入的传感器相比的重大创新性改进，因为它们会诱导毛细管形成和增长，而不是典型的FBR纤维胶囊形成，对代谢标记和其他感兴趣分析的亲密获取。分析物特异性发光传感化学分配器嵌入这些水凝胶支架中。将所得的传感器注入皮肤下，并使用微型无线，类似创可贴的读取器进行光学监测，以进行连续测量或手持棒，以定期进行自我测量，具体取决于临床需求。提出的监测系统很小，并且形式符合患者对广泛采用实时，长期监测身体化学化学的需求。另外，可以远程查看收集的数据，从而使医生可以访问医疗数据，而无需患者存在直到达到关键阈值。 Profusa和合作者的过去努力通过该技术成功地开发了原型葡萄糖传感器。在这里，提出了使用相同平台的多分析师连续监视器的开发，并具有延长的寿命。葡萄糖和肌酐被提出，以证明多室分析的概念，因为它们是食物摄入，代谢和肾功能的标志的重要性。葡萄糖和肌酐传感纳米球将被单独开发和优化，并掺入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提高，以在体内达到所需的90天功能，并具有一年功能的最终目标。 Profusa的多分析物传感器平台的开发可能会通过整合感兴趣的分析物来对各种疾病状态进行定制，这可能会改变医疗保健。连续的多层传感器的临床采用将使患者能够控制自己的健康状况，帮助他们做出决定以维持健康，同时使医生能够更准确地进行诊断并开处方治疗。