Development of a wearable telemetry module and dual hormone infusion set for use

描述（由申请人提供）：1型糖尿病常导致影响生活质量的短期和长期并发症。虽然许多研究小组正在开发人工内分泌胰腺（AP）系统的版本，但目前的系统需要至少一个激素输送插入点和至少一个葡萄糖传感器点。这种复杂性限制了商业可行性和患者的潜在接受度。细菌定植和感染的风险从多个插入部位值得减少插入装置的数量。在这个项目中，我们提出创建一种新的人工胰腺技术，将以下三个要素集成到一个可穿戴设备中：(1)一个智能激素输送导管，其外壁包含一个多点安培连续血糖监测仪（CGM），其开发资金来自其他地方；(2)具有收发器、电池和数据采集单元的无线传感器模块；(3)连接到传感导管和胰岛素输送管连接器的快速连接/断开端口。这种组合装置的目的是允许更多的自由活动和增加患者的舒适度。我们更倾向于皮下位置而不是皮内位置进行传感和激素输送，因为导管移位的风险较低。为了避免灌注和废液室的需要，我们更倾向于直接安培法而不是微透析。在另一个单独的项目中，我们正在使用固态设计和微制造技术，通过在柔性聚酰亚胺基板上放置一个扁平的安培传感阵列来制造传感导管，然后将其包裹成一个管。在这个应用中，我们建议开发统一的可穿戴设备，允许临床使用感应导管。这个由三部分组成的设备将连接到胰岛素输送线，并将包括一个模拟传感器电子接口和一个蓝牙智能收发器。该组合将允许商业引入智能输液器，该输液器可以连接到胰岛素泵或胰岛素/胰高血糖素泵，例如由JDRF资助的Tandem Diabetes正在开发的泵。这种泵可能会包含一个蓝牙无线接口，能够与我们的传感器模块通信。我们还建议创建一个早期的原型插入装置，并在猪身上进行系统的初步测试。在这些测试中，带有传感导管的三部分装置将被皮下插入麻醉的猪，以便允许(1)x线摄影评估导管插入角度和深度；(2)验证遥测数据传输到远程智能手机接收器；(3)胰岛素的无漏输送。猪的研究费用将在很大程度上

DESCRIPTION (provided by applicant): Type 1 diabetes often leads to short-term and long-term complications which impair quality of life. Though many research groups are developing versions of an artificial endocrine pancreas (AP) system, current systems require at least one hormone delivery insertion site and at least one glucose sensor site. This complexity limits commercial viability and potential acceptance by patients. The risk of bacterial colonization and infection from the multiplicity of insertion sites merits reduction of the number of inserted devices. In this project, we propose to create a novel artificial pancreas technology that integrates into a single wearable device the following three elements: (1) an intelligent hormone delivery catheter whose outer wall contains a multi-site amperometric continuous glucose monitor (CGM), the development of which is funded elsewhere; (2) a wireless sensor module with a transceiver, battery, and data acquisition unit; and (3) a quick connect/disconnect port that attaches to the sensing catheter and to an insulin delivery tubing connector. This combination device is intended to allow more freedom of movement and increase patient comfort. We prefer the subcutaneous site over the intradermal site for sensing and hormone delivery because of a lower risk for catheter dislodgement. In order to avoid the need for perfusion- and waste fluid compartments, we prefer direct amperometry over microdialysis. In a separate project, we are using solid state design and microfabrication techniques to create the sensing catheter by placing a flat amperometric sensing array on a flexible polyimide substrate which will then be wrapped into a tube. In this application, we propose to develop the unified wearable device that will allow clinical use of the sensing catheter. This three-part device will connect to an insulin delivery line and will include an analog sensor electrical interface and a Bluetooth SMART transceiver. The combination will permit the commercial introduction of an intelligent infusion set that can connect to an insulin-only pump or an insulin/glucagon pump such as the one under development by Tandem Diabetes as funded by JDRF. This pump will likely incorporate a Bluetooth wireless interface capable of communication with our sensor module. We also propose to create an early prototype insertion device and carry out preliminary tests of the system in swine. In these tests, the three-part device with sensing catheter will be inserted subcutaneously into anesthetized pigs in order to allow (1) radiographic assessment of the catheter insertion angle and depth; (2) verification of telemetric data transmission to a remote smart phone receiver; and (3) leak-free delivery of insulin. Pig study costs will largely be covered elsewhere.