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

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保健机构进行时间点测试，以监测即使是最基本的健康状况标志物，这可能会错过对准确诊断至关重要的身体化学波动，特别是在高危人群中。连续多分析物健康传感器有可能通过为医疗保健提供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来显著改变医疗保健。PROFUSA，Inc.提出通过开发高度小型化的、可植入的、多分析物传感器来改变当前的生物传感范例，所述传感器由发光组织集成材料组成，用于连续监测身体化学。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，这是与当前可植入传感器相比的重大创新改进，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，实现了对代谢标志物和其他感兴趣的分析物的密切接触。分析物特异性发光传感化学物质嵌入这些水凝胶支架中。根据临床需要，将所得传感器注射到皮肤下，并使用小型化、无线、创可贴式读取器进行连续测量或使用手持式棒进行定期自我测量进行光学监测。所提出的监测系统是不显眼的小和形状因子满足患者的需求，广泛采用实时，长期监测身体化学。此外，可以远程查看收集的数据，允许医生访问医疗数据，而无需患者在场，直到满足关键阈值。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。在这里，提出了使用相同平台的多分析物连续监测器的开发，具有延长的寿命。由于葡萄糖和肌酸酐作为食物摄入、代谢和肾功能的标志物的重要性，建议将其用于证明多分析物概念。葡萄糖和肌酸酐传感纳米球将单独开发和优化，并纳入组织整合支架，以生成原型传感器。传感器寿命和准确性将得到提高，以实现预期的90天体内功能，最终目标是1年功能。PROFUSA的多分析物传感器平台的开发可能会改变医疗保健，该平台有可能通过集成特定于感兴趣分析物的传感纳米球来定制各种疾病状态。连续多传感器的临床采用将使患者能够控制自己的健康，帮助他们做出维持健康的决定，同时使医生能够更准确地做出诊断并开出治疗方案。

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.